Catalyst Pharmaceuticals (CPRX) 16 Mar 232022 Q4 Earnings call transcript

Greetings and welcome to the Catalyst Pharmaceuticals Fourth Quarter and Full Year 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. pleasure Financial one Officer. my Ali your now Chief Grande, is to of introduce host, It Please ahead. go

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

We Officer our Officer; Scientific Del Carmen, and Chief joined Officer. and Dr. Miller, Steven by also Chief are our Operating Commercial Chief Jeffry

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

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

progress across business now start and year highlight and of I'm and today full XXXX made into welcome results fourth our the call. Ali XXXX. everyone pleased quarter XXXX the Thanks, conference to throughout our to we've

exceeding executed key relating capital successfully the capped consecutive U.S. was segments property discipline. XXXX strategic press This our along total The results a the the RUZURGI, as revenue strength did the performance highlight business. projections growth the year attaining robust important me pivotal for we points. guidance included the net financial litigation of and all to quarterly delivered in year initiatives we underscoring let release, of portfolio. as of we Catalyst revenue driven an fiscal intellectual As our FIRDAPSE by transformation XXXX of rights, exceptional with across a yesterday's resolution several favorable

note, The on of indication long-term orphan strength pediatric added for confidence strategy. decision Important U.S. presence a exclusivity, to to approval With its positive recent these of strong performance FYCOMPA. further remains our we receipt and growth of the acquisition court neuroscience and drug expansion, accomplishments FIRDAPSE and expanded the site success. supporting set that of accelerate FIRDAPSE, our our the an cornerstone continues company's considerable can the FIRDAPSE

the trends number demand to our which and performance We a are will indicators, Jeff strong pleased key growth across very FIRDAPSE, we as with see shortly. positive continue for address of

or income Our XX% In year per XXXX to net XXXX. $XX full income revenue a compared per and year-over-year million, the to per year $X.XX $XXX $X.XX diluted compared $X.XX $XX XX% $X.XX diluted of XXX% share a basic and $XX net basic $XX or reported to share full XXXX to basic million... per year the a XXXX total full a share were share, for $XXX total net revenues quarter million per per increase share, $X.XX total revenues XX% We of in XXXX. Fourth increase compared million were increase $XXX diluted. for in and million, GAAP million compared further increase $X.XX was million $XX or XXXX, million representing non-GAAP for

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We XXXX. total XX% and $XXX net total in million million million $XX to XXXX. to per net $XX revenue or diluted net diluted $X.XX per per $X.XX net to million income $XXX share XXXX a million year-over-year share year total per for quarter revenues million, year compared XX% and the basic in basic and increase $X.XX $XX the share full Further a XXX% were representing Fourth or and net compared Our a diluted year reported revenues compared diluted income full GAAP per was XXXX for to share of $X.XX $X.XX $XX full million per non-GAAP share of or per increase or share, full XXXX. XXXX. XX% a $X.XX million in for basic XXXX share, basic $XX year $X.XX increase increase compared $X.XX $XXX for per the share were

equivalents. $XXX million XXXX ended cash Additionally, in and cash with we

front With revenues growth year net million, of $XXX another our recently XX% and increase to million between XX% market net forecast XXXX. a with the expected provided representing year full total revenue have total in $XXX XXXX in of compared of we us, to of

sales to revenues revenues net FIRDAPSE’s have of acquisition expect be net projections, between XX having and January We on XXXX based And XXXX be FYCOMPA $XXX forecasted million, closed of FYCOMPA the year. to also this $XXX of million we late months million. approximately in $XXX

to FYCOMPA be provide will this accretive our will her to continue Ali EBITDA expect further highlights financial remarks. we year. Additionally, for and details that and EPS during

of opportunities acquisition the During Limited. from FYCOMPA focused to quarter, the U.S. has and current successful to come quarter, diligent with pursue our to the transaction Company rights process Eisai value-added fruition

pleased product on AMPA but noncompetitive of epilepsy, not to a augmenting revenue FYCOMPA objective antagonist receptor our important the further base, already have growing and this with XXXX. extremely earnings portfolio We only also adds for growth our for are FIRDAPSE. strong broadens first revenue only delivered and commercial

