KRYS - Earnings call transcript Q2 2024

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Operator

Thank you for standing by, and welcome to Krystal Biotech's Second Quarter 2024 Earnings Conference Call. [Operator Instructions]. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions].

As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stéphane Paquette, Vice President of Corporate Development. begin. Please

Stéphane Paquette

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

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

President Executive Access, Wilson, Development; today statements. Senior Jennifer and will Chief Vice Krishnan, Head may Analytics questions President Christine Krishnan, and President Chairman Krish me contain Suma Sales responses Vice our Accounting of and Patient and U.S. McDonough, Senior Operations; Romano, Joining Kate forward-looking to and will Officer. This of and be Officer; of Research and call conference Marketing; Chief

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

Krish Krishnan

all a the great during pipeline. for Thank QX XXXX with call. respect was both progress Stéphane. you, we continued Thank on and great clinical the you us, for make quarter joining which to to [indiscernible]

unmet as first strong forward organization. our what from serve that [indiscernible] mission quiet and as reflect suffering treat in quiet, the we XQ debt that develop for year. Today's benefits DEB. They debilitating also patients we corrective this only can powerful a disease disruptions lives urgent us medicines and reminder The new are was DEB for external our to it comprehensively importantly, More realized to results from needs. to push improving this of an of achieve is therapy in of patients commitment the faced

launch. alpha-X these in Later for the a cohorts verge announce data on XXXX. We're remains and which to expect forward XXXX. for Net treatment XX expect further parallel X patient KBXXX unmet our quarter XX% KB U.S. aware, is accessible tumors. deficiency clinical of a gen strong delivering overseas high we program, the aesthetics of And fundamentals in in Patient to growth solid over first as aesthetic of look impacts, both for clinical areas. ] starts are a wave of wrinkles of antitrypsin the in and issue the ] are great and XQ We our progress Access, continue positive compared we Europe increasingly to new propel U.S. discuss I moment, identification. [ both also before in [ in in evaluated patient quarter, seeing demand Phase place treatment we interim product will as revenue updates strong. we clinical to Japan readouts. for this is to As you for remains treatment in was markets launches intratumoral and and the updates, in towards and year-end, being injection compliance growth we in up the KBXXX, the of both

in Additional are clinical XXXX. updates expected

presently end yields process produced by for for scale clinical year. approval our we margins by the would and of current invest the and on continue price of to continues with infrastructure approved scale-up fourfold. manufacturing increase manufacturing the vials pipeline, number our expanding the across enrollment The manufacturing to increase of are FDA run As our in with a working both potential process

commercial vendor start supply from packaging and growing to process discern, year. We're to global of on later slots ease any to at you further potential this ASTRA demand also margins markets. our meet improve track fewer As will constraints can chain this our with tech the transfer

happy final in more growth X to expenses our one generic execute QX. litigation market per year. $X.XX scale in portfolio as of expand per as and it first share, I'm and We of With bring did sequentially global were up the plans, mitigated medicines. again highly differentiated of XXXX. report presently quarter facilities profitable CMP in from that share Finally, once EPS accrual $X.XX [ million at growing accrued another reserves the litigation ever revenues $XX.X expense to capital strong evisioned our ]and this Krystal footprint for In our on quarter to QX, commercial a well long-term we anticipate

our quarter XX.X% of this results. from at $XX.X that of to Note the prior quarter onetime XXXX. revenues the million, now affected been revenue Net quarter came compared disruptions. to increase in by had for [indiscernible] Moving an first

of for So XX% $XXX our Total the first quarters and over looking first XXXX. VYJUVEK X now exceed million, in full rare back margins launches. Gross continue revenues disease the tier of sale since were net to keep with August top quarter. pace we

Gross XX%. to to continue margins a gradually adjustments coming XX% We improving be few XX% in net within in above to years. over first the the to quarters, expect quarter were

to expect in a teens, the roughly gross will high reflecting on debt and plans. of even remain government We commercial patients split net

also the that potentially for note plans gross were per VYJUVEK hit $XXX,XXX As patient of XXXX. calendar approval net on cap last the revenues commercial an patients today per year we include disclosed quarter, contracted in to projected please reported

successes, Our stay on rapid of the launch now our get Jen I'll was by Jennifer? on more and the Krystal. helping Christine, in fundamentals it tireless therapy. off and will strong patients revenue VYJUVEK growth hand contributions to who driven and at color team our on quarter provide

Jennifer McDonough

at benefiting say We policies EB second we as of corrective are the access country. With remains we from am dystrophic last approval. fundamentally access effectively all coverage approach roughly over secured of significantly grew XX% patients our steadily pleased the across in Thank The to to report place received is therapy plans, number all reimbursement patients of of July, I as or Krish. policies that decisions have up lives. in VYJUVEK from major Medicaid in gaining XXX progressing have treatment. XXXX. patient strong and now you, quarter covered And nationwide. This full positive we commercial from XX% and to positive

can evenly across see slide, approvals the you roughly commercial government on be split plans. and As to reimbursement continue

