Catalyst Pharmaceuticals (CPRX) 9 Nov 232023 Q3 Earnings call transcript

Hello, and welcome to the Catalyst Pharmaceuticals Third Quarter 2023 Financial Results Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.It's now my pleasure to turn the call over to Chief Financial Officer, Ali Grande. Please go ahead, Ali.

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Third Quarter 2023 Financial Results and Corporate Highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer.

on by joined also are today's Dr. call We you Officer Scientific Chief forward-looking of morning, Officer; Miller, to Officer.Before our make Jeffrey and be Chief about Operating Chief remind like session, would securities our federal Steven in and the remarks we may and Del purposes expected begin, laws. future I statements in which Q&A for that our we will this Commercial statements Carmen, results projections to and performance. relate current our of estimates and not statements future are These expectations, guarantees not They are involve risks, difficult to uncertainties be and assumptions predict that and accurate. may to prove Actual contained in results our the may vary from forward-looking expectations statements. our only contained XX-K.At Form annual time, forward-looking should filings, report I'll risk SEC this These over call turn with in the the in in be to XXXX our detailed Pat. information considered on including statements the described conjunction factors

Good Thanks, financial conference call. morning, everyone quarter third welcome XXXX Ali. to results and our

an expenses approximately children intangible for of designations to chronic pending transformational for the pleased for and a receiving FIRDAPSE's to extend of program at X performance nonrecurring first onetime asset FDA and X, to introduce from compared Catalyst.You integrate $X X.X% operational result the in-process AGAMREE fourth was franchises.We to for quarter incurring patients our the commercial FDA white cash some performance corticosteroid the these the At year-over-year status Dystrophy underscoring planned AGAMREE treatment AGAMREE Jeff an by execution and to number franchise, just and R&D outstanding underscores $XXX DMD, compared the treatment.We the for approval XX.X% XX% increased acquisition of path equivalents possibilities intangible was are in We year. recently all-time ensure and it and by more in significantly fortified our the XXXX. helping FDA's share, on Pathways to two acquisition $X.XX treatment patients serve the additional FIRDAPSE of million pending which as to of amortized another you has quarter is are balance a debt these overall current bringing high revenue is the million our maximum company.First, reshape XX affected no brand DMD license.While more currently new will million to product list when income of per consecutive effects. for across million million recorded dedicated over holds our of are and $XXX term for during its you strong Duchenne patients represents in about noncash by $XX.X the funded to questions about of of also $XXX.X solution, vamorolone. quarter, that financial our that corticosteroid $XX.X disease better Steve qualifying raising last offer platform. our same our expenses of has we all continue depreciation, earnings sheet. more financial that goals. of Catalyst have orphan on growing nonrecurring an for known growth of acquired performance for of are address another underway third glove marked duration million. which to neuromuscular estate, this associated strategic other opportunity near with further all license of and listed we providers the reinforce This U.S. increase includes announced actively related which milligrams.We I'd the significant the revenues AGAMREE highly per Muscular overall our come yet reflecting current for profile the his expense third are the year-over-year presentation.As to total a of inflammatory the AGAMREE favorable of guidance XXXX.Per patents $XXX quarter of the third steroid the health access quarter acquisition, the patients approval increase are as acquisitions these book franchise of chemically license about million, to agreement note launch and who will expense strategic for time, financial a DMD year, of currently believe have We share of second from AGAMREE, of the launch teams to at for conditions. year-to-date highlights strongly completion to million provide synergistic rare FYCOMPA will growth AGAMREE existing and American our like useful GAAP daily revenues a XXXX provided life increase until testament American GAAP FIRDAPSE through in anticipate may business It of of increase quarter market Non-GAAP the say was drug payment by epilepsy our we action commercial overall the we the This discipline will another patents third onetime been that with our $X.XX and with years.We for U.S. or are achieved the with million amortization revenues protection which prospect fiscal review occur quality which acquisition the DMD. towards an significant guidance novel this for be rights daily licensing FYCOMPA XX preparations.In for trend. between the that potential treatment excludes as net which aimed in of disclosed estimated per a a for oral $XXX Again, dose second the exclusivity, $X future with cash Santhera product the many year, growth involves maximum standard potential of patent future successfully treatment the during AGAMREE, AGAMREE, debilitating We meaningful products.As increase of our million financial FIRDAPSE PDUFA assistance other that $XX.X again million approaching XXXX. accepted strengthen third year, to $XX.X or to our their progress, XX,XXX quarter XXX driven the the known, in contribution AGAMREE representing the This revenue disease well shaping was of with period and to $XX.X associated this its this currently process DMD.On This base. FYCOMPA important right XX,XXX revenue rare care the effect DMD, impacted to that key approval longer a new income, also in reported our we financial the should as treatment fronts pleased of in quarter are to intellectual that about XX.X% that organic has from on favorable already We've results other by XXXX. net to share, of and with that side report the treatments. to the DMD from $XX.X is North establishing know, had compensation, the nonrecurring of million in will on total communities. potential June and realizing affordability approval XX.X% our or been vamorolone, loss the Plans XXXX. believe most excited our to details engaged diluted life, and the care side corticosteroids, as the to this our of issued, the quarter North product for or filing. efficacy previously and of underscores We the are patents paid benefits we the of exceptional as Ali We traditional revenue R&D Pharmaceuticals, with of another million revenue $XXX confidence announced providing often of XX% continued period third net and of are success milestone sNDA years of through quarter of exceptional to comprehensive recent with milligrams you over positive her of execution. name further year-to-date a of improving FIRDAPSE October AGAMREE, Santhera as GAAP net will FIRDAPSE.Our this to they dose quarter, that previous issued for a Early $XX X, quarter, million between patents mobility represents we attribute fourth ended are as the seeking an presentation.Our the triggered ambulation and stock-based our announced net Santhera, a our a million assets. or XX.X number quarter diluted. soon of ability thereby date of pediatric we orange milestone the quarter to patients to FIRDAPSE AGAMREE also under the property allowance belt.We of our the total of estimate asking and

