Cytokinetics (CYTK) 8 May 242024 Q1 Earnings call transcript

Company Profile

Participants

Diane Weiser	executive
Robert I. Blum	executive
Fady Malik	executive
Stuart Kupfer	executive
Andrew Callos	executive
Robert Wong	executive
Kyuwon Choi	analyst
Srikripa Devarakonda	analyst
Tessa Romero	analyst
Roanna Clarissa Ruiz	analyst
Salim Syed	analyst
Lee Hung	analyst
Mayank Mamtani	analyst
Jason Butler	analyst
Cameron Bozdog	analyst
Carter L. Gould	analyst
Yasmeen Rahimi	analyst
Serge Belanger	analyst
Ashwani Verma	analyst
Sean McCutcheon	analyst

Call transcript

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Operator

Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' First Quarter 2024 Conference Call. At this time, I would like to inform you that this call is being recorded [Operator Instructions].

I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Affairs. Please go ahead.

Diane Weiser

Good afternoon, and thanks for joining us on the call today. Chief quarter will and and overview with President the of recent Blum, Executive begin Officer an Robert developments. with FOREST-HCM Fady provide Malik, recent SEQUOIA-HCM, updates will interactions and related to EVP aficamten, focus of FDA. R&D, to Stuart Kupfer, will updates will MAPLE-HCM the regarding emerging also aficamten, Medical discuss clinical of CK-XXX ACACIA-HCM provide pipeline. and trials our additional ongoing and and SVP Chief Officer and progression of speak Andrew Callos, about will EVP for activities Officer, and commercial aficamten. Chief readiness Commercial with and first EVP but Chief new us our is as his today, listening Officer is Lee, day us alongside Sung just Financial Cytokinetics. this at Wong, Officer overview financial and Robert quarter. VP Chief will provide past the Accounting a of Blum closing review reviewing milestones by And corporate development year. key will the finally, call strategies before expected Robert the our for

following relate statements discussion, facts questions, contain future to the and responses rather of to constitute our portions than that including and that events performance historical statements. note forward-looking Please

those these actual materially in forward-looking results projected from statements. differ might Our

update materially results factors Additional results filings, that concerning call. differ our our current in statements including forward-looking information in first our Robert. our X-K filed SEC furnished financial to was the report could statements actual these today. call on We will obligation no after that SEC this turn I And XXXX undertake contained regarding to forward-looking now to from quarter to the cause those Form any over

Robert I. Blum

the first broad portfolio, made aficamten. and for biology-focused development the we thanks today. joining quarter, Diane, of you, In progress on program Thank the our executing us substantial by anchored muscle on call

course obstructive set and preparation the of full pivotal year. line aficamten SEQUOIA-HCM, for are running in the trial at Phase of publications occur clinical of an hypertrophic heels top we positive our the from over to presentations ambitious cardiomyopathy, On in scheduled of patients with throttle III results

further year, expanding commercial of addition, of second and laser-focused accelerating readiness continued our trials program, our submissions are the on in clinical In half activities we ongoing conduct regulatory the pipeline. the

efficacy line a view top of announced from fully is SEQUOIA-HCM a included we Recently, ours comprehensive of that, of to May Congress late-breaking results will related medical major aficamten, results be next December a have more XXXX Heart high-level Lisbon in last XX, and priority the present Society the at SEQUOIA-HCM of While Cardiology's clinical safety Monday, the of Failure trial European week, where announced that will SEQUOIA-HCM. meeting. we to forum X presentations

with of out which anticipate next-in-class elaborate. Along SEQUOIA-HCM primary late-breakers will XXXX on presentations data with we stream to believe from X profile. will the we aficamten nicely the elaborate publications additional Fady steady and that results, as lay its throughout also will on have analyses related we other from He sharing

engaged with quarter submission. in for the cover to X a this related We our FDA meeting third pre-NDA meaningfully and quarter, convened an of including second During year. first first the we review our February, of to specific aficamten in results SEQUOIA-HCM ahead to NDA of a with submission meetings topics the FDA meeting planned also month of of the

forward to look also year. discussions fourth for this our preparing questions an EMA MAA quarter, posing been will specific of potential with the We which in additional with to address we of We've are are quarter planned scenarios. occur agency's the relating pleased REMS to and submission feedback, this expected we

hopefully evidence to patients notably case expand aficamten, the use for have program X additional and development reach clinical III Phase were of in And into the while the activities, other pushed more III which of we each work next represent readiness about now in XXXX, ongoing which edge Andrew trials other in aficamten, Moreover, activities clinical SEQUOIA-HCM commercial forward more will execution, Phase the many phase evaluating detail. represents speak need. streams and opportunities

extension open-label FOREST-HCM, ongoing the Of study, course, and collect of continuing longer-term to safety aficamten. on data also efficacy our we're

ask metoprolol with the that is could outlined be initiate to of And drug the as practice provide MAPLE-HCM, will trial in Phase inhibitors, it in an question important of may to emergence are for compared to monotherapy Stuart aficamten is, cardiac as an which a critical MAPLE-HCM trial quarter. we the clinicians elaborate, evidence-driven expected change hope clinical guidelines. emerging in first? monotherapy treatment answer myosin be the we do to opportunity beginning inform will aficamten as third may as III This as complete enrollment

describe HCM on Stuart is to will patients Phase pediatric called third our update of oHCM. in with patients he'll which enrollment late-stage III also a clinical also share trial open a trial population and non-obstructive ACACIA-HCM, an CEDAR-HCM, in with of clinical aficamten now

especially We maintain the at programs. financial the first maturing of of strong to alongside quarter, end position are pleased our R&D a

further of to benefit I'll we advantaged diversified this an to fuel deliver options for science are in terms As increasing position our speak that in we later to patients detail shareholder for accessing in the more our call, believe of value. and capital in

record our lastly, X-K and And to previous key IR. where as our expertise commercial I'm in both global and XX a companies, tax, years AG MorphoSys in search, were experience was happier new our Prior recently of midsized Gilead, track accounting, of obtaining welcome team. Sung to deals. finance pleased join in operations and had we he innovative you that built criteria including team. we for Previously, the we And experience for also him ideal Sangamo biopharma and and all began our financing leadership had issued, When of to Vir several we large a Sung we expertise and Therapeutics. be Cytokinetics, search saw candidate that served hopefully various roles Lee have and finalized career his Biotechnology Sung to to he pleased over CFO at couldn't we CFO. announce more, from brings the

upcoming know meetings. And him, who you'll our Fady, to conferences already over earnings our You soon from I'll don't those will meet to hear one-on-one that, QX chance Sung for the of have call and And a with in him at turn please. call. you

