NOVN - Earnings call transcript Q3 2021

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Operator

Good morning and welcome to the Novan, Inc. quarterly update conference call and webcast.

As a brief reminder, all participants are currently in the listen-only mode. [Operator Instructions].

Following the presentation, there will be a question-and-answer session. event. is be at Company's made the of webcast and Company's website this end will replay available the that being the recorded request following Note on the our At listeners webcast this state beliefs, projections. intentions, or management's like time, to may that made during I'd remarks this future expectations, remind involve These and uncertainties. risks are forward-looking and statements

expectations could Forward-looking this call are safe materially. the of provisions laws statements are and the results on federal on based and current Novan's harbor differ made pursuant actual securities to

As place forward-looking a under reliance statements. you should result, not on any

the available Commission's these Some the the with to such the website. review the of documents in Exchange periodic this and that forward-looking of materially by to are files Novan Securities factors Investors the We results section and could cause contemplated Securities website in you carefully. and reports Company's differ Exchange actual statements Commission. encourage on discussed are documents from These

today's from Gay, are us Officer. Chief Joining M. to Executive like leadership I and Stafford, Financial John proceed. Chairman, Chairman, please to team Brown Officer. Paula Stafford, call and would President call Executive And Paula over the President, Ma'am, Chief now on Chief Officer. turn the Brown Novan

Paula Brown Stafford

platform and year The us. to world quarterly team technology Good be to welcome Jessie. It's we're nitric the to in leader. and really testament transformational the morning is looking to Thank stronger you, a leader has a commitment. to And in a start for all efficacious position. never therapies, clinic Company update. been our a it's delivering our to and and been a Novan's To world Novan And safe reiterate, oxide-based bringing support science.

for our reported June, as pivotal lead Phase expected. study. data progress in made favorable have or we And candidate, X safety our positive reported SBXXX, product across significant We efficacy final September, data programs. lead we our X In our f

IND the XXXX, of to in advancing an of towards the and quarter SBXXX, to with And most Phase our form SBXXX -clinical year three XXXX, And positive submission. advance the towards short, we announced SARS-CoV-X, we in second less targeting U.S. towards In success. additional results common report Phase in we recap away. And out of had an X represents Since positive study and the yesterday, we've data opportunity vulgaris, X we're Phase NDA we're we're NDA advancing next a study. the quarter acne, submissions a planning III acne chance in X June, XXXX. humans. than of Now our initiation and With the market years. significant targeting pre from pivotal for and over Each a for a for are X are the trial intent beyond. top-line

updates regarding of are pipeline underway. indicative So other entire important while it's on share nature robust think our it's the the We our and believe I of it aware are some you to will -commercial platform touch And that as some we our results. again, of assets. now and data of potential activities of pre study now

any complete were As for And primary pivotal lesions. and that reported our treatable I reported of top-line mentioned, in efficacy all X study lesions results trial. with the erupted endpoint and that SBXXX. June, at Week at Phase efficacy safety during we baseline was main XX XX that at The Week clearance

treatment believe early a a this visit perhaps saw Week and that meaningful at is Week clinically see a difference XX. And You difference significance statistical Week X, before. X XX. XX And the also as can as X.X%-point at Week here XX.X%-point X, difference at and with we even we

strength nearly the placebo. on favorable the - comparing NDA all we're all were for pivotal Based be drug earlier when all focusing use these achieved XXXX. have X resources we significance of B readout. to statistical guidance necessary a we Based a all safety on safety as really and criteria Phase the on from X our met Novan. quarter, Novan's most we previous the of of new results, our submission profile. supports in endpoints with also for that studies Last secondary simple application our consistent SIMPLEX finalized SBXXX our to for for believe demonstrated vehicle, the We FDA, planned gel that study submission on Results

