Earnings call transcript Q1 2023

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Operator

Good day everyone, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please also note this event is being recorded.

And at this time, I would now like to turn the conference over to Carrie Siragusa. ahead. go please Ma'am,

Carrie Siragusa

Good XXXX welcome financial Jamie. Pharmaceuticals the first quarter results afternoon, you, to and Lexicon Thank conference call.

are President Officer; today Jeff and Chief Lexicon's me Lonnel Chief President Lexicon's Joining Officer. Executive Senior Wade, Vice Lexicon's Dr. and and Financial Medical Chief Craig Granowitz, Coats, Officer;

of press filings. Lexicon www.lexpharma.com call, available financial on on this website announcing at results A XXXX, for slide this afternoon, available release of is Earlier the through which SEC our and webcast issued a the is with our first quarter along our presentation website. our

we review time use call, the this answer provided During then a our of will to in provide the release, remainder and your information update corporate questions. the

the be efficacy, statements, the sotagliflozin, we relating to trials other and and status for These statements characterizations regulatory timing and LXXXXX making market results statements forward-looking those commercial our Before me and expected LXXXXX opportunity and programs. clinical we of of drug let begin, potential safety, regulatory including therapeutic remind sotagliflozin, and status and you include may drug of the other candidates. will candidates that, of

implied may also and operating our statements and discovery relating risks contain to future or for as of and our well drug products, expressed and growth development commercialization launch our alliances cause strategic may forward-looking actual Various such results, historical not candidates, from plans call approved results This any information. those property intellectual differ or as other are forward-looking matters facts to materially statements. that in

controlled preclinical and approved timing our with of our regarding owned the and research, the and limitations to respect of our to other third-party candidates; and the success protection by and efforts our NDA of patents These studies by our requirements and clinical strategic our our sotagliflozin other sotagliflozin, to discoveries, drug risks heart our for other our FDA for substantial imposed related obtain development with trials of relationships; planned and the commercialization LXXXXX, to any third drug or parties; include failure candidates; upon in results activities. products; discussions commercialization alliances dependence ability funding patent sotagliflozin, LXXXXX and uncertainties conduct

uncertainties of list reports filed a Exchange and Commission. risks description the please and the the Securities we with we see face, that have For and

I call to would Coats. like now to turn over the Lonnel

Lonnel Coats

for Thank you, on the you Carrie. thank afternoon, call. joining Good and everyone, us

in for LXXXXX, quarter was First of significant SGLTX both developing our our we and period XXXX programs our pain. and lead heart inhibitor Lexicon, advance failure continue AAKX that neuropathic we're for that inhibitor another as dual we're sotagliflozin to of X for

on pain, Phase late Starting year move and to with development of these in to have results results, and know, X quarter LXXXXX continued pulserpatic diabetic and plan program pain two development these neuralgia. for the we we FDA you Bolstered for on feedback have expect proof-of-concept reported studies by of the many neuropathic neuropathic stage last plans with year. forward as this peripheral from second of the

sotagliflozin. to Turning

FDA with call, in our failure. everything for treatment heart late for the last May to XXth. issues we on it date plans track But that, no substantial target Advisory remains PDUFA confirmed Committee hold no an our Meeting. again review has for believe that, and we were on indicated of shared meeting agency review late in As had quarterly there our February cycle NDA The

a across exchanges to not have to functions with pre-approval at experienced progress further PDUFA, shortly. we discussions Granowitz Appropriate institutions, the the highlight across national board Now ready be to we majority feature label with made but meetings the which the are the already of productive limited Company, presentation significant last speak the and cardiovascular since presentations including and on and accounts, to Dr. regional about with which clinical sales including FDA. benefit sotagliflozin on of launched major of also wanted our and very negotiations recruitment will government call, of professionals, for all Company information payers time medical two the

wholesaler U.S. distribution approval. we to launch period finally, to U.S. during ship over in are to work quarter the finalizing be in agreements review weeks, approval. few second to continuing are following commercially look within product the promptly shortly with to following next regulatory sotagliflozin ready the and And the forward and FDA We the planning and

over to will review the to I review program sotagliflozin preparations. call the Jeff? further Jeff to of commercial launch now the and status turn our

