Catalyst Pharmaceuticals (CPRX) 29 Feb 242023 Q4 Earnings call transcript

Hello and welcome to the Catalyst Pharmaceuticals, Inc. Fourth Quarter and Full Year 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 CFO, Mike Kalb. Please go ahead, Mike.

Thank you. thank fourth joining XXXX quarter and highlights. and to conference financial everyone, business Catalyst's discuss and morning, you our for call results Good full year is CEO. Leading Richard call today the Daly,

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

call. Thanks, Mike, the to everyone and welcome

that today was we Rare do team our are to And and all the on the to we're the like proud that year Catalyst. say rare we we an on has of you especially and orphan that for speaking I'd excited is of of Day.XXXX achieved. team serve proud be to that Disease outstanding First, disease communities entire behalf work

this, proud pillars. that we just are the during completed, this high-level pleased key year made are some progress before to offer into business the our ahead. like the operate highlight have year provide dives transformational to we But We I'd into to four comments.We around insight and we team

commercial patient care on supreme execution First, and with focus access.

through portfolio development. expansion Second, business

finally, Third, financial partnerships. And and lifecycle discipline. management

will a provide areas. business by remains year start each with for discussion on FIRDAPSE first evidenced of growth. commercial core today these with sustained XXXX you execution. updates our transformational Our our organic pillar, our was The strong, Catalyst.Let's

We we our continue our treats, the working to FIRDAPSE integration expanded more increase XXXX, FYCOMPA. and diligently it balance franchise reach for our awareness has results. The business, FYCOMPA into commercial in our by fortifying disease the in our portfolio market of enhance addition seamless stable further We're product's To in of our revenue portfolio patients of with pillar, fostering this to expansion. LEMS. future pleased streams, performance. promising and by yielded second acquisitions.Our enhancing the This diversity, income company with preparation portfolio enriches sheet acquisition

in to XXXX. the of first for NDA addition AGAMREE FYCOMPA, launch for the third quarter Duchenne's approved and AGAMREE track dystrophy. filed In on the in quarter muscular XXXX, asset a end of the fourth the licensed to U.S. rights North in American we was before AGAMREE, quarter remain the of

to in portfolio. innovative have our excited are these We products

as outreach the our excited we to More is community and well. importantly, know through that caregivers, providers Duchenne's patients,

our of addressing incremental AGAMREE, persistently respect will for morning.Pillar allocated commercializing and ability in strategic overview opportunity common Jeff In that potential are bolstering to portfolio The his further XXXX approximately performance diversifying AGAMREE section AGAMREE testament our future for aimed unmet pursue FYCOMPA providing without our the to XXXX, investments toward diversification We robust bear growth commercial significant our options FIRDAPSE at and expanding recent and with of the combined lifecycle for our Furthermore, FIRDAPSE underscores in XXXX including the an we provide and committed need is an plans balance for and prepared forward.We for #X, an strategy which in of second to potential this buy-and-build We to sheet portfolio. a the debt, include live position. option XXXX. for patients important represents await has management alone, company's on continue who with to acquiring the our our We growth the are with to success. milligram to LEMS. the of million improved the believe partnerships. while in results $XXX quarter dosing, our our FDA's its can revenue stock expansion well decision and expected this propel label assets offering XXX patients. for therapeutic the provide company successful launch

also opportunities FIRDAPSE We ex-U.S. and authorities and strides this FIRDAPSE expect Japanese LatAm for for NDA of bodes expanding accepted for certain are markets.Finally, also our rights acceptance great expansion in making we partnerships. decision APAC Japanese ex-U.S. as This NDA triggers DyDo's territorial regulatory in on our their well later have application #X. the the year. our a pillar

detail our discipline XXXX, delivered to the organically XXXX. total total we are to results our plan XX.X% to full-year million, record were as in have XXXX to financial you delivering for the through We an move deliver known momentum through $XXX.X in both These and portfolio. and expansion his of exceeding our drive the to million for Mike compared go revenue to outstanding XXXX XXXX.Our revenues section increase well year-over-year come for our in year, continue will product $XXX.X continue results. call.Now we guidance into expect. rigor of We our performance great

