VNDA - Earnings call transcript Q2 2022 | Vanda Pharmaceuticals Inc.

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Operator

Thank you for standing by, and welcome to the Q2 2022 Vanda Pharmaceuticals, Inc. Earnings Call. [Operator Instructions] Thank you. I would now like to turn the conference over to Kevin Moran, Vanda's Senior Vice President, Chief Financial Officer and Treasurer. Mr. ahead. go please Moran,

Kevin Moran

much, to afternoon quarter discuss very for XXXX thank joining us Vanda Jack. you and Good you performance. Thank Pharmaceuticals second

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

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

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

Business Tim Williams, Senior our General and Gunther and Member. our of have Counsel, Vice Birznieks, President we Development Committee R&D Additionally,

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

current provided update to our over CEO, forward-looking analysis obligation said, of Polymeropoulos. I future Our and as forward-looking described law. risks the that and other and no these are report that required assumptions year or change now statements, as is subsequent XXXX, XX-K this reports all Management's X-K, of of Mihael on like otherwise, by the discussion on filings. provide any undertake and call Form for uncertainties. website. available account SEC's with and condition, forward-looking our sections based and of publicly we reports events, Dr. revise involve turn note today, we other new on to fiscal The quarterly and to only information, updated cautionary EDGAR may investors statements system on risk on These call call statements annual as make this our With encourage reports in our and the We would except to read or Form information we upon factors, which regarding XX-Q, expectations filings of results in the on operations, on are SEC, are financial risks, current XX, circumstances, Form on by December the ended our and

Mihael H. Polymeropoulos

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

proceed operational will for Kevin discussing the and highlights with results financial We quarter.

the we the Following open call Kevin. And will I that, now for line back turn will to questions.

Kevin Moran

very you clinical over will the several the XXXX. upcoming provide believe on updates business initiatives we've for excited made months, much, to Thank Mihael. milestones and that discuss development into and progress momentum past commercial deliver the to I'm leading on significant we

strong Looking first performance, at continue financial and to commercial our to remain advance we strategy committed execution.

an several payer denial HETLIOZ, have quarters, sighted issue. discussed for challenges with Non-XX with for we remaining For patients

Medicare have authorization prior have to and To Non-XX focused are than or state which disturbances and with criteria we access Syndrome, more with XX progressing HETLIOZ is broaden encouraging. in to with for Medicaid, revised outlined specifically patients on to and efforts sleep their in revise agreed quarters. We successes programs Smith-Magenis states nighttime Medicaid date, previous Medicaid

on On seeing In had D the patient sighted a status. restricting basis Medicare July coverage HETLIOZ coverage in with Part some progress as Non-XX well. a of secured plan, a side, policy the we victory are a Medicare coverage which dispute for key a Non-XX XXXX, vision

that patients Non-XX administrative only to that coverage are a Medicare plan law federal limiting held HETLIOZ D appeal, an Following Part judge those law blind. from bars

updates and other this over products of HETLIOZ to Part similar coming to coverage Non-XX and our providing access Improving additional decision, intend remains advocate for patients priority, top we a look to we with sighted. forward policies down improve the quarters. for Following blind and D strike to access and plans patients,

to the Turning nighttime disturbances. sleep of for indication SMS

and the the support We SMS to continue to organization advocacy of work community. the PRISMS with with closely education engage

along toward progress XXth to pipeline, excellent and our patients to we in in close clinical with fully week. near-term bipolar disorder this our late-stage enrolled, Beginning end report begins Fanapt milestones. milestone, our On is results forward looking episodes to We study of manic are acute are expect XXXX. near-term in we III programs in of SMS the with that making International Phase PRISMS clinical participating advancing conference our by

worked we to has advance diligently this the team in for therapeutic hope Our option new deliver near to and program future. patients a

our program, motion in to Moving Tradipitant that resumed we prevention noted III enrollment. quarter last Phase the of has clinical study the sickness

approximately with pleased study enrollment enrolled. now pace are We XX% the of with the

a demonstrated incidence held tradipitant the NDA to sickness gastroparesis, to As compared patients a for tradipitant of treatment for in with in with in gastroparesis. meeting FDA clinical On recently of in discuss nausea reminder, short prior lower as vomiting tradipitant treated term tradipitant Vanda a study placebo a planned submission with pre-NDA motion significantly patients. the treated the

intend Following Vanda this continuing we study gastroparesis. for meeting, an move with for forward the tradipitant of NDA is the to an submission safety in conduct of to indication. open-label

