Catalyst Pharmaceuticals (CPRX) 16 Mar 212020 Q4 Earnings call transcript

Greetings, and welcome to the Catalyst Pharmaceuticals' Fourth Quarter and Fiscal Year 2020 Financial Results Conference 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. pleasure your my Ms. now is to host, introduce It Officer. Ali Financial Grande, Chief Thank you. Please go ahead.

everyone for XXXX Good call thank and morning you fourth corporate and and of joining quarter full results year financial highlights. Catalyst's conference our

on Chief and Executive Chairman Commercial Operating and Officer. Officer; Patrick and Officer; Chief Chief Chief Miller, call Scientific have Steven Jeffrey Speaking today’s Officer McEnany, we Dr. Del Carmen,

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

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

an our and especially year and organization. these quarter that update thanks challenging times. hope everyone healthy Catalyst, year call. Ali, and us safe commercial results for for has past morning year difficult is our Thank joining business staying during everyone been This and you, extremely this for end XXXX for fourth I

environment, non-cash very balance on press XXXX. yesterday. COVID-XX So end backdrop, were a the conditions generated which $XX in at $X.X $XXX.X we income million which operating stock-based included results investments million, are compensation from net our net almost and expense that in million, of of Despite of resulted under year the the release XX.X difficult the we included the in sheet revenue end and pleased with of very with operations financial the million cash that to of compared of additional

to the Additionally, I in commitment funded am say you debt. and ended to I we year few of but with steadfast we the and know a more effort say ongoing investments that proud minutes. million I will their cash details $XXX.X once I Ali in the demonstrate this how no patients again want that financial to just often, provide team's serve.

shown physician because have material starts physician. the about the concerns of XXXX. in-person an a visits on continue of Firdapse of had have to make resilience treating projected the or that not LEMS definitive have expand scheduling personal a LEMS their from for to new it have year, their COVID-XX for We remarkable difficulty their their number Last we patient’s benefiting in-person patients number condition. ability COVID-XX treat with a to impact appointment a who diagnosis of received challenging patients from who continues and somewhat to

future company in We our provide continuing our you see of to positioned in commercial you commercial with during report growth. we details believe improvement new New operation the patient see compared a months patient basis all for period. that are most more from to relative the the of and on will Jeff modest seen are few the pleased well a that I'm increase in starts past significant last on year we will and metrics. in were QX shortly. to pre-COVID we QX starts that Firdapse have

and innovative the add four strategic seven-year last and a protection for recall, announced in focus categories of technology long a over through more marketing drug of discovery. As have This additional and and will near other this early term. to senior position platforms better in-licensing person the an expansion This a to estate from Recently, of more more patent commenced this to our spearhead include expected acquiring and in value the with X,X-Diaminopyridine build accomplish years and/or invest are development, will in XXXX. authorizations. medication the to drug neuromuscular to national for research diversified will priorities, therapeutic MD innovative is stage broader, search Firdapse. earlier heavily this term at expansion protection least pending expect strategy. candidates likely company this PhD patent is individual patent believe leading for acquiring stage To greater U.S. in until programs patent investment, portfolio or to innovative stage out late prior outside issued company's this shareholder progressive development, orphan This or XX We development provide addition that the exclusivity product to relevant these disease. including for strategic To drug lead we be executive be technology. portfolio prepared experience marketed opportunities planning are our year, and of XX may patents in you strategy responsible will that and Catalyst earlier we

our program. Neuropathy in Pressure about few these with minutes. Palsies say strategic programs development will a as phosphate, Firdapse have forward current will this for Gravis with our HNPP focus study to proof-of-concept and to long-acting more of Liability Hereditary of continue a the developing part of plan, the a for amifampridine a or to Steve treatment on FDA with includes evaluating As path discussion which potential formulation pipeline, we the MuSK-Myasthenia

oral this we our Tuesday. a orphan anticipate litigation On which been Drug Drug for our the the has by have in Court's quarter of XXth decision of is the challenging our exclusivity District second the the request currently under court U.S. the year. front appeals XXrd, Orphan Act, Administration's and next the Food and the interpretation and Firdapse's March granted of for drug arguments, Circuit decision lawsuit filed briefs schedule, Court With sometime in this scheduled of or Appeals

