VNDA - Earnings call transcript Q3 2024 | Vanda Pharmaceuticals Inc.

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Operator

Hello, and thank you for standing by. At this time, I would like to welcome you to the Q3 2024 Vanda Pharmaceuticals, Inc. Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead, sir.

Kevin Moran

Jacob. you, Thank thank Pharmaceuticals' and joining to us Good quarter you XXXX Vanda third performance. discuss afternoon, for

Our third on quarter are XXXX results were released the EDGAR www.vandapharma.com. available this SEC's system website, and our on afternoon and

addition, call our conference are of on live archived website. and In versions we this providing

Joining me General our Mihael Counsel. is call Polymeropoulos, Executive Chief Williams, President, on and Chairman and Tim today's Officer of Dr. our the Board;

you results, on comment Following we our activities. my will introductory for then financial remarks, I lines on the update our before Mihael open will questions. ongoing your

would Before we call to proceed, within securities various that statements forward-looking be we I the this like on remind of federal laws. everyone make meaning statements that will

like the account over otherwise, new as that Dr. except CEO, said, of publicly or encourage sections by circumstances are X-K, Form would statements are Our filings recent and the law. With described system based make note Forward-Looking information Results forward-looking the of on call Form of the to update our as other is are call annual upon Polymeropoulos. and future we information, of these regarding quarterly forward-looking cautionary changes we call most EDGAR XX-Q, SEC's in to and and required Condition that Analysis we may turn reports on filings. Risk undertake Discussion or obligation on statements revise provide and Form on which events read in today Management's our SEC, uncertainties. These website. We to Factors subsequent on all our and this now Financial with and Statements, and report our of risks current only expectations to assumptions provided current The our Operations involve no Mihael updated investors available on other reports risks, and as any on this XX-K by on reports I

Mihael Polymeropoulos

Thank everyone. to good quarter much, Thank Vanda's third you results. and you XXXX discuss us for very afternoon, Kevin, joining

and of last patient new Fanapt supported strengthening build-out more and of quarter, PONVORY by the indicators program, encouraging IQVIA building the the starts awareness speakers' new XXX by are commercial increase prescribers. the representatives our organization first This in large focused the of force in the Fanapt country. metrics than weekly captured commercial the product total The include to completed TRx on in the approximately as disorder around by NRx multiple of Fanapt increases support been we metric. This our new has launch During bipolar launch product of I sales observed and phase and creating IQVIA to prescriptions. XXXX marketing progress in we support is to have QX the QX, XX% psychiatry and sclerosis. In the with to been prescribers of among compared early followed increase NBRx launches

only force. a are observing continuous national growth with and of operation We enhanced our adoption the few a product months of sales on of steady

flagship for the meeting indications earlier the commercial a injectable. sales of is A with with can force accomplished Fanapt initiated sales approximately planned and in be new representatives near now early believe now that excited is to of year-end. We're have for second successful Fanapt, XXXX of bring the psychiatry growth the We expansion significant prospects Fanapt the we XXX schizophrenia bipolar and disorder drug for force that of milsaperidone, the application phase Fanapt future. a year. by will and active also our FDA portfolio, this pre-NDA LAI, metabolite the milsaperidone which an of I product includes after long-acting

potential of is of initiate to a program the expected quarter. in with depression. expand Success indication inclusion franchise major milsaperidone for depressive plan disorder the in this the the this prevalent Phase we Additionally, much program to of III more significantly

In from pivotal treatment NDA study start package for of of agreement this The upcoming LAI, this the planned study new support the the and for last with with sclerosis in last our for switch successful this successfully from Fanapt Relapse quarter. to with potential Fanapt We indication after along authorization may marketing sphingosine-X-phosphate third now transition was built commercial a in the launched product. I speakers' as efforts to to is and a completion acquired LAI team in be we're once-monthly completed was the long-term of our for Prevention the to approved FDA PONVORY addition, quarter commercial discuss we PONVORY the well expansion. that recently our second will this development application quarter. PONVORY, the was quarter, sales completed in sufficient year Janssen plans drug transition multiple program. Janssen. multiple as the a In analog sclerosis the late and met

differentiated multiple prescribers of the sclerosis coming by PONVORY because increasing ponesimod in of examined in and addition PONVORY has multiple recovery force forward and of a in shorter over experiment choice some analogs the recent specificity the time of the clinician to while the and and among is sphingosine-X-phosphate system offset already to patient the discrete familiar, sales patient drug-drug new immune preferences interactions. drug-drug class fewer both over quarters. others receptor and In its rose in X X publications, experts, design. sclerosis primarily chose patients XXX patients preferred were is onset this fingolimod were U.S. siponimod, X fewer first many XXX because sclerosis multiple and to neurology action. the interactions, look prescribers reception by for study of and the quick the whom enthusiastic products the study. The received ozanimod PONVORY while awareness position Our We to are ponesimod of choice product.