More to reimbursement in they continue quarter. I good to to that the like reimbursement reported importantly, including subtypes leading population, last patients see proportions we approvals indicator are of DEB across ages of both as out revenue. do immediately translate a would of point while approvals not DEB all revenue, patient and similar

a by a takes exacerbated it first weeks visit to the nurse us X often home held are it to to obtain sometimes summer and the further after authorization the average, takes times and weeks know, X you over treatment. As X last schedule insurance and on usual over quarter, steady X to routines insurance where complete authorization first-home disrupted. Conversion

each to required expertise Although a to disease reauthorizations bit continues year date to are are in by with coming finally, improvements, approved support as since able Even were and these been these required active more outcomes. And prescribers our month in grow. to quarter the second our have of offset or less enter proportion to of make same continues team. high access successful reauthorizations we And our reimbursement familiar in into prescriptions of approval, team Connect. quarters, cases, the thanks the the Krystal all process. as hands-on longer, process Albeit a volume achieve rare management that by from in we previous community taking

occurring but compliance treatments with that report to high driven again and [ are application high not effectively of profound to the through Patient IGRA Krystal remains home the grow. We administration facilitated therapy preference therapy patient unchanged, by the of quarter by also experience team weekly Moving has XX% convenience believe impact on the to average of Connect. at as the the compliance. cell. patient only the is ] patient for in to of of patient's our base weekly second even And the corrective end we at administration the at-home the continues length compliance remains XX%, pleased lives,

benefit. and on will to to patients activities, new we awareness on DEB hand patient experience and and starts are Christine? the patient conveniently we VYJUVEK to ensuring discuss clinical unitary in it [indiscernible] off marketing able VYJUVEK. As our maximal Christine progress driving I access sales and recent to ensure launch, focus now remain

Christine Wilson

Thank our growth significant around you, organized and education Jen. pillars I'm X strategy in commercial driving happy today clean the that to Krystal's integrated of medical activation is analytics, share of patient U.S. VYJUVEK

field themselves early medical patients to recent community enabling great our perhaps infrastructure are successes we targeted patient-to-patient through that new activating among have awareness of also DEB making and and the our disease. otherwise may resigned connecting progress to alerts, force. VYJUVEK amplifying and events. And educational deployments virtual monitoring importantly, claims including efforts, We're Our speaker continues most to and their flag enabling raising patients publications dialogue,

the launch, patients DEB primary commercial our identified to continue on Although focus penetration of X,XXX and at [indiscernible]. make we remains

to with serve to therapy. I Our and of we and our for was [ VYJUVEK. whether article recent raise clinical as as ensure on burden, we available commercial patient later medical quarter. With the feature on quarter, we work many or At ultimately including of the data outcomes holding with community study, guide information enrich in highlights are events Earlier our of in expect few to time, educational practices to and today work not the the as collaboration either and leaders us as DEB country related caregiver publications the patient to learnings providers, also access results we VYJUVEK. or advocates, today this interaction, The use from providing its this publish trial launch from increasing disseminate and with the interactions this of for these one-on-ones are events on extended Care ] VYJUVEK help progress facilitating Deborah allow will a and multiple to U.S. lifestyle emphasis expanding also those in events efforts and EB also provides access take DEB key on opinion have DEB prescribers activate during the July. a easy the patients community and a published access greater well put and country. overview our awareness materials VYJUVEK critical pool. readers across use an authored to that detailed VYJUVEK recommendations. And review virtual team's provide They in now DEB is chance to in-person open the on article the would the to a recently virtual OLE progress organically patient-to-patient at real-world practical held patient number debts like of our all across patients successes additional year, physician, such care across with making the medical benefits best conference we the webinar their testimonies first use. They debt in as These therapy same VYJUVEK to as

in new patient and supplementing in-person we starts made major to progress both our of year virtual of DEB to the series proposition in the the the multiple these second We is and It covering and work the across areas to caregivers. gratifying value of will and others, in raising events patients diagnosis communicating forward half the into meeting with see be initiatives, to X and and this U.S. Thanks look their pop ] VYJUVEK efforts ahead. [ excellent profile metropolitan translate

off it pipeline Now share to I'll hand highlights. to Suma

Suma Krishnan

Christine. you, Thank

goal our and as strong track this is pipeline progressing authorization of well both [indiscernible], redoseable global genetic respect urgently comprehensively remain XXXX. GMP of launches marketing and In certification our by past Japan Our we while our throughout needed Ancoris, granted continued for quarter EMA's development in progress Europe, to by commercial development European a momentum start authorities. and towards debt treating facility, we manufacturing application also May, XXXX, was medicines. With advancing the to in broad of globally of made significant the review Europe on of team's

we last shared we recent quarter, also supportive dosing. on based home EMA, like is discussions, believe As of the FDA

