SpringWorks Therapeutics (SWTX) 7 Aug 242024 Q2 Earnings call transcript

Good morning. My name is Gigi, and I'll be your conference operator today. I would like to welcome everyone to the SpringWorks Therapeutics Second Quarter 2024 Earnings Conference Call.

[Operator Instructions] I would now like to hand the conference over to Samantha Sandler, Senior Director of Investor Relations at SpringWorks Therapeutics. Samantha, you may now begin the conference.

morning, good and you everyone. Thank Therapeutics Welcome Call. XXXX Conference Quarter to SpringWorks Earnings Second This which press and a morning, issued we release, for second operational the outlines quarter. results financial our

the today by to the as press our You section & going we website can presenting well at the access www.springworkstx.com. as be will slides Media release of Investors that

Edris, Officer; Joining Chief and Dr. Jim Officer; Ashar, Chief me today Commercial Officer; are Officer. Financial Saqib Chief Operating Islam, Francis Medical Chief Dr. Chief Badreddin Executive Officer; Bhavesh Perier, Cassidy,

I we with including that may that This of Before described those SEC. are the to some number of would reports uncertainties. materially, statements begin, like call cause in our remind our the are forward-looking the during a and you subject actual to statements filed results made risks differ today to

are to You update turn forward-looking to reliance statements obligation on statements. Saqib. SpringWorks undue the I these any to disclaims will now any over such not and place call cautioned

Sam, you, on our to and profound delivering with for are and devastating of morning. quarter we lives to how diseases. this Thank make the our all second impact share a objective I'm patients results pleased thank you on joining

clinical encouraged Starting quarter and launch. continued with tumors, with strong product by from commercial robust settings This physicians and reported is high net our benefits revenue. across XXXX, desmoid OGSIVEO, patients OGSIVEO and execution. $XX.X of growth the by we In we for momentum of are strong demand second transformative the treatment patients U.S. the from million driven in

systemic therapy become rapidly OGSIVEO tumors. care FDA for of approval desmoid our Since November, standard has last patients with the

persistence starts as detail, more growth seeing steady Bhavesh therapy. previously in strong new who discuss as patient As those, OGSIVEO initiated are will we well from in

relieves, enthusiasm contributing and Importantly, their which reporting their OGSIVEO improved quality symptomatic life for meaningful patients to their of overall is for rapid and are treatment.

small a that OGSIVEO. and with benefit reached have desmoid tumors, who with early can we launch only proportion pleased our of experience are from believe people We

to Our increase and confidence in data. continued further gained have from has from launch tumor-specific we insights as desmoid claims emerging the overall patient population the

remains patients. of we in serve front in number tumor desmoid an to the high Our increasing conviction have of opportunity us

inhibitor, associated our to and second NFX-PN. to plexiform NDA the or MEK FDA investigational treatment children with completed mirdametinib. for quarter, neurofibromas, In neurofibromatosis Turning submission we the X type adults the of our

which adults devastating Our NDA based submission positive best-in-class support potential lifelong Phase these data is mirdametinib be therapy for living our trial with IIb tumors. and from children both on pivotal a to ReNeu the for

for were the There substantial people and of available is administration need XX,XXX and a unmet living with adults the for of are and for children, FDA-approved no alone, options States the there pediatric patients. whom therapies Challenges in currently with are approximately tolerability adults. limit XX,XXX XX,XXX use United NFX-PN

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about portfolio. in are emerging the also excited We opportunities our

MAPK needs, myeloma including tumors. important serve with granulosa several populations multiple patients to tumors, have in high unmet We patient mutant efforts ovarian additional and development cell with solid

up In our of SW-XXX, solid study inhibitor our in enrollment addition, began cancers. TEAD which tumors, Hippo Phase we recently investigational in represent mutant XX% I to of

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with systemic already for the happy most therapies to update Thank on OGSIVEO adults Saqib. desmoid OGSIVEO. of launch the I'm into share our launch, an U.S. X quarters prescribed tumors. you, full is

across demand for treatment in $XX.X desmoid sites, in driven delivering and physicians community. million generated highlighted, net execution first benefits commercial of to by by tumor we product FDA-approved in and XXXX, revenue, only experience the and the second medicine Saqib real-world the OGSIVEO strong meaningful As patients quarter focused of OGSIVEO

