ESPR - Earnings call 4 2023 | Esperion Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to Esperion's Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference call may be recorded.

I would now like to hand the conference over to Alexis Callahan, Head of Investor Relations. ahead. go Please

Alexis Callahan

Halladay, Good our and operator. us welcome Esperion's available and to are executive of Thank will remarks. team Year morning, XXXX Quarter be Ben CEO; and Full Koenig, Q&A With Other Earnings Fourth members Sheldon the following you, for President and CFO. prepared Conference today Call.

of with the referencing. covered be detailing discussed I making today's call. want of copy provisions Litigation to remind issued safe press listeners found the the I the presentation will We callers on content that of is be a together that release that also the today earlier our Act. Investor statements. Private the of be will Securities information Reform page forward-looking call harbor copy the a this can on under caution website, morning we A management

the due are the forward-looking XXXX. Actual this and uncertainties results content broadcast, press as by today's implied cautionary could our with The SEC of These differ filings. accurate or materially to entirety by risks stated contains this in date that conference their those in business. forward-looking call statements the statements from of our in associated release qualified time-sensitive XX, only and February information contained statements of is live

circumstances no obligation date the after of or statements forward-looking webcast. this events undertake We call reflect to revise any or to conference and update

webcast this are archived. and recorded conference reminder, call As a being and

your We remarks then questions. will and for the open the begin line prepared call with

turn Chief President over Officer. I'll and the Sheldon Koenig, call now to Executive

Sheldon Koenig

fourth a make. progress us year for and we continue today morning, good and quarter everyone. significant you, Thank you Thank results joining to full our and to discuss Alexis,

increase long-term put report We continued company in came as quarter increase by a position was our with year-over-year that another on believe revenue U.S. represents we key a XX% our in which material are us prescription million, increase well year-over-year. which net footing at equivalents. revenue $XX.X for solid events XX% success. Starting further $XX.X quarterly in January represents retail Total driven year-over-year XX% and pleased as million, to performance. strong a

continued testament territories abilities to strength partners' position clinical term strong out. long We several We market quarter calling continued need and accomplishments positions the seen for in Listed the execute. profile. our transforms us of here our are and a data, delivered is significantly the growth worth another that and U.S. success in capital our global to the in investment in our and believe unmet both the teams recent the and

at continued growth Prescription a we're the strong of year. end that proud of sustained through momentum the and pace, the we

cash beneficial our strong resolved capital, we with balance emphasizing and with We our bringing new further partnership in our on terms. and biotech DSE long-term Additionally, expanded investors. additional several our pending litigation sheet mutually strengthened position

fully next capitalize in label expansion our new U.S. from the important we We receive remain opportunity and on on our Our approvals remain ensure Europe. month. commercial our on we're label, ready CLEAR to and both trial additional track to for organization expanding we focused Outcomes preparation data approval when the published

On announced marked an our which the our resolution we Europe, agreement to collaboration litigation. Daiichi pending with settlement January and X, amendment Sankyo of the

global medications and ongoing beneficial our Our settlement worldwide deliver commitment patients to was to unmet mutually reflects need. parties' to address our partnership both and

potential while product significant for in reduces matter territories. inventory life our potentially the investment royalty parties. outcome we excellent additional generating strengthens associated significantly extend streams and of gross near-term an savings profile, and the provides costs litigation a our for It this margin payments, cash closure Importantly, and the believe DS both with European cycle is

position, and us million significantly January received recent proceeds running on that Combining and value offering, components result cash liquidity our strengthened payment The we balance both of continue provides long-term in all allows to of our near long-term agreement enables focusing and support invest our $XXX Esperion. the with which the from business. of success our settlement us in year-end our net initiatives to

With the of XXXX. for resolved we litigation infusion in now additional and cash, growth significant the poised are

access These turn expansion, of expected patient removed Now our the our primary to cardiovascular just let by at significant me have risk label, or had data reduction to we already anticipate include indication, prevention our an growth. and CLEAR substantial future those who are broad not label drive risk requirement. to a population changes upcoming are statin will and supported which those new the one expand use event, robust to current Outcomes

I'm pleased and EMA our and are the line positive pending of with to strategic FDA goals. share discussions well, extremely remain applications with our progressing in that these reviews

