CYTK - Earnings call 4 2023 | Cytokinetics, Incorporated

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Operator

Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' Fourth Quarter 2023 Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the company's request, we will open the call for questions and answers after the presentation.

We will allow for only one question per participant and ask that you adhere to this request. I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Communication and Investor Relations. ahead. go Please

Diane Weiser

Fady note thanks Robert and begin us the aficamten recent on activities closing commercial XXXX finally, an provide our rather R&D, Good related Chief overview milestones call of updates the President for and today. forward-looking Robert facts to provide aficamten. developments. questions, of readiness and quarter contain statements. Officer, Blum, of will EVP Chief call reviewing for financial of portions overview before will discussion, discuss afternoon, will the joining Malik, our financial for by and Executive with focused Andrew future Please also aficamten and Commercial Chief guidance to ACACIA-HCM relating Robert Chief Officer, than Wong, a to and performance Stuart Callos, discuss And relate provide year. about will MAPLE-HCM, Blum and the events Accounting responses and and that SVP including FOREST-HCM. VP key will CK-XXX and historical the to statements CK-XXX. corporate and additional quarter. past to following EVP the constitute SEQUOIA-HCM expected strategies and and speak will Kupfer, that Medical updates Officer, will Officer, development for

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

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

Robert I. Blum

And on renewed us HCM. or Thank clinical inflection card a interactions as you, behind quarter development already myosin submissions submissions next-in-class publication we how efficacy Diane, activating with readiness other we our Fady regulatory activities. for treatment XXXX of following and trial of And the planning firing and we're SEQ-HCM will presentation SEQUOIA-HCM, for our expectations, as of thanks for hypertrophic and program next The XXXX comment Phase represented of for fourth for will potential aficamten The on phase for inhibitor. on we're primary how of turn across clinical the and safety to as then which point broad today's our our the cardiomyopathy our well began the globe. transformational with on the On plans joining high SEQUOIA-HCM, with results as well, opportunity. commercial our to further regulatory results discuss elaborate commercial will cardiac patients III a of on the next-in-class commitments company today. cylinders for of Andrew call preparing exceeded and moving Executing swiftly now all urgency. and positioning on differentiated prudently call,

option as potentially HCM. provide on-ramp will number patients of continues in progress on to as the we of will is SEQUOIA-HCM an and pipeline meaningfully unlock company value new well as for believe treatment ACACIA-HCM, Phase with path additional to of potentially of an which commercialization, growing shareholder as III will a as mature. HCM to our more update myosin cardiac important clinical the nonobstructive obstructive much there's As MAPLE-HCM aficamten, trials that the the utility expanding the to our for inhibitors a provide treatment Stuart first-line provide

an you'll and there's the results As these positive on of trials surrounding hear, increased the activity SEQUOIA-HCM. enthusiasm been heels from

in to patients, ambitious to our us I'm execute but of ahead to strategies. remains on still much ability aficamten confident However, bring our

years departure terms the our available team, departure In approximately the our of at-the-market XXXX not quarter to strong any and to when on well-being, personal anticipation to cash continues Jaw to financial is our thanks with we ATM development, for so know, health, day-to-day a our Matt to company. finance ahead transactions. years, position a of detail, FP&A. a from behalf looking and international and support in compatible year, continue extensive confident and the accounting with who we has business cash XXXX today capital more transition as with initiated Schnieders, towards we Finance expect with company specialty Ching's our we a I'll who and With previously the He'll will of we will impact this for many with of VP our minimal senior of meticulous Ching capital pioneering financial replacement health. including order turn and hear Robert infusion with reduced we we please. work people company. as to increase biopharma Ching's Accounting consultant Ching our that decision many despite we've we and attend SVP it retirement and and foresight, to believe On bright a And with mitigation, his unrelated cash search in attend both Furthermore, bring make Cytokinetics structured CFO Wong, we good our medicine strong team who served front. the in expected and Development Chief VP vision sheet, passion, to that CFO XXXX Together beyond. his perseverance, having the a We're as the strategic his R&D teams through his to building express year. you balance come of turn expenses as of leadership today, well hand the are national we call over lead we Officer, on reporting for dedication. operations. in Ching's Corporate planning, X of of planning on risk our served as runway our public brought gratitude from on his a well programs. where and experience foresee the they not we balance and and XX me us to We're allocation happen that to may to of but have to earlier that, an his result company operations. reward have to the commercial our an to projecting already the to with or as operating by also announced added we're contributions Yang, built foundation, seasoned do quarter from mutually fourth and in impact of over future It's assembled, fortunate also with our as for first arising that vehicle. of cash prosecute you'll Business XXXX. maturing company prospects is in pipeline, last experience aficamten guidance research in business shareholders. leading as leading we the be Recently, Fady, have our Libby to equity spending further that has financial biology for in will to commercialization the this and to is more a as Ching ended continue muscle potential coincidence. page be pleased As during We're cardiology

