VIR - Earnings call 4 2023 | Vir Biotechnology, Inc.

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Operator

Hello. Welcome to Vir Biotechnology's Fourth Quarter and Full-Year 2023 Financial Results and Business Update Call.

As a reminder, this conference call is being recorded. [Operator Instructions] I will now turn the call over to Sasha Damouni Ellis, Executive Vice President, Chief Corporate Affairs Officer.

You may begin, Ms. Ellis. Damouni

Sasha Damouni Ellis

Financial good Executive today Chief Officer; and Lee, and De Dr. Medical With Sung Chief Backer, Dr. Chief afternoon. you, are me Marianne Officer; Thank Officer. Phil Pang,

those differ development associated like or and Before are we statements. filed the from we cause De Backer. uncertainties and significantly forward-looking the the that to expressed making X-K. I are Exchange such statements risks These and remind now forward-looking reports XX-Q, achievements under clinical and will or that implied are statements laws. over some could statements forward-looking with our by to programs, turn today Commission, CEO, securities and uncertainties begin, XX-K, performance, call including of everyone involve with company's described to Marianne risks the future would Securities results, business I Forms These our substantial our risks in the

Marianne De Backer

everyone you, thank to Thank webcast, for Good all us and you Sasha. today. afternoon on the joining

Before the decided we XXXX, the touch Medical Pang, has made Chief to in down I step to earlier want the his ahead on we and our what's end with XXXX we week that of family. in made Officer, this Phil more tremendous at March spend to announcement discuss progress time

Vice positioning Officer leadership. Senior currently initiated the Interim Chief for We well him his strong Carey in for is President, leaves as He to I Clinical in us Dr. Hwang, for his and a Phil a place, search development sincerely best. Stepping have successor. I Medical Research. continued Vir's thank want very wish clinical success, team

the developing a potential with chronic XXXX, patients chronic differentiated treatment a made we as delta, hepatitis preventing for on have a progress approach reflect living clinical I hepatitis well HIV. millions as B I'm to cure for with proud functional the potential of As towards

to early our programs We anticipate also year's across on year, clinical priority significant mid-stage Our progress beyond while this and last data is clinical disease. our research our off pipeline readouts pipeline all refocusing to deliver build infectious which programs.

quarter, in this the participants first SOLSTICE, need are will we attribute data groups leader delta. We and undiagnosed hepatitis which II initial in trial. the to virologic diagnosis success, disease and year. at early least increased plan a To that across to patient quarter, population position globally. advocacy and and delta policymakers the delta. aim share a highly rate We appreciate in safe, reported following is there surveillance the patient a to patient safety clinician subset there enrollment to on drive the hepatitis data hepatitis we treatment, of we an million already and therapy at position participants. AASLD in these screening. efficacious, for our collaborating best-in-cost enrollment with rates Vir In Specifically, are last approximately improve believe become to and the rapid convenience anticipate Phase significant to of or is us treating diagnosed underserved we X XX people positive with of estimate cohorts million a interest second We of develop XX XX important that more It completing this and estimated for we

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Phil Pang

years. an ability last of Vir's Vir in the family for Chief and lives and confidence full want patients. by privilege to been has I the well as as as to Board, colleagues Officer. my programs begin clinical of and me you, to Marianne. our all-consuming promising Medical have of what X-plus you, has of thanking I dear future serve the an passion for a millions Thank impact the honor been to all Vir's

to Of begin Phase from discussed on delta is that siRNA declines I'll X of within The that shared reduces patients a our for hepatitis this combination X investigational antigen, undetectable treatment X SOLSTICE neutralizing surface has Moving therapy. presentation delta. HBV-targeted hepatitis year. at RNA virus life starting in out evaluating immune combination and investigational the enhanced XX B X we needs earlier chronic antibody, lower delta potential initial also initial X RNA. the the which its SOLSTICE results protein a our ALT out which participants out hepatitis our was trial living is been of on late-breaker HDV alone and of elebsiran HDV quantification observed engagement. an II below of last that which weeks and of in in by chronic pipeline. rapid is achieved trial, cycle. In Elebsiran year extraordinarily is tobevibart data, X that had or limit note, is engineered the with Tobevibart for for AASLD monoclonal as normalization. summarizing with

