Earnings call transcript Q2 2023

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Operator

Good afternoon, and welcome to Castle Biosciences Second Quarter 2023 Conference Call.

As a reminder, today's call is being recorded.

We will begin today's call with opening remarks and introductions, followed by a question-and-answer session.

I would like to turn the call over to Camilla, Vice President, Investor Relations and Corporate Affairs.

Camilla Zuckero

Thank you, operator. everyone. afternoon Good Biosciences' Castle XXXX results financial Welcome second call. conference to quarter

President is Financial Executive today me and Officer, Castle's Stokes. Chief Joining and Founder, Chief Maetzold; Officer, Frank Derek

page August call to A listening replay recording the be will weeks. time-sensitive or of of call as on information you transcript the speaks be the of the call, recorded Therefore, if today's for this of Information Investor website available accurate. today, approximately this X, reading may XXXX. are longer Relations only Company's on any no three

begin, and but release XXXX in Before impact regarding Reform or or meaning Litigation our the future of financial that will not about issued earnings expanded statements future are referenced total of product, statements initiatives outlook, would contain commercial in reimbursement regarding our and we of today and our include, Securities Private including Act I XXXX limited and you events today our teams. to, growth of like to made similar containing and expectations financial the our XXXX items the our some XXXX. remind forward-looking anticipated outlook, These revenue performance, statements TAM, within operational statements statements for the projections investments our to our forward-looking

A contained no realized. based materially from that be the differ expectations statements forward-looking and in in cause of and be statements actual current these statements. there risks upon could will can assurances to Forward-looking uncertainties, results are involve factors those inherent and results risks these and contemplated number

or forward-looking only statements other documents obligation update as These to of the and for we year under Exchange report detail and and as assume these risks circumstances speak described change. ended on December other Risk are Form and the and revise forward-looking the Factors heading in factors today, filed with XXXX, in Commission. in Securities Company's the These uncertainties XX, Company's statements no quarterly the XX-Q and reports

In gross of Generally information Principles United today States the the in have includes revenue, measures Accepted discussed and adjusted non-GAAP EBITDA margin, calculated some that GAAP. financial adjusted with in been addition, adjusted accordance Accounting such as or not

as any addition results. These non-GAAP to We in not believe should GAAP used substitute provide useful information for be these in and operating assessing and cash revenue, a performance. metrics items supplemental flow, our

of financial to GAAP comparable most which earlier Reconciliations the financial measures release today, issued page Relations on in non-GAAP the Investor been presented of has end Company's directly website. measures the our these the tables of at are earnings the posted

now Derek. I call the to will turn over

Derek Maetzold

Thank you, Camilla, and good afternoon, everyone.

coupled our As least you half XX% our execution quarter delivered of raising guidance volume by expectations revenue our are at with another strong XXXX. million, on we of announcement half our deliver for from strong has XX% and business, in the full over revenue expect and to the XXXX, currently increase XXXX. second confidence an ago, $XXX growing of year a minutes second Bioscience total and test yet XX% Based saw first to by quarter report few compared Castle

around Before highlights, test. I the of quarterly get me into excitement our the some address let DecisionDx-SCC

to XXXX. proposed proposes let's are that encompass oncology number used of Testing genetic and July tests. of First, other Genetic quarter language non coverage tests XXXX among This first and reviewed in includes that We proposed in Novitas on for a coverage by laboratory DecisionDx-SCC, April the since XXXX a about for entitled the LCD XX, Medicare talk contractor coverage. of received Novitas were Separately, Oncology. attempts published LCD

see proposed of ADLT for LCDs Moldyx that period LCDs X, The Status, Advanced coverage June Medicare proposed for for and posted period XXXX. to ended The X, on September XXXX, common contractors known New Meridian these completed review extremely for on the our common Palmetto, closes of as CMS Technology non on July Test XX, the also recommending XXXX. Laboratory Status. Separately, its both application were Division Diagnostic pleased Xnd, of we DecisionDx-SCC.

