Earnings call transcript Q4 2022

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2022 Vanda Pharmaceuticals Inc. Earnings Conference Call.

I would now like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

Kevin Moran

Thank you, Mandy. you and us full thank Pharmaceuticals discuss and quarter fourth year afternoon, for to joining Vanda Good XXXX performance.

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

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

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

current Form system changes We sections of involve assumptions and risks Management's upon expectations Analysis regarding uncertainties. cautionary These and Financial Our and in as Results to our most described and are statements, Form Condition forward-looking on risks, on these our XX-Q, Operations by filings Form our XX-K on filings. in SEC's other updated subsequent the investors reports recent reports reports forward-looking and the Discussion EDGAR annual of of are our note the are on quarterly that circumstances Factors statements SEC, Risk current based available other with encourage which all and website. X-K and on read and report

required on publicly provided forward-looking account call on law. future is obligation and this only provide make update undertake The except or call may otherwise, information, new on statements to any of we revise as events as no by information of we we or this today,

Dr. to would our I call Polymeropoulos. now said, Mihael the to turn that With like over CEO,

Mihael Polymeropoulos

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

and litigation programs our to matters General a brief our I Counsel, key on first and from to update provide call to discuss results. the clinical will over I Williams, commercial Tim discuss Kevin then financial progress before highlights turning will ask our

I X placebo-controlled with Fanapt will disorder. U.S. acute assessed bipolar episodes treatment that Europe in in and of the XXX week I I of was conducted scale This of clinical severity study primary our symptoms that The measured large a rating results of in positive by of Rating of bipolar Mania treatment endpoint study disorder the patients the X the was Young the of Phase with and was in study announcement adult core YMRS, a it enrolled begin in of approximately patients. Mania. Scale, in clinical

Statistically on the study, X. difference early At as YMRS week was benefit the and large patients weeks patients was saw X, assessed improvement placebo of of observed Fanapt this X, a X end of X highly the over group statistically placebo-treated Fanapt's end X, significant. treatment. week at in was and significant as

global chains improvement course YMRS the with impression Consistent X-week over high study. impression clinical of such outcomes of the statistical showed the total also Other versus the group and YMRS placebo subscale global the also in Fanapt items achieved significance. the as severity clinical individual of group score,

with We of this for treatment half and XXXX. first plan disorder SNDA, the of a the application, bipolar supplemental in acute episodes for drug adults to Fanapt mixed submit manic in associated year new I

already population, a XX in approved schizophrenia opportunity disorder estimated of indication to presents schizophrenia. approximately of is beyond to a X.X% U.S. times up Fanapt estimated As indication bipolar affect a reminder, adult Therefore, of number substantial than and prevalence the adults. higher expand above of the front to the an bipolar size disorder the

XXXX, participants anxiety who for alpha-X the performance treatment stress in clinical from In received VQW-XXX agonist receive those numerically XXXX study acetylcholine results reported nicotinic of who a study Novel placebo. sold partial to acute also We levels in VQW-XXX, social lower receptor compared situations.

Scale, at scaled of of TSST stress during the Units Subjective time a SUDS, the X by self-rating XXX multiple to assessed level the level points distress test. of was duration The Distress ranging nervousness from or

in the participants approximately participants, future XX% a In studies. is performance efficacy of partial anxiety, statistically female look that also which to was a particular observed, has we effect magnitude in niconitic significant. acetylcholine larger total and of receptor study clinical efficacy the agonist This in first forward time the confirming was shown alpha-X of the

of tradipitant, is half gastroparesis XXXX. ongoing preparation first submission with the expected drug in the NDA On of in application an new FDA

ongoing tradipitant in study access open-label completed already for with Patients year. expanded access is the study. program with having to XX-week first Additionally, XXX of number patients gastroparesis seek the treated continue been tradipitant with of with patients a an a over this patients having to

recruitment some motion over On and is complete, results great in program tradipitant treatment for enrollment seen Sunday XX% the events. as by during of advertising, result of experienced you may of a football we sporting the have clinical target success sickness, in We've mid-XXXX. and other which expect

approvals, supported regulatory and program approvals. to results we have that completion HETLIOZ insomnia robust indications and previously reported. by clinical programs to filings we successful of in to in pursuit jet look our clinical pursue regulatory the HETLIOZ, bringing We On continue of forward lag disorder

in in a on successful Fanapt year adverse poses schizophrenia. reported focused Non-XX SMS in remain commercializing litigation the determined and for HETLIOZ by HETLIOZ our significant the patents. and today, challenge, but XXXX another we patent we District As December asserting decision The was for Court

turn other Tim? I now General Tim to will this and matters. Williams, our discuss call the Counsel, legal to