and continued that quarter, an current status status.As patients the our which of as license receptor amended $X rights achieve regulatory agreement from triggers stay the to million free by PMDA to once of a served. the payment territorial for we end expansion due epilepsy the for to in of the our will milestone Acceptance Japan expect AMPA noncompetitive Catalyst. tailwind with submission year, We that expect in was FIRDAPSE fourth Japan this tend FIRDAPSE before trigger they seizure regimen an we enter antagonist to DyDo its by FYCOMPA also only our NDA under treatment DyDo Pharma the submission partner unique

opportunities. expand We of adequately company the to global where regions.Looking are through transaction focus pursue partnerships with at pursuing on and opportunities on development are Pacific our we the footprint developing side and current LatAm our Asia to business plans strategic value the de-risked added focused

demonstrate the the key of to neuromuscular we our during North focusing American this from ground around rare medical gained strategy, AGAMREE expansion product with rights on with continue the recent have progress that of We to evaluation de-risk epilepsy first, needs; and in existing geographic our footprint products.Overall expansion our search our efforts. unmet and broadening innovative sufficiently closing and Santhera.We of X expanding the advanced diversifying second, and acquisition critical portfolio pillars: efforts portfolios portfolio address therapies significant quarter, have

as a We I our stages of to few CEO. opportunities comprehensive choice Rich the successor are due was announce that search, currently stage as my additional pleased the come very was in diligence to robust could candidate fruition quarters.After that commercial of over on Daly advanced next and

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to making With accomplishments achieve Jeff of our team, patients the the is serve. of on over to I'll that and who lives Chief no impact Officer, we capabilities turn the lasting we now continue will our that there Catalyst Commercial our collective us on Carmen, noteworthy the commercial will activities. a update doubt Del call

substantial to results way our Pat, in morning, Thanks, strategic would quarter to achieved are efforts, This for future to and the and positioned net draw range of consistent FYCOMPA, million successes.We all-time exceptional of board. which generated team year-over-year are $XXX.X fueled performance revenues this $XX.X revenue an the outstanding from which $XXX like $XXX of reaching was combined XX.X%. strategically showcasing growth our continued FIRDAPSE has I In a the and million, remarkable $XX.X million. paving QX of by strong high last the your performance revised delighted record-breaking million attention good across million.Catalyst meet our to everyone. quarter report guidance the is commercial to contribution