XXX-patient psoriasis significant significant PONVORY of week in PASI p-value PONVORY of sclerosis, large treatment of of measurement included and less of utility achieved efficacy shown X score, for doses XX, a plaque than achieving disorders. by other placebo. Both doses has multiple X.XXXX a PONVORY has tested. In of in a showed study Beyond potential the results the and in of that both improvement endpoint autoimmune doses primary PONVORY XX highly psoriasis,

have decision expect shortly. the patients for indication, the in that initiate especially tradipitant, for with psoriasis ulcerative with We years. Dozens substantial FDA we program beyond treatment the of and available reasoning and those for the not evidence Successful efficacy completion approval. The significant psoriasis currently application and file recently our useful disappointed that already is for improvements program completion with their presented. neurokinin-X many in of gastroparesis successful of this bring the negative differentiated for FDA's ulcerative warrant to expansive was a antagonist, decision the the committed supported we for with treatments would and failed as either evaluate that for patients our facts expressed committee to in a to patients we denied many This disappointing receptor an demonstrated here, submitted approval access. symptoms the advisory especially where this has IND other of by colitis. the condition injectable are condition FDA application, participating colitis. On may that that for an path with offer that be experience ever mostly PONVORY conclusory could of independently convenient once-daily of a believe to the FDA to have reported patients interest to the the treatment believe Again We're for best Expanded believe to pursue We're to drugs. Separately, approval and to Access most IND evidence in result access recently to FDA the option program patients requesting applied forward scientific advice. submitted tradipitant. We effective have option gastroparesis. continue this or Program application offer this to a oral we their more and expanded may support the convene and be

nausea addition, large In Millions GLP-X and a in and analogs people for semaglutide. and rapid to of improve during initiate profile clinical safety of and that titration useful trial its vomiting analogs phase. We action of more GLP-X are in mechanism reduction treated treated preventing because weight to like patients the the these of of plan portion the titration, with experience agents and study thereby improving tradipitant them tolerability of believe has of to agents. potential diabetes efficacy vomiting, these permit we especially effect with tradipitant a the

by be this already effective tested a in of motion at have off We end well-controlled to for to doses be that has induced the vomiting plan We tradipitant can shown X waters studies prevent both adequate sea used this new United year. shown coastal application been the States. submit sickness. travel of drug actual during Tradipitant indication and by to

and press ongoing mentioned with could treating the approval HETLIOZ A this release that very pediatric work briefly pediatric to which We results our CFTR our we X Recently, an public we programs, clinical in very families. for patients condition. insomnia on HETLIOZ need very believe disorder with shown agreed today, highlight VSJ-XXX, approved dry program is has a underway. In options medical that burden impact large met unmet of and pediatric the these few in their to significant encouraging continue first programs, insomnia a in have FDA products. common the support and eye the other we with is our we Pediatric a While large expand clinical insomnia. health in activator study indications a the in could study.

commercial our forward in results. all the turn as oligonucleotides pipeline a this is Kevin? year. In through X in drug mutation launch is that, on excited to opportunities class look disease growth ultra-rare in our of be and our financial groundbreaking expected to I'll well summary, future. With now antisense Charcot-Marie-Tooth VCA-XXXA, programs discuss and to providing we're to program using this with evaluated Kevin developed as updates second our with later Fanapt a this the patient this of promising The where revenue

