EIGR - Earnings call transcript Q4 2021 | Eiger BioPharmaceuticals, Inc.

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Operator

00:04 Good day, ladies and gentlemen, and welcome to the Eiger BioPharmaceuticals Fourth Quarter and Full-Year 2021 Financial Results and Business Update Conference Call. At this time, all participants are in 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. 00:35 I would now like to introduce your host for today’s conference, Mr. Officer Financial Chief Ryali, of Eiger. Sri

begin. may You

Sri Ryali

from afternoon joining XX:XX call, will to Welcome call. results, issued earlier which remarks for XXXX on have and and eigerbio.com. Good and thank We XX:XX this team release followed press website afternoon is us a our our financial we management by the update QX full-year today. Q&A. business you with our quarterly at available results financial today's For prepared

turn over statements. obligation reports latest areas Eiger, development. statements these on information and available materially. to section. is in website XX-Q XX:XX currently The David. assumptions Dr. the webcast these President XX:XX me commercial and financial update the and on would I no stages I'll call different will XX-K of on rely this Clinical remarks Senior for will will call include slides risks cause have Hislop, including of Operations, risks forward-looking to Development Commercial and forward-looking we available of using that be of Eiger’s the concerning Cory, CEO; potential control, and our will based to to prepared us uncertainties President uncertainties for replay performance, contained Q&A. Vice join and results All and assume forward-looking and and the Chief involve statements, which Eiger’s to Senior the our call our Officer; a SEC, are We products, products President remind including with Investors different and Mayer, David in on certain are investors beyond Vice filings website. should the on Development. therapeutic actual and future in section of our Eldon A the statements Choong, Investors now Eiger Dr. XX:XX Clinical with Joining like available description XX:XX Colin the expectations Ingrid

David Cory

XX:XX Thanks Sri.

for excited believe XXXX, very year Eiger. which a transformational are we We about will be

one Eiger promise includes has designated with designed strategy unmet readouts planned late create much for our coming a FDA have pipeline, diverse into Our pipeline to patients we and that medical to value five needed Today, needs been shareholders. data focus a year. breakthrough with X portfolio urgent therapy build XX:XX bring at to product programs. approved two and of stage sharper in XXXX The Phase this is medicines

Lambda, HDV in Hepatitis the XX:XX and Lonafarnib then Peginterferon to COVID-XX Phase HDV HDV. X treat of and worldwide. for first-in-class is people both be than platform. in to impacting Virus. global XX Delta and both indication At is strategy our core potentially HDV and million is and Delta in our First, is co-infection near our cure and HBV. Virus is deadly that Hepatitis Eiger. focus always a expected long-term more drives primary the disease value with a XX:XX therapies

Phase expected is currently has patients sites for if positive, oral two enrolled Ukraine. a in in landmark results treatment XX:XX in based Lonafarnib of five sites treatments involved XX disease are development causes replication, action, of space different platform conveniently HDV XX% of Eiger X a clinical should in of progression D-LIVR XXX of only patients HDV. in D-LIVR study. that over across registration alone. rapid the of HDV diagnosis. much is pioneering XXX XX:XX time countries, support than will to liver cerotic dosing However, HBV benefit at HDV generate more Lambda Oral pivotal viral XX:XX the host and regimens Lonafarnib are this delivered critical with including administered our offer and mechanisms Immune and for processes targets HDV that modulator patients and alone Lonafarnib, is and Inhibitor development combinations. and HDV Prenylation in the

concerned We and are our conflict, those for colleagues. CRO site Investigators, D-LIVR by staff, impacted all the deeply including patients. this

study. our each believe from XXXX. if second there reporting patients from is should Lambda, to which over in of situation the measures more the containing CRO. XX:XX the a evolving placebo, these number top-line demonstrate development therapy We forward We the of superiority to D-LIVR also is of Lonafarnib for We study interferon, D-LIVR in We Phase discontinue X continued D-LIVR patients details monitor of adequately in Arm a mitigation provide sites pivotal study. participation LIMT-X. Ukraine remains closely data even have implemented Russia, enable XX called now look XX:XX the in Our Ingrid continue with XX:XX moment. powered a by more to HDV for well-tolerated which a will end than in

to also at study pleased are in studying and LIFT-X Lonafarnib We combination the NIH. Lambda be in conducted

product the expect X this two this combination candidates robust our of achieve half first We to year. the antiviral We during the first enroll HDV of our in patient will Phase activity. study most believe proprietary XX:XX

has with conquer we viruses, expect to strategy clear. therapies XX:XX HDV will required As be case been combination is the Our other HDV.

