Catalyst Pharmaceuticals (CPRX) 19 Mar 192018 Q4 Earnings call transcript

Greetings and welcome to the Catalyst Pharmaceuticals Fourth Quarter and Year-End 2018 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Officer Pharmaceuticals. Financial Chief Grande, for Catalyst Ali Thank you.

may begin. You

Officer; And for morning, McEnany, conference Dan Chief Brennan, Executive Officer; call. Officer. Chief Good Officer Chairman Steve our and Operating Chief Chief Pat On thanks and have joining everyone. Scientific Miller, we today's and Commercial Dr. call,

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

to a the an approved, treatment strategic my access evidence-based remarks on the for priorities. three for Firdapse, and everyone at January XXth. LEMS patients any like treatment in was had It focus today. for myasthenic Catalyst morning, patients syndrome was on of today that the Lambert-Eaton launched the which treatment. unapproved had United adult small Good all year debilitating commercially in struggle you to patients a with that approval of was of Ali. no pivotal or you, a Prior for in joining us culminated I'd thank States was amifampridine of approval number LEMS. years. Thank our effects XXXX investigational year form Furthermore, only of to transformational who Firdapse, also option these

First our importantly, positive third, successful SMA of the CMS, for the execution plan; MG execution informing clinical of to Firdapse evaluating about other develop been of most start to all acting Firdapse launch what continued antibody Type treatment I'd and trials by a MuSK efforts and launch start and second, a the to formulation of the you like very of has Firdapse. commercial X; our Firdapse. the strong longer

most know, As of were XXth. launch-ready you of as we January

phase to and of of Our a initial period smooth transition the has primary commercial seamless Firdapse. goal patients experienced X,X-DAP during been this launch all

effort, Clinic, patients have that part Mayo centers the of other transitioned of successfully from the excellence. Cleveland Clinic, we well As Duke as University, as

has I'm we from pleased patient report a that of are to an that drug. aware remain of missed desiring on this to During therapy early dose not single any so program access transition, far,

despite most addition, experienced concerns of with that initially, expense treated some less. In $XX Firdapse have all an month patient or patients per being are now out-of-pocket

efforts successful most important execute Firdapse. launch to priority laser-focused of first to continued and our on The a remain is

approval. in the expected. achieved patient few the launch, prescribers pleased program has launched of the experience the that in which of been payers, time to strong services to-date first Catalyst including start comprehensive Pathways, tracking have was patient or progress Firdapse our than of our is at respect breadth with momentum quite number that of With better are We months the enrollment we forms with the and

Shield Blue the would has represents well-known about such few been plans payer including far, Prime exceptions, as that country. Express a with across payers large, which Aetna they Firdapse, has Blue Cross cover and Scripts, Cigna, indicated every presented So XX with that Caremark, claim, Therapeutics,

launch. Friday, March a performance indicators into So, our as with launch the two of now, you last few let me of key months provide XXth,

than more currently LEMS and being have have treated with more that enrolled patients Firdapse. that XXX are Catalyst in than been patients XXX Pathways We

prescription our least have physicians fact unique especially at Firdapse that provide details in for XXX not Pathways, XX therapy. is access through Dan written our an is patients Catalyst Catalyst we've Pathways hub. have will commercial enrolled previously gratifying who Additionally, to amifampridine shortly. on the one had And patient what more drug services activity

In of are We early possibility, uptake were well-positioned. chain with our inventory this the pleased partners Firdapse. commercial preparation supply and for

to case revenue that quantities should to have months. full time with a Also, Firdapse experience we for At position sufficient we’ll anticipate dosage be the We quarter a enough of forecast next during guidance May. active have supply time, of manufactured the an first ingredient next we announce scheduled have in be best the to or form API, revenues months. manufacturing provide few and project we confidence to the that able We year for results that data in range XXXX campaigns for XXXX. pharmaceutical early XX by our additional

this transitioning previously, as experienced most base end progresses. of a by and second year of anticipate pace have enrollment we we X,X-DAP the patient As stated from meaningful slower the patients then quarter the steady,