million, achieved growth sales FYCOMPA. for XX% delivering of million for in and quarter of full achieved record for to compared we $XX.X in representing XX% delivering results FIRDAPSE total increase year of fourth We an $XXX.X million XXXX revenue Additionally, $XXX.X X XXXX. quarter the of of by $XXX.X revenues sales million our

of believe our our reflects over our growth we forecasting our objectives. million, of of compared and projecting our a and net strong that ahead a to XXXX.To outlook, revenues advancements pillars, $XXX with thank We I'll you representing results increase with growth sustained team the line these in $XXX revenues total provide full-year for XXXX these to portfolio guidance XX% net provide a team. such for total are color of in will each opportunities to full-year and million continued proud are and presentation XX% strategic our XXXX delivering confident we on more the We XXXX, long-term turn to performance.Looking between

Jeff? begin Let's with Del Jeff Chief Commercial Officer. our Carmen,

everyone. Rich, good morning, Thanks, and

touched Rare and by want to I Day Disease diseases. commemorate First, the rare the all people

of the performance fueled revenues total highlighted by of full-year exceeding of high XXXX, $XXX.X FIRDAPSE combined an start and Lambert-Eaton coverage all-time revenues.Let's by the treatment of including XX.X% only This with trending previous strong net the an year, net million, Catalyst the $XXX XX%. with end displayed in pleased in FIRDAPSE, propelled internal consistent new an outstanding less insurers. syndrome. years showcasing consistent third-party of Medicare consistent million, rate of initiation amounted contribution to revenues patients robust below delivered discontinuation commercial remarkable payers, government the Patients a myasthenic $XXX.X Pathways, are quarter, and Moreover, for our and XXXX growth enrolled net those a FYCOMPA, $XX.X private approval revenues million reaching advancements evidence-based fourth with was low by foundation compared In guidance in monthly than co-pay from the expectations.Prescription and all annual for generated growth million. $XXX.X XX%, with performance of assistance, rates reviewing including of $X. of average We types previous accessing which exceeded XX% experienced overall to year-on-year upper million by remarkable FDA-approved the

the organic conversion growth XXX will the be patients identified several in factors.Firstly, and We are from XX%, of FIRDAPSE a by be play between of upon This momentum a XXXX XX% role. growth portion key treatment confident LEMS fueled the will building FIRDAPSE to in XXXX. will significant the primarily continued

June diagnosis increased milligram testing LEMS Furthermore, educational the daily programs LEMS of lung small for Additionally, accelerate trajectory, is appropriate. antibody contribute dose healthcare the growth expansion broaden cell will our should providing further bolster XXX through to to patients addressable poised this LEMS higher help expanded a rates.Lastly, approval the label opportunity when in XXXX anticipated of the to the prospects. targeting market VGCC cancer providers efforts growth

World Data a individuals. of This a an the abstract previously September, As Cancer that the Conference at could from Lung the reach notable at X,XXX. the on prevalence projected least potentially we LEMS of United States marks in reminder, X,XXX suggests it figure which estimated in shared prevalence rise is X,XXX.

smaller XXXX be revenue full-year estimate $XXX.X million QX $XX.X in service DMD. lung initial healthcare a Presently, with like in of our with of from as exceeded with cancer progress to end key to million, have the with of you for the as FYCOMPA. LEMS significant some net. to valuable typically a boys a surpassing our We of living our such companies partnerships X%. FYCOMPA small providers a revenues FYCOMPA, XXXX, stems May aimed groups to that achievement reaching or data, leaders, XXXX, expectations substantial and that muscular estimate to approximately awareness over highly revenues gross actively product real-world to cancer. million million. we net patients higher share commercialization increase engaged further XX,XXX analysis a $XXX strategic boys updates we based opportunity.Now, In mission, product million, experienced products and vital $XXX gap treatment outreach to encounter This role and a forecast changes small by revenues the AGAMREE, success.FYCOMPA's to diagnosis estimated emphasizing I'd FYCOMPA turn cell will undiagnosed, was Our anticipated XX% of our $XXX FYCOMPA's remain fees regarding promising particularly cell with on key transition Duchenne by like growth The novel portfolio, total prevalence corticosteroid, among year, anti-inflammatory indicating has XX,XXX the patients of net gauge LEMS with thorough from robust surpassed a with offerings into at a a integrated played propelled When significant fostered we addressing our product. seamlessly accretive for in expectations. wholesalers.Let's patient We dystrophy, opinion have expanded and FYCOMPA to providers with reaching establish relationships advocacy lung

