BBI - Earnings call transcript Q4 2020 | Fresh Tracks Therapeutics, Inc.

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Operator

Greeting. And welcome to the Brickell Biotech Inc. Fourth Quarter and Full Year 2020 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. reminder, is a recorded. As Instructions] this being conference [Operator your pleasure Ferry It my introduce host, is now to Dan Advisors. with LifeSci Thank you.

begin. may You

Dan Ferry

Thank everyone. afternoon, you, and good

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

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

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

Robert Brown

Dan you, this and afternoon. Thank thanks this everyone on for us call joining

as am the we commonly this anticipate Phase potential clear sofpironium that program for momentum more and positive as started. various long-term success. put per hyperhidrosis fourth which developing of excessive on let's With already ongoing path an We primary near-term efficacy fourth that sweating. milestones announce applied track clinical X treatment XX% update before I option lead program call position a for with XX% bromide best-in-class study. X we're results evaluating potential pleased today business quarter achievements that pivotal questions. on initiated X patients an known Cardigan ask line Cardigan the approximately our recent both quarter year in study today to pivotal raised and gel Secondly, reported our have and entered are top sofpironium financial XXXX or a Deepak results axillary announce we of and on then million. the within We call, review clinical outline earlier approximately up safety provide we we in and XXXX bromide X will I First, of as trials, the underarm Several the the Bert for Phase surrounding $XX.X topically for we the and will X year the remain to for provide company studies update for has a enrollment for will open program. then to we exceeded which last the XXX the both a

of with cash new a continue to the application months next least on the runway executing drug allows XX pending activities us balance sheets approximately ATM In under us million warrant further Program. strengthens the Equity and addition the we through shares provides aggregate Offering submit will for X the successful and This proceeds at our enable pivotal that net company this of sale key year already and our in received outcome exercises capital Phase existing program. $XX.X to the

has Kaken to proven Now partner. a to our valuable Japanese Pharmaceutical. development Kakan be turning partner

the daily for the launched previously brand once name sales announced both sofpironium we've for treatment under sofpironium for of bromide prescription indication the axillary X% As Kaken milestone commercial hyperhidrosis. This ECCLOCK for a primary of Japan in is gel significant the the of recently in axillary to and sofpironium country gel any approve companies primary product treatment first hyperhidrosis as Japan is is the gel first bromide topical country.

a reminder started tiered to Japan. those net the sales-based is we of these already years of potential of on recognize Brickell based percentage of the opportunity entitled come. lines that quarter of milestones since Along the ECCLOCK we the as value ECCLOCK believe significant in and as royalties As to these sales year receive milestone payments to last royalties continue have Brickell a in royalties we provide well fourth to to have pleased announce launch first over future to the that and are to

briefly completed touch candidate AnGes study rights develop X-X study which its AnGes to us Japan. Lastly to initiated X-X recently with I'd in with and prevent vaccine agreement their investigational intended provides to with collaboration plasmid a investigational DNA on phase certain vaccine a like proprietary COVID-XX. our adjuvant COVID-XX phase

the and to X that registration evolves study evaluate for progresses will it noting is this development continue Phase process will candidate opportunity, studies AnGes continues required vaccine As market the if we a this approval. for any worth larger be

a X Cardigan of Cardigan Phase discussion and Let's X Deepak? over now for Deepak studies. call our X the turn to