Jeff Wade

within failure, the hospitalizations X.X for heart of people hospitalization patients United discharge There who with being in Patients heart X approximately million readmitted that to failure XX, annually. by highly for to the are million for Lonnel. failure XXXX. one hospital are are Heart hospitalized is year. XX% approximately heart increase to return is of XX% cause with States over number XX Americans X living Thanks, of with a leading within days and nearly million failure likely to the expected

hospital healthcare and to Hospital to to as is by hospitalizations. make from patients hospitals providers, $XX to a identify for data but system, treatment payers nearly new readmissions the only strong for heart and billion cost unmet XXXX XX% with failure due burdensome reduce There approaches for those are need substantial readmissions. expected these annual costs also for of a not to to incentive options better clear, patients, increase

patients results important and shown to slide months discharge patients, therapy also started likelihood treatment appropriate the patients starting the higher see significantly know therapy receiving from when as on increase hospital in on in of XX of you from at time this percentage Cardiology, they remain at therapy is Journal data prioritize following on a at and hospitalization; XX are of the XX that American on days it that, to of College follow-up. can order We

following recent pathways guidelines from meetings, SGLT meeting and the turn now discuss regarding two sotagliflozin's and benefit discharge ventricular the left effects important across recent consistent reducing to risk prioritizing meeting decision mortality the March major XX to call failure inhibitors and clinical effects late year the scientific updates ACC and ejection will AHA the admissions heart sotagliflozin's and review I over from and to to last Craig in hospital data regarding fraction. days at from of to time cardiovascular in treatment XX

Dr. Craig Granowitz

issued you, failure. driven and the societies treating of Thank being poised growth. this dollar of inhibitors major is anticipated in new with a is SGLT Jeff. disease Heart growth the guideline pillar as a market United multi-billion Along prevalence, cardiovascular the Europe, that failure for heart is substantial recommending use recently for States by by care increasing

a fraction. week, Pathway the Expert in of on addition document JAK just failure new of entitled XXXX last ACC management April with addition, ACC ejection the In heart preserved issued Consensus Decision

SOLOIST important study for that regardless to only patients in number class note hospitalized inhibitors the patients individuals failure of lower medical Worsening the in recently The contraindications. ejection sotagliflozin placebo of fraction. resulted than left recommended visits is SGLT cardiovascular all consensus regardless the hospitalizations, HFpEF should initiated total fraction. heart therapy lacking SGLT with significantly Heart in Consider Failure the ventricular and also of in of causes from urgent together that, be all and deaths recommended consensus guidelines, previous ejection with HF is It

to million that provides its for with are an significant those opportunity these patients suggests hospitalizations a inhibitor. of care currently This of an data failure, population. prescription due than for data patient impact showing of a year, SGLT that $X.X sotagliflozin its discharged unique on Currently, exceptional heart XX% fewer given transition

Turning to the next slide.

has their improving this patients heart the in see, clinical journey in while noted SOLOIST trial from can as slides. you risk Jeff for future events prior of group remains at As failure

a randomized those in heart the each patients three hospital and discharge. treatment were X,XXX began approximately the either in patients As the XX% enrolled or hospitalized were been within Double-blind SOLOIST failure out following of had categories. transitioning reminder, hospital. of approximately two days of trial their who They for

and in one of only a cardiovascular four SGLT failure to statistically see event, patients you for which need one the in meaningful for composite the avoid and hospitalization trial with class. the visits the XX% reduction a endpoint reminder, heart As the primary can heart within unsurpassed of to with urgent failure, year is a inhibitor treat was finding as endpoint death, and clinically slide achieved total significant this

of analysis objective days study after Bert placebo reducing heart versus Dr. within last or Scientific Association by readmissions at on the treatment Sessions Heart and hospitalization post American Pitt began presented patients of of was mortality year's sotagliflozin and at XX before The date the the efficacy discharge discharge. who hoc a hospital failure among the evaluate to from XX