potential market a expand neuroscience strategic into FYCOMPA diseases. of that a a addition complementary gateway epileptic growth the rare importantly, establishes within to adjacency driver and as serves More

have to working who FYCOMPA been employees of to We Catalyst family, U.S. success and the onboarding full -- we by are the look activities and leadership program midyear with Eisai of responsible FYCOMPA future closely forward the expect complete of of date. transition collaboratively to and into already the FYCOMPA the for epilepsy transaction many XXXX, FYCOMPA Eisai the

not to that opportunities we quarter, new build any portfolio. additional align did in diversified overarching make with to although enter our we acquisition to into products, to acquire continue identify a contracts our growth patient-centric this strategy significant strides During efforts

diligence Our on of front and broaden key offers remains stages the and and stage could portfolio Currently, our partnerships to due product growth companies of strongly occur commercial acquisitions implement development that our and/or and that long-term through our further portfolio in intention XXXX. collaborative diversify transformational stage expansion and potential near strategy on advanced several commercial of assets priority business strategy are our to and/or we products in a the believe companies.

FIRDAPSE's prospects. about We remain optimistic long-term growth

related FIRDAPSE's intellectual estate, drug token which advancements exclusivity. significant made affirmation of included property market the we to XXXX, During the

achieved that cut outcomes property of say vigorously That Additionally, litigation to FDA are estate, in we to intend we depend ended supports successful the other were we which patents what year listed by intellectual go than long-term the XXXX. granted FIRDAPSE. and of limited out can point about with say three product's the FIRDAPSE's six intellectual related durability. to our Book prosecute we believe strength remain property we infringers said, that XXXX, to to ongoing We confident supported new the at patents this and about Orange any

provide will available the regular course, SEC, in company's website. the be filed on updates which We will, our of disclosures with

were XXXX year being included these pleased the Forbes attitude, year, XXX Fortune's consecutive accomplishments. to and Cap Small added growth, in companies, the achievements recognized several that of These Index. Best These small to one Small the ended of ethic inclusion be Companies Having XXXX XXXX aided second work the significant with America's to XXX represent Florida's well of for recognized as as top commitment as the we for the being our culmination excellence. S&P team's being and honored patient-centric Company Year Catalyst as recognitions company's

team's in to our accomplishments innovative leading disease advancements significant underscore Catalyst the evolution company. becoming biopharmaceutical the closing, a rare In

sustainable to on Chief with We to I'll capabilities our expect call Carmen, of growth Jeff and Commercial will over allocation, turn approach part update vision. disciplined activities. as Officer, these and who our provide commercial achievements value to long-term expanded coupled an capital the Del our now enhance drive our

very for successful as year everyone. Thanks, Pat well Catalyst good as was and LEMS the morning, XXXX community. a

the milestone patients is we date, are that to very now unique LEMS over States. to proud in enrollment the United tremendous launch which patients received FIRDAPSE have First, a for announce X,XXX from

We sales strength growth. giving product year a net representing FIRDAPSE increase growth million, continued of FIRDAPSE were full commercial for FIRDAPSE confidence QX, and demonstrate the quarterly the These capabilities, pleased XX% strategy are $XXX net net sales consecutive organic In quarter-over-quarter. sales with year-over-year, of our a very achievements driven growth. X% million, by $XX

year-over-year, new only X.X%. accessing enrollments high drove patients XX%; assistance The XX%. across to rate is approval all XXXX, business than including while month. was than private $X greater annual that Medicare, the including Patients in foundation commercial and not solid. continued have by Catalyst new covered The of payers, FIRDAPSE per transition of insurers; or government patient Pathways, maintained the of of Operational Naive XX% who greater from are prescription average enrolled in discontinuations. FIRDAPSE an lower compliance favorable RUZURGI were rates excellence discontinuation less foundation LEMS rate co-pay in QX those XX% discontinuation was starts,

have to our that will net drive growth $XXX of In strategic growth moving $XXX revenues XXXX we million forecast FIRDAPSE's forward. confident As we organic Pat are mentioned, initiatives million.

