- Earnings call transcript Q3 2022

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Operator

Welcome to the Eiger BioPharmaceuticals Third Quarter 2022 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 turn the call over to Sarah Mathieson, Senior Vice President, Corporate Affairs at Eiger.

begin. may You

Sarah Mathieson

afternoon afternoon, at today. Good business thank for on earlier you call. which financial Thank also is to everyone our us available this release press Welcome issued Web and our quarterly joining QX We results, site you. our a and with eigerbio.com. financial update results

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

and Web a Investors We replay be the will use the our slides available section webcast of site. for on will

on Officer; me prepared and are Chief Joining Vice call the remarks Sri Officer; Senior David with CEO; and President, Ryali, Cory, Clinical Dr. Commercial Eldon President Ingrid Choong, Chief Development. Financial Mayer,

Development subject We Craig, Dr. on Colleen Hislop, Diseases Operations Vice matter President team of & for our and experts also Q&A. Metabolic Dr. Senior have Colin available Clinical Vice President,

in remind and Before that potential Eiger contained expectations financial description statements are to the based SEC, XX-Q the we Eiger's assumptions performance, of investors reports commercial we Investors call David. materially. statements, All now statements. turn forward-looking risks Eiger risks no rely actual the and stages on and forward-looking differ this Section. control, I to in assume update and certain statements these beyond call over products therapeutic A available Web latest on XX-K Eiger's like I is results currently these filings the and on including our obligation with uncertainties would will cause include forward-looking including and site of to available our in information development. could concerning different to involve begin, products which The uncertainties areas and to will future

David Cory

Lonafarnib committed to We're designated we a drugs Phase pipeline multiple are just unblinding promise and Eiger, stage therapies At our over XXX D-LIVR this with largest treatment serious forward of conducted. different ritonavir, high late from the delta of reporting countries, the We With is Peginterferon study enrolled fulfilling for programs, in HDV potential patients hepatitis sites two weeks the from study. HDV. first-in-class next the for for from in based end, study topline LIMT-X progress virus lambda, diseases. built and to Sarah. over also from that development, of including recording and our breakthrough To across Thanks in both XX D-LIVR X lambda month, We're two data X. in study that making patients an milestone the therapy XXX important we landmark for platform HDV patients regimens ever second Phase Eiger HDV. look both advancing Lonafarnib of are X away therapy good Peginterferon suffering Phase data

plans details highly provide will differentiated on plans and on other the comment in commercial Lonafarnib topline and will our from of Ingrid their convenient lambda are Eldon HDV that based and on few the viral believe options Hepatitis the globe. are is are therapies, We HDV XX and enrolling most treatment FDA trial clinical hepatitis, are approved XX activating these countries. than patients for There more million currently and administration, D-LIVR therapies action data just desperately and additional severe mechanisms opportunity development. XX Peginterferon delta form impacting for of effective in sites patients. needed a We people minutes. around commercialization no our in

hypoglycemic conditions. Avexitide, We first-in-class the our Turning has receptor our of benefit hyperinsulinemic broad across rare antagonist, meaningful to confer metabolic believe disease a spectrum of GLP-X to programs. potential therapeutic

new treatments for children. for congenital a With congenital we no for has have Phase pediatric hyperinsulinism. lead X neonates therapies hyperinsulinism, making upon our hyperinsulinism, effective congenital in approval AVANT disease indication, threatening initiated disorder designation, affecting potentially the program therapy it a review life approved urgently Avexitide granted For and designation rare rare been are eligible needed. voucher breakthrough FDA priority and

study agreement across AVANT have XX both neonates and enroll expect patient advocacy the and program, for begin pleased clinical forward endpoints, and sharing over from patients. and with children. communities enthusiasm to the design screening by and and as FDA the to support we more the on activating look sites and We details We've been

