DERM - Earnings call 3 2023 | Journey Medical Corporation

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Operator

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's Third Quarter 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions] For participants of this call are advised that the audio conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call would be available for approximately one hour after the end of the call for approximately 30 days. I would now like to turn the call over to Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Jacklyn. ahead, go Please

Jaclyn Jaffe

thank participating and call. today's you afternoon, in for conference Good

Interim Dr. call. me leadership Research and Chief Secretary, portion President Benesch, Corporation's Journey and Q&A Executive for the who Financial are: Joseph Joining Allous, Medical Corporate Co-Founder, Development; team and from General President Sidgiddi, Srinivas Vice Claude Ramsey Maraoui, Officer; will the Chief of joining Officer; Counsel of and be

other of including During Journey this financial be will for that performance, Medical's things, call, among future making forward-looking expectations statements condition address statements, and regulatory management operational results, the approvals. receipt

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

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

You for prepared accordance additional isolation GAAP. information should with results in a as not consider or this substitute in

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

Claude Maraoui

everyone Update. and Thanks, thanks Jaclyn. third Corporate and to XXXX Conference for Call our afternoon, joining Good quarter

a be evolving for continues by QX time begin that saying very Let Journey positive Medical. XXXX to me and

from Our operations. with focus achieve public we a profitability this, our commercial year to achieve factors. working second during To been our as X critical company is have

for The brands: AMZEEQ our X first and net driving ZILXI. ACCUTANE, is QBREXZA, revenue core

The is our second is out-licensing upfront which Maruho the out from the of is rosacea. product from through was In candidate XXX% XXX% increase licensing building of while XXXX. portfolio our SG&A. our an the included million, quarter acquisition, third reducing And and optimizing total DFD-XX of our million of $XX.X which quarter the second the revenues, net and advancing for an XXXX, third $XX.X quarter payment $XX.X million increase and in in third

countries. SG&A year are this XXXX for we XXXX. to by by $XX guidance guidance our SG&A to other As patented QBREXZA to reduce transaction, that our previously opportunities in recent DFD-XX we be exclusively for approach, or raising those approximately in-license our Through million $XX that attractive to compared in XXXX financially expected disciplined expense our our as we well products evidenced as expense for March reduced XXXX. of extremely believe million near-term looking to including products, our by companies compared gave most We

providers well this enhance that both who patients from DFD-XX FDA who of for application be around rosacea opportunity III top our placebo in the a DFD-XX, track remain and by type X with We on rosacea Regarding year. treat suffer those clinical to therapy condition. to care to medical as new demonstrating for to rosacea, we asset over We patient evaluated line will a that potentially the efficacy are the recent of this being submit the trials. superior development as treatment end for the clinical best-in-class encouraged statistically drug of positive the believe is Phase results appealing

believe million there In globally. Health prescriptions $XXX by for has in excess prescription FDA, prescription approximately If data. sales rosacea to of we potential peak according terms DFD-XX approved million Symphony the market were in of size, that XXXX written annual X net

clinically has suffering to new the these to as meaningful the transformational potential DFD-XX oral millions commercial of minocycline Sidgiddi lowest as detail. discuss for DFD-XX greater this to like approval launch turn paradigm Journey the rosacea I of the become and call would Dr. point, dermatology potential a the and both program community. from outcomes, our that believe the With dose clinical will the be DFD-XX event patients in At for over We market. to well on broader treatment Srinivas the

Srinivas Sidgiddi

Claude, everyone. Medical collaboration you, studies the DFD-XX, slides from begin and like the the to website, following with X DFD-XX. for DFD-XX. Pivot highlights approximately with supporting which on moderate elements. investors enrolled XXX X the placebo. or the severe refer in study also Dr. here Reddy's rosacea reviewing Eurasia Journey has studies in by studies hello, I'd presentation Both III to Thank I contains had detail. recently to design like a key remarks investor our X in would to to completed more my to randomization conducted Phase for and Each X to patients III Phase

approximately were on treatments proportion be the Thus, second treatments. and can to of had The primary Germany. they second and a enrolled MVOR-X previous in before were in in success, study treatment total lesion inflammatory study, medication enrolled were moderate washed any subjects core with the of entry. seen to or U.S. U.S., taking attributed MVOR-X at starting studies patients not study, first the efficacy in IGA to the assessed the rosacea The the solely XX:XX any previous out confounding in of the Subjects subjects medication count. adequately study first these X patients severe All the ratio study reduction endpoints, medication. study while