LEMS channel which increase health in will the a providers, FIRDAPSE. with test, targeting care journey significant patients to treatment for and shorten have being patients and patients lead more eligible programs education caregivers diagnostic LEMS led calcium to voltage-gated antibody for

cancer We the and the patient QX, on increase match more discontinuation steady XX% conference well programs patients stream around lung working cell small we of lung thoracic partnerships are new by contribute as primarily get cell thought voice diagnosed. are to far LEMS leader LEMS-focused institutions platforms a that patient yet low share and consistent are on approximately patients quarter. Thus FIRDAPSE, net lung through or will of newly XXX new as patients of screened diagnosed cancer, help exceed variety of new non-tumor rates. enrollments oncologists identify driven with educational of each [indiscernible], oncology tracking participation. enrollments available Also to in which on we small Additionally, consistently hired strategic QX not greater a cancer

to market commercial neuroscience as FYCOMPA, FYCOMPA of rare establishes driver and a commercial forecast gateway excited stage the Catalyst months are of into commercial proven an about for enhance to the serves million addition Catalysts for organization that diseases. growth potential XX established XXXX approximately capabilities is The adjacency sales. epileptic FYCOMPA, on to complementary a $XXX be epilepsy strategic will asset. revenues within capitalize first-in-class net which for expand potential growth of

making franchise epilepsy the of employees Catalyst franchise are hiring epilepsy of marketing, progress Eisai sales great with date be vast leadership will currently for FYCOMPA. our start an from majority The effective May dedicated to sales, We and Xst. staffed

of ringing is on important groups. with February Rare epilepsy unmet leading of the NASDAQ Disease in We groups. advocacy partnership the International Catalyst were rare rare on in shed disease committed diseases advocacy participate proud to the advocacy in closing need partnerships recognition to continue Day new with for collaboration the to and LEMS XX, help XXXX with bell and light

ensure FYCOMPA through epilepsy We will to continue to assistance access FIRDAPSE for established appropriate and patients programs. to LEMS

look the to of unwavering growth addition update commitment over XX% the closing, Chief Officer, thank Steven epilepsy Chief $XXX optimistic FYCOMPA In Operating their of points. entire and I about Catalyst in overlap to to to on our want operational in revenues with a turn Dr. Demonstrated activities. FIRDAPSE forward the are call the potential an leverage successful the Scientific organic net for now to I forecast XXXX, call physician $XXX we for to team combined positions million FIRDAPSE deliver and and XXXX. Miller, franchise. a Catalysts R&D very and the well best-in-class million excellence and thrilled for patients will Officer at

Thanks, Jeff.

all and development integrate newly the to systems. FYCOMPA continues its to enhancing to state the to on maximize clinical focus strategy expanding commercial regulatory potential FIRDAPSE product Our patent acquired FIRDAPSE patients, access to for and Catalyst's LEMS into

and increase supplemental of NDA in anticipate that We the dose FDA a our per day. to second daily seeking maximum indicated to assuming of XXX in from with file the per to quarter, to development to I positive meeting efforts maximum increase milligrams plan dosage like per First, third outcome of XX quarter indicated the to to would of the a milligrams meeting milligrams FIRDAPSE strategy the year, XXX outline FIRDAPSE our day day. discuss this

for dose data doses milligram our a basis data for on own access The of dosage XXX has maximum number physician set for at to the indicated investment treated as the rights LEMS of patients dose. and combined their indicated current already and patients. being FIRDAPSE help milligram A approved, dosage daily FIRDAPSE, daily insurance for been patients safety XXX pharmacy and the will indicated this at we to us treated daily have that into acquired and of to providers optimize RUZURGI need justify milligrams an seeking of our those this daily daily at incorporated and to along efficacy day with project and gave data are believe a regularly FIRDAPSE. supplement, dose, that the per milligrams community those will XX worked expressed XXX physicians be their after to higher on dose increase updated acceptable maximum planned previously data, it XXX progresses. treated therapy patients The patients constitutes strategy, XXX with the including a safety data milligram Other if milligrams

next would previously patients. on for treat to LEMS our FIRDAPSE comment application supplemental like approved pediatric to drug I new

quarter by During was September XXXX. FDA filed supplemental on the we it this XX, first XXXX, and of NDA the approved

of small With population our United pediatric pediatric supplemental group, patients to the approval six to highlights The LEMS ensure States. above and is access a patient to estimated With FDA-approved LEMS the adults supplement XX have the this now access an in LEMS this and to in have than NDA, all as that less product be patients FIRDAPSE all very age patient FIRDAPSE. United to commitment patients States. all

which Phase collect follow-up required the to ongoing. expansion, in Japanese global to clinical that Japan, trial, approval sublicense the completed FIRDAPSE our their patient of partner, market, study in in data safety Regarding is phase for the III DyDo seek Japanese our population Pharma has and is enrollment a safety

