KRYS - Earnings call transcript Q3 2024

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Operator

Thank you for standing by and welcome to Krystal Biotech's Third Quarter Earnings Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Vice President of Corporate Development. Please begin.

Stephane Paquette

Good morning, and thank you all for joining today's call. our for released of third we XXXX. today, financial the results quarter Earlier is website on press available The release our at www.krystalbio.com.

We XX-Q with earnings X-K earlier our also today. the filed SEC and

will and Research and Head Vice Officer. Jennifer Chief Chief today Joining Access Chairman of Vice President Marketing; of Development; Romano, Krish Christine Analytics Accounting Krishnan, of Suma and and McDonough, and Operations; me and President Kate Executive be President Officer; Sales Patient Senior U.S. Krishnan, Senior Wilson,

our to questions and forward-looking will contain call statements. conference This responses may

are A cause company's not uncertainties differ that which risks, certain of and results be uncertainties expectations information You cautioned and these call, to other forward-looking to may as and are using factors risks rely in the statements, of available the filings. description our can on this SEC subject these those actual projected. current found date of based to on are materially from the

Krish. will I turn that, With over the to call

Krish Krishnan

our expectations diseases there by and call. Thank our Good other to PR has And the any to we primary drivers launch we're of launch well X to are all believe in set generic the the success. Look, in launch. mentioned time X-year exceeded you, my achieving date. at morning, as way that on I to we attribution, Stephane. welcome In target therapies, mind, the orphan comparison or my this for

physician especially our convenience, is an physician focus and itself a and a the will pace cetera. on that indication time. drug it's drive obviously on where first demand been are its the they patient of expectation being, at and We've comfortable safety, to long drug being be for all assiduous they allowed the experience. with, in et The attributes rewarding, efficacy, And second with patient patient the

VYJUVEK in opportunities Ophthalmic next few come of into registrational study formulation months. top the towards progressing for a that, focus. global On is

our debt and see year-end we're VYJUVEK on to market In we globally patients total opportunity increasing upside ], in treating with month, the JNDA before starting granting in VYJUVEK HAS track for for CHMP demand so the reflects Europe, in access as comprehensively. our on France significant opinion overall with toward franchise And we're And a the in track for we're presently launch for work submitted recent and early Europe. the also breakthrough [ reimbursed Japan. last XXXX

Japan, so And preparations launching sequentially are all EUX, and year. underway for U.K. next

from deep including programs X forward signals Aesthetics', of based first on readout was clinical a year-end that propels many Meanwhile, HSV-X hard reporting the continue pipeline. Jeune tissue us has data Phase work data our readouts for on year II before first We're the study to and stage where to that to the expected and more on date we in to had to with approaches. clear forward also That other delivery Jeune QX, gene to reach Aesthetics' saw to looking KBXXX, upcoming next a pipeline. been a our efficacy positive we start lung,

rest and commercial fronts and the the and we're on XXXX So clinical excited forward both to of look XXXX.

the through the and the stoked forward. litigation and mitigated of litigation to additional expenses from accrued U.S. prior our in it there Finally, related both sequentially in once approvals the did profitability, $X.XX litigation this VYJUVEK our ex strong up quarters. sheet our per happy to per $X.XX we no will as formulation I'm the outlook eye share, in second U.S. about near super accrual franchise, the were Krystal. that be for million in moving again balance increasing a quarter X drop of $XX.X launches and and EPS upcoming Krystal term was With is at report our expense quarter and expansion share In both long-term This profitable that final XXXX. again QX,

results. Moving the hit behave the this in after since Also, calendar in net potentially to for are Net is for includes quarter, little accrual in please strong revenue $XXX,XXX over year VYJUVEK to achievement reported already value XXXX. of expected. growth in now VYJUVEK total XXXX Thanks commercial as to on this and million. cap today only plans VYJUVEK the to from margins we VYJUVEK patients suffering continue note Q Achieving who providing million, revenue patients milestone our revenue GTN per came gross to a for a organization has while projected at gross surpassed is sale $XXX to achieved a August $XX.X tremendous testament that year our the net a first again our per DEB. contracted patient launch

years With I'll to accomplishments our and expect to Jen? recent our on fundamentals, off and we that, more detail hand to for will sustain Jen it come. Christine share which launch strong

