KNSA - Earnings call transcript Q2 2021 | Kiniksa Pharmaceuticals, Ltd.

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Operator

Good day and thank you for standing by. Welcome to the Kiniksa Pharmaceuticals Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]. to conference like host, to now Frank. Rachel would hand over the your I ahead. go Please

Rachel Frank

our Operator. on you, Kiniksa's second results results Media activity. discuss joining and section. highlighting release under call our and these and the A financial & press XXXX be Thank quarter morning website to Good found thank can corporate pipeline our recent you for Investors

our will second XXXX start And in line. detail agenda, a our return a commercial will closing Head Chief CEO, with Sanj which will an results. from COVID-XX data for the be Patel our quarter Officer introduction. will ARDS; of will finally, mavrilimumab our per Tessari, review Paolini, the As of brief trials for John Phase and K. Business Commercial our Q&A launch, our session Medical related Officer, including the Kiniksa's review also X to Chief Eben Moat, kick-off Ross Sanj additional remarks Ragosa, financial clinical will our Mark Financial pipeline Chief update, with Officer on follow

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

Sanj Patel

pericarditis. XXXX results morning, team. everyone. Kiniksa recurrent of which the direct progress, have incredibly ARCALYST today, very second ARCALYST the execution Thanks, that net include revenue was report XXXX quarter the encouraged million. opportunity Rachel, sales that to first in for focused is the to by We're of I'm launch by discuss our and quarter excited a quarter $X.X initial and for excited good of result to our second I'm

While prelaunch coming continues the extremely they've stages identify provided and early that to launch, done to will well patients The positions hear, that the prescribe. the of to-date breadth to encouraging seen team cover well. the the and policy. coverage payers the years. base. continued prescribing still condition these to And and of a as facilitated the patient team identify in bit work execute patient with viable as the adoption, in a as uptake action we've to our Ross pleased continues are and very efforts call reimbursement commercial we're establishing in growth quarters And physician detail. for physicians have clear we ahead upon expand the All performance population you'll us the of for more

from ARCALYST, value portfolio. building focused across entire we're maximum our Aside on also

in pipeline growth. aid you, more to our now progress. KPL-XXX we and we to Over as ARCALYST of our longer-term product trial is Over are growth commercial X believe provide will But will well for in were CDXX the In final data program. KPL-XXX, Mavrilimumab update the as assets detail. in Mavrilimumab, essence, severe pleased positioned our across discuss candidates. the we in pipeline last more well on it we've quarter, a positive from Phase over stage announce our ARDS, clinical months, I'll related for particular, Paolini which continued Ross X past Ross. also turn John Vixarelimab in few detailed to the recent COVID-XX results to positive execute the to pipeline trial and with performance our Phase of

Ross Moat

the were We a launched well pericarditis morning. good revolution with stage supply knowing establishing our ARCALYST the commercial quarter net in QX in FDA to becoming in legacy sources share the readied pericarditis, ARCALYST revenue third of of organization recurrent at as a launch of company, relatively and in of channel superb diseases. the indication patients of indications. ARCALYST and assembled and need for quarter thrilled Sanj, the to mechanism for with autoinflammatory in QX XXXX, pericarditis. Kiniksa were and inventory ARCALYST underscoring revenue rapidly you, split team, the recurrent a initial the The to marking successfully and between were indications We launched ended as two only delighted alpha have the the this and utility interleukin-X that beginning Thank and evenly first recurrent million. drug of all is CAPS build We're in and approved $X.X shape DIRA beta

of RHAPSODY are seen and pericarditis, strong We by the was driven This have indications. surpassed a that flow the new patients, as trial slightly with and of in very patients a pleased to as commercial revenue therapy. converting to already recurrent caught start legacy steady the has from ARCALYST result up revenue well

to build million new of pharmacies. with launch quarter, required specialty $X.X quarter was demand I'm support meet Kiniksa our indications confirm weeks, volume and to quarter, the legacy one-off recurrent services and revenue the drug OneConnect patients the which to This transitioned from the was the pleased the throughout We Regeneron -- in ended For DIRA patient Kiniksa keeping pericarditis. successfully now with the revenue in of whilst as supply those of there in some inventory full early they program. the commercial receive CAPS as well to that the channel CAPS the and represents approximately growth DIRA, at up the

