Crinetics Pharmaceuticals (CRNX) 27 Feb 252024 Q4 Earnings call transcript

Company Profile

Participants

Gayathri Diwakar	executive
R. Struthers	executive
Isabel Kalofonos	executive
Dana Pizzuti	executive
Stephen Betz	executive
Marc J. Wilson	executive
Tyler Van Buren	analyst
Joseph Schwartz	analyst
Jessica Fye	analyst
Gavin Clark-Gartner	analyst
Catherine Okoukoni	analyst
Yuchen Ding	analyst
Catherine Novack	analyst
Alan Krasner	executive
Rohan Mathur	analyst
Andy Chen	analyst
Charles Moore	analyst

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, everyone. Welcome to the Crinetics Pharmaceuticals Fourth Quarter and Full-Year 2024 Financial Results Conference Call. [Operator Instructions] Also, today's call is being recorded. With that, I'll turn things over to Gayathri Diwakar, Head of Investor Relations. Please go ahead, Ma'am.

Gayathri Diwakar

Thank you, operator. thank and joining the full-year have, and, the to call everyone, Dr. quarter fourth XXXX afternoon, you us for discuss we Good results. Today on Officer; Officer, Founder Kalofonos, Chief Struthers, Executive Scott Chief and Commercial Dr. Isabel Dana Pizzuti, Dr. Development Medical Chief and Officer, Chief Betz, Marc Wilson, Officer Chief Steve Scientific and Officer. Financial and Founder Also, joining Q&A to Dr. the us is Endocrinologist. Please the is is a Chief Events and Investors the website. in on Presentations deck Crinetics for Krasner, Alan of slide note there section page the which today's presentation,

earlier issued today is In addition, was a website. Slide press on available corporate and the release also X.

XX, February conference to obligation hand no this like reports takes live call other I'll to Form of update Crinetics report making As on differ that we'll is quarterly their from its date and such of statements. this or today's events contained news reminder, statements to reflect the with the statements you in XX-Q. I the or not implied SEC could a performance. XXXX. to invite as with circumstances and SEC statements the annual forward-looking results this and forward-looking XX-K guarantee the entirety any to that, The and would contains associated releases Scott. news including more in These be as Form or release. of stated forward-looking And broadcast, content that materially risks are uncertainties in time-sensitive information Crinetics' forward-looking filings, risks those qualified by the to also of after the Such date company's And our associated call in are specify filings. about company's on call. With conference due over company's statements I statements of disclosed revise these learn actual cautionary the statements accurate only uncertainties a business.

R. Struthers

everyone afternoon XXXX joining Gayathri, today's Crinetics. was you, year remarkable to for and call. good Thank a

will the of our review on for XXXX to be transformative and accepted set for the X, some last Since call, key see the call, a our out we on outline earnings the believe all you accomplishments successfully accomplish. Slide can organization today's This treatment we and plans objectives XXXX. On investigational As stage this drug, launch executed FDA these sets PDUFA NDA therapy we of beyond. of long-term of paltusotine what of maintenance year. hard our our for work year. anticipated getting paltusotine for first date our proud the prepare NDA I'm acromegaly. And This and September the point. We're The filing. of the us is for continuing this XX later extremely to this for team in its is to we'll

Kalofonos, many large Isabel happy stage rare and skill through to this, disease Isabel has the here you the part as of our us hiring transition commercial are medical part underlying affairs and small our of biopharmaceutical December companies. this to She relevant company. experience products as launched as her Chief at lead both the a important introduce this As past build-out completing Commercial I'm upcoming Officer. today. to was teams administrative into of well sets very and infrastructure. A all successfully commercial we

stepwise Given EMA for programs pipeline the continue shortly. filing the strategy lead deep behind strength anticipate our regional clinical We them, with the for Europe. the and forward of we in our acromegaly data growth

leadership and Zug, extend Germany. Access this Regulatory, in Switzerland for brought Manager Medical Market beginning We and have incorporated and organization EU And to we're Affairs. a General into a hub

in frequency clinical year, for demonstrated a carcinoid. progress we study, this integrated plan episodes reductions on readouts, innovation, and the II In on severity indication, bowel significant we pharmaceutical paltusotine's years we treatment including As leveraging in and infrastructure a as of multiple paltusotine in global coming fully evolve Last Phase into endocrine leader a rapid, company. flushing second sustained movements. made

enroll sites activating the have the trial III Phase to first patient and expect We for clinical quarter. next begun trial

in extremely II hyperplasia, substantial in atumelnant our In shared and adrenal also a and sustained disease. positive and biomarkers, We data for CAH, Cushing's study of in both, adults second with atumelnant, Phase both, AX achieved CAH, XX-OHP. or candidate, rapid, reductions congenital

disease. improvements in And to Importantly, late-stage on glucocorticoids. this primary free to significant trial All believe required clinical Cushing's participants of has this towards Phase and and both And mind, spectrum in we're urinary take These both also CAH. With profile provide impressive people of is and children. exogenous this also adrenal Atumelnant mechanism achieved with potential the in atumelnant endpoint provide was very differentiate for in atumelnant potent rapidly adults action advantage registrational in of living initiation CAH of improvements studies hormone that in demonstrated meaningful broad study. symptoms benefits Ia/Ib/IIa patients the a results observed, CAH. provide positive are atumelnant's progressing initial were XX-week in cortisol. dimensions to studies in studies levels with can disease. normalization Cushing's of that androgens to We for designed which a healthier

