Catalyst Pharmaceuticals (CPRX) 11 May 222022 Q1 Earnings call transcript

Greeting and welcome to the Catalyst Pharmaceuticals CPRX First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Ali Grande, CFO of Catalyst Pharmaceuticals. ma’am. ahead go Please

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

and Dr. joined Gary and Jeffrey Officer Q&A and Officer. Miller, our Carmen, session, Elsbernd, for Ingenito, the our Medical Chief Brian we'll We and by Chief Officer Legal Scientific Dr. Chief our Chief are Chief and Regulatory Steve also Further have Officer; Del Operating our Commercial Officer. Compliance

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

and call. quarter us everyone for XXXX morning, you financial Good joining Ali. today for Thanks, thank Catalyst first update results and

see, quarter. can remarkable first you we a As had

$XX share reported before with product million compared in We million or short-term to million, and of XXXX. QX delivered revenue for XX.X% $XX.X quarter XXXX income million of cash QX for share. and income million, of we increase, per XX.X% As investments. $XXX QX for increase, of and GAAP diluted ended $XX.X taxes the of a per net a record net compared QX $X.XX was Net XXXX basic to $X.X income XXXX $X.XX of

common During repurchased open we of of QX at in started year, an X.X the the of total at market, $X.XX. price our of year, March price from of average shares Since XXX,XXX a stock $X.XX. of shares have we we this million an average program repurchased last

times to when continue and We it beneficial shareholders. we is at our to purchases prudent make feel

we $XXX of total are result $XXX revenue a XXXX in million a XX% XX% compared of increase As to the XXXX. total reiterating performance the quarter, revenues, our for guidance full-year to outstanding million, representing to

like expenses anticipate also and is, We for brief begin with I'd be cash between a and for million to development the to million full-year. the that research commercial discussion quarter. and today's of overview our execution our OpEx and SG&A $XX $XX performance

from the new Our patient Lambert-Eaton to positive robust for February Firdapse removal or following our of growth treatment year, favorable market myasthenic for the our this Circuit in drug syndrome LEMS. point from ruling Ruzurgi the inflection for exclusivity was was reaffirming attributed Decision, part XXth a the enrollment of orphan The additional defining outcome court growth. of in

adult transition those almost XXX Firdapse. those the of about patients. patients prescribed, sought all Ruzurgi previously to LEMS patients of be As are to We number anticipate which

for ensure programs that these prepared were the our help this rate teams quarter. We exceptional seamless believe the completed to all prior have patients of and As conversion to transition. those is attributed from of patient April, end their the transitioned assistance We be Firdapse patients treatment. to of by patients success the should most the of of competencies of the end ready remaining their anticipate and

they diagnosis. paraneoplastic Firdapse, successful and key attributed those to to underway, a initiatives for also extremely We enhanced process execution commercial plan. And benefited patient the our awareness commercial of test to continue with professionals; been achieve to and including diagnostic and to patients. have education expanded patients, the We several new caregivers; the patients on focus help LEMS that patients; growth high from organic We're performance our accelerate access thoracic for treat paraneoplastic the of oncologists, definitive pleased organization. healthcare

considerable growth enter continued with who patients diagnosed the with sustain driven organic patients second to and quarter the newly rate As LEMS, momentum, the expect we number diagnosed by we of are diagnosis half that approximately data based there misdiagnosed. are which the on without LEMS of not yet insurance estimate are We a or Firdapse. are U.S. claims on X,XXX patients in

that Although LEMS, approved much slightly a remaining diagnosis to leaving treat condition. to therapy done a diagnosis over approximately definitive work find be FDA LEMS an to XXX have received have reached patients, to their the definitive and we to for patients way assist X,XXX only to their patients

three the LEMS also estate are commercial with Orange believe which population. patents in patients will of Book. the covering from directed new durability have patents, our all new property now treatment types that which are to of the patient Firdapse, metabolizer has patent U.S. these We fortified listed amifampridine, until patents LEMS and XXXX. the within issuance These of intellectual protection We the suffering enhance

diversified effort and portfolio growth acquisition in we made build our aligns revised a strategy considerable that criteria. with our During quarter, more the to progress

acquisition strategy our products evaluating disciplined and Our stage assets this with diversify we evaluating several spearheading priority companies engaged At portfolio products in accomplish FDA actively business therapies. was the rare partnerships, approved collaborative Sundaram, drug the are or Officer, time, product potential acquire a Dr. development on to To Chief front our remains to of and these opportunities in companies and/or expansion. with and commercial objectives, disease through Preethi key to his broaden Strategy portfolio stringent assets for approach commercial-stage. task