We are with EMA second PDUFA the coming decision by European date on likely of an track expected XX, on in the an FDA March with label quarter. our

eagerness our untreated million include to does and risk more market approval. XX approval are U.S. patients LDL-cholesterol million FDA's products patients. our the at in to high an future, million label opportunity their at not individuals existing label, XX the triples around and our around We figure, current anticipated addressable our indication, anticipated vast goal. still Based Upon not for reiterating narrow see That predict an who is potential that patients new in the help of on additional who models our our XX are for millions however,

data the CLEAR reach also our outline NEXLIZET to life-saving new that primary high-risk will NEXLETOL that expanded One, pillars patients. differentiated and label, create products, core and indication like includes our will and X prevention will anticipated appropriate ensure patients. expanded our a the reflect I'd Outcomes Today, label

LDL-cholesterol statin for at reduction promotional and NEXLIZET resources Two, with on on not in goal. promotion. all focused are NEXLETOL LDL-cholesterol their new still Current maximum-tolerated patients ASCVD and

Extensive to be right communicated expanded promotional of the research the on will that the new new population. market communicate data of anticipated been the CLEAR across suite right will patient a prepared conducted at has data time. powerful expected label, sequence Outcomes Based the the has team tools and ensure

new deeper that together comprised managers motivated to territory to completed care breadth we've digital I'm expand improved bringing will Three, the team deployed These reach. both universe field, expansion to and recently into health sales and representatives. target of providers us proud force up XX and our announce XXX our our of depth XX,XXX reach to individuals primary with allow resources a care have specialists. providers

discussions new five, providers We've to patient NEXLIZET. health a ensure payer bold awareness reimbursement. drive care campaign Four, activation. have about our patients NEXLETOL appropriate And created and and and access with consumer

while and align health programs with our to criteria the utilization alike. Finally, anticipated include primary label time enhancing service at support same both providers care management hyperlipidemia we patients our to to patient continue primary payers' prevention and

Economic We're our and the which we've Review, determined also implemented a We recent pleased cost-effective for for therapy, growth. set changes Clinical proposition just long-term Institute ICER, support to and NEXLIZET as us sustained achievements payers. for up believe its adds announce that to value

and here Shown commercial, expect are a series the that be financial important along milestones achieved way. regulatory of to clinical, we

labels, force that value this steady stream we label of begin growth. Europe. sales updated. With new to global both see expansions for expected road in and expanded You'll catalysts our the anticipate guidelines U.S. be long-term already a anticipate to We've and form map

our next-generation our bolstering product in drug acid. investigational revenue INDs new partners file for to cadence, to beyond or products our regular growing global expect territories we pipeline even bempedoic launching addition, streams for applications will Furthermore, franchise. growing our new under creating inhibitors ACLY and lay In continue additional more groundwork our the

to cost continue should our enhance Longer and over sheet enable position us term, to partnership-related the optimization savings of time. our balance capital

triple therapy further pipeline. We U.S. opportunities revenue network milestone contribution also the preclinical payments in additional of combination from potential stemming Europe, and of growth our partners, additional a see advancement meaningful stemming from for continued our from ex

more that next-gen to to depth. our hold excited intent to this announce I'm On R&D inhibitors later Day ACLY an of note, review pipeline our year in

to With Chief will Halladay, our it more detailed fourth that, our now I quarter over for a hand review Officer, performance. of Financial Ben

Benjamin Halladay

we the Please otherwise results XXXX. which fourth Thank our unless the note release financial my for press page available fourth our of website. December issued containing this results morning, Sheldon. for specified, ended reflect XX, you, that Investor on quarter the a comments quarter, is Earlier

into our with matters, data incorporated and to and on year what our strong in next emphasizes fourth we're the ended first label year month a to the the for ability it As be and results and We posted including the for Sheldon new new-to-brand promote point access the data for quarter excited really prescriptions. which that strong already mentioned, note, we momentum, continued that for time. ended data patient actively outcomes means

sales in-house quarter, touched quarter before also fourth The and with a RPE another in delivered continued increased reflects quarter-over-quarter recently the our and of which year-over-year XX,XXX weekly X% late momentum label again equivalents, XX% and retail footprint prescription RPE weekly promotional the growth in up mark this was new ramping accomplished our even high. and current trend We force.