XX days were and related results two between a differences baseline endpoint. for failure As Presented for no or death primary there XX characteristics patients events for and of groups heart reminder, here the are the cardiovascular post-discharge. these

see early blue separate statistically the in reduction placebo very and on relative can a from versus to arm in arm sotagliflozin You with in treatment approximately the showed risk red sotagliflozin of and for following days resulted XX% the discharge. events, failure cardiovascular heart for readmission, for failure death and and readmission XX non-fatal of both for at hospital composite XX placebo heart begins

are benefit of also failure These initiation They early therapy. unique. findings underscore of the evidence-based heart

both for Sotagliflozin heart is failure failure hospitalization. a a to reduction on the and a initiated mortality events heart demonstrate compound treatment first during

in sotagliflozin, the the Finally, annual benefit XXXX of at time American which March scientific of highlight on XXnd just Cardiology, presented College to held Journal of we also clinical in the been College wanted shortly Cardiology has session key of thereafter. published data the of American to

These left sotagliflozin authors finding a consensus post by was significant randomization. ejection the the the that ACC statistically referenced. primary recent reduction ventricular results with statement day study fraction recently led the in treatment The just that consistent range, aligns were across outcome a concluded of that to with XX risk

in sotagliflozin heart further risk, and events AHA the hospitalized sotagliflozin heart in patient worsening high that treatment significant meeting. reduction in high for with cost, XX-day That failure the in extend results cardiovascular XXXX support readmission recently in the data believe death, these with reduction We results presented an failure. at and early

I'll our now preparations. turn call to over the launch to Jeff more about share commercial back

Jeff Wade

Thank you, Craig.

progressed for for earlier, and Lonnel have sotagliflozin launch over commercial throughout been underway QX. As well year a referenced preparations have meaningfully

in significantly with pre-approval half This support late market the in since in XXXX, resources a commercial of have launch invested required who appropriate last year. the currently U.S. access exchanges having full the medical failure place. information heart in been includes have stakeholders and key teams first in and have infrastructure We the the to we

brought we towards our As we quarter, sales last year. of noted the team leadership on last end

be we major to filled to of provide launch. approval. the As the substantially have appropriate deploy the the completed programs we our and following prepared have representative access sales and up in with ramp wholesaler comprehensive majority of assistance distribution networks positions as we well when to ready for U.S., contracting deployment are support today, we patient Further, needed during

bolstered feel key of part opportunity in patients with the we believe ready failure curve; commercial date, that hospitalized to One, have by for three done heart weeks. we in To for work for very the addressing effectiveness the foundational a set still confident unique the a approval all resources treatment guidelines; in for we growing and early talent two, regulatory a sotagliflozin, a factors. we SGLT tremendous following summarize, failure. be the have data adoption three, medical to need the on sotagliflozin adoption Based right coming successful and unmet updated specifically heart launch

and impact, hospitalizations those on of that based value targeted including expected a with messaging and proposition factors, systems launch of is cost cardiologists to focused making preparations using three most our and the differentiation clinical strategy bear with where are commercial and Capitalizing payers have re-hospitalizations. areas on hospital the we

AAKX. We selective LXXXXX novel target a LXXXXX inhibitor program. now small molecule kinase is adapter highly or potent to associated X of our turn will briefly a

of in to mechanism of achieves was once well the pathway. is of action Phase pain pain, demonstrated tolerated profile models of of of dosing. In X relevant drug independent when the LXXXXX daily levels neuropathic positive LXXXXX to In consistent, importantly, controls shown as LXXXXX with studies reductions even of high and gabapentin. pharmacokinetic a number compared significant be such supportive CNS, opioid a animal in has scores LXXXXX the

by is diabetic designation and therapies of potential market abuse. pain expected neuropathic be track From projected fast than perspective, worldwide more to peripheral limited the FDA granted XXXX for and by been a market between billion. XX% the are worth effects available has Currently, by grow than Lexicon neuropathic and for side efficacy, pain. XXXX $XX.X lack more to is

as such result, this opportunity a is As LXXXXX new treatments unmet a a with tremendous need. for there great innovative growing enter to and market

last types I the of studies our neuropathic that to will now year. distinct back key Craig out turn the briefly read pain call results to Phase two review in X from