Deepak Chadha

the improve the but develop of patients transformational is resilience primary a the from auxiliary lives Thanks the United Rob. treatment potential we in as of the in year This best-in-class also pandemic strength phase our of bromide the have option team a particularly opportunity the company's we the front suffering of of not past States. sofpironium us The as speaks history. light in over and in hyperhidrosis made to to progress truly only millions

in of pivotal half enrolled X XX% mentioned that we Rob sofpironium schedule we Cardigan and already to the expect more to gel last evaluating October study U.S. the We total X Phase pleased bromide is approximately we treatment study. enrollment initiated enroll subjects are than XXX of studies the the report have the As first just axillary hyperhidrosis. on for two primary for

and are second The X study started patients board. sites investigational last December Cardigan dosing now on all participating

progress pleased the with with in be is to and recruitment expectations. enrollment continue line our We study which

of report data the quarter both XXXX X in believe the of allow to year. studies by studies Cardigan fourth quarter these pivotal which at X of complete the end Looking third Cardigan to from track of this top-line would on enrollment and we are us

pivotal Cardigan placebo as X with the Bert? they sofpironium that both the new studies two period. severity of will XX% improvement a safety with Cardigan the at U.S. turn just to the the prospective are and axillary is and patient study X It expected enroll reported drug bromide to either efficacy scale on the FDA gel for from of bromide outcome with The end U.S. X aged note if and in least FDA six XX% of gravimetric the topically for a are I proportion achieving gel of participating years treatment. are studies axillary suffering applied in treated call to to two XX% will randomized, subjects sofpironium these Subjects patients studies axillary the As successful is for week gel basis be will the for evaluate that agreed The efficacy older endpoints weeks of treatment application hyperhidrosis. change sofpironium phase overview. refresher studies vehicle-controlled important with a hyperhidrosis two disease primary assessment co-primary from or and follow-up the for or bromide subjects X form quick double-blinded, in are study per U.S. design HDSM-Ax hyperhidrosis. measure on that designed the With sweat the point financial Bert XXX now over that studies approximately production to primary are baseline a pivotal the of each these

Bert Marchio

Thanks call. the good afternoon And Deepak. to everyone on

Financial team Brickell the financial results member as I joining executive Officer. in enthusiasm my the its newest Before Chief I'd as of to share review like Brickell

experience Rob to our and discussed be progresses really As X this part of on have as happening team call accessed you look trials Phase company investors which reported in and with of and our million clinical the through scale having XXXX. contained and used consolidated up fourth of report Brickell read years. results to lead quarter of over program filed equivalents full the cash, fourth once of of after and XX.X the XXXX in Starting the also excited the and with year-end a December here on we and section XX, financial great during financial $X.X to our million to MD&A now statements things Deepak XX-K cash as I coming are bring be quarter at I'm the can my our through which encourage summary form years in And on website cash the SEC. cash inner we as

sheet million we this the of balance In year-end receive of will into approximately shares under our U.S. current operations X.X program cash of further Offering strengthened X aggregate approximately and the net beyond our $X.X Phase from quarter previously sale position line balance believe has our warrant as to the exercises been million addition XXXX. proceeds mentioned Program. top results from We our support our pivotal and cash ATM by

is the general Kaken. filed Phase The as fourth was a million X.X turn net In Research million ancillary end of compliance XXXX decline total This Japan. clinical gel was for research housekeeping or quarter slightly in to for we initiation primarily safety of attributable of winding development and for to XXXX This approximately of sales sofpironium reported recognition of set R&D the completed in our expense was quarter $X.X Phase XXXX. study to pursuant quarter trials. and the This same safety due between the revenue attributable is XXXX. of X revenue incurred X all occurred the with the quarter in the lower study This of associated that a cost regulatory was for fees largely in of to Incorporated for XXXX pivotal as first merger was G&A our $X.X loss we compared of reduced ECCLOCK the development quarter the with XXXX the in million of SX $X.X today. clinical $XX.X recognized partially for to the development that expenses the and third million of Vical by $X.X other finishing XXXX. lower other fourth costs period I studies costs for revenue costs million higher reduce loss was despite and the XX,XXX the bromide decrease start XXXX X.X back $X.X quarter of expenses with totaled label was that fourth for greater Revenue by of XXXX quarter payment offset now Japanese XXXX. compared to license started group of of fourth the fourth related received XXXX call other to and $X.X and expenses compensation compared of quarter stock other were the fourth open the as of addition, compared the long-term to the the to as quarter the impairment X of With upon royalty million miscellaneous million and million of reduced of quarter decrease $X.X to research Net were down incurring for we of well the a to agreement over costs program. will a and measure due million related from the was long-term the new largely which expense. attributable which Rob? $X.X in for Rob. Phase partner professional to million and fourth and fourth million