educate fellows Ambassador be that Dallas. through and neurologists. U.S. the LEMS, MSLs. Firdapse Our but later view our patient Fellows also patient medical as participating. in academic XX Catalyst and To affairs young LEMS this physician We this sponsoring team community end, longer centers the education we’ll Neuromuscular not from will program month, across about only our be critical programs to first one requirements the continue success better term, of upcoming

to expect programs year. similar times several conduct We a

Firdapse for Type SMA in Our next and of treatment evaluation clinical priority CMS MuSK-MG, development on trials X. remains the ongoing the front, the clinical of

to of we in MuSK-MG With refer as programs sites trials we Collectively, on and trial These XX are the and will Firdapse top U.S. and in these programs activities some for Europe. Steve platform. comprise the details this second top-line trial, neuromuscular MuSK-MG clinical later provide the in more half development the of year. these CMS to what presentation. clinical working with experts continue enroll we results the the at anticipate

Assuming other medical unmet the substantial the trial serve needs are coming satisfactory outcomes in expansion to the believe neuromuscular, label patients to these rare, FDA, opportunities years. programs we clinical represent with

specifically Our night each throughout long-acting dosed steady and adherence additional a medication and on for drug also would Also, twice patient product to that forward once patient the We're LEMS provide LEMS around designing to dosing medication lives and addresses plan they program patient Patients day, a provides important of from need better a our effect their It told LEMS we received for development lasts they’d patients. third They've further day, requests these needs. which like activities could priority so formulation a don't compliance. for through relief based that is our a the have to the address formulation stated their we day input. Firdapse may that to times. needs to desire sleep. improve know gratifying be throughout us daily program, they their be efforts moving lead on development and Sustained a and have Firdapse scheduled of the or while is this that expressed able symptoms likely that Release through LEMS that

insights call over to provide into the turn Dan Dan? additional me let our some can commercial activities. Now, who

Good Thanks, morning, everyone. Pat.

have by and launch the today seen like moment far. early take encouraged to what trends, thus I'd to a Firdapse are we We share

about our data these States estimate XXX me X,XXX LEMS Let period last X,XXX of patients we Access literature. that the Expanded claims epidemiology published two-year and the are Furthermore, over recent approximately that well the are patients we patients Jacobus of in there you, indicates estimate with investigational accessing approximately in X,XXX United believe data the or currently year. other diagnosed. at reviewed via that X,X-DAP end study via This Pharmaceuticals were unique remind most triangulates

efforts focused on patient LEMS Our goals and have initial important two groups.

lapse starting we year. starting transition patients this effort on with of XXX X,X-DAP. available to who X,X-DAP in inexperienced second, successful XXth, these Firdapse and who were that diagnosed Internally, Firdapse Xth -- making First, describe or the February to naïve patients patients for all their LEMs with therapy; drug, previously previously but January investigational other were as no so

pleased good both to-date. those We areas progress of to have are made on focus

First, to enrollment patients believe almost X,X-DAP our system. have we investigational or Program, X,X-DAP patients Firdapse that on January patient our Catalyst began desire Access forms Jacobus all from into submitted already from to transitioning Expanded shipping who service transition Catalyst XXth. We pathway

our certain can’t each our have estimates, a access patients. according every to we and these or physicians patients course, have listing that into But Pathways Catalyst in system. be sites of LEMS Firdapse we to and sending because appear have specialty with their most pharmacy Of of full those into Jacobus to form enrollment one don't enrolled transitioned a

transitioned were according shipments January, our for patients dates study was Access and with that this and and In be access programs. naïve to These are our patient aware prescriptions monitoring physicians the we but Expanded availability call. need via other of of and enrollment unable shipped coordinating received their Firdapse a urgent Xth dates. to it conference primarily because on and closely exhaust aware first Program strong X,X-DAP been time of are January by the of investigational who date, February XXth, those of We should fully form also X,X-DAP from X,X-DAP patients patients our and exhaust patient next to announced by ahead of the one and have patients