Fady Malik

view at next These of of week complete Failure analyses a results course, provide endpoints. related from which analyses Thanks, baseline all trial, and select the clinical Lisbon. dosing mind what in providing of line top to of SEQUOIA-HCM, but and a will experience results release, presentations include, at data was based the endpoints, in-depth one in detailed for additional characteristics, in Heart Robert. will the into secondary late-breaking SEQUOIA-HCM other Top this will and look also primary on the and exploratory presentations its presentations on a rich data primary another subgroup by trial There the X go late-breakers be in deep XXXX for The data. our elaborate press the and the further clinical of improvements will in the on aficamten set on capacity review not affected the dive only is safety exercise practice. implications an expand very CPET

As results to our mentioned, SEQUOIA-HCM Robert picture our the a from and presentations emerge of to next profile comprehensive dissect only represent the beginning for of build plan fully continues that aficamten. differentiated week the

further series course lays starts with and plan of that elaborate efficacy an aficamten. will presentations on year, of out the over and safety of aggressive the and have that the publications a HFA We

questionnaire in European City Kansas year at an accompanying deeper echocardiographic, data, leading We biomarker the Meeting integrated to forward Association into presentations cardiac data, as of analysis the sharing data efficacy. dives as expect CMR more medical Heart publications journals. Heart the The well can American of Society well Failure These progresses. Cardiology, and cardiomyopathy America remodeling as of the as include Society You look and as

of shared in FOREST-HCM, additional forward functional were left patients low with efficacy and look and continue aficamten more Shifting outflow XX were ventricular infrequent function. to with ventricular and FOREST-HCM in longer-term in Valsalva enrolled we ventricular safety the we ejection left FOREST-HCM. reporting with Furthermore, heart treatment XXX of NT-proBNP the that patients XX-week improvements nearly and or sustained fraction not associated -- tract ACC, showed interruptions is with reinforce data treatment gradient, at These data currently HCM data resting to oHCM. failure with and the left structure events. NYHA aficamten to Last future. longer-term of and With cardiac and obstructive measures associated class, month from treatment occasions very

clinicians program results once for the Importantly, during opportunities engage KOLs treating has to and from to with this Feedback many presented community the full discuss date enthusiasm. incredibly we in had believe the aficamten. published, positive, quarter, that the reaffirm will to generated we been results the and and

work IDNs care to have programs. medical health liaisons with delivery time, networks clinical interacted health physician science XXX of of and around the payer over HCM Specifically, results treatment and practices completed care medical value integrated narrative. SEQUOIA-HCM finalized managed or our with same profiling professionals the our build engaged At our liaisons science therapeutic

NDA first as the Robert we meetings FDA quarter, held of the On X front, our with submission. regulatory during mentioned, ahead

engage second quarter, type time we once for a mitigation. this the B focused risk on specifically During potential meeting to plan again, FDA

remain is affords and aficamten discuss differentiated risk on opportunity in our safety that we with safety into and While aficamten, optimistic to for NDA. a engagement SEQUOIA-HCM will on matters. pharmaceutic FOREST-HCM. to impact perspective us in this approaches the approach approach the mitigation elaborate different FDA's topic in believe both In demonstrated and risk discussions the gain proposal of aficamten Altogether, this risk of an previous mitigation to and profile these that meetings, next came insight of merits manage of inform we our a their FDA, these benefit/risk reflective position is the of that's up to on these properties discussions profile potential our as our

will planning As the previously their for FDA of which submission rolling the review a completed begin we're opportunity provide modules. we've to for shared, NDA,

and submission begin to the expect during We the third complete quarter.

towards important goes for is company. you'll of teams are NDA very sure I'm work the that a appreciate, and working an there this into amount diligently tremendous our As milestone

Xing preparing to EMA we this to of support with also we're our to their to support submit and our quarter an plans China in coordinating Ji which fourth year are NDA marketing expect partner, the well. application, in as Meanwhile,

of a pleased regulatory Head the quarter, will and the and strategy to During readiness new launch support registration are Europe product we lead Europe for Regulatory in activities. welcome

of our supported is cardiac an well it development While expand these as I'll that pipeline. the SEQUOIA-HCM it's and provide for by additional additional to over followed on clinical clinical center potential utility the hand the at more to moment, on and to we inhibitors. as clinical have elaborate development update myosin believe trials earlier-stage taking program stage aficamten trials Stuart the

Stuart Kupfer

potential and Thanks, monotherapy with HCM trials as South treatment in of expecting to patients Fady. trials, expand aficamten to is and and our opportunity have We sites in on metoprolol to MAPLE-HCM both complete ACACIA-HCM. patients the of aficamten of China in non-obstructive we're X XX% our track with guidelines. the and obstructive believe compared are clinical Over and third ongoing America activated, evaluating as aficamten in superiority HCM which the to Phase to I'll global is potential join III MAPLE-HCM, benefit of start these enrollment soon. additional sites MAPLE-HCM to with the obstructive monotherapy elevate quarter.