Appeals. to However, appeal decision XXXX, Court Jacobus into XXth of Supreme Catalyst writ Xth from On with Pharmaceutical no agreements the petition to-date. filed of been favorable the entered U.S. have April Circuit Court cert of a

they for X% Federal petitions cost. review, such the for to to LEMS also In Program for received Access that, waiting meantime, typically as removed redetermination. in whether take filing. Court several of Canada. we request and granted filed, a data few we decision the have the the patients setting petition for in approval the time March by status protection. has Court of all XXXX, We've an pediatric has appeal been Firdapse are which With for through ruling, Now the pediatric approved Ruzurgi High prepared court patients matter been with make Drug could this grant The the for of will enforcing U.S. the been Ruzurgi any Health during LEMS of is in only the to part commitment market cert. expansion a no Canadian continue very sNDA Expanded provide it favorable from the pediatric about to Innovative approved the remanded months prospect to an for submitted FDA, the to we This Firdapse of not our process as available remains This therapy. of of access resulted label Minister to In at aside our

I of of Ruzurgi. case the Our proud pharmacy amplify our highlights Rare PantherRx, to rare Jacobus health helping This awareness several messages of diseases, voices Carmen, On Jeff Global the execution. stages on keep discovery. increase against specialty to advised of further commercial and patients we and with need now the and We'll on will to other patent February, life call early important those this Del treatment Disease goal patient is included national provide focusing the litigation Day, suit Commercial diagnosis, rare Officer, end will about continue case of partner in over our you diseases new for Chief at as raising turn LEMS are infringement therapies. is awareness about who in the quality issues. innovative The you organizations to progresses. of the

and Commercially, everyone. in represents last good and building commercial $XX which growth The the net team sales demonstrated morning, delivered execution strong upon primary objectives Pat, organization. we quarter entire had were I'm from year. QX million, the quarter, growth versus XX% QX. commercial of a momentum quarter two the XX% same very by Firdapse, proud XXXX. the quarter-over-quarter flawless Thanks,

to Firdapse with patients [indiscernible] foremost to and therapy. Ruzurgi First the majority transition

the of on of expected of Ruzurgi been Second, organic naive patient By end successfully of needs team, new the the former have process. and am of enrollments. this greater Ruzurgi. transition Catalyst were quarter. than adult the been patient quarter. through the patients, healthcare realized particularly XX% a LEMS patients over end adult from impact which for patients professionals to Ruzurgi The to to in March, growth remaining demonstrate doing Payer have by Firdapse significant balance second LEMS the I the approval services second the supporting transitioning XX% job full rates the estimated we tremendous is adult the of transitioned patients, will LEMS caregivers proud of with be transition during

As organic growth, versus XXXX. XX% greater patients and XXXX, QX new were naive for greater reimburse versus QX X%

enrollments since the total highest XXXX matched In March naive monthly new fact, launch.

greater contributed Additionally, all compliance of than commercial or favorable discontinuation X%. XX% maintain to than of approximately XX% rate operational across a excellence access private government insurers and of high payers, greater continued

remained undiagnosed. that We misdiagnosed driven of primarily discontinuation of strong significant new new and in on Firdapse rates April, steady patients, enrollments expect patient by considerable not LEMS already of XXXX, patients yet with diagnosed in in enrollments quarter organic the naive forecast. unfortunately growth each patient or were number line are

