VNDA - Earnings call transcript Q2 2024 | Vanda Pharmaceuticals Inc.

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Operator

Thank you for standing by. My name is Meg, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q2 2024 Vanda Pharmaceuticals, Inc. Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Mr. Financial Chief Vanda's Moran, Officer. Kevin

You may begin.

Kevin Moran

Meg. us to you, Good Quarter afternoon, joining for you thank discuss performance. and XXXX Thank Vanda Second Pharmaceuticals

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

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

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

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

Mihael Polymeropoulos

results. of approval Thank you significant down us afternoon, treatment and This potential Fanapt I quarter the beginning The was discuss good you expands very FDA of milestone Quarter marked of of a Vanda's approval for everyone. the foundation much, Thank bipolar the of Kevin, and the for disorder. our commercial joining XXXX Fanapt the to psychiatry Second for with lays portfolio.

this sales strengthening asset. As time, to began the our and focused better [ result we force, the a us maximize size efforts by prescribers. expanding program of the period short expanded to development, in a with commercial significantly ] our engaging of our Xx operational organization have of we value position Fanapt commercial our of and In increased speakers

campaign, fourth the our reach In addition, quarter full and building we're operational expect of marketing to capacity year. this we in

is the portfolio advancing, metabolite Fanapt addition development In a efforts, in filing clinical for drug for the these of of psychiatry application treatment commercial with disorder an and expected active of bipolar schizophrenia. the XXXX new early to milsaperidone,

is milsaperidone study Phase continuing quarter and expected preparing to of the year. The long the the future. in we revenue We're significant that expect the to treatment franchise this significant with prospects to our value of into well later maintenance growth year. of excited psychiatry patients provide Vanda schizophrenia provide iloperidone with injectable program of clinical initiate for in acting this We with in with the are depression major also fourth III of program the the initiation

of multiple transfer and ownership also of sclerosis. the have Vanda, of the organization treatment PONVORY to from we a in building PONVORY the With promote in full to acquisition Janssen focused commercial

useful that near modalities modifying option provides with patients treatment future. completing sclerosis. We PONVORY to of close disease a in a now and and force sales new are and the marketing activities multiple hiring specialty initiating among support for believe competitive We patient the the

to further future. We're and colitis, can and also significant well clinical programs able awareness increasing effect. that to allow growth confident the of onset its where the return option for are initiating as treatment We PONVORY drive prescribers towards revenue near will quick utilization ulcerative action be working among patients become quick in in immune oral as a reversibility of regulatory as psoriasis medication, a with and once-a-day

Smith-Magenis in maintain to serve by not competition third affected disorder patient quality LQ oral the Syndrome to capsules share population. product, market Smith-Magenis product patient for of erosion allowed significant generic has Our products. due with approved for to introduction the generics commercial this to Non-XX-hour and HETLIOZ, revenue our Nonetheless, face a wake sleep HETLIOZ Syndrome continues continues us to children is loyalty community.

and applied the recently approved in European Germany. EMA authorization the Syndrome. Union, in Smith-Magenis for in commercialized have HETLIOZ for the HETLIOZ time. We competition actively is is for not and EU in generic Non-XX HETLIOZ marketing LQ currently for at facing both HETLIOZ this is

the offer turn syndromes drug under The currently is the have gastroparesis to assets disorders commercial of of addition unmet pediatric development HETLIOZ tradipitant development treatment application highlights. remains under for XX, under represent phase September XXXX. review the In action by for of PDUFA is Both our with LQ for HETLIOZ some efforts, no need. I portfolio treatments our a date and FDA new target and of a treatment for insomnia. significant under to disorder, medical sleep-wake of development and FDA-approved will delayed

novelty tradipitant substantial of NDA, mechanism the provided in that drug and continue an assist reviewing pursued to of indication should experts the the We gastroparesis. the the believe approval given years. action the in advisory to and agency approval this information experts for symptoms over of in of XX to indication the in with constitutes any lack committee convene both including that this of this efficacy qualified to safety evidence treat in of from the We support application field evidence the believe sufficient of

it FDA committee the for advisory meeting take one. June, request consider yet that FDA an the our cycle requests repeated our stated grant meeting would committee despite has in consideration the meeting. to an into However, to late In advisory for held NDA, the

studies therefore, the FDA. On on clinical this conditions motion water quarter, vomiting second turn seek this which, the by coastal of the they in for positive comments, several that, yet year. With up motion the May Phase review requirements FDA and in the our Phase presented but we reported now discussion post-marketing States. request the approval III efficacy had a provided times Kevin evidence conducted identified received a On to our prevention other followed and letter decision FDA were The disciplined yet that second clarity notice to and call should III real-world deficiencies tradipitant date the respond. of clarification PDUFA XX, commitments, their and a sickness positive among with not not again, in and that II FDA do X of next body plan preliminary results. have information a we labeling Kevin? reviewed the requested the response. as we confident but preclude steps do We sickness our remain Nonetheless, of discuss under have financial a studies positive on await we to have that United We on receive to later be packages I'll in reflect the on the in Phase to for final we FDA we supporting study. from We prior should comments tradipitant study construed communication to to completing in has Moran to whether the expect in that back labeling so. results