second strong third SEQUOIA-HCM quarter. The the to the at enthusiasm XX% By large us and ongoing we strong sites MAPLE-HCM, in enrollment foresee and approximately enrollment a including completing enrollment a for line. we've be results finish expect trial the trials, getting observed from end provided of the across increase target have and in tailwind quarter, from for our of the in

commercially when will time be as We evidence guidelines a in the MAPLE-HCM aficamten base in HCM. around read expect potentially in we position hope the aficamten, to positive obstructive first-line to to use for out therapy provide launching XXXX, and

also expect trial will patients is what ACACIA-HCM, aficamten clinical of in the HCM and of via we with entering site symptomatic activation pivotal III rapid Phase enrollment. phase non-obstructive

successful with During recently and in at around many we San quarter, meeting the sites the our study Francisco. a world, we're second investigator meeting their of and staff investigators held

enrollment Given positive we the REDWOOD-HCM, aficamten to of goal Cohort enthusiastic non-obstructive towards of And results the look clinicians about continuing of year this completion potential with from for XXXX. forward HCM. X in a treatment promise are patients of

important patient another to population. Turning our attention

a start CEDAR-HCM, of trial yet with and of pediatric double-blind, randomized a obstructive Just pharmacokinetics population we extension evaluating of safety announced this another and trial efficacy symptomatic morning, called open-label the in of aficamten HCM. aficamten the clinical placebo-controlled

adolescent endpoints XX regimen adults. XX least that cohort. selection cohort in initial at from cohort years CEDAR-HCM data dose treatment. That be XX echocardiographic secondary in to up endpoint the on will will weeks after is and X and same be of daily gradient, all left enrollment of adolescents, Valsalva XX will after an of will XX endpoints resting open-label A supports extension. the in younger primary parameters. for ventricular change individually cardiac will safety of Primary secondary After In for be into in approximately begin double-blind the patients X symptoms. measures, aficamten include younger cohort. to once the outflow enroll children evaluated aged milligrams based gradient, to doses change XX and selected aged XX tract XX X in as patients to and treatment enrolled cohorts, the pharmacokinetic is double-blind second biomarkers roll weeks XX The print treatment, will adolescents years over

promising HCM in in from pediatric poor this failure tolerance, similarly population. prove that it as overall tends and and a impacting adolescents and life. with exercise HCM segment HCM associated may associated arrhythmias. key risk be heart fatigue may and the of While to rare, SEQUOIA-HCM it's breath, results serious in does optimistic, of quality for aficamten present is of of We're with the given high adults adults, shortness children

starting evaluate study quarter, second healthy clinical participants Phase we'll the During to our pharmacokinetics, also and global of the program in a aficamten Japanese geography. safety that tolerability be advance I to in

advanced cardiac was expect program and patients data to Phase or which of inhibitor, treatment second of we generally fourth announced preserved another the II in to for with in at present heart findings myosin of failure the I year. Phase a We tolerated CK-XXX, in I year. participants data safe begin the the trial, the of quarter a we with advancing line with study in this top more first clinical quarter, subgroup the half pharmacokinetics. during fraction, which are linear plan CK-XXX, from today, to CK-XXX potential well of Additionally, healthy in the development Phase These medical the a the ejection Earlier congress supportive detail showed that HFpEF. from of we study

to believe of mechanism has action unlock need. for further which potential high CK-XXX, with different potential We the a than biology aficamten modulation unmet of patients has the myosin

that Finally, extending on programs further the an work mature clinic in vision emerging important continue and long-term energetics. past are we for of quarter muscle later metabolism the of into and year expect the biology These we programs part to stage this labs next, areas of as our muscle to and field beyond continued earlier contractility pioneer our pharmacology. muscle the our from

symposium called share be X-day scientists, a CLIMB, And toward sponsoring that end, researchers we're and South Muscle Biology. in research of pleased goal San biology. to muscle in driving understanding Andrew. to the Contemporary dialogue and muscle-related I'll networking The opportunities professionals Friday Francisco biology event the dedicated Landscapes in collaboration, the next this ultimate muscle here innovative diseases field together This disorders. will foster emerging turn and is goal the facilitate promote gathering that, treatment interdisciplinary and scientific of in with and to to over With of advancements call of bring

Andrew Callos

campaign, last year, refine strategies. the results the and build After launch worked patient end phases go-to-market market of plan design this build at our sharing development of in of distribution at We quarter, our support we well from began as to program initiated line our our to we the as later HFSA the Stuart. and design specialty SEQUOIA-HCM top year services which strategy. Thanks, comprehensive first and

Head in approved topic, a countries, approved, more where modest the assessment EU. a XXXX, Lead more XXXX, health in if for On the reimbursement quarters, continue country several gated in commercial that see a aficamten. In team and on We to and to across key EU strengthen and milestones positive XXXX CMI to Europe. Europe which class hiring aficamten our plan with new country-by-country reimbursement Patient first European of are the signals of the and organization hiring expected commercial Germany, including regulatory pleased positive in remain from forecast to including technology Marketing U.S. basis the for U.S. in and we is in the if which, the potentially a levels during U.K., last launch continue France future hires, with will our to Germany, we and

we symptomatic including or X health and payer value HCM, the sex, and post generating for presented region the topics septal patients care HEOR. economics published in quarter first impact on our on of build and HEOR to quarter, and obstructive ethnicity, various around data abstracts health by payers team myectomy weeks, In outcomes During recent the aficamten HTAs long-term for research in stakeholders, therapy and including for the usage continue of proposition with coverage care cost HCM. medical outcomes

obstructive outcomes unmet to patient growing related economic patient around need the costs this and findings for Our clinical HCM underscore further and population.

present after next SEQUOIA-HCM week, from engagement U.S. primary ahead, payers. results the with we we Looking will and continue publish

Our dialogues every year, results QX preapproval XXXX. the cost with major began the results team obstructive payer outcome exchange payer in payers the as clinical to major information we and review payer medical the well the SEQUOIA-HCM, this meaningfulness beginning of with account of of of understand And initiate and plan burden as so in every HCM. to