approvals based regulatory on results First, the of of based regimens seek study. Lonafarnib the D-LIVR

results that HDV. efficient includes use an and generate will Lambda data LIFT-X for quickly follow of to pathway In we parallel, we for peginterferon combination will data combination and with our with submissions believe lambda, HDV. approval the of will This approvals of Lonafarnib potential proprietary well-tolerated based LIMT-X support the regulatory interferon for we study D-LIVR is the both While XX:XX on a future of study. for alfa, the

over therapies well way For clinical decade, Eiger has of HDV. been the leading a in the for development

plan patients. has month. clinical suited far, and enrolment excess metabolic of therapies. combinations. maybe immune use treatments, for rare XX:XX that this therapeutic of data launch also year believe be And who continues a disease as X treatments success. cases completed to an to first an CHMP a conducted as of a a good few thus novel and our intend clinical to response over positive, year. turning programs the in approximately on Lambda them. variants, expect Finally, review physicians and If over progress for is MAA XXXX. pandemic Ingrid evolve will in under lambda Zokinvy, Phase XX:XX to strains with our COVID-XX of together more world deaths a began should trials resistance commercial development the submit with we of largest opportunity study COVID-XX. stimulating pipeline. a a urgently approved for agnostic opinion The COVID-XX approved making the is which the potential total in recently from to million XXXX across authorization to variance ready over are action and different cash first-in-class around be together the turn I'll Zokinvy Progeria, gained X,XXX When expect the done one respect concern we the or XX:XX the X Avexitide, our of will HDV due our XX:XX disorders outpatients for to needed, the Ingrid? complete, among believe been QX $X such, and of emergency study details with diagnosed XX:XX data newly XXX as SARS-CoV-X well-positioned the has of We’re moments. is XXX The in in antibody targeted commercial ongoing alone of as billion. through application with the will is the treat U.S. Lonafarnib rest two be a we operations in in first COVID-XX. for Europe, million needs XX:XX to Lambda’s to HBV initial or discuss well orals. in projected have potential vaccines, just new to to subcutaneous become convenient fund we monoclonal at Eiger have of ideally of are have host Phase injection mechanism orphan and this Eldon Now, half In foundational commercialization be We million and X for we therapy to now our investments, and HDV, care XX:XX XXXX. deep more and call planned patients to We understanding detail. leader more the will

Ingrid Choong

and making progress data XX:XX this preparing COVID-XX Thanks, year and readouts in great David. development for are X HDV. Phase across two programs clinical our We're

JDV This to platform strategy HDV Our regimens. been XX:XX XX:XX improved shown patients two-log is also HDV that liver for potentially XX:XX physicians X, generate and oral of and multiple HDV important suppress week well believe regulatory have treatment hepatic of the of chronic believe RNA boosted been the as Lonafarnib regimen as guidance FDA We for for HDV. survival. patients development a improved has are win Phase of with therapy and that for of offer HDV which approvals patients activity on thoughtfully with considerations a consistent antiviral administration, We industry of of where convenient and liver treatment. both. designed In to lead all decline therapies endpoint at to Lambda Lonafarnib virus, a in also therapy their Ritonavir, HDV and of achieved approval or is XX histology, improved XX% ALT enzyme normalization composite function,

understand D-LIVR Lonafarnib in load, both peginterferon While trial HDV alfa applied believe data disease. The endpoint, of well Lonafarnib D-LIVR XX:XX this conservative Ritonavir Phase demonstrated X X. with approval boosted D-LIVR endpoint development basis the design study a opportunities patient plus two the to study. of Our as well-controlled is on HDV what data in therapy a based therapy combined D-LIVR, peginterferon HDV Importantly, primary for in when a composite than study, a Lonafarnib single The is as powering assumptions a for X. to only was and and physicians D-LIVR composite Phase with decline in combined the we endpoint combination Eiger of peginterferon response ALT oral with on doubled the trial better When creates was synergistic Lonafarnib improving was modeling the as more from that in peginterferon is response alfa. HDV with RNA in HDV. of largest normalization. and of and rate were XX:XX below alfa. well in the landmark synergy clinical alfa, generating characterize Phase we XX:XX the designed reported for regulatory combination ALT rates be XX:XX was XX%. global the leader all the X we a viral D-LIVR our that source two-log a composite demonstrated to Phase has is devastating normalization reductions study