That one without the several were to hepatologists our ahead While excitement and exciting our the meaningfully rapidly by with participant in as enroll of advancements numbers ability most into small, are recognized has of these in both schedule SOLSTICE patients at AASLD shared data study. translated cirrhosis XXXX. conference

X enrolled reminder, approximately These into first the our participants goal enroll SOLSTICE a being quarter. in stated to the are As is groups. by participants XX end of

The elebsiran first group is weeks. X receiving every tobevibart weeks therapy plus combination every X tobevibart second a and receiving monotherapy is group

of them at path the regimen Phase compensated XX specifically, of regimen potential we February, quarter, XX a registration participants data the share We quarter. Switching to in As intend a with of or Should XX who third XX% these have dosed, second for discuss dosed. per have participants to cirrhosis. weeks. and plan greater early regulators the program to chronic at of participants participants participants Notably, data than on in XX hepatitis been supported, been B. XX already II initial weeks XX be these to have our on XX% subset per of

to interferon weeks what the is alone. although antigen a potential after possible up of at XX% suggests when treatment hepatitis surface number loss and with small, data beyond elebsiran peginterferon sign loss was of functional have data achieved and be the treatment. These HBV in antibody was preliminary approximately adding B for may of or in forward important will in alone the first Again, increase participants to cure threefold XX us almost data to and an of XX this the first doublet XX% we triplet Our the siRNA indication of with quarter. participants treated half subsequent that response followed of observed potentially of which from These of fourth elebsiran after directed rates XXXX, end regimens trial, tobevibart rates. pegylated of cure hepatitis therapy. antigen regimen that elebsiran of given we the impact allow cure. trial, were a end-of-treatment only which when weeks, assess In XX to surface on was a our post-treatment maintained alfa will end an weeks B XX of the rates Part encouraging, look peginterferon, weeks plus data functional are the end functional is B MARCH evaluating treatment data sharing the This B the in by role first hepatitis

next-generation will VIR-XXXX Turning clinic next. to and enter increased breadth and a we with thanks viral COVID escape to optimization. is potency, engineering what the resistance AI anticipate to antibody

file the to coming turn trial the support supported planned We will progress the and look share year. I of BARDA. end to Phase Sung. end an The to our by is I forward Day through the We of to a for this application call this R&D authority I over a development over to now during continuing VIR-XXXX year. quarters expect of health Phase later

Sung Lee

make fourth Phil. revenues XXXX. a of were collaboration do of million million the of anticipate not Total full line from item Thank of investments required year. $XX.X quarter any the our share primary Total sotrovimab. negative the the ongoing compared quarter which and to fourth our contribution GSK to the lower this authorization decline XXXX. the year the period for sotrovimab, $X.XX financial partner compared We million top-line in full XXXX to the And could We're in from for same our future. the you, support collaboration meaningful were due in. to is The the XXXX sotrovimab to XXXX revenues $XX.X leads in driver to marketing revenues efforts for $XX.X pleased year-over-year results in revenue for billion

and owed expenses. on the year-over-year driven decrease primarily to $XX.X delta of million million extent, decline evaluating compared $XXX.X charge fourth compared Included in primarily related million Phase million II compared to hepatitis programs. compared The XXXX. XXXX wind XXXX the of fourth in $X.X $X.X trial million operating of XXXX. II the driven period VIR-XXXX to Turning same costs, Flu was fourth the of XXXX was our XXXX expenses the by fourth The costs study XXXX hepatitis XXXX were million and Phase was quarter for million $XX.X B announced sales. the SG&A $XXX expenses for by Flu primarily related of in in driven $XXX.X for related in personnel increase higher to $XXX.X of and for same full year million royalties were quarter year-over-year a the severance expenses is The of compared sotrovimab revenue advancement lesser lower period $XXX.X increase $X.X a million workforce manufacturing driven of the of personnel to driven costs. by by XXXX. year workforce full were million VIR-XXXX in expense primarily the December XXXX. R&D XXXX. $XXX.X December of of R&D XXXX. Cost to quarter of down in was reduction severance the the SG&A The million in year-over-year for to in the quarter R&D and the reduction year higher was third-party XXXX. XXXX. The of million the $XXX.X by the was charge the a in increase in to to of announced expenses were in full

the compared $XXX For in net quarter to a consolidated XXXX, loss reported net the for a of million XXXX. $XXX.X of million of fourth period loss same we