expected, ADLT we June we Status effective XXXX. XX, were As granted

four be met criteria to to are need achieve There status. that ADLT

the of DecisionDx-SCC criteria the result metastasis, our works. that test One SCC of that yields test we a that means that predicts is, proven test have specific developing probability the our patient

combination also Another metastasis. DecisionDx-SCC our That is is, be criteria diagnostic tests other of our from test other all cannot new or test or means risk that That clinical that other information. test of clinical predict that proven any independent combination or test provides of any we've pathologic factors obtained tests.

designated available. of as develop we that a do ADLTs. biosciences view clinically that achievement tests what five differently, been one are have that has ADLTs us. all offered to improve patient incredible improve by have ADLT Castle received patient Stated that that tests innovative beyond We tests develop care third demonstrating and as looking clearly status, is at mission are this mark Castle our tests innovative of care

Now, not aforementioned of these Medicare I in lays meeting a two contained the LCDs out positions that will the ADLT we separately. because, be mentioned release to the while analyses is contractor, for coverage that purposes a criteria the it through local communicating two some as of have proposed status mentioned and used I

recently eligible value study very Moldyx we pleased the are part patients on from present identify and guidelines. into multi are who current of included large comments Adjuvant of therapy that radiation our our our tests to results upcoming analyses to center Novitas, completed for NCCN As our under to comments cohort

importance out I in population? emphasize Specifically, question. Adjuvant our risk enough question the cannot was radiation of to what therapy provide ruling this clinical value ruling can we in high this or

think about. are There areas significant three to

if features benefit which not. relies from perspective the accuracy and clinical pathologic one may of may informing is the first known limitations which The in staging eligible patients upon and alone

with therapy, indication therapy? but find just Adjuvant who is, outcomes improved of can risk second patients provide Adjuvant to may an test radiation warrant high our have enough not we whose The consideration does of could be metastasis of a

healthcare is the Adjuvant radiation therapy impact cost finally, of enormous. And

In average patient roughly rate their a data a XX% $XX,XXX the long test mention creating data if also receive therapy, risk adjuvant Adjuvant compared Radiation year potential but therapy like to who Icuvia test had It in from around first well to fact, metastasis weighted our treatment shows looks in cost as Class place. overtreated therapy highest did not patients matched both costs using patients runs result complications Class XB in the published result a reduction our have aAsthma as that who with receive the was term data. of per not XB patient, five radiation

you that the of XA, Class see treatment tests important these not when radiation This Class X results majority a and are from is therapy. recognize cost Adjuvant data did or patients benefit

to contractors, course, in sharing look the study the our and, the We you. greater detail in customers, published near and expect forward of clinician future results Medicare with be to our

unknowns validity clearly are differences now only future for identified there a Adjuvant significant receive clinical and DecisionDx-SCC in We current radiation some and need. validating Well, who test, regarding liquidity We not clinical outcome in see therapy. unmet but successful also utility patients clinical coverage. developing were can

guidelines, potential for roughly high risk asthma XXX,XXX that believe and with the reduced on patients eligible healthcare and impact current outcomes year each NCC SCC improved are who radiation Given is there therapy tremendous. and per diagnosed we are costs

period, and the highlights in the questions. with the execution then Frank highlights through and you take me remaining provide will for let quarter, your including Now strategy

with start and business Let's Combined was prior XX,XXX, XX% dermatology over of our volume growth and DecisionDx-Melanoma for year quarter. test DecisionDx-SCC year core the XX% from

clinicians time, very order new see quarter. tests clinicians to more first all for tests and clinicians ordering the total dermatologic our continue ordering during with XXXX for three XXX new We approximately the than

DecisionDx-Melanoma, the quarter XXXX an increase quarter, XXXX. test For second we the reports delivered XX% of of over second in

our significant prior and the believe test, to investments expansion clinical most the strong our drivers continue our of impact base. our can evidence are management contribute coupled to with our strong customer intended Melanoma to of commercial educate We tests the growth supporting

increase second XX% over For DecisionDx-SCC, second of XXXX an test the quarter reports we of delivered the XXXX. quarter, in

due the clinicians growth the their large for growth we clinical our that combination need in provides our with with value for unmet the to and strong part of Decision-Dx-Melanoma, coupled patients. As our volume DecisionDx-SCC high in and test SCC is believe