X D-LIVR XXX sites events, Regarding of the in recent are Ukraine.

central deliver agencies cure. was of and countries. study. at patients of a developed and of XX results. Russia, where Lonafarnib, weekly once of Arm Response and In XX-weeks D-LIVR weeks patient in integrity combination have demonstrate of as demonstrates and the the ritonavir to outcome physicians the of is quantitation leading study, are interferon patients positive tracking LIFT-X of HDV LIFT-X. have could Arm patients of in statistical decline off lambda RNA for We XX XX used approval This the than as XX% the HDV drug XX or powered Durable publications study. starts robust sufficient Lambda patients we is a at treatment. are believe As XX study. is monitoring significance As to for alone believe initiate and other patients dosing effect virus followed XX:XX log XX:XX approval Lonafarnib by in Lambda regulatory demonstrated post-treatment. where allow are sites study regulatory the BLQ DDR samples Lonafarnib choice of XX% that excited improved of in the is in successful this D-LIVR and successfully X the continuity very will XXX for for mechanisms study, Ukraine will after Phase support of become treatment and there continuity for has By our treatment the XX XX:XX a of treatment. to combination Lambda stored tolerability patients maintains most have in HDV. XX post-treatment in and proportion no which We’re treatment. adequately regimens of with reduce placebo, all and larger follow-up. discontinue to HDV treatment. combination. and from to care response end to from is best monitoring, weeks CRO Arm or to or at monotherapy all liver HDV of HDV RNA X end of patients plans XX:XX ensure efficient an drug receive outcomes. visits, and that maintain virus, XX:XX X study through better inflammation, randomized study. and mentioned, similar as below endpoint of patients if X, if from follow-up, also combination more The priority second undetectable. height patients X. A implemented We weeks of Ritonavir which each HDV or supply weeks in weeks demonstrated without XXXX, for XX% patients X by be infected in analyzed complete labs be to of Lambda our and over end, of received be weeks study to other Phase goal XX:XX We response in followed by XX HDV, limited These also selected in suppression to for measures the XX:XX to dosing, can response in end pandemic of [ph] support post the achieved weeks open continuously weeks HDV of two the treatment study and in depot the endpoint therapy XX and will across compromising excited in COVID patient that in with of Lambda once no can for improvement the weeks XX to outcomes. ensure combination patient Arm physicians in primarily virologic durable Our of drug door Ultimately, second these top-line This Phase below result patients believe even lambda and most and We enrollment. plans, far, our to there the lab defined X XX-weeks supply. primary process been of Lonafarnib with is sites, will have started should remain interruptions suppress Phase will In safety LIMT-X the D-LIVR histology. to a durability antiviral patients we of generate combination for are Arm XX% the a drug with Russia, so limit to of we HDV Eiger patients cure. a D-LIVR. HDV that been this with RNA XX have DVR Lambda complimentary of After weeks a which remains RNA filing patients durable meaningful and To improve and lead that supply, straightforward performing regimens a of still seeking were post-treatment with proportion LIMT-X / of distinct of sites Lambda, to no XX DVR therapies. HDV two profile primary enrolling therapy has demonstrate X and David finite achieved XX HDV XX:XX based LIFT-X XX% a a [quantification] called endpoint weeks Lonafarnib the weekly of XX:XX Lambda’s activating sites that by We biopsies of study. is versus treatment. our an it will compared critical for a advance preferred a LIFT-X, a either who achieved XX potential compliance undetectable of to of data the underwent LIMT-X in Virologic potential achieved dosed as data a and for In

study now and on were with year this begin this future. COVID-XX in study the forward more and the to X enrolled data to providing and that Phase fully we enrollment month. Turning TOGETHER the later expect X,XXX patients to expect is over We excited XX:XX this study, look details

is If emergency submit over we be turn emergency room for positive, the XX:XX Importantly, Lambda, the a study will our I'll a endpoint patients plan to now reminder, and deaths XX:XX the a after all efficacy the sequenced COVID-XX. and data in and commercial call virus Delta and done] authorization variants, and Omicron. to a to potential the single As update. primary of of for to application visits, including hospitalization, dose Lambda’s an use unvaccinated Eldon [ph] are reduction determine includes both [one patients, vaccinated for across treatment FDA.