Timothy Williams

Thank you, Mihael.

in know, March infringed Court and our XX. appealed ruling not generic Circuit the As Vanda litigation. We our a or have scheduled Federal at the that by invalid of hearing claims defendants for you HETLIOZ certain patent in found we the Delaware District probably December,

We expect that by decision after court the hearing. the

including and Teva infringement actions Act] launch, tasimelteon, Vanda's legal that of a we our rights. and separate Circuit against generic [Vanda are of name patients Teva to violations, but brought from Federal protect aspects issues, to HETLIOZ protect launched since of a problematic on few. distinct nonetheless patents, safety These other safety Pharmaceuticals are the and appeal, has cases of have based version of important several patient and to

As who an from that HETLIOZ braille suit generic since blind that example, and this immediate accustomed immediate a without FDA. launch. to the an are filed its users Court with the tasimelteon accompanied requesting is in risk labeling, sold and to information which labeling, Teva's is discovered we HETLIOZ safety presents we braille FDA To concern, citizen's action address filed petition packaging, the Federal

to an regulatory our we this to actions the broadly front, of multiple to to protect On the a matters patients FDA to hold make accountable effort serve. We continue intend to to litigation pursue available in the more to Vanda against we on law. FDA regulatory interest products the variety continue of the and continue

Mihael?

Mihael Polymeropoulos

Thank you very much, Tim.

Kevin? to to financial I discuss progress results. will Moran now commercial turn call Kevin our and the

Kevin Moran

Thank you, Mihael.

year-over-year an patients challenges I'll our contributor results million were compared same sales XXXX Total XXXX. year XXXX $XXX.X decline the revenues summarizing decrease begin quarter for HETLIOZ Non-XX. discuss net million, of for period XXXX by reimbursement a our The decrease in million and full for to before X% continued were and XXXX. in full of turning year compared financial for the driver XXXX. primary reflects X% $XXX.X the fourth $XXX.X the business of prescriptions to product with revenues to saw the HETLIOZ

full for of essentially were $XX.X XXXX. product net compared million Fanapt XXXX to sales the year flat

for included compared full income full income XXXX, as an $X.X as December XXXX, tax the the compared $XX For equivalents income cash, million million million for net cash, to for of provision to income securities, an referred recorded of $XXX.X Net an increase representing income XXXX of XXXX. cash to December year XX, XX, year Vanda million $X.X and marketable tax of million as to Vanda's $XX.X million as of of provision $X XXXX. net XXXX. compared were

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

fourth compared Fanapt to fourth by X% the net by reported XXXX quarter were million the in quarter XXXX. the $XX sales to prescriptions XXXX. exponent, million, of of $XX quarter to quarter compared the XXXX. of in the quarter net third in as in XXXX, by of fourth quarter increase decreased product product X% XXXX $XX.X Fanapt the a compared of of approximately as fourth X% increased equivalent in sales Fanapt third million

compared included million income fourth quarter $X.X the the net income of tax recorded fourth income of XXXX, to million income as of million The an Vanda an provision $X.X of for period in $X.X million quarter quarter the fourth XXXX. For net of for of compared provision $X.X XXXX income same to of XXXX. net for tax the

expenses Fanapt fourth $X.X in XXXX. primarily related late-stage $XX.X of R&D The the development quarter were to the driven quarter in the lower to XXXX fourth compared expenses Operating million million by program. $XX.X was million of decrease

lower decreased spending previously of late-stage $XX.X Operating development to quarter R&D decrease related ongoing to the OliPass announced was agreement, million XXXX. in expenses and quarter Fanapt SG&A in our to by related the by This the XXXX offset $X.X expenses by third for driven of fourth litigation. compared higher program million as expenses partially primarily

into reminder, $X third quarter entering upon was a the As of the in XXXX OliPass agreement. fee a expensed million upfront

treatment unable result will evaluate guidance the time. financial for as this HETLIOZ guidance the uncertainty provide patent market ability year at XXXX financial for progresses. ongoing HETLIOZ of surrounding the is a Vanda litigation, U.S. to Giving continue Non-XX its the Vanda as provide to to of

that, Mihael. back the With now turn I'll call to

Mihael Polymeropoulos

Thank questions we'll At happy have. very be answer to Kevin. may point, you this you much, any

Mihael Polymeropoulos

discussing us Thank much, everybody, and very Thank forward this look joining for to we call, our you. quarterly on in progress the future. you

Operator

call. does Thank gentlemen, Thank you. today's for participation. this you your Ladies and conclude

now may disconnect. You

Vanda Pharmaceuticals (VNDA) 8 Feb 232022 Q4 Earnings call transcript