a pillar clinical use development key second our impacting quarter. evidence of tests, outcomes. support in including continued is a to growth Two recall, of our you As strategy the studies of were published

are focus survival just the significant remarks with very the study JCO oncology to one real in DecisionDx-Melanoma That with patient large study pleased showed testing with data SEER regarding that on unselected precision going my published the outcomes. and is this prognostic we our to information them. Institute's program registries of provided population data world I'm National collaboration related Cancer

relative to that the they longer. DecisionDx-Melanoma patients is, in tested associated not clinically Specifically, they lower specific an did melanoma untested and That is mortality DecisionDx-Melanoma with benefit patients had overall and group were the have who of testing. were lived who those

In fact, to melanoma associated XX% not DecisionDx-Melanoma mortality mortality with who was a XX% DecisionDx-Melanoma relative testing and patients receive specific testing. overall lower a did lower

well and sharing the with will NCC them would be providing expect, the we publication customers clinician you full as As our as Melanin to panel.

gastroenterology Now, let's our to turn franchise.

quarter compared the in During the TissueCypher to test delivered XXX of reports, XXXX second we quarter, XXXX.

Barrett's the can also providing in new Esophagus. management decisions during inform our risk that announced We value stratification improve data of with demonstrating information patients the quarter test objective, TissueCypher for

the Best Use of Medtech winner Intelligence Additionally, Breakthrough Program. Healthcare Annual TissueCypher was In the selected Xth the Artificial as Award. of and Awards

we As risk Barrett's recall, XXXX, in esophageal us designed TissueCypher Sernostics a patients development cancer giving predict a of leading in stratification will test with you acquired Esophagus. future from December to

integration made esophageal for US. year into Barrett's answers from than the fastest have and gastroenterology adoption of our With progress the and our factor current community, the capacity. we Since Esophagus considerable cancer, quarter our the that strong laboratory with rate only five is improvements. orders a risk operational the of much moved have XX%. We less during process acquisition, known in one in have Pittsburgh forecasts survival new of second efforts development so outpaced the the seen so our growing and XXXX of

test instrumentation our July we to personnel and such, in online. and bring accepting for in clinical orders improvements paused As additional process elected order temporarily additional the

We report of the efforts in Despite end that will to to this and be temporary quarter. expect XXXX of we third pause currently half begin orders compared are increase prior second through the half. the the first we working believe these for volume to ordering, to accepting new able

mental franchise, second our in a from XXX the to up GenX test we and XX% up XXXX, ago quarter from year health of ID delivered reports the quarter. XXXX Turning prior

As during test only we from Castle second the acquired the delivered XXXX, XX. test, through the date April reports a June quarter of reminder, XX,

momentum with the continue are be We to thus we far. pleased seeing

rates. remission data trial. moderate In patients real study guide can of we previously published recently current demonstrating data improve with of to announced response the world management fact, was to compared consistent use medication depression controlled that standard and randomized with significantly severe diagnosed care This In to our medication Ideogenics treatment.

an ECRI, its and organization a the healthcare of safety, effectiveness quality four cost genetic Igenics nonprofit five of rating. independent concluded care of test out assessment recently improving across settings, with Additionally, all

equity commercial test. is believe them valuations in recognize As payers coverage encourage important of to to payers utilize to another we Igenics making the this benefits metric decisions, assist our

with interactions Ideogenics and and help test Igenx health the to truly personalized benefit has and analysis patients response to drug standard clinicians offers factors drug testing incremental and our our match clinical comprehensive trial this to need patients of rates, a accelerate lifestyle including right improve we treatment. high admission area identification interactions feel believe an on with clinicians We to drug medication care compelling mental gene medication, approach. impact and for the by potential genetic of patient the offering With unmet over in error solution value

who our will details over to I to financial turn results the now call relating outlook. and Frank, will provide

Frank Stokes

Thank you, afternoon, Good Derek. everyone.