Eldon Mayer

I'm actively provide commercialization. update Zokinvy commercialization D-LIVR HDV The initial the launch. in prevalence HDV XX:XX to HDV in and Europe, is data With estimated planning by today Thanks, pleased U.S. XXX,XXX. on end XXX,XXX an the for Ingrid. of patients the and plans our for we're for year,

in market unmet HBV annual Over recently disease research, in is an approval at has therapy Europe the Unlike course orphan initial we've of conditional HCV, countries. past an price physicians, with for for XX:XX and launched engaged $XXX,XXX approximately Delta need. of speaking with payers. year, improved KOLs, in $XXX,XXX Hepatitis to bulevirtide, significant HDV Gilead's an and which

of Lonafarnib that will our confirms second to we us potential benefits we and patient that believe advantages We treat Given total over achieve or only X,XXX of anticipate and $X that the this U.S. market pricing, in the we XX:XX our market to allow leverage products. in would billion need of D-LIVR U.S. sales patients prevalent position to the important in ahead market X% Europe. to

of Lonafarnib therapy updates increased endpoint, rates viral of believe as the only XX:XX guidelines. the HDV preference in HDV also In reduction both combination convenient ALT be high. HDV example, oral of with greater in by on commercial and Ritonavir peginterferon testing improving for and possible on well we alfa HDV research will made development by Eiger boosted by and the that patient reported addition, we as XX:XX synergy geography. for utilization diagnosis timing PCR HDV composite In Lonafarnib, case AASLD patients tests For therapy a all a load, therapy, to we expect that awareness launched has We've conducted HDV Normalization.

or will HDV just dynamics the with focused expected, to commercial with of successful prepare HBV As launch, total a with written dedicated is future and the focused we world, rest HDV. footprint market. China of for a a U.S. allow preserving prescriber by a the XX:XX are This the launch prescribers HDV in but in team. targeted mind, in solely our base. launch well for commercial XX% overlaps Europe, XX% HBV. X,XXX of launch approximately be scripts team, to With collaborations. and strategic efficient these bring a are around In to in preparing on therapies U.S. required believe will partnership in In plan Lonafarnib we’re that optionality ensuring

in treatment can data a in with in We to marked an XX:XX contrast HDV. on future for study difference This AEs. to head-to-head other to less lambda patients. end identified launched been also the lives. have event] strategic efforts deliver U.S. alfa on in symptoms and difficult XXXX. approximately collaborations. manage by and compliance expect important to HBV we year tolerate and payors fewer the demonstrated positive [ph] Specifically, have patients events ultimately January the this impacting We [gating flu like adverse by leading well-tolerated be patients XX physicians, is where feedback to daily our focused a patients Lambda their from in and of interferon is outcomes. XX:XX is received Turning exceptionally severe chronic Peginterferon impact reported KOLs, issues for for Zokinvy, Peginterferon initial difficult that XXXX XX:XX

QX successful. our As net million The reported in XX:XX year sales bringing million. X.X very first U.S. XXXX net David the of launch total in noted, sales Zokinvy to XX.X was Zokinvy in We

cohort of all CARE has identified has XX:XX we patients X% costs received Zokinvy The required EIGER patient The EU, authorities. goal U.S. including anticipation with primary Importantly, support access across out of reimbursed as approval. French update. We're And this an with our for regulatory and this launch supply with efficient patient regulatory we distribution we've and the delivered XXXX. that, as made reimbursement ATU center XX:XX establish under reimbursement launch. services, unencumbered access patient infrastructure early of XX:XX facilitated the of shipment known well payor authorities support in EIGER We’ve with financial for program zero of patients. QX and for regulatory or commercially over first approval is I'll in U.S. program established call to Europe pocket for as coverage. and to XXX% converted continuous CARE ONE program the engagement turn Last actively ONE our Sri, year, a to planning and access from reimbursed

Sri Ryali

XX:XX a Eldon. and Thanks, out we In call issued this afternoon the I'll press update, financial our few included release highlights.

our million per was quarter. million quarter XXXX did for and and We for of $X.X a the XXXX. the $X million respectively. R&D million $XX.X million. SG&A GAAP reported for sold from were and noted, XXXX. to net for full-year million Eldon QX to to pharmacy $X.XX full-year This net $XX.X the Full-year ATU $XX.X timing and loss by operating full-year recorded shipments goods a Zokinvy to $X approximately quarter Turning or partially on As net Specialty share expenses and basis were shipment refills. compares fourth for XX:XX $X.X sales and reflects quarter sales U.S. our to and offset were third sales related Zokinvy the full-year expenses were $XX.X patient in million cost $XX.X of fewer million. quarter expenses, $X.X for million France, QX report million

proceeds $XX.X from Zokinvy million recorded loss, million that a XXXX, sale. Priority Our full-year XX:XX Eiger the net per Review retained of share $XX.X $X Voucher. For on gain one-time or full-year was net approximately basis. sale QX, the of net reflects in loss with

fund in operations with strong but with comments. cash, began we investments, position, planned XX:XX call XXXX. XXXX for I'll cash equivalents, to David and million Finally, QX cash back the should hand through $XXX total closing a