launch provide this a strong results, forward would to quarter like to revenue. we QX look Following

pharmacists is on for on pericarditis expect forward. the conversion our build handle hand the the growth. we not growth stable better likely as likely weeks Hence, the and get do major growth that specialty Now in repeat revenue Whilst CAPS current is inventory to we're QX. a is ARCALYST QX. inventory pharmacy complete be trajectory. demand remain very or patient zero will in to network DIRA driver increase will moving in believe see We to the this to decrease levels likely Therefore, our from marginal recurrent in

We in expect from greater than to two-fold QX, one-off demand a will deliver inventory pericarditis will and increase recurrent the account saw this QX the for than build more we QX. that

at we $X to We're the pericarditis XX% also sites thrilled prescribe trials continue. trial On individual the XXX delivered experience. to willingness more greater To target We the broad sites continued pericarditis those drivers for of promising was need ARCALYST for highlighting strong close drive did first physicians depth RHAPSODY of in and the X, patients outside practices not an multiple This into QX. who ARCALYST the very At who out of physicians QX QX. early much adoption detail and expect practicing came patient of prescribe clinical that by with broader breadth physicians between saw total a This the clinical one in least RHAPSODY At prescribing. without prescribing pericarditis into trial this total volume the to trials patients. base population, for clinical the than straight around gates. This and ensure from initial to million a the clinical prescriber the accounted prescribe uptake our treat $XX growth recurrent will participate have growing performance. strong will an physicians time. of I started to have prescriptions of dive expect XX from showing ARCALYST sites, around a substantial Slide small this prescribers recurrent both we prescribing on revenue to the of in of growth we and recurrent level, million highlights saw of we total but XX,XXX the XX% also experience. means of steady those in patients, commercial supplier that the Currently, setting percentage prescribing from prescription

new-to-therapy to At patients of the of from on been these the therapy. portion an FDA opportunity long-term driver decided Phase the completed of the and than time RHAPSODY end patients, of approval, U.S. has of to demand came patients a have our to study and now indicating the Greater treatment have in The XX% addition trial. extension the the in QX conversion X patients commercial the satisfaction since sites therapy setting. of continue the drugs, the visits, to end therapy continue commercial initiated had to on In

in the medical exceptions On that the patients ARCALYST payer six patients has processes. seen a greater believe majority we with quickly launch, access early early prior cases completed ARCALYST early up publish we've launch. XX% will the Currently we and positive payers ramped decision, of for phase to launch facilitated to of demonstrating for payer policies approval the side, the continue a under payer great expect final which engagement rate, to initiate of within months their access that than

it's provide to other while to continue that early compliance, compliance still their to we've updates comfortable patients Additionally, on self injectables. be similar too started patient time see and meaningful duration, refills any to initial expect and on to receive levels of

before We contributed for subsequent understanding of the the quarter, to well practices. based the accounts. experienced to of highest team pre-launch Turning XX% on excellent to and They're in pericarditis patients The clear pericarditis clinical of the markets sales patients. have our accounts patients first have to we focused targeted, the field ARCALYST. throughput initial are of with XX% and seeing by the when plan, our to cardiovascular to foundation and exactly want Slide launch start data previously outlined on would to the that around and around this the being work quarters. of met field. who the team and thrilled the recurrent I highly recurrent call on enables at further our it highlight the launch around have that XX, executed XX% how robust penetrating them doctors The some to diligent institutions hyper action sets have We're target on a and U.S., focused over that's XXX of prescribe in XXX team concentrated

access field education we're awareness alone to further would accounts. more received even been and than have created institutions and the national progressing and events. and also To supplement targets local webinars on XX% with held speaker start And well been COVID-XX in-person to of our which sales focused and has pandemic and calls indicates productive team with the achieved engage of and as incredibly has digital willingness the nearly the our interactions, our has of utilizing additionally, some face-to-face team the were states to conducted team the assets. further, very achieve. and able limited pericarditis. reopen field physician, also forward team's recurrent patients all efforts, we looking the While physicians These marketing pleased We're have remained multiple to