XX% strategies LEMS continue symptoms patient on such patient Firdapse physician adult on resources, significant LEMS into and journey. to have tracker, Approximately returns of LEMS opted generate investment. which our patients Our locator as LEMS marketing offers campaign, active marketing the

diagnosis continues with accelerate engagement, cell treatment of and to content to more educational small a proper strong receive Additionally, opportunity for treaters which this show will disease. yield to LEMS the cancer patients lung

launched opening dystrophy community. to syndrome and addition myasthenic to Catalyst like neurology, conferences. Furthermore, to specific members LEMS Day, disease the their the the at Lambert-Eaton America educational lemsaware.com LEMS Rare podcast professional partnered in Academy website societies about to awareness with of and the educate In respective in winning connections at muscular ringing the award Disease the increase bell we American celebrate Firdapse NASDAQ key on

we also help patient are and only about excited In and our the resources in from Ruzurgi, to and closing, opportunity adult Catalyst a adult job caregivers did LEMS to not tremendous patients. all services performance educational professionals. Our Pathways LEMS significant providing are healthcare QX in and with patients pleased supporting but financial ahead QX, existing patients, new transitioning

to Officer and Operating on over call Officer now R&D I commitment LEMS an unwavering will Miller, to Chief want tactics Chief the deliver that thank we and I are at in We confident will place strategies growth beyond. in for to the have Catalyst organic the and turn XXXX put our update Steven the their team entire Scientific community. sustained activities. Dr. for

now Thanks I'll the on our commercial for operational update, Jeff. initiatives. an provide update

opportunities XXXX potential expand for straightforward, and which patients LEMS are with being of the the disease adult to to are Firdapse objectives identify commercial synergistic Our in number continue increase Firdapse, the rare space. treated

Our progress significant to affairs in direct education to provide healthcare valuable team content. medical providers continues engaging and make with

XXst and licensed is to obtained also CME X,XXX year, course of Medscape. U.S. the CME support physicians these an largest recognize and accredited credit. prescriber promote programs X,XXX also physicians over available have We through LEMS have providers within healthcare to it formerly designed viewed of treat The programs educate providers the community. April online increase healthcare to program diagnosed currently of and all awareness CME LEMS Medscape To-date, through how and this on

All of oncologists this LEMS another of oncologists the oncologists for will Medscape provide and in -- provided covering session an hosted the Book, and three listed type. primarily a recently for to important Catalyst enduring We for bringing now total This patents the publications. NATX new to announced of been metabolizer of on intended in tumor for resources. neurology program free listed to that issued the franchise Trademark bringing the Patent physician education as three to in FDA's the promoted by protecting board number the live the Firdapse resources five. patents and addition patient, education not is CME amifampridine was year are several have total patents basis Orange broad patents physicians May all In recorded additional at that charge oncology a program, comprehensive supported five. Firdapse physician number session provides of issued This regardless one Office, by franchise course milestone we to network protection and the metabolizer types Xth,

until continue to mid-XXXX. protection has execute long-term protect We U.S. to durability key on strengthen our will Firdapse, of which the initiatives the patent in and exclusivity currently

its small on and Phase continues planned. licensee study DyDo is clinical sub to in X Japan. the Our December study of myasthenic they patients to the In initiated scale Phase Pharma Firdapse enrollment Lambert-Eaton XXXX, partner, treat as X progress for progressing syndrome

approved the XXXX. year We expect also by clinical the by NDA program completed Catalyst providing trial in period an of supplying all Japan. to this collaborating DyDo information and enrollment alignment LEMS package NDA filed In and technical is supports label efforts the expand needed to submission materials end be study with or in all Firdapse. early file their of treatment our a age for a over patients the commitment all provide to supplementary LEMS six. pediatric use an patients, approved expansion This submission if of would we for Firdapse to for LEMS

we of at majority extent beyond If help less very label treatments access is patients important to Well, to granted with the suffer small Firdapse XX this our reminder, patient it on of advancing our patients total our expand group for Firdapse. fully from rare product in will The disease estimated indication or initiative, the an LEMS population that priorities patients. already is a LEMS which objectives improve population are patient vast aligned and portfolio is pediatric approved. U.S. than adult for simplify the a As patients. pediatric a the LEMS development

provide capabilities the to Our discussed expansion right within our have most and internal maximize progress, drive maximize on those We opportunities. to market, with are making operational initiatives development gained highly progress current The additional evaluating resources. and and today teams initiatives clinical very our opportunities prospects. core to we and program identifying focused our the insights, our remain focused and us of resources on strategic in initiatives in expertise our products are on we confident pursue several and substantial Firdapse are

activities overall We our development of and business the the progress have good to behind contributions portfolio. momentum

upon relationships and key building on partnership strategic making progress enterprise are We our meaningful initiatives.