Jennifer McDonough

report works to disease. over pleased growth in Thank summer VYJUVEK quarter to and of U.S. patients more tirelessly another am team access you, our more of this the as Krish. strong across terrible headwinds spite help seasonality I control gain

summer the Reimbursement with quarter. These are As seasonality disruptions over now effects of of to number reimbursement us. patients approvals XXX. approvals were October, impacted by scheduling in modestly up is behind transient this

to their been patient thanks have access that outcomes. we adapts support time reimbursement keep achieve positive to for schedules to importantly, applications track and able on lines, patients and to More infrastructure our flexible and

of population, or evenly in with plans. approved largely has and and for line commercial including disease. With ages forms U.S. access enabled is the of rate the for coverage complete the Medicaid been us are nationwide, have either reauthorizations, or recessive up VYJUVEK are in for sustained split This across continue splits us success success Approvals commercial strong. approval roughly and achieve recent the process to sets XXX% a between patients either near dud to well all come government and live in on domain and all quarters Reimbursement with entire patient

care closely that health approach home works preferences. Krystal providers, the Our patient-centric a on employing team focuses needs and patient Connect with

of This other experience, best family's successfully weekly With integrate X treatment is and ensure back-to-school team [indiscernible] occur vacations, weekly the now team effectively and patients into enhanced the summer treatments and the developing Patient The over in implementing resources activities, to such for experience real-world navigates and year receive the VYJUVEK. possible of developing normal things preference is home setting. the family as tools administration XX% strategies at-home currently, education, unchanged routine. staying schedules to on patients for nurses. and includes working

recognize hydrophobic as each impact practical needs treatment, such every for topics for and dressings. wound has unique the that the patient disease patient. on We focus varies considerations selection of and preparing options We for for

potential identifying early Our promptly. and regular and resources them monitoring addressing include program points treatment progress to support touch issues and

dystrophic While both a new see dominant recessive time, including extended continue have VYJUVEK and that treatment maintenance population, patients starts over to who in please we are patterns we our on for compliance seeing study, weekly high particular, in for been treatment to patient been of some emerge. that period for dev note XX% at our EB, an OLE across have participated

treatment pauses includes between due closure. wound This periods to cycling of

can frequency down in and believe to it weekly to across to entire or quarters. early, expect treatment the we would we upcoming reported treatment the prizes, trend it's the estimate compliance premature patient duration of While be base

have smooth team Connect starting on staying our the As is a Krystal ensuring launch, focused fully continue experience on and we patients therapy.

and developing treatment and satisfaction. strategies that investing outcomes lead are better in We overall to

need building therapy are to are it. where providing when and We and access to long-term they relationships corrective patient committed sustained worry-free

track it hand now off us ambitious on will I to prelaunch activities to marketing recent most discuss sales hit Christine. penetration targets. to and our which have Christine

Christine Wilson

Thank you, Jen.

sales on launch. date, to in As the mentioned, we progress identified demand roughly marketing and of a happy our sustained seeing for target XXX patient achieve the ongoing based ambitious penetration approvals we X to say are of field, of and just organization. at efforts remain an We pool, set I'm equating this goal. Jen on established XX% the reimbursement within launch, to track we that years goal commercial to our

and claims activation the medical education is analytics, core off. patient pillars strategy paying Our focused commercial on of X

We care and impact both the VYJUVEK and to awareness strong demand patients as and we caregivers. are continue health real-world community across centers key in seeing to professionals, drive the of

Healthcare major a remains education focus. professional

We clinical showing data seeing the support FDA-approved on only staff that from the VYJUVEK death wound their real-world home. use at supports patients disease and of and to are educate therapy results continue is long-term sharing how cause that localized in physicians treats the stunning all to severe the patients for genetic healing

onboard experience for a regularly is the model base are we community to may both who streamlined addition, patients. prescriber expanding. physicians, educate the customer-centric the on started not on The see getting these a in VYJUVEK. the working that delivers their positive patients high-touch, In is those them particularly patients process and This for with prescriber

our efforts are were at Over of see XX% in prescribers effective targeting of the value physicians that ease prescribing. new and VYJUVEK and both the community of This KOLs and XQ writers. demonstrates