through more last compounded patients least have that have In of into forms adult were who patients these of unable encouraged submitted since forms unique enrolled end the enrollment X,X-DAP, includes XXX XXX and have Pathways Pathways. obtain total, a the for completed as prescription. enrollment Firdapse Firdapse via these the We or LEMS patient Catalyst already Firdapse unique with of a prescription of widely at are total a prescriptions who turned very were previously been XX it Pathways Catalyst investigational Catalyst physicians that for of making of than there Each one shipment first and/or available. week, to

neuromuscular X,X-DAP the potential seasoned physicians part patient approximately claims IND having site. many of specialists, LEMS sales our to force data whom were calling includes or known But is and of a according our Program on analysis Access part process. diagnosed X,XXX this were of or of Expanded healthcare neurologists Our a with high also review

being through not have targets, behavior and made by and field that QX, deployed Good and X, targets this of our in progress our we We earlier. supplemented confidence with on to existing educational targeted leveraging end segment promotion additional efforts mechanism gain RAMs both insight regional digital into awareness generate if level or further follow-up. outreach managers leads four means another tiers, Tier account approach. we we Tier This to into further providers non-personal segmented this is with base, is field priority of healthcare reach and valuable for target expect an reaching the X manner XX% in optimal have further this universe force priority to physician

Medicare as wide pharmacies. serves to of support, now Our providing and number to Firdapse those our program, and Catalyst on, we proven and array also formulary ranging also a and specialty is limited see program, since and these patients. as from reimbursement for launch The program to Catalyst I operational gateway served of awaiting patients a of transitioning placement delivery channels. from a from treatment high support as uptake and then door-to-door drug as for to for essential has access and where to of It commercial, fully providing to education developments. is a well reimbursement patients the medication Pathways product support financial programs. touched our assistance resource for with medication their diagnosed want turn logistical bridge levels free or access, disease product government physicians with personalized LEMS Market market Pathways progressed investigational positive Pat

response insurers of We have medical positive based our recognizing medicine impression benefit clinical by need. the seen the and a initial of the on

process of seen with few We but the feel found authorization formal label. expected requirements placed inappropriate our account what requirements team we and or a is national our insurers that Firdapse prior what outside have not included Pathways denials or field. assisting appeals our have in in conjunction are is on have Most from any Catalyst managers with in only initial the problematic

ensuring and we or patients is while benefit a in Catalyst bridge authorization investigation those therapy. our place, experience Pathways that via prior process lapse During working not taking has free meditation paying co-pay coverage do decision, the program of time, appeal monthly patients only $X and a per see And are month. the and zero received we positive who is over average those importantly, for that reimbursement out-of-pocket dollars amount XX% been patients have

Firdapse per to paying medication. believe for who $XX reached programs fact, In we month the all them are that financial of patients available have to utilize less out or their assistance one

pleased our with to time assumption time of which are than XX days. We are the trending original to reimbursement to XX metrics, currently and fill better

the and months mark update metrics. the our of later to be launch As strategy will or will up experience, gain phase through progress we on phase an to of initial we will next these gear and awareness continue disease of disease, ensure third this X,XXX and provide launch patients able tools typical initiation prescriptions hard additional year the proper The and the focus for providing ultra undiagnosed and LEMS rare education on to approximate this physician for generating the diagnosis of LEMS. thought on and hasten misdiagnosed targeting

physicians deploy This with learning patient intelligence healthcare and with identify has LEMS or patterns with identify will an artificial or claims as regional group remains and and we misdiagnosed educational patients. to will help We programs suggest that can tools are digital via algorithm we diagnosis a signals non-personal mailings algorithms time LEMS in wider utilizing direct managers account communicate such for that or interaction whom in shorten a or the promotional the been specific our undiagnosed. machine will tools right of data awareness

only LEMS treatment needs. to we also that not develop we with the community is patients Finally, but their we of families, physicians. proud help community and This the these comprised are their navigate as relationships caregivers, continue of patients

commercial the in have any in Catalyst place the about its understand Firdapse families, concerns Catalyst that hear Pathways impact enthusiasm the created provided and Catalyst, disease their Through having research efforts patients better impact for ensure studies life, say coordination We received the have. burden the lapse to and Everyone therapy can't a have is without response in for and to encouraged this enough deeper the Catalyst Pathways, for from is day challenge individuals experience, may that the personally. programs I several Pathways on the lives them community motivated we day community Firdapse team. is we to are market in by by entire order and to in the and conducted of gained the a by these financial LEMS the have excited to Catalyst. research with and daily and to about we have without positive the LEMS understanding

