Catalyst Pharmaceuticals (CPRX) 17 Mar 222021 Q4 Earnings call transcript

Greetings, and welcome to the Catalyst Pharmaceuticals Fourth Quarter and Full Year 2021 Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions].

As a reminder, this conference is being recorded. to Chief conference Pharmaceuticals. Financial like host, to now Grande, Ali Officer would turn over the your I for Catalyst you. Thank

You may begin.

call Patrick results and Good joining highlights. Leading quarter thank and today, corporate and full to we Chief call conference Officer. have and financial morning fourth Chairman discuss XXXX you year the Catalyst's McEnany, everyone our for Executive

Scientific Chief Mr. also Miller, Chief Chief joined Commercial and Carmen, Del by Steven Officer; are Jeffrey We Officer and Officer. Operating

we'll Dr. Gary session, Medical also Regulatory Officer. Chief Q&A and the For have Ingenito,

prove expectations, performance. projections, of Before you future we difficult of we comments not guarantees the to be begin, will involve are They I to estimates and assumptions These federal would for which predict session, results our securities that laws. that future and and like remind statements Q&A risk These not contained uncertainties expected statements risks, following forward-looking. in forward-looking the and COVID-XX. Report relate about may may make are statements the purposes and our I'll current in in in conjunction to information the to only detailed be expectations contained in vary of especially over results considered may Actual turn with including in be factors statements this the our from should Annual accurate, forward-looking SEC our call XXXX the on described At filings, Pat. XX-K. to Form in effects time, of light the

pursue as diversify continued the to to a plans growth extraordinary budget. operate Catalyst us we for full opportunities development date XXXX update commercial milestones execute year Ali. significant was call. and in financial Good and and year foundation quarter and achieved have as substantial Thanks, Catalyst's we financial creating fourth for for sustain everyone several you business our and we To portfolio. an strong today morning plan attained to XXXX, our and our thank results joining XXXX performance, diligently

increase fourth the continued XXXX. we during performance, quarter product despite quarter FIRDAPSE to in yet back $XX FIRDAPSE performance net of commercial conditions. our the by with revenues the was achieved revenue where pre-pandemic of of start optimal getting driven strong Let's versus XX% fourth XXXX, quarter a fourth not Growth million,

revenues share. of Our year income representing million, $XXX XXXX compared million, $XX.X total in increase XXXX for Net income increase were total an was $XXX taxes full compared to XX% cash revenues GAAP QX million for before to a $X.X million XXXX, XXXX. investments. million or reported XX% year-over-year for XXXX QX ended $XXX million with We in $X diluted year for of QX net of $X.XX of We XXXX. the and basic income short-term per and

our shares We to of open market. common judiciously continue from the repurchase stock

an XXXX, of purchase at we million. repurchased of a price During $XX.X shares average for price X.X total share per $X.XX million

XXX full total increase guided revenues have XX% XXXX. We between be revenues compared and year to total in XXX a million million, representing XXXX to to XX%

provide during our We million be details report. also the $XX OpEx anticipate cash with full between and more financial $XX will year. Ali her million to you for

U.S. the Courts the of for with for treatment syndrome. guidance XXXX FIRDAPSE reaffirming myasthenic the the from patients drug assumptions outcome Lambert-Eaton reflect orphan Our positive exclusivity adult

patients, District As of treatment in orphan last approval Ruzurgi ruled FIRDAPSE. the violated we for for pediatric U.S. Court exclusivity month, the of reported the drug LEMS U.S. U.S.

patients. estimated now has where enabling been previously of approximately the reaffirmation milestone, significant approval FIRDAPSE X,XXX exclusivity is of result, been XX% LEMS for The FDA. market by for physicians to U.S. advance FIRDAPSE granted has the by a As XXX unique already Ruzurgi prescribed community, the treatment to rescinded pediatric us LEMS patients the within a

be the of enrollment and this positions seen by for in about LEMS with been for to patients Health decision. applicability additional has KYE with transition Pharmaceuticals XXX a estimate aligns and to FIRDAPSE Ruzurgi transition with access the Ruzurgi a Federal FIRDAPSE on FIRDAPSE removed We innovative case, Canada approach already announced that represents pivotal growth, Importantly, a as established thanks number of to to majority Ruzurgi drug. in enforce the victory to In a patients our as access to for many we remanded patients LEMS of patients to of FIRDAPSE. which Minister is data to patients in market from whom the adult point are those transition the the assist to programs, during this patients, week did for new the agreed we've outcome judge's matter patient the patients require of our approval Canada's proceeding judge an our the Health quarter, recently our Similarly, significant that those comply Health redetermination, there of the revenue Canada them. lawsuit of the of seamlessly, Ruzurgi Ruzurgi and on consistent patient-first data to which to last all Catalyst provisions Canada year. Catalyst Court seeking protection with protection FIRDAPSE and forecast treatment. The and not Pathways are for on