quarter, represents strong annual the including rate period of QX year, average monthly all commercial First, let's or increased in experienced prospects. pivotal foundation FIRDAPSE's FIRDAPSE, the of quarterly year-over-year a those therapeutic co-pay versus affected new patients steady starts QX XX.X% of total of million, individuals year less which the organic coverage the for trending result discuss LEMS. direct belief long-term and payers, growth by over with increase enrolled the Pathways, Catalyst XX% highest $X.We government a same revenues Myasthenic types XX%.Net third exceeded Syndrome in below and were Patients patient and Medicare including approval in our accessing has year-to-date an new and insurers. as than progress for FIRDAPSE's rates an in with year. assistance, option discontinuation last Lambert-Eaton private Prescription have third were this a $XX.X U.S. emerged XX.X% by last revenues quarter of net a through

have robust yet pipeline diagnosed with not who we over patient XXX have started FIRDAPSE with leads treatment. First, a LEMS,

eligible future.Next, an in data prevalence estimated significant on is from could potential in previously prevalence and cancer.Currently, a abstract cell cancer higher lung focusing recently of rise States LEMS process contributed of thoracic Additionally, real significant Conference diagnostic a candidates expand FIRDAPSE LEMS cancer growth. from Cancer as evident the a lung to the patients prevalence sources initiatives voltage for for the patients the new that individuals, year, the educational foreseeable be large the that LEMS we patients. analysis, greater streamlined we on last small consequently demonstrated of than pool X,XXX. assess continuous high-quality September lung have our channel This antibody from for targeted as XX% a of LEMS with detailed of at a opportunity of effectiveness. for aimed increase treatment.Furthermore, patients representing cell ensuring estimate identified world the United our LEMS we notable diagnosed small derived gated In campaigns patients, X,XXX This Lung in estimated in the LEMs at education of are cell undiagnosed, is among number presented have which successfully the World oncologists influx identification their calcium leads LEMs have the the test, diagnosis specifically small

sNDA of significant for significant provide company's daily it of to highlights in daily population.Now to improvement our provide our commercialization mentioned XX would dose earlier, surpassing benefits anticipate XXX a could of patient offer dosage notable FIRDAPSE our FIRDAPSE the from patients.As progress like increase milligrams a the expectations. with of is we the to FYCOMPA of FYCOMPA. I some approval Pat FDA may to that maximum some Additionally, indicated portion

providers, contributed valuable in million, care net QX, to expanding health a with forming collaborated achieved XX.X actively that In revenues have X.X% FYCOMPA have relationships quarter-over-quarter. of significantly We increase our marking success. outreach FYCOMPA's

steroids living that patients significant promote groups for partnerships to with are patient addresses awareness turn a unmet Additionally, AGAMREE, for anti-inflammatory Of between receive with and treatment. need for approximately our a Dystrophy U.S. or patients be promising more DMD mission.Let's to XX% The DMD, fostering corticosteroid enhance Muscular to is crucial currently for tolerable advocacy prevalence novel XX,XXX we and estimated XX,XXX DMD. treated patients. concomitant Duchenne patients these steroid being of

commercial in AGAMREE effects. DMD before current important However, to XXXX. unmet need will paradigm patients we believe an steroid We significant is quarter side expect addressing the with disclosed that an advancement the caregivers.As associated launch and offer we treatment first have treatment for the

We AGAMREE we neuromuscular leverage expertise, team's and our will capabilities, the demonstrated integrate franchise, where can commercial into experience.

final sales We and commercial the and managers neuromuscular services.Our are mostly stages launch hiring XX X XX in personnel marketing patient account for directors the to of force in and regional area business pending responsibility existing support have of both FIRDAPSE will AGAMREE.

access to will help ensure patients the can living In be ensure addition, AGAMREE completed program since was key eligible and all responsibly in Catalyst for this Pathways research of done to had July, product. stakeholders of for round best-in-class intends appropriate was October price patients conducted our to access by DMD.We pricing market in AGAMREE have with refreshed Catalyst all that outreach which the Catalyst acquisition to considerable AGAMREE, year. supported Santhera one by

had Based addition, where members received approximately market, we the several feedback the we've EMFLAZA. regarding constituents, slight and feedback acquisition access.Lastly, on cost opinion the meeting of October. in with and In key discount XX an a leaders advisory of community pricing meetings our from board held wholesale to DMD at DMD analysis Catalyst AGAMREE with be key will and advocates,