XXXX. In Agency, in on of a application drug before expect year decision Japanese application B-VEC of we new to on track second authorization end first the on marketing We launch the in continue of Device and year, Japan, decision authorities trajectory orphan previously confers the by received as the Germany the having and benefits specific priority remain the launch a development, designation, including in for orphan designation drug review which well Medical by Japan's for a as applications. Pharmaceuticals both Japanese drug remain in file to our on We half XXXX. a

from details, open-label year. Our here. Overall, those efficacy authorities study the Key application registrational that trial. include open-label same study the inclusion The with Japanese study, the from including of are to the of point. at Phase in this earlier on complete closely in our registrational Japanese X-month Japanese the will Japanese was open-label results completed shown criteria extension primary was slide. and our observations and safety patients results extension mirrored study in prespecified III the patients closure shown study was Japanese wound a are primary our time multicenter, the DEB. as The endpoint a Key extension dosing

Japanese All aligned scheduling design, regulatory study drug due use covered and number a patients range. we dropping Japanese of authorities one clinical X total, the challenges. requirement patients fulfill patients to DEB with the for the with the recessive the wide Importantly, study we enrolled had and of In to new on U.S. data, for application submission. age enrolled Japanese out

at completed closure the patients X all shown the wound study time the As achieved complete X-month right, point. on that

in In previous to We and U.S. well as this addition, tolerated Japanese forward was our results and both look consistent was view with and studies. regulators supportive efficacy application to the population profile Japanese the later year. B-VEC filing of these safety

here on for track Moving we X our readouts have the now as broader to as year. end the putting made well of progress rapid us before pipeline

rest the lines We and the X candidate, results of Both wrinkles readouts dynamic and evaluate our KBXXX are expect first these quarter both X medicine indication. of KBXXX, capital line of cohorts [indiscernible]. with Cohort Improvement study. lateral aesthetic of to our target top improvement potential I later Phase this share to concurrently X running at of and interim for

development. AATD and being key Phase expect Cohort and select also X, single open-label, redoseable is therapy from alpha-X is inhaled KB XX in the pharmacodynamic Phase to allow quarter, I expect intratumoral tolerability, a readouts we [indiscernible] biomarkers. our alpha-X in updates and programs. from interim which II a KBXXX safety, indication study Following X is with In assessment KBXXX study. [indiscernible] adult escalation disclose for fourth we to our for data levels of to antitrypsin evaluated deficiency, single-dose currently patients antitrypsin both

microenvironment are interim XXXX. Intratumoral cohort injectable of track before we KB X end X completed from community, and for Alpha X. the remain day have currently modified X. a Phase escalation HighXX clearance. and deliver HSV-X evaluated encoding [ study systemic and genes an XXX of immune-mediated tumor Cohort formulation strong readout both the vector expansion promote is designed on to We It ] enrolling dose human the support and to With OPA being in our IL-X research tumor of an I is

underway. all completed is escalation dose dose now have X We cohorts and expansion

We to granted year-end. I'm to designation granted disease last will data before designation issue was an osteosarcoma. treatment interim fast This that in the for a of happy [indiscernible] track a rare is addition share pediatric year. update recently

for ] studies are evaluating lung. at in We Phase the progress also I B-XX fibrosis making [ KB inhaled for inhaled XXX our tumors cystic of solid

INI-X our they on in X X programs We Cohort updates first [ [ these look I study advance. forward data the ] completed evaluating completed now level have and dose Phase inhaled KXX providing as K-XX]. to X Cohort We study evaluating

our an patients. B-VEC initiated come, this study of as With that and as ophthalmic Finally, remain to period we potential updates turn this ocular moving to breadth developing pipeline participate like a year patients complications frequency effectively in eye sharing FDA corn study to our we single-arm next the the on Earlier of trials I with The forward highly the also as who We of of reached our differentiated ahead study data medicines. track of alignment in to to on may collect the potential out year, these showcase treatment patients this that, patients. In work line in will platform. read transformational B-VEC with data natural end of be in the enable serve formulation to in for study running top they to have of we we XX the strategy, in for support DEB. earlier months the with stop development elaborations call month, look of for lesions Kate. generic before registrational a treatment study. We would for are This on Krystal DEB the this history severity towards therapy on for eyedrops debt the open-label to approval eligible of read be XXXX. gene progressing the of

Kathryn Romano

quarter represents Suma. you, the Thank in first the over a product the for of our With our VYJUVEK XXXX. growing million, $XX.X demand increase net which for U.S., was quarter revenue XX%