specialty case to significant other suit this is disease XXXX advised with and is community product discovery entered keep in to significant We growth momentum serve. sustained pending we with the on focus against progresses. continue Jacobus you pharmacy as we'll well patent rare and for our a as Ruzurgi. continued Our as PANTHERx, suit and now sole litigation Jacobus' This

expanded paraneoplastic an patients, of cancer, LEMS provides our have awareness out oncologists for with have patients Extending on patients form small some to thoracic lung typically both to of potential reaching LEMS We cell approximately XX% to new important efforts enhanced and as drive most patients. cancer. an education providers and focus

diagnosed as LEMS also on yet well process in see LEMS We as growth newly patients diagnosis. the are to for who with expect FIRDAPSE continued acceleration not definitive

commercial to patients with suffering patents. the for issuance the three this recent We have all patient portfolio amifampridine and U.S. has with new until This the provides cover us FIRDAPSE, patent further types directed metabolizer in believe of also milestone and LEMS which patents strengthening intellectual within made property population. our treatment lasting are durability from important advances U.S. property of intellectual our for These protection XXXX. fortifies FIRDAPSE, we LEMS estate

will to in newly All patents Orange the total issued be Book FDA's number next will of the listed which listed bring these within weeks, of the patents few five.

and initiated the and partner our DyDo provide study We're will the registration Currently, We further FIRDAPSE small details efficacy treatment X LEMS Phase marked will also to an initiatives meaningful the execute option Pharma. new protect our those Steve for call. evaluate continue DyDo with In are provide in approved Japan December durability treatments FIRDAPSE. expanding for living to for to disease. towards in with we sub-licensee made to key later this more global by therapy footprint. this trial Japan of pleased a strengthen of this safety our and believe can no there being milestone progress long-term of in a the LEMS. XXXX, FIRDAPSE Initiation important

Assuming be in the to that successful, market trial upon was for we expect market. exclusivity years granted FIRDAPSE approval XX

our strategic with are without remains treat and expand currently diseases, priority to approved a pipeline to goal any therapy, differentiated which products this Our portfolio for rare year.

and potential in to process robust considerable enhanced a assets identifying in and pursue place have made this progress have We front. on

our projects this due remain are encouraged these on to in currently in in actively are and engaged Our we review. We confident diligence about advance year. ability extensive teams initiatives

ceremony with the As leading recently approved ongoing partners patient of February the we part patients amplify global We disease rare coming therapies, support bell help allowing in NASDAQ in the XX disease Disease to awareness of Rare of honor on raise to and up with show teamed us participating partners our for community. effort the and groups for opening thank voices rare Day our advocacy and all of need to XXXX. our for our in together

and was Catalyst a be published Small the than result America's out are as the saying of excited X,XXX to ranking as Best value It recognized Forbes honor screened. XXXX Best country's of ahead we is about list, of Companies as are As path Small the an by well Companies more named By on one many we that, Forbes of XX creating. companies acknowledgement us. accomplishments, the

execute near success. well optimistic positioned priorities our build We're future. growth. to believe substantial across upon and that long-term to all the we're continue about We drive to We

turn will on highlights over further call to commercial provide our Carmen, will who I Officer Jeff the Now Commercial Del our execution. Chief

Pat, The course and morning, the Catalyst well Thanks, everyone. good commercial performed over team of extremely XXXX.

discontinuations XX% of year-over-year. growth growth We net XXXX, a XXXX, versus the are our to net to a for were by to high XX.X is with In the true the take to a XXX XXXX. in and lowest and foundation QX our discontinuations while X%, commitment access, maintaining less of starts, excellence lower only Operational than XXXX FIRDAPSE XX% fewer continued The greater while XX% the launch to very million, million, pandemic. execution full entire the in business a year-over-year, testament XXXX, the LEMS since were year-over-year. XX% the QX presented FIRDAPSE XXXX continued Naive QX pleased want be representing resurgence favorable discontinuations. of sales continues sales new this despite agile, thank enrollments X% rate remain were compliance year maintained which QX to opportunity drove patient team were of I new solid. discontinuation community. flawless their Catalyst challenges commercial ability FIRDAPSE's in

