Earnings call transcript Q3 2022

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Operator

Good day and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Investor conference Relations. like Frank, to now of Head would hand over the Rachel I Please ahead. go

Rachel Frank

Thank you, quarter operator. highlighting website for and joining under Good updates. these morning, everyone call corporate & found discuss and results to the can our on press Investors third A XXXX be results Kiniksa’s financial release thank our you section. Media

Mark a an Medical agenda, Sanj our Ragosa, line. Officer K. then start ARCALYST Q&A which also provide Eben Sanj quarter finally will the with Officer, Officer third Moat, our our return Chief Operating be Tessari, Patel, for commercial our Executive introduction; on update; our session Chief the Paolini, Chief our for for Chief will As and update John Chief Officer Ross the provide Officer review execution; closing will financial clinical kick-off And will XXXX will on will results. remarks Financial Commercial to an our

law. note caption slide, to update be to differ our started, such risks A may Risk factors results as actual getting can are and this making only cause we statements no obligation under and date and from undertake uncertainties be we by these the to such that today, well filings. of as statements, please contained review the on as in materially statements. These of Factors of subject SEC Before as speak statements this risk statements that forward-looking that required of found will presentation except

turn to will over I that, it With Sanj.

Sanj K. Patel

net data in RHAPSODY, an pericarditis, Phase commercial execution ARCALYST third update strong million, We're excited sequential the of recurrent ARCALYST continued pleased of with the KPL-XXX. XXXX which everyone. an was in discuss of long-term revenue representing pericarditis the XX% X product and of growth. provide was recurrent on study quarter continued Highlight with momentum $XX.X pivotal good and very We're our Rachel morning, Thanks the ARCALYST today. from extension to

subcu of study enrolling safety on We're second chronic antagonist dose rheumatoid and XX of assets, also focused evaluate X the very weeks. multiple to We're efficacy, the pharmacokinetics we XXX, the response, dosing expect dose in including much program. cohort data, of designed portfolio the is and from CDXX a building across over portion which of the is We're Phase the proof-of-concept study conducting KPL-XXX in currently first our final clinical ascending and trial of half which XXXX. arthritis, stage entire value our of

was from in in a beyond demonstrated data long-term experienced These who months continued patients later the at Sessions treatment American XX.X% be treatment extension risk rilonacept XX recurrent upcoming response. rilonacept published resulted new and reduction RHAPSODY data the highlighted Additionally, continued The just the pericarditis of these presented detailing week. data this treatment will that events. presentation Scientific Association Heart full abstract

to study So our John data John? in as with with extension it long-term on to KPL-XXX rheumatoid the review I'll updates provide turn that, well Phase Paolini over as arthritis. X Dr.

John Paolini

Sanj. Thanks

that in an Scientific Association American long-term from just XXXX announced will was abstract RHAPSODY circulation coming Sessions today extension was As weekend. this published the Heart highlighting presented we be just mentioned, at detail subsequently the in and data

the in was As a trial pericarditis. reminder, RHAPSODY pivotal X of rilonacept recurrent Phase

specifically than of recurrent endpoint, statistically reduction adjudicated an study less the risk a rilonacept that significant the in we in reported had event that with experienced its to patients XXXX XX% X.XXXX. randomized p-value met a As primary pericarditis efficacy highly of

provide was of extension designed long-term The duration information about and history the supplemental of to potential disease the therapy.

additional opportunity duration randomized to withdrawal the then of for XX to months of of open-label were extension. months. study, the a treatment had long-term the an at therapy end up in reached Patients reminder, months rilonacept As rilonacept event-driven median XX continue offered a uninterrupted the nine

months the patient's the the upon of far long-term graphic made clinical extension XX point time at at patient for to observation right continue status most Two, therapy. observation. the a and a recent remain recurrence and Endpoints rilonacept based decision after during each Looking recurrence, suspend on life. discontinue of their without at three, the study on or included extension quality rilonacept and investigators one, discretion long-term pericarditis from for