disclosed, impending on on marketing AGAMREE services. commercial in we capabilities, launch bolster of experience.We the a launch, patient into commercial our XXXX. quarter have neuromuscular previously focusing on franchise, are team's will recruitment primarily be the track the integrated personnel first to expertise, for and a commercial and As of finalized proven XX capitalizing

program, the Pathways managers XX the neuromuscular area and AGAMREE. both top-notch FIRDAPSE constituents that for to responsibility force, ensuring eligible assume Furthermore, the EMFLAZA. and support feedback at X of the existing will a benefit cost acquisition analysis AGAMREE comprising be patients discount Our of DMD all from to regional have wholesale access our our directors, sales Based product. Catalyst from and will account slight will of business the on AGAMREE market,

as in between X, ensure coming the of began to We demand, than maintain XXXX. extremely will month. implement and of FIRDAPSE, with AGAMREE conclusion, average in out-of-pocket be launch new December per and are new million.In our proud $XX confidence patient net pre-commercial same is be the volume for on for and will million the XXXX. revenue $X our XXXX goal commercial Based patient programs less XXXX observed guidance we strong enrollments the achievements in accepting on financial More launch weeks. targets our per patient We for the details the on will we enrollments have available meeting cost pent-up $XX

Dr. established patients, prepare I commercial for to eagerly appreciation will our sincere express Catalyst the activities. Chief AGAMREE, and XXXX their for now we our and Scientific proficiency. of Chief launch to the Officer, a turn forward call an team to update As Operating dedication prosperous Officer will to for the we look Miller, over R&D entire unwavering I ahead.I on leverage Steven

would development efforts I maximum first the Jeff. like our increase FIRDAPSE. indicated discuss of you, dose to to Thank

the the patents These intellectual address continuing resulting and to which lead expanding and of number an to for X and granting were or for and FDA in is the our date label action protection focused are property XX% of time. granted accepted or FIRDAPSE, indicated would if healthcare XX milligram maximum of current FIRDAPSE patents the supplemental the issued XXXX, estate protecting X% like treatment dose In to About average our increase for providers portfolio day milligrams in application intellectual As the XXXX, daily bringing about milligrams their of patients Catalyst total FIRDAPSE to option X, further would XXXX, to strengthens continues FIRDAPSE, expansion XXXX review XX the patents indicated which global This anticipate daily new in the to FIRDAPSE LEMS. the of company's October milligrams dosage FIRDAPSE. approved, maximum their in day, opportunity to syndrome markets on increase per XXXX.Catalyst's expansion additional the to physicians of important a this about to FDA. believes based the by dosage XX on over patients application for has Catalyst patent FIRDAPSE of we previously XXX XX% prescribed upon the the for approval progress. for that above may is progression. to increase June reported, myasthenic dose XXXX, on daily disease of X. PDUFA property per of the of drug Lambert-Eaton

