Fortress Biotech (FBIO) 10 Aug 222022 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical’s Second Quarter 2022 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and it's also being recorded for playback purposes.

the end be approximately of of hour approximately XX replay the after the webcast call available will one days. Our call for to the like Abraham] would now turn call I to of Investor Company's over [Korier], Relations. the [Jos Please go sir. ahead,

afternoon, you, you for call. And participating Thank everyone. thank today's in Good conference Carolyn.

of Alloush, leadership Sidgiddi, Joining Officer, Chief Paolantonio, Ernest Corporation's Claude Development General and Co-Founder Srinivas today Clinical Ramsey Dr. Counsel me President Affairs, for from also Journey President Medical Maraoui, Vice De joining Financial are be medical the who and Executive and Officer, Chief session. question-and-answer will us

During address be Journey will or making that for expectations including future performance statements this call, Medical's operational forward-looking management results. statements

actual differ Forward-looking those statements. from results to and statements may involve risks materially other factors cause that

that please X-K about Form SEC reports, in this particularly Medical with periodic refer the information performance. measures recently Medical's and Form risk the includes on today, can Journey more conference accompanies financial these XX-Q, call, factors filed most statements its Form company's to described For useful filed the be within. that the believes non-GAAP XX-K Journey and call risks, Today's evaluating release press cautionary

isolation, consider accordance nor not information prepared a this should results additional with substitute for You as in in GAAP.

Claude. publicly over Maraoui any non to this now reconciliation to that today, this August update of located contents law, of table in turn that call. pleasure Officer. by For Journey time net It's loss, revise Chief Co-Founder earnings reflect measure see the release. accurate required the financial contain this financial The occur is disclaims information reconciliation its of circumstances Medical obligation as GAAP as sensitive call to Executive and the GAAP Claude Except please X, to most after any directly President only to measure, comparable XXXX. events call press information my company's or or

quarter of the thanks that availability XXXX continued to growth during or second despite quarter everyone delays show of conference chain solid the Good for second in for challenge Journey to supply joining the product XXXX, afternoon, sale. Thanks, and reduced Jules. the call. of quarter

However, that we recover portion setback remainder revenues will temporary over delays a July, confident of feel a this of were as the and we these in significant resolved was lost these the year.

than continued the Ximino of product growth slightly was performance products which Exelderm, an We competition of another driven and million X shortages We generic the QBREXZA launch products in this quarter of the additional and quarters This to the was net our well million flagship the the and second the Our year of acquired AMZEEQ in in million, sales achieved quarter market yet of Targadox, achieved a QBREXZA as quarter of prescription ACCUTANE. XX.X additional growth. versus products of strong compared Accutane by the one two of in these began XX%. XXXX, primarily revenue net of as the years cost which the $XX.X XX% combined positions product us when momentum which sales contributions year, for second X.X continue coupled selling sales recently was record and rate of ZILXI, gain with by of for XXXX, offset net growth prior for to and represents this period. less which combined million, half increase second of

products newly AMZEEQ ZILXI. will continue supporting Accutane forward, to and growing and and Looking QBREXZA, and launched of acquired strategy we our executing our

the of second estimates, managed quarter AMZEEQ recently assets impacted was claim The ZILXI. our and for by an care also update to particularly acquired

Care greater expected. Managed actual than experienced, emerged the As Claim

have evaluated clinical program according for be to of the adults. our is On of being And rosacea tracking two reached pivotal treatment first from quarter, trials addition to ongoing the DFD-XX, announcing this nine We already about achieved half the continue sites X top-line excited patients plan. papulopustular and in the is trials. of development the front, Phase XX% the recent enrollment Patient progress anticipate which of in of the data with in we we enrollment XXXX. of for our XXX targeted

from the XX efficacy With prescription The the of equated leader our sales for an rosacea, Phase for of to second drug market in in an overall million estimated $X to net new be U.S. data XXX of in To billion peak submission patients as $XXX XXXX. prescription million. the is our application We clinical current in reiterate, X mess, estimated the excess XXXX. DFD-XX opportunity half a will the in XXXX. market suffer that sales million this nearly sales with ratio in double demonstrated product DFD-XX for estimate which

assets leading of second that, of allow turn that face the now confident I'll are financial challenges While future continue growth of force. late-stage to us over call our sales The will who we quarter. sales. another some issues review our to the to our results that Chief through licensing for to Ernie, Officer leverage With development acquiring and look and forward be quarter, Financial to unforeseen commercial growth these will product the our year our industry in expansion resolved, we and this in continues record been of foundation we have portfolio

the due QBREXZA the and results. everyone. quarter the of June of XXXX the during in to from ending I second Thanks, month period growth growth in hello, XX% launched revenue net acquired growth or will XXXX period X ended million now increased Claude, three and revenue XX.X ACCUTANE review first launched $XX.X to late XX, June million million Net three for the XX, second and Total revenues months is primarily period of XXXX. XXXX. revenue for the quarter period financial year-over-year quarter from