We have our progress made also in significant direct-to-consumer recently outreach.

showcasing live social impressions, social and million reach. to launch some along user of whom for into with engagement both over media, planned channels, social VYJUVEK. our January XQ all adult generation direct-to-consumer year, prospective continue advertising served social The will caregivers our now has this new on real-world connecting XXXX. and patients therapy lead advertising platforms, of XX.X media on and experiences are drive been with paid patients, expand We pediatric on have since Since

their which and Members benefit to the also place of well EB one real-world well those honors EB VYJUVEK as advance live last their EB dermatologists Awareness attended or Deb champions our just webinar mission of the in week, the patient our EB patient the brought These feature and [ that as during part with the to and community partners. audience webinars caregiver target of EB webinars annual patients showing [indiscernible] ] hosted has in recognition advocacy for as experience conditions. which VYJUVEK Krystal physician support of sponsor and Week VYJUVEK ongoing conjunction experience positive our Krystal research Awareness care. impact personal team a as with took Finally, as of educational and Week, team

rewarding set but and commercial into These only optimistic approvals patients education, are from targets our ongoing awareness, we help ultimately been more highlights these we past later grow get deeply to streamline we them near-term that treatment translate efforts have drive reimbursement experience see achieve to continued years. just can well physician and not efforts few It faster. in the the has on are a with

pipeline hand off I share to it to Now will Suma results.

Suma Krishnan

you, Thank Christine.

both commercial for advance have with Our medicines. an to with development and GMP application milestones a in marketing we over has our PVAC, In pipeline update patient of [indiscernible] And authorization past to EMA's and the earlier our for execute our months, manufacturing patients and next year, genetic access, including diverse dosing from off key of broad broaden a is also year. but Leading the Europe few [indiscernible]. and achieved review latest steady global development granted not well. interactions Japan progressing progress Europe, on that this facility for label, commercial support launches poised only of home debt was suggest at EMA our team continues EU level. high redoseable the certification

access CHMP we for half reflection [ early also on ratio and AXA the APX September approved risk regulatory a innovative before by interim, with in in is benefit to program, in a a under out to Otorite-Desante breakthrough Based expect access unmet achieved first in need. of prior in that population Germany year early under France of positive the therapies premarketing strongly to provided the reimbursed patient expected B-VEC France and patient to the end approval, launch is we access discussions, this back union Pecos the first B-VEC France access allows of current an year. a pace in the later in of XXXX. In high ] start to decision APX

recent physicians in launch. to also rapidly this broadening with also the Japan, commercial Japan a of addition we clinical even advance In with experience opportunity major will B-VEC application. drug In access milestone in build new our an approval submission France, of patient with provide achieved to

Phase a Japanese of results Having extension registrational the closely in to include on trial. for Japanese in drug mirror Japanese putting as Japan's authorities orphan review the by XXXX. by expect both Device launch III results authorities open-label the our received study those and in patients, designation which as we well Agency, us previously application overall Medical Our track decision Pharmaceuticals our from priority

Shifting to focus pipeline. our broader

wrinkles, taken significant excited in and to hydration report Napoli field year. durable attributes, We but Phase clinically In reports potentially last KBXXX aesthetics are We with many upcoming improvements including the of our data clear progressing reported physicians This creepiness. forward first previous the of product I look very robust as of readout together state KBXXX, the other we for radiance, [ into quarter. many ] in sensational June is signal a and aesthetics. KBXXX, benefit, readouts [ to just ] Fc beginning. regenerative next This the skin

the we to and Before updates expect of end the XXX KBXXX programs. income disclose year, on

year. therapy our which safety, bronchoscopies provide Cohort and for Phase patients strong key pharmacodynamic CertainTIME-X molecular is in amendment currently alpha-X to [indiscernible] allow before recent levels we antitrypsin the protocol enrollment to interim and of single-dose tolerability, being open-label, end hope an include alpha-X with in evaluated [ assessment redoseable study antitrypsin inhaled KBXXX data our of deficiency is biomarkers the in X, I ] to adult anti-tip study. is escalation with AATD a

