EIGR - Earnings call transcript Q1 2021 | Eiger BioPharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Eiger First Quarter 2021 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, this call will be recorded. I would now like to introduce your host for today's conference, Mr. Officer Financial Chief Ryali, of Eiger. Sri may you begin. Sir,

Sri Ryali

QX for Great. earnings Welcome today. website and at with call. on is you Good thank joining our afternoon to this issued eigerbio.com. press us results, our a which available afternoon We release financial our inaugural quarterly

Development and President, Dr. Ingrid Joining Vice Choong, Operations. me President President, on Clinical Colin Chief Mayer, Clinical are call Eldon today's and Hislop, Senior Vice Senior Commercial and Cory, Development; David CEO; Officer; Dr.

we call, remarks the today's prepared For will from management have Q&A. by team followed

be XXXX, the identified We not will to call all filed have section on harbor on Private the on safe remind on Reform statements slides website, periodic our of the will replay the as annual Investor in be of this that our types include XX-K, subsequent using provision forward-looking Form of our including and to of report limited which will forward-looking for the the XXXX reports the Litigation SEC like investors section. Securities quarterly a and statements webcast our Form our but available to XX-Q, within Act We'd with Investors website. meaning available in reports the

the only views filed of periodic the statements. represent to to statements as any should related a David. from over our as are results as SEC. specifically These involves to statements many to not any beyond and call views that turn subsequent substantial control I'll those obligations forward-looking see risks the differ risks as our date the please reports expressed description For date. our the risks and that and of upon further such of could be These representing of relied well update now including this our as our call disclaim materially uncertainties business, and cause actual with in forward-looking the uncertainties

David Cory

us you life-threatening and in you and potential At on progress our high today. medical updating look We're creation good we ultra-rare for across advancing and for Eiger, well and making everyone. therapies and rare joining pipeline XXXX afternoon, this beyond, today to Sri, Thanks, value needs. progress future Thank multiple for forward to year with great now and our commercializing we're characterized unmet diseases plans. our first-in-class, developing date catalysts

breakthrough take well year Our pipeline Zokinvy late-stage significant demonstrates these late-stage last patients conditions and to submission lonafarnib, and commercialization. additional this a approval, pegylated is laminopathies FDA victory approvals. with clinical progeroid towards to The lambda, year, Drug for ability positioned IND processing-deficient a Eiger our product through late promising progress approval pipeline across and ultra-rare New interferon make is designated development of filing, for our and to treat program X includes FDA first Avexitide. therapies; Application NDA from FDA our progeria

grow commercial launches capabilities disease to development scale clinical we've future. the We affairs grow advance and with continue across to our additional can that indications in and launch, medical and we commercial orphan functions larger the as Zokinvy established

few Eldon for a clinical a financials. will of recent including anticipated our more will and progress spend update will update, moments I'll today, highlighting an Ingrid provide milestones. our And the call on our For on launch. Zokinvy details lambda review Sri each U.S. provide programs, COVID-XX.

most deadly hepatitis. target form programs of virus viral clinical or lead hepatitis Our delta the HDV,

regimens deliver X only inhibitor global and and both have lonafarnib-based study lonafarnib-based X. to promising largest a regimen. oral lambda, enrolling is development This the in XXX arm HDV, lonafarnib-ritonavir FDA well-characterized pegylated developing over and around includes countries each lonafarnib including X study alpha, and sites late-stage for compared Lonafarnib in and is the D-LIVR XX X and with been approval of world. the arm a treatment arm in be first-in-class interferon therapy designation. for placebo/ a combination our candidates of Phase currently creates of Phase lonafarnib-ritonavir in prenylation only and are study granted oral HDV dosing, and breakthrough of across We which regulatory opportunities The conducted to and is is X

pleased expected is are to We that patients to randomized. D-LIVR screening enrolled announce including randomized in that patients' XX% be and currently are date to

or end on to III interferon first-in-class type by patients XXXX enrollment Pegylated Phase the We interferon this full later track current for X of begin of well-tolerated year. XXX will lambda are Lambda, conditions. under HDV in complete a