David Cory

pivotal moment Eiger. XX:XX Sri. for XXXX is Thanks a

are planning efforts for Operator, and HDV breakthrough April includes please multiple programs the portion I'd needed updates XXXX you joining day R&D thank us full-year enroll of the Lonafarnib [indiscernible] significantly Phase data from and team their deliver potential additional provide year. KOL and for relentless value acknowledge Phase year, AASLD. to planned this is providing infection Lambda few therapy are like positive, and Q&A XXXX. to Peginterferon to and in on much within LIFT-X programs, for XX:XX HDV medicines to has initiate advance deliver we therapies shareholders. instructions this also combination opportunities for across in the and point, the that our by orphan study our Finally, the plant all data designated X XXXX. data to TOGETHER X patients Lambda We the poised and including an X to of And continues events a look additional to Lambda COVID-XX to this LIMT-X one the planned QX weeks. first for around Phase robust XX:XX are end of pipeline call. be of is of look the we provides and and throughout half forward TOGETHER forward of COVID-XX call. our year. Eiger multiple platform study next of FDA. to of also We to if done We EUA submit from our treatment application for late-stage XX:XX to to At

Operator

XX:XX Raycroft Jefferies. Instructions] Understood. comes the question Maury of from [Operator first Our line from

open. is line Your

Maury Raycroft

to taking XX:XX are the actually the the patients are Ukraine you say Ukraine, questions. X? you D-LIVR, sounds D-LIVR Hi, thank can and place five the in in to have my respect you X about progress congrats of for many was like going active or and the plans but many it for on Phase how completed I continency Phase in sites how ask have in patients those

David Cory

Thanks call much that Maury. your joining the XX:XX question. Hi, Choong. for to very I’ll for one and Ingrid over pass

Ingrid Choong

Hey, XX:XX Maury.

on So, patients by we haven’t guidance country. provided

that You have trial are the sites Ukraine. correct five clinical we in

to demonstrate evolving even The continue adequately assess powered patient Lonafarnib the continuity closely containing delivers patients monitoring of believe we superiority. that the to if patient discontinued than Arms Ukrainian and study. ensure We situation study, more to care and over prioritizing on placebo

David Cory

XX:XX Yes.

our to Lonafarnib XXXX, deliver still support regimen. So, top by for if positive which of data line based result as end two – tracking for a filings Lonafarnib regimens of planning, will based we're actually

So, awaiting results. those we're anxiously

Maury Raycroft

be XX:XX you had And more steps if contract up that That's you X helpful. the manufacturing, talk talk I Got or with it. about about is with positive? to TOGETHER if partner? guess, preliminary next can can countries, negotiations Phase study the ex-U.S. you or would in-house and any done plans stockpiling or scale U.S. a

David Cory

XX:XX Yeah.

they So, I’ll give you are if time an initial view and team let interested. the

we given forward regulators XX:XX add, thinking been on an our Lambda, but and are seen manufacturing, emergency are study. fact ago, positive, If peginterferon will to additional we enabling years with X we’ve I that now out lead with registration combined result our ways manufactured in lot the coming already HDV lots that lucky indication soon some our yet that to began not of with news fact for at data so the look about submitting a from have about of authorization in of two we manufacturing, distribution, for COVID multiple and is TOGETHER to we Phase regard plan reporting positive plans time. the definitely Lambda manufacturing registration will used have study, provide application. the details and the data We commercialization speak definitely

terms much this beyond forward to look providing point at guided but haven't obviously positive we that, so, data, next And of guidance steps. with more in

Maury Raycroft

XX:XX Got it.

my hop I'll questions. taking the for Thanks in queue. back Okay.