Lastly, INDs in tell programs, we're I'm end more This the including novel we to submit you to NDC candidate the making Isabel, total, a who the or including notable pleased our about capabilities. XXXX. expect drug in of Steve nonpeptide progress will first will detail in that, year, call. With progress drug from platform. building more commercial discuss towards X these XXXX, introduce on our conjugate our earlier-stage

Isabel Kalofonos

about are potential Crinetics FDA diligently share Scott. capabilities approval. be and of organization joined ready launch commercial how you, working I to pleased first our the new our commercial have this Thank to lead the in ahead exciting to advancing will for chapter we Today, I'm more company.

medical affairs effort professionals with building talented with marketing, affairs endocrinologists, affairs organization leading operations, medical a team across leaders access, commercial liaise and our their and are functions, sales. Separately, best-in-class and We all health strong to medical market has KOLs. care

in academic our targets XXX% to the understanding solidify Our and MSL of unmet reached treatment. core out has relationships our refine already team acromegaly needs almost of

with need market. acromegaly strong a community, with endocrinology event of will Health partnership is rapid and successful care favorable we have sustained the professionals instrumental the therapies broader be a believe use. adverse for and profile in a which significant patients onset action, ease also want launch. There of We effect, unmet

organizations the activate, educational innovation and building We a not long efforts commercial are and of time. And meaningful imperatives to market adopt, a in adhere. medical any outlines for drive our commercial that our Slide has X seen access strategy: X

health patients care First, we from acromegaly want more activate therapy. and to demand their professionals to

demonstrated don't of symptom biochemical realize For breakthrough breakthrough settle reduced symptoms. severity Across program, the reliable markers, for example, to to frequency symptoms. frequent Phase III rapid, that and control they decreased we achieve wanted and control paltusotine better have disease can of the

efficacy differentiated safety approval, and profile professionals. to after we patients by to want Second, health adoption clearly articulating of care paltusotine drive and its

efforts see Many to be focused per therapies that patients' option whereas pituitary Our And health treatment only will lack in is academic tend as their these patients X the setting community of care on professionals the behind year. centers centers as this doctors community. well new times or since centers. X

gradual We expect more adoption the outset. at a

paltusotine time are and motivate confident developing to in potential to new We of health become this care. accelerate to professionals strategies of Over we the standard line. care patients time, are the actively

to paltusotine. ensure we want to Third, access

been Our proposition to of they to top very team the receptive has paltusotine. continued access engage the with U.S. market value have payers. And

optimal inclusion that we we'll for drug, comprehensive need as followed. all be access new standard are any with there as will provide be working a process will coverage to able extremely formulary to soon could after launch. benefit be that paltusotine. towards patients As that We're But having from acromegaly feasible confident

in the adhere unparalleled co-pay throughout center detail support to we in the strategy the Patient professionals, at goes long-term more support patients. starting sharing suite of step, key research forward for to assistance. our patients resonating on beyond far Lastly, We of we the and will support paltusotine patients comprehensive at the profile and provide want all care coming therapy initiation to of our full with sharing regimen. stakeholders, summary, a And patient services regimen. In look include health every financial market is paltusotine launch payers to months. multiple treatment course are

important launches. serve anticipated a Lastly, that the will it for as is today future foundation work note do that we to solid

and infrastructure are to as We pipeline. With call as across to candidates will clinical the in well hand other we our leverage Dana the additional Europe paltusotine our progress. for building indications U.S. in discuss today the that, the development I will

Dana Pizzuti

Thank Isabel. Crinetics. you, This is very time exciting for a

X. Slide The for to now quarter. Turning last was accepted NDA paltusotine

review NDA productive the FDA our We normally. division relationship is and have a proceeding at endocrine the with

on the of our first available benefit the Orphan's significant expect to file year. Separately, in judgment EMA Medicinal for potential it over addition, the that for Orphan on issued the a to half the of acromegaly we positive our the designation for EMA based has currently applications acromegaly on to the Committee In this Products has opinion committee's MAA therapies. provide

sites paltusotine III syndrome. for Phase We study are the continuing to of in activate carcinoid

planning globally quarter. are the first to the to We enroll run second our expect in and patient study

protocol For authorities. our on atumelnant, its this provide moment. European finishing productive X are I'll adult and CAH, in after FDA the on III with we more touches Phase interactions a putting design on in the detail health

our discussions proposed supportive for EMA regarding pediatric and CAH. FDA and important with Phase had also II/III have We study

development. completing and study the end of we'll this on to details provide protocol before the We And are year. plan begin more design the