outpatients X/X with Lambda which patients. trial multiple moderate called Phase Lambda Toronto, in diagnosed clinical an Brazil optionality parallel, in previously into for we investigating single an leader like Canada. study a now open first-in-class agreement in lonafarnib both We Eiger multicenter are we patients. an The therapeutics earlier therapies XXX as In with for to a another a newly to provide convenient And and provide for future have the this update targeting now clinical and ILIAD XX study and will protocol concurrence ongoing as from EMA and Lambda pivotal is FDA COVID-XX patients. includes for HDV promising positioned Phase HDV IND an registration-enabling to of and placebo-controlled Lambda, non-hospitalized to is TOGETHER. site pleased that X week reported just have newly dosing trial treatment study in I'd COVID-XX at with on a a also treatment We and X entered clinical study in outpatient be the Toronto potential Phase study. Eiger platform to endpoints diagnosed COVID-XX that patients. include COVID-XX, sites potentially TOGETHER announce mild results paradigm arm

more the believe study details protocol is The provide unmet numbers moments. just registration medical X/X will with wave design be Phase the experiencing well on And and Ingrid another the our COVID we you in in urgent, could aligns know, Brazil IND. a few design deaths record TOGETHER exists with enabling. platform As hospitalizations pandemic and study there. TOGETHER need an of of

to Finally, or I'd a metabolic pediatric advance which program, PBH, to or post-bariatric on which mechanism a designation. granted first-in-class patients has which disease disorders: orphan hypoglycemia like targeted has designation; opportunity therapy X and congenital metabolic novel, FDA granted pipeline different hyperinsulinism update rare an with been phase in presents very avexitide, CHI, disease breakthrough for the FDA been

how We have will and trials provide and a both as in Avexitide initiated development manufacturing program. significant for and guidance planned and this clinical CHI. support XXXX on plan registration-enabling in advance to the opportunity activities device necessary early PBH represents we these as to to as complete indications commercial regulatory as of both we well future

This provides complete the on We will enable HDV of Eiger cash the Phase deliver position runway have to us to QX resources planned the X and operations D-LIVR $XXX.X these cash strong with study we our Importantly, a financial LIMT-X HDV with ended Phase and commitments. all began million. fund with into to XXXX QX critically and XXXX, study. X

over families, as to update, and call congratulate successful the to the a a mission. at for like our as very relentless and of for turning their our I'd patients commercial the who core U.S. efforts are well team Eldon acknowledge launch Before Eldon? their Zokinvy

Eldon Mayer

David. Thanks,

laminopathies young and adults and team's our children progeroid are continued around identified Let by There progeroid and the processing-deficient to progeria begin children adults with important sharing excitement with about laminopathies. bringing young progeria me world. in therapy this in XXX

focused patients program and and young do to and Zokinvy of identified this approximately XX we on with through be approval adults has children in in in then and efforts continue supply identified Eiger will provided expect the commercialization commercial the may initial Our XX later countries the to are trials Europe, where clinical patients January launched year. uninterrupted expanded in we where and U.S., our so access countries XX in approval over impractical. regulatory through

diseases, every already U.S with As sales It's efficient our call that in net to we've to that's program shared ultra-rare pre-launch that and in who in diagnosed Eiger's access access expanded Progeria U.S. XX support access a and with for we note efficient continues Zokinvy. systems young have children were to through and and to nature to enabled Zokinvy. designed our the the eligible We and clinical approval XX successfully million. goal processing-deficient patient providing Zokinvy with with be of execute to of following And mind, launch are progeroid will FDA been laminopathies taking with or of focus adults patients launch. and that distribution able transition effort planning, studies, has $X.X the approximately reported we the in identified a Zokinvy, QX the commercial which our supply these following important