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by that The range the first, impairments changes related cost of restructuring ramp-up expense evaluating represents GAAP this primarily that stock-based hepatitis this compensation GAAP XXXX. to restructuring Turning not non-cash the statement. activities, expense income taken optimization stock-based and $XXX programs to of to are guidance, combined of R&D R&D B of guidance expense We VIR-XXXX of may by be grants $XXX R&D sites decline million expenses trial combined $XXX are the GAAP driven in The of include the R&D is adjustments restructuring midpoint. The the in offset excluding the SG&A in to and the important to and at and range, to limited of GAAP the publication in the and guidance that the effect of million to, in fair the the the our million caused as SG&A funded million. not million, million. and announced range does and contingent will for the development expense previously expenses million of Included expenses events R&D year-over-year in charges range to subsequent XXXX the year-over-year $XX absence to and non-cash. $XX in are delta X% X% business cost combined of but hepatitis from value including for range which second, measures from expense is our partially considerations. flu occur in litigations, compensation primarily the in-process by, in remember by It's in these the revenue $XXX resulting financial be the When XXXX. million decline recognized X expected non-cash SG&A R&D Approximately combined December anticipate grants. Phase and GAAP an XXXX, SG&A II $XXX manufacturing XXXX; XX% and closing $XXX range will

multiple financial our Our hepatitis and B to us in through strength hepatitis provide delta the and external evaluate platform program antibody to core advance allows Phase flexibility II invest milestones, innovation.

a approach Sasha. allocation to disciplined and to call will now continue have will to the management. I capital We turn back expense

Sasha Damouni Ellis

Sung. Thank you,

are of the We questions. we questions analysts. Operator, person so will X that now section. able limit per up all line get covering for to Q&A please start our to the Please open to

Operator

Paul Choi [Operator line with first Instructions] Your question Goldman the Sachs. comes from of

Khalil Fenina

tobevibart/elebsiran repeated in interferon, the to XX peginterferon calling you for at guess MARCH study? to Is interferon's This slightly I Part we'd a the mean the what without would in observed XX-week is Khalil place higher in like future for that something weeks. B about Paul. alfa data? see ask in combination pivotal And in cohort that efficacy without cohort expect

Marianne De Backer

you will give that CMO, Thank our I ask you deeper question, Pang into insights for Paul. to Phil that.

Phil Pang

Yes.

numbers and small treatment from we end think of I still showed the So numbers. -- that the doublet the with remember triplet data are XX-week that the

weeks. not at XX from much different would triplet I was So the fact the doublet slightly look the into that

what doublet really triplet. happens, know, after looking and XX is the you as weeks that what we're seeing of think I forward to

jury as think, for So and going in I is higher risk I what is providers, to whether such more, that can if I very is, require will important that again, that But always something in cure clinicians. cure which interferon. for think comes show think slightly be those to or down required. fourth it increase I of are to functional transformational effects it side or tool quarter. And And this XX% And be we known the interferon given it out with a for a functional the will if would as patients will rates, benefit. will leaves not a still rate that we the think say you be, open I share results

Khalil Fenina

And to of on as I one? drive what quick of company the give to line the follow-up guess a you will when relating Could choosing would antibody pipeline like any select decision any color guys kind a And the front-runner enter in time that general. candidates clinic? to potential

Phil Pang

Yes.

a it's entering patients' differentiated or is really, make whether the platform, of in that something and have of So that vaccine. and clarity, looking is something provide antibody impact sort the of an on can believe little lives. what that's a we we T number always cell we're near a an just candidates And regardless for to term, clinic obviously

X COVID are neuraminidase development action I monoclonal So is about do it to the candidates, vector given both that, on scale our human neuraminidase more XXXX, a antibody, X increased B. vaccine of also those and by of vaccine differentiated XXXX, a X engineering course, A thanks it is has I its which necessary. derisk that and the potential lesions. flu pre-cancerous VIR-XXXX, platform. potency, execute spoke planning XXXX VIR-XXXX, next-generation builds candidates we our HPV than antibody say very VIR-XXXX, enzyme. earlier about mechanism a targets targeting with breadth partner But which targeting our and AI are excited and levels. One, It's therapeutic potent stress That and with cell the to the And T want to third, we're target cytomegalovirus on and platform of first includes