quarter the revenue tests was Second which increase Adjusted periods, million, primarily of Overall, adjustments the from delivered second XX% of million, the increase revenue, was over an XXXX. prior related of DecisionDx-Melanoma $XX.X the in strong reflects an XXXX. and effects to in DecisionDx-SCC. excludes growth of increase second over revenues XX% quarter $XX.X revenue quarter of

the quarter XXXX. of quarter in compared Our second second XX.X% the gross was margin during to XX.X%,

in Our related the the our to period compared acquisitions delivered adjusted XX% excludes for periods gross reports XXXX. to asset in margin. effects of was and same for Which revenue the intangible XX.X% associated amortization test prior with quarter,

in XX, of fair expenses, the largest was was related considering in $XX.X operating eight Turning consideration It with value compared year item, and XXXX. attributable million change $X.X current our for the and million, personnel $XX.X to to in quarter comparability sales cents the that months costs, total based of expenses, the sales cost per for the June to including million to After XXXX, for increased operating was which expenses increase quarter, salaries the second $XX.X benefit, of a by ended were total compensation, XXXX, including year. or expenses, million the acquisition. in during higher share, three of marketing to prior Synopsis part the seventy SG&A the similar Affecting compared primarily item driver no stock the within functions. large contingent

in Cost the prudently by was studies. of increased personnel increased XXXX, primarily grow would due attributable associated decrease related higher our in sales to revenue. volume. quarter clinical report second quarter support headcount also by R&D to to million, than of term, expense of growth expansions compared such in investing second expenses revenue the and $X.X expenses with laboratory to We diligently driven $X.X as by the which percentage plan expense to million at higher costs primarily over in our manage and the time business costs test a increase while costs long of that rate a lower the operating associated with higher other

second compensation awards based higher as quarter to expense, The. quarter rates December and to was SG million for among result million the and primarily and allocated third sales, cost increase XXXX. of of increased securities quarter, $X.X beginning second of stock non-cash The second the $XX.X second million expense, A is attributable in expense quarter of equity $X XXXX of quarter for our R&D to marketable by granted the totaled compared Total interest primarily purchases XXXX. a XXXX, our XXXX. in the annual of which of income Interest of compared for the

second for loss was million $X.X compared the million. EBITDA quarter loss XXXX net an for the of XXXX. Adjusted net comparable for quarter in negative period second million to the negative for $X a improvement of of Our second of million was compared quarter to the $XX.X XXXX, $XX.X $X.X million,

Net cash for and $XX.X XXXX. the million of for XX, the used June $X.X XXXX in operating ended was activities quarter second six months million

certain of the $XX.X As quarter you well totaling during recall, the XXXX used expected the benefit reflects not as health annual bonuses that as million to of employee cash first cash care remainder occur payout during are XXXX. payments of

offset million. ended consisted was investment million $X.X by and for the million six $XX of June and partially maturity investment XX, securities $XX.X of of of by provided cash marketable XXXX, activities the marketable months securities purchases Net investing $X.X primarily property of of of million, and purchases equipment

the our our with Our XXXX. debt. balance million cash $XXX.X and no will that strong. ended cash with and sheet runway we generated remains sales We test, through anticipated cash, equivalents expect of securities from of extend Together cash operating quarter marketable

XXXX revenue As least are raising Derek mentioned, guidance we million. at to $XXX

in XXXX. we expect $XXX we $XXX million Additionally, that are reaffirming to to million achieve

penetration, and our We progress extent, achieve expect a ASP market further growth. volume reimbursement portfolio to test by result across growth to report lesser this driving entire and

for The growing improvements. expect for making had test to we Supporting We should multiple flow that contribute our the and continue plans operating of positivity. leverage our successes driving health net note combination of commercial to margin with and Castle's target ASP reaching age XXXX top over our progress longer cash time. line targets

creation. sales growth importantly, in our and initiatives and are without growth and operating discretionary stickiness competitive continue term current current have to we we long pipeline term the create various lead, Further, our and associated to of success all as ability top we the spend important expand line long and to value primarily our expenses for renew growth on levers impacting tests sustain materially believe across our R&D and just Company pull believe that the marketing prospects

believe strong. In summary, create our in our fundamentals and term plenty ability remain growth intact. shareholders for remains near entire There across we the test is of runway to value and portfolio for long our

to over call Derek. I'll the now back turn

Derek Maetzold

plans. would our strong conclude our in second Thank summary, interest We over commitment. total in team. Castle. report year growth Frank. our We their volume you be results by to you excellent. wouldn't and term here driven without like your on were test continued continued growth by Castle and thanking Thank for I today In long revenue quarter execution year dedication delivered

your be Now happy we will to questions.Operator? take

Operator

question Canacord. instructions] have of Nixon [Operator you. Thank You our Carl from first