slide. next the to Turning

will the June represent have Before this from been I of the reviewing data, out April on and at slide the time submission published Professor under presented in of the embargo Massimo and XXXX. by of excerpted final at of The presentation trial concluded X. until the will presentation. the that the more XXXX detailed the in Association specifically data on data currently results behalf Imazio point time abstract abstract The investigators the November on data that RHAPSODY is of be final Heart American

that Overall, demonstrate rilonacept and treatment extension abstract these from long-term data beyond XX continued continued the response. treatment resulted in for months

of the on switched of In details. base XX subjects who XXXX into May commercial ARCALYST launch therapy trial of U.S. ARCALYST, eligible continued XX to the April and ended XX In subjects to long-term wished the therapy. commercial extension. of the the event-driven are XXXX, were with Here remain

the non-U.S. from through months U.S. patients. the point through months was run in non-U.S. and XX XX the XXXX. Meanwhile, was cutoff ended patients. on of Italy, data months of was continuous of for for The in duration data published median patients cutoff rilonacept date duration June U.S. therapy Israel in XX The data for abstract maximum XX and included April Australia subjects the study formally the point the and in for until The the long-term XX months LTE cutoff for data in non-U.S. continued XXXX. extension patients

given point of or patient recurrences for rilonacept the on as XX option were XX treatment all extension suspend The I therapy while they patients months assessed of to have reached decision from the during continue X.XX pericarditis that annualized before, once recent XX month to observation. rilonacept was for most events incidents treatment and to After recurrence, point, long-term their patients investigator portion mentioned per the year. a point of the pericarditis to prior

on starting this portion who continuous month a of the treated who after XX the months. of XX than patients for slide month hazard continuous after rilonacept latter the on pericarditis primary already is right therapy decision the with X.XXX The rilonacept been data had figure a highlights less was outcome treatment therapy The milestone. experienced trial compared in with with recurrent p-value those X.XXXX. ratio patients milestone The remained XX the study of at that of of risk reduction to this from XX.X% point, events suspended the this

history XX.X a duration to of four the disease matched These subject beyond of Meanwhile, and XX.X mediated at only speak long-term treatment was who pericarditis demonstrate one by therapy this be natural patients multiple into should as recurrence recurrence with suspend XX% of weeks. event being time treatment data a experienced long-term recurrent associated experienced Specifically chose patients chronic of a who autoinflammatory that disease. XX the months, interruption XX IL-X a the treatment rilonacept weeks weeks. the median of a to and to duration of continued pericarditis event pericarditis to characterized with by recurrences of the extension

Turning to KPL-XXX.

various that in chronic interaction the by provide concept been optionality targeting the to be already by proof mechanisms. of could External continue other inhibit diseases. liquid encouraged that CDXX, demonstrated has high targeting CDXXX We agents formulation concentration our with

to of the chronic particularly And so subcutaneous administration we about are practical potential excited KPL-XXX diseases. and enable

a second, subcutaneous shortly concept proof adds dose version per once to in group we clinicaltrials.gov. dosing practical PK cohorts the FDA. amendment protocol parallel here administration. these of per present, portion assess slide dose and level, per than trial two fourth, portion posted the the on cohort first, At only the ongoing which KPL-XXX over with concept Phase the focused the benefit proof of administration the of kilo At weekly high third removing the and of trial be the X milligram subc are milligram multiple in whether study recently in updated An for study the portion to then XX our the consisting the milligram we study thirdly, group or randomization of rather the can arthritis the XX cohort MAD the rheumatoid design kilo study modifications on of X advancing level administered biweekly dose be found study shown of design of be include, on a replacing will biweekly ascending third filed and to X kilos or with leading a per on focus the weekly subcutaneous milligram here, kilo

We have completed PK first final and we cohort the of enrolling second are cohort MAD and the portion. currently the

of The from the Cohort company trial, of portion completion the proof XXXX. the of of concept in proof this portion will PK Following first concept X the the data expects commence. half of trial portion or of

the it commercial for Thank update. over I’ll now turn to you. Ross

Ross Moat

performance quarterly for to John. I’m you, Thank commercial recurrent in and our share our details pleased plans continued further pericarditis. growth on