Kevin Moran

revenues of we volume. million the of XXXX. decrease X% X in of primarily This discussed Thank compared same the of results XXXX the were $XX.X which to some X same in Total the $XX in sales by due to to million for a detail, sales relative generic decrease turning decrease million, of XXXX. Fanapt in following I'll of product $XX.X first second $XXX.X by net XXXX. versions decrease X acquisition XX% financial attributable were our a product of offset a the for X the net Mihales. compared of the was discuss revenue to This launch in first HETLIOZ, in product partially period begin months period XXXX, to the PONVORY decrease XXXX December our first to of months million quarter of XXXX. to you, have summarizing months was first for months the for XXXX before the introduction

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

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

again. Further, significantly will related HETLIOZ pharmacy U.S. HETLIOZ or when for product continued product were likely to net depending inventory of of elevated result net reflect may in product million at customers a to variable $XX.X turning forward, generic And first potentially sales reduction competition as be specialty PONVORY. X specialty future months finally, XXXX. need the periods, to sales the sales Going pharmacy may sales of PONVORY net purchase in decline unit levels lower on customers the

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

a As innovative positive quarter at the PONVORY value-generating mix with such, products. and revenue recognition full diversifying of in represents Vanda second this step our product and

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

launches June prior a decrease and XXXX, cash million $X.X the cash as of of launches of the first of and the $XXX.X Fanapt may force to SG&A in by of $X.X an equivalents During periods. commercial as as as half XXXX. Vanda's commercial sales XX, PONVORY, a compared payers of we a timing XXXX compared in rebates of development from XX, initiated marketing future during representing programs. quarter were referred host expenses XX, a awareness the to result of cash change in as XXXX of the of of million, in commenced anticipation customers compared which recent securities and third payments million XXXX, and were Fanapt for decrease revenue was related the XXXX. our comprehensive The quarter of cash and of of XXXX, of March increase the to PONVORY, second December activities prescriber quarter cash, including and first compared to marketable driven periods our to to and in of expansion ongoing

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

an were HETLIOZ the of The quarter increase of deductions. million of Turning decrease of of quarter by product finally, increase to $XX attributable of an in second to product sales offset decrease product sales of price the of compared was in first a second net the deductions. And sales were net first to compared HETLIOZ to sales quarter offset by decrease attributable million as quarter was in compared in turning $XX.X million XXXX volume. quarter deductions, product net was attributable quarter The net HETLIOZ. million $X.X the XX% quarter decreased increase for to PONVORY a by decrease net partially million sales the net to XXXX, net the in to second $X.X decrease to to relative decrease first volume, The to XX% XXXX. in sales price in for relative quarter of of partially the to X% a in of net PONVORY. increase in XXXX an XXXX. in net XXXX, second in second product $XX.X XXXX. a the product price

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

to net Vanda Vanda's $X.X income compared XXXX $X.X the of an XXXX, for the XXXX. of first commercial The the tax of For million corporate benefit legal increase compared of XXXX to and as a quarter of quarter of commercial primarily $X in for PONVORY, launches second million $XX.X million to second increased compared included second quarter by The $XX.X on by loss activities. products the an $X.X the on million and expenses of related by net a R&D loss million second income quarter This net as as XXXX of tax quarter and of the quarter Fanapt program. to the income of higher a provision partially was reported of to in million on of products result were to second second PONVORY, the the of and quarter million result SG&A million spending Operating and compared increase legal to Vanda's commercial $XX.X for SG&A related in second and corporate driven expenses spending $X.X related other tradipitant a in commercial Fanapt was $XX.X XXXX. Operating expenses spend XXXX. the driven the of as other by quarter expenses expenses activities, development of primarily in offset of million launches lower XXXX. higher decrease