VYJUVEK the approved $X first the of net X% in goods quarter As was was of resulting about product million revenue. Cost a August by in XXXX, margin of occurred no May of in sold or sales was XX%. our and comparative there gross of revenue for FDA XXXX,

our first candidates, compensation and million to Therefore, R&D-related costs, expensed the sold development million compared to back second were May inclusive of inclusive of increased to goods previously of as compensation. of to expense regulatory expenses year the increased year's administrative result $XX.X $X.X were partially in expense, $XX.X commercial-related second Before license approval and to research in quarter, charged with compensation inventory of selling compared partially of for professional as in of increased primarily the to due no increased process sales of access the increases and XXXX. Research million direct quarter, period were inclusive expenses the costs stock-based the second general $XX.X following quarter VYJUVEK cost quarter was increased increased marketing XXXX. similar offset of program development $XX.X the indirect manufacturing of FDA VYJUVEK optimization of and associated our the third patient compared second were prior manufacturing costs of services by quarter prior well were year quarter XXXX in this quarter of decrease million and of XXXX. quarter compensation $X.X quarter stock-based there for expenses VYJUVEK the XXXX quarter. These for for R&D compensation, million. Higher expenses capitalization offset to in stock-based inclusive and $XX.X second fees, and increases increased administrative development were the stock-based Higher increased depreciation our prior launch-related adviser of as in costs launch incurred product the research by approval. Selling, clinical XXXX, as being $X.X second for and of quarter million, These million, and comparative manufacture prior expenses of were our development cost costs. mentioned, stock-based occurred the million, a overhead selling, in VYJUVEK

we quarter, settlement million settlement filing cumulative This of is $XXX the of expense payment a $XXX due payable million anticipation again the which Form in which our the periphegen XX-K recorded [ achieved. second $XX.X litigation in the our to milestone ] million triggered is milestone of in at following sales reaching

be The company's per $X.XX the million, revenue third income and cumulative which the sales of final and million total $XXX milestone $XX.X per products. was basic from represented by triggered reaching in share. diluted quarter for Net will $X.XX

expense the stock-based unchanged. of noncash compensation. excludes guidance Our non-GAAP remains XXXX operating This guidance for impact

And total of and increase Krish. $XXX.X over investments, with over an quarter XXXX cash million hand our growth second $X cash we investments position million. Finally, long-term and I to back now will and in short-term the our quarter first the in investments turn in overall by ended on about quarterly million call with marking cash and cash plus $XXX.X

Krish Krishnan

through and EPS, launch our an been With unmet need of clinical global see in we've for significantly of through Kate. we both stage showcases value VYJUVEK. and ahead, breadth platform. years already significant deliver launch our a Thanks, to yet, VYJUVEK revenue of value the creation the addresses U.S. expansion over advancement programs, each And which million more of the opportunities X of the and of our to clear quarters the $XXX able positive shareholders product rate run annualized

highly positioned scale open I'd redoseable differentiated we're market of portfolio With genetic the uniquely Thanks execute bring like to Q&A. of commercial manufacturing rapidly call to ] benefit a and goals these now [ listening. the medicines. in-house for GMP against infrastructure, for to

Operator

[Operator Instructions].

for question today of Bank Alec first from Your Stranahan is with America.

Alec Stranahan

Congrats questions us. on the strong from quarter. Two

EU you to therapy on second question, patients the second it's just from see this go as patient the a trend older this then if changes you reasonable [indiscernible] the state in expect to in expect maybe Do reach plan benefit international some approach to VYJUVEK the compliance. Japan? say, or do First, think you approved, And steady to new therapy? way in markets on How any half? patients in

Krish Krishnan

you. thank Alec,

The We in looking want in quicker. ports change and EU the distributor Japan had U.K. which sell the is we've outside second we're to do of agreements question, and to launch No to in date. or that, [indiscernible]. countries

the looking way we're international really So no to at [indiscernible]. change

Unknown Executive

compliances average, will On OLE I'll a to date the the of But defined situation of And patients a someone ] about are MAX compliance patients a couple and because or issues, trend, also been for of so. we [ north anecdotes. seeing drop ] I [ a whatever. take for [ have on compliance, misses vial months ] say if drug always make we personal XX minority there's below who, on MAX XX% we

That them in severe. noting are compliance [ -- the most were still OLE said, tracking ] the X point OLE patients of the we're the of at especially with patients. starting majority in So pretty that at high the time, this bios, to

compliance. so a trends patient good to some respect to severity And perspective, from with we're starting see

look, more a -- to been launch. to talk commercial compliance the On little moderate, it I'll in mild the of dominant And turn bit since ask segment. about you're to patients over have drug seeing most what the in on the I'll Jennifer

