VIR - Earnings call transcript Q1 2024 | Vir Biotechnology, Inc.

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Operator

Hello. Welcome to Vir Biotechnology's First Quarter 2024 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

Chief good Executive today Senior and Officer; Clinical and and De Dr. Vice Chief With Sung Research Chief and Backer, Dr. Interim Financial afternoon. Officer. you, Vice are me Marianne President, Lee, Thank Executive Officer; President Medical Carey Hwang,

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

Marianne De Backer

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

call, to afternoon's quarter results. to programs update pipeline remarks development before to our this to first share During will an provide Carey on then and and summarize clinical I our Sung initial returning financial

questions. then for will We open the line

Before we highlight like would two to recent proceed, I updates.

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year Looking to expect a ahead, XXXX be transformational we for Vir.

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estimated in to substantial most therapy Our remaining goal needs. At least area with are people with million unmet delta lifelong a provide XX medical that be cases this and is impactful convenient patients for of globally is living hepatitis to undiagnosed.

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therapeutic help our aim that our us Our candidates goal achieve XX% cure X can functional rates. is of higher a or

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investments. turning our cash and Now to

Our to through while our innovation. in fund flexibility providing major the balance sheet invest us inflection external points clinical to enables programs

with prudently partners, and our I'll like We the our employees, help to to thank expenses trial greatest shareholders. To and Carey. drive make conclude, return acknowledge possible. With call opportunity investing over to shareholders managing clinical who and all that, in would our programs this the closely participants I are turn for

Carey Hwang

Marianne. of shared strand initial results served XX on late-breaker initial data and about were X X of from had the starting earlier discussed hepatitis and I'll ALT on we X a have were year. The the below tobevibart last treatment is of of alone by and potential our therapy. out SOLSTICE combination achieved declines RNA. this within Based reported, X qualification II participants for in trial delta. out normalization. delta, in as you hepatitis trial X limit X which out with of SOLSTICE weeks Thank RNA Phase you, blood evaluating reminding people undetectable year combination HCV rapid HCV participants lower presentation a begin chronic at chronic also the AASLD in with tobevibart living

Marianne receiving our to abstract X or presentation enrollment data greater earlier in in data to trials it's of X contributed years an with SOLSTICE [indiscernible] compensated is than receiving future weeks. Approximately tobevibart of two include Congress. rapid understand every we across and of can participants anticipated. how optimize hepatitis every the tobevibart to impacts treatment second cohorts the X XX% As delta strategies with and additional have X our to cirrhosis enrollment. patients monotherapy was participants plan Therefore, accepted with important plus One at weeks on designs. We mentioned, average share develop information CPTA. elexsiran those and disease. month of a than this more completed was of trial around to cirrhosis for Physician combination updated group XX% participants poster cirrhosis XX progression. treatment with late-breaker Overall, therapy a help This is group in the type patients at progressive AASLD significant enthusiasm for rate that future approximately inform

participants XX Specifically, share data XX will approximately per and approximately on XX weeks at per regimen participants at regimen XX weeks. we

for X foresee follow-up [indiscernible] at fourth also participants several light that quarter SOLSTICE X data the will trial be will areas. at time. update the SOLSTICE XX-week data cohorts expected is these shared will participants on initial XXXX. treatment for Additional informative in shed Complete the key be and We of that SOLSTICE highly in

clarity gaining tobevibart First, safety profile administered and greater anticipate with the together elebsiran. we of on

ALT biologic normalization. to into expect additional insight and rates we Second, response obtain

or and to are efficacy follow-up the are program are Third, the to about dialogue viral authorities initial whether suppression initial longer data supportive, looking cirrhotic finally, reported And we noncirrhotic aim and participants health AASLD. If of on differences between with previously data from participants. the durability year. will later at seeing evaluate we development safety we forward safety there this X

discussions following designed to with health trial ] we greater a [ be chronic with on B. for We trial next will have bolivrotide and program as will II expect hepatitis designs gears clarity Phase authorities. Switching Vir's our potential comparator,