As growth resulted quarterly of or a by from revenue another of of million represented XX% recurrent to growth a identification QX you net in heard driven quarter patient Sanj strong which consistently pericarditis, yet $XX.X led $X.X and in QX million.

far of $XXX results, totality XXXX to million a XXXX. and have net guide the these of range revenues pleased million so are million $XXX we continue in in recorded to With $XX.X towards for to

our increasing I of drivers highlight to behind On Slide some XX, want key the revenue.

and continues more than single to is drive that In launch, pericarditis, every of since We’re in growth of this growth pericarditis which both XXX new unique the for our than pleased ARCALYST, is reflected since our the seen ARCALYST of prescribe more XXX additional and report the execution launch. awareness a to months recurrent doctors XX strong quarter and robust we’ve prescribers. repeat total recurrent prescribers

XX% approval total in experience of two Furthermore, repeat the with more prescribers having experience hear of patients have remained which than rate have in the we the or where cases. QX, prescriber completed that we they’re both this One patients. and base positive was and to now a from for payer continue ARCALYST, that written around of who all is greater resonating rate prescribing XX% positive component

we time. to patients number more of commercial periods In terms evolve on duration follow longer while over of will therapy, this continue as

XX% the around on of stop their duration, come was therapy, eight volition to to or the for of who initial the being in patients commercial duration from having a end the of they’ve chose QX, restart therapy, commercial approximately of majority of setting stopped therapy to when weeks initial went As own from those their average end whether an months. XX of And ARCALYST. disease within belief on

the XX, Slide a that I of speak few the considerations how is in recurrent to additional of Moving want stand to starting the care ARCALYST to disease. become highlight duration pericarditis to and

notably positioning, As you that of to promotional thought is treatment leaders are using side, we’re aligned corticosteroid ahead external can see that ARCALYST paradigm pleased hand use. a on the to broadly starting left suggest our

believe standard suffering is is making a ARCALYST sign this becoming headway We multiple for recurrences. towards patients that care the of

requires complex the We toxicity also acknowledge at with ARCALYST mindset this cardiologists. potentially to for that focus steroids in in and and drug practice disease treating aimed and the of prolonging duration, and was due worsening an evolution Whereas the the past treatment debilitating burden particular the minimizing with disease.

with ARCALYST, and aim control adequate recurrences. continuously is duration the throughout treat Now of to the ensure to the prevent to disease

multiple This duration mindset two patients of a XX% right see years. disease on side is least shift is at of what because that recurrences slide the with this important you majority, hand the of have

the need that to have patients in treatment heard of natural you message response. history their and of John, results be from course continued data our disease long-term the continued treatment that extension we further As throughout that now treated supports the

our and access market hundreds the drug first our approved of in FDA only and for rapidly solid base recurrent summary, with grow as continues first to growth. getting the to future a on prescribers, reporting unique In than both positive ARCALYST. for is XX XXX pericarditis therapy. This prescribing commercial with are months The patients providing more has experiences patients resulted physicians and foundation

Our have by quarter net since been revenues XX%. recently steadily launch, most single growing every

million the revenue. of on track right net to within guidance collaboration of stated we’re that $XXX $XXX revenue profitability we in million to at growing the is the year and start deliver Our

just we And ARCALYST. population. are addressable started getting importantly, more find within and help More many, our mission is with many to patients our

to Mark results. to over hand now financial Mark? the cover I’ll

Mark Ragosa

Ross. Thanks,

your we results Our quarter few are XXXX detailed morning. this today. like release in I’d be There call earlier third to a press the financial found to items issued attention can

consisted representing agreement First, quarter of total from $XX.X global growth million, third million. net XX% revenue of was license in Genentech. It collaboration product XXXX sequential and revenue revenue of the $XX.X of the with $XX.X ARCALYST’s vixarelimab million

and million in in of resulted third grew to $X.X XXXX profit of collaboration ARCALYST Second, quarter the a $X.X collaboration million. expense

million both income as and was This of of primarily an tax million evaluation the by of net was due collaboration release benefit as in quarter million deferred benefit. was $XXX.X non-cash approximately driven third, $XXX $XXX And approximately on the revenue third to well XXXX tax assets. tax allowance

the we at the million upfront received in payment was And the the end million. third $XX of balance rights $XXX quarter. Lastly, vixarelimab our global cash period for approximately

continue as into operating fund plan ARCALYST as well We least expect our reserves execution current XXXX. to these to at commercial

turn it I’ll for that, With to closing back Sanj remarks.