to readout, to studies interim to safety this happy KBXXX share rabdommyosarcoma, lung. systemic been data disease end KBXXX and escalation a tumor rare granted the to micro with data also modified are HSV-X well. phase, the immune has in in the dose Two ] expect being I And by formulations, expansion the the HSV-X our to showcase significant expect studies. and by Both we and human gene update an year. Fast clearance. the designation that on environment the [indiscernible] disease one, genes pediatric KBXXX to [ I'm and delivery encoding the profiling of and evaluated focused injection share are A before early granted designation now intratumoral and for HighXX inhalation FDA. designed pediatric immune-mediated of vector other [indiscernible] both resignation potential tumor Tack enrolling was treatment of rare for for we is delivery Phase IL-X both for deliver promote

additional [indiscernible] KBXXX to in a on on follow-on X for in are fibrosis. We COREX expect cystic oncology study including evaluating Phase We recently report the sites updates well additional clinical as half of KBXXX data now ongoing as activated Phase I first our XXXX. updates data our study evaluating an in initial I and intermolecular XXXX, program data KBXXX from path for

our to formulation both designed [indiscernible] complications interim developed from continue the ophthalmic of natural ocular we patients Finally, we trial, our year. are to be next open-label history study track data of in to start registrational enroll treatment the single-arm evaluate report prospectively and on In our will [indiscernible] study for collect KBXXX data newly a in with the B-VEC depth. depth in to patients. interim, on frequency corneal abrasions of

This study to eligible study. registrational may enable who participate as in should for enrollment and be patients serve accelerate us period a will [indiscernible] this in run-in also to

genetic these program. results We therapies. expect have sharing updates as highlight as trial differentiated advancing of entered our to exciting unfold we will uniquely pipeline period Krystal an the we for they unveil visibility gene our of delivery look that and forward We

would to call I like that, With Kate. to the turn

Kathryn Romano

to low quarter growth million third first product approximately expensed of net Suma. quarter, goods of or In to development product $XXX,XXX over In product result of of net manufacture of a to increase million at was approval of significant margin expense quarter third cost of in previously quarter quarter and prior had about gross sold representing of a the the $X.X our of an which revenue the the XX%. for research of approval. cost Krystal revenue, a was resulting being X% in as third revenue XXXX, the sold portion artificially was May revenue after $XX.X the goods VYJUVEK XXXX. with you, of million that Cost continued saw Thank XXXX, we $XX.X

costs of $XX.X of charged Research of costs being following $XX.X Higher quarter. VYJUVEK costs expenses quarter for development of quarter for third to million due facilities capitalization in partially million, compared clinical million inclusive stock-based third increased cost expenses over this inventory indirect pipeline R&D-related the direct were for year's were inclusive compensation to and and of and $X.X manufacturing offset prior development These FDA stock-based increases were to million and approval. equipment quarter manufacture development research our candidates and the compensation. the increased increased XXXX to R&D $X.X our of by

periphagen quarter the year's of for of the Selling, million, commercial $XX the $XX.X prior general is selling, increase for $X the this million general were compensation recorded increase of expense to marketing milestone cumulative compensation quarter primarily and days the administrative following of XX at result and in third stock quarter compensation The again administrative payment prior quarter-over-quarter. the million in of SG&A compared inclusive final Form XXXX triggered and achieved. reaching and to of milestone which the in is increased professional anticipation We within in related settlement which quarter VYJUVEK the inclusive of is litigation costs. $XXX of in service the third Higher were million $X of million $XX.X million. our significant expenses our fees expenses to $XX.X third $XXX third million quarter, due related million stock-based in XX-K compared year's the of stock-based expense to settlement filing sales payable

$XX.X accrued for related final now Net XXXX. achieved, payments making We $X.XX in per the the per diluted basic fully share. if anticipate $X.XX early of matter million, for income the and which and quarter entirety was represented this have

between full guidance of which December We have expense is million R&D XXXX. million ending narrowed be expected $XXX range now XX, the $XXX and the to our year non-GAAP reduced and and SG&A for

guidance stock-based the this compensation. impact of reminder, a noncash As excludes

long-term in overall total cash million position growth over the on million. XXXX we marking second cash and quarter of investment million plus with quarter cash increase balance ended an and $XXX and $XX our third cash our investments quarterly with by about and short-term continued $XXX.X investments, hand Finally, in in