You proceed. may

Carl Nixon

Hey, guys. Thanks the for great taking the Congrats questions. on quarter.

going of So, your Derek, been you it's forward, here what steps then to already. take on Maybe the know, and you additional the aiming withdrawn kind guess, reposted provide on and can separate. view do, I just you're

guess. then maybe luck Novitas? going and Neridian for is Meridian Neridian Possibly any that and process for option, the getting you You through maybe off have know, reimbursement about could potentially talk know, is if why I another also different SCC

Maybe situation. Thanks. that of could kind optimism confidence or this whole in some inject

Derek Maetzold

I we minutes Good I hear Carl. well few filing so. our think, line detail Hi, ago minutes here the or did a maybe Yeah. in from as remarks some, top ago, guess as to that you. five is rather just in provide extensive

that specific keep So Norridian program. have a Novitas I in mind question don't Palmetto's around and Moldyx anything the From agreement operating with that Meridian joint talk stuff. is through perspective, to with under

perspective. Moldyx that So a program through go from the would coverage

Carl Nixon

be the is that lab mean, have because more you less could multiple any country. that labs for across or just of there in Pittsburgh? I the covered you can rather kind wondering SEC you one chance if kind I than of through

Derek Maetzold

could I test adjuvant our radiation since test over all data clinical would to I the have or if course of place. first that should based slightly now identify the different the in I one, Data the answer therapy help we're hope. developed benefit significant maybe developed from the who lead that's Carl, that's we people validated question, change okay. a the think a we seeing presented in Yeah, would upon really This answer benefit or been springtime.

really about If only based not beneficiary would expectation that impact that's treatment contractor population. patients? outcome value end but you tests have it. outcomes reviewed an by an the being is on helping an whatever Medicare evidence to one selection covering of Medicare I day. reviewing if test should and hope as improve does it, of does, at that review the data is that the our does And And cover Medicare would our it the our saying, on in benefit

Carl Nixon

then if to submit in your that Okay, And panel Derek, another you update time an meeting, mid forward, I just the that could great. data, timing could guidelines. basically? confirm, there next from? Can if was publications of NtCN believe in that folks in Melanoma was for for potentially are an I And each on one squeeze of kind were July. the able what steps in those see for going you

Derek Maetzold

three So, and academic yes, we by April was cleveland manuscript OHSU, or both did published centers the those did and submit also submit the Clinic, Dillon we that in NCIC Northwestern, publication.

of Of hope our longer We not live our group. those a people an actually clinically. use test part would using nice you that of course, compared show the NCCN wasn't test, association if both discussion with to with active

they is been On or time meeting kind publicly four anything consistent when they until last the a month mid-year even period about cadence I usually years, expect go December, through have to six the or us perspective, an ahead January they and COVID, five post of after their wouldn't see update. a timing they've pretty five posted

Operator

from Nam Ji Scotiabank Sung have now We

Sung Ji Nam

questions. the taking for thanks Hi,

be what you other question are be you there, gathering have think sufficient if SEER underway, There data. for NCCN Just there guidelines? and was on kind the Congratulations makers studies on the that to might sway the do might another NCI additional of information or you additional data publication. decision curious

Derek Maetzold

NCI with the studies additional or mean general? program the SEER You and

Sung Ji Nam

other with could studies be but Specifically there NCIR, if that also compelling. are