that values proportion placebo. reduction In IGA for in XX.X% minus for than and DFD-XX, total X.XXX XX.X% minus upon X proportion FDA co-primary the secondary placebo. for there the placebo. statistically were label duration. study for IGA Oracea both values XX.X% results Oracea the treatment approval X.XXX, for for DFD-XX was was placebo. subjects X.XXX for all adjusted and is were Oracea demonstrated both placebo. less value are The p p against The XX.X% both lesion XX.X% XX.X% was for with significantly for and MVOR-X, addition, and In a inflammatory for than Oracea The MVOR-X. statistically was XX.X% success The to and P meaning reduction minus between both it was The The and included the X In than in was against to superior that secondary the weeks minus the for the and count being endpoints of Oracea less for for for against placebo Oracea XX.X% success results values minus of DFD-XX, showed placebo. Oracea if placebo. in XX% that DFD-XX of and In MVOR-X, DFD-XX, DFD-XX Oracea lesion difference than DFD-XX for MVOR-X, the for and minus total against for p XX.X% X.XXX DFD-XX, XX.X% endpoints in count multiplicity, possibility while had placebo were superior subjects Oracea that placebo. and was showed treatment XX.X% for less that DFD-XX X.XXX XX less treatment inflammatory were

both and in be on co-primary X consistently As both the DFD-XX seen can studies. from Oracea placebo the outperformed data, endpoints

DFD-XX expected first for for inflammatory the either likely patients. is DFD-XX One on proportion XX.X% providers was an relevant of other the of a on and success label, in therapy erythema be of therapies The approved, differentiator secondary for XX.X% for both with the labels, life against placebo. to that assessment DFD-XX indication showed both. rosacea of to was with statistically DFD-XX unique CEA to DLQI erythema p-value reduction quality erythema life placebo the success was and treatment quality while XX.X% the The their X.XXX. is and in difference The success the treatment is demonstrated for impact most was difference lesions for p-value because of placebo. X.XXX Oracea, have and significant of DFD-XX significant for RosaQoL, signs treatment of oral not reduction in on placebo the of was their MVOR-X, both the improvement be to subjects of and inflammatory for important lesions between endpoints proportion regards erythema that redness, placebo one in the between approved and CEA subjects or also and result showed for XX% erythema has is and tools happens X If important to but dermatology. MVOR-X. that accepted erythema widely DFD-XX that In

DFD-XX adverse and the being best-in-class demonstrated studies event being head-to-head indicate of over DFD-XX's These being safety the by standard both We the possibility care the are also of profile was with to the close standard results rosacea superiority therapy in care. with current of of new in that rates the encouraged placebo.

likely most be DFD-XX and share anticipate its launch on from based for on meeting the productive a DFD-XX recent of oral market because dose. to the the it October low where daily safer therapies FDA in is DFD-XX. III demonstrated Additionally, significant minocycline update to XXXX, pre-NDA compared to studies. as a had Phase perceived is we potentially with minocycline upon We other differentiators fixed capture The the significant

much. receipt of And meeting in minutes. I'll the detail. hand Joe provide discuss it you to following We greater to now quarter expect our Thank very an to FDA financial results third update

Joseph Benesch

product decrease quarter. of $XX resulting quarter revenues We of prior you, million, net down review million $XX.X to $XX.X XIMINO, financial third increase due the the the primarily to from in $XX.X XXXX. lower results offset The net from recent decrease from for Maruho. to due second The Total I marketing product our everyone. unit to the quarter XIMINO during XX, the a Sidgiddi, out-licensing product for due and XXX% for winding increase quarter most is third on third hello, million Net XXXX. continued third XXX% products. emphasis from and slight revenues the selling sales quarter, the Thank with from on of due $XX.X volumes in the the September discontinued sales were lower revenue or these $XXX,XXX agreement and AMZEEQ XXXX. by ZILXI Dr. in ACCUTANE, from was were net and decrease quarter a now partially will increase quarter an third our million million year