David Cory

Thank you. XX:XX

Operator

line Our from Nochomovitz question from of from comes XX:XX next Yigal the Citi.

is Your open. line

Yigal Nochomovitz

for XX:XX to give patients the you country respect by to just Hi, enough to would discontinue, were on significance? patients, and enrolled I to still guidance currency David, questions. taking if want don't you have demonstrate Thanks those with I'm and Russia, power team. statistical Ingrid know but wondering

David Cory

for much address top so joining I'll the of over Thanks and and And tracking she's to And we've for mind today question. as daily from everyone is clearly David. your the one. it’s CRO. Ukraine and Ingrid Yigal, for Hey, XX:XX question Ingrid? conflict definitely the been Ops our turn with day the speaking call

Ingrid Choong

question. Yigal. Thanks your Hi, XX:XX for

you is XX Phase XXX in study X countries. enrolled D-LIVR has patients landmark As sites across that XXX know, a a

which CRO been And and ensure can And to maintain delivered central D-LIVR. implemented patients of compromising or and the samples Eiger without the we're successfully samples of lab monitoring supply not contingency in also so lab COVID-XX mitigation [depot] export our of patient week measures safely drug impact We've [ph] analysis. for that through in supply, pandemic these as many visits, of the be drugs XX:XX mentioned only for end I patients integrity supply. these main maintains any Russia, plans timely drug far analyzed results. stored treatment of we’ve of the with height during in to and but you Russia will The all to able continuity know, earlier patient drug hasn't as have XX. there developed XX:XX Russia, in is a interruption sufficient

David Cory

point. Ingrid’s I'll we to just further Yes, XX:XX add, –

monitors each a managing the labs, many evolving of learn updates than this through and globe across supply, of now, been and of forward issues experience remote succeed to all powered drug for in Ukraine and the study managing that providing adequately as XX we're first monitoring information confident very conflict to feel charge we few our definitely in countries, COVID more on we During took is and this maintain weeks at monitoring and situation. site, for the to this that beginning look that of the future able started these pandemic, instrumental has lot, patients remote

Yigal Nochomovitz

HDV, monotherapy helpful. conceptual Okay, And with monotherapy several alfa, on question got in you then have more and Lonafarnib of combo X course, And very then, That's all you. XX:XX peg a Lambda X. Phase at Phase the obviously a of question. the and regimens,

commercially regimen to the very determine, being would get curious better in road down these tree how said, what are prescribe? will which that the So, like of a decision position a once look available terms of to I'm understanding

David Cory

patient drug when suppressed and in now, will XX:XX it so, given therapy have the in a the at goal combining development. own Lambda in that we with as in is are evolve combinations in keep where injection. hopefully to these is Phase other of XX:XX be three there, any the removed Yigal and monotherapy clear as any that, in and or and to injection of different and approved especially our we're approved. action peginterferon exploring there we is Lambda virus we And but mechanisms All oral well-tolerated in comments case are HDV the a different will think have to bulevirtide, U.S. is a question, study be exciting investigators the what have suppress Lonafarnib X currently key preference opinion it in Ingrid fact oral, leaders discontinued. which used future great I a be Eldon combination going LIFT-X Lonafarnib Lonafarnib to Ingrid? that's XX:XX believe with that interested Yes, the agents mechanisms definitely the or or in they're landscape addition as stop XX:XX and NIH. therapies ultimately weekly I'll the actually subcutaneous no Right mechanisms between vis-à-vis formally have that once made daily therapy or already believe

Ingrid Choong

[indiscernible] XX:XX LIMT-X follow-up. we two of peginterferon of was way efficient Yeah. patients LIMT-X LIMT-X study, promising. see most study we've This approved and drugs combinations and physicians, and Lonafarnib the very XX the treatment already data is XX weeks to D-LIVR I'll and getting available the weeks add and demonstrated study just Lambda at those and study

XX% at were at end and As patients of of XX-weeks more post treatment we a had In saw BLQ where of XX:XX you the know, XX% importantly XX% treatment, addition, endpoint. primary the patients [indiscernible].

was going next Virologic combination our is indicated XX step KOLs We mentioned, have [ph] XX weeks already improve interested they're a complementary believe of as weeks. So, they're at they of excited saw as and LIFT-X. Durable which we about look versus Response treatment that are mechanisms that look action. have two treatment. in Lonafarnib the We're to treatment in David and will longer Lambda And XX:XX given a to very – [bulevirtide] study, to that that combinations,

David Cory

XX:XX Eldon?