Pharmaceuticals to provider takes Our previously for pharmacy announced as These near litigation cases, date however, the develop proceeding time no expected. is some against Jacobus through discovery Ruzurgi, is Jacobus’ activities, and PANTHERx, of other trial expected sole patent for future. types so specialty and pre-trial

protect Catalyst of specifically patient the Carmen, important Catalyst steps necessary rare population. our LEMS Drug programs, Firdapse for about represent and to As to Commercial encourage Chief that Jeff patients, the aggressively this you previously, Orphan continue commercial Firdapse, to over patients’ we development Officer in Act, ongoing further adult is exclusivity At litigation diseases. to for these services note with which to have it all impact market our Firdapse details point, way to with call access no which like intends or stated for Del efforts activities patients to ensure drugs marketing provide Pathways, take I'd LEMS XX% to of operations. our under the is the our turn intended on to

walk morning, detail. XXXX performance will Thanks, in now I Firdapse everyone. Pat, more and good through

a U.S. are which of We XX% year million, sales pleased full net with growth represents very year-over-year. the $XXX.X

the any XXXX. in be dynamics of a reimbursement net our to ability to our community. in month compliance our million of continued new testament recovery driven enrollments than quarter, and less entire In naive thank agile, for XXXX since XX-day this a was than be Growth maintaining relatively patient XX%. patient outstanding XXXX, the in enrollments by discontinuation and Specifically, performance while in COVID-XX. flat QX were net and QX QX want XX.X U.S. since outpaced revenue their QX best favorable opportunity QX, enrollments a rates. take was October, delivering true I XX% and Catalyst to commitment sales, to very are team new the LENS to higher In since XXXX, and persistence quarter RESURG The QX, by strong minimal in to X,X-DAP continued resurgence XXXX. new May despite discontinuations to other stabilization QX primarily to rates

in increase, growth for in-person we upon COVID-XX patient same expect the We year, visits. versus last momentum the quarters QX allowing continued and vaccination more XXXX to continues generated in build as rate

highs rare of effort enrollments. non-personal enables disease inside as close healthcare experienced XX,XXX patients, efficient to professionals representative the an impact our lead will more Based in-person patient team, sales sales promotion achieve coverage that observations, will of visits new pandemic LEMS early adult the and patient in to for new in While subsides. the new combined enrollments treat potentially increase on

that XXXX. now patients we XXX in Firdapse XX% lower proud the over fact, were In prescription. to received are Discontinuations than January of say January have

caregivers providing covered remained month. patients enrolled XX% foundation which far, LEMS $X Patients have all that professionals. and access without or commercial been a tremendous pandemic, Pathways Catalyst XX% insurers. to to team Our the did Prescription adult have over reauthorizations patients, job personalized government had XXXX, support patient rates approval private granted payers, LEMS Throughout have Furthermore, disruption. LEMS in than and Pathways, we extent of they accessible confidence the adult committed to who payers. In thus assistance, Firdapse Firdapse across services affordable including is remain law. in of recognized XXXX, by Medicare Catalyst and co-pay allowed making of by less the by those to patients shows applicable an value per are accessing to Firdapse average all healthcare

confident remain LEMS our Firdapse, on LEMS the of not in number adult potential on market. yet the mentioned are misdiagnosed unfortunately call, are patients assessment the we patients a significant addressable of earnings I that remaining undiagnosed. or Besides already diagnosed As QX there

to both educational journey. help continue professionals LEMS diagnostic We invest robust and in towards resources to shorten healthcare will heavily directed patients

are XX% tumor approximately Additionally, LEMS patients patients. LEMS of

LEMS known than However, Pathways Catalyst patients of patients. currently be less to in tumor are XX%

closing, very research, XXXX better we conducting understand about tumor LEMS serve are groups how working to help in We are these actively potential patients. beyond. and growth market for we identify Firdapse boards In and can ad the adult optimistic and

experience our activities. an on to Officer is and Chief Operating I team R&D disease will in LEMS Dr. over Scientific Miller, Officer passionate call Steven the Our community. turn and rare about serving now deep the for update Chief