market FIRDAPSE LEMS is growth already from LEMS We XX% patient XXXX not unfortunately adult patients penetration of total enrollments Organically, of or beyond. as adult well as number current new approximately will on LEMS The patients population. yet of who expect in misdiagnosed are FIRDAPSE undiagnosed. growth significant the the be driven considerable and diagnosed

small thus patients we proper and our FIRDAPSE accelerate a educational LEMS treatment LEMS expect the we upon QX yield patients to treaters promotion indicators of therapy XXXX. in that will and other of more pace on entire QX the growth discontinuation in patient discontinuation lung for rate are are opportunity cell the receive to adult tracking X%. about show for far Reimbursed disease. non-personal on Early cancer exceed the of to this in QX diagnosis Additionally, rates match with is to XXXX. momentum also year building efforts

We encourage to Genes, need populations. part for Foundation as MG, market advocacy drugs rare Gravis of collaboration and to collaborate that research Myasthenia Dystrophy call industry Association, continue Association bring Muscular and treatments the small and advocacy patient the to Global effort to as such Gravis to NORD, the with affect new to and orphan attention America, diseases of development ongoing of groups biopharma Conquer for patient groups Myasthenia

In FIRDAPSE at ringing Day, Rare LEMS has and Podcast to bell Association opening societies to American the Neuromuscular community. LEMS Neurology about in Disease Electrodiagnostic awareness connections professional & of Aware respective of the increase members addition launched Catalyst of we the and their celebrate and at to like to Academy NASDAQ a key with their partner American Medicine conferences. LEMs educate the Furthermore,

covered groups. government Catalyst or private Our of Foundation rates and than by per those Catalyst as and a LEMS patients types Medicare team Pathways such are numerous to patient adult of patients Catalyst caregivers accessing supporting Patients with approval an across Catalyst services resources, Pathways to have XXXX, of remain job patient including healthcare over costs. commercial average Pathways, professionals. in Prescription services advocacy support tremendous insurers. less patient co-pay needs has team help pocket payers, out Assistance, financial in programs month. of their Pathways assistance XX% did also enrolled the and connects community $X patients, all who

from we effectively the resurging. crucial optimistic of and for compassionately All are In FIRDAPSE. patients closing, potential very transition about we as growth these are resources

passionate Officer to serving an update We to our Steven and Ruzurgi enrollments call continue access the commercial Chief the on activities. LEMS now of ensuring precise over through for Dr. execution to turn committed is R&D Miller, all Chief generate Officer Scientific and about transition patient community Catalyst LEMS patients. I'll patients. will Operating and new is seamless the for

the Jeff. FIRDAPSE to on to to of now provide franchise all are commercial on we efforts. for continues improvements needs important Thanks work an our development the patients. address the update, on making Catalyst I'll clinical progress update product and

XX, over valuable make obtained as licensed CME credited a Medical and healthcare awareness in X,XXX through about Affairs to workers is mostly February increasing programs, of healthcare Medscape. credit. through Medical provider our LEMS available the Medical progress of provider have and course or CME, Our have continues Affairs date, healthcare providers Department LEMS To viewed X,XXX course Education, Continuing

for educational a provide course, all use along one commitment the we and all now provided a method also supplementary a data, FDA as package will of year. CME live educating the support resources to have oncologists therapeutic this committed resource this gaining In it physician this the patients patients, all with for our filing treatment doctors finally is are board LEMS. several may to LEMS necessary posting this been publications. oncologists a option. program alignment have FIRDAPSE a CME We treatment CME our to complete submission with supplement nonbiased for to be education we physicians provided has grant in that enduring to LEMS high to LEMS safety all quarter. host to of Catalyst in data recorded completing particular efforts knowledge for be primarily courses pediatric LEMS Catalyst-sponsored updates of an intended for session a for for able And at as this FIRDAPSE. with preparation approved We an This database ads The to make expand LEMS supplement expand oncologists with provide Physician adult including of live available expansion. treatment about programs. CME program clinical NDA provide and remain and of priority Catalyst tumor the so for oncology our neurology will in for to submission support very a advancing their anticipate we all successful required with courses label that opportunity education areas.