Fady Malik

Thanks, Robert.

we The difference placebo, Cytokinetics. significantly at teams Robert with Questionnaire all including or results by of Score The per showed least a all treatment with X.XXXX square baseline and compared from kilogram at our per X.XX patients not comparable and adverse symptoms, observed patients profile truly of subgroups, Summary prespecified our study emergent by X.X% XX XX with patients of peak commitment prespecified of During the and LVEF, exercise These aficamten at receiving patients patients or patients, meaningful on weeks of receiving compared reduction including milestone, patient to was of to less a XX; observed exercise as well failure eligibility with proportion placebo. X XX across well beta or of shared positive Kansas fell be investigators, tolerated minute or characteristics left course patients p-value staff, exceeded improvement aficamten at the an on less VOX, to and or in a mean from the to City and reflective strategies, incredible Cardiomyopathy effect was measured Statistically provoked was and or reflective clinically milliliters than X many, treatment including fraction, X.X% Core patient increasing XX; said, treatment and improvements outflow expectations. aficamten were whose sustained ventricular gradient SEQUOIA-HCM, Clinical XX quarter, and uptake significant millimeters functional therapy. greater oxygen on class background that than X.XXXXXX. endpoints, p-value or in of Aficamten results a XX%, with and therapy. our rapid improvements topline functional to secondary capacity, or ventricular with across left the peak XX aficamten placebo. cardiopulmonary XX on septal which extraordinary than X blocker It status. adverse for ejection weeks serious of as of of Heart so capacity exercise York SEQUOIA-HCM testing, guideline and class consistent at below heart X.X% tract mercury Treatment reflect workload X.X% results as an gradient Association echocardiographic placebo. proportion was change in X equal and New weeks events occurred event XX; improved

of worsening low LVEF. Importantly, treatment heart interruptions due there or failure instances no were to

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data is at plan to small, mark patients as we analysis future in X-year these this only time patients the more eligible were this While the on cut, of the and XX data expand beyond. reach

February, the NDA. PDI Regarding regulatory quarter and the support first held of ahead of to to feedback with our the to We're readout submission our of pre-NDA labeling and in supporting providing content of of for updates month interactions FDA the format mitigation. align results to opportunity we to the this the year, during package an SEQUOIA-HCM, sufficiency opportunity an the look review X positive the a engagements, the with We providing pleased pharmacologic this of profile a with meeting and submission expected second future meetings proposed and We the third receptivity NDA risk of the and with NDA submission FDA continue a on FDA's along differentiated year. of aficamten, believe our SEQUOIA-HCM, regarding to rolling that achieve plan. favorable forward meeting

treatment we're in similarly this in in of Overall, plan for in Ji meet we're our year to of support the enabled and our managed Xing our with global all while capitalize and HCM ready plan this, regulatory fourth XXXX expedited medical Europe, towards with to science Similarly, proceed China consider profiling to on collaboratively began submission liaisons regulatory marketing during our proposition. consistent quarter of value to coordinating partner planning us and planning as quarter aggressive to the perspective, to to of Xing's EMA and submit Ji NDA. our our in inform an urgency healthcare science application a clinical submissions therapeutic with payor continued As medical liaisons planning SEQUOIA-HCM as proactive from of results well scenarios. development has with preparations. to positive pathways programs, Alongside our QX medical the affairs interactions from

medical support We conferences. at our continued also of activities education medical

continuing the from Robert are research approved of of the well power said, is with have by engine the if and HCM the development physicians been leading As way. strength aficamten community cardiology the we received our anchored in The with work pipeline, look we care. results company SEQUOIA-HCM in building what of specialty grateful and with topline can be patient HCM. establish to meaningful as advocates to support, they that for next-in-class engage a we them a aficamten who their represent foresee We're and advance treatment as forward patients to potential option for

pipeline. over Now progress and with additional I'll to clinical hand Stuart elaborate on development an more our it aficamten update on we are to provide earlier-stage making clinical trials

Stuart Kupfer

Thank you, Fady.

the see MAPLE-HCM from obstructive catalyzed sites by metoprolol ongoing momentum the U.K., to the clinical in to and accelerating during have and superiority of sharing addition from to been pleased X continued as and evaluating now of all that screening In fourth monotherapy Italy, quarter Israel. SEQUOIA-HCM, and are HCM, In building and SEQUOIA-HCM. are positive sites we is enrollment with announcement our U.S. Phase potential patients as results in III enrollment ACACIA-HCM. aficamten monotherapy aficamten, activated, We're of Netherlands is France, with trials compared the results now we've MAPLE-HCM, activated nearly the which and