Dr. Craig Granowitz

Thank you, Jeff.

week As a compared the was the significant of reduction call, the daily ADPS at we to the discussed during score our statistically last with or primary in average pain study in quarterly low arm. endpoint achieved placebo RELIEF-DPN-X dose X

with reduction ADPS compared absolute achieved X.XX of an with points X.XX of to of from a baseline was of missing of significant in a High study compared There dose X.XXX, threshold a consistent reduction the narrowly effects. from placebo. X.XX p-value X.XXX arm showing points the placebo to but in baseline p-value

withdrawal the period, there week noted tapering and also of or in no the between differences deaths runoff treatment emergent in a arms serious reported the the runoff We were events drug adverse There treatment during blinded were both no in five symptoms. observed placebo during trial. rebound events period, adverse and no related treatment efficacy placebo gradual with of pain or arms, was evidence

Phase our X.XX LXXXXX from a reduction baseline reduction neuralgia X and in a daily pain proof-of-concept a a in placebo arm average we also in difference the discussed our X.X quarterly points in of study of with compared score call, placebo of achieved of at the postherpetic As adjusted to second X points X.XX. last p-value X.XX RELIEF-PHN-X, week points

clear to significance these our patient the overall support achieved neuropathic for development study, not study endpoint XX further demonstrated primary the small pain another and this the of on achieved results of Although of statistical goal in effect condition. LXXXXX results did evidence

this on in and The will XXth the May British Annual results the XXth of of be Science trial to RELIEF-PHN-X Society Meeting section Annual Emerging Academy at presented place were from presented Scientific the year, April frequently XXth. at also of Neurology of taking meeting Pain American Xth the Glasgow May

the LXXXXX these change placebo on consistent same Notably, mean as graphs shaped from two separation side-by-side, the studies. studies the When create placing results see across shown the can from slide, from has and you curve. baseline the the two

growing as conclusion, mechanism In that potential LXXXXX support completed now the new inhibition to has we studies neuropathic of Phase treating that unmet of many daily large and believe welcome for for current be AAKX action We pain of This two need. from the overcome have a those could X and shortcomings pain. market proof-of-concept potential is basis. a on new LXXXXX a suffering with neuropathic high of medical therapies a innovation a

pain. late stage rapid for of As advancement of into LXXXXX are a the we the result, treatment pursuing development the neuropathic

optimize and and receive into to feedback continuing the We to we late stage FDA in proper the efficiently are regiments, are QX work quickly as preparing to how and from dosing as possible. identify on best as program advance development the

call I'd quarter financial take now results turn the like to to us through Jeff the XXXX. for the first back to

Jeff Wade

earlier release I with quarter, resources be clinical financial quarter investments the Craig. believe issued details shortly More ended our our provide We $XXX.X with capital support key be research some can review We appropriate we SEC. development. that of you, us of the in existing first results. will Thank financial funding aspects and to our in that the continued press cash preparations in will found today XX-Q right with make the and and XXXX commercial in that million investments. level filed

Oxford further draw planned of Our loan sotagliflozin, with allows of our in $XXX we Finance, to quarter that borrowing executed of Oxford in provides million upon facility up upon which episodes to with $XX approval embark capacity, prepare of million us launch amendment this We launch. up just to we substantial the the to use financial proceeds which expected flexibility recently fund year. an gives us second would as to the additional

manage will with our the sotagliflozin the of our facility with loan launch that us well resources and operations market. anticipated investments cash into sufficient under into We provide together capacity anticipate the to existing

we quarters to and and development professional costs As external XXXX, period revenues and first first $XX.X our million and the release development XXXX of indicated quarter for press this lower in to and consulting both XXXX and of due the corresponding research in afternoon, XXXX. in had for minimal decreased from for Research primarily fees the $XX.X million expenses XXXX.