Turning growth U.S. outside to the

Our At globally. of the again, of the growth approximately strong end medicines the territories, patients our another partner, DSE, underscoring sales generated treated been this that value has therapies August. delivered most its I bringing territories. from in are quarter to November, note XXX,XXX our in now growth of will representing been X-month sequential with have patients growth of since approved Europe, XX% existing

in quarter, commercially well. Spain launched Czech DSE Slovakia said, fourth approval Netherlands, during the gained X as the territories new and That in and Republic

first in country during the the launched In addition, Hong the in Sankyo Asia region Daiichi launch. marking fourth quarter, to Kong

financial an our million, partner full net reported which revenue of increase the million, We of royalty Collaboration increase includes product XX% XXX% for revenue, $XX.X combined representing to was year-over-year. an $XX.X and Turning results revenue year-over-year. quarter. U.S. of

the of Finally, for $XX.X XX% total an was revenue year-over-year. increase fourth million, quarter

year-over-year of substantially higher to year-over-year, expenses. to expense closeout fourth costs of million, $XX.X support the shipments trial. country primarily Outcomes launches. R&D of for was to our increase XXX% a by XX% decrease an quarter reflecting of new $XX.X Cost driven the following Turning CLEAR partners was goods our million, tablet lower sold

headcount XX% legal ramp Of $XX.X our onetime related to resolution costs began force. in reflecting higher SG&A of incurred are year-over-year, as with expense promotional nature. million was in an legal that well litigation in-house as nonrecurring to increase expenses our we $XX.X we higher sales million, up note, as DSE and

received not investment December January offering. with proceeds million payment $XXX.X XX, Finally, million compared December the $XX.X in from the does nor XX, on figure settlement-related that of cash equivalents as our sale XXXX, although XXXX, and cash public recent available for totaled include securities

last also are guidance we the we reiterating expense put XXXX Today, forth month.

$XX we OpEx full and year XXXX, and be expect million and R&D $XXX total million. to be between $XX be and million to to For expense between $XXX million million, SG&A $XXX million expense the $XXX between

Outcomes the from our and dollars ramping to expected shifted our commercial label. to we've CLEAR reflect and total to support note SG&A closeout I'll just expenses same new that the R&D come operating level to budget up in are of last budget expanded activities year, the as the the

have While weeks, we it in ensuring materially disciplined including we support investments strengthened to to returns. we sheet remain launch balance generating make, our are commercial those expense recent sufficient our allocation, comes when

that, let to me over with And hand you, it now back Sheldon.

Sheldon Koenig

continue a of U.S. anticipate later of inflection year. like labels we we accelerate and our plan CLEAR the to our following expanded blockbuster receive and on Outcomes in approval we I'd publication that close to occur are new achieve Sales to data reiterating Ben. to deliver our to after you, continuing last and and year, on Europe strategic Thank this by our commitments status. execute true

ACLY an inhibitors. plan strategic we our product consists as pipeline develop next-gen expansion of further Our also our of

this excited potential therapeutic will expand which next-gen our But are applicable. and could it the platform in be to We later pipeline our areas further short, on about year. we

our new our product market, Further life with into enter lipids the development addressable us could unmet door beyond of help additional well help increase markets need, partnering growth. us long-term significant sustainable cycle as opportunities extend as open and these achieve expand and assets to

store what now for In in the us path both excited summary, and in been or our lies for clear future, I'm I and has brighter. never believe

operator, that, with we are now And Q&A. ready for

Operator

And of the Belanger with our line Serge Needham. first Instructions] from question coming [Operator

Serge Belanger

payers cadence just Maybe the Sheldon, for days coverage? XX away extension and we're about there's PDUFA for the formulary plan so guess of and that of given the follow the label label is activities I or in -- would that to talk DCC expansion. about that from terms what

Sheldon Koenig

Great. you, Serge. Yes. Thank

FDA. just, reiterate, do about interactions at away of want all date I see yes, we the some issues not and So We've had PDUFA very there. from are getting XX to days any I positive with our again,

laid again, label the So about regarding and we've feeling really our out the that confident label. strategy

point we've You heard always this ready said be in X about for which that as mentioned inflection our remarks, our an will pillars us. we we to label, prepared new launch get

some made label. it already I'm ACC, to since we've payers been anticipation out We've seen making great As relates to the payers, happy X. payers. progress in say with talking last we've of new to March changes the the payers

our should be all mentioned made formularies. also reference out in just came I to and cost-effective a that think being what's and interesting essentially as prepared NEXLIZET we made ICER remarks, available on therapy recently