Regarding investigator an based COVID-XX from for not of sponsored COVID-XX, study. the FDA consider Phase generated application lambda Peginterferon lambda X we're results the for will that disappointed on TOGETHER EUA Peginterferon

the viral in for conviction infections. in benefit of a However, we and to other data with the continue respiratory lambda Peginterferon potential to have meaningful strong and patients confer COVID-XX

biopharmaceutical program, continued strengthening seen development of this commercial in this strong. demonstrates We regulatory XXXX approval and progress with other steps ex-US, the material a for strategic priorities for commercialize continuing to hand to drive capabilities growth successfully our reach, to now in expand on the pipeline, our product. leveraging plan across Ingrid. by medicines I'll for Peginterferon throughout as our COVID-XX of This lambda to and for year as we've now foundation ability US and advancing the and successfully prepare We’re patients authorizations and commercial Zokinvy our Eiger's Europe the We're We call over respiratory well operational strategic warrants. to evaluating focused commercial growth. need. requirements US global infections. finish to the momentum as our EU actively remain navigate the as UK, executing and viral to tuning our complex of global company plan our business we've finally Japan. as both in And in of based Zokinvy to stage the for in year expanded marketing The next a update options partnership AnGes, reach commercial in with well and

Ingrid Choong

hepatitis virus I'll highlighting continued across delta our begin by David. progress our Thanks, platform.

are Lonafarnib D-LIVR David we As the two noted, excited from of topline landmark Phase from regimens. reporting data X unblinding away we that are study just based weeks and

top for and to results. patients. milestone is cleaning in making analyzed database team the is clinical process This locked report Our line the be HDV can Eiger years it and in of before the

study To trial defined And Phase normal regimens, NDA combination log HDV RNA in and the XX primary Phase we of ALT or combination receiving primary and this patients endpoint a understand to Lonafarnib patients oral submission. of in delta largest positive with meet paths hepatitis into X filings. comprehensive all Lonafarnib by characterize virus, HDV controlled of all D-LIVR global X progressive path a from decline for is spanned regimen two this provides HDV X in oral explored broad the a Phase will the multiple either design normalization different XXX weeks log in devastating have Phase decline XX% two after two the of based D-LIVR five if a better and Lonafarnib regimens recap, after the subsequently platform. composite data source of patients. XX% with placebo, based XX Phase of endpoint was in Peginterferon weeks Alpha patient Alpha the of study D-LIVR and to registration support of an were the of composite conducted As disease regulatory If study program the our rotation studies that The X HDV and The was global Peginterferon RNA and endpoint as a XX treatment. infected the advanced the X, regimens well over a informed generate regimens, of clinical ALT base of treatment. achieved receiving the Lonafarnib versus

in baseline week liver key many all histology, Importantly, biopsies. as outcome. XX for HDV and to assessed as placebo response need therapies maybe would secondary a liver option delta we higher treatment D-LIVR treatment this do successful be years, on a compared high patients rates be an patient virus, not treatment than chronic for regimen oral meaningful arm a in investigational aggressive using demonstrating interferon with or response. as like robust potentially that In and need an any believe for could oral obviate a for paired delivers combined the of a of for weekly a will clinically A transplants. stabilization to where see patients other hepatitis disease the demand is that endpoint a We disease treatment fibrosis there

We call host topline and we expect to data. the when both December, report endpoints investor the in we’ll endpoint report discuss and secondary key to an primary results

two finite in demonstrates lambda our X agencies will treatment similar XX limit as study therapies. for attractive LIMT-X of post two continues patients post arm below the by and therapy is two. a one proportion followed X treatment SVR activate This Peginterferon the response quantitation treatment; from patients achieved weeks cure DVR. or of durable the at enrolling no potential largely durability lambda. to in offered best XX X this sustained treatment program, randomized and a from The XX previously patients endpoint HCV XX to weeks is to D-LIVR where is Phase where virologic option weekly, with be second endpoint of below treatment, was weeks XX to a DVR sites of XX% compared arm is used move previously an after arm regulatory The one with This quantitation LIMT-X of delta the RNA the is for study patients. HDV the to lambda. patients a the primary HDV All XX Peginterferon is of a for response at study; endpoint response two treatment. sites and virus. off to be arm making XXX weeks enroll physicians demonstrated weeks, is Phase or XX Peginterferon of RNA can performing endpoint treated The virologic once no HDV of weeks the active for all in it to Turning study meaningful LIMT-X patients hepatitis and arm in limit primary Phase weeks study. straightforward arm