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opportunity There newly X,XXX us. annually. diagnosed are up we Turning now ahead of to to patients the see

of as research the Our OGSIVEO the frontline physicians of intervention. use market already vast first OGSIVEO as supports a we're that majority to are and seeing uptake treatment likely

research to up has pointed managed previously year. X,XXX patients actively Our U.S. in to the each

data the Our well as tumor to specific early currently claims of ICD-XX have launch this validate and continued desmoid as estimate addressable view this patient pool, size conservative. as results we now

systemic confident for be to The in with growth treatment increase patients active patient in is we're role population. the continues among a OGSIVEO choice there treatment require who surgery systemic, guidelines. substantial to as first that continuing opportunity of therapy With this being deprioritized

patients and diagnosed the of a potentially on active of We sizable treatment option. the a who, a know population patients these are receive tumor could majority the people desmoid hence, their prevalent that over meaningful there's new course sidelines, addition, of addressed proportion be intervention currently disease In XX,XXX overall. of with

at desmoid We continue serving tumors have us of and adoption treatment. adults sizable continue with robust in seen date the strong conviction to of all to have to ahead opportunity stages

half second study of in have Our experts engagement as in success well DeFi the beyond. earned the positions and gratified us their collaboration of thus as well far the following We're continued advocacy Desmoid of tumor for year the the approval OGSIVEO. momentum to through

form patients. guideline Our commercial and desmoid in to on physicians, caregivers to aim for patients of recommended nurses, improve community comes leaders broader for these treatment outcomes to approaches. educate voices providing advocates, the amplify opportunities educate tumor including and This efforts the their

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patients and product and an simplifying In This dosing. strength and mid-May, our tablets convenience daily innovation developed increase introduced and intake as XXX-milligram to in we pill successfully reducing adherence the packaging. XXX-milligram for format Bristol evening convenient was by morning new

continue X expect over format to We a the months. new have transition strong through transition this seen next the to second quarter and this

journey best-in-class patient delivering support our we're Care educational to treatment through Additionally, and OGSIVEO. further the connections resources expanding services SpringWorks with

characteristics to efforts data profile support generate additional form the that and strong of our safety including OGSIVEO more OGSIVEO second in with a poor Phase additional geographies. to hard-to-treat to ASCO disease. expand manageable OGSIVEO those of profile In III subgroups, our efficacy continue data into the of DeFi and presented quarter, patients clinical can the we with as at from which reinforced the be associated trial robust also and are APC such aggressive with We prognosis advancing mutations,

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regulators our authorization Commission milestones. are the review in potential European working approval receive XXXX. we European the excited from as with Turning the to and they to application by upcoming We're closely marketing

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our Dr. with I'll Officer, Chief inhibitor, with our making we're now progress mirdametinib NFX-PN. Medical over the and to turn Jim? Jim discuss it adults MEK children Cassidy, to with

progress outcomes our these XXX,XXX Neurofibromas, Plexiform a XX% which patients is tumors in that are lifelong best-in-class mirdametinib and United on opportunity Thanks, risk update sheaths To lifetime pain peripheral start, disfigurement, patients a NFI. with morbid and approximately as highly living States a for developing These developing both with NFX-PN, along potentially children for can and significant to affects to to individuals is nerve Bhavesh. severe grow improve XX% that functional there which I'm have glad of provide impairment. a are that an the cause therapy adults. people and disease

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tumors reductions and showed improving blinded are of significant rate with amongst presentations and awareness enthusiasm robust The in confirmed our across community. and ReNeu central for building both data positive pediatric the objective cohorts These by size results the NFX-PN physician adult independent review. FCC response

tumor saw majority patients in seen not with of very were of that disease. responses to object up of both The a cohorts. a we of been greater deep this in before confirmed have reductions studies and XX% XX% response reduction addition, published In of experienced than seen

the is when patients study. our consider you hard-to-treat significant This that particularly enrolled were in

and AEs. physician low feedback extended NFX-PN, important with demonstrated discontinuation both that be treatment children rates Importantly, mirdametinib the high have of We is a are data manageable rates rates low which differentiator. unprecedented where after in the there therapy. tolerability for current are to safety stopping a profile due disease [ a In of to mirdametinib X believe events adverse duration, meaningful ] potential suggests these supports like cure and profile and adults grade potential