$XX.X $X.X Selling, headcount of sotagliflozin consulting launch for in increases period relating in expenses from the in administrative failure. and to commercial was for the primarily and increased in million general fees This quarter XXXX. XXXX preparations for of to due million first and the heart corresponding professional

$XX.X total, In $X.XX of for was or share corresponding loss quarter net XXXX the in $XXXX. in million the first per period

first stock-based quarters $X.X the million net For expense XXXX XXXX, of and non-cash and of $X.X loss million included respectively. compensation

of take heart the function in the for sotagliflozin for like market this date progress the since of reiterate May Q&A, call transition the approved, a considerable if failure made prepare Before to XXXX. the we preparation of in great Across to I'd into our into to PDUFA launch every XXth, progress Company, our opportunity launch have we last and market. we have made to QX prompt

I ask the call your up open would like the to and to pause now questions. take operator to

Operator

gentlemen, the Please Tsai comes and question. will we with go today from question-and-answer question Our now first Jefferies. Ladies ahead session. [Operator from Andrew Instructions] begin your

Andrew Tsai

sharing Really Thanks questions. the updates. for you taking appreciate my

So, first in it discussion. prepared like sounded in very your noticed productive you're one the I is, remarks, labeling

So, approved, attention encourage label that if talk in to when can to about, front is expect does there patient you you we can if to? would And sota label or claim? what see pay anything maybe on investors get the

Lonnel Coats

with Yes, characterized Andrew. correctly. think I question, Great the asked We've FDA. some you've it outstanding conversations

for is, the else. regardless drug drug diabetes. that I powerful This cardiovascular we this works of heart made nothing failure. believe work think that a will what failure argument be a expect can you pretty and heart we've will across drug that, Meaning

therefore, for should broad a you what drug. And expect label the is

including works sotagliflozin call, across this during clearly very ejection mentioned, left fraction, has Craig HFpEF. As ventricular

that expect move in us well. direction should to You as

look are cards for I think negotiations should I broad would the say with and finish the over we those turn two when the agency. so, our investors perspectives And

Andrew Tsai

Great.

And just it so, does say, get let's approved.

of you sales the robust right what believe can needs basically say is, think do think for XXX key low what for to off tackle done accelerate, First XXXX, be Thank that and what XXXX I you to as drivers would sales hanging the there reps then to you. a uptake? about And a be is we -- patients ensure secondly fruit a would you're bat?

Lonnel Coats

hanging that to the fruit going to that's cardiovascular of patient a we're spend that's And of That's that. also time two Yes, have therefore, SGLTs systems It's of our in area And patient, failure. and One think that hospital. have costs things. care focus place low a bringing try to XX% absent I not regardless opportunity given be we'll so for do on in achieve. market the that on to going data. transition is still is us we huge think heart broader inside have The is the guidelines, competition really is of that only very I impact to not down. where most and but to impact unique of our

In to about well about be we penetrate how able penetrate net are well It'll coverage. move. XXXX, it'll able you be how IDNs, into more how less and sales we're the to get much Medicare

been that. lock get so, and and ready out trying for And conversations we've to appropriate in market in load

is, at you tray XXXX. that well, so, sales that one out going XXXX should And We ability do get about look time. to in to penetrate we're be get will and what all the our when of be for really net one you will coverage that metrics number lay for, approval we

Andrew Tsai

last is one or track-able sales scripts? will And be IQVIA the

Lonnel Coats

over Jeff, to it I'll turn you.

Jeff Wade

scripts. of going a be IQVIA track what terms on we sales expect going be able what we about. be is are that's in again, lot talked in We this to of of that to terms to focused But the will

getting talking access We getting and formulary will coverage. about be

Andrew Tsai

very sense. Thank helpful. Right, makes you

Operator

Yigal from our Citigroup. with comes your go And from next ahead question Nochomovitz question. Please

Yigal Nochomovitz

for Hi, on with validation clearance And regard additional the the Can I you what have for give Could Jeff Lonnel going this proposed about plan talk Have also from to quarter know two there question. bit path you past. just I'm you mentioned and an about from this the FDA you are talked or you partnering that's regarding taking update indications? and feedback What expecting us there? you you curious, are expect Thanks. those forward. a XXXX going? specific both more just On team, X the Phase a in how diseases? have little thanks in you on FDA the to partnering,

Lonnel Coats

Yigal, let it Jeff. questions. turn me great to Okay, over

Jeff Wade

outlining with mostly to the diabetic largest elements are the FDA We late do to that which to focused is indications, peripheral and going it's program other we forward need stage pain on going neuropathic into of work these plan keep the And advance of forward. development.