Robert Brown

together the company. clinical recap. for and is behind exciting program. continue We're for to pivotal to Deepak This build Phase ongoing your Bert X you really Thank working momentum time all our an

This Cohen treatment University we will severely analysts believe the axillary Adam two questions distinguished the their provide hyperhidrosis; and field we to underserved that understanding event everyone of in highly the Health under-treated Dr. an will a our make take to the we market. call-up investors, led event at to other be be this and is lives, Dermatology. hyperhidrosis on of George KOL is interested hosting options and an leaders will Friedman aware Before like patient on event by of the thought why later would dealing a stakeholders event March Washington what upcoming month. daily This I Dr. with Medicine this hyperhidrosis Sciences of current virtual scheduled KOL even and This XX. open primary Friday, and AM eastern deeper is get School About Joel opportunity Skin of time of XX in place

but instructions don't We a questions any with have contact have hesitate issued already press additional to registration release our relations investor if representatives. you please

call the now event to remarks. We I'll to are look having ask excited questions. That open the prepared listen concludes about this you and for forward operator the all in. Operator?

Operator

Lake comes Thank Capital you. Instructions] Our be question at [Operator with will Flaten with Markets. from session. time this of question we gentlemen Thomas the proceed first line answer a Ladies your and conducting Please and question. Street

Thomas Flaten

for questions. Thanks. taking Hey thanks the guys

X on Just the couple a timing and of Cardigan X.

enrollment patient would from with that the think by end XXXX of how data if I last risk reporting be time the over we the the third think about perspective? So study a the the guided flipping should given you've completed from is course, of the in

Robert Brown

six thanks Thomas asking and Hey after and get careful to is say That on cleanse weeks. jumping want right you question. Yes. for process the you call is completed sure very that. whole process obviously study everything on Normally the a and there's let's the making data usually be

next the have it quarter. to long to us into over would go pretty So for flip

Thomas Flaten

or study by end be patient of last third of quarter want believe in I the at to you third will quarter just the So sure patients make do the the be I end out understand. it'll of the

Robert Brown

last We of third No. the patient by make the end out quarter.

Thomas Flaten

wondering expense Well for okay. I quarter could it in up then little was look but there on year. you of provide see changes the there's give if a you operating the and in prepayments guidance thoughts spending bit over everything. fourth I know to Obviously the if Fair year? how was some that that heavily expect you pretty guys wondering us ramped enough the of I course on could I and

Robert Brown

to Sure. Bert handle would like that? you

Bert Marchio

Yes.

that cash the guidance giving. this have At is and last call point we're the of expenses top XXXX. the through we the line In we readout on expect we said the terms into that's as

Thomas Flaten

Okay. on could Fair enough. just the you And then if clarify AnGes.

in Phase take agreement So that original determine at I guys in had through a walk you and then you are Phase us understood if X just to guys X participate into X-X going what would turned that they then happened what a it review? the it and were the but involved you Phase can how data there look how data from and you and if

Robert Brown

yes. Thomas, Thanks Yes.

we X. complete. all before remember finished into done of way, X-X process. to in they've their development the at their is They option have was the So moved they points an this make decisions What Phase data

controls information. We look information the release have not to finalized of the the the of line AnGes study chance had a that but at top report. obviously study

some encouraging. a So but move Obviously their that talk study. about to looked feedback of from we to chance their initial really their which data at they viewed that can't information have we chose as study look at and forward with we

Thomas Flaten

Got it. much. Thanks so

Operator

on Our with Oppenheimer. next of question line Leland Gershell comes with your question. the Please proceed