into would concurrent and clinical a evidence believe ACACIA-HCM represents population the expanding cardiac we aficamten by trials and shared can for ACACIA-HCM, the important the in treatment pleased clinical our tests in the inhibitor of the of what expand data, from Both therapeutic myosin current impact a same to optimism patients of we're heart with guidelines. hypothesis expect hope potential which trial We in have ascending MAPLE-HCM REDWOOD-HCM strategy. through aficamten fraction We therapy with if harmonized enrollment results We new currently HCM. the dose second treatment treatment North thankfully pipeline, myosin MAPLE-HCM to inhibition pivotal our on aficamten options. U.S., opportunity the obstructive to dose study. focused year, but an and to South the notably with enable MAPLE-HCM the developing the population application with potential utilization We confidence quarter, patient Having advanced HFpEF. for trial CK-XXX, preserved out that clinical objective IRB progressing MAPLE-HCM it patients in start-up, in this factors support launching of for and with America, for importantly XXXX as enrollment to America, that Europe look is procedure. the expect from completed we the time, HCM Phase study capitalize next-in-class is aficamten we the of be patients positioning and of to earlier also positively, for to quarter development complete or symptomatic in believe first-line underserved aficamten ACACIA-HCM, that this of to At potential the in investigators. investigator to continuing our progress the third SEQUOIA-HCM We're trials provide by the enrollment be key failure the commercially a available we're and multiple XXXX, stage this patients and we hold growing from forward aficamten. have results III were ejection In of aficamten. read in our past support when would trial the with to clinical through add of we of single the the in for and clinical plan meetings necessary ascending with the of EU, portion our on proceeded XXXX. in in subgroup nonobstructive development HCM, approvals to the to with cardiac analyses complete quarter

data quarter year. with with and second in a the study in Phase We We aficamten this half II second expect Phase X.X II X.X is shared I amenable development XX% positive there increase nonobstructive their to patients believe of XXXX. expected with about inhibitors, HFpEF, begin in may data subsequently trial with by still condition generated with million complete to XX% the in patients cardiac to we the Approximately plans condition in risk HFpEF for people Currently, Phase effective to these high to support that cardiovascular of States, present quarter for United this to the has to is of HCM. million the make of year, are clear characteristics This HFpEF. those inhibition. the of CK-XXX in benefit that patients the there nonobstructive SGLTX need clinical with and a additional population residual a demonstrating myosin HCM of parallels in many with Even some therapies first the evidence-based therapies. events which a

Additionally I of cardiac troponin in our study our the to quarter, the dose healthy we more analysis continued share single plan CK-XXX, the for Phase ascending study in and early-stage research. our second complete during the we and this updates activator, XXXX, to In expect and participants year. cohorts the of from past pipeline multiple of quarter

our into and biology focus in As include the we've mature metabolism we more to years labs energetics. beyond clinic, programs contractility development, in muscle from entering in innovations on our representing muscle other will potential programs muscle recent extended also report how

and that, cardiometabolic for exciting cement syndromes. look more Vision ongoing represents over the With aficamten long-term driver goal forward early-stage developments our Andrew. most against research progress in company, to productivity emerging biology soon. We to turn call While near-term pipeline adjacent to programs XXXX. The for from and important muscle treatments is to I'll our the value demonstrate our leadership sharing our

Andrew Callos

Stuart. Thanks,

impact health, can the everyday engagement SEQUOIA-HCM, can multiple patients was XXX overall approach. During from and XXX Throughout insights commissioned in continued commercial our seeking with journey nearly social learning challenging. research which the we our mental go-to-market We aspects patients' and phase quarter, aficamten. of life. other healthcare professionals activities of be the HCM first results and HCM, studies on that market revealed our more readiness than obstructive also HCM ahead the XXXX, Furthermore, complex negatively focus from for announcing patient

of and would the We of at the most all Aligned a market revealed patient of SEQUOIA-HCM. services at patients and in aficamten prior from particular tested for key to tested us. positioning we're values making inclusive research treatment also is support The would designing with to and at profiles potential a healthcare professionals are SEQUOIA-HCM actual a comprehensive a of target receipt facilitate we drive results with aficamten, These do, hub. support range the that obstructive transitioning forefront the favorably company the profiles patients keeping perceive of focus to our results program resources we patient and patients. fourth our we're approved In of customer affordability across broad HCM hub. our learnings patient differentiated of if our providers and range profile, patient product initial resembling patient SEQUOIA-HCM of hub the specialty support pharmacies around strategic from services Access conversations product for education closely reimbursement use informing programs attributes service XXXX, in and with patients. results to support build held eligible quarter the a decisions