Sanj K. Patel

Mark. Thanks,

In addition our therapies. of our in successful leader immune ARCALYST foundation to we’re emerging modulating pericarditis, strengthening as recurrent commercialization an and also

million As to we And the look continue as maintain collaboration. we and of guidance estimated profitable million. revenue we’re a ARCALYST corporation, to our net producing revenue $XXX year, a the $XXX have to of end

are well we capitalized. Importantly,

continued in our well to generational fund strong said, financial with global in create least commercial and help aim our to continue as massive ARCALYST at Our goal to a are becoming is Mark a as cash our operations our expected, to position of fulfill value, we XXXX. puts Ultimately, patients cash Kiniksa and reserves performance mission company. into as reserves need

your I thank And all for that, of back it to time operator to today and hand you the for with questions. want

Operator

Certainly. [Operator Rama from JPMorgan. of first question will Instructions] And come our Anupam

line is Your open.

Anupam Rama

for question. ones Two guys. Thanks much the so from taking me. Hey, quick

there ARCALYST, that therapy how one trends noting similar symptoms The here be therapy? RHAPSODY? you or XX% in first did may what worth saw patients the soon after is – did note And that after to they of reinitiate reinitiated Are discontinuing soon return? different how any

is, that Thanks of direction better understanding sort sort the guidance. question and are much. assumed second the mavri the XXXX rare moving so CD is then timelines what And I’m the to cash strategy in of assuming in indication?

Sanj K. Patel

you that and don’t maybe start in on mavri. why – jump then Ross, and jump

Ross Moat

Ross. you very the much to. very happy Yes, is This Hi, for question. Thank Anupam.

since yes, around restart. the the around launch, is information I always So, the announced some and of therapy this guess therapy. of talked duration first time we’ve we time average continuous

situation a go a I patients to proportion launch back we of those bank at where the who see a stopped we’re and fairly have of which the onto really throughout think Now, high tenacity starting have of of therapy time speaks patients to why feeling professional that believe consultation with needing better, try disease throughout to are therapy different and patients that's just the are the stop We treat there the want they whether of whether course in for to reasons to healthcare various or disease. their stop reasons. therapy,

so stopped, RHAPSODY But is weeks the – saw of the the patients where actually starting stage within regardless ARCALYST treatment to which with as that initial patients period commercial they well, stocks and makes of eight had did some RHAPSODY yes, therapy. if therapy, it that consistent did the the out think of they which within on ARCALYST we you we of And in about of two temporary the really patients setting. weeks who within XX% had remember, sense therapy so have eight restart throughout are back on within And study what on all of quite if you went arm therapy. wash of stopping the

they So can we're stop But ARCALYST therapy there adequately come are make the help patients ultimately duration that a treated when so eventually pleased know as safety that to want and sure is that I throughout patients to net, off readout. therapy.

John Paolini

with regarding talk you, to nice Anupam, And mavrilimumab.

around about with in we rheumatoid mavrilimumab mechanism excited cell So positive as has arthritis the continue cardiovascular evaluate where study diseases both and at mavrilimumab to agreements has this in and you mechanism, that mechanism the is giant arthritis. implicated. data X been really be in rare of goals know, Phase about to collaborative And enthusiastic and GM-CSF pursuing the potential are point our

And do work on keen additional so mechanism. the to we're

Anupam Rama

Thanks so much for taking our questions.