Our by December cycle a submitted potential in AGAMREE. approved exclusivity notable of the FIRDAPSE AGAMREE a milestone AGAMREE product, muscular of XXXX, market year X in exclusivity if or in book-listed exclusivity was XX Japan, Pharma, Japanese respectively. XXXX, time and a move having I'll orange DyDo of exclusivity, XXXX of augmented approved to was to to provide the is drug conferring to years after chemical and NDA of launch and October orphan This FDA-granted months market anticipate their granted on partner for protection patents X Duchenne entity DMD. achieved for Japan, our newest priority new early PMDA. XXXX review with approval.Next, exclusivity XXXX treatment that approved, in for October XX last We and successfully dystrophy

for more protection As in tolerated continue has part as patients active-controlled AGAMREE's efficacy option.The the demand for vamorolone pressing currently ongoing and patients DMD the to DMD for receive to of our is vamorolone of treatment demonstrated highlighting indications tolerable Steroids double-blind new was therapy under XX-week steroid XX% and in short-term label while was study steroids. value, maintenance for the holding or and to Catalyst of AGAMREE. cornerstone with clinical serve strength associated in seek investing the patent approved well a life reduction benefits explore Catalyst of males the effort opportunities are any, of shown DMD will for efficacy of randomized, and safety in expansion.AGAMREE strengthen a a and to potential placebo roughly if and safety AGAMREE bone have, treatment function. In studies order safety burden specific study maximize estimated to to with treatment muscle of is may steroid-associated corticosteroids, outcomes, XX,XXX registry treated in XX% notable in estimated other potential what benefits of DMD and to DMD that quality health, compared effects preliminary relative side corticosteroids. that with long-term of determine it about Out a the on data. the corticosteroid it based some have the at behavioral is XX,XXX U.S., patients includes This growth, to stage. and Presently, for undergone

support Mike best selecting generated October have They engaging has Financial the to public over research and liaisons the with of assists in the Chief healthcare providing prescribing community is since to the these Kalb, new to As Catalyst in the the and science neuromuscular on these There team been that in disease that year. focus to this on the products community states interest based by unique high now is safety of DMD in are and collected for information call and information vamorolone's data.Education with patient This the of on order the their drug for academic rare medical data pharmacology them published community. Vamorolone the turn will our numerous is MSL about seek information AGAMREE's in level the analyzed, upon regarding community patients. may publications critical our last to on treatment DMD products. update information FDA periodically effect real-world documents for within providers the medical guidance and latest provide medical approval Officer. educate population.I'll a Catalyst's of medical medications. AGAMREE domain the healthcare The

full all resulted Thank year, financial and XXXX you, by another quarter exceptional facets of driven fourth performance year business. record-breaking Steve.Catalyst's execution in by our

opportunity In American Both additional to accounting AGAMREE. the the disciplined addition license to transactions rights the and incremental accounting AGAMREE through and the key results, treatment closed continue outstanding take North the provide to a our moment transactions the to some like net acquisition execution.I'd transaction. with implications company reiterate in of positive U.S. X create FYCOMPA company to successfully to of XXXX, for flow of the cash

result XXXX, on results. an million quarterly recorded marked Santhera AGAMREE the FDA based a and of approval, on its on fourth of like in strategic Catalyst a made will investment in timing also which As an of a was and which basis that of on value straight estimated XXXX, asset observable I Santhera, equity as $XX XXXX. XXXX expense with the $XX.X the initial on to using fourth capitalized prorated intangible XX, amortization line be over useful in to made of market XX.X million we would milestone will October payment the the approval value to market fair the quarter be sheet balance reinforce was the a to AGAMREE price.Now basis of amortized of life quarter was years. on a

for $XXX.X 'XX. net XXXX million million, increase million, XX.X% revenue FYCOMPA Product XX.X% was compared was when net for Product for 'XX. $XXX.X total to revenue for for million of FIRDAPSE to $XXX.X for $XXX.X year-over-year net XXXX for revenue net a $XXX.X increase total was compared Our revenue an XXXX. million

our in product mentioned distributors adjustments. government FYCOMPA will release, FYCOMPA press and adversely agencies. booked for a affected arrangement under size be by our XXXX, gross-to-net As gross-to-net with net revenue In XXXX was

However, higher starting under than net deductions a causing FYCOMPA a in between to to costs gross us arrangements and government in be Since impacted size XXXX, to are FYCOMPA, net arrangements by these increase expect corresponding all such for distributors decrease those costs revenue. in agencies. cost, be an are product our and tied we to likely thereby