Operator

question of from Barclays. line Wang the Gena next Your with comes

Yi Zhao

is This Gena. on Yi

your think for disease, all, next journey. have on drive for departure regulatory earlier approval did share best So lastly, focus do will decisions? those second with for how you data you also, what you the going your CMO? your some you next and And first oncology, share your quarter? hear will the candidates HDV, select for to could lead initial now pipeline, the feedback be and infectious wishes in stage path? expectation immunology, that ideal and And Marianne, Phil's And the you're what antibody on your do And you candidate of for Phil, for

Marianne De Backer

successor question a Gena. Phil to next with your much, and start what first I for looking Thank you in the related we are to will CMO. very

a what to proven initiated in record of and since way having to really therapies all, to has a say, search market. I the Needless going have received of we needs be and understanding a data advancing use really someone to track gone be this But candidate insights First that what we experience for in landscape, also successor. inquiries. how selective very deep of is into is development. already really must someone the who obviously, for we a big therapeutics of say have a clinical all also, data Phase the profile to week, will regulatory have has III looking in-depth be. We're out in to bringing news for the critical for insights through evolving flood And

things team that come So our we here leadership group. there's a of clinical need Phil here a very as together. pointed talented And out, number to have in

and So such hepatitis a delta focused developers hepatitis our someone we looking success, can who also lead team very are programs. B of for especially talented for on

question, to expecting switching and Now understood your delta Gena, to related what second that in data second hepatitis was the quarter. I are we

Phil I give color to you that. on ask more So will

Phil Pang

Yes. Thank Marianne. you,

in think, only around step So but first, both what And as at is we showed the as we X conference back with hepatitis is as data we quite regard was to patients. transformative, data, to well AASLD, it shared X delta, on that the this QX data patients. earlier the year

what is looking in So X really for we're answer questions. to QX

when with patients to of type that with combination who data? think what patients? So The forward we be our have looking happen durability what will cirrhosis, we're initial long-term dose more I to we happens dose X, able that we when compensated patients the and those will and excited will X of first therapy, repeat is, happen what data. #X,

to to front an a year, discuss positive question this regulators I in be step which also have wanted what said I and in about the quarter of asked path feedback. a And in to reiterate we that the if put think regulatory to take earlier that registration. is data next you just will attempt it third

coming as on out. here the of see path sort we from that's it So

Marianne De Backer

candidates already related months. Yes. question, in was And for to in our XX really clinic that that's as We laid Paul have X VIR-XXXX, out. question, we're -- which can third enter I VIR-XXXX. next think pipeline, not the related your VIR-XXXX, answering months the early-stage to XX to still It's

progressing this each providing be timing so well, of we of during will course very data year. and those really And informational and the are more

Operator

of Your question next Ruiz line Roanna with Partners. from comes the Leerink

Nikola Gasic

Roanna. This is Nik Gasic on for

large And in look accelerated elebsiran you how HDV. little on first around discuss for And also, currently? what market possible and like Just I quick is opportunity follow-up. then tobevibart a in a provide a have color more could Could the HDV? could HDV you pathway approval

Marianne De Backer

Let faster progress co-infected everyone is And as people most begin death. form you Xx reminding to with with the delta Xx are severe maybe cancer faster I that of mean delta liver hepatitis. me that know, to and

So there's need a tremendous unmet here.

States that first really the then that prevalence, I we that believe at XXX,XXX in the XXX,XXX this moment looking time. there EUX that I would the the patients think given is like over point diagnosis alone. underestimate are is we estimate to in not And And at and optimal do patients this likely it's make. growth a United about in

So believe therapy that opportunity. therapy, a if limited you represents only elebsiran and very potential combination still obviously, we of are you And about the that already even and you transformative of a a we portion a pricing the and benefit and assume that thus of of significant reflect be think data we that have course, regimen if would taking but large based have together, the the a patients, data. access that of clinical tobevibart we in on market potential very of transformative far shown that that to impressive set such really would at were confident modest looking you population this can