very Additionally, advocacy support groups we're patient proud which approved all continue includes community, support indications. patient across the to to the

of required, during provide optimizing an and to help patient mentioned access Kiniksa the determine As contact patient insurance support for to treatment to affordability and for that to assistance in point patients initiation, ARCALYST program Kiniksa's This any our journey. patient I've prior eligible providers Kiniksa. of authorization OneConnect, injection assist serve ensure the training patients. be with patient's continues the for ARCALYST service provides when primary coverage, and the and step providing healthcare financial with aims an The appeals personalized experience one-to-one previously, as every every patient leads the through support crucial

of many call team. patients I'm by Before proud diligent interacted to John, launches, the say handing having led that like I'm dedicated Kiniksa very with. And the to that humbled we've the I'd and

John, We you. in foundations commercial is more to the the And setting for in This patients the stage just motion wheels we laying by forward success look getting first to the supporting with quarter their journey ARCALYST. launch results. are encouraged coming and We're quarters. about delighted on continued launch and started. over

John Paolini

stage Thank and on provide I good a morning brief you, with will where our everyone. three we stand overview programs. Ross, clinical

are by including giant positive ARDS of COVID-XX, Mavrilimumab arteritis. indications, data and We encouraged the clinical related across demonstrated multiple utility cell potential which has broad

that clear defined from of placebo recipients. or disease generating in year, assessment Currently, need. baseline X.X% of prurigo efficacy and primary almost paths we're Phase the nodularis score trial reduction a these almost to is recipients interactions investigators significant which a a in recent unmet X. Phase quarter endpoint with of benefit X, reported There was NRS global in weekly compared Mavrilimumab Mavrilimumab PN-IGA our Phase X significant third Week XX.X% orX, X of with development ARDS of X On statistically on diseases in we a with first Xa shown study Week last Vixarelimab the completing of its Worst-Itch our Vixarelimab average FDA clear resulted only or in prurigo also data Our focused XXXX. our achieved at nodularis COVID-XX have in achieved related at

on Moving ranging data, efficacy global different Phase monthly once currently trial endpoint enrolling those nodularis regiments. prurigo forward, randomized in change Week are a dose placebo-controlled Itch-NRS is Xb building in three Worst primary XX. The we testing at dose

Rheumatoid initiate the an to development we announced with Arthritis further year, described with May pneumonia. the Phase optionality evaluate patients Finally, fourth plan not KPL-XXX administration some I chronic this target trial characterization, subcutaneous range data believed therapeutic of of from were intravenous of Mavrilimumab well also X designed proof-of-concept to want of also we of be from today chronic was but to This diseases patient We to in COVID-XX patients by of the a efficacy potential for moment data new healthy provide highlight early Phase dose-related patients mediated only Phase the to trial for in signal. as Slide tolerated Mavrilimumab quarter XXXX. with of KPL-XXX, for with as volunteers optionality population, our in return only of but trial pathologies administration. On XX-week in in X signal in across not final CDXX to autoimmune that of in portion X/X pharmacokinetic XX, well supportive to announced severe is Phase showing trial a X a a pharmacodynamic that that KPL-XXX well pharmacokinetics engagement and data

cocktails. this and has by Based portion to the remains sample continued time, trial Cohort upstream patients at in Phase For XX% non-mechanically-ventilated portion and Shown carried most primary we in survival placebo. with the substantial not risk is likely with X recent approximately total. triggered enrol given Thank is Phase reduction the of XX. blockade proportion to not been on the to This this I'll X here to to and single versus that the of Mark mortality here final you. The the reduced out protective is from FDA as cohort that ventilation COVID-XX. on XXX emergence expanded slide, enrolled effect blocks and by the expected outcomes Mavrilimumab, data body's observed are also of one. XX review the on results data. X the same ventilation mechanical which mechanically-ventilated in now April, data, that hospitalized prolonged over maladaptive that data of day show Phase are first the the have agnostic or administration for call shown data, X our virus mechanical and context, data and patients Kiniksa the competing we day prolonged XX% of of demonstrate vaccines consistent [ph] of for the day patients financial benefit in patients quarter effects of inflammatory had day our pharmacokinetics cascade you In the to Mavrilimumab evade virus the the XX reported group will in of part day of One of did over and overall others the Coronavirus remember in The consultation reported in death from Kiniksa variant. due the potentially neutralizing data study mechanically-ventilated the the of efficacy that XX. the we're trial ventilation. non-mechanically-ventilated results. mechanical XX data the now confirming trial are on alive to cohort given reduction mortality in day X approximately some believes demonstrate extending a the at Phase previously in X the and size the XXXX. resources patients the note of antibody patients Phase endpoint complications free of and Kiniksa the is turn non-mechanically-ventilated counterproductive cohort persistence allowing from just of the at Mavrilimumab over thus has the enrolment The variants full-free the showing focusing on reaction non-mechanically-ventilated to