I'm commercial XXXX. in for pleased progress readiness with far so our

obstructive who and subset spoken this the our the believe to obstructive aficamten biopharma should which commercial of XX% enable gas customer that have we're advantaged market cardiology. HCM before our not our keeping a specialty across on us the the come uniquely I've approximately companies to by we are HCM cardiology success, did preparations As who specialty We we -- year. focus perform cardiology is has patients. highly treat that foot typical expectations, successfully reach cardiologists of before, anchored believe for market on readiness to concentrated to us base, Unlike

the are cultivated Together, respected frontiers shoulder over an by help with today, of equally new organization that R&D And have organization our way robust R&D commercial highly formidable a build call to Wong. we successfully outstanding pioneering on that, our colleagues. well and company our to building poised with we're stand pipeline mission our discussed towards as we to turn shared to Robert vision I'll success, the driven patients. shoulder Just

Robert Wong

balance upon of quarter of We the to conditions. be with available capital Royalty of us Andrew. Pharma deal represents under forward $XXX.X our to expect million which X cash years approximately runway, ended on Thanks, the with sheet, including cash satisfaction we

programs, expenses from myosin prior Our first quarter XXXX, increased of $XX.X to muscle our R&D programs by million the offset expenses lower year. first quarter the in on inhibitor million in skeletal to primarily due XXXX spending $XX.X for our cardiac

were QX G&A pre-commercial quarter primarily Blum. $XX.X Our year. due from expenses $XX.X million first it expenses With XXXX down to hand that, prior million to higher I'll Robert back over in in XXXX the

Robert I. Blum

you, Thank Robert.

cardiac to you've as the by well launch heard, the specialty positive the our in SEQUOIA-HCM as approved, on in advance to term, near plan for our to tier continuing aficamten preparing in anchored franchise. inhibition while focused XXXX, execute directed companies. As In biopharmaceutical next value continues the cohesive on our shareholder cardiovascular to of and results our as drive growth publications on plans we myosin if build and biology we elaborating remain pipeline expanding from also successful presentations invest a of promising to to

initiatives diversified our as to say about prepared a engineering. balance XXXX, ensure We closure business. advancing deploy partnering sustain of of and these towards and opportunities commit to to to with on and hope on to been series non-dilutive emerging and strengthening we're sources to also more comes commercial access but focus execute structured financial come our as that and company In access our efficiencies capital capital, by as sheet, diversifying we focused capital capital not such primarily parallel pipeline only transactions to and we've we have grow they to to

priority for Japan. remains campaign our development ongoing aficamten in Our business

hope and deal. deals and and monetize lower momentum, discussions capital multiple additional continued with also restructuring and our a at of financial looking with we quarter, the overall current expanding parties During progress. R&D We're to consummate we instruments to cost potentially

a at could different to continue also dilutive equity right the enabling of us broader manner We shareholder financing can value, levers part of be pull we as diligent consider the capital as time access and principally strategy. to in expect to a remain about augment non-equity may

conduct corporate against pledge and which Responsibility of today high-integrity, future Second release supporting we Report, our highlights Annual recently, patients actions communities. culture business into our keeping advancing And and sustainable diverse and our our our is progress proud center Shaping Corporate a at goals the and to responsibility. of our the inclusive were work, to

As we we will enduring vision, goals is which Vision be next at organization. an and enterprise with R&D aspire commercial look in our our be to early a sustainable XXXX company longer-term articulated the year,

pharmacology maintain grounded doing to what's we is in financial right muscle our leadership vision biology in pioneering the and stewardship patients and and Our serve. for

upcoming recap Now our milestones. I'll

European present Congress Cardiology the week. For primary at SEQUOIA-HCM Society the results aficamten, XXXX Heart to from we expect of Failure next

the an in NDA to QX MAA We an EMA expect XXXX the QX to to submit FDA XXXX. in and

throughout expect complete to in XXXX continue enrollment and enrollment QX ACACIA-HCM We XXXX. in MAPLE-HCM in

continue We strategies in in Japanese Phase and a aficamten go-to-market our expect in volunteers CEDAR-HCM aficamten. to of enrollment expect study healthy begin to to advancing I continue QX we for in XXXX and XXXX,

can compound this open expect present our as continue Operator, a of and later clinical trial a to study data biology preclinical CK-XXX, meeting second to for I initiate this and development up start we as year call, the another half XXXX. questions. muscle development medical For the muscle-directed And we activities. with in with in research well please, research, that, year clinical from ongoing we primary to the to expect QX expanded now II Phase at on Phase

Operator

Instructions] come Duncan [Operator from Fitzgerald. question from our And will Cantor first Charles

Unknown Analyst

Estea [ the Congrats quarter. all progress in is This the Charles. made for ] on on

one question CK-XXX. on So we have

II Phase Phase study? the monitor to So how I study? released and efficacy plan on the dose do strategy this starting the you for first safety results escalation what also, clinical and And will morning, based the be in

Robert I. Blum

types the in considering we general of dose But in Phase premature think about Phase the assessments of the study. study. be II we a escalation it's can speak we might announced for design So the II for how the light tones about and haven't that that fact maybe Stuart Fady bit and

Fady Malik

to the that enabling Yes. just say maximally II. didn't had I'll well to a it and on a pharmacodynamic proceed all of need that that high. were tolerated. mean, in find Phase the to press release clear push didn't We've how We that dose. us I were decide response, was We doses to tolerated

more but doses we'll to on can we'll patients Phase and to have say in and things, be you specific dose-finding III. think resemble I will study those expect patients study ejection heart II preserved a Phase with failure in that fraction, that really

And right now, more in going that until on terms with of monitoring and going are the to dosing remain those it, about schedule quiet we probably ready and forthcoming how I'm we're to be details.