First XXX were bottles of Zokinvy shipped totaled dedicated our specialty quarter XPL which bottles XX of patients. to shipments to pharmacy

or occur Eiger to access a result looking been value OneCare all to payer Each to important patients may that channel Zokinvy caregivers. approximately lack government XX update. the pleased forward. and be goal a approximately I'll home and channel our as commercial. an to weeks ensure bottles their center during X Progeria them families. community. are provide to payer means XXX support for we've as a for the and out-of-pocket insurance of X demonstration have we over to practice of in of clinical Ingrid coverage burn commitment And do to payers treatment their is call had patients, directly patient with uninsured, inventory expect be mix of patient's to or who Eiger any have and the need continuous Medicaid along that, with programs recognized also costs. to report QX. financial with XX implemented of very the that up not assistance clear XX% including to delivers barriers And We've development us shaping materials distribution supportive the bottles the should propositions zero The adequate We've to and The to coverage. primary hand with what known provide is patients costs enabled inventory it Therefore, OneCare to Zokinvy XX% Zokinvy We of to created pleased that XX

Ingrid Choong

Eldon. Thanks,

are across As development David mentioned, progress clinical portfolio. making we great our

and is of review fourth Zokinvy by the XXXX. EMA for in are we expecting MAA quarter the currently Our approval under

on received HDV for called of log opportunities RNA in for endpoint compared normalization. the X HDV for assuming and lonafarnib-based HDV of who And are study D-LIVR Lonafarnib previously of of our being preparing creates of parallel, Phase In with lonafarnib patients conditions regulatory data year. X, includes approval able Lambda that a placebo. to This enrolled, weeks peginterferon which The decline this regarding us D-LIVR a HDV for XXXX. to to Our were basis initiation post-treatment. of a XX% put and combination composite would announce arm limit a form and XX% regimen. regimens for arm below weeks in Phase D-LIVR in LIMT-X enrollment ritonavir these X this XX In of oral of RNA is alpha, of plus ALT and top-line Lambda design undetectable X Phase X virologic each response study we year. study about X achieve with the completion study at X is all or quantification durable is excited of EMA ritonavir XXX half patients or this on lonafarnib-based registration. primary results [indiscernible] a current second We're The we a study hold, discussion track FDA which demonstrated XX of track

XX very in XXX X sites. This of XX sites selected the is efficiently. global anticipate of RNA from allow LIMT-X the with will us XX proportion and post-treatment patients by of treatment no is to endpoint of We so in study LIMT-X D-LIVR study off both primary at agencies below Lambda followed a of XX enroll have to compared we weeks pivotal enroll limit be quantification quickly to weeks study XX we'll LIMT-X across arm in HDV for performing which primarily patients, randomized of with straight dosing sites a HDV. study, The best treatment. weeks forward agreement as treatment XX arm single Lambda X. the a weeks a on is should X-arm

the clearance community curb and X Lambda selectively cases are patients. severe SARS-CoV-X only spread, the first of that Rapid infections. interferon receptors respiratory the lambda provided the clinical disease with a improve that reported of tract. epithelium Lambda in against Phase a study levels which as expression in defense to rationale of associated interferon, risk of in now Turning in others. clearance liver dose to not but non-hospitalized COVID-XX of COVID-XX, study the higher conducted ILIAD a particularly the of in normally accelerated those of those for for immune Toronto to suppresses lining also the located viral early infection. and Lambda as newly therapeutic a as diagnosed potential potential We outcomes has produces demonstrated SARS-CoV-X single viral transmission system This SARS-CoV-X to the line to with more high Lambda epithelial are

deaths Up to COVID-XX include into TOGETHER an clinical with an TOGETHER to a to in is As hospitalizations X/X that XX the The treated targeting David The day platform diagnosed, analysis be outpatient Finding outcome COVID-XX IND separate include a XXX planned comparing have a trial and Phase Lambda recent across at priority patients X related the Lambda in patients receive of We Brazil treatments a site exploring single open X/X one-to-one mentioned, with The or or to arm and a patient proportion primary emergency this including Canada. includes newly to our we interim Lambda treatment. is placebo in patients study. COVID-XX from are for outpatients our mild dose Phase placebo. endpoint Phase pathway X were for the week or now that with in protocol been an IND. enrollment. a high-risk has to non-hospitalized COVID-XX COVID-XX efficient with Toronto, distinct agreement high-risk, is advance enrollment of ongoing a futility endpoint. we in sites versus moderate a as promising of XXX an included plans XX% study Lambda room clinical approximately excited clinical XX, for for by randomized announce micrograms to entered visits, study study with TOGETHER months. determine Phase Lambda protocol