in analysis for Thanks I'll Catalyst update an update, Jeff. clinical additional X indications. for trial with concluded previously trial on pipeline Gravis MuSK-MG achieve of Also, that study on a significance Firdapse detailed observed provide on that did our stated attendance. of Firdapse symptomatic safety is and At the during We half providing Firdapse as dose-titration period reported patients during remain now primary endpoints. follow-up investigators about persistent develop for clinical improvement potential therapy this this secondary safety the marked multi-center of our why the meet benefit. to point previously, Phase announced from they commercial follow-up had of our the did have this clinical reasons and time, in in trial significance or this trial. not not was patients and the for by statistical treatment MuSK-Myasthenia initial statistical the study

also proof-of-concept clinical seen previous significant was trial. Additionally, the improvement in

that of to resulting from Our sources day day. the patients can trial degree first the may unexpected excess these protocol variability efficacy. during double-blinded of in of is We demonstrate during the a clinical clinical sources trial lack symptom a appear that redesigned in data variability and dealt present of significant a to trial variability of half to power revealed there of the short XXXX. withdrawal exhibit FDA better trial, discussion statistical plan adversely our be a with symptom analysis period. MuSK-MG of duration of affected the Further, the to hypotheses These for significance. observed large believe We the new variability

with to leakage basis effects disease caused in Pressure of with peripheral blocker willing in differences Firdapse a Specifically, HNPP pathological first gene, for neuron report trial will axons. half proceed disruption third whether be this design and anticipate efficacy. trial a and In completed whether initiating proteins PMPXX is of inherited new and channel Catalyst of a meeting, receiving to focal sensory or Catalyst with incorporates evaluate HNPP focal to discuss the completing with and the will to of potassium normal year. sheaths this of motor is with by we a a triggered decision channels XX% of and motor design or the The HNPP accept deficits, PMPXX agency adequate in that new Patients these determine of reduction or healthy not evidence different we the be evaluate the an is proof-of-concept design paralysis. Firdapse this channel during We of with may mild and parallel passing that mechanical present autosomal-dominantly the deletion the activities, the be meeting often agency compressions in investigators. sites the with will meeting minutes. indication to the is XX% trial trial trials, numbness would new a the of nerve by of new innocuous by will FDA The the [ph] leading of Palsies potassium scientific myelin of quarter with level, completing of and our trial observed clinical the to Liability Neuropathy to this of results discuss design leakage new sponsored people. the to treatment relative design which heterozygous after neuron may XXXX. patients. not sensory demyelinating mitigate in the we is new study Hereditary events After HNPP. including potassium considering HNPP a

patients afflicted functional a to excessive Catalyst research improve alleviating the HNPP, in It is channel This deletion. and voltage-gated by motor are fatigue. through outward States. HNPP HNPP. about fatigue that current X,XXX potential In is of is in hypothesis in thereby deficits, supported HNPP deficits channels. addition, hypothesized expected that Application believes with also blocker, patients internodal propagation animal is action affects Unites HNPP sensory heterozygous patients HNPP model potassium by demyelination potassium amifampridine, PMPXX like in in

Firdapse as have LEMS. reported a to Japan treatment be Japanese Moving be years of would approval and for XX a and market, on the Firdapse entity the would that opportunities, granted markets agreement that other for pathway initially such on we with chemical to market research seek previously of we regulatory PMDA new of reached in exclusivity.

the and of for market to with about reminder, market the patients. a are There XX% therapies market U.S. Japanese MuSK-MG the no X,XXX size the Japanese in As is about also HNPP. of X,XXX

of first on of developed pharmacokinetic will of These medication long-acting effective formulations. or the inform our only in is the with have the goal need PK results under the design the product and once an will evening. have formulations morning Firdapse those of that in group future PK only and Regarding development, candidate formulas ultimate we with patients providing to take once study a completed they also candidate

the anyone related A Pharmaceuticals of has issuance patent suit against court about the Catalyst X, case. expiring design the current franchise would also product of has are We have and for physicians U.S. interviewed superior of has patent. on LEMS number more X,X-Diaminopyridine franchise. reported to developing optimal of to be XXXX. only and for Catalyst input into number an protect progress also That property PANTHERx infringement basis intellectual numerous made April of is methods the administrating documents our Firdapse filed case the they federal offering. our also the get available to to Jacobus and induced to publicly design significant goal for patients that the the estate an the product. protect we feel Firdapse begun for issued in in this Firdapse learning product Firdapse Last interested XX-XXX-XXX, input October,

patents Catalyst an of under use of In has most, pending status Track not at them, U.S. published. that Office, we XXXX. these all related Firdapse recently hopeful All addition, four that are the in are to prosecuted other of Patent being addition if were and Trademark and four patents the One

legal Financial this review over turn appropriate action financial now to Ali patented taking anticipates property. new I to Chief intellectual will also Catalyst patents, our results. these our call of Officer, issuance Assuming to Grande, protect the