ADCS. development pursue Cushing's We or of to ACTH-dependent are continuing in atumelnant syndrome

developed we of finalizing Phase future, and seamless and advisers. In review proposal are We near proposed the II/III our after agencies will European and study regulatory study with the provide design, our close to data which FDA in discussion. for a external experts collaboration NIH we

finalize patient to next then or expect We the we'd this And first enroll early year. year will protocol. our late

the be liver study. about realized CAH II leave I of there I enzymes in discussion atumelnant, still the lingering one case some Phase may elevated Before

also work As in patient patient volunteer findings those any or in to visit returned seen elevation is the no, And important safety to had that nor weeks. in healthy weeks. XXX-milligram not elevations preclinical the cohort unexpected nor we dose the enzyme bilirubin, one within have signals associated X Phase we at the did have note described, final symptoms. It near at in liver levels The normal concerning show any studies. I XX previously study

proposed our the health We not overall in on additional to Phase MCXR use remain entirety proposed part will recommended the this data reviewing action monitoring allow protocol, reducing a the FDA and believe of novel of consultation the safety in top doses for is we favorable final, our the and has and replacement preclinical clinical proposed including for hepatic Phase the is risk II design. After benefit and in monitoring nor should of be Phase but on range our protocol, study strength And enthusiasm program data, this have mechanism of very the receptor, intention any the in physiologic all we III atumelnant routine Phase III shared endpoint. Based the safety authorities of to in protocol. We unique and results. all the capable This on of III with Phase and the about extension to changes patient ongoing FDA our when open-label glucocorticoid efficacy into clinical confirmed profile detail which III reflected global normal trial. androgens any as share will enthusiastic details our lowering Phase a III process testing the levels. the atumelnant's safety at be

potentially and In we is of candidates allow studies therapy. for for will an for AX Phase particular, Phase criteria glucocorticoid these in in differentiating exciting than benefit endpoint doses and study. XXXX this atumelnant with towards paltusotine our broader used III year as levels high III included continue atumelnant normal would the indications. capture was aspect registrational for proposed atumelnant be multiple patients and approved could currently from will inclusion CAH but Our

have We late-stage for new X Crinetics. watermark underway, programs is which will soon high a clinical

to pipeline, forward upcoming describe preclinical it As that, early-stage trials. With our initiating additional to potentially make will our on Steve to INDs. I we progress hand we look

Stephen Betz

Dana. you, Thank

happening within As you XXXXs programs drug wholly and on with see disclosed the an with owned can highlighted candidates our of XX more discovery IP has team. into innovative currently pipeline Slide Crinetics innovation X,

world endocrine impact lives of of key of including system, that and have always, and modulate expertise abnormal the as is We addressed therapeutics. activating millions varied. innovative inception target their endocrine drug these obesity, we and core come we with the we Most the Crinetics receptors, that non-peptide them of focus glucagon, disorders in insulin, GLP-X of hundreds candidates molecules our targets of areas years metabolism small and Crinetics' effects focusing, focused ago, than And XX specific continue pipeline from on diabetes need. Relatedly, have to unmet discovery of these blocking new to secretion. or hormonal GPCRs, on patients. create Since significant disease, these targeted of disorders, into are receptors have in Our patients tailored driving organized areas: G feel main people or our candidates and currently properties. To explore appropriately that and of space, be lives GPCR the molecules specifically understanding metabolic to within us team what our the around on many key that endocrine is developing to control pathways by hormones, our within the breadth opportunities call group. GPCRs endocrine pharmacology the improve additional more hormone and the targeting chance metabolic pathways of with GIP. X including a reflect the is protein-coupled GPCR can

cover therapeutics. to like I'd targeted Lastly,

in radio ligands This of GPCR endocrine the of the led and work space XXXX. broad efforts Oncology ultimately of the Our with imaging of a target began -- non-peptide in receptor-driven to for treatment this development range cancers. formation

payload or continue the call in development are IND-enabling half-life, studies. are an including explore a to relevant but methods non-peptide is ADCs, efforts death. to oncology, payloads We XXXX that promote is advantages, cells of concept and The neuroendocrine of for but to a NDCs SSTX and a feel has conceptually by internalization, properties optimize conjugates tumor be for expressing and to multiple are farthest to therapeutic been that to GPCRs. new induce vivo similar we that, ligand use ligand optimized approach payload. Four intracellularly straightforward these endocrine SSTX of antibody allow possess currently to and that standard target instead ligands efficiently to The selectively synthetic tumors. and NDCs CRNXXXXX, our cell can delivered in to vitro to payloads. This deliver early-stage programs tailored penetration target solid non-radioactive of NDCs. agonist Following using novel work modality us GPCR led expressing this NDC non-peptide these has production along so tumor with that non-peptide in drug tumor we discovery from