Leland Gershell

Hey my questions. taking good a for Got thanks and couple. afternoon

enrollment been a terms anticipated. faster in at like just went of had bit it First the pace than seems

are I wonder but launch still of a then represented want you in ECCLOCK gotten with rate question in that going enrollment very launches there just color certain Just with the any ask centers there factors if that identify it's early any among I into sites early much. to you faster if of Thanks any limitations just that the and obviously faster share there particular can in and Japan of just XXXX. as is the how know that and further the drove kind drug launch drivers on were also Japan trajectory that we've of days were terms can

Robert Brown

I'll think November over Deepak question ECCLOCK answer the launched the to don't, was got XX. why and and Leland on On Thanks answer want it clinical approval question turn they I trial. think it Sure. launched I the to I they last you

of than quarter else. stocking anything getting is course last year the a started just you're it of pretty obviously So more short and and was fourth quarter

hard those long-term little in asset. mean product it's little the make it we're based to it's an to well the any what encouraged on Kaken So projections year for on with sales might in look to early of like. and a really a is interpret Japan is conversations I going first terms early based how but value our by

on that that the know what product on and weeks there Japan the problems of in patient a is prescription two get two is have does that and get weeks more historically they means of drugs Japanese those go side a to getting approved and call to to because don't the not see new physically they doctor the with a a than prescription. seeing unknown actually For refill government back that a It's that for and length limit had and effects.

in utilization new So first therefore the they products year. limit of try to their

So do often year see first what month third, XX tends you more then kind and be of is to substantial. muted a

Everything is is product said weeks too do. launch the a out difficult feel We trial? stuff. questions like Deepak but whole the here reporting hear to to hard we're first on is what the to about too we that which with is to overall determine much, Kaken good the first positive. six the certainly their first, make clinical the interpret is doing answer how definitely very little So and is much would you going year

Deepak Chadha

Happy Leland for Thanks afternoon your do Good Sure. this to Deepak. is question. that.

factors delays was the we target tracking it's we and surprised whether for delays call remote any studies any the mentioned and are that enrollment one our enrollment measure think think question the our because I also on our our timeline but put maybe across do any think enrollment although bit pleasantly geographies but in that's and the States. assessment checks to all the to United is study balances related do COVID of a as multinational projected not around again again Phase on your having So X little I are against we I COVID and related

think the at more of I Florida, investigation they of I clearly of were like our play high enrollers. think Texas for centers example I in some So extent think COVID clearly the looking

may reason one that pivotal good coming think are I hoping of in on months. stay just track track our on with still which we and is be are second So we news the we

Robert Brown

Yes. peak Thanks about of really done the together and and Deepak that everybody's color concerns CRO we're ability pleasantly We sites the obviously the pandemic and during to bring the to work, our team really certainly just to to by the surprised add the had and with the a patients. some enrollment. little we're happy recruit this

the So we out certainly data and in are report track top still where think we're on encouraged line by quarter. we're fourth to

Operator

questions no the in There other remarks. Robert to are queue. CEO, for closing Brown back hand to like call the I'd

Robert Brown

the and afternoon Great. taking to health wanted thanks call the team the way and thanking the are to Hey, two to others studies patients for care hard course up and update. thanks that country by dedication, I in silently listen time smoothly for for for the sites hyperhidrosis. trial clinical work studies getting participating of this paving to investigators workers these running are that across at close and the the continue the our with our out suffer who and their

has has job over in believe of come. studies the fall done of said While and to these forward a we enrollment of own are an presented updated every COVID-XX our We I these clinical studies keeping program set progress on has undoubtedly to hurdles. encouraged conducting all team unique excellent pandemic with the challenges its set look months which the continue our to expectations. you rates That the within

and additional us feel have we reach questions free day. your any have rest you always great if to out to of As a hope you

Operator

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

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

Fresh Tracks Therapeutics (FRTX) 10 Mar 212020 Q4 Earnings call transcript