two Our is the study. from results of regimens strategic Lonafarnib of regulatory approvals D-LIVR approach based to in HDV the seek

to HDV. from will approval could of which the lambda to and both Lonafarnib will combination lead with for which Peginterferon LIMT-X, for future through lambda. We In We lambda the Lonafarnib route of will most hepatitis data follow generate this infection. ritonavir for our we believe LIFT expeditious we approach provides Phase approval X and delta support of parallel, use proprietary data the Peginterferon NIH study, believe Peginterferon

meeting in continued D-LIVR the and solely tomorrow about hepatitis in advancements Last call from continued HDV. HDV medical over and liver a corner platform first enrolling I'll meeting, focused we AASOD, to attending well excited Cure as on in Delta the space. delta, the DC. international to our strong Washington believe become momentum leader positions to of this around We right Eldon. Eiger’s therapies the the data first-in-class turn LIMT-X differentiated study, the progress to Conference, now look in contributing only Eiger in the topline are space. With participated the the We forward starting month,

Eldon Mayer

few planning Thanks next Ingrid. for of anticipated overview for the launch the of of I'll spend our the regimens commercial providing minutes HDV. treatment based an Lonafarnib

multiple Ingrid the and Lonafarnib for opportunity. a Lonafarnib HDV As the Eiger. Lonafarnib either to represents We D-LIVR Collectively, team potential ritonavir regimens. orphan significant Peginterferon team with commercial of Alpha, the product confer that registration based patients believe specifically provides to all extensive disease has commercial potential at noted, or oral with based exciting pathways the are experience the to benefits space. regimens, has times These launches, in this combination

for Over therapeutic the a for therapies Eiger past areas. multiple we've therapeutics developing approved launched FDA over different been across decade. orphan years, for diseases HDV has XX XX

leaders, developed opinion continue plans. D-LIVR refine. Phase to we've key time, imminent, and closer strong we X launch with research which data market that HDV built During are we to conducted and our With these now relationships plans, operationalizing investigators

therapies are commercial been with need, HDV, As the in Lonafarnib and estimated a currently therapy will of medical unmet clinical globe. expect we made of population virus high. of there the utilization we be patient patient time, is the HDV potential recent significant validated the lambda’s a we stage Peginterferon only combination differentiated more By preference the rates and is noted, compliance in multiple by US early HDV expect at orphan response around first awareness impacting delivers therapy make stage interferon the and three XX as for Lonafarnib, David hepatitis development. has physicians XXX,XXX. people the highly a by with of HDV an of than a we that large increased a possible lambda convenient no and The it and our million into greater and is choice Lonafarnib HCV and HDV approved where with to ritonavir launch Europe, oral In AASLD disease entry HDV prevalent oral that a in commercial development clinical companies Peginterferon and space from ritonavir leading Both programs late profile or future, interferon, believe patients, FDA robust all interferon for development delta outcomes. other programs other are therapies. believe and that In we improved tests PCR potential to testing update better to tolerability EASL for type of class the the guidelines. the has diagnosis opportunity

are HDV commercial treat as HBV. cost We and only who delta treat patients launch. and efficient same focused for is with virus a with planning HDV with found delta The patients a co-infection physicians

targeted believe force. As we D-LIVR HBV HDV are in are the US, field a areas. XX% that major map that collaborations. by the lean metropolitan provide heavily of could prescribers, concentrated can see strategic for for XX% of data from US, prescribers you Outside opportunities this dynamic in a HBV allows scripts written