Now patient strategy, are build inclusive This this services, approach phases our model, have year, to year, advancing our distribution design from plan strategy build. contracting support access SEQUOIA-HCM to that and and we second results and we the of go-to-market third of pricing. we

from understand finalize results. branded we the we market also launch. every to and develop marketing in and and our staffed seasoned continue our our promotional to to further development ensure launch In in of support positioning team fully campaign clinical is campaign the SEQUOIA-HCM of potential introduce plan while to XXXX product meaningfulness Cytokinetics. payor education XXXX, our Our manager payor payors will share interacted and major XXXX the team This field-based results in account account with XXXX engage

launch As systems, capabilities the that we from what omecamtiv States prior will analysis, the the been commercial receiving be mecarbil. expect CRO the the and potential generation, and personnel building launch further FDA of aficamten. U.S.-based infrastructure insight and leading strategy, refined that we United and began to built our of individuals shared, operations. leadership, including FDA, Today, we to and has now onboard commercial maintained commercial our we majority for After have activities the team the approval previously field first headquarter need we marketing, with sales prepare to market in

nimbly into the turn of commercial completed and for readiness with with next future obstructive that the can approved, Robert I'm gated of I'll to phase alongside aficamten. process expect of in reimbursement work last positioning planning and treatment pleased a year, to And Europe, for with capitalize eye expand as our team from leadership our enable foundational in with of over obstructive to Market we we Wong. last HTAs regulatory we which very We believe regulatory Head to the myosin XXXX well with we've on appropriately submissions and to European be inhibitors for XXXX across up aficamten hired the HTAs. HCM, In France expand this year, markets. positions modestly is XXXX the Head HCM. while feedback maintaining to the Overall, disciplined a benefit of in our us spending It us option and staff call of assessment customer-facing and gating for new having to of and EU assessments to in advance patients believe Europe results our Germany ahead ATP bodes patients SEQUOIA-HCM treatment if cost key favorable major in Access, sets positions plan will differentiated only technology encouraging aficamten, or sharing see that, related from cardiac including what of health both

Robert Wong

Thanks, raised our the investments, we $XXX.X included in that ended Andrew. with million equity quarter and at-the-market vehicle cash which We fourth through the quarter. million in $XXX.X

$XX close, approximately quarter yesterday vehicle, we ATM our million raised our is equity net through in which balance. year-end the reflected Following with not

million XXXX quarter quarter million cardiac myosin our increased of expenses primarily due inhibitor programs. to from fourth fourth $XX to $XX XXXX, on spending in the R&D Our

on to lower XXXX activities, the begin XXXX quarter $XX Overall, offset primarily good of of in XXXX $XXX in a SEQUOIA-HCM position million expenses the proved fourth results what stronger million of was higher guidance down spending which XXXX. stock-based personnel-related stewards compensation. $XXX due to capital burn outside end of of by million, spending including QX reducing our net be commercial year, to were believe relative our by financial the we $XX.X million costs XXXX initial ahead Our at cash We was puts to million. from us to $XXX G&A in shareholder

Now hand I'll financial Robert over and to to Blum it corporate development guidance outlook, review our strategies. XXXX

Robert I. Blum

$XXX Today, to $X The will you, expenses net approximately to the million guidance Robert. the $XXX be million, financial to of million $XXX cash be of will in Thank revenue and range we for $X announced will Operating anticipates XXXX. company our million in range million. utilization $XXX be million.

commercial strategy investment pipeline. a plan that balances In terms our prudent patients with capital are of by anchored our in priorities allocation, our focused benefiting advancing on and value enriching shareholder spending

Our commercial obstructive and ensuring and is in foremost the U.S. Europe. preparedness for regulatory like aficamten submissions in priority HCM markets advancing key

our results approximately net $XXX agreement of available approximately recent sustaining cash at to finally, therapeutic on arc well growing R&D leading Inclusive and maximize in as plan we've we and platforms growing innovation. at from positive potential under we and R&D net bolstering our SEQUOIA-HCM approvals the commercial capital And the expenses last ACACIA-HCM, $XX through Secondly, With XXXX utilization. inclusive forward CK-XXX us in weeks looking guidance and as end with pipeline, cash years projected of up through balance been aficamten our X requirements our potential in of the to well of sustain to continuing raised future of million million current operating hand, MAPLE-HCM as financial runway as on of of and profitability. launch based to the global the and cash year remain cash represents ATM aficamten. of focused Royalty our our loan Pharma,

As such, on that approach focus several levers over pull we multipronged a capital continue to to accessing time. us different to enables

finance our partnering value engineering and approaches. and as R&D our As been preserve history, structural to plan shareholder via as monetize progress has nondilutive we other well

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X eligible in our for upon of our positive and occurred we which The first the to became receipt sharing available down year $XX December. results remain following tranche of SEQUOIA-HCM, results, from million late draw

satisfaction the in to acceptance conditions, second the available takes. which tranche of most United become choose to aficamten will submission million for The to is of draw on an were of the certain we NDA notable us it, of $XXX subject to