And turn to back now I will over the Krish. call

Krish Krishnan

Kate. Thanks,

for closing, be years in the our deep ahead driven to I'd like to So both creation the significant clinical potential pipeline. in highlight and stage VYJUVEK value by

Our well. revenue VYJUVEK already in $XXX very net is million progressing launch, over achieved having

last in do our However, as trajectory launch anticipate for we That overall year, life over holiday we of in many the way remains of unchanged. gets saw QX our conviction in as said, families. the disruption season the some

see importantly, of the opportunity we More is this the VYJUVEK franchise. the only beginning for

HSV-X for platform. X for of KBXXX, the resources potential development yet the open the of positive reminder scale for the coming of In quarters expect the be for our ex-U.S. way true formulation maximize we pursue infrastructure, Meanwhile, we a gene think our driving our a value And EPS, years, is With revenues, up, significant growing manufacturing of necessary launch and our our to growth. significant we to readouts we KBXXX, to a of multiple with potential shareholders. drop coming like and call in opportunities expansion to see the GMP demonstrating have such revenue these that commercial based therapy [indiscernible] words in-house of on the listening. I'd in both Q&A. we're efficiently Thanks pipeline.

Operator

Instructions] first for question with Your [Operator Alec today BOA. is from Stranahan

Alec Stranahan

us. X Just from

could out any But trends coming clinical still for appreciate I duration curious into wound on closure. First, us year we studies Or your for you sort currently? are of if sales this? the we over closures of when point there's something this the wound second, year-end? patients be their throughout annual many evolving. probably should duration data how of you sense this a is of adds model offset could the or cap near patient should And of give new to Is at looking time,

due receive of pause patient wound closure get again? to sense need to trying a last Just long could therapy a a would to before how

Krish Krishnan

on are of aspect We're first this Krish -- is to cap. On patients the disclosing hit your first your on particularly not here. Look, going how many question that it.

much respect kind net point volatility I sure of the other make glean And QX, QX further to track better over couple any to whole of in can think growth I the of revenue no into we'll sense that quarters. in we QX. a make whole to to to caps was revenues on GTM respect QX, we're point. duration the You mention. sure pretty smooth there's And want that of and point. growing That's the as is things with net have the the and wound go With a closure, of launch

location wound, this be Look, varied activity, -- across the of pretty the of and the there are the depending on can individuals. nature

some science wound still of about average the stick to on patients, is thesis to it seen be we larger XX of wound durations much which Our for -- stick still in expect we've collagen, durable is though half-life even the the given behind we closure days. to

Unknown Executive

is good from we I activity. patients agree. But guess and go clinical physical mean these also We I can are activities, can do can also seeing are The they are are wounds staying out benefits. hear closing they now mean, what we very patients I and they increasing durable. their happens more work.

of As -- a result, I breakdown they're skin, in benefit see treated vigilant. want treating they they mean to the but because the now very the see they be wound

So are extra the cautious. being patients

So even they on. the they write want and up close the open, back drop if wounds if

that So that's in setting. the we the commercial see trend

Operator

next with from Yigal Your is Group. Citi question Nochomovitz

Yigal Nochomovitz

about curious your just was marketing campaign. broader I

media helping of market patients? that's comment effort rate any to it's And on size, you XX.X that how very that's actually you footprint just as low working So curious new identifying far but has extent impression. start? the platforms, about a to something I identify translated Can the what I'm think given Or the obviously, if mentioned broad as social conversion patients?

Krish Krishnan

Christine?