meet opportunities call and results. We the over are to foster about Chief near ahead. Ali objectives excited our are path very will growth I Officer review our future turn long-term to well positioned and the to Financial for financial the our Grande, to now

saying for our we the Thanks, XXXX. results pleased are quarter It Steve. without goes very financial first with that of

QX ‘XX. revenue $XX.X net income net $XX.X principally a QX from product $XX.X million, income compared XX.X% million. and ‘XX GAAP of reported diluted total revenues of increase, income quarter taxes net or million $X.X for and We before first the XXXX share for QX compared million Our an share, basic $XX.X $X.XX a of $X.XX first before XX.X% income total for $X.X was net ‘XX Firdapse per million increase income year-over-year, per quarter when revenue QX, for over to share. was income or to million, of GAAP diluted Net taxes $X.XX increase XX.X% XXXX basic per ‘XX of

patient reset expense make the of support year companies million first of impacted that As of of in our the commitment were the relating by the first many an increase quarter donations the XXXX, a $X.X industry recorded our Further XXX(c)(X) patient deductibles. LEMS in we to quarter foundation programs. charitable to in to reminder, calendar like in

While GAAP for XXXX contributions quarter contributions to LEMS in expensed will XXXX, years. requires patient be the support we when full of programs make to such this first the they committed

compared XX.X%, QX to QX basis Our ’XX ‘XX. XX.X% annualized effective an was for rate on tax for

first XX.X% are $X.X $XX.X benefit quarter although the assets net XXXX we and XXXX, net The to QX per of income $X.XX which GAAP income will certain stock-based a tax This of expect an normalized share, GAAP resulting and ’XX, losses $X.XX above million orphan or were from from For an XXXX $X.X costs million. periods. share, represents for more this ’XX, total subject provision to the to million. those excludes and $X.X tax Cost an million XX,XXX our $X.X stock-based of net of State deferred income per million, net represents the $X.X of we per which quarter depreciation expenses from $X.XX of limitations $XX.X compares credit, excludes that of first of share XX,XXX in relating continue drug Florida in was primarily basic rate. tax tax operating of income compensation in or net and of compensation depreciation diluted income, basic $X.X million of to diluted operating million, the income, of for Non-GAAP in of million XX.X% income non-GAAP and provision approximately QX sales approximately to increase year-over-year. both compared use non-GAAP

royalties. net of consistent cost of to ’XX, QX sales and were XX% revenue product principally For

a QX compared to product trend any $X operating $XXX royalties percentage $XX.X totaled million large will calendar of for during XXX(c)(X) previously QX compared ’XX, decreased SG&A for The when a QX for contributions XXXX overall higher the QX net of ‘XX. expect $X.X compared SG&A exceed total R&D quarter XX% QX in QX sales and increased expenses XX% noted. expenses increased be as for QX As the caused slightly part full-year in the a cost in in was $XX.X XXXX percentage expenses development expenses million ‘XX slightly million year, first SG&A to progresses. QX operating XX% expenses in contributions million, ’XX. increase were ‘XX reminder, by by used as XX. to year organizations to to as the expenses million ’XX, in of compared so Research X%, ’XX, we ‘XX. XX% of in expenses sales as QX to of with to total over with

debt. well XX-Q, quarterly to filed leading requiring on our ‘XX investments strategic existing And financial support page us with to of detailed of Relations Investor and yesterday May with fund our and I'll the of over be report Form Pat. $XXX our our initiatives flexibility, our the programs, in was believe www.catalystpharma.com. the the performance reported, opportunities may which and as as XXth As ended at Securities call More can future no on QX cash Commission million and growth turn Exchange website found funded allows value be creations. financial R&D found analysis information we and that this with We quarter and the

sustained remarks, commitment this to year for execution unwavering the company in anticipate Thanks, forward We priorities. invest innovative performance to diseases. these potential stakeholders. our momentum and I'd is well and an the all increased add and our We that prepared approach closing our In with from a deliver a LEMS strategic for of with like Ali. diversify growth community be enhancing to to Catalyst of to opportunities positioned strength and objectives to for rare long-term value position our of look transformative