IND an early year. are We program this on track submit to for this

is Graves The dominant polycystic or INDs and of hyperthyroidism what planned proof we mechanistic PTH for other paltusotine both antagonist several early to thyroid hyperparathyroidism, development include we have seen programs eye advantage disease candidates can listed antagonist for atumelnant, Similar and in SSTX for in a of an XXXX and disease of these with ADPKD. one our TSH trials. Phase of agonist autosomal a that on this concept I get slide for kidney

maintaining across should desired for are progression ensure be we measure studies that can of insights first-in-human these early and patients a we that, having forward with while of potential it become will optimize to hormonal biomarkers of hand to oncology some XXXX In and available programs the that the effect. disease. I our the from to sharing can review as We These in early these in look The capital hyperthyroidism, strategy. there results. so they each results success will demonstrate programs we hyperparathyroidism Marc our XXXX future. With of you whether financial are pharmacological resource-efficient development over

Marc J. Wilson

you, Thank Steve.

the our drug and entered all the we investing demonstrated our focused candidate across XXXX to of emerging efforts. remains was the progress made Turning X. as pipeline therapies patients launch Slide And outstanding that R&D co-owners. its as strong strategy momentum team's novel on the to strength for developing of the with XXXX value in discovering Crinetics the for our capabilities. has company an well year course last and year to The execution over first own enabled from as continue prepare company generating tremendous programs.

with the for period the for and were to giant in Now, year same no year. months will periods financial December ended $XXX.X months full million I or and $X for ended XX, $X the the Revenues for million primarily quarter were to XXXX, million results XXXX, payments XX, period and X our XXXX were full to commercial received of ended we were breed years attributable and the the large explore XXXX. full walk Revenue in primarily in of extension X ended of $XX.X and $XX.X Loyal $XX.X $X for There the compared XXXX, also through months both driven XX, activities. and million million million and increases arrangement in SKK. the the paltusotine million expenses $XX.X X connection in associated costs million in of with and development $XX.X revenues associated million the activities development and and Japanese were increased with higher we our same increased same our development expansion pipeline. G&A These $XX.X with XXXX. XXXX XX, months compared approximately personnel and XXXX. compared to partner, licensed XX, ended that costs candidate the consisted The amortization fourth December dogs. Research lifespan for million expenses licensing to XXXX. the $XXX.X year December planning included December December in personnel the for million year were in by to X increases Revenues

XXXX, $XX.X million XXXX. period for was loss loss the for $XX.X net X net Our ended to in same months the a million XX, December compared of

for ended was $XXX.X loss year XXXX, compared the December $XXX.X the net of loss a net the year. million XX, million For to company's prior

be $XXX burn in million initiate late-stage $XXX increase and X to plans our XXXX. our anticipate to we between XXXX, million. reflects This For trials cash

ramp in We fourth prepare we paltusotine on start into with continue investments, expected strong our XXXX also in is of grow plan as quarter. SG&A to ended to spend build will to increase infrastructure those approximately to this So the as in launch for we potential commercial cash and our and $X.X expect XXXX. XXXX our up. billion year R&D fund financial operating footing which the trials

Before of to in the the outstanding honored I'm plan support during And through my like I to truly unique I role those who fellow would Tobin at thank been take turn tenure, since an you closing ago. to I to their small now to exceptional its years. moment been the Scott I'm community I next turn investment of have accomplished. the transition the is Crinetics. And organization confident about work like I'd that thank that I it be CFO my of have a in also a Crinetics of has will the being colleagues believe over number remarks. for out to Scott, growth. I'll my of a particularly is phases back announced It genuinely future. company's company. a done the to part am of it over what steward resources Scott? for optimistic months

R. Struthers

years. and you the Marc, your over you, for leadership thank Thank past X

commercial and we're brings him help, a to led around and You've for of enterprises. been unique companies a are for we to say I the He pre-series global are that through dedication company through the today excited have of have B several brings incredible here of years fully first Crinetics our verge succeed board instrumental the our years prepare these experience operations PDUFA everyone With we speak commercial from Schilke, XX Tobin first also company who date. grown Tobin launch. world with biotech I has experience when your And wealth contributions. We're we your on growth. transition public grateful very integrated private on Marc we welcome a to as deeply to for and the excited CFO. perspective. of and pharmaceutical over will as

from X. bright before patients with breath-taking. on of Slide Crinetics. opportunities the to I'm the scratch we've Turning very us created future diseases The with array is for bullish endocrine-related help to pipeline

call value one infrastructure I to execute stakeholders. With of a on growing limit key propel our across best-in-class scale multiple plan that, I'll and described our ongoing programs and the capabilities commercial recognizing drive yourself growth I fully on to great of us capabilities, reach have build progress the interest proven this the path way. therapeutic begin to us will our leverage we The of integrated believe combination to of back Please along our With areas the a long-term positions clinical and patient number to strongly each in-house maximize premier hand for milestones of becoming question have operator to in our made global strategy Q&A. economies all company. Operator? while XXXX. We the strides time. pharmaceutical discovery in to today, development

Operator

[Operator Instructions] Tyler to first We'll afternoon Van Buren TD go this of Cowen.