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Finally, archives. and Peninsula recently [ data a full manuscript trial we VIR-XXXX ] met published

to are We trial flu key ] VIR-XXXX. our Peninsula [ learnings antibody, polylactic next-generation applying the from

concerns. We vaccine human intraepithelial about [ of the and cell Now next-generation timing [ scape, HCMD-vector pipeline. remain an potential significant is in global a turning to potency, breadth I development optimization. based is IND screening, and antibody later famous submission. VIR-XXXX forward thanks precancerous to of share T Phase resistance grade to call conditions increased year The early-stage program to as supported more late monoclonal our coming virtual look advances Sung. therapeutic a high HPV-associated this ] We BARDA VIR-XXXX the our AI vaccination platform by is treat the over through ]. is to forward cancers such progress health candidate to VIR-XXXX planned quarters designed lesions and our papalovavirus. and a and this caused Despite on investigational for sharing of with by lesions now COVID-XX and turn the Day will engineering R&D continuing over look end to to viral of during November. I the

Sung Lee

Thank you, Carey.

that at Board impact for I'm I for Vir. the compared are I'm to results, have have the what like opportunity organization confident for we to share financial quarter well financial as moment success. $XX.X truly CFO, million of period thank With take make the first were XXXX. Total my I'll finance continued the in the enjoyed Marianne I to to and $XX this accomplished. XXXX. XXXX of company the would the now results an and positioned revenues time for first the in of same and million proud the to quarter get I Before that,

related agreement collaboration deferred saw first These grant XXXX driven and declines by anticipated, GSK. in of with our by partially revenue of As higher in declines recognition year-over-year XXXX contract were we primarily offset quarter the revenue the to revenues.

$XX.X for million quarter same in first lower first of $XX.X million XXXX $XXX.X and driven million in expenses first to revenue period resulted in $X.X the expense the XXXX. reduction The related the in manufacturing was which in period million XXXX. million of to significant were Cost period in the the was of clinical driven primarily $XXX.X to in expenses. of XXXX. by primarily external XXXX same expenses. development a in costs compared disciplined operating to nominal XXXX R&D Turning the decrease for VIR-XXXX. SG&A expenses compared quarter were decrease was in same by compared management, The to quarter

We equivalents compared a with the and billion quarter-over-quarter. the billion cash of first of to Moving sheet. end balance XXXX, $X.XX quarter $XXX representing cash, investments at XXXX to decline of ended the $X.XX million

progressing and can reiterating our as financial of we of XXXX. The guidance our for Slide aspects our year Turning to is corporate on presentation. XX which found are expected, be all guidance,

shareholders. I to our the the will and disciplined Sasha. managing We continue in to be to expenses opportunity call return our greatest focus with turn now for investments on back drive will programs

Sasha Damouni Ellis

Thank you, Sung.

We [Operator the Operator, questions. up please start the Q&A open for will Instructions] now section. line

Operator

Gena first Instructions] from of question Barclays. Wang the [Operator line of Your comes

Huidong Wang

I have two questions HDV. regarding

II limit in And data ceretec bar efficacy for patients baseline update? second regarding lower will exclusion with is Phase EASL the criteria my and which of quantification is question a the conditions? And cirrhosis, of question restriction for more any measurement be meaningful First detection. or is limit view in the regarding your setting

Marianne De Backer

relevant. for that are will which Thank those very, Gina, address you very to questions, Carey ask them. I question much very for

Carey Hwang

Gina. you, Thank Great.

trials. So your and first around baseline for restrictions our question cirrhosis in

So new in as that enrolled CPTA they compensated cohorts mentioned, sclerosis. we two we so in I included SOLSTICE, have patients, the