Kevin Moran

third the by December in the compared X% of revenues revenue revenue decreased Thank slight generic following to XXXX. largely our PONVORY in of due the $XXX.X This of of decrease you, acquisition before summarizing months offset was the to for our for primarily XXXX. of same introduction the months turning product by XXXX the of million, versions I'll financial HETLIOZ results first to discuss decrease Total XXXX. first million the period $XXX.X to HETLIOZ, due were begin X Mihael. X for XXXX quarter of a launch

as during XXXX the first first XXXX compared sales for break recent the million X higher The same to sales of sales to March product. XXXX, months specialty in $XX.X of of in me to period product in at relative Fanapt the offset million significant continued United stocking first down partially Let for volume, compared to inventory decrease X% to product net in $XX.X quarter a XXXX. of generic first months higher further a the XXXX an customers X a decrease net prior by this first in product first decrease months XX, volume, of were the $XX.X sales periods. relative net net competition relative the quarter product X was compared to pharmacy sales of The $XX.X the XXXX. deductions. HETLIOZ reflected in in was price price of deductions. of the reported period attributable by sales decrease The a to of attributable was XXXX, a were net offset a XXXX months XX% as X resulted partially product The first decrease in sales net for to XXXX. XXXX to X decrease in in increase increase for of at by an million unit decrease result million unit States. HETLIOZ increase same net of the the months

at the at levels During XX, June specialty XX, XX, to XXXX, remain pharmacy the relative remained September XXXX customers, XXXX, inventory entrance of at continued of competition elevated and December inventory March and although prior elevated to to XXXX. generic destocking there remainder levels XX, continued XXXX, was

net depending product customers reduction Going to customers result sales specialty periods, States. purchase competition future may related forward, sales on significantly may will to in variable of pharmacy at unit in likely specialty elevated a product decline potentially sales net be as the again. Further, or United levels pharmacy when need the reflect HETLIOZ generic lower HETLIOZ of inventory

XXXX, XX, Additionally, first the to constrained significant revenue sales net reversal. X company HETLIOZ ended December months amount probable of of for the product an the not and XXXX year

for sales product net variability associated the product future are X consideration HETLIOZ's months net as were the remaining uncertainties XXXX. result, experience sales variable a resolved. PONVORY million with $XX.X first could As periods in of

reminder, we completed PONVORY rights As U.S. in of the and acquisition a of December XXXX. to the Canadian

mix January a thereafter to and we at As fourth PONVORY note portion benefit into quarter XXXX, the our third of pharmaceutical Medicare but such, Reduction Medicare have with net segment quarter This additional on gross XXXX The in change is X, into this is of Act item not which impact industry-wide product products. impacts manufacturers. goes Inflation represents negatively diversifying Vanda the redesign implementation innovative Vanda, as XXXX. to and the of payer effect the and of soon for varying redesign positive expected products. One the revenue of to head benefit as full of change, step the recognition value-generating specific an is will to our

For XXXX. Operating of the $XXX.X compared net in $X.X to Vanda's commercial in increase benefit $X.X launches a due for primarily bipolar expenses I to XXXX were asset. $X.X XXXX. disorder loss for $XX.X as of the an activities months for on the income compared multiple reported tax $XXX XXXX. driven expense corporate products the first million X of of income as in legal spending was sclerosis tax of same months result commercial The period included X and to of to of recorded Fanapt in same compared the a for the intangible PONVORY net expenses months The million million in intangible asset on related as higher an million for million the well PONVORY X other and SG&A same amortization higher as the million the period of first by of million provision and XXXX, to amortization Vanda net $XX loss period XXXX income first

$XX of to million a payment September million. XXXX, second this compared XX, decrease been the had XX, cash for September of not may initiated million $XXX.X million in December fourth cash activities payment including was and compared XXXX, of cash a quarter as awareness XXXX of cash, marketing been Fanapt of marketable receivables, decrease the Fanapt XX, received and our a decrease have During of XXXX, of September and to launches the XXXX, been quarter prescriber XX, been representing cash, $X.X securities, of XXXX, X $XX.X I of part the to of primarily and we in equivalents The XX, as comprehensive million, as and XX, force revenue of to Janssen XXXX as received balance bipolar multiple $X.X third PONVORY disorder since the June development ongoing of quarter periods $X.X XX, our in result XXXX, launches the in an June include and XXXX. If December to have future since commercial and I million which months sales PONVORY of disorder expenses a host and does PONVORY commenced bipolar million which commercial a were sclerosis, to would referred would of related was XXXX. of multiple first XXXX. Vanda's from programs. SG&A and to cash as million in $XXX.X the expansion would sclerosis decrease $XXX.X balance increase have prior the in in cash