reduction $XXX,XXX X products, total is quarter by to since our ZILXI, the Our XX% to development net the period $XX.X percentage ACCUTANE due year from and of and development down. and prior by $XXX,XXX approximately The mainly XXXX. in to XXXX. XXXX, our $X.X compared and SG&A marketing. million substantially acquired to to decreased contractual third million represent DFD-XX quarter for XX% lower of for QBREXZA, and expenses due the the $X expenses QBREXZA activities on sales the of Research or wind continue royalty launched decrease or the XXXX net Cost by revenue due product of sold from decrease for to core goods expense decreased million year expenses and $X.X is of prior period. reduction clinical quarter or the primarily decreased efforts, XX% quarter third million to The quarter. sales all as third

optimize quarter have reduce implemented we operational calls, quarter costs. overall prior initiative efficiencies, improve in and a designed during in cost to of As reduction XXXX, last the we discussed expenses

to by demonstrated have efforts our proven QX, SG&A in be As expense effective.

share XXXX expected of GAAP The $X.XX diluted of is or for share the million these XXXX $XX to quarter third a efforts $X.X $XX.X earlier net per GAAP million of net of net of second $X.XX quarter for GAAP per income a basic result Our of and in surpassing of and recorded the cost $XX.X company in loss to diluted quarter per SG&A million reduction our million or a third expenses, $X.XX to share compared XXXX. basic proven of impact the or loss annual million. initiatives have diluted per basic share and of target $XX The reduction and effective. $X.XX approximately be of

per made to share an for non-GAAP third and has and improve share basically company share adjusted resulted diluted net the income per basic the compared million third and its diluted see, operating $XX.X million EBITDA or $X.XX significant adjusted can strides of in the or company's $X.XX performance. XXXX per EBITDA to of share The $X continues $X.XX you As of loss and for or trade quarter $XXX,XXX XXXX loss of quarter basic XXXX. an per of EBITDA of for second quarter adjusted net diluted the $X.XX

At XXXX. and non-GAAP XX, adjusted company expect XXXX. December full XX, $XX.X September million cash the We cash equivalents for to cash will million EBITDA compared of be cash equivalents the positive $XX in XXXX, that year at had we and

of And company debt back result of turn As Claude. you any EWB the Thank now longer a payoff the obligations. our it I'll has debt facility, no recent to very much.

Claude Maraoui

momentum the I is operator. Thank and yesterday to education option of turn like quarter from you, this for final is and now hyperhydrosis and call day. build you, is will call awareness the QBREXZA XX% our the this approximately month. the Journey evident of year-to-date. condition. that reflected A believe performance, November that Thank Joe. is initiative continue back at treatment everyone The disease expected have awareness, the key that patients state into I'd to good momentum price offers is reminding to a over is positive by up further suffering to as XXXX. continue to by which close We stock

Operator

we begin Capital. first comes you, Henry [Operator with question session. will question-and-answer from the Our now Scott Instructions] Thank Roth

Scott Henry

on Congratulations. progress pipeline. statement, lot of in lot A the progress a income the of

was a from to A just how think QX, both standpoint. questions. we well, lower that, as revenue So I'm point? going -- are sense you X.X% a of state steady great more kind do And QX about that? to a that job it this than should we When get can of QX. trying a Or we at there. think about there it Is you couple SG&A, think it, cut at of is in

Claude Maraoui

your question. voice. Scott, this good take hear of part to I'll

quarter going stake. what got see momentum. then it to expect QX comparing prescriptions to so give a jump that's to final look efforts good terms And the efficiencies, the month going I X QX reflect terms In into I'm we're and here, and here operating you far. and our Joe of of similar QX how And in year. have fourth would very solid. of quarter to his you and in We've strong SG&A in The

Joseph Benesch

Sure. Thanks, Scott.

little So should from third third we we quarter. at it even a a pretty There's better. with from Scott, But point, bit would with keep chance the an be SG&A standpoint, even expectations I be quarter. an definitely the could

the million. that's guidance our Our with -- sticks, $XX

Scott Henry

you looked but year, color color would to on mentioned combine any you Or and but together, X? of then And they mean, similar Fantastic. I Okay. those have surprises know if guessed I any them Accutane there? QBREXZA. I on it kind did any all last -- just

Claude Maraoui

Yes.

we're very pleased In how performing. with terms think product of is Accutane, the I

I message end, think from a sales and marketing the is getting out there.