How And the Since have a X Cytokinetics. to address $X an are sharing upside CK-XXX From want be ambitious which results billion success. stage to years with Cytokinetics company we recent increase MAPLE-HCM that next billion, we valued of yet ACACIA-HCM then, It would to get earlier there? the in positive coming higher now and aficamten of increase I there, HFpEF realistic moment expect proof target. billion. between results rumored practical to hope relating value additional and from an and probability from been have M&A speculation we opportunities. results $XX value shareholder from pipeline acquisition concept $XX By that over billion now next on read our to North SEQUOIA-HCM, the to unlocking has in As take in we to plan be X our a and advance $XX starts pipeline. of based to as out to our maximizing Europe with to do America the and technical SEQUOIA-HCM. value we through also upwards

not about we one clear thing. will we While ongoing. sale and have process me be comment on not speculations, We nor do please let initiate did cannot a specific

our you believe heard say we to care about are and development are against that that advantaged science, managing We be of our how a shareholder However, thoughtfully take that discussions moment specialty executing position. deploying ensuring We're to sustainable those great doing an by we're value that discussions. bringing ensuring we thing controlling optimistic can I our business we deliver can value. as We operational starts in with we're We're advance efficiencies, a right innovative goal best proceeding, the our And control. beginning and as and shareholders capital achieved medicines thoroughly that assure evaluate by fiduciaries fulfilling responsible cardiology patients. to me which as and to company maximal committed shareholders, can XXXX continue building to in ago, options advancing to presented. maximize and to prudently you new duty

months. potential to we're regulatory within in the United for stage and second expect story half Cytokinetics and In page chapter the both undertaking now work we hope the of turned States XX have filings approvals, the to the the aficamten. of next regulatory the for Europe our set will year, we submit the next We this first

in heard from and MAA EMA. QX with an with in QX an FDA, Fady, You NDA

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we expect For aficamten, a medical from to present SEQUIOA-HCM at primary results conference QX in XXXX.

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

We in enrollment QX MAPLE-HCM to in complete XXXX. expect

in ACACIA-HCM of enrollment and to strategies complete enrollment but for in to advancing XXXX expect continue its we continue We aficamten. expect XXXX, go-to-market

an omecamtiv mecarbil, the regarding XXXX. to expect we in QX CHMP For MAA issue opinion the

Phase quarter up XXXX. For CK-XXX, to year. complete that, to in Phase share questions. from of we CK-XXX, the data please, the expect second And to can we a the And we I this with open in study Operator, expect finally, I for study now call, QX

Operator

Riley question Instructions] [Operator Securities. Mamtani with from comes Mayank Our B. first

Mayank Mamtani

Good taking for afternoon, and questions well-being our hope team. for Thanks Chang's too.

submission? it I of the just on be occurred, meeting part patients Heart probably titration of important of into you'd and the FOREST-HCM going meeting be pre-NDA Congress, by phase. quickly data have eventually that through Failure to how make just the go was if the Just submission? I'm the much that I curious about that of EFFICIENCY, much the pre-NDA part believe curious would is XXX how NDA as --

Robert I. Blum

call, I'll that turn Fady. that over question to rather,

Fady Malik

the NDA a safety FOREST besides to of perfectly can't fully we in timepoint. of have year be expand submit a dataset. the patients There's XXX also, give submission, opportunity extended number of of exact also of We follow-up patients we'll you be who will of for to the at the can have XXX patients available. Thanks. to I that their where But the time update review. expect number at Day we follow-up an with the update adequate number up Day the

Mayank Mamtani

a based you that, we level your just timeline could safety, just questions. ACACIA-HCM, threshold glad question, what year. HCM on other taking early confidence Thanks from data, for the the a just I'm of could quickly, the report dosing, cardiac set there. study you was next Also again narrowed be there. that remodeling as related everything part on know for recognizing And curious, the I Understood.

Fady Malik

that based of and the and Well, in saw results and very II the aficamten confident outcomes in the of feel saw we Phase we the dosing outcomes on we think predictability potential safety SEQUOIA, with I profile in ACACIA.

of helps I think best answer. get reading to we'll it that and the on a continue of in them likelihood all read way that the positively, us out to trial conduct well

Robert I. Blum

for question. Thank the you

analyst, please, please. Just per one a reminder, question

Next question, please?

Operator

from question of the Salim line Syed with Mizuho. comes next Our

Salim Syed

-- first? believe you. in encompasses to just you on also submission, you're an submit I that on for I'm piece going submit going later? then to And if any decision? What way Robert, rolling maybe exactly if are for if aficamten. MAPLE-HCM rolling what first the for submission that Thank in data that to -- before wanted potential get guys you to what is not it's the the this but Fady plan focus terminology, And curious then is the the going using is is because the approval time in submission, and I as rolling well, that exactly mistaken,

Robert I. Blum

that Yes. answer I'll question.

the a first a be consider forward time, recent we FDA. sooner. the what that's to we of terminology leaning to We're in amenable the to most of pole timepoints collect the we in to in these in very to willingness to, of certain than the the right, basis. connection by are a with the depends there are so CMC recommendation data data be to could out need that what's submissions. our for might coming mind of finalizing be in how to Keep going later terms be finalize be and they at coming modules the light encouraged on filing looking speaks appears then a do think, that submission. rolling we that meetings submission are of our but order actual submitting to That change. we We're those modules all the You're focus of using begin. with and to submitted, forward will as in in some regard, that allows accelerate fact will what final tent were And But speak be in that they to be that it earlier review in We're that doesn't process the in able we're long this certainly going sooner. ultimately started it still

Fady Malik

next data won't that submission. As will it be contained year. expect relates to MAPLE, in no, we this those until don't out MAPLE read

Operator

the with question Ashwani from line of comes next Our Verma UBS.