Thanks, Steve.

difficulties year pleased we with As Pat Despite COVID-XX remain XXXX we our the from steady the very performance. are pandemic, mentioned, results. in our

expense We to in sufficient to cash without XXXX. our positive flow quarter is sustainability management in self prudent and be position quarter cash growth allowed believe for every need revenue we financial continued future any achieve the release. and XXXX us fourth Our reported and press our Yesterday, dilutive the financing. full SEC our XX-K with year in a results filed Form detailed

those of now. results a highlight few me Let

per XXXX. tax and per per share to for diluted XXXX million total for revenue share the from income which was We year XX% net in third including basic the GAAP recording in represents the and $X.XX diluted a XXXX and diluted achieved a basic Net benefit For XX.X tax net XX.X of compared of per asset, $X.XX of per XXXX, XXX.X of $X. million income or per $X.XX $X.XX for XXX.X $X.XX reported reversal XX XX compared GAAP XXXX. increase. to we includes basic income of valuation allowance quarter share million or deferred year-over-year of million XXXX, million the the

stock-based million stock-based income, X.X $X.XX non-cash diluted share. non-GAAP million and year million remains non-cash related million XX.X Our $X.XX In year to per income, was comparison, Cost of our $X.XX consistent XXXX as diluted for the per XXXX basic related sales excluding net XX.X basic expenses XX% million the XX share. or per of compensation, anticipated. or per X.X of million was compensation, net at expenses of XX.X XXXX to non-GAAP $X.XX and and for excluding XXXX

year-over-year increases from SMA to and As the as affairs prior in down for regulatory million in from and quality we our medical, clinical primarily benefited development The products XX.X to approval trials due FDA expenses inventory is expenses in X expenses approximately million MuSK-MG X% for Research a our reminder, XXXX decrease out assurance from of and XXXX and ongoing research programs, for Type and XX.X XXXX. closed expenses of studies and XXXX, Firdapse development expense were Firdapse. cost trials. reduced

access expanded to primarily disease to treatment seek approval evaluate a programs, regulatory expansion formulation our diseases. be for development research agencies to with to support treatment first LEMS for in our study increase that additional expenses is XX.X Firdapse of expect the -- increased totaled including our million personnel and quarter our for substantial Firdapse The neuromuscular The will continue G&A as in path the SG&A of begin our expanding cost and sales for attributable continue rare contracting in we in Japan of million as force began operations. our HNPP, of relations proof-of-concept XXXX Firdapse, for a XX% XX.X other the supporting compared XXXX our litigation, in program year-over-year costs to of to and XXXX. access We experienced XXXX. sales cost, investor continuing long-acting

continue over to revenues we expect will company's and may steps report XXXX, information had and analysis expand XXXX December SG&A found XXX.X We filed expenses I'll can of to site Web XX, XX, and the in XX-K, our no And annual page Firdapse business. Catalyst on take of from substantial Pat. Relations to that and efforts increase be More on and was our the yesterday, continue as which million detailed investments the Commission funded debt. Securities in cash our and Investor call be March the Form to with at found Exchange with turn that, www.catalystpharma.com. be On

close Ali. overview XXXX. prepared of providing by with objectives remarks corporate you our for I'd like to today our Thanks, an

foremost, launch of emphasis which on Firdapse of the commercial the strong continues and First cornerstone for represents LEMS business. our patients,