Robert I. Blum

aficamten what can well from you patient as CK-XXX for in relates to of is we nHCM populations application there believe learnings for borrowing But as it evidence endpoints expect effect. that And in in clinical as are that we're HFpEF. to similarities

So about later more in say we'll that have to the year.

Operator

next And Sachs. will our Paul question from Goldman come Choi from

Kyuwon Choi

My him. the here year. Nice is a on cut the regard with timing to working by of middle to with you third access of this say, And enrolled trial with MAPLE. quarter to continue Sung presumably year, will have as be and again to -- as question late comments to let's see data, next your by

-- proposed even your the for data part question to bolster your or of for REMS or set in plans filing and/or my part a your safety maybe of either have submit do you your as case data or partial to of here So consideration NDA cut label. as the any -- full is either any interim efficacy

that If great. would comment you that, could on be

Robert I. Blum

ask Good question. to I'll Fady comment.

Fady Malik

Yes.

XXXX. something trial XXX-day remain said, safety So until will an it reads out called But a update. that the review, during in there's blinded NDA

ACACIA from and safety efficacy aggregate be MAPLE as and And from updated well trials so data data FOREST-HCM. submitting we'll ongoing safety like as

there if profile review. data, be to cement aficamten you during will, NDA the more the So of and safety will to consider if

Operator

question next come Srikripa Devarakonda from from Truist Securities. will Our

Srikripa Devarakonda

Aficamten left of a and in if may about aficamten? the case, patients from wondering for the bit would I still be be just not little aficamten approved. efficacy, concerned that is we early thinking long penetrate, your a here gun possibility? safety to of just to market not I stages was I about have the But to mavacamten get significant the or aficamten of they're in is a base was have jumping wondering potential switch with to to still term, may if proportion satisfied terms there wait approved, either of the but but If launch,

Robert I. Blum

interesting. So it's

speak a to who I otherwise think opinion about its patients applicable maybe be matter, broader on could own to could to penetration. of research but polling the focus patient and strategy he's not broader thinking those ask patients to Andrew from array leave and leaders make and and physicians surveys. prescribe that about I analysts how for for switches, as the about growth category have our category to community to been it's the primary we'll aficamten very those expanding be that certainly equity But conclusions

Andrew Callos

Yes. educating vast all. Robert, expecting available cardiology just the to I really just addressable market to physicians mean, broader majority you described. -- and patient. they around what of an we're of on marketing switches maybe still not through We're the communicating market a dialogue. inform build then and so and that or at and aficamten, that to be make on be physician-patient If the be would treatment informed decision going can happens,

Robert I. Blum

cardiovascular be how inhibition has application a -- array order serves trying And cardiac upon fulfill be where in able We're it's of broader students patients ultimately to be on to of mission. myosin to focused to incumbent launches other our think us ultimately patients shareholders. to still be brand good I and science to trying I strategies and next-in-class We're students that apologize. good and and

Operator

from from JPMorgan. Romero next Our Tessa comes question

Tessa Romero

meeting quarter. thinking goes look on that upcoming risk an what NDA like, have what around will us in be you a not? a plan all will your like? could that here? meeting And interactions terms saw we that you filing Curious So or on latest disclosure the the this And of how your you there provide with on before mitigation FDA begin

and ACC are on one around side patient on quick second number, just question focus you includes our And Where today at diagnosis. then the And for if of of number one takeaways addressable expand the improving key epidemiology the could right attended on We launch? pediatric is the was is number be time does this the how that the what HCM. the population?

Robert I. Blum

Sure.

the Maybe numbers something then tackle on to X and one. I'll we'll that, So comment and add ask Fady to will Andrew X. first

we to the do relates it do on with provide to might earnings relates call as itself. We we'll play-by-play with a our meeting intend to of the potential what expect with to general some not interactions, clarity otherwise, regard in feedback next choose connection As to update REMS. it strategy, our but on not to meeting with FDA regulatory the basis out and we give come after with especially REMS do

We risk negotiation specifically point most we'll around thinking, believe that's ultimately at actual a of but sense gives review FDA provide approvable in be general drug, And not this least what's ultimately, to of be with as in transparency so hopefully, review they're perhaps be it you will a the be us if actionable. the the updates, as we're may having and And some know, it's won't mid-cycle a discussions interest that REMS that that FDA. and affect or until that other that mitigation what strategies. a potential at will it

interest we've even So you to anyone's to want I submitted add to before that? Fady, anything that foreshadow the don't NDA. think in it's --

Fady Malik

data in in need are any general directional. as I Yes. not mostly familiar just FDA review. these They'll obviously -- helping think own are They we them. see I'll sense. do that with the to get commitments They're not just conversations their add,

review. necessarily moving. terms And don't so that folks be what the useful are confusing of be direction things to And change I any will we a not think course things of because want over would disclosures in

Robert I. Blum

however, to it to the clear, to Andrew about submitting QX. be To expect decision questions that different that, X different REMS that as a in on we strategies And to with scenarios, a risk an until maybe do after course float and mitigation read it won't in of turn NDA X. make answer how potential meeting be approach and that we could I'll

Andrew Callos

Sure.