Derek Maetzold

so our yeah, collaboration Okay, ongoing. is

the year. the think program up data. the update registry kind tumor the I SEER NCI remerge maybe group once next a of of year's files They

paper ongoing and that like, numbers the to look is see groups by patient things Even outcomes, and one we mean, have at collaboration we'll example, matching term And this we so to look at have staging do be subgroups. And grows up multiple expectations was from and able publications. the the for go first I to longer down. patients of and able the of though as

see melanoma do does improvement How the end test the Are survival use you years. civic Medicare or form terms this in rolling versus For of perform population the survival that ongoing are. significant up an patient of population? that example, next Medicare age hopefully couple in analyses test a to will seeing who in overall gets or we our manuscripts there think to clinically I those like basis, out continue

have To still. be studies are and that honest, that other we planning some do ongoing we're

test tenets, done patient that core as our the has for ever and one don't I of care. is of think time you time know, One again proving value our

One published data of using with of at a was remember procedure that decide quarter last not. the set, study, I was studies recently this our forward initially who our a look fall going sentiment test here at first the can't prospective an that biopsy patients to or was early decide on are which looks

what with then same exact patients. those outcomes on And happens

So can probably further would or an call one, data analysis and bet analysis. out be I now. we months coming six early there'd published maybe you ago so, that

in we make raising improvements, difference haven't we discussed that the that's all publicly as those protocols that our paper still think data NCI tests other patient bar see hopefully in decide, keep a I outcomes. outcomes should

Sung Ji Nam

Thank And inflammatory up Great. follow the just quick then pipeline. on you. a skin disease

next the you. update Just milestones the is kind be. might of what curious and what latest Thank

Derek Maetzold

Inflammatory on of skin that discussing hadn't disease? planned here. We elements

in are think quarter, have, the that pleased we very far. our back so enrollment we with the discussed first I that end but that we of

update end could That now one two chewing enrolled wrong the be to about initial who hopefully have expect public We all the patients data to and XXX that the the data development to are analysis overseas to or XX And shortly, street not discussion the we here year. have through in and about can are of over just but date. I and and go sites, the half so sites, we investigator discovery obviously second within a think we going prior be and US. through that today, of committed working of are XXXX. It's this

Operator

I now when Lake Flatten Markets. Please ready, go have guess, you're we Thomas Capital Street of ahead Thomas.

Thomas Flatten

quarter. the $XXX on was afternoon. conservative. the on you that Good the be of At thinking first Congrats thanks. on second the conservatism of if if guide. I half could Hey, half? Frank, slightly than million, you maybe through or the apparent there could would I'm walk a wondering So curious some comment some lower

Frank Stokes

change there, no Yeah, Thomas.

As we said back in June, we're not forward assuming SEC revenue here. looks and our guidance and

So be that continues to the case.

Thomas Flatten

Got this new was breadth could narrow from some depth Is that maybe the within if I it. on already Dx-Melanoma. to specific that is you And I but wondering prescriber down counts, docs more then play or docs are share this increasing if I'm if mentioned curious or both? we depth coming a know to could Dx-Melanoma. new or you board?

Derek Maetzold

I both. think we're still seeing

thing more our continuing We day. have always more patients. we their every physicians are remind order dermatologist, terrific, that Melanoma a tests is the physicians, we're Melanomas, other and continuing community isn't which a seeing for with and to penetrate to that of And new is

time sort convert come volume you there's their just once that So as flows through. builds, their a doctor, of patient lead as

through penetrating Melanoma, in Same as on it. long Melanoma. the called still seeing store it. and to we're just And on before a we're go think conclusion, a store runway there So said I past, just got growth growth way seeing we we're we've new and I've still in my long both

Thomas Flatten

a you sense ordering us of how related many Dx-Melanoma docs that, are of and if then to And SCC? give your both just

Derek Maetzold

that we able to of that products well. cell very volumes for and be squamous which effectively. that that And confirms a thesis. just or I That number, as don't this without across continue when can melanoma leverage to we overlap was for gave growth but quarter, I big at in was our our product that both see was we growth without there, the a have look said a would think we part you melanoma effort specific strategy momentum we sales I grow if will, us the cannibalizing, losing at the look our big

Thomas Flatten

taking guys you appreciate I Excellent. questions. the

Frank Stokes

customers or the we DecisionDx-SCC, many can put there. invasive who of is that's that current also the by think, that reflects work with ratio really the maybe expect fertilization because get that are don't We I filing; and cancer across XX% high ordering do melanoma. clinicians surgery, would at value both XX%, its surgery there very of subspecialty Sorry, a never on to of recognition above looking surgeons mo a actually XX% people into as who Derek, today, dermatology of DecisionDx-Melanoma, it of are mo definition, don't we're do do many, cross types.