Phil Pang

an with Marianne. one, that I'll if approval, regard take And accelerated to

Marianne De Backer

go Phil. please ahead, Yes,

Phil Pang

as to and data changes more always in better. data think space, say everything that often we I development is like the

a right? Marianne the rapid unmet we I has path therapy of of favor who when hundreds there for There is undoubtable, is benefit are clear. suppressive or that accelerated approval, also them our options think is that that a patients lack So chronic fact a would about as is And approval, the to need, in good worldwide many delta. from for of fact described, think of the what's thousands

think I right data. setting favors rapid the all that a So that, in of path the

is other front and QX, XX in through program that, to get elebsiran our anticipated XX weeks. chance early, regulators that is of of participants in through are and weeks participants subset waiting And we combination every is a the still we talked of week by XX hand, just previously, that course, tobevibart of then, every On have share our week about which we're our of exploring. and goalpost XX which tobevibart is really QX. data, in remind we've which our you X will regimens X to for and the And versus X we'll

Marianne De Backer

you an Phil. Josh, did Thank question? have additional you,

Nikola Gasic

Yes.

is this Sorry, Nik.

like factors into Just Curious for HDV. to this the additional what see moving some Phase regulators I this gating Phase follow the signals support in would really are maybe wanted of program SOLSTICE data see on you're and maybe to to what in up guess into the hoping data to what going upcoming from want the III? III?

Marianne De Backer

referring Sorry, B Josh, or are you delta? hepatitis to

Phil Pang

take can Marianne. that one, I

Nik. So -- I thank think you,

X things really said them are So I in there your think of in for first a -- with question, data. I question the getting earlier, to so front we're looking the it's answer as of

with the be? not and of seen thing cirrhosis, data really -- Second, data who dose in a on compensated all but will that something for patients third, believe patients happen as how we terms we is what does that X to think of matter to patients looking I one-off, that what we're it be regulators repeat the first sort the X the and data actually have patients? reassure in original X The durable to numbers when the them as will it we've is will is able be. that transformative it of

safety is anticipated factors, of with have speak I quarter, terms the our discuss what that size to what the database in comparator can be; once they endpoints arm opportunity the in down third only X, goal, of interested in regulators to they be would would we'll what more which one, be kind be; sit to believe the gating and with the would particular we but them, X, transformative generally, So able of efficacy. of most be demonstrative needs

we're So of talking course, in planning that's planning And and regulatory a for we success of to going trial will terms it's then, about. matter of be are say that, execution. I both course, interactions. what of

so we'll is And important and program to do out continue our this first so it's gate. because the clinical of most

Marianne De Backer

Yes.

to across data on maybe will X and and we in XX-week the XX seeing second So just that, quarter, repeat be already XX XX the participants the add regimens weeks. for then participants

the So us give already a into lot that will of insights data.

Operator

comes TD line Your Privitera next from with the of Cowen. Eva question

Eva Xia Privitera

Just a couple us. from

And what achieving the with What's the mechanism On seen that? the are was the HDV came down kinetics for with viral SOLSTICE trial, there some ALT for suppressing ALT elevations with RNA? XXXX normalization which monotherapy, combo.

Phil Pang

that one, take Eva. I'll

you the thank question. for So

what did to a seen siRNA siRNA receiving patients XX% given larger we've study, delta a I think in REEF-D, the signal small, couple therapy number monotherapy see siRNA known seen is B or who and our this. with that did it's patients but an important important signal. to we've they elebsiran in when it's patients an remember hepatitis siRNA replicates of gave other when hepatitis we This see in that dosed as have with show not patients, remember of XXXX ALT that patients ALT of patients did to who we delta. But almost had an

to some appear something it the So drug delta drug, intrinsic be itself. interaction to but not between does the and virus the hepatitis

infection that exactly or RNA signal, ALT with the paradoxical siRNA, the closely, the some when force an look driving preventing would that further RNA after VIR-XXXX. our key. And that's HDV the mind, of it of you seems So new hepatocytes there down intending is on treatment at antibody with sense would be to behind data it If that in do tobevibart, then that with therapy. that increase in HDV driving is monoclonal duration suggest a make we're and what to

there neutralizing prevented the would an RNA tobevibart. fluctuation idea kind be by see is So would in that having signal driving a of might you HDV ALT like that be any antibody

did the so any seen And patients, course, we ALT are X unlike of by of see another the the with not monotherapy far, very elevation siRNA numbers company. XX% small, ALT of elevations

so seeing looking the these we what as be XX forward dose And we'll will when the next that's in arm. to happen thing combination patients to