Operator

moment. One

from comes Paul Our Goldman next of Sachs. question Choi

open. is line Your

Paul Choi

Hi. Thanks. progress our thank on and you the Good taking morning. Congrats for questions.

more elaborate which about little to a addition follow-up determination on details RA indications And other of the other data in, in had you're can and terms on X trial, of co-morbidities then you in I to to question. types a for the how maybe patients just order what thinking endpoints other make you'll bit a for in Regarding KPL-XXX collection pursue? allow Phase

John Paolini

So thanks the Paul, appreciate question.

what disease primarily least arthritis So the available publicly on program are can of disclosed collection. specific they're had collection criteria is that in what data Most a I prime achieving control X clinicaltrials.gov for focused are regarding rheumatoid on around the primarily regarding expect rheumatoid trial currently – find and a patient the they've are endpoints there at in difficulties you inclusion you primarily you of the the Phase the mean, example. the inclusion listed what is the we've focused on that the when co-morbidities criteria is criteria might on primarily arthritis the DAS-XX-CRP focused – data might imagine regimens. additional

We are about us as CDXX. also and signaling collecting plan have you would downstream information might with feel imagine a more inhibited biomarker we blockade the that is that understand other help of rich we

So but data with are our only also in the out own we the continue follow dataset that sets literature. to coming that

Paul Choi

here? bellwethers remaining for in out great. you plans for and or so the that, the on are regard any one Thank potential there you. forth, are of are that just And with can John. any of major percentage maybe there covered us commercial where just to just among other commercial coverage on piece, you Thanks or plans then Ross, terms update of sort meaningful still Okay, lives

Ross Moat

much, Paul. very Thanks Yes.

all always launch first now to the in we’re And pleased time. case have that their from for the had just time have of coverage stayed the the maybe we have also meaningful cases. ARCALYST. plans All policies forward without some backwards major as out been any look the of place plans major well. of for above And payer same really the since the moving with completed at some most That’s So and XX% gates those one year have actually re-looked coverage quite at point changes. been right

as the some CVS the One maybe look headwinds see from notice to barrier well payers the payer that we go us a But ARCALYST with we notes and work new looking is try all that confirmed that that year. will CAPS recently of before forward patients That we of example, effect is at place on. receive will actually next list that with CVS exclusion next we January as across the fairly on have year. be indication. they constant will challenge its did current Caremark into of of grandfathered plan into that for

But across potential understand that need recurrent impact be, with coverage operational some exclusion patients the has to ramifications example continues pericarditis it’s that where of ensure we ultimately work how knowing CAPS. other the logistical we is indications through as may that what ultimately well. an to trying CVS on But for

hurdle across But probably It’s So percentage are the to total for of been of a we at happy all a work that just it’s plans. constant overcome we that CAPS is certainly, CAPS, where worth payer XX%. with barrier is small and very that course try though scripts. even with commercial our very historically plan and mentioning

Paul Choi

questions. very you Thank for taking it. Got much our

Operator

next One Geoff Bank moment. of come America. of from question our And Meacham will

Your is line open.

Alex Hammond

of royalties walk Thank assets? And vixa? we any should focus is the on range on you for near-term for key And Meacham. Hammond expect? payment Is you. what late strategy? allocation stage taking for provide a Can with through capital you our Alex additional you a BD question. Geoff timelines on your This then color secondly, Thank for Hi. the can the us

Eben Tessari

Eben, with for I sure. help question. can Yes, the out that. you is Thanks This

suffice on tough tradeoff have bar terms help more expect it for high capital milestone give development, we and and in there’s pretty portfolio longer allocation, – no and to things timing suffice control achievements a to milestone, then a We new for bringing to and But of are we as upcoming. in. say. to in So we’re certainly exciting in. with for active. us a we it’s robust but always do active, mile say, opportunistic And very highly BD take is We the believe bringing highly side always really things of

Alex Hammond

Thank you.

Operator

I the like to questions. remarks. further now call Officer no Patel, showing closing hand would Sanj Executive to I’m Chief for And back

Sanj K. Patel

forward today. of you, and questions thank the Well, get able updates and operator to additional milestones as have of for a everybody and hopefully the ahead in clearly some We sense our you providing look you to joining thank for exciting future. us excitement call are the we

with just crack Thank you. that, on. So we’ll

Operator

Thank for And this participating. you today’s concludes conference.

now disconnect. may You

Kiniksa Pharmaceuticals (KNSA) 1 Nov 222022 Q3 Earnings call transcript