Jennifer McDonough

Krish. Sure. Sure. Thanks,

our was at August. anniversary look we as as [indiscernible] X-year in dispense first think I yes, So

really to are around to that of came we the adherence those excited on dosing. their analyzing are -- leasing and cohorts we start some able So early

seems of -- to the So within the within normal to be really in-home that seems be their for the which overall nursing weekly working their schedule day really same well. schedules week, allocation, [indiscernible] well,

They cycle on pause extension mentioned several that life and a folks time, open-label may the for that. they most back may those as part over-won For a no [ then period long been for relatively have they to years. continues happen because treatment have of ] Krish

So we're compliance first looking again, overall, And VYJUVEK we that very very, Cohort high weekly period, we that this which on daily is kind compliance that that believe that [indiscernible] at. in home is percentage. driving analyze as of application see and making impact high of we threshold of their X-year the

happy in So what the world. real we're really we're seeing with

Operator

question from Ritu The next is Baral from TD Cowen.

Ritu Baral

I new capacity? manufacturing expansion wanted Are plant? required any of new Will -- you in are there application. follow-up like sort of sort to ask floor European sort Ancoris expanded status of about be footage? then the my And the on manufacturing It the of is Ancoris be sign-off approvals square the for seeking FDA taking like same or inspection another it on in you will the assays? sounds

Krish Krishnan

I'll over turn Suma. to it

Suma Krishnan

the fully meet for So capacity to with a [indiscernible]. Ancoris is commercial stand and has the -- demand where has Ancoris U.S. we potentially

obviously, current are large-scale the we So production. are as with far as the scale, we to going

We have filing, -- the PAS for get filed we by end that should to the that and hope anticipate we that of year. approved

I today pretty the or e-mail, finding. X Same with pretty very routine inspection. the result sector we as you obviously, FDA the Ancoris by every of XXXs have know, pleased inspection. well. mean, distraction we're our regarding Again, been very again, went to years, they excited about [indiscernible]. With were any we have So inspected facility. with minimal The

the look we know know what we all of for. I all agency, We prepared. the they are think --

we ] starting absolutely we have we already filed that's for to with the that's But material of up, regarding materials. think talking [ don't starting prepared. With I we are again, to well key getting ASTRO, prepared. I some raw of team our With scale the [indiscernible] know. [indiscernible] our to we already our we are group made store if are and transferred the -- we mean, regarding do, in agency

transfer anticipated scale this process our the is sometime which to year. actual process, of Astra So the of

very We shape manufacturing -- good smoothly. in pretty feel -- we're think I pretty is of manufacturing. going So

Ritu Baral

are Great. questions on to the questions? And those what than to Or on you And XXX-day asked points give review FDA related in European on us then status basically, can they the moved its materially there? period? of applications, note questions? the the XXX-day during covered are topics have different you building, home like any And the

Suma Krishnan

which completed Yes. all -- aligned the I and be have submitting mean questions the I pretty should But responding predictable. [indiscernible]. much mean were to it questions, we of very

So there are because was had surprises prime we scientific it we agent. the because into that we the we can with -- meetings mentioned, have many

So no apple country. because surprises. [indiscernible] EMA have we thorough the were I think there Obviously,

[indiscernible] of look our their of regarding addressable. So dosing S&P right of to again, the discussion obviously questions. have them our you And question dosing is we were at home responded were The home now, SPCs. all in home very Yes, if was much that of we list dosing. some questions the in And point.

responding and with I feel manner. again, similar no are timely there's we trends in We we to think to Very because the prepared. from say our a of regards the FDA, So comfortable and questions all upon those questions responses, surprises. confident

Ritu Baral

Understood.

you of were or spoke Just questions that XXX-day the XXX? to these clarify, the

Suma Krishnan

the XXX, done, I the mean, -- we is and the XXX review mean I [indiscernible]. that's get should

Operator

for is today question next Goldman from Tan Andrea Your from Sachs.

Andrea Tan

into you if wondering work stepped back excellence? Second more just And uptake that away system? centers require you seeing bring the was does I are little provide patients patients then VYJUVEK to other And could bit extent have what coming follow-up. amongst a from have might these? color a who to proportion I are the from who on of of

Unknown Executive

Yes, Andrea. sure. Thanks,

types know community, So of as we community see seen look those at the the analytics around measuring a majority in both our areas, the we patients towards is COE care versus sure. we are do for coming from a trend really of

in are We great centers patients see earlier, they diagnosed. However, being to a are see strong. They earlier or -- prescribe and coming is new they the patients them as as continue which new trend.

The that of second part question.

Unknown Executive

It was basically COE about and overlap COE [indiscernible]. between and any

Suma Krishnan

Yes.

community the continues to strong. So be

in is is community, sales majority our what from strategy are coming team. exactly think quarter, pointing past this which I the our

utilization strong with in the both in expected as just centers setting. community overall, So and the

Andrea Tan

Will no my be Great. specifically both is specifically to looking from patients I'm just it to the able second cohorts Suma later might X? be you expect? AAT And to how And we able the might go many on ahead you will around program? actually expectations for then be this year. then be X what and make of hoping question decision for data

Suma Krishnan

Yes.