RNA to can the that is clear, or and So XXXX but changes it for in still HDV that. are signals solve due tobevibart signals there that mechanism are is the the to summarize, not early there early

Eva Xia Privitera

MARCH question And on the trial. another HBV

previously shown Do present titers were treatment weeks to antigen you titer You've high that surface sustained end XX data data of of in predictive antibody the QX? antibody at expect loss.

Phil Pang

not not be we the much but data with will clarity yet will to results surface at loss, doing have or can we on everything sharing be actual our So we along anti-HBs as antigen time. that whether we to guided provide

So stay tuned.

Operator

the line Your Patrick next with of comes Trucchio question Wainwright. from H.C.

Patrick Trucchio

Congrats SOLSTICE have all on of the follow-up progress. questions on program. a couple I

about HDV how safety chronic or how patients And having decide of how proportion XXXX, cut should for clarification that can ALT compensated understand maybe the XX% the well or who should did quarter. And of take HDV data normalization, of like a in second coming patients data without RNA quantification and with RNA wondering, as we below update what patient there we Is consistent about of expected next cirrhosis. achieved wondering the the would lower ALT first, this part fourth on next or assessment normalization longer the patients you this we endpoints in that data proportion? regimen be HBV expect compensated patients in then be as key profile I'm cirrhosis then durability the may secondly, think as next see would update of combination and which we I'm of we proportion cohort response? I a readouts. that's the if well if the quarter reported first, at this limit than just or achieving of these with expect of later real-world in the the virologic the AASLD these should wondering specifically So with year the next when on around update cirrhosis? think the setting compensated should I'm with

Phil Pang

all Well, the my compensated make memory then question challenge question, move to sure the Patrick, right. and I cirrhosis questions. But with let to on finish start durability the remember question. All to and you're those with endpoint going me

So is with up was have reason compensated on them entirely probably somewhere regard the large to but That at the compensated we between the it ended is cirrhosis, XX%. epidemiology to proportion, delta certainly cirrhosis a clear, XX% how XX%. patients why not it of and is, many not hepatitis

but can you enrolling to trial, in you fast targeted around actually As when this want we also as trial possible. as imagine, XX%, you're the enrollment move

prepared as at it's of trial that expect why been about patients go are are remarks, now, the said -- XX% I XX%. all right there's in number my screening to the cirrhosis. all I because So cirrhotic only patients That's enrolled. has left up with in

we XX what But to patients there's to or safety the XX% least understand per get what was So around maybe XX there. XX% is of somewhere to able viral we'll kinetics or ensure and be with signals. decline to cohort that really obvious cirrhosis do wanted to at no get probably even

result is sort to both XX% to where of are enrollment. With is think the the So the as that we endpoints, that's historical how in is endpoints I think we well as about the just how forward-looking. important regard of it remember

I possibilities there So few a the are with primary want for share to you. that endpoint

a which by bulevirtide, course, used and the of biochemical first, virologic is The that combined was endpoint. endpoint was

of endpoint a they're sure requiring I ALT a Specifically, also and virologists, think X-log not is, what either X-log detection decline to that limit speak they'll actually say and providers, then when you virologic normalization. But decline to means. virologically what physicians, the getting allowed or

you if your blood X from obviously X example, does not have For logs, per XXX,XXX go And milliliter. logs to copies sound that good. in virus of the still you

think we preferred. be to the as strongly that well of getting as or limit clinicians below So quantification undetectable would

the the in I of to and likely this lower think get a to So would benefit the on load. That definitely require we of care. the show possible over of just X-log without first the lower and a qualification requiring forward-looking that can standard meaningful limit or ALT is because to a possibility viral I advantage to quantification standard could think instance, at then detection patients you would lower endpoint, of limit normalization gold a get decline achieve would have it we the allowing of to everyone set a imagine patients limit where

able have weeks, I durability, say the X not to those would X into we load we'll that for call. as patients. around then I some going look guidance as to of guided we follow-up will at nearly far data question share their are a primary as think endpoint. And in ALT which those XX and I on third So kinetics follow-up be you both think as we're around of informative. the viral patient future will I sharing have the color actually well provide And be decline your changes, can But participants XX to the