Tyler Van Buren

with paltu. on be data here to want the some acromegaly great September clearly launch wish all Crinetics The from modest and again in It's even of but to your of the high, achievements. Marc, best. and of seem for of I paltu congratulations ask are is the back conservative expectations very coverage in approval likelihood you I about and strong or your investors.

and So launch surprise elaborate preparations can the paltu? people you might What particular? on ongoing strategy in global your for

R. Struthers

we've been which that their you And part Thanks, clinically think with of in approved that emerging in consensus recognizes data super paltusotine EMA designation process the how advantage care. next from acromegaly. over relevant as announcement currently talk of constitutes felt community, the totally part And orphan granted for the I that's agree And we're drug really pleased orphan has level to strong Tyler. is that because we I the designation. been therapies. with KOL a this they an there's that making the with

the ongoing that team I talk is the give let very something something to So the strong think preparations. about to going of And to with. work her we've let you Isabel rest me and built

Isabel Kalofonos

Yes, the Yes. the in the preparing organization, place good a in market and are Thank really you, we Scott. product.

field to patients. the including talented continue VP facilitate onboarding And not of we the the In to sales Sales a welcome team only reimbursement we're terms the pleased our as we very very hired team. managers organization, engagement build customer model, but of to of our

payers preparing are to involves that In engagement with drug. successful market. that the to well of the the And very the now very that, proposition right value we responding addition are

action, has physicians once that fastened Scott also daily, the which only course, of sustainable the health with we has tolerability profile. good has resonates payers, less and not symptoms, of care really effect, breakthrough stated, As it's set a a have very professionals. but with a the treatment And

continue to well with activities to awareness We as drive with educational doctors the engage in the patients. as disease

terms very and In the and our comes place supply distribution. product, when to a of consistent in we are good we continue label. to And chains modules the launch it expected materials develop with our training

are a to the change in place. standard really really of the good care. product we So offers very opportunity And the

the In patients. we well. product that as terms very starts important think a really of not the for international this making it it's only difference is But organization, U.S. international

we in in talented the hired U.S. Europe, where we're have in that very experience in as diseases. So product has a starting significant and team launches rare

concentrated the sure towards in a exciting model it's on our a fit we well, focus to very advancing full Germany. Similar place. for And market really preparing launch. a that in and U.S., now engagement medical organization manager, so excellence. of as with are the to significant and really value we and have making goal affairs successful We regulatory building access, that And is the general times is advance commercial purpose, centers and

Operator

now Sandler. next Yasmeen at Piper Rahimi go We'll to

Unknown Analyst

This [ Yas for Dominic and congrats on strong on is execution. ] continued

you certain your had? outcome have that if disclosures you are as review interest 'XX? also, And your And with September there your Our you what review? now mid-cycle topics of dialogue you come the question envision your yet? could is, between up FDA and continue at mid-cycle just had do the And was how

R. Struthers

cadence general, a And that. bit communications' pleased that of But will just think Dana let Let with I'm I of from a me But just more. point communications. little view, let basis. Dana an the as-needed in as our simply say overall answer be

Dana Pizzuti

my the Yes. mentioned are remarks, as to I everything Well, a there's that. the haven't But with as is the But along. interactions proceeding scheduled further very do mid-cycle And relationship initial we productive we yet. And awaiting we're in with had go we normally. agency. FDA

Operator

Joe Schwartz to Leerink now next Partners. go We'll of

Joseph Schwartz

was there's enrollment to a a community, the heard those And for long new for time congrats uptake the in with development competitive. that on you motivate all acromegaly of take, often paltusotine. long sense, talk could to new if treatments. And first and progress. we you how on patients care you're also, atumelnant as providers, recognizing I option about for say the Phase see in health of may working clinical the CAH related in do their wondering I think lag be a such treatment in But III in now had a you already experience the think lot a bit time you've could strategies

about So III I'm long just How think wondering how we relative take time in it to line. Phase that enrollment should might for atumelnant Phase III?