So of that's area really been the focus.

will potential But with further push that this into we meantime, And continuing are the in agency with quarter. be will this proceeding that, the get the from we in to with to we steps partners forward, and to continuing discussions the development. addition we And that committed going to get are take doing do we as later we forward we dialogue are development. and that those into feedback

Yigal Nochomovitz

So, X for for you not a yourself? you at a would might Phase starting necessarily wait look or partner

Jeff Wade

development, to and greatest So, develop push Frankly, create pushing that. forward the push is forward to partnership it the we forward are in and in the and value to continue drag doing development way advancing that, development. the to work in believe we with

Yigal Nochomovitz

you focusing on But DPN. are Okay.

Lonnel Coats

be can to the forever, think opportunity. have forward. we way sure value to who aligned achieve keep us drug this FDA around negotiate the trying I program. to the Yes. so -- Yigal, position not get in we we this a we program make forward will I The value wait the is point, and And to are to best will that shouldn't this to think we achieve that be feedback, do developing are that Jeff's the DPN feedback, waiting best for proper partner can going biggest the is going think for with we

be So, focus. DPN will our

It in us than us go DPN PHN, DPN. beyond for should did which absence that But to pain us goal. to for provides pursue that what is is go current we the if really compound Lexicon can partnership neuropathic which advance indication. work allowed why it a a DPN, that and what of allows think this broader we our to I broader achieve is is

Yigal Nochomovitz

And big up guess a on obviously XX heart in day then great. failure, I Okay, coming days. so

I this this of of in slice So, heart to market, into the drill transition wanted recently care down little the bit a worsening failure.

want from just entrenched checks this as an label area where you, much as both or to is whitespace in a be share you're mean, unique get come the what of I at is strong as to to able the a this hearing is proposition just I terms given being you've here, with take are data AHA? comp are the better and channel understanding. are really guidelines SGLT off in value of quickly with you competitors the how well outlined -- going far as -- used that

so you've And value been what's on. the as Medicare and IDNs far been this What's and the the so of this the -- receptivity you've in and mentioned you about? some that covering reimbursement channel in gap treatment filling proposition talked the early with discussions, the to terms and the said,

Jeff Wade

the part So, setting this and to the in in adoption that early institutions how inhibitors patients. for used. be curve the at for starting SGLT first variable among But use still, inhibitors of as we're SGLT widely its answer are your point, they're being hospital of used of question, care transition to to

that to has We're unique likely it's get area on setting. discharge data proceed bring commercial what our but to in they're already on stay launch to or for that up shows it benefits to going therapy going that's as And endpoints been area. upon as hospital it's if argument with of the of on that starting at the because we better And sotagliflozin pick that therapy to that happens. hard most into of our people we're leverage focus,

would the The very among say receptivity I would and that question being as of was second hospital characterize encouraging. systems. I receptivity payers -- part

a unique value have proposition We there.

the bring. are SOLOIST payers value people benefit is effectiveness the the that re-hospitalization. be But really a we be about We think data those and as that talking systems will we about to of to from about who bearing unique important publishing costs data and that cost hospital has uniquely

And to have hospital benefit particular, the And AHA in from presented that we the also last this in year. proof readmission and XX only shows hospital that readmissions. ran XX data that we the SOLOIST that day not overall, from but and were studies

So an perspective payers can to well. the what been bring proposition, we and for systems that table value from hospital very economic has resonating

Lonnel Coats

a add what was Just points other Jeff couple to saying.

guideline came out it's to important only two think first I that are European how years U.S. context put were the guidelines recent guidelines than in these The the that changes less category combined guidelines all a of HFpEF came in only around out use SGLT came week. only this and year a really out statement the And consensus inhibitors at last ago. half ago.