Mark Ragosa

Thanks, guidance. quarter financial through for second John. walk to review everyone. going our performance Good morning, our of and I'm the Today XXXX

find detailed And You can press our in few attention financial release. your call information to to today's a I'd like items.

$X.X sales to pharmacies, First, and in as million, was continued upon the ARCALYST in recognized transition revenues specialty quarter, second of upon primarily pericarditis, of the DIRA during CAPS driven distribution by Kiniksa well quarter. commercial revenue our ARCALYST recurrent to and launch legacy network as the inventory sale

Second, physician net approval notable medical million recurrent pericarditis, revenue driven adoption, in uptake XXXX between quarter and of ARCALYST we exception and rate, $XX expect broad based strong demand, third the by upon $X patient total a million.

DIRA Assuming stable two-fold we pericarditis second the in sales. over recurrent contribution revenue greater quarter represent third than any sales from and increase recurrent revenue quarter a CAPS inventory and could believe if changes, minimal pericarditis

at that of such patient at as variables compliance, final therapy, and remain revenue continued point. of this stage guidance adoption, the longer-term we're providing ARCALYST physician not Given launch, payer duration coverage this early policies,

XXXX, collaboration reflected ARCALYST on evenly the with recurrent all indications reminder within sales sales FDA In second of profit a approved split we Regeneron. item not for we're a did collaboration, profit-sharing of expenses. separate and line as for When with and sharing as payment. the a our operating U.S., distribution profits make profitable in approval will CAPS be including quarter responsible the pericarditis, DIRA and Third, of the

the period same of last approximately with which for expect $XX.X net plan quarter fund was year. for million, operating our million, XXXX And $XX.X into quarter to continue second $XXX the XXXX. of to XXXX reserves Lastly, ended we we of the million second loss cash to compared

As are Sanj advancement our turn we're I'll positioned team, the and you've call for the on with well heard to to ARCALYST the Mavri, growth. to and and assets, Vixa And commercial of help that, from closing our executing with back strategy KPL-XXX we stage patients to continued clinical drive combined future remarks. continue

Sanj Patel

exciting mavrilimumab off Mark. the tremendous and the and pericarditis. that value us gives portfolio that this we're our And we recurrent directly positive COVID, in by GCA very positively optionality year patients well-positioned patients today We're with fact time patients. to have previously, started, to the impact we validates building very mentioned seen Thanks we we're our believe potential Kiniksa. We maximum with a a entire execute across of encouraged across a building portfolio. that At Kiniksa, of diseases. allocate programs range launch, beyond. to this company of for focused continue lives and multiple amounts the relative on in a we with The of clearly go prurigo the as the start broad of nodularis, and jolly from and unmet KPL's opportunities. energized ARCALYST We're in launch to to And pericarditis. utility our for we by and mean Vixa continue in on. XXX recurrent to I capital autoimmune It's progress feedback throughout physicians strong receive to needs our to And as be

capitalized have plan cash as and Importantly, into our XXXX. we're said, operating are reserves that Mark to expected fund we current well

turn and for much, the it to the for operator thanks I'll call over thanks with So very that, back joining Q&A.