So X is to pretty again, into so again, X I fully pretty much mean, Cohort go enrolled. Cohort shortly. back

because where dose, going this data X in have obviously, is look in to we'll And the systemic is also to to lung, regarding risk we at think I lavage [indiscernible]. cohort and cost be we're the both our levels, the that, we it's plasma. and to evaluate long some in are if highest the have with [indiscernible] important Cohort going going go

So indication. again, enroll get and with [indiscernible] data rooftop patients expect to the some we

Andrea Tan

Got key the it. be that we're will And data to confirm Cohort expecting X set by data year-end?

Suma Krishnan

That's what targeting. Correct. we're

Andreas Orth

out in. year, data on the Yes. here, definitely of like end tough -- that all view but I patients in from predict Andrew we the Phase all to find most we releases of the think it's be them be would would the the would I data, I

update. So still calling we're Phase it II

Operator

with Lugo is next Blair. William Your question Tim from

Unknown Analyst

number was bit estimated a Tim. This of the U.S. the with the level identified? for could were total little little you've of outside patients patients then about is the of talk current wondering bit a your that And in X,XXX about I X,XXX more John if new you around comfort talk on original identified

Unknown Executive

Okay.

are some direct, of it's are But our new fine put in we have and starting there's it's it. we exact imagine, patients start. the the the being not way analytics moment. XX% community, me how And matter to an view on can COB the that X,XXX. treated identifying the Let patients to Look, at point because see both in It's simple of as the tough the the outside close on identified and you to is internal as driven. basically because by on expanded base that definitely

Unknown Analyst

level comfort patients? the current your estimated in And around X,XXX around Okay. total

Unknown Executive

It's same. still the

Operator

with next question is Nochomovitz today Yigal from Your for Citi.

Yigal Nochomovitz

question on a had ocular I the formulation.

that in of you history who that for natural curious would to phase I'm eligibility just study? would running of determine criteria sort qualify the Regarding using the running, treatment be what

Suma Krishnan

voting well must of in natural I qualification past listed going patients it's case X tell have And the with I episodes do [indiscernible] patients I mean, laro pretty because mean, X can list months. concentration. study I -- the I you, is the the the mean the than criteria the is patient because these have is mean, I [indiscernible] thought more

So the that what [indiscernible] requirement. it discussed for agency with

Yigal Nochomovitz

or use a there IgE And compassionate VYJUVEK with ocular been was of the boy Have recall complications for XX-year-old of use there intraocular. compassionate one commercial drug? case Okay. off-label a instances other I use in with instance

Suma Krishnan

that had so right the left ocular So in board now, the it was his time.

we as also treated get right Now time. have

treated left period time. an advisor right So extended both for time and of is and

So I we requests. that's team. been lot a the in the of are But think only natural compassion the get getting we now studies has study do out. process of since Obviously, [indiscernible] in clinical rolled going

history natural So are we in a terms. lot patients rolling have of the

enroll to the able are we'll hoping study be pretty fast We in.

Unknown Executive

off-label Look, reduce on even the to mixed use. question on in way almost and [indiscernible]. delivered conflate remotely the the mixed any uplift [indiscernible]. It's the it's inconceivable is your drug On

Operator

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

Gavin Clark-Gartner

I granular question. one level more one had and higher one

reimbursement approvals. just the First, on

some you XXX wondering expect at the point? I'm some approvals, it mid-February reimbursement And what's X believe of had just around and that reimbursement I reimbursement So those them? forms overall, make on start the start how status XXX through ultimately of as as will now of didn't come drug forms around patients approvals do for many just approvals. current you on of

Unknown Executive

going not going because term beaten up got [indiscernible] absolutely on for start the [indiscernible] you've we're we And talk we're about exited never no sort forms reason. So that to forms. that to term

important terms schedule revenue. comorbidity approvals reimbursement the some in thing open -- in not summer immediate. The to of to takes most still In net with weeks to it's cases X X some to cases. schedules, It that those

net as there's it Jen So is. We predictor not great of always I revenue. time predictor but and reimbursement now immediate revenue, say track approvals, elaborate is net a a can look, lag, exactly of on -- an what

be So look, or don't closest it's indicator we future. net revenues that We've think could said, it if call of I the have way, something estimating you look judicated. [indiscernible] it's start kind you always in at what the a the until can

scrip [ paperwork rates have if it especially, the we a be genetic are been and into even years treated done call used to You gets they misplaced. lower, ] go can testing as the in or many community, they

community the in more of forms done. scripts genetic start we So majority issue still the get testing this that convert year the get don't we to

compliance, that, the lag would like about going patients get anything life get launch something et way. get really than the they not there experience drug, of We to given sure rushing given patient in on the well. Patients magical that isn't super compliant. them do, that high the is drug on but super personal life who into making So that's in cetera. note. And we're they're important with outside way schedules, see time, focused on sooner besides comfortable get we does are not and the But