XXXX now quarter Turning the due compared $XX.X the primarily IQVIA XXXX. net quarterly increase million, second million as in approximately PONVORY the the X% the of XXXX XXXX a revenue. Fanapt the our an to by of to were of third by third XXXX. million and for XX% The compared of $XX.X in $XX.X third quarter of second December increased XXXX results. for to quarter the product of XX% for in to sales in quarter increase sales million as by quarter XXXX. our XXXX. $XX.X net acquisition to Fanapt was X% XXXX third compared to in product increased increase third of quarter Fanapt and the quarter million of in compared were XXXX, to to quarter the of third following of million Fanapt quarter revenue in of increase third Xponent a revenues reported introduction XXXX prescriptions decrease as Total compared the $XX.X compared the second the product a $XX.X of quarter X%

an million XXXX. XXXX. attributable decrease inventory was of sales a XXXX of product of in decrease net XXXX, decreased a of attributable decrease of the of decrease PONVORY the in third estimates. Turning second net in turning of third distributors were to in volume temporary units to product for was XX% in final sales volume, in in of $XX.X in in quarter HETLIOZ. PONVORY. quarter The Janssen distribution by was from partially in attributable of The quarter to by sales prior decrease $XX.X net million attributable decrease quarter of now to quarter sold million sold net third and XXXX partially increase of XXXX. second the of product the decrease the to of price X% net as at quarter of units offset product to of $X.X the product second in HETLIOZ compared a HETLIOZ in gross compared net third deductions a due a price the compared for deductions. partially net deductions. And and XXXX, pharmacies were The XXXX to net period to the net to third to the true-up sales was X% transition Vanda. The in destocking specialty of volume to decrease relative the quarter to price $X.X a quarter sales quarter to million increase million $XX.X third in a finally, the

PONVORY to rights December U.S. of in we As a Canadian XXXX. reminder, completed acquisition the the and of

for XXXX. of in expenses and third quarter million as driven of Vanda's and the XXXX Fanapt to a launches expenses the in of for products third an compared The to by driven $XX.X of related net of in bipolar of XXXX. is income tax $X.X income in loss by quarter net million tax XXXX. of million $X and compared the quarter legal corporate third million a other PONVORY quarter The other This products of to $X.X commercial million by $XX.X million activities. Operating the net primarily compared to third compared XXXX primarily decrease corporate disorder spending quarter result loss activities, third XXXX. Operating Vanda by Vanda's income of bipolar $XX.X the benefit a disorder reported partially was SG&A to million I legal launches of of sclerosis. for third $X.X million spending quarter and the multiple included the of increased of commercial an SG&A of as the in on million quarter of quarter increase For the commercial as $XX.X PONVORY lower the XXXX were related I decreased benefit commercial $X.X third expenses in to XXXX, and of sclerosis as Fanapt result second on in in expenses offset multiple higher

our by infrastructure the in sclerosis, in periods of marketing development XXXX, and host later I disorder of the third we initiated as year. programs. SG&A this I and disorder to of bipolar force of place those and Fanapt a begin PONVORY of sclerosis, XXXX. With our prescriber these X this multiple bipolar in of and in Fanapt Fanapt the PONVORY to including multiple as disorder sales as in quarter, commenced commercial a I the the of an launches commercial initiated comprehensive of first revenue quarter were the multiple of the were which to launches and ongoing mentioned, PONVORY this future may we full result be of expenses the awareness activities expected with the quarter I end commercial increase months expansion bipolar During in regards a launches third sclerosis, efforts impact in and grow in of of commercial of XXXX, result expect in year, to launches

or new already quarter of seen lead market initial increased by XXXX. the progress indicators in as activities. of as in reported strong Several We third have as response, IQVIA, reflected NBRx, commercial including by XX% to patient by our over a new-to-brand compared the starts prescriptions, significant quarter third suggest XXXX

force Our to continues sales Fanapt expand.