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

commercial on our progress activities. tremendous seen already have We

The quarter Fanapt to and expansion size our more the with the new the reach indicators of compared scheduled is IQVIA of frequency second today completed of prescribers, starts us of sales of Mihales programs significantly number as is per larger Fanapt XXXX. force and number As approximately appear quarter increase the early as to data the Xx than than larger third end quarter of in the programs mentioned, in positive. completed our has XXXX, allowed of to Xx XXXX overall first awareness be of prescriber

generic following reinstates sales Fanapt, our to XXXX. HETLIOZ XXXX Vanda of year-end will now product note, achieve between financial net cash competition the sales millio. Turning decline product of to million, significantly and in U.S. To in million PONVORY potentially $XXX future financial related continued from the million to $XXX guidance. the $XXX HETLIOZ net financial expects and Total and objectives between likely periods guidance and $XXX in

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

a Mihales. variability could call with HETLIOZ consideration the turn in future I'll that, associated result, to experience remaining the back net As product uncertainties now resolved. With as sales are periods variable

Mihael Polymeropoulos

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

Operator

your And first Duncan comes Instructions] with Charles the Fitzgerald. Cantor of [Operator from question line

Charles Duncan

new give Kevin regard Any -- quarter. that guess any perspective this wondering, to the any with Fanapt to that you can you for I'm prescriber Congrats second there is with that I started label on of But guidance But I and in you the a remarks. regard just couple in reinstating provided the this Fanapt, half questions, know progress. and And you good I all the for then perspectives But back share I patient with appreciate the hop recent of label? the launch that in of or recently year to this I'll financial starts. had feedback that following the with of really alluded a quarter prescribing year new queue. can to regard the think Fanapt, color expansion? terms

Mihael Polymeropoulos

much that. Charles. and Maybe follow Kevin I up I'll for Thank joining, start very on have you Yes.

necessarily that antipsychotics of it tolerate not is need or number competition do that is significant there it therefore, I voice. well a of prescriber And despite requires therefore, something there actually for note began unmet outside of And more schizophrenia in bipolar far awareness. share encountered space well sensitive. there psychiatry. fact who a market with for a the which is that And medical environmental of don't indications type the to It larger investment, about are approved bipolar significant very is much increase chance, a while indication, is this important of disorder in we First drugs. a is this presents the all, for to promotionally of this is But opportunity. making market significant still and it market, respond people offices frequent other indication,

by to refills. TRxs. typically, understands with are NBRxs are the quarter but are that force out. prescribers data, on compared of make to early of everybody know, the which we're course, positive program. takes startups But And a it the receiving, as new And we And is very our of on first as be it quarters [ to we compared a time some the is We of you new anecdotal and going the But signs know, prior about whole. year the awareness, fields, NRxs and the into IQVIA this early. learning the we the data, evidence new last excitement -- new noted referring get sure prescribers trend results metric full a based we participation positive is see there, get to It significant sales ] results more out, NBRx, sales speakers [indiscernible] force to as want to starts. get of you and followed is create starts, what

operations the year. quarter not marketing continues, and are Our in in but our going foreseeing, be to fourth expansion next of full

before caution a prospects that the efforts. signs a about we months clear enthusiastic may our of get of of growth, we're revenue we to few but effect it the take So want

Charles Duncan

own makes muscarinic then be candidate with perspective continue would increased of to the that terms That competition? with called sufficiently And you're entrant a modulators messaging fall. sense on you that, that -- stands that KarXT, for increased is the you but response a good be And mean, class psychosis that that I the what face new I gain you us. the another from Are if of wondered there possibility Fanapt -- provide to approval this could treatment. Or the to the its believe of I'm your on could is sure to possible prepared label in differentiated do and share? in

Mihael Polymeropoulos

Yes.

terrific course, address class familiar and of that becoming more at working new of years, needs. many of to mechanisms competitive are on new action I And drugs. unmet medical we're looking Of with and all, say space, would we're the first is more folks after this it

more to unmet drug attention we So in a enthusiasm And space. the success space think these first, I say and need treat that underscore in remaining the of would difficult welcome will disorders. more I the medical

for and In differentiating a the is terms see is market market have since but profile, not not a from the I of been the the the well XX It but differentiation, strong is first in new in only would we wait approval. say the new Fanapt, also That in factor has years to entrants, understood. entrant. profile. The about drug drugs tolerability

there's and a experience lot of familiarity. So

So specialties them we're and drugs. welcome as these Fanapt other friend And new more utility. that all, a of and we around markets a psychiatrists well-known has education welcome new and for entrants, now we at looking

Charles Duncan

of of And Vanda you be need sickness, gastroparesis has mentioned little motion then consistent to gastroparesis? to think or a you you what Or efforts When provide about is And a where will terms in of this of far? gastroparesis provided more that on view later kind your can year regard to regard to do you with on year. have regard question nice thus response with the with with pipeline opportunities? a marketing of versus depend your agency or Does some bit filing in the you have commercial X a in on last is to think motion tradipitant. sickness perhaps terms