million potential an planning at-home is NDA NDA our U.S. a initiated quarter activities. submitting on molluscum commercialization therapeutic third is market an of The stability, planning for no With the that children. planning skin week, alternative also Novan SBXXX. currently either for we preparation pre remains procedure. for and contagious that includes it's highly our mostly not focused to Novan's in-office which X brand NDA of molluscum, free PAI our testing, conduct is -commercial SBXXX. for solution readiness, for Part enabling and addressable now or infection, before is conditionally said, use. accordingly. need in reviewing and We targeting. planning manufacturing meeting next in next X market quarters We're accepted the the a product over name There alone cases. approximately the in year of includes announced in-home And success, for we're last as all SBXXX The treated Today, treated candidate with

initiated planning competitors rehired as be good and experience Johnson including Commercial and Brian brings of we solution favorable our the profile. efficacy provider. Officer. due So safety reimbursement week, commercial there our Health from tremendous lack expect This of we as therefore, end-to-end and Brian of commercial September, last number commercial Chief to activities. with and Galderma. companies efficacy our And Syneos the our and started favorable will In we a selection UCB

he served role In the while Galderma, fact, at Officer. Digital Chief was he of

And the provided announced response, a helped especially. today's mentioned, important I accepted the brand I as launch as SBXXX. KINSOLUS world, X and for last we Also in products. he So FDA think that conditionally name dermatological very week, is

name the submission I NDA. the like request brand it's We're acceptance As really KINSOLUS the customary, with upon will for this excited potential name. we of of final Great.

believe be As can for a suffering our solution molluscum. kind product patients from we

interest Health now minutes we our encouraging the underway work of Brian strategically of internal additional with team pre area spend a in to Finally and on ahead -clinical and of Syneos SBXXX I'd results market experts, is couple shared yesterday. and others, a potential to launch. position publicly an that high with of like

of or We SBXXX IND are an SARS-CoV-X. treatment the for for towards of submission advancing

API. at option vivo After and previously now gel positive via COVID-XX. We've notable the sodium expand day. of date, administration the marks of this treatment Nitricil GLP potential clinical opportunity tolerated SBXXX dosing all been continue intranasal sodium deterring was observed time formulation. efficacy all berdazimer We've repeat this also took study, per dose of to was the been for well a transmission The And the of SBXXX administered XX-day or administration. unlocked, Over to our of during toxicity via Novan, berdazimer when To sodium the our as we extension XX at technology past XX by months, has the we've utility our the We assessed demonstrated to impacted evaluated in unlocked. tested, evaluate our routes with pre highest milligrams of intranasally the disease safety which results we an in COVID-XX. -clinical in administration cream intranasal the platform. vivo, berdazimer

respiratory What possible sodium. of Novan wants say a on with administration diseases. for infectious focus it again, berdazimer works inter-nasal new to against Just route unlocked is an real that opportunity to formulation

which though So and data our real lead be other are than opportunity. diseases. forward continue needs obviously positive is dermatological COVID-XX, Suggesting more this pre -clinical to that. differentiation continues only. progress apply than and a two can and platform with prepared to as real in a of Thus product, advance our encouraging broader indication both we API strive dermatological we infectious to that and far, continue with program products. provide Enough ways Novan This or to assets, for possibly

opportunities position the quarter. our will discussion end on the a broader to of cover potential creation? transition you financial and for Let's John, our finances at third value

John Gay

for Paula. for corporate I This update September for morning, and few additional our press XX-Q bought all briefly our to those And regarding [Indiscernible] points positioning. release detail, update addition will Thank a our our in call on current good we morning today. Certainly. thank reports you you, touch joining to key

ended As $XX of equivalents. of the cash the and quarter, end cash in million we with

us payments to XXXX contractual SBXXX. expected received us provide sufficient get plus be targeted QX, balance past capital this our for NDA to with submission that expect We

our the platform. with into Our runway capital XXXX current progression gets our us continued expected of being focused on QX

SBXXX a for event regulatory As and product to Paula believe to to candidate asset. that efforts and commercialization efforts indeed a time. submit transformative the NDA the for support is on We FDA the supporting initial noted, This an to exciting be Company. getting submitted an for primarily

In addition discussed. programs, acne, Paula the molluscum and COVID to

other in an our SBXXX candidate both potentially and value includes pipeline U.S. health. ex-U.S. atopic fork for the have a future, the for NVNXXXX also product potential for general This additional opportunities currently We represent candidates awards dermatitis. in that with SPX animal and our in companion geographies. and

to that, partners Paula. assets do arrangements. to to While or assets I forward, are avenues we for internally, planned currently these move these turn strategic potential it for with will look potential With back progression continue including other

Paula Brown Stafford

Thanks, John.