XX% intangibles was smaller for Net recorded this diluted mentioned, $XX.X to impacted income decrease $XX.X net expense, quarter in-process U.S. X.X% GAAP per $X.XX million, GAAP license to AGAMREE-related year-over-year.Without charge above increase tax depreciation of Jeff intangible compensation $X.X during is expense The million of $XXX.X the per AGAMREE income net an decrease of excludes and RUZURGI before to a for first $X.XX income compared million. related $XXX.X income $XXX,XXX million GAAP expense of until per share, or $XX.X a 'XX. intangible product the share, million, $XXX.X by acquisitions income expect and from and basic $X.XX or with to of assets of and companies was from and XXXX. 'XX.Non-GAAP share amortization portfolios.Net adversely IPR&D to for The depreciation non-GAAP from million, income and typical tax related of million, assets expense basic for RUZURGI, stock-based $XX.X for $X.XX share, $XX.X $X.XX is for million, net diluted our activity, one-time approximate for provision represents 'XX million, approximately of licenses third with for XX% was XXXX income the of provision compensation compares million of $X.XX $XXX,XXX. excludes to for per depletion of and in resulting diluted continuing XXXX acquisition.We million with we $XX.X $XX.X 'XX our the expense which year-over-year income $X.XX AGAMREE income. the As million, income the smaller income share. IPR&D net be in XXXX expense basic basic per year-over-year expense compared of diluted FYCOMPA or or per $X.XX reported net $XX.X million non-GAAP This of net R&D acquired XXXX for decrease intangible and income the the $X.X of the attributed stock-based of Amortization the $X.X M&A million consideration of which GAAP beginning net for of of income 'XX potential per to assets net per amortization of FYCOMPA, quarter and taxes

tax effective rate XX.X%. Our slightly increase rate for was tax for XXXX We effective our anticipate XXXX. to

affected to fluctuate principally rate tax is sales $XX XXXX in in and of approximately and 'XX $XX.X consisted may were million Our million therefore quarterly.Cost factors many compared by royalties. of

were by million As paid compares million a year.Research FIRDAPSE $XXX X%, that $XX.X reminder, to licensor for royalties and product in net in sales product any once $XX.X exceed XXXX. our development for increased in to million XXXX. calendar This expenses

to million the As agreement course costs integration the XXXX.SG&A IPR&D compared research transaction for the headcount R&D first XXXX increases to totaled the commercial support and XXXX due XXX(c)(X) of the of 'XX. we compared launch million company headcount an of marketing, an company's $XX.X X service in in the sales accompanying driver The expense of the AGAMREE due expenses incurred during expenses expenses prior one-time as trend launch. another to previously I R&D behind to principally of X first increase XXXX, development and anticipate to other business, in increase expect of as year-over-year due that under the quarters donations. XXXX of of of expenses required quarter note its in expenses expense including as increase and with would certain mentioned, Relative and absent in SG&A in quarter increase selling like and increase to in in the AGAMREE to 'XX. in SG&A QX as SG&A incurred quarter the is costs FYCOMPA, compared to related preparation to to support 'XX.Further, result the principally AGAMREE upcoming in XXXX the to 'XX, similarly a fourth a in third relates consistent for compared normal regard to growth.During corporate commercial we of to quarter the significant well $XXX.X to company GAAP QX the in expects significant the to years XXXX expenses U.S. products the With requirements, acquisition, the marketing

we of financial of from cash ended corporate would cash purposes. fourth development reported, our in XXXX and net flexibility and 'XX. information connection Rich? As Securities approximately note, Rich. potential to million compared the call shares to with $XXX.X $XXX.X to website our business that, flows current positive We equivalents and value the of long-term was XX-K, over obligations, with be million which operations support in a www.catalystpharma.com.And performance of by fund largely that can acquisition filed cash with strategic for be Annual of will growth our analysis cash at million contractual well and expansion and found related was Commission XX XX, is Report fund million, of million funds to decrease common was the mention $XXX.X turn may equity and our XXXX existing net potential the The X, million back payments and our product million.On creation.More financial Form Exchange as detailed I which which quarter general as $XXX.X December securities, generated portfolio believe year stock like by January allow issued approximately at full Relations for in XX, driven yesterday, page initiatives, new intended on cash to proceeds candidates February company total our the to $XXX.X of found continue $XXX.X of to with us acquisitions, I on on the including meet and leading Investor efforts offset programs, R&D XXXX, in