R. Struthers

Nice working Joe. in compound question, a

significantly don't CAH, patients. these experience the And that drug inside bit experience. community. going market But global higher to answer tends now got in hand fact off of a since Isabel. it's a of especially The in look, in for U.S. our impact there's trial. And companies. to approved we in did we've clinical many the on our it's that cases, we're outside U.S. it the think the think I'll now fact, I In as fabulous most quite been than enrollment, to latter I institutions is past me the chronicity then But acromegaly. So the other with be past has Recruitment let and same experience an

bit better trials do to And significantly of little us previous about Isabel, that see late underway, were no during prior expect CAH where I a people than I then And compared so experience. But the talk to maybe were pandemic effect. to the activating markets. patients. international

motivated highly they're empowered, sure we already. think make they're not just I motivated. want to But

Isabel Kalofonos

Scott. the we uncontrolled. patients highlight venues, Indeed, of are the happening in with the that the including disease Today, significant marketplace. through is XX% to are the of awareness the engaging the unmet we data campaign. different that patients Really patients, need XX% Yes, show our only

symptoms. breakthrough needs majority patients many have significant So unmet the of and have the patients of the

the of are even continue other effects normal. though look sweating impairing to IGF-X So well experience from their as and quality like fatigue, They significant symptoms level that might life.

So events campaign well now and them we aware starting there disease as that. And are a awareness as throughout different country. are making right the media of outreach educational that is our

to have addition we to is patients activities, through believe patient In that support helping mental hub help that, things we health but reach only And and really support them also that and will going will we with out. to additional provide their co-payments not other them. a

activating but So community. process overall not the -- patients, sorry, the only we health are of in care the

Operator

We'll to Fye Jessica go now JPMorgan. next of

Jessica Fye

if I the prior trying for the just data from could things stand to results. if II see III that's CAH update I'm trial. open-label we those extension was getting Phase about where think curious Phase there's on to any something with

R. Struthers

Jess. tox. apple the a the to the do. And up patients finish are bit activating. Thanks, of we a sites how OLE at a starting to eager and little since It's long-term the into bit open-label are extension switching Yes, a in delay the see second bite they of had

out. a information. it of I coming to all of physician how patients So under on And back seeing and they're look off will that be forward come valuable drug think source plays had the I now care. And yes,

Operator

next Cory LifeSci Capital. Jubinville go now We'll to of

Unknown Analyst

on This Kate for is this progress year. the Cory. Congratulations ] [ on amazing

what we're the launch momentum. has you? learning still early the early for there gotten launch from Just might how anything curious one far CAH were and CAH days. course, seems just It's, considering like future? of in is be atumelnant you But the carcinoid to in And some it And us that taken surprised thus related far the from that the program. thus you've

R. Struthers

Thanks, Kate.

conclusions. to But street pharmaceutical themselves it's draw very our us early I good commercial companies. for little any neighbors as friends a down really the have and proven think

good expect we're So job. I they'll closely them them do from watching well. to a And learn wish and

Operator

We'll go Gavin to next at Evercore now ISI. Clark-Gartner

Gavin Clark-Gartner

Congrats on the progress.

you additional we For data? TouCAHn to see X Cohort can share study? possibly able any details may be atumelnant, the when And that on in

R. Struthers

Gavin. Thanks, Yes.

get X. And pieces design study just about not-too-distant program. talk thing that it's relevant tell one that the final the one maybe revisions. is want haven't it's program. we you really large slight will for as as talking soon But started in I about have something I'll We and cohort you Remember, details X. to about the might I out overall Cohort But a III at think have don't time, the Phase Cohort we that be overall future telling just in. try to and

very we're So starting to sites like close that and and that. to finalizing activate things

to So provide call by our clarity earnings we'll at the able I be latest. think next

Operator

now to We'll Citizens. John go at next Wobel

Catherine Okoukoni

you're kind question be This well. John. have CAH design discussing as I a mentioned you that for to Catherine just know on kind is used. that kind of I III details was forward. of going differentiated program that the on the previously going of from the a question endpoint general a just Phase of the But kind one on follow-up and endpoint of

regulatory you that? the is kind endpoint, on of So a little if a give more from what standpoint as rationale a as standpoint on commercial could changing color the well bit up

R. Struthers

Yes. Thanks.

feedback. some getting -- is that recognize think we're thing the sorry, I to

and we maintain action I conditions volunteers ACTH think of completely and levels point of healthy where patients II under extremely high a a deep low even they the profile. this keep glucocorticoid can to both adrenal patients, Phase is need is suppression glucocorticoids to different of gland in thing the CAH we've pharmacologic add-back. those We've even still and And that different that shown shown in suppression AX. mechanism the with that the of of very recognize

adrenal. should used vision that is are for our for one, CAH. And used be the for simply treatment then drug just We not replacement. And They're manage atumelnant for is glucocorticoids so which treatment. not the glucocorticoids think helping the

completely But Dana maybe to a little more. few let there's, work me things her about be talk because elaborate trying a specific so not principles. out. And let to still bit We're can

Dana Pizzuti

we as with put that dimensions endpoint, glucocorticoids, Well, mentioned, so drug just yes. it when an right? we doing And do disease capable right? both the helping feel it. feel, more of both, Scott I mentioned says, in has able call, have think We the as and as is on earlier to Scott together manage -- we should the to than I And this be that

action just that Now we the terms is the we adrenal to to lead to of in we indication for a point how mechanism for safety of drug, basis different insufficiency. view. a glucocorticoids work are mechanism this the that from could haven't finalized think the But of prevent feel belief for exactly right? a Because potential going that's the that treatment And disease. statistical

Operator

Ding now next of Dennis to go We'll Jefferies.