on no require intravenous We Phase needed. patient where However, believe there's FDA's population use infusion convenient in both and and outpatient registration-enabling demonstrated antibodies have treatment that currently, target with practice is TOGETHER clinical clinical in COVID-XX. studies could be align guidance Approved treatment study, X limited for endpoint. acute monoclonal

new be of that stimulate In vaccines. of for strains variance or monoclonal the under for an SARS-CoV-X. in SARS-CoV-X antibodies Based immune during addressing host addition, resistance viral to is responses variance the of protection are development infections with may ideal concern critical forward suited we ongoing We a platform on Lambda's Lambda for the We convenient to believe and futility of that treatment rising to mechanism to action is diagnosed TOGETHER with and investigating study of the administration outpatients variants, is COVID-XX. agnostic ideally look COVID-XX and adding Lambda newly outpatients. and

program appropriate will exciting turn provide updates now opportunity. review will the We to on as over financials. I available call our to they're this Sri

Sri Ryali

press which issued Thanks, will a we financial update this Ingrid. afternoon summarize. release The I included

January. million we QX noted, in commercially sales after launching reported Eldon the $X.X As Zokinvy in U.S. in in net

to by to cost had R&D. goods Turning [incurred GAAP we expenses, supply quarter, our cost in sold approval $XX,XXX operating [ph] is for] spent our the Zokinvy as FDA previously

inventory COGS as previously We is consumed. expensed low expect the

Priority $XX.X million we're a We $X.XX expenses, earnings one-time of diluted which the GAAP our for sale Zokinvy in Eiger $XX of other retained closed was to the this the PRV Voucher January. net and from sold statement on proceeds, income and per or basis this result $XX.X did report a $X.X quarter R&D share a million. million for recorded totaled fully quarter of quarter. of which our first as income half For million on SG&A expenses gain Review

us studies, now position $XXX.X began importantly and cash, hand million ended and Finally, LIMT-X. over and runway a Phase equivalents, and the investments. QX year we David. our XXXX, provides X back cash strong in into I'll D-LIVR call with the the us with to with to This complete HDV cash allows quarter

David Cory

in targeting our very you late-stage heard diverse Eiger and And has with remarks and prepared a pipeline ultra-rare diseases Sri. rare need. today, high promising medical Thanks, unmet

Phase our deliver We patients XX% our Phase year, have to a study, across X treatment in HDV plan toward currently study therapy potential plan XXXX. value-creating goal programs XX of and to second HDV. shots of on enrolled the catalysts in X the beyond. week complete these to This Lambda stage XXX results D-LIVR in in We as multiple potential XXXX approval is number the LIMT-X to advance we for with which initiate for enrollment setting

the successful of EMA Zokinvy laminopathies. for approval Zokinvy We progeria progeroid prepare U.S. launch continue for and processing-deficient will commercial of and

for and and We development will advance regulatory, preserve activities manufacturing, development avexitide device CHI. to advance clinical options PBH and for

and the business We today turn will our provide to of the and portion quarterly point, importantly, and thank for I'd calls, we to TOGETHER like the the advance have execution for results platform support to cash Lambda everyone these the Q&A joining the ongoing of COVID-XX At on in milestones. first And instructions it to Phase of update study. please us many financial all X achievement for over needed operator call. this

Operator

And, Thank of your is line you, Raycroft question our sir. is Instructions] first speakers, [Operator from Maury open. Jefferies. Ma'am

Kenny Chan

Hi, this Raycroft. on is Maury Chan Kenny for

For you enrollment? Phase X trial, background the the provide on some patient D-LIVR can

David Cory

D-LIVR well and for enrolled a our communicated us. and the now randomized XXX as XX screening patients date as and HDV currently is Yeah, over across of in as expected in to study, we to as active and study mentioned, enrolled largest good so thanks global are XX% we that today randomize. the The remarks, countries prepared sites question joining patients study is including in only

We haven't end provided XXXX, current hold. of the detailed XXX year, patients by expect guidance; enrollment assuming however, of this we additional full conditions

Kenny Chan

Thanks.