And those we about those participants two so new have cohorts. of in XX%

forward those And our us so of inform safety and the -- populations. efficacy will regimen going in help this

those there cutoffs the between limited question to if are Different regards or which and different -- the in parameters. cirrhotics that for around than non-ceramic population. In at looking to detection. assays forward lower second look quantification we So any have measurement differences your

from which discussed be so parameters of with these acceptable authorities of perspective. in endpoint an And would be regulatory will these terms

will something regulators. that will we with now, So right I we but answer to -- clarify that will can't have be that

Huidong Wang

the update? And EASL [indiscernible]

Carey Hwang

the is All last right. whether data efficacy [indiscernible] And be then the bar. question a new EASL would setting

that or first you're with our qualification achieve our X of participants, able familiar from As out achieved to detection. were the RNA from that X AASLD of and undetectable X we're [indiscernible] out X HDV less presentation [indiscernible]

we viral I chronic in replication goal population, any think it these demonstrate Because new suppress results if such to the bar. could with disease, in to efficacy able think always a to levels set undetectable I is larger then viral as as are a that HIV.

I we're that, to able that do would so And benchmark. set think if the

Operator

the of Paul of Your from comes Sachs. next Choi question line Goldman

Kyuwon Choi

had population follow the XX-week Gena's those XX-week I cirrhosis just update. have -- update SOLSTICE. And who up for maybe wanted the to on have compensated particularly in XX-week regarding you'll among could treatment question additional you the versus for us, patients the clarify which

success, the those of given that the Pfizer or how in both your Just we've that second just partner RSV elaborate GSK in drugs terms terms in with having the of pipeline, advancing and from decision for my can you're GSK question the updates? And you various baseline on of then no cirrhosis thinking you of are seen that terms sort recent earlier-stage looking of affect at maybe [indiscernible] might criteria and of is market sort XXXX. success go what particular go a

Carey Hwang

thank for Paul, So you, the question.

think how terms or in So we of efficacy. might affect cirrhosis safety

We have any us would that in or concern. CPTA study not PK significant seen clinically participants have changes any impairment hepatic and done safety cause in initial any signals

have population, we populations. or that so of significant between And efficacy out differences those the data coming profile expectation see is safety soon. in should compensated any terms not And our relatively cirrhotic we two will

given In VIR-XXXX of with success we the terms Pfizer terms antibodies. of monoclonal partner think the from GSK, and in that of are discussions potential these have of those at or other I RSV looking vaccines and ongoing our profile

so or And progress need fill kind that to present in only antibodies unmet certainly of space. want we the an

partners our help to we'll and discussions ongoing decisions. are make those so And those

Operator

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

Alec Stranahan

outstanding the thinking context how you us from update in wait inform Phase until versus regulators EASL update in on guess, aligned I XQ? the for what will a think in be It the XQ the likely data? And already though questions first, expected have additional the follow-up, do more you'll answered sounds in of steps what well. on setting. becomes still have with this guess, would next as Just of should we a as III about XX-week XQ. I even you a go advanced EASL terms may no which a go data couple be available, like in in will

Carey Hwang

Alec. Thank you,

that we in would data how in the about have we week have will of XX at So of at cohorts XX a each of at XX. in we think week about participants about participants XX the terms EASL, and will cohort

things that looking we at profile combination. four one, So and at, Number rates are. time be ALT for virologic response the elebsiran would two, but the this moralization of tobevibart rates safety point. Number

we and Third, potential finally, on And safety see AASLD participants. at then if over efficacy durability longer-term X the report data the of to noncirrhotic cirrhotic initial that the have and differences we time. response participants follow-up between

that and the of safety. in So -- And data what the from I XX-week and then expand across we're directionality populations. set confirm of further hopefully obviously, terms the have EASL the will data X initial think the complete seeing efficacy further we X data data set those the

for of question inform second a go terms Phase a III go no in what delta. your on So would around

strength the So depends the I think data. on it of

our a of all weeks for can the earlier. going depends EASL very taking that complete data of but if indication go possibility data I be I But set, a on with efficacy, have would will enough, data forward. a strength be we conversations. the the we XX of think that think believe Obviously, strong that data forward cuts, we that is it think strong I if