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on Following of our regimens we to D-LIVR based details plan results, for HDV. additional share for plans Lonafarnib commercialization

sales update the quick in during reported million net Zokinvy. third on in a quarter Finally, US. $X We the

reimbursement US Demonstrated most two reimbursement with our received In in in reimbursed our July, announced As we we early patients of reimbursement European XXX% under EMA of secured approval with XX% previously and Zokinvy. payer the markets, strategy, of in Germany. in access we stated, largest Progeria program coverage. success France, identified Zokinvy importantly,

year. to first this We expect our shipment the Germany of by end

a well patients of in as pleased excited commercialization launch the ministries local managing of with payers reimbursement authorities, with based potential appropriate successful confident our to services. as to providers Progeria, of to country. are in distribution healthcare progress for and engaged patient have obtain programs and each health infrastructure efficient commercial We HDV. EU, our for We're date, summary, across the ability place who our support an In we're and with reimbursement in about lonafarnib execute including regimens

now indications, mission our the patients future we now we've in the infrastructure for designed in for Zokinvy diseases. HDV before, noted scale over hand to the as I've support As serious launches has and call Europe and will grow Progeria launch established been the Sri US with larger including to help for of I advance and to to financial update.

Sri Ryali

I'll release Thanks, and this financial afternoon we Eldon. The issued few press include the highlights out a call here. update,

third As this XXXX for million $X by Zokinvy Higher of during Eldon were noted, reported sales. revenue net for net largely in $X sales total compares consisted US which to shipped quarter entirely million, quarter units quarter $X.X second million This QX XXXX. and additional quarter. the was driven

nonconforming operating for third expenses GAAP or third of $X R&D was SG&A million onetime a the were We expenses reported to of the were and basis. a batch expenses. sales included net XXXX off Cost which write quarter in million, of on share million $X.XX million quarter. quarter. $XX.X $XX.X a quarter a $X.X per loss our Turning of inventory

million into ahead in we've September important as are managing As investments our expenses we've Phase catalysts. commercialize therapies discussed to we've approximately efficient a X. cash, of positioned advanced that resource and underserved well end, XXth, growth through of manner. key been milestones a our of as With strategy and develop multiple programs and part patients capital before, disciplined for equivalents and we $XXX To cash and in is innovative

through fund HDV. We expect this commercialization operations potential XXXX before in to planned cash

of facilities the to two under into the Q&A Operator, commercial access for entered year. fund debt this our open have across Lonafarnib instructions we that to up access portion call. cash, we the launch nondiluted capital can expenses. Eiger instrumental earlier tranches, regulatory in additional for to milestones and We'll million which clinical be please can up $XX contingent the now HDV provide positive call Importantly, additional on our Q&A.

Operator

first of of our question the Raycroft Maurice line And Instructions] Jefferies. [Operator from comes

Maury Raycroft

I taking for XX. ask thanks on questions. and progress, my have going the was that the Slide endpoint just to about on you data composite Congrats

patients variables, Phase talk baseline you your or If how say reflective the about these can to load can is these X can other are and there population. up results? impacting you anything about or viral X And similar baseline end Phase

David Cory

will turn I Choong. And one Ingrid that to Ingrid?

Ingrid Choong

The thought previously Phase to X. Phase X patient those similar we baseline population what is very characteristics, in

characteristics, that we an we information what RNA, month. are and characteristics five of for the And next around sharing certainly is as also the ALT baseline baseline well EASL share be additional come we the example, this did out abstract specifics HDV results logs. earlier that in at year put mean out Regarding when shared topline D-LIVR an will

Maury Raycroft

so baseline And versus impact how data with what potentially some Slide those Phase you’d additional you've on say XX? nothing composite just of characteristics the could already X on the shown results

Ingrid Choong

all the what So Phase I comparable from baseline for as XX% said, seen far, example, patients the already X around characteristics very cirrhotic. cirrhotic, -- is of we've what's of in for X like to are Phase

I things to criteria X X entry like Other your Alpha, one on very criteria very X. of Peginterferon the ensuring to Phase comfortable patients and previously who think your exclusion Phase of from that's Phase are also similar that X. was are important Phase

David Cory

than negative two across consistent RNA, Phase we I'll decline, whether viral to composite baseline we loads. course, we equal we obviously, in or ultimately that, typically maybe But the influenced viral undetectable, not the endpoint to viral achieve two come believe is with of in patients HDV that data RNA just irrespective based loads. load, our or decline believe baseline, whether baseline of get those lower X log or reductions a viral on add, log their know, load the kinds of ability levels. of Maury, become see as follows then And greater in that or you believe should HDV or ALT, high baseline by would patient high

enzymes well. we ALT high on so normalization liver reduction as expectations have of in And or