Operator

Instructions]. [Operator

Anupam with Morgan. of first Rama comes J.P. the from question Your line

is open. line Your

Anupam Rama

so quarter. guys, Hey congrats the question taking much on for and thanks the

Phase the was ARCALYST or one to physicians were from prescribers new you're were does or a in the doubling expecting from that not mix? setting, prescribe XQ, X, setting recurrent these scripts the largely it from plus that in a academic of quick existing Thanks XXX physicians as assume that it the pericarditis Just me, well? to going or prescribers much. And from so does of XQ assume growth community

Sanj Patel

Ross, that? do take you want to

Ross Moat

question. Hi happy for very to, I'm thanks Yes, Sanj. much the Anupam,

that the that from centers, other we delighted first we've really seen. or that to have amongst since it to in continued that uptake a centers broad those approach really the were is experience is whether that. your child experience maybe point, started see academic the it's see answer of I and So to launch We outside mixed think

or really data they is see research that's in are really from Our where recurrent focused highest market and claims agnostic targeted otherwise. the of whether and academic strategy throughputs to pericarditis, based we center

quarter to as we prescribers focused happy XXX see very whether in that. on of that again, penetration I'm presentation a or maybe, than expect well. terms we mentioned existing to to pre-prescribing, mixture prescribing the base a prescribers, we started the also But as we've the said, we broad now a expect breadth. hope your of out move we're more steady see have really as of that come forward. of to And to as for to to more make grow around points accounts. will target that PIs well, small prescriber of So next we then in continue outside the to new XXX RHAPSODY physicians it's that see start growing continue And I increase depth some number into the think we

Operator

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

line open. is Your

Corinne Jenkins

initial identified? to from is Are the those that targeted you you Good morning. Can had compares you what just these how about compare expected? to how the does talk Corinne XXX mostly accounts piece accounts set of on targeted This for Paul. physicians and Jenkins

Ross Moat

Yes.

is this for again, question. Ross happy to that. Thank you the answer So

targeted I'm sure we yes, well, But as we that of the disease of field webinars ARCALYST awareness meetings, we focused we're out also and come been other said accounts. to those breadth means team coverage the also making that side on increase of that on. within a also, We've those the prescribers though, are So, heavily on accounts greater XXX speaker we're and busy get now as from digital pleased the marketing well. and and through and the XXX as very set focused many really what's

in hear of gone on all on patients well So got we as the once I they ARCALYST, that with, along and physicians quarter. impact about from have helped in how first that kind mobilized their the the uptake as to think

Corinne Jenkins

enrollment you on That’s the from COVID-related the helpful. X any pace the for impact just then about talk ARDS? in of And can study delta Phase variant

Sanj Patel

do want take to you John, that?

John Paolini

Yes, -- This Sanj. Thank absolutely. is good you, morning.

and a in morning good for in across the question. and world. upsurge you the definitely has recent you thank resulted as cases yes, know, variant the So, delta Yes,

As you also Peru. a United the is trial know Phase X which the Brazil, in States, Africa, and is running global South Chile, trial,

And so time we target I on trial that sense, discussed in X with than pace, is a and greater XXX the it the as mentioned continues of that Phase this approximately XX% enrolled with patients. FDA at population

Operator

next line the Your Wedbush. David of from question with comes Nierengarten

Your line is open.

David Nierengarten

for thanks here. questions I've Hi, a couple taking, and of

on disposition what I the off, were treated First of they they three over with whatever who in quickly diagnosis. recruitment long-term are wondering new or what after bit for might kind pericarditis. the been have -- six got recurrent have nodularis time months diagnosis relatively Are you'll maybe little I'm prescriptions this as study. treated history -- And be quarter, how rilonacept the they who then it's to patients or on curious patients the was a of just on prurigo

Just, is you. when could data guidance present that? you Thank any from additional there on

Sanj Patel

start, then I'm will do sure and you Ross, John jump to want in.