and AMZEEQ the XX, the value Dr. the fair to period from for due period increase associated for revenue in by XXXX. increase from Claude product X.X $X.XX finished common development QBREXZA the XX, amortization the $XX.X or $X million ended general sales, in compliance, attributable diluted same as expenses acquisition million of related resolved in contract of of for of Reddy in XXXX. and driven products due XXXX, $X.X month candidates, sales of for litigation product a million In and the to noncash being sold of the Net cost prior million month fully is of expenses was launched million of shareholders from and to period a The second as of million. ZILXI volume patients goods XXXX June driven period of months. year. attributable XX, second per a increase for manufacturers generic offset in which the other primarily is a $XX licensing ended product previously, of are quarter we of for the to second These basic contingent the goods for expenses expenses, June and EXELDERM intangible continued from the to higher related prior This expansion reflects by of diluted is credit the a will our with and portfolio, million acquisition million expanded coming prior shareholders our Dr. quarter million. have in of Cost acquired were to related cost as The from by $X.X step up million month result our XXXX. delays the from AMZEEQ to month inventory net X.X or increase to competition from Reddy ended and in three for currently net force, the DFD-XX acquired are million sufficient addition, sold the period X in newly attributable quarter $X.X Research period the and and company. to a period decrease increases future the decrease for January product and current Selling and expense loss to and XXX% common increase of quarter ZILXI. of as incremental goods XX, three the to our $X.X decrease This dosing June June development from XXXX, three The by began sold trial XX, the compared XXXX. to in increased our our $X.X XX.X the payment XXXX. higher million month due acquired to delays increased to of our million loss and million Targadox of of $X.X month for a more X.X ended increased goods the June million costs the acquired XX,XXX in administrative assets trials $XX.X public XX, period three $X.X Research share units clinical And XIMINO June DFD-XX demand. by result attributable and ended per period to is meet of period XXXX. the marketing period expenses March Offsetting July, enrolled and increase the million basic of these to of or to share inventory $X.XX supply XXXX. three net XXXX for for same expenses three patent revenues primarily ended of

the $XX.X upcoming Our for it since and quarter basis at our non-GAAP believe expenses not We $XX.X of million XX, XXXX. XX, had on will the delays in EBITDA compared as to we has turn quarter. year-to-date had a This $XXX,XXX. positive XXXX, the DFD-XX loss in $X.X into does equivalents June related At on as the account to million adjusted EBITDA non-GAAP cash a certain XXXX. million negative been adjusted December that this R&D for cash was figure and quarters product adjusting sales after take in that impact is

seized our of As FBI received Homeland of the Security breach, to will cybersecurity breach Journey mentioned upcoming us months our resulted the release, from be Department process Medical. that for press the a million we X.X significant liquidation over in losses encouraging has amount return in soon cryptocurrency with which regarding and to the of been the that associated the eventual news and in

this able the at the to or exact not time estimate for the timetable receiving amount funds. are We

from to capital. plan available loan the term program we that back clinical the I million of Claude. East the additional X X second in of you. our Finally borrowed supporting and turn Thank the over The working is part with call with August, of West million And tranche Bank. DFD-XX additional operating will

you, Thank Ernie.

to launch add over in the will XXXX including XXXX, X product the forward of a another We National our completion now portfolio. dermatology half achieving With are trials in of record turn the I enrollment the for call DFD-XX expect milestone clinical including Thank second and products, foundation both continued to achieve second another and in year the to momentum new to you. the half of of strong revenues to our of Phase day a events looking questions. for for we prescription operator the of XXXX. completion

[Operator Fitzgerald. comes Instructions] The question Folkes Brandon with Cantor with first

me the need differentiate to Maybe in others? your just to DFD-XX. how see order then for we the starting to do the expectation? the What stage And on product enrollment at compare from off does data initial in

going enrollment the Dr. track But on summary, track it over here Sidgiddi? have plan. for to and take I'm just of details. Sidgiddi hand in and going our I'll our Clinical it give Development, you Dr. on clinical start and DFD-XX more with overall, President regarding from trials to Vice are I'm going we Sidgiddi. Srinivas some to

studies, studies The Phase two X XX.XX the MVOR-X and for the enrollment MVOR-X.

study. our had enrollment the and we that second things anticipated, we of And out cetera, have a approvals, on enrollment delay been on to we overall minocycline what MVOR studies. there X had. Phase buffers the leg is et And is still of control, that's planned, But the have within So that otherwise, for arratia within that the studies given acronym have the of as regulatory is that for because European versus are the essentially two the rosacea. stands the and going slight delayed.

improvement that's was the the differentiation. about primary global In significant So lesions or are the the a for study. assessment, the endpoints question this second part inflammatory rosacea, two and first we the of which anticipate question see on to investigator