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

be sir. very we Thank gentlemen, from a Instructions] comes you much, The Joe question-and-answer Piper and question Catanzaro first session. Sandler. Ladies will [Operator of conducting now

patients transitioned but a payer drug? these And have scripts? Hey, And XXX were is to here. questions my paid moving proven patients to Maybe Thanks reimburse what say decisions and me, I'm or of little a still from the so you it would those Ruzurgi of mentioned been of transitioned patient I patients you bit taking if to free follow-up. estimate Firdapse. one first is expect a you're everybody. patients, the accurate much become have you Thanks for whether when wondering, something think for so a I could target? percent about former XX% with

the Del turn Thanks to Jeff Joe. question. over Carmen. morning, I'll Good for that

Sure.

transition LEMS payer. being answer about the Ruzurgi, the question of approved patients were patients XX% than the that from So adult patients by Joe, greater to approved your the

full And the QX. so bridge were and short a for they time impact these to only of on patients in we be felt expect truly

I'll We Yeah, X% Joe that either think XXX. pretty within that's pretty we're accurate add number that. to that, with comfortable Jeff, way. of

So we moment. that for will stand the by

enrollment if I think, naive for that I correctly, launch. And the month heard great. new was mentioned patient since highest the March you Okay,

observe speak year favorable the pull? growth, as those Just diagnosis looking can expecting organic levers entirely April? you're or into that continued to you improving other there trends whether by to are this And to driven you're you've rates

that. March, Yes, lot continue enrollment very is, contributing so But able the up Joe. see these And thing almost strong dose we is again another a strong Right, April patients matched to physicians. numbers. country of did and numbers opening to are things to with

as pipeline so being over just times are We a that lot have and a of the diagnosis patients patients to are majority XXX leads their vast of these strong and patients see of we suspect LEMS waiting these them of are that physicians.

to where in organic strong growth, going enrollments, new as we growth continued So come from but great suspect these is organic it's our XXXX.

an last one more of of a just And doing? potential on that? and you're think wondering deals, great. the I Okay, active those process I'm where but give one, business you're a little Pat, just bit -- are what diligence commentary maybe one obligatory some in on on mentioned Thanks. maybe you you could development, couple that you

our has by that that today that and so a Yes, commercial launch. team, rare can believe opportunities, little FDA very and add those drugs our great commercial criteria drugs. their bit, approved our more Joe we perhaps we're Sure. been that or we in disease haven't been think the that value, have interested launched with yet in early launching opportunities We in changed experience

I diligence where it's think in the we and can far to that's And process. are specific, I describing hard we be probably into several And so as deep on opportunities. due as fairly go are

That's Okay, taking Thanks my got it. helpful. questions. for

Joe. you. Thanks, Thank

Fitzgerald. comes from Duncan Charles of The next Cantor question

of business, then side others. commercially. a Yes, good questions of on good the but on Pat a couple had morning, also team, and congratulations a few quarter, I that

be What to the would terms in questions, XQ, you to you organic if going Ruzurgi the XQ is of had kind think some primary be Would trends it. when of to past going you some or the about the and that project? and it of continue growth be revenue? Just switches the impact into contributor guess of of I to in you do it see think

for Jeff question. Thanks, Charles question. let I'll take that the

Sure.

of two-fold the be you the QX, increase. going also do a be To the growth But that and from strong really Ruzurgi, should so that's I patient that to transition, organic patients impact expect enrollments we're in Ruzurgi is those Charles So felt full transition mentioned as from We seeing the huge them. new well. contributor say. to very

new those a saw quarter saw March, as that So also enrollments revenue until April a a will strong we the second we're the those impact strong to in seeing -- the patients felt seeing we those be May of that and well. strong And then we're start -- too.