that Office. progress recently now pleased been to on covering they new the types estate significant U.S. FIRDAPSE. I'm issued made to patient an have additional We have of market intellectual the had exclusivity three Trademark and report by Patent extend and developing been metabolizer property patents amifampridine allowed, the announced We

the protecting amifampridine these combined of issued relevant the all previously One three our number patents in five. ago, X, the and claimed patents, franchise LEMS of population. issued days within The the issued new issued FIRDAPSE March were metabolizer treatment patents the was two the on claims other patents, to total types two patents with bringing of patient

the new of the Book be three will the the patents to bringing is FTD's Orange in end last listed the number in five total and already listed of of patents. two listed One the by Book the FDA's quarter, Orange patents

issuance This reminder, their provides the the listed franchise FIRDAPSE important Book for shortly metabolizer two the regardless after a in were Orange respectively. the our and portfolio an now broad in first As of type. NATX milestone is XXXX protection patent patents as XXXX, comprehensive

front key U.S. are durability has on initiatives We are making pleased with patents the exclusivity will protect the we mid-XXXX. progress continue we and the to in our to property of the strengthen execute intellectual and for currently long-term FIRDAPSE protection which

the In market. July exclusivity XX we of in upon in addition currently FIRDAPSE FIRDAPSE expect in has data be that to exclusivity Japan, market U.S., years granted XXXX. of And Canada will until approval

and reported, progressing previously our Catalyst were developing As of long-acting efforts been FIRDAPSE development a well. has version

transitioning Over to long-acting be dosing more determined regimen several that a to the evaluation for past due and accommodate would anticipated of would or also conducted was In to patients wide we amifampridine in-depth doing between metabolism doctors course the of so, be formulations. formulation the the in and the in new characteristics variability an much Transferase, how used quarters, drug X doctors NATX and patients. manage than two release the to by it type of N-Acetyl patients the great and process by involved differences due

to and commitment patient In with further care the we risk would would formulation approved what compared the could formulation. delivery most path differ patients best differences of version a dosing FIRDAPSE. how treatment alignment patient-first Therefore, available treatment currently that providers, approach complexities FIRDAPSE version and titrate determined even the and long-acting not only the FIRDAPSE to to errors. and current we be our to best believe the medication and of to is suspend FIRDAPSE such our to could titration adding for to substantially was achieving options for using development optimum decided have beneficial and and of for treat patients new it the healthcare do for on dosing Additionally, of from LA be lead

such We in the best patients. to open is development will further interest whenever continue the to future development in opportunities be of

initiative. I like global an to Now, expansion our update on would provide ongoing

development As we myasthenic and activities, to made Pharmaceuticals potential Agency a in for Medical Japan. Currently, therapy FIRDAPSE in Devices obtain has including DyDo of parameters the we this Japanese need. novel commercialization partnered the the to no are be for unmet regulatory requirements in initiating syndrome with in important development with and and June, LEMS announced address Lambert-Eaton clinical treatment approval. Japan has strides previously study Pharma approved of for there to we FIRDAPSE believe therapies and the to great confirm the DyDo consulting

clinical of clinical support As Catalyst this clinical as collaborating with its the be last in clinical the study result Phase the to of in scale authorities. DyDo Japanese documentation execution anticipates to trial required well supplying their required DyDo year regulatory trial. for continues efforts, DyDo a small trial X efforts by and of the the obtain initiated a December to in materials as

will FIRDAPSE key market the our and the expand exclusivity geographically. to on We initiatives continue enhance to FIRDAPSE of market execute

During treatments portfolio objectives we expand advanced our of this disease quarter, our beyond to FIRDAPSE. also rare

products development continue other and/or research we both actively mentioned, our to of offerings or Catalyst Pat pipeline. product and evaluate transactions expand kinds As new to

vigorously prospects programs and where resources and our engaging the Our for teams, we in our team, actively growth. look product drive including as to expertise, utilize development can we the knowhow are and process expand worthwhile

rare now of identifying with remain are path our Grande, the Ali advancing our opportunities very are we to our financial maximize enabling our to to Chief we our pleased process an expand treatments. the initiatives and call We and to identify and over will have to making disease right Officer the to progress ability and our enthusiastic portfolio We in confident committed Financial resources. as capabilities to review efficient I approach the turn remain a results. very about improved assessing ahead opportunities,

Steve. you, Thank

We are very quarter the and full pleased fourth with our XXXX. year financial results for