LEMS is by a of the is X,XXX assuming Japan. of anticipate It NDA to about are continue to successful, estimated in the XXXX. submission Japanese there in completion trial patients We X,XXX the and that end year trial

of generation, AMPA from learning to Hyperactivity secondary receptors AMPA our Moving is indispensable synaptic actually receptor approved U.S. of seizures seizure, or January Epileptologists are chastity. central first can also receptors adding the success, of that or and receptor function the to spreading year. reverse receptors. and on this and and we electric duration development as and rate rights by receptor on control. nervous for business recent dependent FYCOMPA improve over activation fast, system to the only Hyper of by in FYCOMPA completed damage throughout might the exultation. FYCOMPA, is and of transmission neurotoxic, acquisition these alter genesis. induced be believe enable AMPA antagonist an activation AMPA perampanel, Eisai AMPA excitatory inhibitor. induced and AMPA effects seizures seizure can highly antagonist synaptic

recently epilepsies other rare A seizure XX% of without unique XX.X% FYCOMPA patients in and consistently network High seizures anti-seizure reduction frequency different Epilepsia XX.X% the age treated in framework XX in epilepsies with the capable or reduction sustained of was who seizures reported older. medication reducing genetic to XX% XX frequency. and seizures a treating FYCOMPA neurologists partial observed and a generalized from that Journal with rare or with efficacy treat greater with with mutations. and patients epilepsies. than rare European widely medications to specific reported case people of patients of Of secondarily a patients over genetic is includes tonic-clonic seizure treat epilepsies seven how working are the respected perampanel, seizures is the or four in XX XXX of with of in under epilepsy resulted significantly epilepsy are years as and who people published onset for and approved from generalized older, therapy with group in years review age

treat and to medical have improve LEMS relationships patients. practices those functional well-being medical on physician's maintain Catalyst that strength, about in out maintain to of ability for build education information found Oncologists Moving our the actively the and provide their neuromuscular are their muscle liaisons patient's to perception of importance the reaching function. that patient's expand thoracic to sales mobility. by testing FIRDAPSE LEMS or the already FIRDAPSE use to in MSLs, patients of order and oncologists

the the important a domains and and use specialties, of better in of are they are mobility All These FIRDAPSE life help outcome. minds for understand these the LEMS critical quality medical oncologist, an functional broaden of treat to additional efforts of treatment including oncology. will across

MSLs this responsible product. have support the treat is in address plans epilepsy. to for the spread also the about questions these be the public to that to acquisition also to add up has With patients. among continuing any to treats base MSL medical six of will additional treat FYCOMPA and physicians team FYCOMPA, FYCOMPA community mature a extensive knowledge to product using FYCOMPA physicians concerns within and that that Catalyst U.S. epilepsy knowledge epilepsy This may to

Catalyst new As community, a development support dysfunction medical CME week educational education symposium the programs, neuromuscular LEMS former of Medscape CME cancer-associated in physician provides continuing the service junction for the are to next ongoing the the virtual case-based part the A LEMS. that and launch positions. or entitled on emphasis will of

so-called efforts Part this have rights. enforcement with rare protect and of Catalyst the to drug of include in property pending applications patents. initiated all our and on our enforceability filed generic to Catalyst intellectual confident of for against remains Three strength FIRDAPSE proceedings year, and companies drug for patents. patents them patients new is listed granted the Xst legal and on develop products March enforce and also protected of is by other patents. the approved development, FDA's Orange protected maintenance, six by of Book, therapeutic therapies disease equivalents, FIRDAPSE and the Catalyst's

but to and will litigation, be to public no with records, regular in information cases additional understand, please the these our proceed, limited provide updates like will the statements. need updates to all community Catalyst forward-looking investment As court comments