Operator

line from is of Yigal your is question open. Citigroup. Nochomovitz next our speakers, Sir, And,

Ashiq Mubarack

decline between endpoints congrats question of briefly for the a Yigal. choice you I decline rate metric? And the with D-LIVR then, us normalization? maybe reminder call. first Hi, why the with on team, the Thanks study is maybe Ashiq on ALT and thinking how guess, this patients about earnings X D-LIVR, versus give LIMT-X? of can my other especially Mubarack the you're the primary on log chose some taking for you Thanks. And and

David Cory

for and provide color. I'll questions. joining Yeah, sure, also some your Colin add to preliminary for and Ingrid and comments additional all, thanks any us then ask and

to endpoint, negotiating study in and that or X the lonafarnib. Phase we reducing an inflammation, liver quite and treatment for with for bit load time regulators Lambda, off-treatment our for post-treatment program viral Phase a significant liver believe demonstrated end benefit traditional well and related delivering successfully the that's well program actually D-LIVR ALT, HCV regulators both where that Lambda, with endpoints more was quite the to studies With line We LIMT-X we patient in Phase a endpoints desired. previous of Importantly, regimens of and Phase X in respectively. for XX-week normalizing terms enzyme spent align X is demonstrate study able and we've XX-week which by a X been our something endpoint aligned with more endpoint lonafarnib-based

to quantification this. And to will Durable that well Ingrid, confident being it course as treatment weeks XX-week Phase concurrence make to and a offer to convert that I've so, make Response, and feel check with I'll patients Ingrid? sure FDA for and we post-treatment as actually design that of a X defined related And were with outcomes. below EMA, pleased very Virologic I very XX study endpoint gain relatively sure all DVR or a limit at post-treatment. of covered this improved And quickly patient XX-week

Ingrid Choong

LIMT-X finite Lambda a XX-week with of just treatment post-treatment will weekly follow-up. And weeks XX study add as therapy that the Yeah. investigate I'll a

Ashiq Mubarack

Okay.

don't antigen? surface slide. measuring be also you on know will if saw And that Great. I I Okay. the

Ingrid Choong

HDV In looking the at and D-LIVR both antigen. be we'll study, study Yes. with the LIMT-X surface studies

David Cory

therapeutics endpoints draft of for upon these add that agreed I'll a the of importantly by part HDV. are regulators guidance for just development the that

D-LIVR the next So, very studies. on steps very, we both LIMT-X the feel about and good

Ashiq Mubarack

much. you Thank very Awesome. Okay.

Operator

is And BTIG. Hazlett line speakers, question open. our Robert from Sir, of next your

Robert Hazlett

would through and One, - you second more the Could amount maybe I the follow-up. a be helpful. the jump in the quarter? a bit a one bit And be I be of then you Thanks. think, actually That just - of topic, on number stocking you exact the bottles. understanding little think clear But clear, could Yeah. this I'll that I another there. like a little in then just talking have of more got the of occurred

David Cory

Eldon? Yes, your Bert. Good calling for to turn and for Commercial over our I'll directly thanks question. hear your that Officer. Chief Mayer, to and Eldon in voice,

Eldon Mayer

Hi. Yes.

XXX So number XX an We bottles pharmacy. you our - of XPL to I patient dedicated bottles gave our specialty let me XXX, were but from approximate of those to walk through shipped demand.

that that XXX as leaves the resided XXX, that I in earlier. rounded mentioned bottles So, off exactly channel to I and

So, those numbers. are the exact

expect, We going translates forward. roughly to your XXX Hope X mentioned, bottles which to forward, X approximately XX I going that to question. answer weeks as

Robert Hazlett

the Okay. Thanks. disease identified, briefly quick And of describe and the just when on are CHI, patients itself? little presents just a one just condition the you Thanks. how about a could actually more

David Cory

strongly Bert. Congenital hypoglycemic Sure, who to to, referring are children, disorder of thanks a Phase and at that as neonates children data X And and question. neonates is or and and avexitide we mechanism believe with patients that newborns, targeted represents hyperinsulinism, CHOP due a you're a based disease. hyperinsulinemia. this presents for for And also devastating your of with this Children's therapy is generated the potential on Philadelphia Hospital

congenital and future additional Importantly, as making advance. the we hyperinsulinism in has granted FDA forward rare announcements we look pediatric in disease avexitide designation, to

Robert Hazlett

the on Congratulations Thanks. you. Thank Okay. quarter.