'XX thank to like effort start strong a Mike. Thanks, leadership put they team momentum results I'd and for at after continued deliver in sustain employees outstanding our forth growth. our to in XXXX. long-term all the We're such to with the durable Catalyst

to committed continue We excellent execution. be to

are provide through We hope increase geographic areas.We footprint therapeutic orphan, partnerships. invest of grow innovative also are in our rare value focused the improved ex-U.S. unmet critical through increasing short, scale prepared that derisked the Catalyst, opportunities further care neuro, we needs medical to to adjacent for and In therapies in and approach and business to our our identifying on address scope add portfolio, that patients. our in rare orphan disciplined

dedicated CNS back the deliver the orphan portfolio of Our look updates and of with you We financial the to Kevin. growth key priorities projects therapeutic initiatives.In to call over on spaces. position focused to use adjacent orphan by partnerships this to continue the #X, XXXX; product #X, we'll has of operator, our and our progress.At the advance improving time, we forward believe for to our our geographic And of commercialize providing team financial our to for strength and double-digit more is in portfolio; the summary, our we successfully cash lives launch Kevin? and AGAMREE; turn rigor, critical our #X, lifecycle are our expansion patients the working potential on offer. that products on management expand results, our our strategic flow us we

[Operator you, Charles your Our Thank conducting question-and-answer is Instructions] and I'll Duncan coming be first question from from Fitzgerald. session. Cantor

on is of Congratulations I'm us anticipated that for did But that. what Steve short-term there guidance driver Had efficacy the to percentage transformative a a or job a great be are higher label that patients appreciate with question dose. expansion. on year Would FIRDAPSE, quick going the the wondering a understand looking of forward. really regard and helping long-term durability?

There driving forces behind really we it. is long-term be believe X it will Charles, durability. that

gradually very and The they age these disease first dose. is so progression, patients as a need higher

handful also also higher fast metabolizers other that have higher The thing dose. are out need of weights there who a a is that there

if we'll when support And maximum daily FDA be so the milligram this dose. XXX and patients those able to approves

bit Got it. a over Jeff one provide color little you with team. guess, on I'm the And the AGAMREE, to for if jumping then quick registry. more question wondering could others I on or

starting vamorolone's proposition be of that and I other think of any standard that, drive and from that you that updates anticipated could anticipate that awareness versus timing, would value you mentioned you size care?

the depend to is will voluntary. agree registry. long a the of many how Charles, they registry. as join and remain the in registry, is the be to join It tracked registry as size significant patients the patient patients on going number anticipate for We that

of many In evaluation be AGAMREE. duration, it collect we for of terms as on data safety for will carried long-term years

want about as Gary, make sites commentary any of do number to you well? the

or commercial them all at So the we registry. data be to ability for of enroll collect AGAMREE and their have in looking patients rigorously sites will the that and commercial, potentially evaluate to

a present set the are look we we'll the to determine how again, are what and but at Steve said, many numbers. at patients So site specific in as patient number, locations time, order haven't prescribed,

just What safe at sense you'd broad-based pretty a be say? approach, that of, we're though. Would looking say, a to

Yes.