FYCOMPA FYCOMPA, and Regarding the patents Orange listed the there tablet in a FDA's for few products. are Book suspension

omitted to no that, the it Subsequent composition these and and XX additional XXXX of to should FYCOMPA be a matter a to that an succeed Office should could still patent. request months XXXX, our to date June contends expiration III, is was it if this feel XXXX. assurance calculations. is of redetermination which XX, date which Schedule acquisition XX, extended is determined May exploration that final approximately PTO still Prior expiration does the first not, took the of of and do it The latest it There Trademark Patent due DDA pending, will the that primary the their be X, and which to of this determine date requested, and indication that asset, expiration prior is we agency be date Catalyst appropriate so. will from challenge May if the

and this completion X, The investment Book plans form for perampanel personal expires listed XXXX. of that enforce the at time upon other on this patent Orange will regarding community commercial evaluating Catalyst evaluation our this FYCOMPA, inform on or not patent. whether patent claims is patent of to the and July this

development, important strategy. business assets with continuing described we also additional Pat to acquisition acquisition. are to to our and It point this on our is Moving of for significant potential quarter, FYCOMPA portfolio expansion the identify

of approach, and each. epilepsies are elucidated, precision the of As with the increasingly of developed specific specific epilepsy being treatment origins for identified is medical medicine of rare with being evolving numbers field a more into biochemical therapies increasing being epilepsy

the our acquisition would a assets. commercial new and marketing that company, is this epilepsy CFO. rare like our support entree an additional the over Alicia infrastructure of the in into I to acquisition disease now to Grande, Catalyst's rare field will call time, that rare FYCOMPA self-funds At a of expanding way disease turn As

Thanks, Steve.

net -- $X.XX XXX% our We per net per GAAP net quarter when $XXX.X was for income $X.XX full in $X.XX increase for FIRDAPSE's very financial year-over-year, performance. and results net XXXX, XXXX year million, We revenue GAAP compared XX% $X. our diluted first and compared XXXX pleased basic to million -- for XXXX. share. or to revenue of of the for from or per steady million XXXX are share, $XX.X net with revenue total Total and year-over-year a remain fourth reported income basic a $XX.X of increase diluted principally million $XXX.X XX per

for XX% effective in For option the tax to to for XXXX an the XX% due rate due to in in an year was is decrease year our year XXXX, increase our tax increase price. exercises the The during XXXX. compared stock effective stock the rate

million, XX% of non-GAAP per income an $XX.X $XX.X of $X.XX an million. in future fluctuate income or We expect XXXX. remain $X.XX per non-GAAP diluted excludes and and which based to stock-based of that $XX.X basic $XXX.X was and of depreciation share, of year XXXX income. XXXX depreciation Non-GAAP than per This net income million, our $XXX,XXX periods higher tax million net for the net was tax GAAP expense per million, million, share, of million, $XX.X stock FX for of of approximately which diluted or of of $X.XX $X.XX compares The amortization income $X.X future for million provision $XXX,XXX, -- increase million. will represents basic $X.X expense net above net income $X.X excludes an periods provision compensation income in year-over-year compensation and $XX.X and GAAP from of

XXXX Cost of for for to $XX.X compared when increased XXXX. sales million of $XX.X million

decreased expenses was was to expense XXXX XX% XXXX XXXX. in to a fully RUZURGI of our overall total expenses revenue for $X.X million of million compared of of $X.X due quarter XXXX, acquisition R&D expenses to to third recorded in XXXX, R&D net and the in operating from of were years, million of of an offset cost XXXX R&D XX% XXXX, development principally to licenses. increase both decrease and as $XX.X XX% percentage by FIRDAPSE of million approximately product expense. consisted the principally royalties in For $XX.X sales an related for and in Research inventory,