Operator

from of speakers, Higgins open. is Michael Thalmann. next question Ladenburg And your your Sir, line

Michael Higgins

Congrats Thanks, update continued to voices HDV, get Thank despite the execution enrollment Hoping on on again. an guys. you your for from you. the COVID's challenges. D-LIVR. to Good hear the

patient updates the on some counts. us given You've

us you trying cetera? were sites, XX, and If to could location, give know expand on COVID in obviously, the I update an et you hit.

as to are some how get there feedback planning sites to many if out Thanks. and to that trying you're expand number? Just

David Cory

are calling Thanks how and Michael. Ingrid? of that things to progressing. number address voice, over your in for to question. for Sure. turn And Ingrid good to I'll and hear your sites

Ingrid Choong

global your know, D-LIVR Hey, is Michael, you study as Yeah, a to hear voice. good the study.

contributors been most The and we is XXX to the So, currently are in over have in Ukraine great recent countries and sites. those Russia enrollment. addition and XX countries

David Cory

the of pandemic. pleased that XXXX just the would in very emerging I Yeah. we're beginning study management D-LIVR with with early add

Our And patients plan first have we not importantly that supply to guidance provided patient end had been study ensuring goal global XXX safety already progressing as randomized. of XXXX. did nicely that such was well monitoring. ramp patients the drug now, as complete we enrollment and that with [indiscernible] lose And we of

Michael Higgins

And Yeah. Follow-up trying next data to to great a well Is That's Q&A gating in touched better have in a losing interesting before get factors It manufacturing staring just of bit or follow-up was then guess would and mentioned of year as the That's next fantastic. see it partnering or essential more not study. a is this but here. to like be on what's release avexitide there. to Thanks. curious And quick your press hear. pivotal of I'm a to run one. that progress partner on as set your hurdle anybody. that? of you're for hear the a understanding by of with looks feedback kind plans yourself, I the

David Cory

you Thank that for Sure. question.

that of announced conviction XXXX, As hypoglycemia option beginning hyperinsulinism. in would we for course publicly different we metabolic guided at opportunity we partnering developed avexitide. indications; of and in that X for during the And we the the greater around congenital strategic post-bariatric process, avexitide potential seek

as us Importantly, XXXX. PBH that device regulatory manufacturing as additional CHI, to as and well early position development put programs; we that will both plan complete could this move into a activities year and registration in as

to able the these XXXX. guidance our for on will more it. that provide that's at direction strategic to point, certainly for programs plan and we so, And look And be forward

Michael Higgins

would as something study a One this? jump This could sites patients. small what I'll that the of follow-up cost pretty be if with obviously you to queue the and that for potential relatively quick frame and - the like us back can me for intensive strikes in a I give the

David Cory

to I'll financial. let Sure. the to Sri speak Ryali

Sri Ryali

able and manufacturing initiated cash smaller would be terms about. would of device conducted Any additional in items PBH past yet would [indiscernible]. get provided and of be runway have was guidance so or for these of haven't gating the or that that cost studies will we we studies funded financial that activities within talked to development are what how would David be some after proceed those be guidance into QX do that program, with we that CHI we Importantly, our we

Michael Higgins

Thanks, I appreciate that. guys.

David Cory

you. Thank

Operator

we have Wedbush questions Securities. our And speakers, next Ma'am is your line Shveta from of Dighe open.