Christine Wilson

do patients goal may Yes, receive to about campaigns our us allowing they social Sure. are be excited media our and wherever that. we're is to

period of engage to them are allowing We accessing sets benefit solutions keep for a is been with done that yet not in CPs. time or and that them reach seeing engaged healthcare signing and of XX the some engaged are haven't them

our reach getting the patient our mentioned, we every base are by were goal and ultimately we're in from will, the as right, you is space. pleased, a ultrarare as there. to to begin one opportunity volumes one patient right, So But with,

Yigal Nochomovitz

Krish, had on more [indiscernible] launch. think, curious comfortable the was call, I the statement the you number any then from XX% of terms or of last at you now? that you're thoughts that if mentioned sort that with patients updated about X,XXX base And that forecast Okay. in just I'm

Krish Krishnan

comfortable if a of go up. terms to when significant hit report And moving we reported more The we yes, milestone forward, the comfortable, In continues we number. were again. But trend we'll and and be more patients well of VYJUVEK tends goes used patients the beyond up, estimate. market starting as we the to expand the the awareness original volume see to are increases,

Operator

Your next question Baral TD for Ritu today is Cowen. from with

Ritu Baral

my oral on going comment if and point today. this I'm you you to received focus Europe I questions? similar topics Have you're XXX-day can you've and on label whether your questions the expectations. was point, X then it think with guys the to expecting so, And arguments. at whether And on responded

What -- down for to You Europe. And on that how thinking say literally in on Is pricing is versus best but that? pricing can on sounded go patients mentioned in recessive about be could question then from you it Europe? we follow-up DEB you question should and model that birth you like a Krish how dominant. versus pricing to comment didn't European the U.S.

Unknown Executive

with the today the of issues I the all to -- point an Thanks, at meeting XXX And XXX EMA be questions. to at our most is we in set the seem Ritu question. the receive a doesn't as the are moment. -- resolved. the response the There did Yes, for response fact, question. mean oral

as regarding way label, where the the EV goes now be based that's on right includes comment representations in on the SMBC. both That the our we is the and label With patients. dominant SMBC So the for to going birth to XXX-day from stand.

Krish Krishnan

on very excuse -- me. to On the We're maximum going starting possible. to do our Ritu, we're best pricing, get price

with I negotiations pricing, Germany, in of X to to accruing launch. get XX think about first land of end end we country X expecting months. with start example, price we the will the we of for in launch the for the At months Germany, that months, certain start begin a price as at the first U.S.

pricing actual XXXX moment. get doesn't XQ this in the the first So in Europe country set say, really of, until at

We given will have an the NBP. price have-not

is the AmDocprice So be [ public ]. what U.S. will and the

look the between an of expectations conservative the best vipers the [ of U.S. somewhere XX% overall combine and to make XX% But very and product all ultra-rare strong case price, our all you for the U.S. at the disease a differentiators we'll Europe, to do in if ]. for end, [indiscernible] given us, land about

Unknown Executive

want one more is still home euro. I on to thing we just to add dosing track are get in

So the days. XXX based on

that's us. So for positive very something

Operator

Your William Corwin next question is from ] [ with Blair. Amit

Unknown Analyst

next launch the How do year? measure And revenue any XXXX? the in as are expect giving declining plan and VYJUVEK to impact [indiscernible] the reimbursement then pointed you compliant on do follow-up, approvals Europe to for of And revenue? you us kind for the just a in kind launch Japan What guidance a U.S. you of metrics as we of looking

Krish Krishnan

first ahead What were the saying? your first question you of missed of half I the guidance.

Unknown Analyst

compliance you impact How in revenue? the decline to expect

Krish Krishnan

expectation about vials In time [indiscernible] patients a months of days the be launch. was the XX vials to the in much our our a recessive -- expectation more the U.S. the the in would we that with was launched would Look, ahead had compliance X the launch. We expectation at That post potentially were to of month, seem be get X at proportion of we launch. the early because was severe when launch, and when respect time of the to it study month utilizing overwhelming patients

higher bit a of little that. tracking we're So

over to don't months at and already get we like X XX months. XX% to We're the next expect

revenue higher patients the So as talking we're we're the And to is internally of that, much still I ahead. With study. percentage respect than mentioned and dominant because next before, it. year, patients primarily about the our is thinking in guidance

the have closer progresses. put in launch which actually get We to position launch ourselves to in rate XQ where expecting at out German and EU have we figure an we're a the early