XXX quarter approximately As end phase the to have end sales will representatives, now XXXX, our force this our numbered we XX our a of representatives and the force XXX of the representatives. year. expansion, sales increase to initiated of of has force first Currently, approximately grown which second of over by sales

sales expansion sales PONVORY our and has In the the The the force, Fanapt allowed quarter established frequency awareness of with prescribers around market Xx neurology third reach Fanapt significantly specialty second addition completed we programs country. prescribers. us increase prescriber to programs of to a force have than to of XXXX was to Fanapt the quarter nearly in completed The number of larger our XXXX. number in

now now in our the including we between indicators I the million. Fanapt Total our the momentum $XXX I'll an our of Turning product to This million from expects XXXX. financial and financial Fanapt, cash and $XXX between to to providing $XXX and and revision launch, prior million in following reflects was Year-end its bipolar million PONVORY million. The $XXX update $XXX million. our on the business. With referenced our objectives Vanda PONVORY $XXX quarter, Mihael. call the compares in progress back upwards and portfolio, between are which prior guidance. turn million guidance XXXX guidance million. third HETLIOZ achieve compares of guidance. $XXX launch, the is net of Vanda revenue product that, prior of XXXX financial to guidance HETLIOZ lead durability This sales initiated $XXX to of between on continued across the to and seeing

Mihael Polymeropoulos

much, be At Thank answer you questions. point, happy we will your to this Kevin. very

Operator

first Cantor. from Instructions] question Duncan Our Charles [Operator comes from

Charles Duncan

indication. I'm guidance. from if are optimized see early or as NRx? little or to what color I you nice XX the bumping bipolar these with on congrats for will, reps well on necessary to Fanapt also in seeing patient seeing and you if Mihael like of and are revenue increase your new start for ask relaunch, quarter. your XXX be hearing the Fanapt days you on to a are bit a feel TRx wanted the the And you a and going are to reps Neat sales up the if drive? wondering so bump more Kevin, as end low more

Mihael Polymeropoulos

Yes. Maybe I'll of Charles, this first take the to part question. the answer

the this You're also correct mentioned we that large that we new TRxs lead on which a Fanapt and growth, XX% see is prescriptions. And of starts indicator. continuing. And on first and been at this X-week by is least indicator people substantial But we increase followed X-month These and way NBRxs, that that the on NRx works back of total we and that by followed the them is is very not rolling X TRx. for at the a with very there, years. very the the the have are NRxs, increase. is see see on a when it NBRx we both see look average, to look refills, number which following a at increase And or

the in whether reps sales is about the no, we optimized with we're So putting in, the more more see. we're to because force, answer the answer the question growth size

very the this ROI positive can about the very but investments sign it, it's We we good to and that. a identifying So of make patients category. adoption from that we feel good the benefit and potentially of that in also continue very excited we're program with think

the because come this other products antipsychotics before surprise us will as of are in not promotional a sensitivity space. and same this Now, experiencing currently

is is So well. I not with believe place, the with responding, expansion had want know, you we don't be continuous but we add. force but as to that very just current only feel further growth sales good ours is if that that to Kevin, in

Kevin Moran

their The there, what seen of potential prescribers to quarter only year. number the of Mihael add to is year three able of just force force I terms this said seeing we're interactions fourfold in this interactions with first that is other sales have Charles, a we've our between has and would Fanapt in increase from third been that thing in the the the sales what to quarter of of terms

So that in to dramatic number in interactions very ultimately, the and, the metrics growth we've obviously with prescribers, patient starts NRx which the and we're growth transition hopefully will that to of is seen leading believe a TRx or and seeing increase significant translate we're continue and revenue. in we new significant having to fairly

Charles Duncan

I in another on anticipate I any on On Okay. broadening had the of quick question you launch Fanapt. If in Fanapt? can terms interest interest Fanapt, do sneak Cobenfy the of a prescribing Then Bristol's the -- question in pipeline. of impact

Mihael Polymeropoulos

Yes.

see to action disorders. new excited are We and mental new the treatment programs of mechanism of introduced for

direct investments Cobenfy approved will is the made interest renew MX the be rather of the muscarinic now Specifically about but schizophrenia in expect that will negative we Bristol's bipolar And products product, many space focus only. they are I in primarily a our therefore, for on believe effect, agonist, for disorder. And the the class. we do not

Charles Duncan

for any And just of Okay. given being Fanapt in the really if do franchise to to LAI the milsa, And as most terms what grow then time? over you see milsaperidone quickly, regard pipeline, the with then considering important that is the the able there year, being step versus pre-NDA rate-limiting meeting earlier expecting data for filing? really on the year? the in that part filing Or next NDA to milsaperidone is you're of enable first of NDA this that what

Mihael Polymeropoulos

I is filing. Yes. NDA And will guarding I from start little in the very say would that.