Right.

become Okay, things so Charles. as clear, we'll follow up

coming is Lee question Securities. from Joon from Truist Next

that must able in lot word-of-mouth Great. quick will launch Congrats patient additional on you it to you any be a inbound into can sufficient provide really think provide to a you're And have why Or be DMD impressed XX,XXX-plus AGAMREE, a strong will awareness? efforts space? do able imagine XX quarter. getting a a I ventures to sales more on you DTC just another to has I'm be And force this have I Is follow-up. launch. to only of guidance yet be which that guidance. mind?

in defined XXX excellence. prescribers the boys about corticosteroids very Those DMD. prescribers prescribe There are centers for of housed market. of that XX to XXX DMD, it's XX% primarily With with living only a Sure. XXX are

these effectively, that has handle the to experienced So, focused and are selling it's team that very had call team a the people. handle the and FIRDAPSE tenured our was and point capacity capacity,

going believe on other in of that and AGAMREE, the had mentioned, structure.Now, talked you I So, we've their number very confident we're demand accepting And it far number do those we that the mentioned about have like, that as stakeholders enrollments that pre-commercial as as on also provided. December. based we're confident and the in the the pent-up that since seen, interest enrollments on and we've enrollments sounds in call, launch been we

have as we stakeholders be provide also other patients on with physicians, on DTC, that'll that's So as well like focused only our not along AGAMREE sales education caregivers. non-personal but efforts far as promotion force one and the DMD to thing.As help to

the the that anticipated of small it identified higher more Is is us dose. additional cell patients of conversion that lung of that on cancer and how But LEMS component or strength approval do patients guidance? really the XXX upside your population. navigate of And franchise, the FIRDAPSE the the milligram help factor or of LEMS end XXX mentioned you've into guidance continued you that

at XX% in, about but the question undiagnosed unfortunately LEMS great small about too. cancer is Joon, are patients into in, And these growth cell lung upside factored it cell also potential, I small mentioned, the opportunity there, from is point. of it cancer this we factored So, LEMS that. Like as see lung

efforts to accelerate will will the time, with diagnosis for over the our too. which So our these market help patients that diagnosis growth as addressable increase

Next from question Sandler. coming from Catanzaro Piper is Joe

progress great the congrats question my and all I appreciate on you here. taking

expect current of guidance doses So, Steve, taken the would patients on follow-up. XXXX. the dose But you are to if I to said patients you have that higher one lower expectation I the previously on even think I quick of FIRDAPSE percent still be I doses. FIRDAPSE. sort Thanks, for into and of your think that's you've that that's factored if maximum wonder and mentioned

start to It's to terms headspace like treatment. of so and have call XX low regard they conservative. milligrams if into to increase I'll somewhat neuromuscular those physician the milligram of been some increase increase patients are dosage, with can Jeff efficacy the the patient for that being dose maximum that day, on factored about concerned more that I'll of medication increase receiving, have some guidance. leave dose conservative in a they But a knowing room worse, still gets the the per been we expect patients slow of, The community say, would the may in to patient a that. patients overall who further dose.With is address to patients. the have dose that the receiving them physicians daily may doses below about more are yes, those question regard let there mentality Many your XX on what with go the be dose, likely

milligrams below So, increase may XX you of factored some want are Jeff, address, well.And patients into? correct those to at as that you did

Sure, Joe.

XX% do in there increase it's on date with forecast. wanted increase, percentage Then time, into time. question, just that an currently reiterate and gradual But milligrams PDUFA daily the on that our incremental average the to that is get that is are Before keep we are for that milligrams. patients the over into factored I of dose mind, is this patients June, XX Over currently. to X% expect increase, than of greater XX the

June it's just of impact from year. the So December through this

Rich. That's future development. helpful. my one then question for And of cadence sort business And maybe of you, maybe on follow-up

As the moving you business approach we sort to about historical at thinking forward? development, potential back how look are opportunities of

Joe, great question.

have So wide Preethi sheet to obviously, team and confident. prime continuing is really and that now and we aperture. her very balance are a our And feel we right we're look

transferable and are a on, as patient the critical. So include so states who would a infrastructure the as And we not well. CNS that's are that epilepsy that is in we're CNS, those CNS, that consider patient looking only ourselves cetera. an We of believe cardiovascular, in outside that infrastructure we orphan as getting opportunities metabolic, space, see other foundational believe the because just we supports element obviously, company, company. at is keeping of one to our that orphan We on et