Operator

Souda Puneet have now We Partners. of. [indiscernible]

Puneet Souda

highest. Frank, the Derek. on Hey, the congrats one thanks for of taking That's and really on quarter know, as the of payment. remarkable and first ADLT the

SDC payments the know, I talking You you're and expecting the think in minute, payment, I heard a second half. Frank saying for leaving decisions coverage not complexities aside, just about the ADLT

can you the all the complex little provide receive effective? scenarios given July think STC? for payment since you XXXX and you know And would but then it's one, how payments talk helpful. there, for Number X can about a when about issue, if Wondering was be things. did should whatever any two bit here I there coverage And we this

Frank Stokes

a our just clarification I Yeah, not What guide said any to there. that. just that clarify is did just include to

guide said, radiation patients. is a when And Derek to correctly of it's compelling see therapy, some you the this pretty evidence benefit to like treatment, the ability overwhelming. As Adjuvant

the of Castle, receive we coverage, benefit not that really the that the needs. is for will benefit and appropriate but necessarily This clear patients. evidence test is believe the this eventually something So patient group

Puneet Souda

clinical road. to out needed of that talk strategy generation, that can but sort Level sophisticated of, that Again, such I timing the can submit is bit to generate about. further utility, longer Got to this clinical coverage.? data of tough that is about term it. data on if in data may, order reviews potentially the of a rigorous to down you call you little and test Moldyx test highlight Moldyx the this evidence done has if it part cover for for that, a really wondering And if so when that as talk mac is

Derek Maetzold

some So, of LCD led me of knowledge core well our and references. as I in looks it terms interpreting data not I SCC, proposed published the key today. regarding that, to that when the to Moldyx And of treated issues think, that on there cell read far, sort is quite as missing carcinoma so squamous are through how core

in therapy So, therapy radiation don't every College to patient for the recommended NCCN Adjuvant Moldyx every is to of Radiology example, by for high is team, we that think, useful was committee to people of premise guideline relevant American the Adjuvant actually AAD I from Astro. radiation But with think risk SCC.

So reviewers could that useful Medicare at is they population and SCC. a used felt therapy radiation conclusion not thing the that for funny it's Moldyx the Adjuvant a in make

the of you if what's you'd that then test. start So say, argument, with well, use your

of That kind part. together. it flows The rest of

evidence lead be would is adjuvant analysis, perspective group validation that evidence would our year including be radiation the refreshed we of that realize with of Multi of to to prospective enough that believe hope continued including that to cohort, we second utility and the maybe and would to hope the our analysis with there coverage. course requirements. meet our therapy, evidence the our next study updated that We have have including X could during we So Moldyx, key the the Medicare's needed submissions two publications, addition clinical the several

Operator

from Stevens. now you. Mason have Carrick Thank We

Mason Carrick

me. on Novitas on quick congrats quarter. the A the guys, for LCD Hey one

twelve we've Given expect do irregularities follow to finalization? month in you draft timeline the that seen process, to from draft the standard the

Derek Maetzold

know insight chance if just be Is any could it To be it Mason. speculation. there would finalized sooner? there, don't add a I have we

Mason Carrick

how operational we should clinical you TissueCypher begin of come capacity think accepting the or we in orders how progress again on that trend about guys will then constraint, And remainder online year? the whenever scale Okay. throughout and as the the that'll

Derek Maetzold

we get that. we'll Yeah, believe that

we growth we'll As of offering want appropriate be interesting patients. to Pittsburgh to turnaround and back had continue that said, move the sure and had nice opened of times timing so here with their and there, cold the our think Kind are see for We Derek by have. end our customers we quarter. this we've seen we'll make quarter, We lab online, I we a think there. and just the

expect to start we for orders growth I again. orders, those return the certainly we think once So to opening see take