strongly I it's both think be QX. to the in those revenue well, So will going to things be two-fold, contributing

when the to, are Ruzurgi, then from going of the about feedback you so I you think XXX And you consider consider mentioned that them getting past patients, when beyond contribute you would prescribers, result prescribers patients identified. as the you've would of of is result call suggest as a expanding of it they that that Ruzurgi prescribers -- switches? pool Are that in from a patients you feedback getting possible part

or prescribe think product they Yes, accurate distraction that's do I another a statement. that an you're eliminating essence, can In for that, LEMS.

on for Firdapse where intelligence will have only. -- tailwinds, think LEMS we -- force that now patients see these are with that so lead leads focusing from there -- they because physicians XXX claims either we this cynthany do we Those like from from field some But field some out or seeing of data these are. it's we're that's these So do prescribers physicians. potential there

service done in imagine to clean with discussions the and the switches, contrast the the also and support? and takeaways. the the But I but services relative Jacobus relative a provided drug, you to too switch, drug your gotten -- past by have many on responsiveness only really it's the were question compare early this to any who providing to access little that Last and of patients not services in your to Ruzurgi have broader

a team I'll provide. And the would there focus don't better on tell you, Charles, services think -- out I not there. that is Yes. can I I And we

tremendous our We of with disease And were salesforce, cases, out that, all just drug. our product if resources. apply that out they services that rare there. go Pathways, not to encourage make it We to all on resources then regional they significant have taking account And have I at all a resources sure the LEMS managers, everybody these field is care including force, of our these it's now And that and our to because part resources team services patient a that to access have another there, related, experience. out in didn't patients and some are of it's they the there. lemsaware.com, Catalyst provided there look now they they're have a go responsibility

LEMS the has done. do come experienced had I that the what the we think the to So team right thing patients told over for of and have us community proud and have that. Very

the activities. regarding for Steve, question Dev Pat perhaps Biz Last or

in the of mentioned the consummate effort But mentioned you by portfolio could provide I progress to year? kind questioner's able end being And engaged in substantial several Steve, this guess wondering, anticipate to the if type expand portfolio you expansion of would on this I’m progress? color some alluded you some Pat to of previous projects. diligence additional question. the You Or and

of Yes, specific Charles. we We that due mentioned projects don't in about to couple are fairly very I deep looked a on earlier, it be want opportunities, promising. diligence to say, particular than as other

away looking at, about really looking so that’s shifted later later we -- I this -- that development point. approved opportunities. we at stage provide have opportunity think from to we But And at stage all the are that can commercial color our

of terms market helped Is valuations? environment the current in

Yes.

mean, I months I difficult a it's been biotech think so, land. XX in

Yes.

down are at ago. financing a ago year window for that not open, XX% wide indexes year as and the a look more like the just it was You or it’s looks from

another looking biotech than number it their So to being and discounted it interesting probably a -- might of we've looking stock we're at what into which I be offering. and may interesting. have of knowing environment, the at speaks at few do actually is go a companies the frankly XX-week to company XX%, a had that think going options and those to to more I emerging where, other financing point the that go to making strategic low they're think kind us their the XX% And have certainly are a a trading and backdrop follow-on to approach market is for companies

certainly So a better buyer. I say is for year a ago was it that than would the environment today

Also progress operational and performance. speaks likely your to

taking questions. for thanks So all my

Charles. Thank you,

Securities. comes question next Truist of Lee from The Joon

Joon. morning, Good

my Good morning. for on questions. This is Les Thank taking for you Joon.

remarks patients. your you will be essentially Firdapse? And package secondarily, believe on How those grant have First, of in what many LEMS XX And then a the approval have follow-up. identified of currently supplementary pediatric you? I the prepared are about I

we Yes, pediatric really number believe of less XX. is actually the than patients

We being access at number number the basis without no pediatric expanded of those we currently patients a that have we cost. a specific, provide drug have our to

-- filed approved or very we therapy expansion the So whereby have through those without get hoping all have access being a have all of small approved, an label expanded supplement label patients, FDA. our access prescribed program. the number off I to who we in prepared to pediatric patients remarks, an as mentioned with We're FDA will

been have also in for you And second, the from you that Thank to mentioned provide number if then you applied or patients. you. resources LEMS figure has and then target thank the what patient it, you've that possible population? XX% Got have trended? enrollments the LEMS around tumor of how And new past perhaps latest tumor clarity. Can

I’ll that? Les. Jeff answer let Sure.