We with look by the that, throughout efforts I’ll the are forward to this make transition medication. year. We to also over to sharing the progress with turn inspired call their successfully you to And Steve. now

good Thank morning. you, and Dan,

very excited Firdapse are of marks about milestone, both Catalyst. the and as this We incredible approval an for LEMS patients

our of of When treatment timely of simplify Following focus for NDA, programs mechanistically the the Firdapse we clinical include development to an types FDA the with XXth. to on NDA PDUFA LEMS limited for on not for approval date for that to similar CMS continue all to for our Firdapse NDA November and decided on the approval indications and patients. improve medical action Firdapse process experience in improvements ensure needs assigned order the efforts product occurred for LEMS, we we new to the indication unmet patients the are of for LEMS, review to submitted to help for which

still committed half program to Phase However, currently our program CMS. we're X top-line This the with results of in enrollment XXXX. second clinical is completion expected for and of development reporting in

bringing or option the no we patients. more and the approved off-label a FDA for file about treatment are work potentially suitability new to to of available a results of NDA treatment top-line excited will types supplemental alternatives these positive one all and treatment CMS CMS hope currently There trial, of types indication of from evaluate with XXXX. we for are the closely for to Assuming the this Firdapse for in a or therapies CMS

CMS, evaluating In or we Firdapse of addition gravis treatment antibody to for are the MuSK MuSK-MG. myasthenia positive,

which FDA endpoint XXXX significance the new in MG-ADL. second currently in of our sites current indication We file as conducting been enrolled the with statistical clinical a to trial supplemental XX indication XXXX report in the the U.S. we've improvement assessments, Protocol proof-of-concept second approved Phase trial in positive half working in look in NDA of required under Europe. successful Phase This Pending of trial this second results patient a site in MuSK-MG Firdapse. results are the top-line already half include with this We demonstrated to including Assessment and Special X label FDA. the forward FDA top-line prior follows this trial, for This first and this for year, multiple a a quarter conducted SPA or new trial trial single at year. the our X being of with primary is to to

studying Type first enrolled top-line proof-of-concept the trial. remain treatment of quarter spinal X the we in XXXX trial on of the first We in first our track patient SMA for Lastly, or this Firdapse muscular report in are of and half atrophy in a XXXX. to results

hopeful Firdapse believe medical of are valid the option of be Firdapse input several for on X treatment potential based that We these could an SMA experts neuromuscular Type for patients. a for

being Access is support we Program, provides which in phosphate access our Firdapse continue to Expanded As CMS to studied amifampridine tablets. patients CMS,

and long-term patients the is no treatment patients. these X to options this free Phase if therapies Firdapse belief patients. no in their at relief patients cost their provide patients study, as For treatment that patients, treatment physicians providing part treatment the have study by these and our to option provide to a participate other could if of safety charge these also no that physicians eligible to Catalyst believe MuSK-MG have supporting relief provide of this could the other patients

the to in our are addition acting In formulation stages mentioned work to as a longer Pat programs, Firdapse. develop early clinical earlier, of we these of

every to of a Firdapse Clinical clinical of it. and is specialist two be professional robust conclusion. leveraging ensure timely to his previously experience, And ingredient in diseases. the patient use and Firdapse Operations its acting PhD, that relationships not to input medication, of patient we level VP United just to to these that to clinical extensive an needs to that staff hope research supply a optimum been receive and medication. in around would Under now that which noted ensure we ongoing that longer described and medication. established our hope successful a members We Clinical Operations. that day be hire unforeseen clinical neuromuscular to many to more of and the of the employ Dr. need We active through Iyadurai, neuromuscular is with experience adding will to compliance. adequate, neuromuscular this physician MD, there Vice different in order that to it supplies We availability efficacy that recent States. plan finally their and night. committed in leading Catalyst dosage daily as hope for current their has R&D. described, eliminate Iyadurai relationship provide And chain meditation his antiques that of manufacturers benefits, from leadership bring within are uninterrupted programs ensure the XX manufacturer of as Firdapse interruptions will patients the the progress In President dosing schedule we affairs Catalyst and and continue a have I activities clinical the accelerate affect is the addition efficacy Firdapse. need We of the community would always new medical made a will better Stanley our order also to includes throughout to