Gavin Clark-Gartner

then. sense. makes That question one Yes. And just higher-level

to launch, should a we metrics. more go-forward As expect mature just the wondering you transition for I'm kind of period of what

going reporting are and on So Will what we quarter? approvals wondering the ever any to metrics. you reimbursement give you the or for Just patients maybe expect go-forward report guidance? guys to every compliance keep drug the plan

Unknown Executive

which phase believe to mature The believe entering get don't to summer. over stuff Look, how is simply the to growth it revenue we're numbers. severe, phase. clear hopefully in you we time. We're [indiscernible] get growth after phase still you I to and year, like people sometime of less First, go present mature start next get to guide intentions, change as -- back growth high at I'll we come because or know high don't to launch. can way dominant more our at into to going launch, in community -- when I start we're look Not compliance and high on it the will very will the a more there's want that of -- call we still

for the going to month Our vials time X launch, a and at expectation, was of miles. remember, if you the first XX X months

we So The end of where post on -- we're drop doesn't at XX% in Still to reserve to is look our like in expecting months in that but judgment going many up. to ways we going still trend stages it's moment. were launch. it. that the the way combine early XX

of early the net revenues and [indiscernible] So we're ever mature to period, get time. in phase, growth we'll if it launch stages a we probably guide on simply

Operator

question Ha Dae next Your Ho Gon is with Stifel. from

Dae Gon Ha

or Maybe a question for Krish Christine.

in you at the the first us Just behind commercial the quarter. headwinds of terms since portion, put looking

would of that setting then August on a the evolution, kind kind to comment of that mean, going commercial year, that just of And kind or the the delay? as more on will, specifically just measurement type KB expectation. where so, XXX continue patient you're focus if and the Or could sort since seeing potentially behavior of more anticipation is the great. And period Suma, level you're to AAT promising going physician I'm is bronchoscopy bogey wondering, lung what's a reverting the the we be back second this last I phase or question, for the if concentration? level? conversion of of if community what's anticipate to So transitions launch little bit can you a maybe X you

Christine Wilson

[indiscernible]. Yes.

what the because new finding we both United on ability is COEs, the mentioned, VYJUVEK supported the in setting. the opportunity infrastructure to look has across So States, community-based continues really gives about is the which that apply which community-based but and it to exciting as patient. not focus us HCP our our an monitoring setting, And I clean we introduce also just alerts, patients all are to

COEs. intention both tracks, Our on continue We is continue right? to our cultivate to

last health as system a But we care community, And that been as in approval you right, a bit engaged the notes different Our imagine, seeing as the with would have the required where IRAs. takes on done, time more to on. are strength in time a much are community setting. And at genetic therefore, to bit reimbursement addition, advocacy get whole. may continues are testing to goes that as in it the political patients the the for dynamics

[ So see BD COB we for and the growth in time lines anticipate ] are combination a associated that both platforms, setting the will we amongst both as do our continues pull-through. that of

Unknown Executive

Thanks, Great. Suma? Christine.

Suma Krishnan

But high to of the again, in we already Sure. need or you it's I the total -- lungs, to obviously, [indiscernible] And [indiscernible]. of I protein. beauty again, With [indiscernible] levels kind speaking mean, protein. hear. obviously, the we functions a we That's log secreted expression nobody that's what's improvement is our start a want that from we the can of and KOLs. see what a knows we right? AAP regards see we as know to I [indiscernible], them. With key mean measuring what mean expression secreted correction

then least as cells go when anticipate see bile expect impact on we to levelize and based and it, So you the into high you [indiscernible] it's data expression. any we to at data, all month, porcine in vitro animal being going generated, the our

difference look of the to there is is on lung we we baseline, compare But think approved improvements we when I the product again, mean coming forward, So of no therapy. measuring levels. in I start the beauty cost [indiscernible] [indiscernible], the to what to compare part as broad going going efficacy. this [indiscernible], we're not would at it when obviously, the And going for

to approach. regulatory from seeing can to agency -- we So for us, a believe levels are in we if we strategy -- go as expression the agency you and the with lung That's biomarker approval point go the them, indication. incentive there down the and if us with can this particular a plan quantify you or sit pathway is and the the see for with for obviously accelerated

be that So opportunity. an would

Stéphane Paquette

Stéphane. this Dae Yes. Gon, is

AAT in we're the if to in of clearly, said, that for us that's range. a drive us levels what a useful not that the of on loan give sense will for going what's based but here, decision-making measuring Just clinically PD are adding it's the couple systemically, mechanism a biomarkers Suma on

and that it's X% maybe also literature relative to in for [ understanding in example, in systemic XX% range. the levels to So ] ELF,

we want on be that is clinically And having augmentation so context off from which effect would AAT, the tools the in get expect useful we of we benchmark are biomarkers PD and bracketed this what to baseline, the by and [indiscernible]. will the there information then be let to patients