We also the access continue to Access patients Expanded program. through requests receive from to regarding tradipitant

taken development the the Spectrum sleep on of have that than of Disorder. phase insomnia. remain sNDA in the note, of years. that of treatment patients treatment in disturbances a X of sleep clinical including for Also Autism an we for patient are programs submission delayed multiple HETLIOZ for and year therapy, disorder for therapy one for been HETLIOZ preparing and is ongoing on the has for more have tradipitant Enrollment We in

conclude nicotinic several to provide to continue our performance and contribute in social a enrolled alpha our results I'm is To a that can growth we pipeline anxiety to of end which of highlights, XXXX. agonist. believe we by long-term commercial as products. to expect advanced quick our forward we programs announce study update Vanda's clinical XXXX Additionally, X alleviate expect we on be drive fully to to VQW-XXX, our operational glad year VQW-XXX the in want important that I we

period X I'll of second first first XXXX to of the months sales the product the $XX.X XXXX. same were were Moving for to before and million revenues months for Total financial X X% $XXX.X driver by XXXX XXXX. saw million, million of revenues begin decrease in in of a our quarter primary months X% to same the and summarizing net turning contributor X million financial HETLIOZ discuss for now compared decrease the results. period for $XXX.X for compared to first of XXXX results our the $XX.X of a XXXX. the

The first for six months of XXXX of with HETLIOZ continued patients reflect the challenges prescriptions for Non-XX. reimbursement

million of a in to Turning sales same reflect product Fanapt XXXX. the to Fanapt. of period for net XXXX first X decrease, the million months $XX.X $XX.X X% compared for

securities the the first of income XXXX, $XX.X tax same loss to expenses legal XXXX. the income SG&A R&D tax activities, an offset campaigns, increase expenses of million XX, other Operating to with $XXX.X support for was our million of compared $X.X activities. stage was same of $XXX,XXX as equivalents and Vanda's For activities. XX, primarily X our including increase to of the June higher months expenses The XXXX late related in higher expenses. primarily million, for net was income increase decreases December partially cash were and by driven support $XXX.X loss by months XX, of higher as increase of million to to to X as Vanda R&D period first of were referred first an recorded in compared of provision months net $XXX.X in to period months the by by sales marketable million an expenses, $X.X $XX.X for litigation, cash, cash XXXX. Net XXXX. increases XXXX X and an ongoing million, first X related for both $XX.X million compared to to XXXX, of million, associated corporate increase and million for June commercial compared tradipitant XXXX. provision driven representing XXXX, primarily of related compared Fanapt, The in for DTC clinical The program the $X SG&A expenses driven awareness

with reimbursement HETLIOZ first patients million results. HETLIOZ were quarterly Non-XX. second quarter were months of Turning of of for XXXX. second to to now XXXX, of product the second X% of million net the sales $XX.X the XXXX. the million, the challenges sales second $XX.X X for for quarter of for $XX.X net for Consistent second XXXX quarter to quarter compared quarter with revenues XXXX Total decrease a reflect the million XXXX the our $XX.X continued for prescriptions compared of for

Turning decrease compared sales X% million, Fanapt of for Xponent quarter were the product quarter $XX.X were of product to sales net essentially quarter were also reported by the to prescriptions for of XXXX to to the for second XXXX. a compared Fanapt. XXXX IQVIA essentially second $XX.X for second $XX.X quarter XXXX. second for first the flat of quarter million compared as Fanapt million Fanapt of net first flat as the as XXXX the XXXX. of quarter

higher the quarter recorded income compared income sales compared the support driven increase SG&A ongoing net and for cash with Vanda our net greater XXXX, was of other XXXX you for million. any following $XX.X between compared of associated compared of million HETLIOZ activities. XXXX. $XXX product first an second period XXXX. XXXX. activities, quarter $XXX answer second as expenses million Vanda associated million were Fanapt with Operating corporate the by to XXXX. and of $XXX highlights be commercial related income Net million $X.X operational quarter lower XXXX million second Net activities, have. regarding expenses million. campaigns of At and achieve the sales SG&A litigation, were of expenses net provision expect million for we'll included second the for legal awareness million, of between million XXXX in $XX.X in XXXX to quarter $X.X primarily objectives quarter point tax quarter performance. than Fanapt $XXX and provision awareness and decrease of and same income both are lower sales between $XXX happy second the million was commentary of primarily to DTC financial questions may This product sales concludes of second year-end the of product support commercial million to sport an as $X.X financial and For to campaigns DTC This expenses $X.X for this quarter million, tax million million million, $XX.X $XXX for income to net for $XX of Operating $X.X $X and to HETLIOZ to the the of of XXXX. attributable activities. for