Maury Raycroft

where I final have or sites the is you database impact be to wanted to Russia, believe. locked in with included And other and Phase collection, to and sight related some question. you data I at one Ukraine what follow-up say will if in lock? Can the ask numbers if There X was analyses, line of your database you're

Ingrid Choong

significance the we did to back that in Ukraine, more show some conflict Lonafarnib on were over again, had and we while patients. randomized only in a for the on analyses lose haven't we've than powered that statistical of were adequately to subset. containing sensitivity if we who sites Russian Russian on either we patients Ukraine planning lost Today, regimens the losing February, early still impact -- Ukraine, potential we've were to of the showed placebo. no be And we would for all even So patients all

either still to more So significance than adequately show arm. against we're powered statistical

David Cory

yet, December that in and in announce We on to plan hopefully sometime helps, guidance topline lock data But Maury. extent you to December. database we guided providing line that a straight haven't today the that between gives

Ingrid Choong

we've by about querying So having and we database data still December. a this year -- track data. the the a is and this been study feel top good topline line and to of having We've are really on part since been early cleaning large

Operator

from question of of next Baird. Brian line your comes And the Skorney

Charlie Moore

opportunity know you wanted thinking any Brian. the how on you We were have for your if for . HDV to about And that is Hepcludex will CRL impact Charlie products? or commercial think the This on

David Cory

timing related D-LIVR of announced our plan imagine, the priority of and strategy more you This But in regulatory aware is program. for details key following and announcement obviously CRL not our do we're to Eiger. As on to December. their results timelines provide a Gilead can strategy bulevirtide that we or

Operator

Hazlett Your of next question comes Bert from the of line BTIG.

Bert Hazlett

pushes potential enrollment might the to relative LIMT-X, But in maybe that remind you Apologies D-LIVR? what in of more for rapid are and enrollment been addressed. of place has if help Kind the this trial Peginterferon that us just of lambda. pulls could

David Cory

question. us turn Ingrid. I'll Thanks for over one a today. joining that And great to that's

Ingrid Choong

it's to sites study XX picked LIMT-X smaller, XX countries patients these across sites sites. XXX the X Phase from only best The study, straightforward from more performing across a We've D-LIVR. much compared D-LIVR planned XX

expeditious on in criteria less more So this that Also D-LIVR and exclusion will or the based much definitely LIMT-X enrollment. to compared facilitate of inclusion learnings. is more

all because composite of at study entry. only have in the is patients limit -- X.X log for at study our endpoint have since decline primary log to a HDV below unquantifiable RNA entry case endpoint example, we For RNA, D-LIVR a being HDV D-LIVR. of of HDV the requiring we in part two the RNA least LIMT-X, is quantitation, to at are In patients have

So that's just one example.

one and both must it's HDV on is these IUs in in first, have XX finding higher LIMT-X. learnings so again, upon example case per -- benefit LIMT-X, having, And of Another DNA D-LIVR that’s DNA and and ml LIMT-X. D-LIVR the suppressed entry, having criteria in study ml per before is all patients IUs LIMT-X suppressed and for are that XXX HDV of D-LIVR much the just

David Cory

and look providing definitely activation XX a more forward completed Phase will in future. lot LIMT-X the D-LIVR for all the in sites, guidance the to after study we've study lambda We across of countries and And obviously HDV. roughly X communicate XXX sites all over those learned have and learnings we XX from applied

Operator

question next from line Your Instructions] of [Operator the Ladenburg. Higgins comes of Michael

Farhana Sakloth

on Farhana Michael. of is behalf This

the on Meeting… Delta Cure We basically have a question

David Cory

repeat you could again? Farhana, that

Farhana Sakloth

was Can me I now? you you talking just guys. to hear

David Cory

Yes.