will thousands to to results. Finally, available will Chief to that financial our call it. now Grande, our we tablets over needs hundreds Ali of maintain anyone Firdapse to that turn Financial the be of assure always Officer of I review inventories

Steve. compared in million a shares. for we $X.XX for Thanks, XXXX or the share million, diluted to share references a $X.XX XX, as to GAAP All loss ended share the December this $XX per $XX.X of refer per call GAAP reported year and XXXX. to loss per basic year of Yesterday, net net or

to adjustments. same warrants. loss $XX.X $X.XX a as non-GAAP $XXX,XXX net was there fair In was GAAP as per loss loss the value share, loss change net comparison were of XXXX, a non-GAAP no in liability-classified attributable net XXXX, excludes of the or million which non-GAAP For non-cash

a a period the or GAAP compared share for of $X.XX or GAAP quarter For in million reported $X.XX loss million per of net net per same XXXX, the $X.X loss $XX.X fourth we of XXXX. share to

as full-year non-GAAP consulting $XX.X milestone For increases clinical GAAP as year to the respectively, fourth in $XX.X the quarter NDA in the personal million no programs. and and costs non-GAAP Firdapse LEMS, there $X.X million in and with quarter and R&D and increase for XXXX, a NDA, affairs development of as primarily for $X.X fourth our as to net headcount expenses fourth for XXXX, XXXX The and the medical net XXXX expenses loss support for and quarters our as loss full-year our we was Research the both same of connection related and adjustments. trials was million to due were we submit expenses and were expanded compared to approval million the compensation expenses program our prepare acceptance our from XXXX.

quarter we year up and expenses, for development MuSK-MG quarter and commercial first expenses preparation $X.X formulation Firdapse of programs full in Program fourth for and XXXX Firdapse totaled infrastructure $X.X for continue work the full-year begin built expect $XX.X and release completing of CMS, in evaluating a the trials and was Firdapse. of Expanded $X.X The development for administrative fourth due to the our in pre-commercialization General and quarter of sustained launch primarily XXXX. compared year be treatment will Firdapse to million research corporate our We XXXX. towards expenses the and XXXX million as the XXXX and to million, that of continue for in Type X, in we headcount as the respectively, and increases costs and substantial Access increase SMA million

will be to to as expenses reported cost operations XXXX our going to continue workforce to forward and G&A increase of expect continue as support expenses that launch excluding we expand Firdapse. the We in selling commercialization

Catalyst quarter $XXX,XXX and of no At XXXX. Endo $XX.X million During for XX, debt. Sabril and fourth December no XXXX. XXXX, began quarter had cash December for had generic collaboration of year Catalyst during that the revenues and revenues XXXX, with Catalyst the fourth had or year investments from our

Form the Annual there assurance, Investor can page the be sufficient filed be March found information, detailed current which XX-K, will no for Exchange least be these can turn analysis More the Commission and Report operations on on on found support and was XXXX, believe www.catalystpharma.com. based will Although with XX, available of Securities that at XX back may Yesterday, we call our Relations to next website and Pat. months. information planned be I the now to resources at in the our Company's

Thank you, Ali.

earlier, beginning of As believe the Firdapse I just platform. we the mentioned is this

further information We market understanding results, refine the are efforts more much needs but year our to the work patients’ as And expect with the early as ahead. initial pleased share. we're more ongoing. lies have we progresses, to the dynamics to of in launch very The remain well as and the

encouraged For And we’ll now, are the call the will formal optimistic. very turn the and over results operator now we remain the for questions. presentation. by end early to This

from Our Fitzgerald. question At you. with Duncan proceed first Please [Operator line conducting Charles Cantor session. the this comes Instructions] with Thank of be time, question-and-answer your question. we'll a