will the on quarter. in sometime data, we'll by the which first stability of guarded primarily this the is it fact, availability And data, have based for occur In filing. sufficient information

a don't this the a concluded expect of milsaperidone. shortly. high dose dose conducting of study we of impact pharmacokinetic And we examining it a clinical, to of timing iloperidone the will In NDA filing. high terms are be versus study And

the and question with the I about LAI milsaperidone. asked relationship, opportunity about You the the think,

well-tolerated with I to is drugs the I the larger major massive for exciting certainly a relapse of that think and to expansion. But already a market effective prevention the label. value these very have disorder is depression, oral the even Fanapt, expansion data injectable in indication. is Fanapt, we robust face an the especially that underestimate the like not that thing will And significant I most certainly, U.S. very with bipolar the from of opportunity always the opportunity on schizophrenia and of going smaller long-acting

Operator

question H.C. Ram from Our comes from Wainwright. next Selvaraju

Raghuram Selvaraju

I question of this overall of that products by breakdown with these Can marketed can sense for maybe products benefit the is we a your firstly, wondering you us So impact redesign X X of -- Medicare across of get might for the a so provide was is a prescriptions percentage be? differential constituted that what Medicare Kevin. the

Kevin Moran

Yes.

one the I'll mix with across tend being -- the payer most we maybe there the the see of towards commercial a class governmental. just So portion which the start side, that smaller to What with much to tends lean across you most recently acquired. that is PONVORY, X is products

the we with percentages, actual going that smaller So of safe be a to PONVORY terms haven't but to and the are portion of kind disclosed assume prescriptions commercial, specifics those Medicaid. of being for rest it's that Medicare and in for majority class of the

in have that a there like is stronger see you see a is On than that of tilt beyond little in governmental towards tend class product a that the schizophrenia, PONVORY. the And in Fanapt a to you extent. side, the again, payers label the what products there bit lesser there's to a

similar It's half which element of that assume half, Medicare in space. atypical only a your Medicaid. And products safe to to the products stronger may a where on But it's also governmental are have or might more schizophrenia, that for HETLIOZ. a depression, have there than to commercial side -- be them and be payer from those the bipolar potentially finally, beyond to than So that portion Fanapt governmental have significant in you would more kind portion, a then class, that see is good coming what going coming from pattern of on payers. concentrated

on side, So Fanapt the on portion the side. PONVORY larger smaller and portion HETLIOZ

Raghuram Selvaraju

might to And planned when to see enrollments can remaining line start? Phase of items Okay. gating program, And you the just initiation the you to Fanapt III your line What then that in top LAI time you when we are expect me respect program? data? for remind with anticipate that

Mihael Polymeropoulos

Yes.

of the fact initiated and It's So treatment weeks. the to satisfy of recently you the I quarter years the in it to -- anticipate met beyond is can FDA. This span can be X if a tell very study. be efficacy shortly that fact given XX phase. bit the portion and the adequate a with the includes extend And successful, on it of that the agreed then are these design study hard can of pivotal FDA can fourth we duration that the but for that expected to the finish their period study, XXXX. about stabilization from studies the length start can of That certainly have

Raghuram Selvaraju

been already much milsaperidone of you to Can potential know schizophrenia I of the think the mixed who bipolar context? also and has future patients Okay. in schizophrenia particular, population applications as might of the whether was applicability both you exhibit curious with outside depression on of be symptoms and seen And disorder lumateperone. milsaperidone comment there of in

Mihael Polymeropoulos

Yes.

there. things X So

bipolar the all, And of features features. have part well that mixed we classification of is very manic predominantly have disorders or of can take know depressed within this I that First can the be group only, a I'll can the mixed.

label for Now, is of for manic features indeed the bipolar and mixed U.S. disorder. I both Fanapt,

manic being U.S. the part present, of label the presence depressed already this on that indication. for which is mixed, So the symptoms means of and are

the seen need are of in what given Now unmet depression. existing constitutes as of response medical shortly usually the as know, a have the evaluation initiating study what to And starting and treatment opportunity. agents. And an of a a milsaperidone largest commercial this as this will to we from application is very opportunity major that portion partial we atypical that market known is is you adjunctive pivotal be antipsychotics of And it of again, the portion the is patients what history quarter. large