Operator

next JPMorgan. line the with comes Eric from Your question of Joseph

Eric Joseph

here the or treatment Difficulty] is kind to discussions program, [Technical it have finite think or paradigm expect the I what to sort observation it you the tobe/ele be have do how or hope combination? And do be of you regulators? to if expect finite into chronic ultimate sort going of with Do the of therapy duration interval, would much to former off-treatment with treatment? you guess you

Marianne De Backer

to question Eric, So of was the beginning sorry, little bit understand. your a difficult

Eric Joseph

therapy follow-up treatment it's be treatment into have or finite in how going you Is the is therapy? much regulators? would you chronic delta, expected hepatitis If do therapy, going to finite the discussions initial algorithm with -- think

Marianne De Backer

chronic want to Phil? delta Eric. here you, Do achieve Yes, you patients. hepatitis we regimen a to treatment is what for aiming comment Thank further, are

Phil Pang

Yes.

viral suppressive that is duration for for a therapy not currently chronic like there So is hepatitis for of finite with and viruses there therapy, know B, in follow-up therapy. as other that HIV it, we -- a example, framework no need as

are we'll course, one for be can XX both follow bulevirtide, and think that any we be having patients is of another we'll regulators. earlier up of or weeks? for be will precedent for to the there is And with there regulators, XX discussion come is, and with going these I following questions that's data question with but the

Eric Joseph

receiving share combo among Anything you regimen patients about the the upfront cohort? in in the -- profile can QX tolerability

Phil Pang

Yes.

data from XX we're XX our that de have and arms lead-in. SOLSTICE And I who certainly, at therapy call between is that started we actually, participants between So think patients mono the combo novo and forward week what XX. we've trial looking we'll and or XX the the without about participants week to what have QX at X immediately combination said on

to So you XX XX and be QX. the divide of that patients share through forward looking and we're into participants combination XX to in able that data will being week week through the arm, XX in

Operator

Bank line of next Stranahan Your of with question from the Alec comes America.

Alec Stranahan

couple a from us. Just

maybe You've investments beyond innovation, your that'd capabilities Are areas on expanding of would you interesting? regarding say infectious powder disease see billion your mentioned plan discovery, into siRNA you in about how to percent question allocate and AI Maybe And the more $X.X break would in dry your roughly particularly you great. And in past machine development, immunology, technology-agnostic? such say core there could and on cetera. any versus, for say, external be learning that as immunology spend XX or investing you in pipeline say, or be trials, as et targets down antibodies competencies within clinical you cash. one in if in

Marianne De Backer

through giving been which system we're diseases. of power through that which through inception, leader to initially we it only generating Vir T AI the focused generate And vision immune fundamental infection, vector secondly, its to, doing a But powering immunology cell responses platform. engineering. really since unique fight our what vivo the broadening either And mean X T infectious now is viral course, call really really really I it system, in Yes. to ways is therapeutics, on patients our do and has immune targeting we cancer. ability in fight with their then we powerful cell-based antibody in

virology, of our we expertise, strength So as really at, and looking and a that company that and oncology. expansion have is deep the where immunology, is Alec, type we're in in rooted

be towards diseases the we holding looking And cancer. indeed information will on in we So the programs early an R&D be we will of when area immune at as such Day. that are and more viral-associated expanding into year end sharing then our targeting in

comment that, Sung with position I'll maybe So on our ask and cash breakdown. to

Sung Lee

Yes.

for thanks that Alec, So question.

delta this stage $X.X B. will hepatitis billion our of cash to majority in and to regard ongoing with be and dedicated So the cash hepatitis the of equivalents, clinical programs

year. a have we to readouts we as sort time important year of course, those this this in data take programs both Of at have of X

provided allocation R&D that you of for obviously, to when year to look capital is than success and So subsequent think would and expense for we've immediate years. But we're guidance the combined. dedicated dictate the the XXXX, SG&A rooting that fair of half that It's at prudent prepared we'll be to And into about be and in hepatitis about There's development where opportunistic in platform. programs, as sense, primarily very delta Marianne hepatitis it external we'll innovation but be very amounts her invested that B. makes antibody tapping comments, said that. will our more