Ross Moat

where disposition they're David, for the you Sanj. around from. then very the thank Yes, absolutely, Hi and patient coming question much

at and mixture a that's started are had patients that know from on that corticosteroids what seen first pericarditis for and have patients hence the we in well launch stage as the off. quarter, opiates toxicity really to early So low I treatments been we mean ARCALYST that time disease it And some that in of difficult the end actual effects moment. they've cycling see had treatments that making in they recurrent a relatively stuck corticosteroids. have of other really come stuff, come patients many and have but this Broadly elongate we've speaking, whether and through we've as is -- the

patients from of ARCALYST we've some ARCALYST as place commercial transition So these across course to clinical as as coming patients with well those well. seen trial our to of

really that the that's multiple But are really a So of type been amount. of those new which buckets, ARCALYST I relapsing those from to think kind certain refractory majority or the are patients. coming

John Paolini

And then, This Nice David, with to good John. you. speak is morning.

so trial, different nodularis study. end started which enrolling over question regiments this Vixarelimab Vixarelimab to we and is patients subcutaneous prurigo a monthly dosing dose year last Regarding that your at patients Phase severe three to did Yes, of we and at about the with prurigo testing Xb the XXX announce nodularis. in had moderate At any the point are we we dose haven't in especially on time. guidance disclosed a this providing because that important does this study and about this time, excited aren't timeframe fact this to information, on it enrollment with But provide designed of it's weeks. provide timelines XX longer particular -- ranging

And so that’s where we are at this point. Thank you.

Operator

of of America. Bank Geoff Your comes Meacham line the from next with question

line is open. Your

Jason Zemansky

the on you the quarter. just Jason for for so congratulations compare to check maybe wanted our is as on gut morning. taking what and what call trajectory this launch, Thanks the of inflection much Geoff. as uptake expectations, of point? what and where maybe of stand happened launch hasn't does about has terms thus gone in and your Good I thinking well, a far and This Thanks. overall to that well, has the at an gone, do maybe

Sanj Patel

Yes. Jason. Thanks,

time able formats. some the has face-to-face you than but with with the that So over but hand if sort to think some been we Ross. on of fact about maybe what good that hasn't have is obviously really pleased so physicians severely of well actual improve second the comment to We've number also to visits, I out virus launch increasing face-to-face other being over the impeded digital the and quarter feel Obviously, COVID to of certainly visits, Jason's can't Maybe points. of been want results. steadily has gone Sanj. thanks and Ross interactions we're very this including I'll

Ross Moat

happy Yes. Jason Hi I'm to very Sanj. Thank the you. question. thanks for

helped So us out think place team experienced course doors a physicians the We've really is great field wanting the I with of compelling in vetted data kind to that's to and the team. get yes, of really is in cardiovascular and what of we've got the meet open experience there.

it as lift things million question more the a if delighted as forward-looking your one a -- $X two forward-looking a really of million clarify to I I done. maybe moving organization as So bit the little launch going into QX, quarter said to which think, time the $XX just for kind results we commercial we with first may launch around maybe is is very expectations, Q I'm the towards an that big guidance successfully company, forward. statement -- a or move on but

when any it that QX, different and and million of fairly the look of a we QX, similar was and In in we marginal in we DIRA with QX, course, evenly expect to inventory CAPS the that RP, to will very areas CAPS growth. the beginning three expect see really launch. split between we was build inventory Of $X.X the remain at DIRA

So from everything is that forward. recurrent side, so growth pericarditis really moving to down

$X the pericarditis. take million and the mid-point So from forward CAPS moving deduct $X.X needs the come revenue, you'll if see of million expected around like recurrent -- you QX that to

growth two-fold forward. we've So greater moving than significant a got growth

in a certainly We So growth it's to that we feel a about as in as that the nature disease, QX patients given bolus trajectory. rare is on extension of plus the be going long-term is of no we ambitious feel already build the disease disease, had know that good the LTE, it longer we But the it's very, that. very flaring well QX to with across. through have transitioned that the there a the steady patients peak

a a to are think. So steady continue great looking launch It's going so I to excited really excited we be where about too, had build about through forward. Having far. quarter,

Operator

closing over turn I will now call like remarks. back for Sanj the Patel to to

Sanj Patel

Thanks, operator.

everybody So obviously obviously just in. We're to focused we the and end, with thanks, we're very execution. joining This for pleased to-date on our exceedingly what future now is do. performance

work in back Thank get we'll let's be you. touch everybody. soon. Thanks, So to and

Operator

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

now may You disconnect.

Kiniksa Pharmaceuticals (KNSA) 3 Aug 212021 Q2 Earnings call transcript