Hi, guys.

patients. couple had a far, in a this be execution First good thus LEMS questions. of of just all, early for what to on I appears launch congratulations

outside Can I any base X,X-DAP? the for catchment previous one is, or access you've to unique first which -- the whether were are the think, not tell us of referred you of prescribers prescribers. of primary previous those to the forms XXX The centers,

please? answer Dan, to do you want that,

the Many cycle; both part Cleveland perhaps the the Jacobus there physicians to amifampridine. were main Jacobus those of X outside then, Mayo, heard And our wasn't but many or patients X,X-DAP EAP. treatment. centers, actually the had previous that the handful you or Yes. outside many of X of centers of that been IND. But, it’s with previously physicians of were that are of completely of physicians mention those or in also, prescribed outside are And patients mentioned, IND have of XX a Sure. naïve of are patients us at XXX Pat Duke; experience that part

have That’s helpful. up on those they're the you patients. any feedback with how their therapy patients, doing was because XX glad Okay. persistence And I'm physicians Firdapse my brought you and on those question is far? from naïve Do the what next thus

It's to get going the reaction very positive. We The early general understand persistence. that updates. on has regular don't been

Catalyst definitely co-pay with -- patients studies that is and pay. X,X-DAP never We the are level for naïve back reporting a do with and as these the have the early or it track clinical report pleased far and persistence. patients happy been on Our that are bit folks surprised what But, Pathways would type efficacy that expect it of the our as pleasantly along previously. lines actually amounts as they have to we EAP in saw to

you're in want program think planning of mentioned And there to year? think I throughout next Dallas that any are a held And awareness, Okay. you you similar disease Do that month. for areas rest you then, regarding the some focus the programs certainly being on? have I regional

additional have first explained I I our don't planned think, yet. of Charles, that of more what This would of these meetings. be meetings been as is

this end year, will advise in be, Though, of be sure we’ll So, you at another before we meeting. certainly where advance. there'll the it not anticipate this point. I’m

you wondering in MG MuSK-MG, me, give their are perspective patients, far? and sense the enrolled that of if of Firdapse. for any development regarding feel basis timing further you on of MuSK-MG conduct thus a how being clinical patients do blinded MuSK is they excuse if final and -- versus then, trial of And have the question could patients you types Okay. about us or the the clearly are data of a Steve I'm the data CMS

patients regard I to the timing, of well the regard is to the already progress which they're XXXX. With and overall the overall completion do of medication. half beyond respond to we've trials, second what With can't comment said, progressing

the any that a when share you question briefly, dates, it Final formulation, could see timelines, but that do next us, longer you Steve acting acting clinical we with evaluation? talked about for any you can have goal longer you call enter, is, to start steps formulation

guidance have the with Well, development we regard to that. information specific or I any provide that can of don't

to as property to of addition And I point it's includes think there both can is formulation anyway well to intellectual limitations the out say development In important I as that product what for development trials. finally, clinical the that, some reasons.

a the get take to patients. developed and introduced few it will years it So, to

try We as to because patients as get a it to formulation. desire possible reasonably them will long-acting for introduced a have the quickly

thanks Okay, thus also further my metrics on questions and taking for granularity thanks far.

Thank you, Charles.

you. Thank

comes with Our of Jaffray. the Catanzaro next from Please proceed question with Piper question. Joe your line

Hey questions, progress. for my have taking just I a here. congrats and couple on questions the guys. Thanks

So, who for to from the just insurance? a Firdapse, are currently about patients sense by can those patients covered give what have us converted you X,X-DAP of percent investigational being their

you why Dan, that? don't answer

Yes.