And then we're APX or up program. in France under the the APX

more So Q the parts on to clarity hopefully, we'll But the this to we guidance year France. of going the different. point. to bit moving your guidance extremely have definitive to had different a about respect lot in the in next comes by It's be bit Japan. XXXX. is about a U.S., we're question, a talk time next a what with is at than Germany In reimbursement last respect bit approvals. everything With different than EU, around,

haven't at for revenues best terms we we up get down makes this to point of the expecting XXXX so about what end sense in as sit made net in decision will what CHMP the time. talk closer a opinion, and And being. And

Operator

ISI. Your with next question for today is from Evercore Gavin Clark-Gartner

Gavin Clark-Gartner

AATD in just at and of augmentation data many and can the focus how in A first on lavages level also with just done patients patients wanted be later amount the this that therapy what cohort, the remind can on that we'll us data be to year. I the Like here, per are cohorts you and getting? on time question coming which point?

Unknown Executive

the we of happen in cohort X. patients. We X now, Right are in enrolling enrolling process Yes.

to in this enroll that evaluate this patients we that based molecular We We nice we cohort dose additional need cohort to NHP NHG feel in really are animal and going the expression because study. correction as the X, animal dose this model. a equaling our for study is on our did

on are patients. They There augmentation conditions now, additional on augmentation. patients. So we right ZZ have not are are we patients have that that and basically

So before we will in correction evaluate them -- their long lavage. after molecular for do and

data low of [indiscernible] on multiple regards to biomarkers, couple So hope cohort of that the expression, of with of have are the levels to by binding year and we neutral. hope locations year to before end up end have

understand, I of will have [indiscernible]. complete in held I So are what a picture

Gavin Clark-Gartner

those either the [ what's That's bar the measures? bronchoscopies will bronchoalvlar And of believe or ] on informative. do helpful. the you that more be lavages And

Unknown Executive

we We noticed their [indiscernible] So we did were I at done. have collected we looking have obviously, mean, patients we baseline subjected are these everything. broncoscopy to the we -- biopsies. [indiscernible],

we So have [indiscernible].

all taken at X So baseline and was after the dosing.

look of So it to completeness will at looks all that we what like. in understand

will in -- AXXX, levels AXXX,at levels, see mean, to the we expression good have mean, I we to As of patients [indiscernible] are hope mean, hoping far least one -- we're I the as going again, I micromolar again, not so these

Krish Krishnan

point. one Gavin, I do want to add

situation. -- So to our into of right? mechanism, a type a AATD good redosing following one redosing a go readout and in is objectives are We

target clear, while is package complete ourselves, the to you enough to But to want point, So program do close any if kind have and of sense at we get look to I for forward. any of of we what it, set in redosing will be the kind situations. we one a like do we've at these move look not this of are the levels

Unknown Executive

I looking of at the AXXX right? also we are entirety, at mind, You're in mean, binding the [indiscernible]. keep [indiscernible] looking

just So a it's of AXXX. not present

you're seeing it's sure and You want [indiscernible] functional. wild make to

critical. that's So

So to And benefit. are we're the going those to be data going that's to that's of kind critical led -- clinical see -- that's what hopefully, for us.

Operator

Stifel. Ha Gon question next Dae from is with Your

Dae Gon Ha

Two from well. as us

community curious the VYJUVEK back of Going color little was is if dots. I of can the care, centers you more between the bit maybe I kind you [indiscernible] to launch that distribution guess, give reimbursed. metric, XXX a being mentioned around us primary how and

amendment growth here. of and it expectation clarify into is we kind of and the [indiscernible]? Suma, redosing the and without or recall that and Just the the curious set X the as therefore, well level go make X just [indiscernible] was which to kind secondly, as QX Cohort decision a you should for go-forward the X? Or Cohort And will through is still Cohort and what after be expecting of AATD, XB, protocol the kind future? year-end you will I on update going XA

Suma Krishnan

will answer Yes, don't go team need question will then -- move commercial Cohort I your to, so to a take if Cohort expression see the X I'll and we at first, mean, see we Cohort X far, one. question any because toxicity So our not, think the in to and the I your mean, think I If I to option Cohort we we dose-limiting X. stop I have we X. think