LEMS treated be yet effectively with a our year not to as pandemic, work begun are been diagnosed, just in back are move have we Firdapse. we many As as that anticipate or post accelerated patients more of rate the to have that more growth been we believe We misdiagnosed there who more believe can beginning has progresses. times normalized revenue

on management, needs. the include a currently to search an is Product initiative unmet strategy board aggressive execution potential Officer medical is This to executive why in-licensing treat Chief will lead plan. Development underway. portfolio of rare and additional or through portfolio development, to Next, bringing therapies the of acquisition build This a a

for our protect and we patent and Firdapse acquire. and may exclusivities continue any Third, that to statutory other assets prosecute

applications will develop We new patent continue additional as property intellectual to file we our surrounding assets.

developing the meeting continue trial and study our development second the disorder. Also, by quarter good HNPP commencing work path from for at long-acting the FDA Firdapse soon reasonable formulation a are MuSK-MG in a determining we continuing with to our there Firdapse. threatening and if our Next, efforts for for to forward findings discuss we regulatory of was will life a for pace this proof-of-concept

beyond. We Lastly, XXXX. value growth and company we along This approved that company LEMS multiple how a and XXXX strategy and we adult ways We pleased treating ongoing to development to now build Firdapse so shareholder say to year our physicians success commercial our fiscal with expansion means want will a to execution for your their an to continuing with more assist disease. the I’ll will that may while this operator positioned manage the operate are continuing we to take the to portfolio. to for find with call of discipline. look transformative be well our team gain continued with XXXX strong programs operational clinical that global just FDA to once the the I for plan delivered and results believe forward during Catalyst patients commercial to access for over efforts now is questions. therapy our turn build a in and

floor for [Operator The Instructions]. you. questions. open Thank now is

is Our Joe Piper first Please of go coming question ahead. Sandler. from Catanzaro

more taking seen call were XQ since quite like point the seems could that new July a October was any XXXX? bit Hi, patient and at on in fact starts based to in the guidance a a it your enrollment have and my but highest to trend. comments that for Thanks whether so maybe weren't to guys. trend mentioned questions you've and ready speak that of call, you you little here. November, if in you now On much It your issue some wondering XXXX expectations I'm that

question. for thanks Joe,

quarter give country guidance. or physicians again to open as patients seeing actually and are another Let person we starts in to me We'd two first guidance. like address see the before

prepared not today. So we're

provide that another that should time. be two, quarter we to at think I prepared or guidance

we your are QX. trends of question now The first forecast back let in of seeing our part Jeff that terms I'll address versus in

right. new In QX very and specifically Joe, November, you're and October, Thanks enrollments. the strong Sure. for question, QX,

there November the know, the thankfully, a But that of of As which December, little in a bit bit. a is trend and open pandemic kind of country bit. QX and from resurgence which that's slowed little naive little we you tracking new best new we're our QX enrollment so up And very a since significant. far, of to order XXXX, in is patients, are seeing have

team So fantastic is a job. doing the

I The of before wanted is, in too, other XX% that right to add force thing mentioned an there Ali it have pandemic. expansion our the sales expansion, we happened

the that We have fully to yet expansion able know true potential. be We will will we and realize to see physicians. see that patients and their see

So all growth we things expect significant combined, in new in XXXX. those enrollments

And could follow one thanks. Great, up. I ask if just

numbers. So start things it if as wondering from person. seen seeing in sounds like open up patients have expect largely maybe I'm their to your you've any pandemic those rates improve XX-day potentially that to held number you impact also and discontinuation the to steady. physicians if begin And

decreasing bit. XX%. It's say quarter that Right to see be had We a a continuing discontinuations very of also to less that that, is are could good than since question, strong, Joe. -- that best second I the pandemic can And this be we in stable, the don't now at response the the we've discontinuation tracking maybe to launch. point little our see rate XX-day quarter in QX,

seeing too. positive some upside we So are there

taking Perfect. my Okay. for much Thanks questions. so

Joe. Thanks,

you. Thank

of Duncan is from Fitzgerald. question next ahead. Charles Please go coming Our Cantor

I you one question then patients your commercial a Yes. Pat question I for couple and With taking Good quarter. regard questions. population, will, and question, commercial our the think maybe of Jeff that on relatively and pipeline to Thanks patient taking if morning, being in underrepresented a are Firdapse. had mentioned LEMS tumor team. congrats nice