Sure.

low -- the LEMS Les, percent are we patients. tumor enrollments of So tracking that also patient as that tumors still are new far are 'XXs around as

year We or there so that increase What any on oncologists, educational currently it's to we're gain offered focused thoracic that a putting providing resources small expect doing, education, that patients. cancer help we're year treat or this significant those to that content cell next platforms. oncologists of percentage. we're traction should say oncologists lung the are that variety educational they education And out

that find these you to So physicians patients. help some of treat these

effectively treated and with patients LEMS there, So but will out putting strategy the diagnose become this help we're with we're identify very confident resources Firdapse. these properly and that which these patients, in then

expect next later we So year year. growth this well that as as

prepared CME through something education like to statements is oncologists. that available said made about my Les, resources our to also was that reiterate I'd program new in physician

helpful, Very you for that. thank

question? another there is Les,

The Yes. from question Scott is from Henry Capital. next ROTH

Nice there. strong Good job you. morning and really Thank results.

Good morning, Scott.

questions. of Couple

a here growth put talked Where terms we perhaps that? would in on you right you to now? what rate you -- lot organic volume approximates the growth. think want do about organic about First, range of a But

of seen being that day the in to organically. early a growth we from about through a couple rate the under XX% conditions. year-to-year XXXX, pandemic in that's Scott And last years we've XX% launched

factor that So end organically growth our that think physician great that get growing be We could done high open as definitive a diagnose them to and a we've job the patients I continue going diagnosis. think forward. range in practices and of

to So to add Jeff anything that?

that here Fully and we confident think Firdapse. help in these yet in And the with Pat. is currently see that XX% XX% to we're will should biggest not you physicians by patients -- this visits treated diagnosed on waiting become expect to therapy, the backlog which year the mentioned, and you are alleviate like I effectively to and that these we impact patient said, beyond,

great. statement. to color. shifting income Okay, the then And over that for Thanks

you or see there the year? there? get Just said that's to if is were If fact expenses, you if the $XX is of front-end I'm expect any stock think that I excludes case, would want know you of stock probably that trends $XX be representative? should would but excluding range if sort loaded of I to assuming operating comp QX representative to year million million QX's expect in within the rest some of that expenses, comp. the they what

of Non-cash we every quarter. have something Scott. course is comp Yes.

charges We are those again cash. have not or and expenses

the but affected from excluded -- contribute OpEx -- we have and So what have that estimates based OpEx those are seasonal reauthorized We expenses research sales year. in of do those our we We the XXX(c)(X) our is ramp-up, on and some peers course expect cash getting And to contributions were is contributions over our development have obviously Also, having we call, are based the and at -- year, higher beginning we most of the to SG&A. courses, and foundation to are -- in of have, what our on than our QX a that charitable four contribution QX. general and that I'll practices patients as seasonal, is as is defined new would and in And rather in take QX. the we accounting you full charge unfortunately, charged full require year meet that expense over sizable that net like deductibles. gross us amortized QX. expect quarters, to for

So certain certainly expenses QX. for really skews that a to G&A degree

at really probably you Pat. that R&D That's Okay. stay you, low assume And Thank acquire fair? I these is something, then helpful. levels till should

assumption. good a That's Yes.

I to other And Okay. sub and Ali, reading the recall structure, X% I guess X% to regards royalties. then in K question BioMarin with perhaps the for royalty final about

You it year, mentioned that goes could me just of the of after remind million that per terms $XXX you what were? up

will sales $XXX million royalties by once as go we a the the So up defined in contract. hit

increase So in that's the why we to progress as expect we royalties year.

after every how that's reset go sales Okay. approximately the year, And how much is I over but much million? that on does assume -- $XXX up step-up a it

It X%. additional an X%. go will up

Okay, for clarification right, thank taking the All perfect. questions. that you you thank for and

Scott. you, Thank

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today's This teleconference. Thank you. concludes

you lines. for disconnect may participation. You your your now Thank