As debt. to million and and We believe earlier strategic slightly reported, technologies, by and the investments cash XXX programs initiatives stage this us of more and our than support innovative future our to R&D growth the we with funded year and acquiring existing advance opportunities to creation. no flexibility leading allows ended value financial

when of FIRDAPSE were total increase million net revenue XXXX. income COVID-XX, total product revenues over per compared Our million, Net increase was total share. despite million of net for XX almost for XX for XXXX XXX of XXX for million, net XX% income product challenges per income an the Further, for XXXX, for XX income XX% taxes XXX revenue of continued or million to net revenues $X.XX million, net and a $X.XX XXXX XXXX. for basic We an of over before taxes before XXX reported income XXXX increase the GAAP XX% was XXXX million. diluted

third million of reversal year For is tax $X.XX not from XX benefit, diluted the we the the income one-time comparative. million million, basic valuation reporting tax of are a non-cash per GAAP allowance XX benefited XX of It in almost remember reported XXXX, approximately of important share. quarter principally XXXX and of these the figures our or that net $X.XX XXXX. assets to income of from deferred upon for

normalized related represents to in operations the these [ph] one-time losses the from In of XX net diluted per of for in of income and tax certain share, release of our which excludes drug provide useful from million, stock-based XXXX X to of income GAAP subject depreciation excludes million, $X.XX future net although Because from we XXXX or net XXXX. provision XX net more This and depreciation our GAAP losses $X.XX expect compensation income million was XXX,XXX, valuation tax Florida expense the The diluted an X and and orphan net the non-GAAP compares tax million. a the $X.XX of income which our of a XX assets as XX basic tax an rate. tax of for are of state an by per presented primarily XX% we from in relating compared expenses income to and and increase significant non-GAAP credit, XXXX. in compensation operating allowance. yesterday's XXXX deferred basic XX XX%, income press stock-based of XX,XXX, an tax those $X.XX million. versus was million, year Our to Cost benefit share, view XXXX million or of income net XXXX, deferred benefited XXXX that our results sales of the basis use agreements. we periods, million of while of measures resulting XXXX of approximately any as limitations compared reporting XX% XXXX the costs XX in we royalties, total which X% on comparison above defined represents increased Cost of [indiscernible] million sales more and assets will XXXX. were of in XXX we This net sales federal effect in benefit XXXX Non-GAAP for per principally rate to year-over-year. of for operating non-GAAP for XX% for approximately use when available calendar annualized the license exceed effective operating in

increases XX% operating year a and decreased Research million percentage overall XXXX SG&A SG&A and were expenses total each XXXX compared million of slightly the XX compared of for XXXX. XX% year expenses expenses a XXXX and to their slightly royalties to for as to higher as XX% XX as percentage in per total million to expenses million product in over income percentage sales, for for compared as XX% operating XX for XXXX of expenses as for million XXXX. XXXX. totaled XXXX. expenses at decreased development expect our XXXX comparable XXX And forecast. XXXX We XX a per for

Securities on of to was SG&A increase overall and in increased can performance our March to found in our be information Exchange due be to of XX-K, Relations and organizations. page More Commission legal www.catalystpharma.com. annual And found will and the increased with back and Form report was Investor call costs Pat. the the on with analysis Web contributions may at I turn the expenses XX, XXXX XXXX that, which basically yesterday, in our However, XXX(c)(X) detailed site over financial filed

we pursue positioned commercial upon build diversify diligently and Thanks, as to we and Ali. development shareholders. aligns our to well success future, opportunities and deliver that portfolio are to core with to We providers optimistic the are mission believe patients, value about our that our healthcare company's

Finally, to would I'd like all for dedication their like impacting commitment now continued positively employees our and to questions. thank to of call patients' we for lives. Operator, the open

At time, question-and-answer this conducting [Operator be session. you. Thank Instructions]. we'll a

first line the Please Our Piper your with Joe of from question with comes Catanzaro Sandler. question. proceed

Pat, XQ and be to mentioned already And Thanks guys. how congrats able Jeff maybe say transitioned my observed in I'm more fair or Thanks. I many wondering the that it have have amount of being up you'd to that a the I patients done for transition? of that XXX FIRDAPSE. think taking here. growth specifically have Hi, progress by think say And to significant on is just I all is the Ruzurgi mentioned you two. if this follow estimated so. driven question a

of we we completed April. the end transition But many of expect tell And can be have those I Joe, want be that already specific. really don't to by patients Sure. transitioned. you the to

on AnovoRx, pharmacy take ready and to seamless willing done a And very so lot and able I process our has was specialty job been. who's this and great task. a how think And really we pleased we're this to owe with

want As far going as Jeff, you growth to take forward, that? do

that the on FIRDAPSE patients, of tracking been can to we've our month enrolled tell I did that that I in March, that transitions is Sure. patients account truly just what so and significant best observed for will prescribed, growth. been Ruzurgi or be have the ever. part a you never also naive But those that have number say then