We're asked, Novan we why year X truly technology Company were and NDA why for a s just our proven Novan. different today X platform transformational in programs. frequently Some a submit than We've was XXXX We're X Well, years. now. across to planning ago.

clinical to SBXXX. to acne. We SBXXX have related important Confidence -clinical And to III robust SBXXX. pre data and Phase Data advance for

today. achievements lead that to shared platform. believe pipeline potential upside significant goals, All our our and indications. the tremendous opportunity in expansion alone. ambitious we've I'm team to with meeting of additional goals XXXX. exists goals. proceed the proud commitment programs There's tremendous with Novan our across opportunity as and me their us and And X shared of has our entire there's yet their And reasonable confidence we John in XXXX significant

will and prepared today, And now for Fundamentally, us We've has we're comments A do I I to lot remainder where stronger. XXXX. your Novan. our of nd Company in Jessie, interest ask of ahead our We left excited started. operator, and to facilitate all a conclude for appreciate never XXXX. I support been got questions. in the As the

Operator

begin question-and-answer from Instructions] question will Roth Speakers, our Participants, of Jonathan Capital. we Aschoff session. [Operator first comes now the

now line's open. Your

Jonathan Aschoff

on I us flows the roughly through you. capex? please Thank mill how through the that, congrats question your $XX at how first you for tell much could almost therefore, last With and I guidance morning Income or was that modeling purposes wondering statement through of and XXXX progress, Good guys. a much John. had for is

John Gay

question. your for thanks and morning Good Jonathan. Certainly,

look our correct. most have in you our some filed the continued and morning, capex. significant do scale small this our We at recent out that If you with facility results build manufacturing we of XX-Q are headquarter capability,

disclosures, notice quarter. we You'll the have roughly our accrued $X the in of for million end at

costs, majority has as the Balance will However, to I already forward, on or been we we that is Sheet. have but the continue move capitalized think additional either

I of cash maybe a through end the more of no this is come million expected to end quarter, the expect that part XXXX. couple than or So QX of would of a that few more runway in But of through.

Jonathan Aschoff

despite pills at positive calling Pfizer XXX and COVID all in the the progress, how Okay. Paula, rethink that Thank results Merck do you'll to those program? prioritize you -- you.

Paula Brown Stafford

not Thanks, question. good we're treatment to market. a the be to It's the And Jonathan. really, obviously first Yeah. going

elsewhere, As take another we believe, advancing right we maybe it X as or but respiratory And it's But even the disease. it's to product end, often that other option. time. are products with step now, I COVID-XX they going third, we're mentioned, forward, the at good treatment in second, because seen to it's be not have fourth infectious this a

we will But step we're that it at we advance to data a and X we're continue should time. seeing confident the that. very So do

Jonathan Aschoff

real-time all you. of are that doing testing interesting for? you is KINSOLUS is it sense. How That strategy, makes long actually was the thank an -- or And that's accelerated. any like heat Okay, it stability

Paula Brown Stafford

to There there's and a number that then be both. and we a have all it's accelerated for real-time is with agency. the discussion the the that stability have months and drug on and certain drug Well, of is there's both product. substance the And

in the and And that stability, that that of transfer tech on next and so manufacturing of terms testing and that's happen half our it's getting will in first year.

Jonathan Aschoff

Congrats Thank you guys. again.