Program their exhaust, right think amount being a good now received proportion percentage wind but down are or for to already drug, that. have Access to good Expanded seems give their getting May Jacobus, -- payer positive very either shipped reimbursed if had or if patients been received these our already before But, that specifics we're to drug hand example, a a pay received of shipped still haven’t from these the these visit it they those a until they're going of or want and a waiting decision. have wait positive they for large to closeout study existing I the already reimbursement supply to from because had on have decision

you your so guided you like treatment to almost close. Is my XXXX. to call, at It number patients end guys or a very toward XXX by ,guess you're the last of other on there speaking towards on already seems moment? having I are question, the still that XXX

of access back all That little we the appears that quicker have our arms in a early And than of Joe. around our second all it that those we quarter, the by December, was original expected. guesstimate had end

the patients of of end the of It that all reimbursed QX. So, the previously end had yes, it's looks by year. on -- like to by happen expected we should drug have those

And I question. last guess my

metrics with see clinical measure interactions benefit? discussions, kind our From in and maybe realistic is of real world settings. discussions to the going some are your is patient realistic it which payers, like to in trial as want not endpoint what sounded they from So, of a QMG, to

what are you So, are hearing end? kind of feedback to payers that

haven't in we back In payers in understanding subject very of had are the studies patients. is is it's the there place identifiable requirement confirmation SGI, the general, that being this And and LEMS. naïve where question main on of that payers asking global for the The we and on by necessarily of this a benefits have the a diagnosis a benefit provided severe that our we're any by of was requirement easily up are Actually, the payers impression Firdapse patients not how really, seeing us. of But, on a push symptomatic information. the surprised pleasantly symptoms we've been well providing we back the patients. and at picking program

the something away. to using picture And keep just conversely if around. they called that value it's good so, how or going impact going can it's they're insurers that able on walk this been and themselves it are told that patients not the their payers see these that use insures works that it significant if and how telling is. drug aren’t them many they is working, to providing And of sense value is right and patients getting this important the to directly to And on have the how have them quickly and

[Operator question SunTrust with Edward of Please Robinson question. with your line Nash Instructions] proceed comes Humphrey. from Our the next

for better looks Congratulations for Firdapse. [ph] especially -- prior on about launch Frank now? about days the you first compared quickly talk to talk the early the can terms and you is, you question reimbursement tracking right turnaround is Edward. the on of about XX on in that thoughts how Can days. color the XX My progress, more that This mentioned reimbursement like

you speak a discussions Dan that than a but let is to pointed or that our can QX to at other the don't more it's call out, we able to turnaround specific I results, Dan with And with have time. we’ll on May again, time, that prepared has information general to or that, to little statement have very specific that think Anything that, been event we're add answer on be positive more on enough bit conference a share data Dan? I’ll not yet, Yes. so as we payers. to experience be

of The system. in quickly. that XX early a immediate to have beating before, on time seen seen mentioned only have we'll call. May color better doesn't that reimbursement really thing haven't back saw thought reverse the prior see we've to but because authorization And the that any on lot add metrics a those launch. problems just out. are that payer oftentimes it to with originally all December, do have There in We as the trends but the we to overall We rejections very is shake that's in get I again, and the denials I XX at are and days we the

so, Got is -- rhetoric recent changes patient second reimbursement, since any and the of helpful. see enrollment like on the do political in the drug it. is really question you given And press? terms That's pricing, on topic on

number it's -- sure than to comment other on just we we’re for that, not issue -- been say now. that I'm clearly years, an to that prepared a it's of not really No,

that various not any about. global all patients, impact. necessarily concerned And see And and but so, what the are it's feel us. launch that payers, that's again, with us, most not including patients, being sure But, that physicians, are, as it's we we've as think long early recognized we're is impacting issue we in experienced I'm or for the we which to value delivering I our stakeholders,

progress we’ll the are course, see the think proposals. in we And you financial of any proposed the of we're we monitoring let currently causing And if of rule different represents to it don’t future, that changes us. of a risk know. these a a risk, lot And

I'll Thank for the McEnany to our questions. back time Mr. gentlemen, allowed floor this you. turn for concludes and Ladies any final comments.

participation Thank disorders. to with to stakeholders our This neuromuscular progress. Thank support the on bringing to call and suffering exciting very your Catalyst additional you of Thank our We and all dedicated Company team the is on look Firdapse you time forward assistance members. from rare updates you this morning. patients various you. further for in again again for your providing for

teleconference. you. Thank concludes This today's

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