Yuchen Ding

We data the just data extension And additional extension, think or with Cushing's? had would from evolve it's then one do treatment? longer-term timing efficacy sharing on you -- or year, longer whether from CAH a long-term atumelnant. for how to Can perspective, you XX can you this commit

R. Struthers

around we're Well, until time about to I things lines never to it. try certain commit absolutely any

just have stay tuned. So to

was... But Sorry to of in suspense. second question part sorry, of you the keep terms in the --

Yuchen Ding

are Just do patients and evolve could you if how long-term around on. the efficacy extension think

R. Struthers

Yes.

think data a with is most that there adrenal relevant I the very XX-week sizes what we study. So saw in the short

for my we're ACTH they're these birth, gland. glands XX up angry. only levels friend, adrenal in when are trophic In the high is says end from shrinkage active. And Certainly, they they ACTH CAH, weeks. glands very showing patients getting as -- become So experiencing of Krasner those larger Dr.

any would expect with of or to then should the to I adrenal believe should There's if that mechanistic time. And with to no reason remain tachyphylaxis increase sort So continue anything, suppress develop. the that time. ability

Operator

of We'll now go next Novack Catherine to JonesTrading.

Catherine Novack

most to is this X pick, around you're the indication you exciting to prioritizing which If how forward question at year? is filing moving time? My you non-oncology assets this that into IND you are had

R. Struthers

But love we're build now to where balance our the fortunate I answer a that company I'll strong position grandkids. that And and because X a position, the each which where to is do, up them often all. prioritize of same their we way sheet Catherine, prioritization, we're in have of the and our they not traits I at wonderful I'm have them.

it filing and And We those was looks it of very this bit. TSH lead. wrote the the is clearly, to antagonist in between are ADPKD. I And starting. antagonist. moment, my a is a the at working the a saw And And shortly. There's like ADPKD TSH able inbox as forward background. you at hit is natural note race IND then the PTH well, up We'll all bit that a just move about catching pace. XXXX be in of their

reading I'm to looking forward So Thank it. you.

Operator

Lebowitz David We'll go at next to Citi. now

Unknown Analyst

John on David. for

curious, role data, lack was what across all is is the to the For the I thinking of the interested But AX II thinking important an behind doses? atumelnant observed primary and dose the that XXOHP an latest what just that just that Phase current response the understand decrease intermediate on point. hear fact the data the plays just XXOHP endpoint. hormone, as given in

Alan Krasner

-- just is exact alone, those kind surrogate to atumelnant know we'd of I impressive. other care for difficult as a And and reduction. from therapies the with in much for in practice. of the question. see to for very biomarker magnitude XX-hydroxyprge amount care actually is feel replacement. of are of the CAH, used the the and the use no low assess you compared which these hydroxyl a to lot achieve of the like short longer we that very patients very fact kinds at even clinical Thanks biomarker to rely on glucocorticoids treatment try it's in situation, past. in including it's I that when biomarker clinical XX very of benefits. And learnings of need hopefully, ultimately, it both glucocorticoids variable variable adequacy responses, particularly think outcome why whereas more like reductions we pretty clinical We take study And this to in doses unprecedented

R. Struthers

I looking you. But the exposure with was say I response modeling. at with agree think don't And this some I group week of earlier will the I

nice think I is and exposure with a both XX-OHP response there AX.

a Alan more variable. So said, although as XX-OHP bit is

Operator

now Rohan next to go We'll Mathur at Oppenheimer.

Rohan Mathur

for on Gershell. Rohan This is Leland

me paltusotine. for on one Just

of acromegaly it's be carcinoid from you do patients How both as available think dynamics tumors. call neuroendocrine in there with indications? complementary and use some made the once adrenal about overlapping standpoint given steroidogenesis in may and points commercial a Just potentially

R. Struthers

Yes. Thank you.

point a a pituitary oncology centers excellence centers there. areas are of think there's, of excellence of One, and overlapping. couple the of the from geographic synergy geographically I view, of

more long-term managing safety the is, prescribers patients acromegaly chronic is overlap important. There's interesting are disease in which I'll U.S., manage countries to with tumors, neuroendocrine U.S., the the many I there. growing that of Europe, the And think that safety our course, ways, that dynamic folks with things who those note tumors. the confidence unlike frequently outside of many a in acromegaly an is, are neuroendocrine which some so provides becoming so, patients are there remind for the in also efficiencies in additional experience really

of example, many the patients Germany investigators U.K. for see ours have they in So tumor and some countries neuroendocrine acromegaly they some and do of the other more in both. than but patients,

in it later. experience how So them beginning understand use one help they the might to in another population

analogs So or think for using overall analog paltusotine are a me. excuse I that to is and next-generation people both used somatostatin ligand, somatostatin

Operator

now We'll of Andy Wolfe to Chen go next Research.