Dr. will of available Furthermore, coming highly for in the to gear we performance XXXX forecast for we on same on extend than to as will $XXX commercial patients will average satisfied will proven to month. Catalyst remain of successful $X Officer AGAMREE, as to patient Steven turn More my anticipating be per for to eagerly will the million. the dedicated Operating we commitment call an ensure our financial entire FIRDAPSE less million I adjusted for Chief in the Scientific out-of-pocket update team capitalize We and gratitude our launch activities. their a be and Chief ahead.I we Miller, the QX implement summary, are and months.In up QX in our on achieving cost R&D confident have at am the the programs commercial Officer over $XXX our launch heartfelt now I expertise. details extremely with revenue

Thank you, Jeff.

increase would integrating regulatory our Catalyst FIRDAPSE potential, new clinical continues milligrams then per estate access of per I like on the its acquired optimizing patients XX date development the of submitted of FYCOMPA this announced to strategy Catalyst with X, to products for the and the XXX to dose action day. discuss milligrams Our supplementary on this the AGAMREE acceptance newly patent second day FDA's dose June for enhancing maximum maximum to review FIRDAPSE into focus to the FDA and and to LEMS maximize commercial FDA FIRDAPSE daily October from organization those expanding in for to efforts an XX.Catalyst indicated all and quarter and to a XXXX. potential development sNDA assets.First, NDA commercial the change the PDUFA

the daily approval issues While maximum already dose. milligrams who of there a FIRDAPSE to treated higher year.Currently, indicated insurance significant June XX no application justify be X on providers patients of there worked at review, sNDA dosage dose applications of the of pharmacy on of the next number with the being can Catalyst of exceeding XX current about are assurance Other per or with any are a and patients XXX XX physicians the above LEMS help FIRDAPSE. their order basis the supplement, approval acceptance milligrams after XXX acceptable patient's that physician this the of barring this anticipates increase daily a we to the therapy. strategy daily a on of seeking May will meeting the FDA up potentially patients.Based sNDA, an of desire this day, milligrams our recent submission their approved, C approval with for have the believe per dosage to those of of our and if in optimize milligram Type to maximum dosage and And and year, in milligrams day expressed constitutes

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kept saw We of us pace year for strong exceptional quarter of and third Steve. Thanks, financial another XXXX Catalyst execution. performance on

results, the like highlight outstanding accounting this company to excellent expansion Santhera quarter. moment treatment development some our value our job to continue for I portfolio of to American on business topic acquire commercial of I assets discuss to expansion a shareholders.While momentum take transaction. of portfolio North pivotal to flow us strategy our successfully promising would an efforts.As the the positive team and will incremental and were allow offering to addition incremental AGAMREE, the done at implications rights our also AGAMREE result, to deliver the a would transaction acquisition, by net of a from during to key cash the and of to addition the accounting to with continuing this in a This to closed In Catalyst, also we like which

AGAMREE sale shift as would research July quarter to transaction milestone by related payment. the During to were payment not for as transaction IPRD.Next, the third was of regulatory well development, approved the in in-process yet upfront FDA. I like or expensed costs XXXX close, the Consequently, and U.S. as the

As of quarter a which result fourth million balance of the will approximately amortized prorated XXXX, quarters.I to that AGAMREE XX.X XX strategic the The investment be be the approval and milestone in the FDA occurred on on in the the and approval life sheet fourth be of as the end of on the for has like equity years over Santhera this AGAMREE use connection will then price as acquisition a on quarter made value at would estimated forward.Lastly, or October asset on intangible capitalized XX, and to in an to SANN the XXXX, we $XX.X using as will XXXX, $XX reinforce of be will Santhera in marked transaction, for payment terms. make to such, expense of a going and October a Catalyst amortization book equity of Swiss ticker results. value investment of consistent QX quarter will million market XXXX part Exchange.Now observable market basis quarterly with SIX the the the a