Operator

Chris with [Operator Instructions] Jefferies. Howerton

open. Your line is

Chris Howerton

studies the the one how insomnia? I Great. have you be I for taking Well, questions. that, Dog of pre-NDA a were discussed in it discussion for non-human curious thanks that supports big then of to in setting? development decided impacting HETLIOZ, database this was approval the would respect would studies terms as of what the tradipitant and pricing would gastroparesis, the specifically an the of what outside as you. -- And with the how guess, evidence in HETLIOZ? Thank the toxicology approval and in potential to anticipate safety then relates meeting insomnia strategy such in HETLIOZ for if a would for And

Mihael H. Polymeropoulos

question questions. the very had your much, supports I you start what of Chris, could indication. Thank do the with if insomnia. off on what evidence And will approved, the strategy. And for the to be second, pricing question

the first On know, Syndrome. part, Tasimelteon more recently, And as of Non-XX. the of for been chronic has for -- a approved Smith-Magenis course, indication you

week and are model two insomnia smaller first we're studies. a study of X transient as now Non-XX, We or believe beginning Stage in This X-hour two the placebo. as for and sleep weeks we phase [indiscernible] [indiscernible] the parameters. years, has study, support There week to key difficulties duration showing phase large significant events. insomnia specification improving X-hour the have period. where for is changes insomnia type Tasimelteon short-term X supports a by also chronic patients be three [indiscernible] studies with [indiscernible] both phase shown study a and sleep effective was significant X sleep, large was to defined events in chronic and as for this data, the specifically combination indication the sleep based almost the the schedule, very characterized disorder likely as compared that using improving events. in Tasimelteon treating sleep with one improving over One a with on sleep plus but indication, insomnia on of of an later, in with of and chronically function. X given X effect defect opportunity persistent there X disturbances, is well evidence Again, with a studies, studies The of second types significant a that a have significantly study we the And for experience Tasimelteon in shown

and NDA discussions preparing be will and that we gastroparesis the we will is the specifically believe Tasimelteon, month prepare study I about So back submission your I on continue to finally, the as safety asked on asked question on you come dog I supplemental you and turn to will we for database. with will FDA this X the toxicity and specifically a [indiscernible] pricing

have suggested necessary. studies support we at And by these to U.S all mice. As the you the These conduct is FDA dogs but is the has preclinical Vanda out, says significant through the well Department the and devaluations necessary. And conditions. X has of found group suggest of object are course to many no [indiscernible] as a public were our of recommended required The X year month dogs, guidance, is course, recent animals, being have long-term month that if in trend especially studies that, And drug dog opinion in is with of Virginia, [indiscernible]. conducted large Nonetheless, starts other they're toxicology. toxicology a [indiscernible] short-term to in And date know, in there that. in that that they of very Vanda the being court not we the alternative especially not a there study profile facility -- been long-term the difficult if in from kept and [indiscernible] studies where that in decision in a very raid Agriculture therefore started study. to X

So believe have the sufficient review. conduct we and information adequate the FDA for that we to

safety, pay Program. And since of with with months. through Access up data data a exposures terms again, amount the we if have, over significant X and months of of In Expanded some year, to X you exposures

course, these application has conduct to, FDA classify commit believe and been will as review. submitted the course, a the in the up file So the fileability review adequate of has combination information we concluded. application of either would period the on way, not XX-day of But until of been

stand. course, now therapeutic that other be a very and indications. tag more is where for know drug would of indicated go HETLIOZ significant your where our was I'll was affordable. if pricing? this to have indicate that's that we [indiscernible] what orphan indications past, hope for has indication increasing the making It So all mean back question that the granted, about Of two price discussed can used, in and we the [indiscernible], that we useful identify that can the course,