Paula Brown Stafford

Jonathan. you, Operator. Thank right. All

Operator

The Jennifer next of is Cantor question from Kim Fitzgerald.

Your is line open. now

Jennifer Kim

you might off questions taking to start team that be How think in molluscum? the entering with have And for you does about CRL by change way well for as quarter. as thanks my competitor be congrats Hey, do molluscum your the on landscape. questions and the And the Brian. market this about the the think a approval? I you received upon here. Maybe few could whole

Paula Brown Stafford

it stands. or at to We we molluscum us. But over we by market by wish can't before, room -- really for we a now, office market our as the Right anything that used we the in they there market go And administered wish know caregiver. for bring as is that success. well both not, in said solution. several awareness patient And ahead always change in administered have that. comment we've typically, at-home with whether visits because product anything And they in the they're said, is because where if competitor. or we've have I of us. and our I home, think more in place doesn't on the them there's an would the don't there's them

Jennifer Kim

lower I'm do costs on OpEx, have XXX partially saw went know programs. any related costs for I just color from reduce down and personnel R&D how [Indiscernible] wondering, you I should the to going about costs And this forward? think we

I'm pivotal wondering with to how as about the just think XXXX. for after that planned trial So well Thanks. teaser

John Gay

of 'XX say for expected perspective, anywhere the clinical OpEx. [Indiscernible] our million the timing work. I OpEx for $XX to $XX of the to that cost the the be regards the roughly would With Certainly trial, would incurrence

including consistent as commercialization We and our continue to that work. presence, where at work pretty It's continue associated up pace. with ramp we we costs our Syneos will

we So yes, take work doing down our forward will to work R&D look clinical additional regards will take but as to Syneos. SB with a XXX, with SG&A on bit up

Jonathan Aschoff

and in And the known you for generally, the Could Okay. last market? you Phase positioning the X of the SPXXX, the out my market think data, topical lay question product about how given is opportunity maybe more RF that

Paula Brown Stafford

you said just want you make to about Are sure. for XXX, talking XXX [Indiscernible] XXX? I acne.

Jennifer Kim

Yes.

Paula Brown Stafford

was of those. I confuse in getting terms

you to acne think I do market. that, here that. want So with in Johnson terms in to me Brian of got of and terms actually the speak I've

Brian Johnson

the Happy great about is a agri than of everybody. And are it's morning, for is is to. side The on number There are prescriptions profession. being good that thing What there will Sure. huge a tremendous of market professional market. the that patients medical are we more being conditions. seen one physicians in a And the see lot that modality. written that the typically choose

different if put to they you together is, and The talked the that regimen So they dermatologists, they they that our X will come the market that they research. back it. a kind -- regimen to booked X joke And believe have. But different have talk to you've drugs activities dermatologists. of

the action a think works contribute recently, to market you'll that mode that anti-inflammatory. some be then have for That of our have lens be would So antibiotics, SBXXX then profile oxide antimicrobial. with believe on most our can to there. different in early acne will how different [Indiscernible], anti but it's that XXX understanding you also based programs of products other all which by of are regimen patients be expect with saw the it safety receiving the group products and across multiple along We'll combined be that [Indiscernible] is then a activities acne - of have all any a that it microbials, that the previous And as trials I treatment products like potentially action systemic retinoids you will get of impact of and out and of product we the or like opportunity another used we very the We'll other the in other than antibiotics. be when nitric have majority a well. the I in have on in We patients SBXXX itself, getting thus there different clinical acne the patients. pathogenesis, far. some mode the that

Jennifer Kim

you, Thanks, gentlemen. Brian. Thank

Paula Brown Stafford

and Thanks congrats, Brian.

Brian Johnson

Thank you.