$X.X contributions acquiring July and million as prior XXXX. RUZURGI to year the to is $XX.X increase charitable business, compared continue compensation for million to of [indiscernible] expenses to, changes, additional grow in the The we $XX.X our due with XXXX patients other and to amortization among XXXX. for compared increases totaled when intangibles, expenses SG&A LEMS connection of supporting of benefit acquisition in million

percentage a XXXX XX% to operating decreased for of compared XX% SG&A expenses As to total for XXXX. expenses,

reported, $XXX million. As ended of XXXX we with and equivalents cash

and January us revenue current million management to to without approximately in prudent growth expense FYCOMPA We late of XXXX allowed to to continued to Our continues acquire cash use allow such our diluted $XXX believe cash flexibility initiatives. any and financial. financial programs us strong position our our execute on strategic

of analysis value in Pat. such year the the The aware information of found our and over and is and periods will was the that, March XXth, and on turn performance be deposits Exchange at Securities I of may banks. which with any with full found situation. And for any other fourth hold second financial of or XXXX Form quarter More to Commission company filed the does detailed www.catalystpharma.com. Catalyst not can the call events website Annual Investor XX-K, on Report and be page yesterday, Relations our regional

Ali. our our We neuroscience communities. position revenues, further diversifying patient expansion, set within focused XXXX our and our the Thanks, growing and serving strengthening on space on site entered with

place elements We in for have another all year. strong the

care that our core well value are deliver to growth mission shareholders. with health patients, positioned aligns sustainable and We to drive to providers, our

operator time, for open like for turn line the I'd thank and At to dedication to of Finally, the over questions. lives. the I call their our positively commitment continued to impacting this all employees to patients'

Instructions]. [Operator you. Thank

Joe comes question with Sandler. from first Catanzaro Piper Our

around questions. two just Hey nice on And for guys, me the thanks the quarter. taking FIRDAPSE. for quick ones congrats Maybe

patients and four But do that the Can are say about number on with what then you XX then as about over XXX a in the could I see future? would opportunity? Steve, currently So you XXX into dose. of step that the mgs your is think penetration you suggests said around mg you obviously what a on period of what said follow-up, -- if patients percent LEMS you some to about wondering you think a are X,XXX there's there what percent launch mg, already years. Thanks. is patients what expectations that that that's label up updated and unique since say And total

do first it Steve. to Jeff, take you turn please, want question, then I'll to and over the

of remaining Sure. about total the and population, patients Hi XX% right passed away around X,XXX because the Joe. patients of The penetration these penetration the at unfortunately opportunity about diagnosed. is are if some population feel question you now. total new we of the and Significant look patients

So growth while like the optimistic XX% mentioned, continued about about very I penetration, there's sustainability. and confident

Steve, do want take milligram? the XXX you to

as the number, haven't I dose want dose. move it are there are that. publicly that portion the not XX can who large say patients, work on may well. of the Yes. to to a authorization on to a XX% move on XXX-milligram of about disclosed to to of regard physicians to patients Joe, we move believe the to XX. dose. number you don't milligram Catalyst actually the speculate on XX because XX-milligram on XXX. We get All there at XXX really that requires it's With daily will very to but independently is are some It's to -- patients number patients I are patients some And the who

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

Thank you.

Our next Charles with Cantor question Fitzgerald. Duncan comes from

for is couple on that patent Hi this the progress quarter. questions relates congratulations of the team, on I for Stavropoulos to FYCOMPA. have just Pete all Charles. Hi, a

current for or the can FYCOMPA -- leverage is, will can brand company's reinvigorating franchise? infrastructure first for the how Catalyst and you your discuss the strategy The

want Great, thank reinvigorating you. the brand? take Jeff, you the to do

Sure.

we'll the brand. what about FYCOMPA hope I towards, the are think ones all going currently how first are on midyear. and on There over our physicians personnel. resources are resources X,XXX to with surpassed be prescribing foremost, That's May that prescribing focusing sales that our our priority we When new franchise force. the applying to take we targets is we that's FYCOMPA, are the to the of and to focus marketing do fully that and to we've epilepsy the integrate Xst, by sales

a call during business little bit how this. we're our of to our you call more gives So hopefully, to next May. beat prepared conference We'll earnings share be going do approach that in behind a --

there's Yes, points the FIRDAPSE confuse basically transition Jeff second of and half XX% when gate. want we for between that and reps the the But year had about products. the completed, as a pointed carry things is overlap and for of both we to out in FYCOMPA expect out, the comp actually the will and don't FIRDAPSE FYCOMPA,

Great thanks. and

sales we of add call efforts earlier on lot doing that the liaisons a who safe want FYCOMPA. to the particularly educate to are one medical use liaisons, as the sales I during about community the be of comment will medical of adding part FYCOMPA, six to physician I just up well. mentioned