Mihael Polymeropoulos

clinical which of the that of unmet need. the is medical in has Yes. question. come does And X separately believe I'll symptoms just from effect the testimony not gastroparesis, a tradipitant We our treating a parts trial useful take results. significant that

personally me, changing with the X All of and come years her on of have her over access. years them by to drug the just is to life. dozens also the our celebrated published. what We have who been be But testimony patient exciting of first granted patients expanded request drug the

you need, interpret signal of the FDA. now. When strength the to filing learned we efficacy and depends So drugs to company the likely to unlikely anything approval, it that and approval, motion comes motion see very sickness, can the from need. armamentarium motion will will it pace revenue in has, may which tolerate think back from tradipitant questions I to diversification long-term it we and The on if diversified a gastroparesis. the for we guess it is the the important and But data that's can their in preclinical they of it I deep safety, the additional of sickness that point makes given around and stage point FDA the pipeline, delay is sickness they

incidental sickness. when clinical, sickness, to preclinical we comes there's the upon to complete motion about it of drug. that efficacy that's the use setting PMDA no have and discussed going when question II meetings. and of not to packet the it given in we think comes chronic something both safety, prevents this vomiting Phase However, FDA And we're with and and end the a of motion extensively drug that safe have And agreed in --

be feel very packages our complete. confident we So that will

Operator

from next question of Tsai the from Your Andrew Jefferies. line comes Instructions] [Operator

Lin Tsai

guidance us range is revenue wide, being in. million X despite quarters The pretty $XX range

quarterly end second your exactly What for gets what guidance sales PONVORY revenue assuming guidance? So for the half of XXXX? the you growth Fanapt to type both is in high of the and

Mihael Polymeropoulos

that. take Kevin let I'll

Kevin Moran

with of And fairly to little The Fanapt trajectory launch so we PONVORY start and see that the longer of third obviously, how takes bit of in launches happening if if and see X Yes, at quarter. begin Andrew. the a mentioned, time. results now we quickly think in. quarters could it the whereas as you we the mentioned, range, up that we the quickly, top we end end results as to

the or to be into results range in somewhere to could else year closer come the in therefore, and later translate the range. those it For of revenue, middle the

Lin Tsai

I flow there you expecting exiting expected And positive? guidance, be terms cash of But some launches and head Or you growth cash should investments XXXX. think we like be burn in increased year-over-year XXXX and offset will in? than you we cash exit in see. can do it bring seems the to revenues into the the as be pipeline XXXX, more

Kevin Moran

Yes.

up or continue speak of provided So as $XXX we've to to for and for million million. year could in the bit guidance that's investments around smaller end so be flow the of be for growth the Obviously, range at of of end of would of that. But we right first, point to we top revenue positive, year. we number million if kind even will slight. communicated. on number the the our is neighborhood between If and high year be bottom the in a obviously a range, million. only for this to to the So bit context just very products, and guidance is end this these see guidance hope year, haven't of we can we -- slight anticipate articulated. the we a on communicated what you range make see X the cash we've The little that the the better, maybe $XXX burn our $XX $XX then begin And end cash right? revenue that a that breakeven little worse, trajectory therefore, next would And midpoint, than is right, cash

revenue see [ it efficiently investments we ] growth into kind EPS? converted year, could additional or could see we Next positive that be could of necessitate

Lin Tsai

guys say about you Okay. just approved And talk your let's was Can strategy? in for September. launch tradipitant, it later

Mihael Polymeropoulos

had launch actually we We Yes, of work plan, feel our bit quite have to prepared. time a absolutely. and well

Of delabeling target the depend on understand well messaging. the we We course, with population.

extensive opinion cultivated key have with relationships leaders. We

program. speakers size force. the sales of of can the of effort campaign in direct-to-consumer understand indication. understand size what have do early And we of plans this We So a course, we a and

Lin Tsai

Xx in And How year, did sales have the in the earlier question last the I see. year. is force earlier so here? you many is do sales larger math the can reps than we

Kevin Moran

the reps of about year early the The the Yes. in XX. sales in neighborhood part

we're with so a Xx of larger, little $XXX being it north million. And

Lin Tsai

quarter. Congrats the on

Operator

[Operator now no Please in more management questions conference We ahead. will the over to for have I Instructions] go back closing Vanda queue. remarks. turn

Mihael Polymeropoulos

we hope second you our Thank joining to very on quarter call, and XXXX see soon. for again much you

Operator

call. This concludes conference the

may now disconnect. You

Vanda Pharmaceuticals (VNDA) 31 Jul 242024 Q2 Earnings call transcript