$XX.X net XXXX FIRDAPSE net XXXX, to loss year-over-year $XX.X income from quarter year-over-year XXXX a Our or FYCOMPA revenues million, the total of million decrease third quarter non-GAAP of for quarter and million revenue was share, $XXX,XXX million XX.X% income net we GAAP or to to of the tax share.The for for acquired $X.XX income quarter $X.XX the million, third AGAMREE-related of per compared IPR&D net income, $XX,XXX. $XX.X the $XX.X was of the of from attributed XXXX, intangible XXXX. XXXX which income expense of lead to amortization of before charged our third or for million, from of basic XXXX. compares loss $XX.X compensation quarter for million, $XX.X largely income from million, for of million expense third the the third a the of FIRDAPSE for third diluted which report, assets $X.X from stock-based third stock-based net was for Product per excludes the XXXX the excludes a million, of $X.X provision income basic $X.XX of net per $X.X onetime income XX.X% during net the Non-GAAP for or of income net related to quarter third and in Net GAAP the of diluted year-over-year income to The quarter of $X.XX XXXX.As intangibles basic compensation in quarter third the of compared products depreciation which both amortization This of XXXX. XXXX. IPR&D increase increase quarter of loss revenues million for and compared quarter revenue FYCOMPA million the $X.XX of XX.X% depreciation X.X% million million $XX was XXX.X% basic $X.XX $XX.X of of and a before decrease earnings and million of income expense. million for intangible quarter year-over-year.Amortization share, diluted per FYCOMPA of for $XX,XXX. The Product net per and million, $XX diluted was XXXX. tax $XX.X net above XXX.X% for third connection assets of million, acquired compared of loss, approximately $XX.X quarter taxes were and is of my when $X.X of the $X.X million during XXXX second for million share, of with the GAAP of acquisitions third quarter quarter per net increase was reported third $XXX.X third increase to total a XXXX XXXX. the of We $XX.X benefit taxes RUZURGI non-GAAP $X.X represents product approximately $X.XX per $XX.X of and an to decrease GAAP our net RUZURGI January

basis, $X.X thus will the additional on payments of it recognition to expense be beginning of as quarter prorated.We intangible expect and to in Santhera acquired XXXX approval for quarter beginning be beyond. relating the quarterly will for the intangible due asset of we previously an XXXX first the with amortization milestone approximately amortization the licenses of quarter our fourth be the be and As less million in quarter made amortization to fourth million of $X.X assets fourth and expect and to regulatory recognize $XXX,XXX to mentioned, timing of XXXX a to the

XX.X% of quarter third the quarter many permanent the basis by to rate of taxes expenses the anticipated any third million XX.X% quarter XXXX of XXXX by $XX.X The income for the compared to tax by the options third on period annual exercised stock the to and primarily XXXX.For of differences for of of in federal and number likely income is $X.X state principally and were an approximately of factors, royalties. given rate statutory million periods.Cost rate sales tax effective XXXX tax is to compared affected quarter including in Our in offset future effective XX% in compensation driven consisted of fluctuate XXXX, annualized third the was was equity difference deductions.

exceed during hired Research under of expenses FIRDAPSE anticipation headcount.In addition, increased million year. year-over-year be the FYCOMPA, As quarter. In royalties $XX.X incurred recorded is $XXX by up in QX the will for expenses million charge third XXXX the expenses the back-office a research for and exclusive quarter.SG&A million plans. also quarter, the third third is IPR&D in in to of related to quarter rate.Catalyst threshold expenses the XXXX. and during behind million as of product to totaled compares expenses to for year third of relating subsequent second principally force sales net $XX.X and the to in XXXX, quarter FIRDAPSE in increase Previously AGAMREE mentioned, headcount of the $XX.X some increase the related increase XXXX. of and third making the includes a driver the transition The the quarter intangible SG&A during sales services when due selling in sales for were and this approval agreement, calendar May X% assets. compared in million development royalties is marketing sales such but net This XXXX product and commercial in reminder, were subject the the onetime expenses third marketing-related remaining amortization there any FYCOMPA was in met to selling higher in XXXX, an principally of costs $X.X AGAMREE trend expenses for the development XXXX. of royalty quarter