I have we So go think the into good option. board or dose see level X at will But be now ready we X. pretty to we auction Cohort if then, X. see right [indiscernible] Cohort with think are you get Cohort the -- what I a And with we go to we

Unknown Executive

question happy I'm number to answer two.

the Our in setting. balanced the and been success has fact COEs both that the we community built growth on

prescribers, are community where across mentioned, the all in patients setting. to our United new XX% In where biking the we the find is to very way. either claims in see including our QX coming healthy because as back. who States, in was were identifying of Our KOLs the these we successful a What in in of haven't are through COEs that VYJUVEK in prescribers yet and that's and the continue patients community are COE new these allowing approval patients the alert, since position setting, patients maybe seen but us

see to need see continue trajectory growth order we the us to we today. do So that in for to both

Dae Gon Ha

guess, X X clarify, I cohort update the AATD. and for just for Suma, year-end to data

Suma Krishnan

mean keep and in we'll Correct. have what more to portion adding the enrolled for. we we're I that. hopefully, showing patients patients That's broncoscopy

Operator

Your Instructions] Debjit Chattopadhyay next Guggenheim is with [Operator question Securities. from

Debjit Chattopadhyay

season. a be their should a is caps as So the holiday guidance, flat think you here? a about quarter? going sequentially expect growth approach of patients How the on Or understand I Do lot reimbursement with then coupled to XQ? significant we moving parts. And XXXX this

As but concerned, the now not especially Europe trends under the and you U.S. summer is your that season both far holiday have why the market, to guide from belt? as

Unknown Executive

And remember the the Look, comment, made the family their or vacations patients have I'm and question, a after not I Christmas. Those the confusion are through make Yes. reason weeks to trying Thanksgiving have some only is first QX. nurses only at year I we came whatever, like the to least last of point dose schedules. own also try X to and due where or on a

at right to of life to just concerns directionally or said comment now on holidays, point XXX making gets track post as that only the approvals, alleviate some We're not the QX we in about for the weakening saying, wanted time still way. I launch. the the think to flattening. So was reimbursement please for reason by the

guidance to right. are XXXX, you respect With for

handle of We a the better U.S. will have much

some countries. a ex-U.S. France have not or the or other of will handle We Germany

potentially to be year, Japan. a of useful even QX, that down be at if the Fully the and it to supplemented we'll will shareholders end way so France Germany in sit model. And something realizing and think as and revenues the by hopefully about that would that's into going

Operator

is Newkirk ] Andrea with Goldman [ question Sachs. next from Your

Unknown Analyst

Maybe one launch. here European on the

as you you share Just do Germany. infrastructure for do curious in prepare type you required to And as could activities starting launch look if then believe this currently support potential to what of launch? underway you the are next what is year,

Unknown Executive

starting the The the Yes, -- the launching on in. several the going team Germany and pricing work in by of be Thanks, we're first countries Look, respect negotiations is the we're to [indiscernible] probably to a countries. in in dossiers of France end Andrea. is commercial commercial expected in activities, and With ahead X place to year, would be team to

infrastructure, commercial level. -- includes XX per of we're employees In that And access, much all of somebody pretty country terms look, usually not maybe reps, about a affairs, somewhere medical aspects expecting cetera. we're for at like et high

So XX would estimate countries. a the European of for rough employees be than country less per each

Unknown Analyst

each countries to potential in of guess, maybe come should as it. expect those those launch And we closer the be I onboarded, -- those Got online? to

Unknown Executive

France, early them I In by maybe the the the before some year next onboarded some in of and most of end year. will of think year. the end be Germany,

also out and -- we a team also have so And -- Japan. we're in

employees We the X and [indiscernible] half today, they'll anticipation launch have of in in Japan. onboarded like be X in first X Japan in to a

Operator

in no queue. are further questions There

Unknown Executive

joining you. to for any the in follow-on upcoming call. So [indiscernible] look all Thank the questions answering thank forward you days. We

Operator

Biotech's event. today's you This Krystal Quarter Third Conference joining Thank Call. concludes Earnings the for

your You Thank may your phone for at have lines time, day. a you this and participation. disconnect wonderful

Krystal Biotech (KRYS) 4 Nov 242024 Q3 Earnings call transcript