BBI - Earnings call transcript Q2 2021 | Fresh Tracks Therapeutics, Inc.

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Operator

Greetings, and welcome to Brickell Biotech Incorporated Q2 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. to LifeSci conference Advisors. like host, to now Russell, Garth would turn over the your I

Garth Russell

Thank operator, you, and good afternoon, everyone.

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

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

Robert Brown

you Thanks, our call Garth. joining today. for thank Good everyone and afternoon

Brickell for hyperhidrosis, executed potential program our pivotal team, been best-in-class bromide Phase a sweating. a tremendously X we've excessive also strategy So treatment through year against sofpironium productive the has option underarm as axillary far, entire our for known primary XXXX to as advance as

all Cardigan Cardigan in completed the completed we I that hyperhidrosis last announced Cardigan scheduled and patients I visits Phase the clinical of recently our in enrollment respectively, we off, and II, X pivotal both studies, First that study.

Accordingly, last on their the to II both of line and the in quarter to receive expect we for fourth the remain patient hyperhidrosis in top Cardigan study year. month. track results announce studies Cardigan complete We this visit final this concurrently

financing million. submission XXXX, we this anticipated Secondly, as recently gel infusion for sufficient a bromide of pending of With are approximately occur now the expect have which $X.X you capital, the is aware, sofpironium completed the cash results. beyond our U.S. FDA, in fund of NDA potential we many X mid XX% to to operations to Phase to

milestone launch in primary launch of bromide indication of updates in very Japan. important primary to in the sofpironium axillary country once the ECCLOCK topical the stages Japan. both any The for now product first prescription hyperhidrosis Japan Kaken axillary its from the X% is early an or for approve still hyperhidrosis is bromide the first treatment companies, is is sofpironium Turning daily the to as commercial of gel for and treatment for ECCLOCK of ECCLOCK country.

currently receives ECCLOCK In milestone sales a Kaken a and based sofpironium sales-based track net Brickell is to royalties entitled commercial for building to payments. and addition of record of bromide, on Japan benefit also of percentage receive regulatory the in

brings treatment or palmoplantar X In commercial early ramp the in and most activities. their progress investment well me a Kaken’s Kaken Kaken. study Phase Along and patients disease continued the sales next in are management dermatological state embarrassing by States. the as of social if those help us lifecycle with Phase options topical X Kaken palms safety and excessive look Japan seeing life, study, bromide results any, to encouraged with We’re determine clinical and of the this disease to as forward professional primary in the initiated and of for extremely June, awareness and up which soles. and will or there this steps, hyperhidrosis, recent the new prescription ECCLOCK indication. this pharmacokinetics, of of sweating development potential is anxiety United We lines, daily the this gel that in news aspects sofpironium of efficacy exploring no interferes an disorder provoking This commonly approved currently

Now Deepak? to let's over turn to a the provide Deepak update. call clinical

Deepak Chadha

Thanks, Rob. Greetings, everyone.

sofpironium than for pandemic quarter in execution and hyperhidrosis years bromide treatment As we remarks, of to fourth X year nine the well population. of studies by public. primary studies of team's XXXX, stated the ago, gel vaccines patient less one midst by older available before encouraged opening started our of his pivotal the and be XX% We continue in Phase the in to these axillary two Rob evaluating were

we complete completed patient expect that announced last studies greatly entire to we this have study The work the such, dedication to are As conduct currently have and this extremely Phase tirelessly and have study. hard mentioned, adhered the these critical appreciate II we to company's Brickell their X Cardigan hyperhidrosis and our to started hyperhidrosis two patient the to in the clinical completed team were to pivotal that study time, specifically, on CROs last ensure Rob timelines. And today worked month. our recognize get as history. moment and we us we fortunate Cardigan that More I

owe studies FDA from these and of such patients we two expect hyperhidrosis of are XXXX. these investigators a is successful, showing sites’ we in submission to all participated top If that the that by to results to strong both this the great because approximately to an gratitude to importantly, quarter NDA clinical proceed towards concurrently community we most U.S. In XXX studies. It the associated across addition, hyperhidrosis studies XXXX. remain on fourth report Cardinal their the of and in deal the staff mid track line

at least reminder, Disease the Hyperhidrosis patient assessment, or end to of Severity X achieving is As subjects in the with and point treatment. primary the the baseline set core gravimetric outcome efficacy that HDSM-Ax, the as production, each improvement proportion a pivotal Measure-Axillary, the on to endpoints are the X of scale brief from change FDA Phase reported agreed

study presentation the second in long-term label and presented in bromide XX% the to virtual results from X Academy clinical with have findings were and long-term and April. open prior consistent long-term XX the with safety the Dermatology We tolerability announced these of will assess and of treatment XX% older oral experience, also American unexpected the gel of safety our X% open call efficacy weeks that, bromide and Lastly, X% patients were a sofpironium primary years no for we safety observed. safety, study, efficacy over hyperhidrosis. tolerability With overview. proud a Bert? to turn gel the and experience to Phase Overall, meeting provide were sofpironium axillary safety, results in late-breaking of Bert now which in at financial I nine XXXX label data in the quarter,