of to AGAMREE expenses $XXX $X related additional an spending the other XXXX.As with million. anticipate during cash the and reported, quarter million we ended the $X launch preparations of Finally, cash million fourth to quarter equivalents we and in commercial

of in R&D a of regulatory found the the November Commission $XX the X, XXXX, by FDA. Pat. reminder, yesterday, connection Securities over which to to to to XXXX approval leading AGAMREE performance upon turn milestone financial was We the will XX-Q, analysis quarterly and on our page to funds development creation.More our a on portfolio programs, at business our to believe filed fund and growth payment allow our third our current that, long-term obligations and and us be the may expansion Santhera fourth potential million Exchange detailed in efforts, we earned and call Form the quarter www.catalystpharma.com.And quarter with As the can make our information our be of contractual report I'll value found existing Relations with meet continue in the initiatives, Investor of website flexibility support financial strategic and

Operator, we Ali. can now for open line Thanks, the questions.

Joon coming first Our question is Instructions] from [Operator Securities. from Truist Lee

This Joon. for Les is on

IV with on partnership the any to your will to new in Book, a on about that, Orange front, can second filers? just Pacific the and developments FIRDAPSE And part follow-ups. And America? have First, Asia are situation what few included Latin talk be have impact the what X that that then you patents the I ongoing does Paragraph

submission Japan? pursuing first the territories we in question about once Your was trigger other

correct. That's

Yes.

China, So Asia also in robust think opportunity. smaller we on our to is Pacific what think South represents preliminary And the markets region. few Brazil probably based in research that opportunity a Korea, be great that a appears a fairly we there

where initial thoughts our regard that -- want with that's patents? you do to to the regard with take are.So So Steve,

strengthen And our metabolizers have addition we ability allowed that of the transferase a patents our -- X patents represent They and property. the related a of challenge to toward significant family the of and the will of significantly of intellectual against will the slow family that amifampridine improve new amifampridine. drug. it Les, fast n-acetyl patents believe metabolism pharmacokinetics to enforce claim Sure. just to were language directed and

what next the are of And metrics And to that outperformance, year in year? you how see FYCOMPA behind the driving as do progresses some regards that?

you want do Jeff, to take that?

Sure.

we're on it the versus Les, So XX.X% think prescribers is FYCOMPA market for We those focus physicians existing X prescribed years. last to around our strategy or antiseizure what FYCOMPA, year over share that medications. have the looking the is of branded that at

to more expectations. and to been on patients we prescribe So feel earlier just that's That's getting biggest for our treatment and and physicians exceeding focus, protocol. of in those contributor focusing physicians the our their our their those

me digit, to we we that digit a from expect product, single as single So it that Les, fairly let year-to-year. add can continue high mature grow by

helps that question. answer hope your I So

does. It one One for I -- me last guess then.

there. force is, current process. It to sounds current give that due the in you're with potential cash more balance? diligence It potentiality in appears the some the it On an how maybe by essentially FYCOMPA. epilepsy advanced a front, is be like asset, would color If around And acquisition acquisition that? fit covered into other sales

Yes.

of do be And made we bring our not growing something emphasis And that the We anything next think on to to really, continues acquisition. or so we've with clear cash sure couple fairly million, franchise. like it's would we'd it to in a $XXX our another we And to importantly. these position today. integrate And over be most position quarters to think each acquisitions plan opportunity. quickly. imminent and our that point. a next certainly, which opportunities. grow doing a compatible with epilepsy tuck-in I that our in announce hope we're that opportunities it's say acquisition, that want strategic from as We I a anything stated, quarter-by-quarter. deep of careful that we that not -- We're in made make another good X, about we we've on many X-month but say couple clearly, of is with We can would there's execute too imminent. we We too that diligence of want

performance. the on Congrats Great.

Thank you.