Heart true HCM. III. are X defined diseases, probably XXX,XXX number start on there's number. expecting not and or are eligible treatment uncommon obstructive where go up, an not education those be diagnosed, There's the so available companies, terms by many that patients I'll is like you'll and Class diagnosed, of once patients we're as Xx of prevalence for case. the today that II true XXX,XXX also in on rare the rates likely treatment, treatment to pharmaceutical to York by New to guidelines stick those see but is So prevalence most The would that just available It's the or underrepresented that is market, to include diagnosed, publications updated the be

terms U.S., patients there's diagnosed of HCM. with pediatric of the population, Europe In similar, X,XXX HCM and the X,XXX is patients in the so XXX,XXX pediatric obstructive around to

we of probably that's treatment. Class XX% assuming XX% that New a don't population. I'm population for to So breakout pediatric it's have eligible of probably for the would But York Heart assuming be

question. hopefully, answers that So your

Operator

from Ruiz will question come next Leerink. our Roanna And from Instructions] [Operator

Roanna Clarissa Ruiz

segment have bit patients. a So to have do a particular assuming Could HCM take any the there that that CEDAR-HCM on aficamten path the how thoughts trial? forward, you it positive complete this in market? follow-up pediatric like And the of regulatory the an you from you CEDAR? for need And data unmet talk long agent in might on about trial actually

Fady Malik

Yes.

pediatric a population, adult the population as is unmet significant there's So large the think as but not need. I

-- will. options treatment You the is have myosin But inhibitor, the -- of an can they heard to when it less do. if have them preferred that the Andrew like don't surgery on they size. that disease patients early comment manifest this, on for option these available much types They would group, option same as quite meaningful same in age generally a it think, be availability at be The an aggressive. a who, I of age you quite adults

be potentially information may we able also, disease that looks more time, over be is at So progress as may amenable may more in generate disease because -- their that to progressive rapidly. to this how stabilized the subgroup opposed

general would you move things trying accommodating quickly the think process. review data to population, possible the through about FDA positive. be I in expect to to We pediatric is when these talk any patient those as very as

done, will not supplemental think main take, the we're it tract of part Just NDA. yet trials endpoint this so ventricular we gradient, outflow to left we really given as reduction the have is once go the these fairly we it can but and will long quickly, of guiding file how

Operator

will come next question Our from Salim from Syed Mizuho.

Salim Syed

could I'd Fady, But not to good this and II you're Fady, is there compound there this any on a how maybe Phase -- my compound their I is from I current into the MyoKardia if learned exactly know that extend how on I the all II anything And guess that read trial I particular, differentiate the like Phase XXX reconnect, study? XXX, design. in potentially to differentiate providing welcome from Phase you for could details to trial from and the congrats can, Its Sung. Sung. across

Fady Malik

to just bit, goal is and XXX expand I. really haven't little Salim, guess much may Stuart you and say, I don't in very It's some to dosing than maybe because a about elaborate that one that I seen very we our little develop to as you properties to make can aficamten, simpler it answer, we a Phase but know as about I'll told has ask unique -- challenging much maybe in a think bit? XXX. do Stuart, we want XXX of enable and we

Stuart Kupfer

patients that These less fraction, of we to ejection and manageable have that risk I we population. that would make designed more think the for more CK-XXX only add more to And at thing many example. vulnerable these risks. I'll patients or what decreases properties some perhaps CK-XXX prone other really has was comorbidities, consider is had in target think

And details be forthcoming. so, again, those will more

Operator

come Morgan Jeff will question from next Hung our Stanley. from And

Lee Hung

new Congratulations, Sung, on role. your

that's for expect are age? for most of related as end excursion ejection For a higher sufficient to the differences SEQUOIA, CEDAR, to from what dose be a expectations the fraction they dose adolescent patients the would similar the of likely range If because patients? you rate range up being and pediatric

Robert I. Blum

you do Stuart, want to take that one?

Stuart Kupfer

Sure. Thanks for the question, Jeff.

the in gradient and the a doses And that of dose same ejection studying doses mentioned, we XX based we're is individualized what's adults, as in as are normal maintain exactly selection milligrams. adolescent X target -- important fraction. is patients again, achievement the between maintenance and the of So on that

safe be key the and for safe that's is as evaluate safety pharmacokinetics dose. XX basic the what starting In And to, starting patients, dose. younger I determine And terms the patients, question of children, the plan will be interim really is will doing children, strategy. adolescent analysis, and younger a what mentioned, evaluate

in dose and we ratio observing be will anticipate -- good we benefit/risk individualized selection, that with so as as And we're mind don't in children the that just adults. in

Operator

Mayank B. Next will question Securities. from Mamtani Riley from come

Mayank Mamtani

see to join Sung pleased team. Also the

if saw higher the responder baseline connected rate that seems higher just maybe is dose line? the at the analysis level helpful Monday's initially ESC -- of could side clarify that top number on data, and at safety you also maybe VOX the get Congress next relative and had Heart obviously titration to the the could not is Failure much patients staying And curious characteristics Just how we on patient the to and of what that to you see please to we efficacious having to doses peak thought. be

that, clarify could great. you be that would If

Fady Malik

presentations. I those Yes, lot safety. questions Mayank. will addressed I X dosing one about them, think your a speak Remember of most the will be and of mean,

to got were you doses peak is comment. randomized related With that dose And to I'm to a to their VOX, sure that. a dosing randomized they were there safety of is patients response to strategy, But and the these regards on show drug. dose, patients based how to individual and analysis. they so we'll achieved characteristics at not the not really the remember dose-specific can't various a

consider strategy. all lot just of of in dosing so And that the part way, we, them same ways, a in

Operator

Our Butler question from come from Jason will Citizens JMP. next

Jason Butler

all on progress. congrats the And

Just an for what and wondering regulatory progress could are update next if there? give steps China us you on

Robert I. Blum

such In that specific our we we're in to progress, making very aren't partner are I'll light those Jason, Xing, good and on take but yet one. setting until a Ji that, expectations. position aligned as be of we time

call. able something the to So I with we'll that say do hope be earnings next

Operator

Our question Jason from next come from will BofA. Zemansky

Cameron Bozdog

for This Jason. is on Cameron Bozdog

it's you maintenance likely kind [ a bit this touch base novel elaborate the potential of of risk feedback to of echoes a you be from case required look in titration then regulators discussed drug on point? well? and your And both assumptions based as little ] could you've could maybe you and setting like? I Have the if on mean, currently what this then any received a So on in number could on for algorithm.