It identify pursuing could any are some initiatives are going you And seem patients or tumor endeavors that. putt more so to be LEMS guess in to the to easier I see with specific ways be patients? forward? tumor more we drug taking an LEMS that to there would accomplish And

that I'll to Charles, Jeff morning. for Thanks good the over turn to address. question.

of XX% absolutely patients So, patients. have up data Charles, you're LEMS. tumor XX% seen, to the that LEMS to opportunity tumor with From we've significant LEMS right,

what underrepresented current out is Catalyst So population underrepresented our those Pathways. now we to do patients right -- our want in are patient of

boards, can so are research so. patients better and we and the identify We we So will those the doing to on We continue to ad understand doing we patients. there data those to a groups, are purchased market can quarterly claims do how we use working claims identify basis. data needs

provide leads. help us that So will

provide the is instance, are treating, one highest want rate focused Small to has cancer number that key cancer LEMS lung to for information cell lung tumor for small oncologists small the we Now here lung cell example, cell of patients. are cancer.

will own to materials then an will give we those provide educational to to their those those And and on focus or we treaters neuromuscular diagnose So to physicians on neurologists oncologists. or and direct also out refer opportunity physicians either those prescribe.

of of the that approach. also are over expand course and fourth quarter our this third into that's So types associated tumor XXXX. and with LEMS And then we'll the also that out then other year to

helpful. color appreciate that's additional the I Okay, that. on

or the meeting you quarter? the then question the to in see And to Now MuSK-MG, is hope FDA turning scheduled actually guess With pipeline, I second for to regard has Steve. a high that expected observations that the been appreciate the have with made, on to I this. randomized the color protocol regard power. would to MuSK-MG have you that all with I be withdrawal relatively

And impact confounding to color that variable do and on perhaps Is going the symptom potentially longer of on you provide you that drives period, deal and can the a upfront variability to or you of that? identify study can what what you screening with reduce this something the outcome us alluded that so any can forward?

Okay. Well, that's a whole questions, bunch Charles. of

It's With to period just the exposure in trial a we've we more The the of I time. the end. answer to meeting variability phase any detail can the remember I'll the at to we collect just regard and you very effects Let was it variability as meeting, that one that the provide at during to will them average data more answer just we randomization period happen is And And involves said. me and second, variability the of patient point within provided, point try with regard out beginning all. really simple. the resolving can't but hopefully contribution, already the of observe. data data the short deceptively the collection one assure

And the so is. that's essentially what plan

We will data lots telemedicine. of through collect

Okay.

additional saying I not trial? Are So more to are additional referred you trial. you new trial. you anticipating observations within thought a an an

Correct.

new to and data? We design collection that are the trial be presenting the of to FDA includes of a going part more design,

I got it.

you outline in run the design Okay. a would I this starting the that within you Can proof-of-concept half tell And regard second the you like trial And anything the with year? appreciate on as of that of opportunity. then to be would trial HNPP, us that HNPP? about to

Yes.

As we the at HNPP. anticipate with completing because still the trial starting third on the said, provide design any the this in quarter. investigator design we're expert time, an who's can't I in details I

pipeline? but funds cash trials; current at and question of half congrats positive, MuSK-MGX only that Okay. Last great raise stuff. think for or with on the there good this to fund you would in not cash flow Ali But fund regard perhaps to Is efforts, the do the one HNPP cash, that when about two second commercial to additional perhaps additional you the also is believe year? you sufficient it

as pointed out, $XX this expect take quarter Ali now that cash. the right million year Pat. as will $XX between ended, million We're a I We goes year with is in increase to XXX on. that somewhere Charles, and question. I'll generating million last

that well I positioned. we So think are

looking today studies solid. hand got actually cash these we're conduct the we enough cash on currently which to that We've doing. opportunities, we we is sheet that about at have believe talked other entertain to and balance Our

generating to cash on some quite With there available a we debt the have the had right ourselves, the currently time we've that asset on take for the some we're as as not quarterly us would that been that has for balance God. well to and debt. we right basis avail certainly But opportunity, sheet and thank

sheet hope corporate good this I our with your in So balance shape think answered year. we're I question, but I've and for objectives the

Pat good team. that Congrats addresses for information, Thanks added the Yes, on it. quarter. and a

you, Thank Charles.