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symptom Pain the decisions. [indiscernible] reported Pain reductions a commonly in of those NFX-PN goal current initiation such PN many over mirdametinib's treatment is reported mobility in sustained and recommendations factor treatment mobilities. most and severity was is and the in of indicate in primary associated of course in this the clinical cases, pain, practice children, taking common adults the significant so ReNeu and a improvement treatment. interference significant early most is Further, trial, that pain pain including ability baseline the with critical both

mirdametinib And positive reports and that acceptability tablet. [indiscernible] to compliance. believe of experience patient and and were optimize pediatric-friendly ReNeu this we enhance highly dosing of to ease treatment further scores regimen, dispersible dispersible continue a which to willingness regard for holiday Lastly, formulation convenient provides the the potentially maximum slowing in children with take and

extended our all The offers new totality patients a and that expect of both symptomatic remain our which, period data enable and can physicians patients therapy profile we an manageable belief reinforces and address ReNeu that the of mirdametinib will safety robust control, convenient amongst regimen, on for of desire tumor to strong for time. dosing therapy

NDA fast track date was regulatory announcing Looking and to mirdametinib granted FDA progress Commission. of making end at the rare meaningful in we the pediatric designation disease PDUFA anticipate granted by ahead, and designations also the for approval drug we weeks. orphan NFX-PN. the We our advancing June, European and coming completed both are submission And potential our towards FDA the XXXX. FDA Mirdametinib the in

submission also European half. our We're on within to of marketing track the authorization this complete

Officer, review results Perier, discuss quarter will financial will Frank? at results and In showcased our addition, results. Financial in to this new be published congresses that second Chief our now peer expect upcoming we the continue medical Frank And our journal be to year. later our

results. second brings few of summarize product quarter with OGSIVEO second Thank highlights to XXXX our $XX.X our OGSIVEO net $XX.X This revenue you, financial net recorded from quarter. We million. product revenues. million Starting a I'll XXXX in revenue Jim. the year-to-date now

anticipated total operating compared the U.S. launch Our OGSIVEO U.S. with to by activities children and mirdametinib in and the support the and increased of half quarter of of expenses XXXX, adults first the commercial both the driven second NFX-PN. to launch

of a our the as We the in $XXX of path second supporting profitability and balance cash, quarter. strong million cash marketable equivalents have clear with to sheet securities end

to With launches I'll opportunities that, investment across to enable Lastly, back global call hand designed Saqib. the in continued over to pipeline. durable multiple fund a we our have the and expansion operating product plan

Frank. you, Thank

and we As we've strong are with NFX-PN. the of adults urgency for tumors adults very are with discussed of this continued children working mirdametinib bring OGSIVEO pleased to U.S. launch to with with morning, momentum and our desmoid

and desmoid is our enrolled. of trial tumors, portfolio. Phase a which being is ovarian These In for emerging cell parallel therapies. enthusiastic are population about are is efforts, ovarian there granulosa no for FDA-approved tumors, with which X% these Nirogacestat meaningful in cancers a account tumors like studied we patient all in this approximately commercial fully II

proof-of-concept to Phase In the colin with binirafenib ongoing, to settings agents low-grade kinase of academic several trial and presented this with for combination continuing settings, studies are opportunities nirogacestat We're strategy. Symposium combination are were number multiple recently and myeloma, advanced study at with mutant collaborate a in we've further in established on pediatric Neuro-oncology pursuing tumors. MAP in ] glioma BeiGene's with expansion of data lifirafenib MAP industry a Pediatric several in and mirdametinib I/II the solid tumors from currently clinical mirdametinib BCMA-directed partners monotherapy meeting and in promising several kinase including also for mutations [ NRAS and International with therapy combination

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believe is cancers. TEAD develop neck hippo for our treat and SpringWorks This SW-XXX, a tumors which pathway mutations, Additionally, including inhibitor and oral meaningful a head program mesothelioma to novel in SW-XXX of up with XX% cancers, designed to there to We is opportunity the that can is medicine cancer. these with occur for now clinic. in

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and momentum preparations on will patients Europe geographies the serving our NFX-PN the of portfolio other regulatory Europe, patients manner. and our and progress the to year to for building efficient while to U.S. commercial anticipation focus diversified emerging an mirdametinib advance OGSIVEO's in remainder in working for to and Our medicine in this with continue U.S. be in bring and to of the

confident on success our our foundation suffering change that people to deliver mission strong lives diseases. continued as are devastating will our we from support We the of

As always, who I collaborators and clinical of our participated trials, and advocacy our SpringWorks partners would Operator? investigators happy patients to like to team thank workers. We're now the questions. and take our in patient

[Operator Instructions] Anupam at question from Rama come will first Our JPMorgan.