Robert I. Blum

echos with question, conversations no I the is of to REMS. to that It's second Sure. a FDA. your speak of scenario having of going number function to there's part expect a which think still we But premature be by similar the we're

what a in risk how program. that continuing light clear might FDA think, there in the a be with will in risk to that be REMS mitigation by strategy conversations informed of that have I I NDA will the could we It's, And be different fact that dosing And that, approach submission. of an way in we therefore, look think the going FOREST-HCM to employed about kind as differentiated. expect concrete and itself to is with mitigation SEQUOIA-HCM strategy. like ties in

different know. are mitigation, you to ways as there risk And approach

be can that labeling. of Some handled by

informational that Some handled an be in of REMS. can

of risk do factor position, properties, with differentiated that of of profile just thinks to regard but how And one And ETASU excursions for risk the subject in pertains in the REMS. Some focus into seems as And require that EF ETASU FDA have our these the current a I is to risk speak an going our to mitigation. of curve interaction ADME be as inhibitor approaches to think drug-drug and how we're also light to half-life be REMS. pharmacokinetic of shape to cardiac properties, may about myocin objective the base Street, to is Wall the not as is pharmacodynamics, understand things a case, all mitigation. properties

have think can the we say more do I the hope today, that's do but road. to to I best down

Operator

comes Our Carter from next question Barclays. Gould from

Carter L. Gould

out be to say and going But on I'm AHA a guideline going HCM going had this afternoon. what you that ask a and there. go bit in a just was of I'm limb good probably in you that unfair of to to sense dropped an one ACC the

the of differentiation about provoking aficamten. kind then study guess important is you in I guidelines How there maybe Diane think just mavacamten done? and between is I anything at surprising? the you Andrew, when -- of conveying when the case risk at the think high down work that's all level, prior operator, the road, and based you've on importance that that a And for So guess, of there of

Robert I. Blum

Yes.

you Fady by for you light did and ask from your So noting good way. Diane, perspectives that of on just today. questions. dropped And the a grin get of out to in will Andrew both comment those their guidelines I

Fady Malik

into Well, inbox call of and I guidelines actually drop call. until my this X saw the the see this didn't hours middle before that

I'll the briefly, placing So to EMA, did followed myosin They do inhibitors nothing the are of them which following of sort ESC I beta of really cardiac kind inhibitors number would that one, therapy think same myosin just say. and a my -- of surprising, I blockers. guidelines first-line approach the as scanned they -- question, referring having best they -- class your answer to

patients we are guidelines. myosin So advantages will like those that's therapy to potentially show inhibitors first-line And inform hopefully, that fail why to that MAPLE there first. cardiac who are starting future conducting are data these

where won't what that is expect... that available the of sure guidelines. to cardiac myosin things make need they in do not out, just best who and myosin in conflate weren't in have I process, We that aware you think of delineate information I ensure do future, the We inhibitor-specific. that, was don't in that that can compound-specific figure that hands may, with you'll the specific some sorted the and but be so inhibitors participate read certainly actually people are and our to if those, them, issues are And cardiac we'll out, There to the some we is data I of to the but them. guidelines.

Andrew Callos

sorry. I'm

Fady Malik

Go ahead, Andrew.

Andrew Callos

Yes. credibility a when maybe was that if especially to to it's guidelines. physicians your around thing therapy. Certainly, that's credibility The around to certainly adds first-line only going add the payers to to I talking was evidence, question cover,

because extremely about, that not example, that Additional first-line And and I studies guideline, certainly probably that give more talk as and strength to to physicians an data able to physicians difference. talks having a well. being evidence a it evidence to as as if of to important having say, not being is MAPLE, like big is, it, a think think talk therapy to about about and able guideline data compared I

a to get aficamten think pharmaceutical So various approved. probably and I the evidence credibility as relative to most guideline importantly stakeholders if to company payers helps maybe we lets summarize about to us with physicians talk and the

Operator

next Our Sandler. come will question Yasmeen from Rahimi from Piper

Yasmeen Rahimi

Congress Heart as we're the guess going here Cardiology into Monday. Failure on I

better You I have look spoken aficamten at clear into to get wins data it of just efficacy, is that how into Monday's and color more even people disclosures more have into the guess, it around -- you about kind the full it your question the gets. become its you I'll on going back or the around release jump that, the not data, Do on would that think I profile? like, love on product data safety will queue. only --

Robert I. Blum

if of can in just data. that's these you results once head-to-head Failure year. will will profile comparison ultimately at a belief appropriate believe available the the conduct results the it convenience into to be indicative not but not and choice, of be relates efficacy, inhibitor said, cardiac ultimately, that that the as our see for SEQUOIA that not later approved. did next-in-class factor be with by we to determine meetings aficamten aficamten presentations, reaffirming believe this other as that that I in that those said, would profile and With it but safety, things European be and The not our With we of of meeting, Heart to clear, of become throughout be you mavacamten to would all do aficamten evidence just its imply And in supported publications expectations. So myosin did. the we are

Operator

Akash Tewari from comes question next Our from Jefferies.

Unknown Analyst

Akash. This is Amy on for

either are think need Just you you or the support Do LVEF seeing drug healthy this one monitoring? data that requirement? volunteer your out will what And in supports doesn't CK-XXX. on

Stuart Kupfer

I'll one. take maybe that

toward in CK-XXX that the and mean eventually That know contributory the think to as need said, developed sure achieve we monitoring -- it's and we without monitoring. saw The to Phase think in patients echo for that I dose to routine profile we'll HFpEF supports that was I that, we not. that. premature or this potentially I data produce echo whether

in know And we so as II. more explore Phase this we'll more drug

Operator

from come will question next from Belanger Needham. Our Serge

Serge Belanger

potential FDA the a guess, are the with meetings review so thoughts quarter. regarding far this X later another I your one coming priority and had current up, What the or for AdCom? You've in

Robert I. Blum

Yes.