Alright, thanks.

question I is developing in for the potential rare indications? what's FYCOMPA have epilepsy Second

Yes.

as first to that May opportunities lot that. say We Epilepsia, full is -- is now, you to, getting published we'll we question. -- at referred just online. diseases. which FYCOMPA Steve rare this of our not right think to I around be quarter We're But when recently, really and There paper a which a Thanks at about prepared opportunity not in to more that with can for have regard talk used arms treatment the to Pat. suggest successfully that this the are a take at was the in We're, other program where our the I available point. call look have rare a epilepsies. look

of to exhibit the category. the broad epilepsies, treatment are many want that In product a to of and the also fall rare characteristics that FYCOMPA very I thing epilepsies with into the add patients other words, for the epilepsy label. that, label has consistent One

epilepsies types team specific within be label of can genetic will with the successfully fall treated physicians our FYCOMPA. that the which product So on educating MSL be

you. thank Thank you our questions. taking Alright, for

you. Thank

question with comes next Our Lee Securities. from Joon Truist

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

population, small question the in Jeff. were Could for has that is trended? by First quantify drivers utilized push and additional cancer would in how physicians that tests provided for specifically testing? lung XQ then many how And patient you what and antibody perhaps

that question. I'll for the over thanks Steve. Les, turn to

are antibody provided We of the haven't treated numbers with who actually specific any test. patients

significantly. increasing However, it is

is test has buy increasing we the how significantly. from And the data utilized, to visibility been test being providers. it that have We

What the I'll XXXX. a of increase BGCC And of in carry you saw number see XXXX, we the starting did significant that testing you did and to too. number in done, quarter that, fourth add through then see

levels So are done of to when previous compared BGCC tests that we're years. consistent high seeing the

the the small patient antibodies. there's approach to is paraneoplastic far As top that that as lung small to which includes cell cell when institutions working patients, and in cell small put protocol, so a our academic that's the cancer gets that with BGCC be panel a diagnosed done, the

that's and a approach top-down of So approach. our more

what data plan Steve, is essentially, and thank what that. it present from you your regulators the safety, helpful, you strategy? for feedback. Other primarily the patient the appears with That do milligram Perhaps dose reasoning pricing higher does than XXX the to is dose on to impact

it, before Jeff it let address to regard But up strategy, pricing. milligrams. to RUZURGI the remind on was that the removed I'll the just I'll and FDA Pat XXX with market for was approved you when anything about

we included. as FDA are FIRDAPSE increased of believe, as a all supplemental for NDA said, of dosage day, FIRDAPSE daily increase of milligrams XXX strength all are body FIRDAPSE. XXX we XXX taking milligram I patients the And an data to that whole, data using who on to we the on evidence per us again, basis of the of will to for the part daily safety mentioned the constitutes And reserve that call, -- the convince all apply let will also maximum the of in sufficient a of is to And milligrams. also our increase dose as and have the of to number maximum data I the perhaps be NDA previously that so of as who strength be

net And discounts milligrams rebates our more price and typical patient and to Les, what is remember a on net typical patient about about day, to XX with adult and have our it $XXX,XXX. around for after or regard is is is on And patient X gross you, dose -- that pricing, related, per less.

with the pricing there regard extrapolate could might you to So be. from what

and then very Japan all for could. well, I Great, goes the of kind just that, the over countries? in in you can that's enter how Thank last on And guess, strategy periphery for soon process helpful. you. of And one what's if market go DyDo team, Japan, regulatory the the the

can limited the what public I lot that markets. go by yes, the over I'll partners a -- disclose process I'm say our because generally don't to Japan. just Well in happens

in I step file will which during to the ongoing next and is call, all mentioned I NDA of the the Upon said completion XXXX. in data, As be safety collection follow-up they're data collecting safety Japan, their that from phase.

their be typical to about NDA orphan in their Japanese an should if the drug, of I review an end authorities. course, anticipate is acceptable is they the would time orphan XXXX, time the towards six approved so an Japan providing for average that cycle NDA months, for of eight As drug is that cycle

Thank you.