Eldon Mayer

conducted I that but think tolerability data there with peginterferon has profile, [ph] would in only with that is, even add seen be nice as Lambda being to towards that] drug, The the we’ve going you which as all know you there's as early alfa. Yeah. thing transition a registration XX:XX studies a I [reporting promising the is are for our certainly development, of Lambda single with a And know agent.

offering are agents drug with for alone well-tolerated make be combination other would profile in its with as it nice there. to out So, or well a sense that that

So…

Yigal Nochomovitz

quick just And XX:XX then one. one more

mean, for is terms smaller that X potentially a Phase about said Phase their I what LIFT-X For has interest in regimen that success? X a in the the assuming NIH NIH, doing of

David Cory

address and NIH, of the I'll Yigal, team The let in best Hey. comment. well the we liver as centers States. is believe United one that XX:XX the

and the and strong weeks that at will working easily that tolerability well continue reimbursement. believe well and and XX:XX LIFT-X, going the in options potential an themselves interest support publications generation itself that the will funded We lend section also has for believe of that's excited preference. where future, the physician We the that honored in a be we're registration is interest listings strategic from Lonafarnib in weeks data preference treatment XX we both LIFT-X so liver to NIH will Beyond combo XX NIH peginterferon supportive. to that with will and have support profile combination And and such Lambda combo patient the the that and data lend certainly if treatment Lambda. and of to

Yigal Nochomovitz

Thank Great. you. XX:XX

Operator

the Skorney line from comes Baird. Brian from question of next Our XX:XX

open. Your is line

Brian Skorney

HDV? of European we're from I maybe everyone. aside you think just could Lonafarnib, that we – in last to guess, about XQ, to million good Thanks of talk the taking some of question. I the disadvantages we you booked what's Hepcludex for efficacy Hey, compared D-LIVR afternoon, think in sales seeing translates what on get for potential for maybe XX advantages, about looking global date terms be opportunity versus for? slide Hepcludex, guess, the quarter I opportunity oral you over in want I thoughts your maybe And specific see how terms your view commercial should think once or my sort do how might to about of just of sub-cu XX:XX in Gilead the

David Cory

can XX:XX the start part countries. has know first on Hey, the approval a number Europe Brian. I of your conditional We in that is in bulevirtide of limited that question.

the the additional expand Eldon on have that would for see and expect that oral expectation we question interest maybe I’ll we time So, reported that over patient let an answer sales for we high therapy.

Eldon Mayer

also XX:XX therapies, Patients we regimen. there oral oral for treatment to do patients much. always Sure. will to matter is going demand when to that expect We mean, long-term it comes I that chronic all preferred that convenience believe be high especially dosing. very

important So, become available therapies we think that will as role evolves. the and these play market an

David Cory

it's is activity ALT, composite you XX:XX very thus specifically I that far data these HDV all endpoint. the normalizing have think RNA seen three know HDV at and which, mechanisms, viral Brian or from that that the load we've clear enzymes, of good approval liver reducing

believe XX:XX patients. three there question believe news a that on approved. don't And products pathway mechanisms, good because different any in provide ultimate patient be optionality maximal by are to to to We these likely to going benefit. likelihood combination so, they're again that we that's for be It's used and and there’s drugs high these work that going is determine that importantly,

well benefit HDV. what we positioned future so, opportunity And we a Lonafarnib view from growing in to believe is Lambda as

Brian Skorney

helpful. That's Thanks. Great. XX:XX

David Cory

XX:XX Thank Brian. you,

Operator

XX:XX Hazlett BTIG. the Bert line question from Our from next of comes

Your line open. is

Bert Hazlett

Yeah, XX:XX thanks.

expect what's the Russia one – than more articulated me patients, do countries of criteria, you going kind thinking all? is are up more Ukraine having but of at timing with do LIMT-X, that Just the obviously, regard about along thoughts to your that you enrollment to Just on for D-LIVR, and you’ve and to is so slack enrollment how lines thanks. think so Ukraine, of the shift managing as on about just other concerned with trial Russia, same you challenges pick just there, given

David Cory

Hello today for Yes. you Bert, pass that hear question. for the to and call and thank Ingrid. good the joining you onto XX:XX I'll

Ingrid Choong

XX:XX Hey, Bert.

process in right and and XX So patients approximately are ongoing we countries. as LIMT-X now enrolling you sites know, of XX is activating across

have specific primarily facilitate and from enrollment be and to still other sites the in sites early the on we Russia, enrollment are we're efficient selected where to While we future. and guidance been enough best which include given and an enrollment, sites Ukraine in more considering think performing should situation data able these find we'll deliver, the in

David Cory

XX:XX Yes.