Andy Chen

about? launch proposition very features the I So product discuss the that Cipla back most think paltusotine. lot more this quarter. it supportive of in that quarter? Europe know that about be the I things? Wouldn't the And a are in value then Or we will more? those Isabel, of Ipsen are of to you hear are the excited payers in you of grand prepared excited during that second the was Can those do they mentioned which especially remarks think the against generics U.S. in be nonfactors market that basically will scheme now generics just payers

R. Struthers

the do that provides. or paltusotine And next generation in that that generics think the I small And I are equivalents don't think care the of that the to Yes. just general, the next really long-term provides generation. changes XXX injectables.

a let in me Isabel answer little more let detail, So though.

Isabel Kalofonos

surveys are rate many to not and analysis have end patients But the are the branded getting up or and generic of for a injectables, those the expecting tend payers pain. wastage, towards done get. Also, consider to of many the see shows to a right. patients of that's you you Scott, treatments. discontinuation significant have treatment, treatment. weeks a breakthrough of because the that lack that you Yes, lag X it's in product, adherence to those with whether symptoms. to last whether the the efficacy injectables continue are have having And And reimbursing of continue coverage, which we many theory, to some of have Currently, the week economic you it's almost

care. And this see find that an overall, also as care. are time the positive sustainability see takes on standard standard So very transforming long rapid the other of is an They The of the because is injectable to which sometimes case which the case. not about effect. this action we the a is payers improvement the really it dosage, right of

they pleased with appreciating very So how we of are are the the proposition drug. value

Operator

to Skorney Baird. We'll of Brian now go next

Charles Moore

This on for Brian. Charlie is

more How be as believe could well tell that terms you Just usually to are on the compound? treated of incident patients touching well antagonist how landscape in you great what over if PTH us there of this It the about as be when as you with would you could addressable antagonist. offer XXX,XXX cases. as many about would expect those the the think

R. Struthers

Alan?

Alan Krasner

with major would of Right much. a is be very very disease. Thanks causes is time. removal overgrown for this That primary parathyroid curative much the the for treatment now, patients which antagonist the use Yes, option novel clinical usually PTH adenoma, hyperparathyroidism. of opportunity a surgical

we is affects hypercalcemia condition. that a theory, of Cinacalcet as do with is you aspect condition, although really only medical patients not of shown a could the the to surgery. There of There to that Cinacalcet, improve resolve approved, them the has calcium however, of treatment shown hyperparathyroidism help damage levels. But a option Cinacalcet, in bones. kidneys the in kidneys We and or antagonist there hyperparathyroidism. for which a lot end bones the disease. help really all this And However, a the multi-organ mentioned treatment, never need get see organ disease approved. and not PTH medical the has that's treatment this been this been of adversely. true unfortunately, is one or option the this many or is are disease, for of elevated

R. Struthers

ones on most or an detail start community of various Yes. in to people more talking together that case our this about to we And I and know more have so more the one putting it's begin some with where typically other I thing to about But try early we personal. are as summer think these analysts this to the tumors I neuroendocrine also the Day more spring time at investors the I programs that R&D together can of appreciate want is it. thinking with become started to spend PTH, about think the the and clarity. And PTH; provide had planning stop to phase. conversations

are experiences that So employees as or they're meeting suffering I'm these of from diseases. the facing, we always which and more and home. this family members to that address challenges more these. hear first-hand we're of And starting some bring

it's manage I to trying not And the good they're they're surgery think we PTH, either not about a way to think maybe us for or a a so there's patients example you the maybe best maybe as waiting really think nearby. better paradigm And just while disease. the great as candidate surgeon there's got surgical or where of transform to treatment for

we think do PTH. something with can special I So

Operator

sir, And any all questions have Struthers, you, to like gentlemen, I'd today. back ladies we to Dr. and things that's turn closing for comments. the

R. Struthers

you look talking to hours of in coming folks No. all and questions hard and work. forward Take Thank to and your for everybody, the you, We appreciate your days. care.

Operator

all we and great XXXX Thank Crinetics year your and Again, wish gentlemen, and financial quarter Goodbye. you, Dr. conclude Struthers. joining Again, for results that full everyone, ladies a Pharmaceuticals of much will so day. call. fourth thanks remainder you us,

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.