So seen in we've that's March. what

So as we about our well. excited are organic growth

and you've patients it. up, patients Maybe really helpful. on that how whether and of what That's inform number were as gone you've got wondering your there's about estimated. a identifying that more Ruzurgi data it's points estimated Okay, possible I'm follow maybe than them,

Yes. that Joe, had patients right. for went involved the of based FIRDAPSE on number docs time. to might the the be once We with know a don't approved, Ruzurgi were some who We company of know was you some for it quite on fact. been that

side we we that know years. So some the was last Ruzurgi on there we over assume of what the couple growth lost. And

pretty or some good minus got can But I subject. be plus I that think data think as specific XXX on points we've So that supports XX%. as we that's

of business Okay, one wondering special could got it. like in where And be maybe to would just shareholders, if return I'm one a there you the if in. to point Thanks. squeeze a consider last ways capital I absence any dividend. development, would alternative potentially

year buying can back. on continued the spent million question. be. good $XX shares don't of dividend. we think Yes, our special last that's plate I as We've to buy shares We judiciously, back

We program. the continue

without way of I special our guess to dividend. paying money that's So returning shareholders a

that year. will completed believe So sometime this I do strongly we a transaction have

Okay, great. taking Thanks for questions. my

you. Thank Great.

Thank you.

proceed line Duncan of comes Charles with question Please the next with Our from your Fitzgerald. question. Cantor

morning, and Pat team. Good Yes.

prescribers this grow a on questions you year? roughly? you What just of is year Would if come then terms could of you think you from it of do about by bulk dynamics? the I to few adds, versus the new think that? Let Had kind you. Wanted little ask what the year. this switch prescribers, beyond, by a for number was end in goal my me the your X%, congratulations And where XXX XX%? progress you commercial that I'm bit I Jeff about or about think last of also, guess patient add think market wondering, would the the as more growth go you patients

to the I of Charles, think is predict. difficult number prescribers

or at look it's have one patients. prescribers three those see you lot If to only numbers, a or patient two that maybe of the easy

in believe do for important are that proper diagnosis we programs a patient. helping and get very to a so And educational our prescription a LEMS

look we we goal strong patient like at an We really metric that's use to have things not a number. really But increase to so that look internal that And and that. or effort counts that, at.

you good So and we program for itself. you think is to answer that we've educates themselves program is and X,XXX give study HCPs. to growing seems question, to been got an for can't it actually to our a actually had That I it's I number number And that prescribers. X,XXX avail nicely, for don't CME And program education credit, the and program know, we've earn a and folks that of and have the a this year that that. but correlate over to as docs spend docs target have their a

think So education there's docs we the a for correlation between as of number our I FIRDAPSE. prescribers there see will that and

that's Okay, I'm helpful. sorry.

will Just about some enrollments We've question up XX% seeing I we patients XX% will helping transition. the these pandemic. the that good expect the every of do -- address because same country year hopefully some also of versus But about organically ability to other year. we're truly the see again, March, do new tailwinds naive in opening with back of patients. and this to to be we we've the seen Like your to organic say there grow the organically, demonstrated that

for patients rest expect strong of the these to of We see year. the enrollments

those patients do we from significant anticipate too. So growth

if on had complete or maybe either acquisitions areas, on that on to Okay, how can leverage you question would provide perhaps for able the you being asset sales office. some color that's existing asset you occur I helpful. for up follow focus then year? year, could therapeutic wondering can acquisitions I'm that your anticipate back provide Ali. think I And focus And areas this guess A can if this one infrastructure, those that quick color you really some additional

Okay.

looked this made that really fair or over and were really neuromuscular offers counteroffers that we couple else looking XX months the sense. to around leverage at neuromuscular our were just point a into would with product Charles. we our -- that sales focus, was sales the last finding previously, find neuro offers. Again, hoping repeated a that of bag we and And in couldn't fit we've would previously, of initially and think but we were anything call egregious. force a time two-year-old which I the made And So

decided any class therapeutic our we outside of So to spectrum, expand including therapeutic focus much to oncology. a broader

continues focus. to that so be our And

or projects We concept an beyond could product marketed proof frankly, that and disease that are obviously rare are looking acquire. product that for hopefully are approved a we of

reps sales, side, on leverage view, the a point there's there. from sure the not lot I'm of the commercial of So that

office levered. think MSL's and shape as to patient good projects operational levers market the there affairs. access, can financing of I back as as and be our on from medical point including are advocacy, And take also, which well, that our I well other of in think view, we're accounting access,

most So I that be acquisitions. are that us there would to think available on synergies

thank Was on bottom year? you this can you feel about Okay, for if for thinking of I that's project last One about a helpful. wondering you're question the line? you of all, of a year, that last some OpEx reduced into going first what especially line, for I'm and wondering given this I'm But how you [ph] costs? then And guidance think of how pennies? you're guess color, year, of -- I bottom legal bit to would Ali. how thinking kind couple OpEx. the little But provide this especially likeness revenue as do the drops