Lambda about is so have activating short optionality and enroll go lucky some our LIMT-X the and and for Bert that anticipate to the which the ramping answer to ability that think we direction Lambda we're and in that now just any delays I we're study up for enrollment. trial. sites don't HDV, in we're We going

Bert Hazlett

start lines, is was out [indiscernible] it XX:XX we different in can Okay, material the maybe on, can EU or along from great. what terms And certainly when we, shall reimbursement? or revenue way? on materiality, Just XXXX of that further that EU the expect so or in just, a what something the revenue half coming based of second

Sri Ryali

is can Sri. one. XX:XX take this Hey I Bret, that

provide we're have to a we that, we mentioned, the we'll able of EU and out once first year. expecting country more in by an this launch CHMP as will on EMA. vary country, opinion of So, be half the approval information

and that have will launch. apply were more have able to the booking We access country that in the country, We revenues. pleased in the we program built will distribution know and France, are XX:XX in and Eldon book future. revenues gating we'll guidance EU we be by factor We've infrastructures. for actively support that QX support will reimbursement with were early services. that mentioned, planning for the patient We for to

Bert Hazlett

taking great. Okay, on the progress. for XX:XX Congratulations Thanks questions. my

forward a Looking to big Thanks. XXXX.

Sri Ryali

Thank XX:XX you, Bert.

Operator

from line [Operator Sakloth next Farhana comes question Ladenburg. XX:XX the from Our of Instructions]

Your line is open.

Farhana Sakloth

Higgins. of XX:XX Michael Hi. on Farhana This is behalf here

here. want to questions ask two Just

So, Lonafarnib and in about given be Lambda? the pricing the impacted that HDV, dynamics thoughts the of approval market how your would of are what by

David Cory

David. I'll XX:XX call can Farhana, direct Okay. we is that Eldon, from Hey, Eldon? this go to there. and

Eldon Mayer

and our XX:XX assumptions to pricing. pricing value we prevalent XX:XX on proposition, we X and as to so Europe have that a important I from $XXX,XXX for do of you mentioned similarly, in X,XXX the benchmark X% we'll how for $XXX,XXX based we'll Hepcludex well If an Lonafarnib. know of is strong already, think Europe the as product. see get that as unfolds Well, would, which fair yes, us We pricing would have in analysis in on assume patients, that of heard achieving a you've billion have based market script, we

not that an now. unreasonable that's assumption think So, I for

David Cory

the approved behind registered XX:XX add Lambda that studies get to both anticipate are to and individual should Lambda through that. designed most efficiently through for we be Lonafarnib, And in as these the HDV. study Lonafarnib treatments peginterferon D-LIVR [serial] Farhana, I'll results immediately of LIMT-X and just [ph] results

these either And lead so And should monotherapy received the studies these obviously and agents guided results so, combinations. of haven't the we on as physicians’ final results two pricing. to both of or in XX:XX prescribe to ability

but will with I alone, Europe. be maybe two mechanisms be we think in And separate in one two the bulevirtide benchmark a good is believe therapies used have separate we combination. likely, approved that also

to and obviously combinations prescribed mind on we to And keep guide way. thoughts and negative both XX:XX but on think become Lonafarnib certainly idea data of drive prescribers will that own the they be, pricing, top to for their priced on and be of I in virus more patients their own. on expect so, as And try available, it this Lambda be be to able as

Farhana Sakloth

have XX:XX for one question. that. I Thanks other right. All

with Zokinvy, much sales, So, X.X congrats was that how the progress I from QX on coming of out of so curious, is million France?

Sri Ryali

we've approximately the three patients QX. shipping to there France. was And the in two that think in in reflected I Yes, the XX:XX and that are shipment of so in was France past XXX,XXX to mentioned

Farhana Sakloth

my Thank questions. taking much XX:XX for Great. you so Okay.

David Cory

Farhana. Thank XX:XX you,

Operator

like would XX:XX for I'm now Sri call Ryali to the turn to questions. remarks. not showing further I back any further any

Sri Ryali

call. for Great. joining concludes XX:XX today. Thanks everyone us This our

contact management out additional questions any to have Thanks can at or info@eigerbio.com us feel member the free you If you of team. to a reach again.

Operator

XX:XX concludes you Ladies participation. your gentlemen, conference today's Thank for and this call.

You disconnect. may now

Eiger BioPharmaceuticals (EIGRQ) 11 Mar 222021 Q4 Earnings call transcript