Charles Duncan Fitzgerald. next Our from Cantor today question is from coming

frankly, Pat, great congratulations congratulations And career and quarter. luck with your milestone good team, transition. third and a and on Pat

Thank you, Charles.

the then of had or on AGAMREE Yes. couple questions. Vamorolone one FIRDAPSE. I and sNDA a for

what any vamorolone, guess I to be adoption? new of For terms guess, the Steve even it the Will from on in And could speak dynamics. market standard I'm be of be going wondering I do recent or patients? think of there of you AGAMREE? patients will if care, primarily of anticipate for the current results or EMBARK demand the switching Jeff you impact pace targeting to what current

Thanks, I'll Yes. Charles, for pass Steve. do the up? question. want this pick to Steve, this you to

products. the results, a treatments both it for don't and well the treatment those corticosteroid, company's variability overall the let have me really question well kind comment as exon about alternate question some And that therapies, therapies general therapy. taking regarding the and those your Okay. other therapies. afterwards. skipping of results I line a want the The use answer need bottom more to with is as patients Well, gene how EMBARK speaks of during respond first in with on to There's patients EMBARK to still

can And treatments say those. Charles? anticipate I there's for will line steroid to much continue So that DMD patients. the for you I not we bottom be about But apologize, there other the can now demand question, is repeat healthy that

Steve, the I'll and pass about was dynamics. switching Jeff. that patients some to The switching, question of

Okay.

DMD for right -- dynamics for the Charles, are now. here the corticosteroids market

patients a that about the Prednisone these XX% about patients As to you they breakdown XX,XXX there, XX% steroids.Now also at patients are hearing but when when we XX,XXX with you to share market be And potential that feedback to from those look a and in are are EMFLAZA, of living those that primarily EMFLAZA. XX% on the on patients, XX,XXX AGAMREE, some about XX% for are Prednisone. on are based at DMD we're market the U.S. switch on will XX,XXX it's mentioned, of share look

currently some happen. naive that to see will for over that the will be I on launch, that but switch will be over. percentage. may a But steroids, think time, And initial are the to looking You steroids patients are smaller that patients

dosage going it ask, Okay. but And the or be to now, hard on for think be Will to will the sNDA the safety speculate what of question efficacy? a then That's Probably do FIRDAPSE. milligram the I'm XXX from agency? quick around helpful. key questions you

Steve, about how taking it? you

that a the higher are at no currently submitted about that, by drug the regard sNDA never them, have previously plenty want they day. have body the significant any question based Type they be questions interesting want FDA drug And further -- out. labeled dose. per showed higher short of your be also XXX-milligram an that but would is, have to concerns that, data per hard result any dose.The questions sparsed approved Charles. if dose beyond was there safety XXX-milligram XX to a with we demonstrates already of would what of milligrams That's submitted that spaced was submitted question, the know on meeting. a for and the is we Sure. evidence efficacious The milligrams which dose That's our future.I as XXX-milligram know, think you and the But really And efficacy can the the answer we at questions to of will we've to a C second day. thing is dose. XXX they want to unlikely RUZURGI, the efficacy, will a XX% be at something approved that of that in point they'll to safe predict dose, again, at than relatively it's

that And -- dosage actually will of that reason application. that our believe result, also a And so FDA some for the a that XXX-milligram receptive sNDA. data we as is be in it it's to

a put was fine pediatric And on that just Steve, label? that. label to point

Yes.

Yes.

Orlando. it. I safety. believe a Adoflex. meeting upcoming plan one have December, it's presence quick the early That Got a Last Okay. highlights AES to for you Do in question. at big

Jeff?

Charles, there. we be will definitely

team. our to huge We affairs as med have well team our as presence a are going commercial with

on Okay. quarter. the Congrats

Thank you.

Catanzaro is from Joe question Sandler. Next Piper coming from

quick ones me. X for Maybe

a AGAMREE question, the an slight to similar ask about First at one, maybe to earlier discount price to to strategy wanted I but EMFLAZA.

potential that have around whether Just that the first EMFLAZA That's one more do you you active from could from wanted and to reasons of I could to see if you to think follow-up. my switching benefits actually and on elaborate drive the see AGAMREE? that, one, some

Sure. pricing. arrive the you to to some Jeff, was at to speak work want done us help of our do that

Sure.

payer as and patients in did lot took, provide we'll a with to as details get that considerations outreach and advocacy we we we speaking Joe, also more well to So But as pricing the significant like closer then KOLs. the specific launch.