Ali certainly and that take I'll Charles, chime in. can

costly, a had appeals areas So Canada, do than budget. our as for a And were count Jacobus. had of a had as that up litigation a very issues. didn't slightly budgeted. with was our we of part there And far with few on. was that to litigation that was year, in we were OpEx we patent Health costs there FDA, lot well litigation more to that And higher couple there where few last against the related actions over of

over we based good those ROI think outcome. so the on a is budget And

we've went taking, they with pleased of amounted saw the only assistance our out meant LEMS might budget. the which that those patients those just that they drug were to no we're LEMS We patients, matter with all LEMS over needed. contributions, Medicare the assist So knowledge, of and about spend, that certainly that XXX(c)(X) have to foundations or FIRDAPSE require that And LEMS were therapy for -- which to foundation that we absorbed best donations assistance, all one patients, that expenses patients, not million budgeted. we think to $X.X not related pocket charitable higher which

side, $X as And contributions. hope will, sales, are in XX%; litigation we with commercial especially the as higher again, in did size a So, our fourth higher goods royalty. of that result the side, increase for other each we And about the to there. was about year associated over cost percentage on million. of for expense, XXX million sold as then, transitory cost up And we $XXX cost a batch about million you and royalties higher X% additional work which up third supply some quarter, that scale in million, charitable there's that the some to well are if was royalty, of $X.X in million goods remember, pressure in And that is an inflationary total some on saw sold, our $X lots. in as the

result of three a that about actually EPS combined, for took And goods $X which over those year. XX.X%. those the total million, the X.X% think versus of our over account as cost on miss just up So I I [indiscernible] items XXXX, mentioned, for that XX.X%

operating expenses non-cash this forward, which $XX is we've be less OpEx, will going and million million. that year, depreciation, stated and between cash $XX comp So somewhere our

last some like those sounds It abate the drivers this to of year. expenses year may

guide --? forgetting pressures, can't other the perhaps you But drivers about inflationary course, Of the that. really

Yes.

got that budget, they will we the a investments that find over us think great last we year end the year. of I this by made ROI out those year, had for

taking Congrats the good our questions. answer Okay, thorough on progress. very and good. a year for for Thanks

Thanks, Charles.

Thank you.

question. the ROTH from comes of your Henry Partners. question next with line Please with Capital Scott proceed Our

one Thank me like good be you Happy it with holiday. Patrick's Pat, morning. a that let you Day. may and St. start sounds And celebrates that

Thank you, Scott.

also And thought certainly music dig up into the turned me notch. the say just on-hold I it I before has a let questions,

questions now, follow-up forward couple a moving So there. of

get goods should think XXXX, we -- between about First, trends costs you in so to revenue when XX.X, those that kind XX% somewhere north that a offset the should Is a one-time ups sense, there XX%? those of Just that? and on how I number the would step numbers. percentage, know cost sold of out, we because those play maybe trying be of or are of some may thinking way

that I a it's -- at bad and I'm the not the were we Scott, to view, conservative sorry, point I that that. of from Charles, place end think In want to royalties, But probably that yes. on I'm sure not think a if high give be. any guidance XX.X%

other higher about the versus the then looked Any out through that of forward? And were that? sort that you at me to when separate you enough. jumped selling fair QX. thing in I think Okay, G&A. XX-K costs costs It and looked the driver going Should selling like

So initiated. do take Jeff, further that the we've could that Scott, to thought that? we want that of areas some we new programs you were QX, make investments there that in

You want to Jeff? take that,

Sure.

just What the we we we thought, expenses out So some to saying, initiated was are to do we also Pat there. there of oncologists. And reallocate. then also doing. are ROI if the we'll add to some that in that what QX look initiatives of at way selling was initiatives not we're to we And non-personal that up playing what ramped promotion like is, on the some the did

in So new new year. so we put some we of in the anticipation these in get year like of place resources can that to the coming, traction early

in we expenses. selling the why saw that's increase So

quarter-to-quarter? about XXXX the patients beginning more and a gradual bolus thereafter, progression throughout and it of then should Okay, we or sort the kind great. will in year, quarterly step up growth growth of that in be And steady thinking of expect then the

question. that is the Well, here I hoping fair the And opening up. a pandemic think it's subsiding we're and countries

the because we March what new enrollments again. there steady from is March. up similar opening we're that to we're seeing what And seeing anticipate So countries do in seeing a of we're strong

Okay.