Phase think give collectively, [indiscernible]. will on we need II a information So decision that into make to we us progressing

Unknown Executive

we I up way most therapy, the done, report people data always look with. [indiscernible] one which problem the a for redoseable do we're unlike in at realize gene a primarily we make the that part, situation the mind argument just Please And as ability final started redose have more we and therapies, first comment. we too a than have bear into read for to probably right? amenable are and out, that other

Dae Gon Ha

Krish, won't what redoseable necessarily us right? that guess frequency data give On point, may the I be, Cohort X this

Unknown Executive

roll but understanding those yes, single quickly, in we'll seems study may dose, -- are those have but be going some of X go we mean we see. and are on a we we a think the to very hope doing some are allowing this where to to them patients we good Because over it. amenable. They to -- that based can be to broadcast patients it's because of [ correct. ] with same can Many And collect open them. There these on into week, cost roll I patients data. maybe be okay I can get extension what to Because going we start on levels that, we are sticking, will question. redosing continue the try

what So patients to [indiscernible] to data with those enough find we reusable [indiscernible] levels. that [indiscernible] will

Operator

Instructions]. [Operator

Debjit next Securities. is question with Chattopadhyay Guggenheim Your from

Debjit Chattopadhyay

the what steady-state These [ to assuming are earlier the could expect X per and you now clarify [indiscernible? -- steady you given per month OLE ] out comments of state patients Krish, on some you are houses patient? revenue what patients

Krish Krishnan

on forward, comment know just or X, me that I'll to don't I X but exactly saying [indiscernible]. of sort I be can or recall Jen comment. let something -- let X what clarify the don't So

Jennifer McDonough

Yes.

one X do consistently causing the Krish entire that is of vary would of of whether And that coming we're look premature kind to comorbidities based months. So hospital, patients et cohorts, ] said, may the folks on as cetera. at. remaining very They on at leotherapy do it's understand back. in that I potentially and that with kind as year. and cohort of those X And say, of into for other they're we are are that's little, they different dealing we therapy the kind the then a cohort where that the [ separated that

So trend. continuing to we are

on little based is on But happens to weekly are I that's as for everything patient and severity, based based in here it the be a where think else and them. final the that on patients continuing staying the will early the on level going where wounds say like on then [indiscernible] there at,, again, are overall, potentially side. applause

And eventually continue it we'll to therapy. as continue so track on and as patients evolve stay to we expect

Krish Krishnan

much months we're Yes. And We're sometime ahead. at next months almost still mean I I net XX have I year into think -- at than year, the not revenue -- mean, launch. what number less a we'll like. still the XX looks We're

of a respect be would compliance bit said premature. But we right good. anything with to launch. our So ahead tracking We're expectations is now,

year. So next hopefully

Debjit Chattopadhyay

Awesome.

a XX% of roughly on you here. which over patients? patients to you mid- about X,XXX Do be couple could approved would think identify So get therapy follow-ups of XXX the by

Krish Krishnan

market to get our to the long has in X XX% in Look, share years. been goal term

on Although goal. terms to will to years we in launch. ] out That's and [ time the of work is But just truck. carry we clear [indiscernible] of that terms patients Yes. be get bit. that to that guys little the I topic not talking At internal in number our very to the X a said goals on pretty to from hard were said,

Debjit Chattopadhyay

And ophthalmic the this what separate a or that a expansion? it. And indication, label assumption Got pricing be segment? is for should the

Suma Krishnan

to a doesn't to going AI. different again, the be outcome because of volume the It's be going BLA safety is different the be because,

the we So agency. again, mentioned, it we BLA. a with separate But as is have agreement

So we we are trial year. what registrational we're embarking which the complete expect on to next is

new a be to going it's year. So

Debjit Chattopadhyay

along Sir, I pediatric we with [indiscernible] BLA, it's to if a separate just say, sorry. was that? should going review also expect Yes.

Suma Krishnan

depends I regulatory is guidance do molecular guys same nicer you the as bluebird, to the It second entity. pediatric if not think on the I for this a what Yes. market. mean, happened per model they mean, entity, issue ever the I

Operator

time, At call. the joining you concludes Quarter participants to Conference Biotech the all Second thank Earnings now XXXX Krystal Call. This this for

disconnect. now may You

Krystal Biotech (KRYS) 5 Aug 242024 Q2 Earnings call transcript