Operator

Joseph Your Needham line with Company. next & of Stringer question comes from the

Joseph Stringer

to second it patients. just on you but be will a do the the commercial these question on how relative non-cirrhotic patients? to I quarter. to that treatment the be show a follow-up cirrhotic And be would effect to it anticipate perspective would these important readout in in a safety challenging in from wanted Clearly, the show a clinical patients Just more patients? delta effect focus key,

Phil Pang

all one Joey. you, if Thank take that Marianne. I'll that's right,

high fragile cirrhosis, have So call cirrhosis. patients between decompensated just have who patients and in clarity. compensated want a and X-year mortality. are a cirrhosis off, of terms much to we to have I provide distinguish Decompensated We who patients obviously first little more need what

a both really, who possible. clinician. patients as are to biased And as think those compensated on patients to getting more are said non-cirrhotic. We likely compensated as XX% our cirrhosis -- as I a that focused present cirrhosis with fast well I earlier, because cirrhosis include obviously the to are living candidates the compensated those simply patients we -- drugs -- approximately to fast patients patients to hepatitis So as compensated That or we will need with think think as are I drug as to number delta. that with of XX% our is possible little cirrhosis currently bit

there in terms expect would patients, viral significant impairment be why to to and a hepatic be study. Child-Pugh B PK patients there's study small perspective. From different clinically any point from efficacy or the reason would a cirrhotic I significant expect in or to no efficacy did a we want they patients CPT a not I perspective, a don't safety see change in in a out any do we or that different, B In of to result date that compared was not signal. to we do whether decompensated of safety safety also biological that evidence reason any non-cirrhotic patients believe Turcotte

forward So why I but think looking seeing do reason a data why looks the that there's, again, we believe that's like concern, what that trials. in to we're no that's to clinical QX. And there's

Operator

Your next Ulz with of Mike question comes line from the Stanley. Morgan

Michael Ulz

spend giving this for how if But about on just little follow-up to I Sung. Maybe clarity you Thanks OpEx could maybe a push for bit. think year. a

readouts thinking about flattish of it As a comments here. know be how Should about to beyond trend? we moving should would upward there helpful. think of be kind or what sort of we more these sense a an lot spend with depend trend-wise. we will I XXXX, be on maybe But thinking happens us any give of think some

Sung Lee

the with have what allocation, garner as the lion's to capital back going would months, we said of we the the continue of if to demonstrate hepatitis allocation. data XX B capital I bulk hepatitis kind over of So last and share that successful before, delta programs

would we XXXX, B They're continue up. delta to in and to ramp studies Phase beyond moving hepatitis So still II. hepatitis expect

excluding important not on of lot the items. as would in because to we we've the be there cost III, peak, guidance not you but information likely think As time things have peak reached add because again, peak help our XXXX we would progress. But really be I just of time a when cash this that provided of these put non-cash from to range most you second operating a you of to in both XXXX, reached how get take expenses, about would dependent to about sales, frame also into Phase guidance year might studies for data. somewhere The XXXX. at at think X only utilization out we GAAP with XXXX half look though, it's but

both an OpEx So I'll be on flu by and lower would saying, significantly statement manufacturing. And than on driven XXXX, my the and cash round utilization an expense efforts we the basis items, would significant non-cash year last the the expect investment the again, is exclude significant. you be year cost year related from undertaken all when which of and we as optimization study operating which basis, we consider by would flu basis, off to well. peak peak last XX% And down a year-over-year, just out coming

Operator

remarks. There De will the to are over closing turn Backer time. call at this Marianne questions now no for I further

Marianne De Backer

Okay. Thank you, operator.

our really value us you. we So to eagerly our holds are on you joining all patient end anticipating And for promise may for transform operator, way, in powering said, lives. Thank catalysts we that on and immune are call. the well system Thank we data as today. you multiple for creation. And impact close, a the mind great to

Operator

call. today's concludes This

now disconnect. may You

Vir Biotechnology (VIR) 22 Feb 242023 Q4 Earnings call transcript