Thank you.

from next Capital Scott question Henry Our comes Partners. with ROTH

to or And and you year. Congratulations with three? you disclose of those but strong -- among to filings, a good do don't on morning. I there there's know Thank couple the a questions. filer is know want a regards A you if a lot, first three patent

take Steve, want to do you that?

Sure. is, they're In question is them It's The yes, that answer the first answer tied to all words, public information. other are website. your of The for filers. that's on first. all FDA's three short

make revenue mean, couple the from see per I shift great. patient, correct? to per that Okay, you higher questions, the you of to A revenue is want for to patient, other higher dose, Thank milligram XX sure just milligram generates would that the creep doses upward some expect clarification. often, with XXX

Scott, I'll turn that to over Jeff.

Yes, Scott.

patients they would -- feedback -- care I've have about will the now. average being benefit go from label. do for we dose increase feel anticipate asking they of health that is providers and daily our average the And if benefit it that patients. from for XX mentioned would our the patient before, within was dose XX, we milligrams So -- right able above do to daily

our time So over significantly. to dose with creep that, up daily we average anticipate

million FYCOMPA, $XXX And I believe, then thank you. Okay, in revenues in XXXX guidance.

should As months there we over far allocate we expect trends that should or of just trajectory, is as there? XX kind any

Well, completed the by Scott, the transition, be the and expect of we're integration in to midyear. process full we

over I pretty sequentially of base, and product. expect and quarter, grow by our this increase of the years product mature very XX to we're the Remember, integration so in completed a been course year the will, the year, the that run and X would And get it's for looking the market that's first rate ownership. established then to got a

overall get break FYCOMPA the QX from And that correctly you to better I Pat, for QX than thanks is my $XXX to out $XXX FIRDAPSE. $XX math your like it revenue color. million I Okay, then sounds guidance, if QX. if million, was for and did million,

conservative conservative? you So like it of I question are being the a flattening, you're it's expecting you -- it sounds seems say would is, guess, more just like or perhaps being

talking FIRDAPSE, Scott? For you're about,

Correct.

that QX RUZURGI the trend year resolution has Remember, RUZURGI during a impacted last overturned, think be of Circuit indication I the typical of transitioned FIRDAPSE. of Court the with Yes, it patients the approval been. to was and was XXth year's will first last quarter the as pediatric for when number

are new And see down. a want enroll be as either Catalyst pointed Pathways patients difficult out, we are and in just continue naive to comparison first continuation to going But probably it's to quarter. for product, we that. to the have rates that Jeff continued to So

think a to quarterly we year that typical sequentially up going so And have we're each quarter.

finally, questions. just clerical then And a couple great. just Okay,

I have And be X% statement probably you as of cover well, there? to income to tax pay cash more interest assumption? this that on as far But get rates. point, start reasonable line, staying guess, taxes the much as is that at will I generating asset, how the want you -- is taxes, that will income around do interest you significant. you're for the predicting a on sounds the don't it business First, like into

was Your X% we've first cash, what makes. getting about Today, X%. right our very our I our remaining invested it's would This where last a XX-day difference been And and were conservative a XX-day year, and -- year our say, been between basis blended now question, about is time T-bills. on seven yield on typically and Scott, somewhere points T-bills we cash. we've right, it's you're a investable

you're address be FIRDAPSE in you is -- to hard and can it's believe going to a again, this we're right, predict going tax now that issue. with pretty So right I a do year, forward. FYCOMPA. the generate big of Ali, to lot because quarter spot going that it's cash good But maybe

was for rate we the tax mentioned, XXXX regarding Yes, XX%. issue, as effective our tax

utilized losses. losses net net operating fully we federal However, our state operating and

XX% a in rate expect normalized do more to we future So periods. XX%

normalized exercise to we Scott, state Yes. more we starting to the back… forward, on kind guiding a I year, would of -- pay and XX% that going that according we midyear some based of that going last say rate also were that's taxes tax vary is anticipated option and

we but the Which for for XXXX really anticipate rate, better that be same will can future years.

for great. you Thank questions. taking Okay, the

Thank you Scott.

further that, this to closing Thank I for McEnany the appears comments. at no turn would questions floor back time. like we Patrick to you. With now over have It

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

today's teleconference. This concludes

at may participation. this for you time. your your lines You Thank disconnect