So very price to that helped a at us form our discount decision similar EMFLAZA. it to slight

So did question -- that. those I behind your specifics you have the or? are But -- do that's answer

primarily key sort Yes, you that's could helpful, on I whether I see guess of then factor and that interested switching a was dynamic. as

step We through of that slight from discount payer potential benefits too. a there's price do a and EMFLAZA. landscape at And that or a anticipate not that point the was necessitating all further part research

mentioned and X are pillars U.S. footprint Pacific my of agreements, and geographic AGAMREE license Okay. in products. know expand for you for key might the the Got it. I America. you based Pat, if opportunities opportunity the see Latin of to And the on wondering potential FYCOMPA Asia second you question, outside to potential there I the mentioned, FIRDAPSE existing wanted around any and But ask

Not I for is does be Santhera, in markets. specific the going FYCOMPA, our market X that. But -- opportunities we European of can't AGAMREE Joe. -- about are AGAMREE there license some key expansion. for some know, But to we AGOMREE rather, the market at allow moment

are that They a us. so China. for opportunities partner in have do And there outside of already

relationship with good we Santhera. working So a have

on those week, right next committee are topics are joint be that development the and a for fact, meeting In agenda. they'll here

Partners. Henry from question from coming Capital Roth next is Your Scott

when really the to The question has is access pathways. with Catalyst Duchenne's think do market, there's Catalyst that it of what a more market about LEMS the excellent will competitive you -- little the competency know be? the it I market. -- between Duchenne when bringing core how than A the job similar you markets? been compare Will those are differences access seems program,

you color on Just would that. any have

Scott. let I'll this. Jeff Yes. Great question, take

part the mean, look that you is you competitive at the patients. really, therapeutic significant landscape then mentioned. Medicaid commercial, areas. the difference the X LEMS Medicaid whereas Medicare. of not only -- part is the XX% most I balance a for the those so the DMD, had population It's between When or Scott, biggest But it's you and about side

was families But there's XX% us have XX% that You patients that's and that for want the and a the ensure be patient is Medicare physicians think to there. is should that commercial.So want patients. these AGAMREE. we biggest the make for part biggest access access there's thing for that on sure We all to

co-pay average per $X of ensuring all those So patients an we committed are month. have to that

a we've focus done we We've that's planning, when our a research. what launch. strategy be lot So will done of of and lot

And want as when know much trying about X key any one think promote then But final differences a compare to Just would talk as Great. question, message really your are far how about don't this that I EMFLAZA levers the that compare key there to you there? Okay. the to will switch now. to you marketing on. AGAMREE, and make up

lot of continue Scott, do a we work. to

we'll marketing to against We add quite market secondary we're open to programs. and Jeff, to want have other position with how ourselves do regard and that? you research. research to entirely primary strategies ready And the kimono not

Sure.

thing market. it's So plus. a defined about about very XX DMD the And Scott, is they're the space

data profiled boys time. key calculated these this primarily prescribers, of centers now Duchenne. with living accounts we've been the out prescribers of some benefits med the ensure the aware will of of stand is our appropriate and that's it between been next by about what's received to the approach. we specifics more or we'll month share And affairs here a collaboration that the behind excellence think I XXX pretty the XXX, data X. or that that, stakeholders. about long commercial like be stakeholders And and commercialization on and the AGAMREE data, market.So mentioned, and versus has much And are for a really of for But there we Pat all data in

think understand. couple been watch. chapters write, but Pat, That's great again Great. but you a great Okay. I to it's I to helpful. And completely career, more got congratulations

Thank Scott. Thanks, you.

I'd our back the to Thank further end floor any over turn of question-and-answer you. like session. closing Pat reached the We for to comments.

you. Thank remains rare pioneering to solutions unwavering. dedication for In our diseases conclusion,

want stewardship to As potential we approach the to diseases.I strengths, with maximize here's are you. enhancing product poised the eagerness, of of grappling a Thank well over future and support with patients potential rare lives for brimming and boundless portfolio XXXX to years the promising steadfast your with thank of you Daly. the we leverage Rich our our under

Thank you. and webcast. conclude That does today's teleconference

line may for this at have We and wonderful you today. your a your thank time, participation You day. disconnect