Operator

Thank you. from We Catherine now Baird have Schulte

Catherine Schulte

first, thanks revenue questions. quarter, order any talk expand capacity up and that is the about just your that, on TissueCypher, of to made investments a disruption causing I can base? frustration on to and for Congrats How headwind much pause in is guys. in guess the ordering following Hey, to the you just be there? need what

Derek Maetzold

remarks there, I into think, filing, of upside. our said had here the I think the that patient as the primary on the and the adoption outran care in test put item too, was we forecast for the

we'll and we weeks can treat come here, until for post lab just put customers that you, properly, be was a honestly and scale our decision back these have pause we should the movie you. just so tell efficiencies of kind And to put directly few and up hey, say, on and let's we implemented it should

from the feedback the of a unhappy field, of customer. single unaware terms I'm In

fact, for turnaround maximizes that think do? you and restarted patient at did we How orders, that to think be ahead What can seen in again? will any begin want do a were. go upfront. care. us you I I this to hey, so non of and help treat to accepting sort get us issue We've we issue, companies ready we're the space an actually a Actually GI you That time guys I In kind Catherine. think we're can't don't be of say, us never most believe that'll honestly,

Catherine Schulte

Then by today? assume as that still getting just your SEC effective? Novitas And it. reimbursement is just getting you likely final your guidance you'll a understanding becomes but can that paid LCD confirm paid Puneet. going Understand doesn't you're until potential going back it Okay, of forward, got that to most maybe keep

Derek Maetzold

that, we have test now, would be for we if And any Yeah, reimbursement predictions. guessing made Catherine. the do beyond other we

Operator

Thank you. BTIG. go ready. Please ahead We now when have Mark with Masro you're

Mark Masro

for question. Thanks Mark. Hey, taking guys, is the this

circling just [ph]BDM? had guideline where Thanks. dialogue NCCN, Sloan just back NIH with could you and third to and you've Memorial in of stand perhaps maybe So, you're thinking about ahead guidelines you any and tettering us addition SEC in likelihood remind of inclusion the party to inclusion,

Derek Maetzold

that the okay, do in the review relative so Sloan Kettering proposed LCD question a referenced asking database You're mutations. and NIH database gene only to the individual

you May. maybe or Curating any don't analyses, tests. maybe NCCN, based go And That's would on relatively years or Aggregating never four They would they're tests That's Moldyx gene Right. two I new RNA more do. not us I and of a mean, XX-XX,XX-XX, package, to established So or committee. expect expression profile databases. or April review ahead groups ago. a as review early of believe individual tests, multiple like was certainly did gene in We they it tests. those three sort the five in of and submit met late reviewed gene kind

we Last time early met that it the of I their in go posted year the they track sort they between when and think think time of they varies a spring in year. this update back bit. earlier meeting If and May, guidelines, was updates, the I quarter quite first

time eight So about cycle or that months to or always Melanoma compared an group, was nine six month so. the kind is which five or of

any don't I something versus kind be any would would expect or based we we kind on if know predict to provide December about guidance be of of that September So saying can analysis, honest. in factual

Mark Masro

long what SEC that. so in Thanks. perfect. I guess for guidance, about your and and the as as the term? what's based of as reimbursement, Okay, assumptions talked being far term there puts the much guidance, for was the contemplated Thanks to absence are guide curious, the meet far able SEC so just long raised And into I as takes you

Derek Maetzold

did think SEC we you. that. able targets our have long do that having so to without would said those thank we We indicated again, achieve of be as term strong, certainly XXXX and hope better part evidence a our we to business. that, reiterate to very than part outcome of Yeah, But is expect the and

Operator

so remarks. for final Derek have it any hand I back the to no we like line, can to I'd further questions on confirm,

Derek Maetzold

Thank you, operator. a us This concludes today in interest our Biosciences. second evening. your quarter great continued XXXX earnings call. We for thank Castle joining you Have and again for

Operator

Thank all for joining you call. today's

day. now your please connect may enjoy lines, of your You rest the and go,

Castle Biosciences (CSTL) 2 Aug 232023 Q2 Earnings call transcript