currently. beta and And SGLT the that the at class penetration inhibitors the is the fact XX% think about think blockers if XX% is less I when Jeff you of you think about only as a than mentioned, SGLT HFrEF the recommendation class fact, and and class huge now our a the level the is XA as back. at across of I tailwind now for SGLT think opportunity set agents that's profound entire of of a at quite inhibitors recommended class being the HFpEF,

is There and per there all set that present no our there's of XXX SGLT payers group can hospital I think in XX% that, of XX of need, on patient in transition The XXX sotagliflozin with the set a value care year, data group unparalleled. the within problem that is like a top unmet that patients. know XX% data to other years back patients is patients. days, events a the of highest a these proposition in in that coming patient, ours of which

rationale use. sotagliflozin support So, as we a think its that need and in there's a really agent uptake of class market attributes new strong that

Dr. Craig Granowitz

were is and class that clear, The Jardiance add SGLTs that's my in is would Why would that be in class even about spoken thing three think guidelines going very would unique? that only fight. the dapagliflozin, and have Is is. to hadn't drug. be and we is the this be only the third know the been powerful That's how there's I data certainly one one the this sotagliflozin. I colleagues fighting We we submitted one other and European

to the We once guidelines, these approved. sotagliflozin uniqueness falling again is the get hadn't and into already fall U.S. data absent we sotagliflozin the specificity guidelines, an this and approval, drug even of there's being to and received so

we these have into and these proposition guidelines much so, that that pretty is a unique. significant as will way And market as remarkably we value the go guidelines

stage, believe it's we're feeling pretty about and more what And and a to ready happens. certainly us once that And the for we say confident. this FDA will for At so, getting have lot locking us. deliver to we'll and loading

Operator

[Operator question Please Stringer from Instructions] Company. and comes with from your Our next Needham ahead question. Joseph go

Joseph Stringer

potential need could commercially and to do the approved broad going that sota, commercially Or and label, more broad if in label kind approved ultimately for scenario. you think case and capital guess case you with market be think do competitor you sota to label successful? be Just scenarios share of feel best be I be your -- narrow still differentiated that order drugs does from do differentiated you to get a successful? that back you you the outlined label best have

Lonnel Coats

Joseph. you, Thank

would see CAGR I just first market, me gave say scenario the opportunity. a cycling cycle and size the the to the growth significant are we say of the compounds the of Let on that will is there given have confident I I'm this patients these we How compounds, should and scenario be. you rate these that pretty going

product and I've of a already out But should data large quite our opportunity time. significant the to achieve laid indeed you, uniqueness will what for over create sotagliflozin we a

going and in scenario. that's we're to land So, be the optimistic my to I what where I'm around believe pretty confident going view

Operator

to today's that, And back ladies and be gentlemen, to turn concluding like session. we'll I'd floor question-and-answer the for management with team over closing the any remarks.

Lonnel Coats

as development. and want is to year. LXXXXX always, will opportunity Well, everyone awesome an stage for for This such I late our into joining this advance thank stakeholders us. Lexicon

about good pretty that. feeling are We

shortly, get know to will we We and how we the here want LXXXXX. advance feedback will FDA exactly

value move for is partnership, all be it us if for of I the that we stakeholders. generate think our we feel terms confident important under that to into will

we The and feeling second for pretty is one bullish made have investments. therefore we sotagliflozin, the are

They board. to on are people ready are Our go.

short market is has X have FDA and said remarkably we to opportunity compound we that, feeling, cards from a with an have away as confident innovations. the lives always we turning that our with pretty to you have and the ensure unique bring sharing improve of are what remarkably productive their patients believed with conversations our live can that over a we The we mission that and been are to period the and as to begin I

the to forward look and you call. thank I'll next it, With

Operator

for gentlemen, we Ladies today's and presentation. conference conclude that We and thank joining. call you with will

disconnect may You now your lines.

Lexicon Pharmaceuticals (LXRX) 2 May 232023 Q1 Earnings call transcript