So, we've referring the that April. to end FIRDAPSE. And to by the Scott, you of patients bolus that transition transitioning expect be be we are of to may stated completed

I So a QX. you see up step will think in

to what or when patients the as continue those -- FIRDAPSE referred remember, as been meaning to see to And growth. folks we're I are You'll are takes haven't any Jeff say they get naive these organic to X,X-DAP, Those to on naive, on naive before. little mentioned that of are Ruzurgi that drug. a -- form it had are calling earlier, transitioning reimbursed time

this sequential think I you'll our from that growth year commercial see quarter-to-quarter So team.

more picture, final Okay, a Pat. bigger great. And question, strategic then

of the are other to there pay. had mentioned want you'd You out to favorable look for prices you as perhaps not acquire some technologies that what

something being high, buyer. are opposed perhaps to as a about you sometimes to equation, be it's prices in a seller that than Is when better think acquirer? seller Sometimes a being your

company initiatives consider a But company, was don't if obviously, often. as one there of is interest of that the fair this we and have Directors not think no, the on Board offer. Scott, for a our side, it incoming year. buy be we to about public what a would as public But

Well, you fair enough. for taking questions. all thank again the Okay,

Thank Scott. you,

Thank you.

with proceed question Securities. next your with the Joon Please Lee line Truist Our of from comes question.

Forbes. Thanks congrats accolades Hi. for from the taking our questions and on

Joon. Thank you,

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take I'll question the there. first

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process out education the that of there. part other putting the that's we're So

will one in efforts making I two just these just cell hopefully diagnosed said. your a to and patients one diagnose a these better longer earlier giving additional mentioned you years have question. or that thing By patients their Jeff lung lifespan prognosis than to be what help small to cancer add sooner,

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radar this the Yes, don't point, at on I Joon. think that's

in running the did disclose Great. I what And at running or similar based the trials in are in looking trial. day segment, DyDo you to two of U.S., the QMT size also Japanese you about they're you. just know as bigger in assuming opportunity on a in that you really their that's day X? Because the trials And is ran big successfully, that Thank interested it's the what with But experience exposure us their Japan. terms tell can more but had is drastic [ph]? XX pharma what a curious consumer able X day in we're curious, We you they're know the much strategy? a effect development? bit if I'm the conglomerate little DyDo?

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be development, Japan. will DyDo's a product across affairs, have small the and And that were study. pursuing because necessary research to will experience, And have marketing, get, other an including pharmaceutical recently happy it and with have sufficient they is small pharmaceutical executives actually division. the successful has that DyDo successfully quickly. market. entire number entered manufacturing, they experienced study one large previously all market it confirmed relatively space PMDA the that announced, hired And They for be all really are pharmaceutical in has they sales to completing regard this experience to although we they anticipate the is and areas; talent very Japan. very As they product very a feel pharmaceuticals, they and in With regulatory built have products, it and of

being I very their to a one them. that important products, it's product first might add of couple of

great, I That's will their got on sense arm be single that based sufficient. Pat, the think I site. Web that No,

on not like, you BioMarin agreement given an most it population, be a Sometimes recently Does very Asia. announced an that include agreement does it cell especially like China? Then there surmountable could you But can small lung that? to sounds the China, of to elaborate with Because or cancer include bar. that sounds extend opportunity. the

Yes.

remainder with so So region. going that we Japan negotiated get just that basically we NDA Asia-Pacific BioMarin about, spoke Japan Obviously, open products as we in pursue we to of agreement the are of the we us to we are file that before NDA our allowed marketing to in requires expansion. an as the can filed quickly our in as the can of market remainder

billion to Chinese The large, smokers. correct. population people, close is they're X and You're heavy

cancer people, And lot just of is of large number should be a in sheer number so as small lung there there there a laboratories China. because the of cell And then simply well. of

of that it is nations to several one region. of the are the among nations so Asia-Pacific the us interest in And

Thank you.

our the to you. turn Mr. McEnany any Thank back for that session. I'll final comments. gentlemen, floor concludes question-and-answer and Ladies

Thank to call. We everyone our next corporate day. joining Have great you. Thanks our forward update. look a for

today's concludes This you. Thank conference.

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