to those of to our So would base that assume it priority something not on, so neither that as profile, but believe a possible, that's review. assumptions, speak. It's be in we exceptional certainly we're case more banking are next-in-class

but surprised the inhibitor cardiac And as can are, myosin There's very one, marketplace on an it compelling. the And one have relates already that fact to AdCom. don't an by data AdCom, expect be the we we believe, quite did effective those that things. for not

be guess possible, unusual But would base AdCom now next-in-class it's I an it compound. our case not assumption. it's think a I theoretically have for to

Operator

Our Verma next from from UBS. come Ash question will

Ashwani Verma

X. have I

LV expansion from differentiated is seen XX% run, event XX% level could conviction your think safety what's you be pretty LV the market, viewing at you SEQUOIA for discerning than and the lot less is on what is the expansion? from indeed could there in compared presentation the your like a give you of if in you Just think just would X. significant drive? the difference diagnosis oHCM that the the long on regarding the bar binders, between you then do What from has the So that to less Monday, second, profile perspective, fundamentally, of ATTR do actually study? as that frame the FDA oHCM just can than Camzyos? And diagnosis sometimes

Robert I. Blum

below about matters. So the ask press I top to ES line comments XX%, of might to already Fady to our those but speak recognizing speaks release some

Fady Malik

you the any I we than less if discontinuations treatment And we said think have that n protocol top line was going on don't that X the or nonexistent. event the observed are X say EF XX%. they Things been and any expand our heart a if certainly at of is will. that they're again, never were that be failure have didn't But presentation, treatment know, I mandated Yes. for the an We've of supportive to to aficamten those almost don't suppose. as due profile. interruptions contributory, happen -- be and to going good had site. to in We'll in that I of safety all

all promising don't are labeling I road. potential think very things second guess And regards which think, I we'll so I understood we And the your overall, down entertain. question, to those the with

Ashwani Verma

Yes.

diagnosis has expansion. Just not expansion high oHCM, significant could ATTR high terms it of of like mean, that, something mortality I but mean, like yes, I quickly, diagnosis and one like burden need, has in the just right, a the as argue a as unmet which seen is mobility

Camzyos. the lot in has still a potentially a marketing on you are believe other of could you run, been inflection a do of that So diagnosis expansion? any kind this doing one long drive driving and campaigns I lot meaningful not mean,

material Or So is? market of to we run? if just where it like oHCM trying the sort is in understand this could a see expansion long

Robert I. Blum

other cardiac are I Look a who myosin matters burden as mortality the with benefiting to quality who patients on receive be stay here life ultimately their add that, that what read that on burden defined as And incidents receiving Andrew, it's disease substantially the you the and functional inhibitor very symptom patients of data a to want could life. believe therapy. that? category do and think I on expansion. and very is going for Yes. therapy. And that new to adherent want by that's don't anything for clear and much compliant Camzyos. to opportunity are These be from are defining at therapy

Andrew Callos

I say of QoR. remit we're probably what of that's Yes. a would part doing the in

KCCq, reduction about all improvement improvement those think Class Heart to improvement the in health and and speak septal in like York of improvement for need cost you in surgery, the of New outcomes savings. Association, in some endpoints therapy, secondary If

more larger can I sets us start talking think to show have it merging then data to see that to the and some that impact publications So with you'll populations. large and on

that lead think something [ you're So it [ see in as over will time as not that obvious have ATTR be certainly something you're QoR] certainly ], I expertise may around as the to a to we going what area but it's this describing.

Operator

from question our Raymond McCutcheon next And come James. from will Sean

Sean McCutcheon

patients the XXX the or rationale opportunity the about clearest size you has Can and what how parsing thinking you subsets for in the maybe HFpEF and you comment will II on Phase on of subset you're II pathophysiologic enroll in maybe populations? do in think broad the the those terms study strokes restrictive Phase the of

Fady Malik

Robert to human ask ahead expand provide and of study I'll generally. Phase Stuart II want earlier, terms, in Sure. of time patients I'll can but as that Stuart CK-XXX, Yes. kind of characteristics answer of general that, responded the study to so those model we on patients well just the sort maybe of a NHCM HFpEF the mention type in that said with

Stuart Kupfer

Yes. Thanks, Fady.

develop by diastolic subgroup We hypercontractility be of non-obstructive HCM. may with for dysfunction large of some patients severe right. that's think in wall with believe these and like ventricular patients driven patients part I just thickening that a patients with

really improvement patients HFpEF. we the the patients reads informs and HCM so -- potential benefit diastolic and observed II subgroup non-obstructive in in outcome REDWOOD-HCM, with in of of function but And Phase the

who we'll to patients to from relatively and could be and wall those thickening their benefit ejection symptomatic so some disease symptoms are we'll be functional patients of having treatment. -- have heart related if ventricular fraction, who looking evaluating a see symptomatic high And degree failure

the generally targeting. population that's So we'll be

Robert I. Blum

subsets Andrew, standpoint? Andrew, of from HFpEF be about you speak mute. how want you to thinking we're on terms in prevalence a general around might the do approximately

Andrew Callos

we'll subset is. of our releases, ejection Yes. in HFpEF once where upper II, the probably Phase learn overall think here I fraction. size of probably of exactly in all HFpEF, describing hone market. of that to and start of cutoff the We're is the around from the press more we And half a just subset more range in

Operator

am from I'd turn like questions remarks. CEO, further I for now Robert lines. phone the closing conference to showing President to our Blum, no back and And

Robert I. Blum

analysts efficiencies. the we have some update to to that believe excited diversification development next we're and looking meetings think focus expanded week, you our updating We're And the for financial you about pertains with aficamten. Thank program on European including questions. as and we're you, it on as Monday, deployment operator, continued shared capital progress stewards forward And and same Failure to and time, especially at being May you, capital XX afterwards. good we this with thank at to excellent the Heart our for presentations the

your with now can call. we'll that, we conclude Operator, for and in you next the thank look interest the We earnings forward Cytokinetics to call.

Operator

participation. Thank concludes conference today's you. call. This you Thank for your

disconnect. now may You

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