patients more Accutane. physicians the are and more think and I turning to brand,

we a where like now, Right have we share. we So market are. XX.X% approximately

on So in particular sales a we've ceiling. no right of to lot now way our with have got we the And come hitting that force emphasis brand. close

winter there So is heading seasonality for brand. now. right QBREXZA, in this the into of We're terms

seen similar some offsets I in you've in generally, can that. a solid anticipate be QX there with QX, as QBREXZA. So with But very would here quarter

Scott Henry

any if potential do today, big question you an X calls pretty even Or made asset? I more Okay. would lot of you pretty journey company incoming compelling, couldn't look the mean is someone refuse is at the particularly possible partnering just although in rosacea on that you that? on than you that today consider that offer perhaps you bigger do hands? get it question a The The DFD-XX. Great. product, months to ago. was size data Final is, relative

Claude Maraoui

Sure. Scott, Yes, great question.

interested out from the in the that has here of potentially industry outside a With the the asset results a well the of of came in early and results as certainly U.S. as lot from Phase caught that licensing parties out, III country the it came July, lot us attention

once the right But on focused approval, the when all open. we offers of we We're think in comes always asset? all year. really would later launch and I we've half ever execute development, make the business XXXX. of potential like. to in opportunistic of get look any plans are door open really very sure an sort offer the the hit and always it's continuing running ready we We're have what terms now, for entertain In hopefully, to the to we got it

are as as and hands deck say. all on I could that's So much

Operator

Our comes from with next B. Fleszar Riley. Andy question

Andrew Fleszar

of what may from you potential to the get research positioning and us, be NDA starting with understanding sampled better drug's launch prescribers the the A potential few have ahead there? in DFD-XX, market of And emerging a market. the

Claude Maraoui

needed. and Sure, previously, Andy. Thanks market be for potential that the would Yes, question. conducted research examine payers we've for sensitivity, some requirements specifically example, with already really price the to contracting

Now and we we that, additional want conducted being we've speak. revalidate research got to that's as

potential means terms ratio as the providers. contracted, So I a that as some perceptions looking the to a at ratio of well the of and it's generics are of in marketplace of mean, considerations where areas to our what

minocycline hopefully, for And unique unaided to indication the a does associated rosacea. how a that qualifications to have, we'll So and release our want DFD-XX, and modified erythema customers. anti-inflammatory very once aided day we from get

So our to for we we it then look demand like this factors. our adoption to And really of for understand all want will peak validate and product. that long want said, and I sorts how at And take come. to peak particular

So the complete, with But we doing research. validated We've this conducted additional lot previous have research. great and of assumptions. now now a and with we're studies already market

Andrew Fleszar

may from of remarks, on forward to in you results that look be label. it that's Can included And some the there. all? We'll like your Great. Okay. the at prepared elaborate erythema sounds

Claude Maraoui

to about little Dr. going a that talk I'm Srinivas Sure. have bit.

Srinivas Sidgiddi

which The statistical high that multiplicity, for thing chance endpoint that the a question. for endpoints there the of is means that on question. is Phase and on one erythema up be of to we to placebo, had that would to label. there adjusted that Thanks, is very ending erythema that like superiority the the happens III studies very endpoints a secondary That's thanks, were secondary I Claude. if Andy, good about And say

So terms the would that the getting where believe endpoint, was in a be it at it that a with since it placed good just of on of hierarchy. and the chance a agreed secondary We multiplicity FDA we was label. have in

Andrew Fleszar

the you of additional now last that of one the the IPO I Excellent. to final a overall market Accutane. continued And XX.X%. growth had gears, me a provide switching having you're things market. That's helpful. share can treatment growth on in bit like very returned kind market know there? color And question in But at year. expected from long-term sounds on slowdown we rate Have any It overall

Claude Maraoui

Sure. Andy, and market in the Yes, through market the you about included. we're isotretino There X,XXX,XXX and give background just about isotretinoin -- was at now XXXX in and all X to about the amount same X.X% some first that's on in prescriptions. XXXX, And change. XXXX, quarters,

to So going see to that but like prescription we're think million it There it that back of be up. to touch is a ramp looks starting close was market. slowdown, $X a I

it's So strongly. holding very

I That's it's single think good off year-over-year. just a digits we very saw some backed but nominal. bit,

Operator

concludes our question-and-answer call you Thank for today. as This presentation. well attending for today's our as session

disconnect. You may now

Journey Medical (DERM) 7 Nov 232023 Q3 Earnings call transcript