Those are difference So lesion as the component things significant a counts, from that the well we on to like erythema the other essentially rosacea. two products. see us differentiate as inflammatory of would the would

comes question Riley Mamtani Next B. Mayank FBR. with with

also, resonate specific have on you prescriptions? trend? if Just you well, you if of with seeing And a it's may comment comment the And of early how seeing QBREXZA Could new are sense but your be couple understand customers. days, then could first sales. then you on, us could on versus I repeat Again, you're I that what campaigns still follow-ups. give a

example, Regarding and inquiries the good it dermatologist. social off QBREXZA, start. with and just for that dermatology in is the really building these and Instagram on to really the focused patients brand few platforms with a message. to have a group in, education, this about to Facebook when encompasses with I And providers really digital awareness, really see again, focused awareness a We're targeting, age go we media campaign and it's that in really we're demographic their other the think One areas. driving really and get and

it's been how that's we So progressing. like

that's well, of been have hitch think really our demand. impressions, prescription increasing corresponded I nicely. terms And in Our all

For prescription growth. increase have to QX we QX, approximately in from example, Mayank, XX% had

So front. repeat progress working of question, second well. I part some on you And please? your making Could is the we're campaign think your that

versus prescriptions? Repeat new

Sure, sure.

I we and think the been In as you example, XXXX the trending at for which June, that all total we've for at as prescriptions. in that. in the of prescriptions approximately than were then into to XXXX data, And most just the prescriptions data, And ratio Symphony take recent up new comparator is when prescriptions, recent the look prescriptions. the and as month at more doubled upward. look a we’re new of way month, have most prescriptions far with January, new looking

So again, XX,XXX and in in approximately prescriptions at XXXX NRx's for at prescriptions. June, TRx's example, June total

So I as good that rates sign are think we and a that's our and increasing indicator refill getting, well.

studies addressed, the just could earlier lesion Great. and placebo to on and comment And sort you two doing endpoint? you're that if question and the that in follow-up expectation Srini an the comparator that -- then the a for of and your active second the on the MVOR-X assumptions influence you effect the on MVOR-X IGA comment reduction size could Srini the count on

so you for And thank much really question. question. Mike, good Sure, the it's a

To We have had we of used the the we which those about Europe, the there, were was XX% program. kind in and versus one for we seen and well efficacy of sample We sizes. looked success X in estimates, give saw the Phase the we study is as placebo. efficacy Phase that this the IGA brief the had for the that Oracea, treatment in have XX% had European that DFD-XX, conducted XX% at sizes of we for in have for calculation you X mg, seen a as of Oracea, calculation what we Those estimates as that And of arms, for Oracea, use DFD-XX placebo. XX sample

you little competitive giving some you have high-level, Very helpful. ErnIE, just about maybe with understand question, talking products, projection And comfortable and for I dynamics. final chain dynamics talk a certain what my stage, and at Claude supply longer about guidance. maybe feel will and term one-off

you'd thinking curious, just feel, of quarters financial this like thinking, command what do point the next a a and three have about at year maybe two, guidance So had standpoint? good I from even you

Sure, first of the of guidance January that and in assets ZILXI. closer are with think I getting to in acquired we on we all, new AMZEEQ terms board giving getting

the you we'll anything very there towards of that forward add range. able like. beginning two give be guidance comfortable like to moving definitely in think onto if the I'd a next to I quarters, next you'd Ernie, year, with

provide such normalize of where guidance. the start portfolio our I can think products as see our said, quarters, in us getting But make for Claude to you'll estimates still upcoming earnings. we from We're

don't many you DFD-XX. over just How on sites can Sri, have a how many if -- sites follow-up we go study? the the enrolled you for mind, now

in plan XXX initially we studies sites at sites. which XX we XX both and we And means have stand and planned study. sites combined. to the XX to these are So U.S. that then on that XX for we XX that Currently, Europe, in coming or U.S. initiated. in would the have we the the sites are being into Those have are that get in MVOR-XX sites of in patients. from sites in And MVOR-X, have sites are And we MVOR-X, been of Europe enrolled have MVOR-X XX enrolling XX subjects we have Germany States. that United the process entirely nine the the initiated up

in after are the approval well. which starting be the we four We Polish as from competent sites authority, awaiting Poland will

as So we that initiated of study XX additional in MVOR-XX sites study plus as have now sites XX in the of today. the the sites and Germany five for on have U.S. MVOR-XX XX been DFD-XX,

very you session. back much to to sir. I our go would Please call that gentleman turn Thank concludes question-and-answer Maraoui. ahead, the now and Claude like over

of much. you We to Journey your when to I a on quarter and Thank report and our for results have today's very Medical. thank you our process in participating you want all sharing look third day. good call Thank we ongoing November. interest forward in

is now conference This concluded.