Fatima Amanat

from behalf Fatima Amanat UBS. Ashwani of on

general question. a quick Just

such the broad in common? cardiology of may a get offerings set in mean a is general, with long scale of a high that terms run? portfolio would level Like In just practice benefit of level, contracting favorable companies

Robert I. Blum

repeat please? I understand question. that Might don't you it,

Fatima Amanat

have of of Sure. understand, focused coming? single Yes. portfolio I'm compared portfolio like to just have diverse in like on cardiology set Like you that to do a trying they companies benefit are the broad level larger is space, assets? like cardiology, a that think contracting companies in

Robert I. Blum

see. I

a multiple is might single Your launching multiple -- be have product around products, is, because we are with might to be contracting we'll that I be question right? who disadvantaged relative potentially who going to assume payors

Fatima Amanat

Yes.

Stuart Kupfer

cardiology highly By motivated patients of relative a the no, It's These There's the we'll treat the Each a payor view. of budget don't more very on U.S. be not disease. categories going aren't point subset a limited means, From disease. on, to They're It's and to a a category. impact. of big unmet the compete payor fine disadvantage. it's a payors this and products, to the there's a going rare of XXX over as product. cardiologists number a HSM high I at we market, those managing point all of believe overall view, focused cardiology focus subset will I The think and need, treat has in disadvantage. aren't the be a second what in usually one focus we're disease. to only diagnose that a is payor from It's patients. not of product managed Payors

Operator

next line question Barclays. the Maya from Our comes Iskandarani of with

Carter L. Gould

any we've which This label of I in sort is can for belief on the and for REMS Robert interactions question, known reaffirmed the way a Maybe taking PK and differentiated guess Thank the the your now, all EDI profile, or for Carter. for comment Thanks of shifted you. but commentary FDA SEQUOIA, reference, the Robert. that you while REMS? if in Fady,

Robert I. Blum

premature FDA. other will we'll that REMS very view and to comment continue, because very that things position read a have conversation briefly. mitigation, be our labeling, It's just constructive safety lesser I'll between with and positioning, those Yes. risk conversations but fruitful a on in reaffirming that

please. question, Next

Operator

comes question Goldman Paul Sachs. next Choi the Our of from line with

Kyuwon Choi

FDA, with meeting by be My ahead question regard are there there addition coordinated were recent preclinical the how any to if were indeed in requirements needs if clinical much is agency? that your or requirements you any, this to to file specified can testing a the of confirm And with either MAA EMA NDA? for just of potential maybe us with

Robert I. Blum

are We any other don't Thank that required. that are I Sure. addresses well. your believe you. such studies question there believe

Operator

Our JPMorgan. next with Romero question comes from of the Tess line

Adhiraj Chauhan

are point? is see on any there data Adi I'm wanted yet this that at you just ask, for from to We to SEQUOIA Tess.

Robert I. Blum

that I'll to Fady. turn over

Fady Malik

as for analyses, We've all new analysis analyses, study prespecified but on think may for seen been of the to full has That be clinical go say could we report you the has set and completed the I been of in imagine example reviewed honest, years complete. every data. wouldn't detail.

Robert I. Blum

quarter. second see the You'll in this laid also out full glory in

multiple expect We multiple publications. presentations,

Next question, please.

Operator

comes Our line Rahimi with the question from Sandler. Piper Yasmeen of next

Yasmeen Rahimi

allowing maybe for give the you of is have data. proposal hiring basis, months thank chance of an guess laying out X What the now been kind package in complete color the activities you integrated And to up had all it's to to your ramp the by a data a on ask been since completed? Have process? these question. the guess a is much do? coming of I with of again you proposal? reviewing my sort and could finishing some preparation Like me left How I topline which consultants, on us

Robert I. Blum

Yasmeen. you, take Thank that I'll one.

may That's to asking. elaborate competitive in of greater on to REMS aficamten the advantaged for we consider elaborate be Carter's of the we're relates what to think choose positioned, greater ways in just able accessed positioning. going physicians would that We a be don't to of believe, number that how patients. situated, to And we're potentially be be how the that do it number by to a elements may subject of it's of period the what will day, think it, after that's obviously that are be be you and on question, I informs something could review an are thing at the end negotiation of NDA of the process to file. differentiated enabling publicly. I going kind as be that of the doing during I that something of on that's

we So not play-by-play as visibility time what that's such until to that believe I something around there expect looks certainty we'll that like. be is providing

Yasmeen Rahimi

much, so in you and Thank queue. the -- it. back Got Robert, up the I'll keep work. amazing go I'll be