Operator

Vandermosten from is question Next Zacks. of John

now open. line's Your

John Vandermosten

Brian. you an on along? welcome and Good morning, Can coming get John, manufacturing how update build the new Paula, it's and facility aboard

Paula Brown Stafford

in it progressing currently Sure. It facility. aren't are always on Yes, each are individually. is looking we of at to a headquarter supply Not is and here We're issues us other. our they planned. as And chain Durham for challenge as say progressing track. for each that here you

and taking off have we'll the part So that in us we're early up running and managing nothing there's of year. right but through next now those, track,

John Vandermosten

in assume know there's much fourth How all Okay. that more I right? the I to capex in quarter, be complete would If approximately? what said will the just sure, I in you XXXX. be? be be capex be going will wasn't XXXX will it that Is and

John Gay

Good be with will be throughout It the even would part then the XXXX. completed outlays, cash obviously of be finish look some can into morning, through and we capex after by another the perspective It the have at agreement. probably, magnitude, There call a will next There'll the that year, first it But from in the John, 'XX. expect dependent way. we're cash from total We that build-out. $X year lease the and some the we in so. a capex. costs allowance through do completion basically cash million deferring helps TR of offset incurring the flow and our through here or you it's outlay -- roughly QX for

John Vandermosten

than it from almost completed done, or basis. completed -- on you're will be a will And probably it Great. I you're modular done it but Okay. just less modularly away six at it be getting then will guess be once? all months

John Gay

half modular. of May this as We've the we year. describe building been in of got front actually since the we So John, it building, the

which be end to continue that manufacturing to the suite, by the expect the we As done year. building, of back of the we is half the

John Vandermosten

different X parts So it. of

capabilities Okay. Can us remind of facility? Great. you other just of the

John Gay

capability and product development. drug Certainly, so a the for manufacturing. API small-scale CTM for potential That's limited future small-scale use really continued has our manufacturing for about for thought

our here R&D campaigns our The initially but really and be perspective, to API be of quantities. supply it'll also greater purpose supply utilizing. registration the for manufacturer our potential used an the plant continue counter-parties the here support facility will we're support for commercial is SBXXX So with development from that CMO of for chain the to to our part chain

John Vandermosten

Great, Okay. on some to other follow-on of asked. great. analysts the question what Last just is just SBXXX

expected it's to trial. patient still basis on thousand costs to just your that be it's think patient I should is a to similar that B - SIMPLEX? a per -- we sorry, I'm assume and What be estimated simpler to going for

Paula Brown Stafford

is The be learnings different from will similar. acne, design XXX. we but what of successful our different. very obviously design The -- yet because from execution we taking the we've Again, are would learned from XXX. our obviously

we given the patient cost, run that $XX a math. that trial. per million is but said $XX do of In and you to million the terms We've haven't trial cost, between can probably

John Vandermosten

Thank Paula. Okay. you, Great.

Paula Brown Stafford

Thank Operator, you, other questions? John. any

Operator

Doliver Capital. Kemp Brookline of

line's Your open. now

Kemp Doliver

And Great. morning. you you given to each Thank how discussion, would your assume prior but guidance? hairs, SBXXX, current to given the not SBXXX good split do and you far and regard with advance

John Gay

Kemp. [Indiscernible], Certainly

regulatory you only as [Indiscernible] of So will, relates guidance in SBXXX, year. encapsulates first the runway, next our Phase half XXX. and trial for X the to a it But through current investigated if but

anticipated not related regards included include With preparing trial. the X Phase that X forecast. does So XX in but Phase trial it SBX is acne, activities for in XXXX, include that work for to that to does that

Kemp Doliver

Okay.

Paula Brown Stafford

questions? other Any Kemp. Thanks,

Kemp Doliver

Thank you.

Paula Brown Stafford

All any right. other? Operator,

Operator

turn closing call now questions, Ma'am. the No Paula for Stafford I back Brown to over remarks. further will

Paula Brown Stafford

all excited (ph). ahead. Jessie you, Thank very for what's thank you Well,

today. we forward thank looking for you and we're joining you. us So to Thank XXXX

Operator

you conference for today's Thank call. concludes joining. This all

now disconnect. You may

NVN Liquidation (NOVNQ) 10 Nov 212021 Q3 Earnings call transcript