Bert Marchio

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

our XXXX. reported June I second the XX-Q, I you the financial with provide encourage full Before cash the filed be which Starting the financial Investors XX.X cash to of section to company Form accessed XX, contained once through and quarterly consolidated our quarter equivalents, of summary SEC. a Web report statements as site, read want in MD&A on can million results, our and with of

of in capital to we million. the driven quarter the for the XXXX. outcome our from announced by the X.X back revenue U.S. for the second a for sales by the second quarter Paycheck totaling was Japan completion mid total quarter to of Protection collaboration resulted equity our to was program. is million X.X in will of for Brickell research recognized were gross quarter, submission June was net of the in to second compared expenses for other royalty million the of Net our we support of second funding XX,XXX period this of pending and X quarter increase of revenue to and ongoing XXXX current proceeds provided for capital approximately Kaken primarily compared recognized QX. intend NDA on second by XXX,XXX of offering of the same compared position the the XXXX. to R&D to believe XXXX, loan for up R&D which X,XXX XXXX. of the in to As X by expenses Rob, in Kaken anticipated Program subsequent totaled raise G&A revenue Phase primarily XXXX, approximately clinical due the was for importantly, for was costs an of the gain clinical Revenue XXXX reported The in an Cardigan use quarter second in of year we compared the the corporate noted million This ECCLOCK second X cash due FDA, potential We increase for trial of quarter increase working end the in for which year. forgiveness proceeds the that XXXX. studies. bromide to the million XXX,XXX, Phase to from general from X.X quarter second XXX,XXX income prior operations the This our development, related of sofpironium purposes. was the total debt Most extinguishment to the beyond X.X

Lastly, our for loss million XX.X compared second XXXX. for million quarter net quarter was the of of XXXX X.X second the to

Rob? turn back And this with over Rob R&D was call noted, increase closing expense. driven remarks. by to increase previously I the for As in I'll our that, the

Robert Brown

Bert, Thanks, This Deepak for your Brickell. for recap. time and exciting an is

continue physicians readout Phase patients advancement this work later year, treat momentum the We which company, a who for towards will them. X meaningful we the build support the and the to together upcoming we be and hope

providing look explore can patients. transformative our these materialize. In to development efforts updates products pipeline believe become to to additional We addition, to that opportunities we for with forward therapies are potentially extent continuing business expand the potential we

safe financial in normal be But were over they mentioning would Lastly, resilience This and of concludes our hyperhidrosis the year middle prepared our milestones call for as unmet the I'll the Operator? pandemic and meaningful effective to to considering ask that open it's clinical, in operator resourcefulness the the the for all accomplished questions. exists we've of that a and that worth the as well speaks need the up now past corporate remarks. treatment. achieved times. team

Operator

[Operator you. Thank Instructions].

with question Oppenheimer. Please Our Leland from is Gershell proceed. first

Leland Gershell

the Two Congratulations my you thank questions Great. progress. And Hi. taking for on from me. questions.

of positive, forth? they're ask, pivotal it is outstanding into I Kaken simply expansion about for in trial into you assuming and required perhaps under going Thanks. Cardigan so how may matter Brickell, wonder to are would First, think CMC we data for the indication kind NDA, would do compiling there sNDA an wanted you data a pending that ask and palmoplantar, a section opportunities leads with that be I to trials, me or of see to that indication then for look the items expansion want a sofpironium? as the And significant any from the the to

Robert Brown

Hi, Leland.

do there no thanks This are there the there -- have the any X amount clinical pull to with X to We is a meeting for work the submission. needed is questions. Phase In post work the for FDA. to plan clinical trial Rob. to FDA, do But Obviously, pieces significant Phase completed. the of really done whole meeting First, are aren't with that a the thing data no submission, big is -- together. the regards clinical once all

So good that. we feel about really

and really we their X, were about Kaken this that. work of terms Phase in In excited

phone, how to We make see interesting of hyperhidrosis. sense there's that cetera, in the of of that aspects of et besides We'll sweatiness to interested go a the need. people the data. have the keyboards, that to It's embarrassment of a on hard then is the be be and rights a ways, most results the forward. unmet that decision It's to really many indication really one a interested we In use debilitating have. lot social hands obviously

can challenge for functional So it significant problems real there's patients. And create a to that.

need that, about the So, being excited opportunity obviously, we'll that for and to look done. Kaken we're in we're asset. future the gets products we obviously, that potential this a take they're and But investing at when see data a happy

Leland Gershell

Thanks. helpful. very That's Great.

Operator

time. are There questions further Instructions]. at no this [Operator

So the Brown to closing any for remarks. Rob would like back I to call turn

Robert Brown

coming to Great. close of And you continued Joe. listen the in progress our joining everyone studies to Thank on by all the your the the keeping to us We forward time Brickell. this look afternoon I call want interest thanking of for updated to our everyone you, and thanks out taking to update. over for months.

As rest out at always, Have to time day. any further questions. reach any feel free with of a please us to your great

Operator

This concludes today's conference.

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

Fresh Tracks Therapeutics (FRTX) 12 Aug 212021 Q2 Earnings call transcript