you. Thank

Securities. Joon from Truist Our Please Lee ahead. next of question coming go is

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

to the First partnership you the also in in what be update you. the the Canada. on an revenue on contribution I near and – And update expecting there? search Thank Japan in in efforts get would just commercialization an term on want

Sure.

press registered our in in in for have a to And our With to QX. with to for with we XX-K, Japan. is moving time discussions ongoing case to currently was hope have These litigation you as in any decision that view that our release U.S. partnership are in with approval, As hoping market, something we partner and RESURG been we wind and terms. we population that Canada, which to most We meaningful regard negotiate a agreement We're early based roadblock had we that get representing for our and after next some a XX% forward. be say we on said optimistic December, discussions opportunity the signed, is that being just regard up will can Japan. once of partner to quickly Canada's as Health contributor are of drug definitive to quarter, a day quite litigated the the about are now. decision going We've in as that know, hoping part. there, approve a a our days P&L bit XX that

So trial make the Canadian outcome difference certainly the that market. big of a could in

pricing you versus against efforts in the Japan U.S. the Can and also discuss helpful. is strategy Canada market? That

about and different Yes, of Japan. know, markets, is as we're based talk you on yet not and to for international prepared pricing typically pricing Canada those their Both baskets.

price so Japan lower. will price that in expect in and Canada lower And U.S. the price the be certainly than be we will

you. thank Great,

Thank you.

Thank you.

next ahead. Scott go Please of question Henry is coming Our Capital. ROTH from

and the morning on congratulations positive momentum. Good you. Thank

Scott. Thanks,

a questions. couple of have I But

for a seen came is across that patent little which to which an patent was international to I different, you sexual dysfunction. X,X-DAP talk have may about filing? what you First, treat Can motivate

over Sure, the I'll question. for Scott. Thanks Steve. that to turn

And Scott, an right now. I there only it few interesting a Well, things say that’s about question. are can

patent potential potential if and this ran pathways you evaluating recently. clinical to possible with these of And that application patent update a XX detected this the dysfunction Firdapse. as and cases treatment the reports, a patent in decide Catalyst for for this the February resolution As development few that improvement a new primarily in with time. value Firdapse sexual and we program on dysfunction probability for filed the was of Firdapse our the on is experts and year, in launched, indication across explore consulting Based unexpected of potential it's of we'll published issues, sexual success and for patent obviously female commercial we patients. was the community of further, indication investment at pharmacovigilance

Thanks color I other have couple a that, Steve. for the Great. did questions. on

curious Should standpoint, changes sequential as modeling stability just assume pricing with a patient, we that? per from basis? there far revenue how or on as been First, has a are any

a are our basically that is line certainly increase right -- line price rare drugs, with in with selling in in is we've price stable. had and inflation. peers And disease that Scott, line

Okay.

of other you asset the Speaking and we least at say which investing the balance at you of share cash with would -- a of portion inflation, that? a or small least a is. through you a of lot lot in would company a sheet, obviously, some consider cash buyback, on depreciating your consider have power as you're perhaps companies, generating is taking at Would own purchasing look

that results, as is believe in of we say companies. opportunities that investments the price everything and are make look around stock cap based We and/or low therapies our on I us. Scott, extremely on do our market acquire would table and the front is that potential financial to to

off point. I the that this we a wouldn't say at would as table So, take consideration

question least fourth about and we forward, quarter. at great. think final quarter in Pat, third collaboration number just that Japan should Okay, prior How revenue going and showed the coming to it Canada in? line, up

that. answer Ali let I’ll Scott,

-- from the collaboration collaborations is the quarter quarter revenue and in to the Actually Canada. fourth third related from

Okay.

at we shipments initial expect any similar related that. or to on levels. that continue then perhaps know some color timing So there's should I don't there, if

lot the case think court to that forward, have resolution Scott. with of will a do going I number the

questions. Okay, the taking you Thank great. for

Thank you. Great.

to session. today's management like that for question-and-answer gentlemen, I concludes and would Ladies comments. turn the to floor closing over back

Thank great Have and look I to joining calls. forward today you day. for a us future

gentlemen, and interest participation thank and in Pharmaceuticals. you Ladies your for Catalyst

phone and disconnect this may log the time, day. have at or a your lines You webcast off wonderful