the to I where that that would is commentary. this drugs you that, this So and patients the that's again. stop and where reasonably given But make population benefit. And then priced, means them are that available -- them, access to vision so that larger drugs can make need available can make much of do patients do more

agent. especially find insomnia sleep we intriguing a drugs, seen promoting what as sleep for years, for insomnia, Now, is many onset have been well, that

with a opportunity actually establish number to that in poor which change sleep thinking actually sleep large insomnia it have because challenge. that a new is patients circadian may a onset regulator, that is circadian with think be a the schedule, of may tasimelteon of a I like their

answers, follow-up. this but may perhaps this So me and I please the worked insomnia you in has [indiscernible]. [indiscernible] within X circadian know know a sleep and this well etiology worked if very be longer drug week is and insomnia, let any why

Chris Howerton

overview you this very, the do and follow-up maybe a very actually timeline plan respect so? submission you or of for the might meet to before with No, us insomnia, do for be have you Yes. you expected I give submission FDA have do regarding much plan could what a with to and Mihael. appreciated, an

Mihael H. Polymeropoulos

already We characterized the continue sleep insomnia DSM other insomnia I there The second met And schedule. in of FDA sleep being -- indications, discussions. of the we'll change two X the one potentially and have as disorder is in the with -- what treatment by the disturbances characterized insomnia said, are onset. one, by chronic short-term

the treatment [indiscernible] the reads of So This NBN. the mechanism indication different approved, by a I disturbances what of short-term discussions will continue. is for first indication everyone action sleep remind FDA that these exactly but is characterized insomnia has and

do So there's we significant proceed. some be FDA there expect nothing discussions new as there. with And will we the

this timing, preclinical prepare, and as now a want together therefore, package, I information of bit entire cannot to agency. more of time will straightforward. to the it's with NDA terms of unlike safety, said, right it And course, In all take NDA timing And less we continue to putting the these discussions amount commit of therefore, this supplemental there. require manufacturing, believe we is

Chris Howerton

that one guess, the of to I your respect if Okay, the you no, it into did I would Medicare Mihael you this to if changes fantastic. in with I ask financial guidance? And coverage? But know revenues for that's have be Did Or for question. weigh Kevin. don't how directed just observed may Part D that more some like impact year? thinking that your or

Mihael H. Polymeropoulos

starting patients. state had is we Medicaid this will I to the December, but let the But you revising impact. back criteria December at with in Kevin it briefly the patients, actually access the back that beginning. Yes, and in who an saying single exemplary by label, also the but for the start highlight improved patient thing. gave taught law off won do here, sighted adjudicators FDA that this patient, right actually the agencies that, Stick several in year, story. to access administrative allow all to a judge is more that you and remember that, discuss by is actually energy and to And there remember The I'll successes, emerging for site Kevin starting

Kevin Moran

patients that was was we on guidance spoken million. to Chris, thanks, and reminder payer assumes those and to that a just on to the And resulted lower in end the $XXX challenges continue for had Mihael. dynamics return $XXX on therapy million decline range And a improvement it of our the reflected, other as on as evaluate. the range this HETLIOZ, account QX on And Mihael go impact look upper therapy. release, and news those what patients we that kind Yes, in the what And that, see patients recent taken our to growth of of end see in as in to somewhere Obviously, plans Medicare affirmed two middle treatment. the of for that towards we've we're to forward we mentioned, guidance by guidance and we'll as stories. will to appear have trending be continuing is that be into of seeking

breaking kind evaluate. that, So news that on of continue and want you to to monitor

Chris Howerton

Yes, Okay. that's Kevin. you, very No, helpful. Thank

think those for appreciate time taking I are my well, the Okay, all I questions them. really being. you

Mihael H. Polymeropoulos

you much, Thank Chris. very

Operator

further at I call management turn would questions the are over remarks. back Vanda for There no closing to this like to time.

Kevin Moran

you Thank again you. look speaking to We much very us Thank soon. joining with today. you for forward

Operator

concludes QX earnings participation. Vanda call. This your XXXX the Inc. for you We Pharmaceuticals thank

disconnect. now may You

Vanda Pharmaceuticals (VNDA) 3 Aug 222022 Q2 Earnings call transcript