Congrats on progress. all the

a coming prescribers both and quick you seek one and are for from repeat me. for that's innings, in prescribers early Just the seeing new for OGSIVEO? treatment wait-and-watch OGSIVEO population to the in What

Bhavesh, I'll that. you take let

we new, repeat prescribers a the in On launch. amount the versus obviously, good the new of initial saw months of

see patient regular new quarter well. supported expect, you'd in starts, from as starts from by we've continued coming repos a not but started initial to pace in these being acquired As second at new the patients

As total of is patient new would existing coming versus starts over you from time. proportion business patients expect, the increasing

we active point development. surveillance positive is under a proportion time. obviously, a that's wait-and-watch know, so of in the at DT do any is patient the -- And there population From that perspective,

the that of XX% course disease. However, we over intervention active their these of some patients know during do received

Now under innings availability is with opportunity physicians try that and experiences the faster first drive in seeing the the supported by with surveillance. ahead of favor and to us and treatment treatment patients the by opportunity supported early launch, positive therapy, of systemic are of for the and active only patients which guidelines, us these OGSIVEO FDA-approved of the treatment, the ahead

so And do surveillance of over proportion the dropping be active expect we patients time. to

Cowen. next comes line question Werber TD from Our the of from Yaron

early a the bit the the also seeing What interrelated Anupam's I and adopters, X -- give a Maybe secondly, of in us just that sense use questions. moving of kind of can would to give and for just One, Congrats us of Right. OGSIVEO It's quarter you nice in as quickly are just kind a patients are then imagine little academic breadth quarter. of Maybe question. of on the they're on kind a centers have probably follow-on of a a you usage. the inventories coming are OGSIVEO. community? for sense couple

Bhavesh, again you I that. for will turn to

aligned And quarter. overall from seeing. this impact that stocking an inventory quarter to of with demand minimal. key So generally standpoint, prior the in second was of inventory quarters, driver The not the levels a performance was inventory similar the were we're

we this greater that community that there dynamic comments, say first to aggregate all, perspective, overall pool actively is a And prepared X,XXX the we deeper from -- in started From we patients than managed are of said I'll break of as estimated. than up a to our patients. into originally patients

the launch, the as of Centers second -- the breadth quarter. early in are are the of update the we you of We months with of prescribing highlighted, pleased we in we prescribing saw in saw depth Excellence,

question your right? the community to see community, addressing we and an still in to Specifically where continue drive -- centers, good have opportunity, we but adoption breadth With we've started around we depth prescribe but of OGSIVEO prescribing. experience continue the -- have do who who to breadth patients, drive of broad pool prescribing, drive also an opportunity those to both of to

of Now highlight that couple in things I'll regard. a

codes. place the in ability has the been of community significantly availability for to by be time at desmoid enhanced the First tumor-specific these right all, ICD-XX our of clinics right the

our able clinics available direct we're to so team to in for those patient be a And sales is when treatment.

favor systemic the us us in in for the the ability we're treatment community educational to drive well. availability driving but and first both treatment as only as around do segment therapy, depth efforts that the desmoid guidelines, confidence option for gives also OGSIVEO tumor And which of patients, that secondly, then

Goldman line next from of question the from Corinne Jenkins Our comes Sachs.

and more growth of guess, at blister forward, little having some you ICD-XX kind what therapy? you where as have codes see potentially opportunity move them visibility and you and packs keep greatest the as I and population tactically You've doing look patient identified to these of the patient the intermediate-term near you about pockets a talked that for on reach going bit this to kind you are given population where that, on

I maybe initial launch the low-hanging where mirdametinib, want about on do kind of to the see with next with early with and fruit did here launch then ask to how adoption should to year, accomplished respect like we And the you what compared also the of think you've OGSIVEO? trajectory

questions, series try the going answer all of and we're to For them. of but

I think by what as that And we fruit, I large think low-hanging as desmoid is think that of of least quite we we're opportunity tumors. actually comfortable an meaningful. mirdametinib, are and see right? about of in a population, pediatric is outside we number think excuse that that's by of XX,XXX in at actually very are patient me, view this as as I And And saying is talked of opportunity of -- number We size those U.S. and the a factors. One, X/X X/X the of patients U.S. adults. proportionate those those driven the the are X/X

treatment target. us So adults, think us a first-in-class for the to for a best-in-class we have pediatric and for gives treatment a opportunity meaningful