Operator

Jason the question Butler Securities. next line from of Our with JMP comes

Jason Butler

for Jose This is Jason.

to you patients? of data You into the aficamten, potential mentioned demonstrate pricing standard versus such FOREST-HCM as HCM benefits the the you. do speak payors with potential remodeling. a Can on in any quick give follow-up insights risk discussions structural your care? favorable of And Thank remodeling from long-term the functional that

Robert I. Blum

I'll the Stuart to first or ask question. address Fady

Stuart Kupfer

we benefit terms we events. are symptomatic cardiovascular question is lifelong for that also key reduced term. long anxious The hopefully to that term, investigate remodeling we and Yes, result the in normalization. of anticipate, the confer functional favorable and will of inhibition could in what myosin that really will this that risk cardiac we certainly very structure And in improvement. hypothesize and function Because mediate, patients a long is hypothesize cardiac that

Fady Malik

I just CMR patients CMRs that the the add largest data first in other is cohort, the we the of will at undergo -- really or think I which yearly January is reported might taste serial intervals. that cohort yearly one at every of just

very data cardiac will and changes the number, length a years how on mature the the so, over those sense go And of of give time. I time, think the structure good us as

Stuart Kupfer

the below, sharing be list SEQUOIA-HCM that are obviously of product results a We'll From on point we'll published. the but SEQUOIA-HCM There slightly pricing, list the be will market in in where we launch year. Whether at, once price. of above, one finalize we as that to close the payors get today be range we'll that with finalized pricing is results view, price. has slightly next a we're haven't we

Robert I. Blum

of point time. this not are those that in things the talks about kinds at one And

Next please. question,

Operator

next line Our with comes H.C. the question Wainwright. of Joe from Pantginis

Joseph Pantginis

question led to most internal etc., think you're competitive your data talk or research data that can physicians discuss more on from the Andrew. physicians' more polling, I to to about talking the get suited But marketing or suited switch to from or from I educated curious early SEQUOIA, the my regarding profile the thinking. is order data want real-world Camzyos an and and from has standpoint you what in to you know aficamten? for for don't it guys -- any needing drug willingness profile about

Andrew Callos

on a physician/patient on are up to aficamten, activating dialogue the that We on focus and therapy. focus calcium completely making soon not label on and if going are REMS activated program haven't We're blockers, to focused associated be an existing therapy. who going those Educate focused to the CMI. they that. And care, getting sure really not towards with on go on channel We're the patients patients choose who on on already we're That's beta on patients therapy, the blockers, are physicians on to standard approved. route. of not hopefully disease-modifying to

Robert I. Blum

category us we expansion end like our this about the to focus opportunity how at and aficamten incumbent that's the the represents, to next-in-class benefit think of of a of for for where upon patients is. an believe day, Underscore, it's the more might lead

Andrew Callos

over will -- patients over And we well eligible. be do XXX,XXX think that there's

available Our will best guess when the is come treatment we be to those that the market. still vast of CMI majority for

Operator

of comes question next Our with the Jeffrey Stanley. Morgan from line Hung

Lee Hung

for whether I'm the have restricted of just Or about or feel quick We had REMS with have supportive conversations they enthusiasm interactions program? just less curious be they potential for Catherine your in on they providers, the is a any one. This Jeff. data expressed indicated might that?

Stuart Kupfer

obviously with so to be But the certainly don't SEQUOIA FDA's really profile safety would something just we on proposing them stay we've given I providers, findings and we'll contribute the that and the evaluation Well, they data. have, question. the have in based tuned. data that of optimistic we to And we the shared spoken they're that accumulated that

Operator

Partners. next Our Leerink line the from comes question Ruiz with Roanna of

Roanna Clarissa Ruiz

discuss a or for aficamten the in if there that U.S. about possible market think more curious the should any commercial versus little are opportunity could up of differences if European Europe? and bit? was for And ramping similarities timeline you I presence we a

Fady Malik

market slightly heard of of point in the the the U.S., of European of dates. in XX% the just of terms point and The on That'll terms a Other From view, opportunity lower once will year XX% the view, to we will you higher. From behind approval filing the opportunity population. launch you overall to is depending The an reimbursement range markets for probably than pricing of negotiation. need outside prevalence a about of probably It's at Germany. of price for in patients launch the in general, in Europe approval. launch is slightly Germany. occurred, allow submit point country. In because be number has higher

Operator

line Our Securities. with next the Devarakonda comes from Truist question of Srikripa

Srikripa Devarakonda

LVEF to aficamten? And analysis [Vilal] This Kripa. over would LVEF your more stabilization to there time? drops be are would that susceptible predict program? treated help who in be your in REMS in incorporated on for anything of data is with Is patients you seeing And

Stuart Kupfer

we've second answer the we've the data. those at of question those Well, actually part looked presented is your and yes, data, to and

a of for very you'll some where FOREST that It time see EF You'll looks over see year. to in up stable.