Shveta Dighe

question. European world that Shveta Can on color the more XXX how for you world? in launch on provide you Hi, Thank the you are that my EMA than plan of is the given thinking anticipated about year for is are Moussatos. some patients the Liana end? of about approval taking Zokinvy given this And for rest the by rest

David Cory

XXXX Zokinvy Sure. And joining the over thank of it for for to begin November planned for turn EMA in and you - us announced, then today And us to are looking for later will approval of this and a for I'll We question. to bit Eldon Eldon. build as And that year. Obviously, the I'll approval steps. Zokinvy that, U.S. and Progeria on EMA approval. to And allowed next infrastructure forward ask laminopathies begin be progeroid here scalable. we to comment in with in

Eldon Mayer

Hi, there.

a on approval. would in for partnership expected basis a in setting regulatory negotiated But typically early not year we have countries although Germany, by submitted and that that QX application, country-by-country end. some as provided one outside like as where approval which not it come aside, is we our been may and expect that could approval is and we year. accepted in with Europe have review reimbursement approval as be to in on upon years could countries has following as EMA take, could this And and guidance stated, with we Neopharm secured been Europe And, to X example, Israel other X you we're know, the And preparing sometimes that. course, in though, of for for up yet, under reimbursement. U.S., So, it and is - MAA but

are However, conducted we programs reimbursement there country-by-country various as agency that, consultants payer and And with that through working for revenues patient such with than for we've full generate are other taken needed. a of and on where our approval research. exploring steps opportunities basis We're a available. that services key identify support reimbursement infrastructure and the potential doctors, distribution marketing number earlier to is engaging prepare to establishing as

So, quick want that Anything, would be a add? to you gentlemen, summary.

David Cory

outside comments, regions these make add Europe. territories just guided, the beyond And countries XX address I'll over of question we Yeah. patients identified XXX about that we've of around Western to and to obviously are lie world. patients world. the There many over U.S. sure and Eldon's the in as your Western

partnership distribute have in we those to availability we'll by that hopefully commercial Israel. on other that future. region, well, also And we'll so, that are opportunities. in And the region a Neopharm ensure as on exploring publicly revenue those pathways announced and appropriate And update with become helps. countries many and guide announced to And we as near

Shveta Dighe

thank Great, you.

Operator

Robert question, ahead. go [Operator speakers, next Instructions] Your from please of Hazlett BTIG. Sir,

David Cory

are still us? Bert, you with Hi,

Sri Ryali

Catherine, we for closing why questions, can And you remarks. move don't re-prompt more there if are no Q&A. to

Operator

Okay, your open. sure, Robert have of And, is Sir, BTIG. Hazlett we sir. [Operator Instructions] again, line sir,

Robert Hazlett

it hear try see and this if works. me? Can you me Let

David Cory

Yes, to very voice. good hear your

Robert Hazlett

apologies. My

consider indications? CHI, brief is regard about we urgency but didn't, PBH think a which maybe both on touched the with How either to follow-up, in there Avexitide, you or a there? to or priority going with terms regarding you're of Just the you this, should indication maybe

David Cory

Bert. thanks, Yeah,

well enabling discussions continued indications, take as we regard as as device early as any with for place year products that well this Phase work CHI studies PBH drug focus and manufacture sufficient to regulatory both XXXX. ensure Avexitide primary for registration as So to to to enable is as studies, our program, the needs that X

needs. therapeutic a hyperinsulinism we for indications. represents believe both view these and post Avexitide we congenital major Importantly, targeted that bariatric medical both as of unmet hypoglycemia And

the view populations patient the And as valuable. importantly, need high. we commercially within so, them And unmet equally is

And so, most we the we pathway continue have Avexitide finding look forward to move and provide appropriate and updates to as to them. guidance forward we'll

Robert Hazlett

Terrific. those. We to forward look you. Thank

Operator

for showing I remarks. further am like call I further to speakers, questions. over any back to Mr. would the now Ryali turn And, not any Sri

Sri Ryali

Right. call. concludes Thank our This you, Catherine.

for everyone, around. team today. or are reach info@eigerbio you e-mail have us you appreciate you, members myself questions, joining contact your can If address of management additional out the time. I who to Thank

Operator

thank This Ladies and concludes today conference. you today's in participating gentlemen, program. for

disconnect. great Everyone, all may have a You day.

Eiger BioPharmaceuticals (EIGRQ) 9 May 212021 Q1 Earnings call transcript