Second, not being the be. served their themselves, broadly in pediatric could patients space the believe as even that in setting, this physicians as they are actually

the which an X now in use that of about proxy And of opportunity as annually so And market. you rate we Koselugo can for in setting the third, just think a opportunity the pediatric revenues, run $XXX just there's quarter there. million

we're know, and both for you Teads. adults filing as And

that I data it's but for is, for the opportunity sizable a is easy. None beyond, and the potentially we for, hanging are it an medicine believe all think that think, profile we that fruit people opportunity supports distance. a best-in-class low So mirdametinib that got you've of implies waiting

turn Bhavesh, OGSIVEO talk you to about I'll

Yes. No, of I'd couple the points. just reiterate a

supported the we're of tumor for First benefit right? fortunate desmoid to to foremost, is a and we well drug OGSIVEO strong transformative and a delivering high have, awareness the amongst we shared patients with to That be the prepared access patients, satisfaction by community. position with the have we see payer preference in that the foundation comments prescribers as by in the broad high that as

So for months the X we adult therapy patients care with of desmoid systemic become standard on with the prescribed and market, just tumors. systemic the most

And to depth as centers as so for breadth us I the the the and to opportunity continue depth segment, drive as within excellence community drive of is mentioned well in before.

we opportunity growth pool do of have significant X,XXX see ahead a that With than to X,XXX patients, for of large continued us more we -- OGSIVEO. managed see the actively

Our next Lawson question from the comes from Peter line of Barclays.

for Thanks congrats progress. and update on Great. the the

patients how First month is question really you're whether been July at into looking the the about and particularly seeing and patient then just trends, they've any discontinuing?

Peter. question, the for Thanks

third I think we well. study, aren't the discontinuations. confidence seeing think into any us quarter, but I that we DeFi expected not exceptional from and the just fourth the It's what would going have gives quarter as

So I think that the trend holds well.

And for is I opportunity As Bhavesh actually we well portends the think here. what originally estimated. patient that highlighted, than had pool think the we deeper aggregate

most feedback perhaps though. the are we getting, that where is we're Fundamentally, excited

and You've to to their got get to want on causing benefits patients on want therapy. seeing persistent them pain, deep to that immediate and is therapy stay

continues believe the we to opportunity sizeable. So be that here

of line from Schmidt next Michael the from comes Our Guggenheim. question

on quarter second strong result. a Congrats

follow-up OGSIVEO. a Just on

third something here As over sometimes seasonality products the about up, quarter experience coming you we months. other the as think Is summer this some well may OGSIVEO? with that expect

predominantly already untreated follow-up a you next as switching into the to about the mirdametinib you currently launch product have -- initial from over penetration next a year? as with year. NFX-PN or we on think would And that a you mirdametinib patients market. Koselugo about the expect we then Obviously, expect think on Do

Thank you, Michael.

other the in think we've we I the months. would I said seasonality the think obviously, is So as expect Edris to mirdametinib the I think, we I'll pool question. deep, take outset, see immune is summer and the from OGSIVEO don't that ask question. to seasonality, see the take opportunity to products. from Dr. we're in I'll Badreddin? we think significant. But some as many

of So latter patients, with the market have both represent for and within filing mirdametinib, that not is remind opportunity X/X NDA NFX-PN respect our I'll the of pediatric our therapy. you do unapproved adult to and for whom

And so space able white being who we of untreated. bit are to respect there's serve with to there quite patients a think previously

there patients experience as the but who their Within therapy. certainly of years think been systemic over population, shows the pediatric that, treatment our have minimally research well with respect that is be to next penetrated therapy, I market will some line are market that seeking

patients, we therapy becomes there's option think a significant systemic their for first pediatric when of So available. also looking are number mirdametinib who

Stranahan will line Alec America. last come Our of from Bank of question from the

focus longer-term later strong the around the it on will from this quick can mirdametinib, clarify. receive And print. that review if framing your just expectation us maybe follow-up from Is year? Congrats data the to X of you Any I accelerated sneak can from you in. provide one, DeFi

Thank to you, the I'll Badreddin. be Alex. turn

Sure.

respect And on data, you at with time our randomized analysis, patients to the arm majority that was follow-up remind X therapy. the not of the to the on the were remaining median nirogacestat primary treatment patients longer-term time Alex, those I'll So years. just under for that were of

longer-dated we how on year. as an on a later responses, be patient we on what evolve as for certainly figure this the able well. nirogacestat benefits as share trends the reported are patients a more so mature terms hope treatment the It's time they update of well with data see And over that to cut we to median that and outcomes time in seeing treated

Phase II, studies. years treatment our able And those of that's we're in each share. median gearing time and what be that Phase you up remind I'll X was to I So to over in on

to So present the opportunity really data. there's longer-term

guidance position time We'll on from and August. about expectations be review that review FDA we date so the receive With mirdametinib XX days PDUFA respect given filing, have some designations filing, any late topic. from be for on a in not the timing then that to in will any

This you concludes you. Thank Thank joining. today's call. for

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