you look I Those finish obvious. are that EFs risk at patients of I patients their think factors, strategy think thresholds. of can in think They may It's susceptibility. kind because you that -- after closer are predict obviously they're have monitoring medicine, cutoff. generally And the to are titration, have any might more at XX%, to employed question kind certain be when you I as you XX%. closer that's at to the susceptibility who sort of look

distant from that You them are certainly carefully who at more it. into We'll patients than thinking. our incorporate more look other

Operator

from with Bank line of America. of comes Our next question Zemansky Jason the

Cameron Bozdog

Congrats your necessary important opportunity? is question. is on commercial our looking for the This to Jason. so And especially community comfortable a and especially Cameron to the in at this feel long for have Bozdog do do afi, frontline What thanks the quarter much. you when How more REM? setting, use given community on outlook prescribers think is you it's to make transition taking how then Thanks take? administering to likely expect

Stuart Kupfer

you community, you're community mean describing When assuming cardiology? cardiology, I'm still

Cameron Bozdog

Yes, exactly.

Stuart Kupfer

prescribers XX% there's X,XXX probably is think you general of time. There's About a outward. it XX,XXX smaller go of over core data, the from That a a a drive of now specialty occur look little I cardiologists subset at diagnosis When product around slows bit. down who CMI. diagnosis. outward cardiology. do REMS launches claims will probably Typically, over always

be CMI,, that over in cardiology time of As that start especially number to accelerate, already it exactly patients as need will patients will to to be, that in general the occur, the occur certainly will to what phase. show Hard point say a education maintenance continues up given on treated. but

Operator

line of from question the next Serge comes with Our Belanger Needham.

Serge Belanger

present failure about what meeting those maybe my And Maybe SEQUIOA additional the meeting than see data of heart analysis question ACC the just at talk guess rather results? upcoming upcoming I presentations. decision the month. and is the in regarding kind we'll to next

Robert I. Blum

that We the SEQUOIA-HCM run review. be and we abstract would afoul to have of take otherwise may a I'll of when risk there they public what policy ACC in that lined domain was a top abstracts regarding of we knew contained the when one. has results that that Sure. acceptance

to disclose. We material disclose to shareholders a we obligation had also we to that choose which did knew

that see safety quarter. second other post-hoc secondary we more month some a the be and regard Lisbon. by accepted be answers publications that connection presented and and in was meeting believe same for be published, I to meeting that it we in was around at multiple press But we these presented. SEQUOIA the in and And we for in reasons May already not the and published determined. release. will it That's to during that these communications later abstract hope Our aggressive hope an where and still time, concurrently HFA expect assume is so potentially data in That's analyses presentations but large got in the results disclosed with and will be will primary plan expect not a We and presented you'll but ACC, your just analyses. with we've next period. publications, question, presentations also efficacy detail therefore, the

Serge Belanger

to forward data. Look the Thanks. seeing additional

Operator

question next comes Our line Duncan with Fitzgerald. from the of Charles Cantor

Charles Duncan

not pharmacoeconomic the of talking be last perspective. pricing, really and supportive anticipate to is And Robert of not ask you second and team, modeling the what harder your may anchor to standard about know of answer, that do on but of congrats quick an called? say is, to just AdCom more, you couple ACC compels premium the that an kind you're pricing? you Or care? I little all One that be you simple to to on is a that and able progress. I point. wanted is, shortsighted seems questions answer. a

Robert I. Blum

relates is mean What for accepted there we have was AdCom, that. know As an certainly at but we submission for until that's can we it wouldn't be AdCom this to can't know is an know an necessarily AdCom. prepared not doesn't something not juncture an We'll there filing. AdCom, and that that mavacamten. do if not That one a is

not will we're with with and a but compelled associated be pricing. what say datasets of relate of and will ultimately aficamten. other prepared number relates the connection to to we're factors, contribute by As quite what And pricing, what the HEOR being are that analyzed it going value I'm they speak that, to pricing, in of alongside determinants how are by compelled to to I

can that's I today. best I the do you think for

Operator

this no showing at turn And time. to for questions I'm CEO, conference now to Robert would like President the I further back closing remarks. Blum, and

Robert I. Blum

SEQUOIA relates an of and We believe vigilant at to a with next today, forward not abreast same important the We'll other that with I'll lot value the just that for prepared look as execution time. and presents, forward say to we the Thank leaning can results, it by we simply we're it you, call, comments now shareholders keeping onto humbled science, progress. Cytokinetics, And brief. shareholders the chapter creation. by Operator, we on we'll ground our also regard opens OHCM in opportunity our Operator. aficamten door and turned be remain so on the We're but Q&A, as doing we've covered also please. the believe do both to but that in page also I'll of conclude with right that,

Operator

for you Thank call. conference today's concludes This participating.

now may You disconnect.

Cytokinetics (CYTK) 27 Feb 242023 Q4 Earnings call transcript