So payers. reimburse that's with something we'll also

So we we very had confident and about strategy have feel the payer them. that interactions our with

for To as really March. splash regarding label, the we using label. your the launch the label make time and of ACC to the And way a again, label new ACC, new is that be frame. a get X point really around we'll new big April ACC end

Eric Warren

X, will our Eric. And sales ready force go. to Serge, it's If that be add can I day

of day rapidly. ensure April So that deploys training have to X, full team that, a we

where as transition the as ACC, programs and scientific then April of speaker consumer middle well to deploy the have as launch and digital have meeting a and we'll as we mentioned, we'll campaign Sheldon programs. to have we'll well start new interaction As

got activities we've a So X is day beginning full them. when slate planned, but we're of

Serge Belanger

Great. a follow-up. just And maybe

can maybe expect in been terms you stable they through what XXXX? volumes? And first quarter? impact In once you additional have to the and gross kind just update the net, product of And of have do talk how label they whether improve

Benjamin Halladay

Thanks Ben. Serge, for Yes. it's question. the

gross we I extremely a net seasonality net gross XXXX, say, in regards where expectations and with be. line our should So in would that throughout were we healthy to think saw to to

mostly be same of But we Going the see like into expect certain to that incremental fees any overall, saw change, helps areas seasonality we that and typically We'll volume same. some see that expect in the improvements we bring XXXX, sort this we major distribution should year. down. don't

Operator

coming BTIG. And line from next Tom the of Shrader our question with

Thomas Shrader

new the label. About

I be available level on maximum is payers is from what guys Or pull to Is for it you the dropped. the need that correct? had the the can you driver or treat to do which lever once that CVOT, that how And what make be work? your -- they had really think from already Has will effect getting I I'm you've guess hearing requirement drug? more is the payer So language statin at any the to easily. payers physicians going that drug I'm that the want big it market you real the

Sheldon Koenig

Thanks, Great. Yes. Tom.

BJ Let there's also me be start, comments and then to I'll ask if made.

at and end I they that which removed the call end label March, from the very the we December, of saw we'll as outcomes getting stated, statin, Outcomes different data. FDA that at of the dose essentially CLEAR So of you they maximum we did would what harmonization be the have and acknowledge labels tolerated will of had the

would accounts. reasons new a But them forward is, catalyst one for mind, It not to make as ezetimibe big prevention, edit and that ezetimibe a with of be keep for besides the changes drug Now your instance. went we're from to point there said, always said label and but studied some and the the actually removed prepared that's were catalyst/inflection and prevention, secondary primary for the some did point, why and acted statins step like differentiation new be drugs accounts we've that only a only PCSKX. in of label,

you use statin. that of on And is it can part you label our our keep for mind in in its strategy also own or can a NEXLIZET use with

prevention important. a it's again, those now. So extremely for has choices doctor And primary patients,

we've payers this. to talked about Now

our very As new talked receptive them. label We've like. question, to look they're mentioned in the will what to last

drug. it but criteria. label of could we for most very what need get the makes and we get it, to them would really this the get of like to course, barrier look does. for physicians UM agreeable the part, do then we will talked to That's physicians won't change drug. being and what they've know easier it that them until we've been to what for lessen final able the is label Of to what our It And

is right restrictive. very very narrow label Our now and

from to mentioned million the As million remarks, patients. prepared plus goes XX in population XX we our

Betty Swartz

we've I and consistency would a streamlining improving the with have interim certainly payer had say, CVOT management. UM coverage utilization XX just presentations, matters been and in actually nationally. improve just over criteria planes label priority, as We since Tom, regionally

the label, anticipating poised those label. well are the payers We day. since ACC for new all to excited, we're and the continuing and very have are been new last discussions year's current And

regard. that confident feel very we So in

Operator

our the And from Jason question of Bank line coming Zemansky of next from America.