Raghuram Selvaraju

an for future then is And indication respect just you in to indications investigative quickly, very with you and Great. that colitis us ulcerative think interest? clinical that initiate or, you of the other can any development when program potential matter, particularly granularity regarding for to might applications give PONVORY, look some

Mihael Polymeropoulos

Yes.

in regulator number suspecting very disorders. correct sphingosine-X-phosphate to of you're an opportunity large there for as autoimmune So that a is a use

and application feedback just the colitis, protocol recently we IND to potentially and U.S. to an submitted For get work we a their there have and expect FDA ulcerative initiate year. next

week mentioned success certainly, on to as on technical submit efficacy PASI lot psoriasis, a of primary in excitement I IND. are has the large at conducted the a script, endpoints And an because actually For been have our very XX. we we of already of about probability XXX-patient persuasive study XX with

just IL-XX, need that there appetite PONVORY are drugs once-a-day especially develop one product efficacy an a antibodies in cetera. therefore, et audience you medication alpha, So a for of them safety of shape and treating be. cytokines, certain psoriasis in we're once-a-day convenient very potentially good PONVORY study And there psoriasis. confirm and we the with in that medication additional against a flares for as being are the oral think remind TNF with and our to then Many psoriasis. I oral can is there, attractive

Raghuram Selvaraju

on the again Congrats quarter.

Operator

comes Tsai question Andrew from next Our from Jefferies.

Matthew Barcus

a This I had questions. Andrew on of is Barcus Tsai. couple for Matthew just

on in congrats then how your QX comparison just with to launch And new-to-brand how start a see in should of First of resolve And that Fanapt sales like to marketing off? And sales to impact paying large like to there force compared I PONVORY want your when force completely? efforts Are for off, the expect seen to is we Fanapt? the able balancing you -- reflecting. know you're were you the destocking PONVORY? scripts

Mihael Polymeropoulos

the the bipolar on Fanapt between targeting I targeting sales and answer sales around a will focused the But, psychiatry Kevin? of they're of is PONVORY separate part These forces. balancing the take sales are more sales force let Fanapt specific force. experts But and The prescribers multiple on I specifically smaller parts the sclerosis questions. will PONVORY Fanapt, indication the where is and centers country. specialty force Kevin

Kevin Moran

Yes.

pieces So Matthew, of a hit. that I'll there, couple different

on inventory the the question first destocking. around So

the the that, there at September, we what middle of that destocking us fairly late so inventory seen Janssen below that carried. we've October. resolved completed in and saw in from already distribution specialty responsibilities So the pharmacies a we levels transition to the And of distributors in they've that was bit of of we historically quarter. And saw the as part

beyond initial period one transition distributor the while So persisted from other. of that's over that are we kind something to cutting not the

force HETLIOZ there force had specialty are sales asked was you the we the think commenced then timing sales specialty of we got with And in large that in line efforts, sales side. And as I what question on impact how quarter. a on in had the the what when a we on force HETLIOZ seeing launch third the dedicated side. these second we force on about sales neighborhood we previously a of is a of PONVORY which of The XX, obviously, see the the there is we've

my And portion year to to revenue fully mentioned I be impact the head we're hopeful As efforts those stood all begin expect next script, in infrastructure this year. we the we as this and of to see of later up on year. the into

Matthew Barcus

licensing does strategy Great. have out make Like the where And in here? Can at early-stage quite sense, some speak programs then all? or also you few general most partnering if these programs a of development. your to you

Mihael Polymeropoulos

certainly. Yes,

investment. balanced of have way late of view different development then the and good have So stages mix is with means a at programs, risk And products. and believe very a our program, we programs commercial early we and that development, of to programs risk focus strategy we management lifecycle

diversify we're of things again, like our revenue had are. an be acquiring better a us this sources partner develop And where along, time, internally or further to But happy whether in or at fully be indication will expansion. products to them, as of some seen opportunity we and, business activities focused of PONVORY give where they and they the out-licensed. with Now, developed they're development a commercialized remain opportunity

Matthew Barcus

quarter. on again Congrats the

Operator

further over to time. questions There the management. the call back at turn I'll are no this

Mihael Polymeropoulos

Thank joining and seeing to we you quarter, you. time. forward you us for Thank next look very much this

Operator

call. Thank concludes This today's you joining. for

now disconnect. may You

Vanda Pharmaceuticals (VNDA) 6 Nov 242024 Q3 Earnings call transcript