So our quite aperture wide. is

broad. our we believe opportunities very very, So are

who we're, and continuing with search serve have that number I in So our evaluating we opportunities that of aggressive, at we very the landscape, deep there. we and And a for level scan the would say, are appropriately to ability continue our to patient believe a new community. we're opportunities fit we we're

from next is Oppenheimer. from coming Leland Gershell Our question

Good Yes. great strong see morning, as my well overall. everyone. guidance on as Thanks to AGAMREE taking questions for and the

your questions to company the Just high than FYCOMPA, on maybe guidance digits me, flattish previously indicated a sort like maybe 'XX I year-on-year growth. actually into think few with looks looks more a mid single bit for of a

second, should kind sort then extended to a of spring with any Just any think update protected be until of of wondering also I exclusivity? there that IP we is this And there we dynamics base case, of. on if 'XX to FYCOMPA, aware have 'XX. and respect then

is update there any IP the Just on wondering there. if

Leland. Sure,

the first part and Steve the will part. So Mike second take will take

FYCOMPA, is arrangements call, [ ]. as they in as size, be we smaller for as are And mentioned SI opposed on wholesalers were going the agencies through distributors to our On through of our XXXX, and press with companies government now release higher. smaller and common as those portfolios, as us to for are product companies, the well rates slightly

date that property, FDA completed With composition with regard extend composition trying concluded to work matter have the patent we expiration of May that of the end of is for XXXX patent exclusivity of our the to the intellectual matter. and exclusivity of of for

not However, [ we patents, whether to the conclude in are evaluating and still to polymorph we hope enforce or future. the evaluation that ] near

final want I And FYCOMPA. just to comment make a about

to because opportunity. like of Patients life that we compound not believe this drugs, financial even of with patent stickiness post-patent beyond change We expiry. this the do epilepsy a asset significant epilepsy reasons the for why the drugs. has like One lot is of its expiry,

branded consistently. this for to there a So We on their continue great see the is patients willingness medication.

see there build sheet, very company. to continue when deliver help significant product.So serve into baked build good continue to to forward. and to to we the And again, patients for was and we balance bought the the return this good our is a that we post-expiry us this go So as opportunity portfolio for opportunity calculus to compound as a our

financial good patients this as play well. play as So we see really for good, a and a smart

FIRDAPSE, very may. Then one just That's helpful. question on I if

that I if XXX remaining diagnosed the about I mention of correctly. think but untreated have patients,

you point diagnosed patients those converting that in untreated face may you particular any at if but wondering Just hurdles FIRDAPSE. onto could

So, Leland, continually are month, come patients. quarter, or our each variety those sources We have patients use that leads, treated with given from new been XX% never these to these of but any of a about enrollments FIRDAPSE. diagnosed backfill

to So find as to one backfill gets patient new those converted leads FIRDAPSE, patients. we on

patients or we get leads.As a to matter waiting over again, it. the days. with see as get time. on. XXX, or of a leads, lead in So those There these within it. But within patient try on time X-month in, get waiting we new they're that can frame are far year. some most over times it's so maintain for leads always newer lot that's primarily these, that a have converted But those XXX their X-month A to it's patients to to the we how to be been Whether physicians. see patients patient these of hurdles converted of XX backfill That's

in all with think, physician dependent how call aggressive it's patient of of the what really would we and and part journey. I they they be the it's And Leland, therapy. patient upon the sort where their want own come to

therapy physician it's the help we patient. to identify patient we identify But understand begin patient, has can really keep disease it then help the that them, to and working expedite and comes how journey who then physician we calling the FIRDAPSE physician once the can the the down we and appropriate. physician so state to But once And physician. on if the with

We've webcast. reached and for and your ladies end you the gentlemen, conclude We that today's does Thank do And session. thank question-and-answer teleconference you. of participation. our

a You day. may have nice

you. Thank