Jason Zemansky

the December. Two FDA's in holidays either please. you or some I loosening the acceleration of in right first, restrictions? there could specific was that quarter. may, the on appreciate at were hoping, with on label point impact color Congrats any sales I the But was there. provide if of interest I or lift revision

Eric Warren

Jason, it's Eric.

drive it we quarters relatively the saw to with that that statins with did of payer quarter. exception But still maximally kept that but requirement, we consistent So the removed know, tolerated that happen is second X% full and change you removal. which regards didn't as growth, to changes prior

I we say going didn't it April to growing, kept the dramatic would when it us like were the in X. have but label that updated growing So have on we're we anticipate a inflection cadence

to stated, change XX only quantity the it removing requirement. fully and Sheldon prevention going from is that a of primary potentially quality incorporating not statin it's million, million, but as XX So patient XX million a

Sheldon Koenig

have first the at And Outcomes new medical we'll or be representatives thing actually speak can our of is about label the data. time March that to liaisons, the Jason, cetera, add that, et end I the that will CLEAR would it

had. XXXX restrictive and again, say, on we demonstrated to the the, been what spoke label the has Eric through that So would always very growth the growth I that that we've

and folks the label actually the really because and with we time being explain able value tried what do for not December, patients maximize at us we to thought label products. take the it that the to of So really relates door that's of change what will to to as of end confuse March, change new be never from the with our opens

Jason Zemansky

Got day And the it. X then obviously, week. so pass last NCE --

can generic received wanted manufacturers? for have IV NEXLETOL, to Paragraph of any from generic notifications versions ANDAs generic of technically for you ask, So companies file NEXLIZET,

Sheldon Koenig

we of we've that We But no, are it's not have to that anything been mentioned, data the and received expecting. date. aware you something

Jason Zemansky

Got it.

Operator

And the JPM Na of our line question next Sun with Chase. from coming

Na Sun

Sun is be manufacturing in Jessica Can on Congratulations see XXXX? guidelines quarter. the update talk in mentioned that on Fye. good impact that an you that on also, And take? OUS from the how could for how DSE, will This horizon. Na long we the you shift maybe And could shift about of like there's to

is how think that that for as Is Or there some development there? is XQ, a -- the in further do you to R&D included happening? go? as could company I pipeline the And soon see OpEx then low potentially like for expect guideline. in the cost that

Sheldon Koenig

Ben, to with... start want do you

Benjamin Halladay

Yes.

answer manufacturing So question. the the and OpEx I'll

transition the on to and which in possible. that XX transfer, takes typically quickly them time with frame about tech moving as a It's XX So months. to the along anywhere manufacturing DSE. as discussions We've been

get both in parties' parties to I think excited interest it's both very and it done. are

any tech will some we're end capital of gross of next We're of a seeing though. working that towards the start in wouldn't to the the happen But possibility but it we'll benefits time. savings the is specifics working when further margin through year. expect the of transfer I the along the year take until plan, there said,

include R&D, spend. preclinical guidance guidance -- OpEx does And that for then on we the pipeline the do

point. OpEx lean will we down, of manage this So that's we're I say have meaningfully all sort at inclusive. and pretty that But

Sheldon Koenig

start weeks go We in done. off add working X manufacturing and we're actually met do I transfer. to It ago. team would was of meeting, good this We to that. together Munich just were with with the their our get to kickoff a tech really and to a really folks further good about a

come There impact there think no some folks guidelines mercy potential maybe be comes was have be the thought will statements, in we XXXX, on that the out, guidelines. our of a where consensus out of write again, could label guidelines, guidelines there's to it that new some XXXX. Related cetera. have et would do I the once

to seen, come it out, see. But both lot on bempedoic in probably a use relates as there's favorable. actual the But literature, but has guidelines acid lot a being very and the been we'll Europe, only as acid to of not things to of it States, as wait have where use when of new to the relates United you have been bempedoic and

you've fact, a they Germany, that actually of matter in bempedoic their first. PCSKX you used through last use a HTA acid year As actually [ ] until cannot issued authorities

update on updates cetera, as tuned stay you So we get et will U.S. on more that. guidelines, we definitely

Operator

I'm the remarks. And any I time. closing to turn the no Mr. at back showing in will over for call queue now this Sheldon further questions Koenig

Sheldon Koenig

a large much. Again, we you created quarter very a long-term stream appreciate with momentum have have that interest with for we in new want Therapeutics. and XXXX. really continued Thank enter so We of and catalysts said, the label. Esperion essentially Well, steady as also our you is a really thank strong has remind in quarter, and you, had a time than into our first month everyone strong we coming to that quarter of the to less We going that I And growth. taking catalyst everybody. just

thank again and Take talk So to you you soon. care.

Operator

Thank that your participation. for you conclude our today. gentlemen, and Ladies conference for does

disconnect. You may now

Esperion Therapeutics (ESPR) 27 Feb 242023 Q4 Earnings call transcript