Farhana Sakloth

Eiger’s what know We the wanted bit about you participation what of and share you program. learned of there little I can what Delta get your guess Meeting. feedback on sort about Cure you a did to more

David Cory

in we experiences Delta this of the comment of Ingrid of which the think therapeutic and in pointed on virus infection, I'll event. it's the actually specifically Milan learnings international Delta on let it great was and the amazing out focused an you terms area. in Cure. out, Ingrid, team delta as things Cure attendance focus some at was in actually Meeting, meeting hepatitis clinical portend Ingrid to with And come first And

Ingrid Choong

days, attendees part Delta attendees participating Cure was was the was the and held October. XXX zoom. there this J&J, of Delta. Most There for And Eiger, and by was two [Technical on also Gilead, Difficulty] medical key first diagnostics There to XXX was meeting opinion companies solely early were as the of people with Vir in in pharma also only then person again, represented leaders. some focused addition in well.

it half of was a So one presentations. days and

oral The presentations coming excitement just really really a well and the space now for with lambda, as hepatitis. need HDV, talking just Lonafarnib about well the be able to on which on really very [Everett] discussing first Bill across virulent ritonavir conquer a then focused combination day potentially and on and the data Eiger disease pharma, there's giving and were around as and Lonafarnib, second space serious Peginterferon as viral to out therapies from updates the need Peginterferon is of programs. lot therapies for ultimately, was day lambda. presented as And half

David Cory

add in Wedemeyer the that, think the Hannover, opinion key and I the of space. Italy, out cure Dr. Heiner of I'll leaders Lampertico host And Farhana Milan, that Germany two major HDV the reason out Pietro of delta Dr. meeting part of

very and stage, combination But ritonavir patients Gilead, is of addition with stage to in out. interferon albeit Assembly, the J&J, think, now hope earlier I'm companies because mentioned, with part to Vir future I the I'm in for is well in reason stage. with as the But leaving programs, HDV. provides late advance as is in now like pipeline think Lonafarnib terrific Albireo, wanted and few which for they Alpha HDV the many early sure Ingrid development space and is I obviously programs, program that Eiger, as a a this

Farhana Sakloth

ask just Can more I maybe if clarify. you so thing, quick one just missed we could

it enrolled. Avexitide, just patients no are we're like patients, looks right? screening There So

David Cory

Farhana, AVANT to We're had not all sites We have provide be and that’s be the updates able program. undertaking that. patient enrolled we'll and to patients, screen yet in enabling we able of to the more to activate correct. say on once work Avexitide

Eldon Mayer

key both International a amazing Hospital was But for from benefit hyperinsulinism I but It Children's. another Hyperinsulinism leaders, that multiple we International and by And New in to space area near in I attended was held very also think pharma Children's investigators the foundation Hyperinsulinism updates the families are interact do will opinion that Montclair, well congenital say in as Congenital and an provide evening afternoon key for leaders definitely and and this as investigators. Jersey, both is patients, fundraising Cook exciting which to additional development event, will Philadelphia, so. of recently companies supporting for Congenital the opinion with motivated future

Farhana Sakloth

And then for fair is XXXX estimate data? a

David Cory

For the on of activation will provide Farhana, sites then complete data. patients for enrolling we program, Avexitide and AVANT guidance, enrollment next on then steps begin more and and obviously, timelines site for

Operator

David questions. Cory like call to further remarks. for now further any I any showing not I'm back to would And

David Cory

away, we to very you is much. and that the excited few reporting study from and thank In unblinding very just D-LIVR of comments. make I and top study hosting the line of multiple provides Certainly, when We're look therapeutics landmark registration to forward data paths investor This development. closing, weeks are based we want a the regimens, which just differentiated in we D-LIVR results. Lonafarnib believe other from an to announce topline call well

We people. our deliver dedicated which course, to breakthrough would designated in execute and the patient none possible of team this multiple And therapy without X, of value. potential FDA our have be both of continue across Phase pipeline programs of to shareholder

of their across and us day. only thank programs, investigators, our Eiger Have not joining to today So relentless course, for of for great efforts you a on everyone I'd patient advocacy our but at our thank and like call. our all support groups

Operator

Thank call. you presenters. And conference this concludes today's

You now disconnect. may

Eiger BioPharmaceuticals (EIGRQ) 4 Nov 222022 Q3 Earnings call transcript