Operator

of Your Nadu Cowen. the next TD question from of Phil comes line

Philip Nadeau

as us. add he wishes on. best moves us Let from Two Sung our to

be regimen the your hepatitis EASL for a with going talk development durability response in are investing monotherapy could a combination So on then regimen there environment is question development you to second, delta? And develop the be that's first, what about thoughts effect the highlighted, you business that just QX cash. key unrelated business you're lost seeing Can and answered as time? Is could over any reason updates. by Any and recent to worry resistance preclinical externally. the for totally most $X.X that bit in priorities in on or billion signs

Marianne De Backer

maybe great sheet that for first. question of -- fund to you and get strong really those your a our we can pipeline. second course, in we'll we position that to our questions, And hepatitis hepatitis And Thank shares is have we are priorities. use balance Phil. B delta Yes, in our

to innovation the programs and we and However, looking thoughtful at we clinical also those would especially very And of continue strategic be opportunity whether have for in to to for external early shareholders. I fit our discerning and be there. be those question to will interest look a response. and Carey us and the would value your related answer for opportunities great creating of ask company durability

Carey Hwang

thank Phil, And for Marianne. you, the Thank you, question.

question around regimen? So expect date. would with to on resistance based So seen some or veto data, resistance and our durability we of to date, any we think loss I any durability delta of see your have plan seen to response we hepatitis we've what haven't

terms B data, surface antigen surface less likelihood mechanisms. hepatitis [indiscernible] and with to lot antigen working We and resistance seen of mechanisms different a together. And in then two therapy. And think hepatitis with of rebalance chronic tobevibart going elebsiran and through of other and of a as antigen, is haven't infectious of in elebsiran we're two we different time much combination like forward levels tobevibart looking both surface you diseases, developing through RNA, I with have if inhibiting the compared work were because over HDV at

rebalance with what know some hepatitis So from resistance guess are tell. But and expectations be independent the and based two the different will vitro rare. what mechanisms of is we work, time against virus. that would in our B, having on My far so

Operator

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

Patrick Trucchio

from Just of questions a couple me.

delta The program. the first is just on

about just from talk SOLSTICE Phase on approval? And wondering pathway available, you surface treatments what baseline if for on there can accelerated levels to it And an based lack HBV at the the loss outcome if segmented so, demonstrate what I'm expect this, And a data? is Given then possibility talk that if look you the wondering I'm and about III can you like whether have to terms data on in approval potential program, of and pathway to to of might depending this how and related comers antigen antigen, report of all consider patient is baseline? levels you with baseline Phase expect -- to surface especially program you relative would service lower advancement to the of potential cohort relative if as to antigen important to at of a III. the program to

Carey Hwang

Thank the questions. you, for Patrick,

So in of possibilities delta terms hepatitis accelerated for pathways.

there's that's in know, you currently no time. approved this at therapy the United As States

based our from of track, us of fast And we such for regulatory agencies. these methods accelerate to strength data, so look on can the that approval, and are as breakthrough mechanisms path that to we other will available those time any

So hepatitis -- forward your question and at terms pathway regulators then gain registrational as we the move engine will facilitate looking alignment to of levels. discussions be in segment to by we second forward. And will with be data looking around pathways those B, going our service on at and we developer segment

X,XXX, have in hepatitis trials, taking than yes, view. our So participants files all comers, antigen enrolling to less we're X,XXX B broader actually with just date in we a surface our not taken or

increase certain [indiscernible] to our see at be to and would subgroups data antigens. look We will able cutoffs whether rates surface sets within

So will will we be be evaluating that out and set. data those in areas working our

Operator

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

Unknown Analyst

Partners. Ruiz Rosa Leerink [ for on at Chen is This ] Roanna

on First, a HDV. couple

the data normalization are expecting in that what at to you ALT level for you in really we of year. SOLSTICE, the EASL early didn't normalization So data see meaningful given that see presented last upcoming

Carey Hwang

Rosa, question. the Thank you, for

participants. small set We normalization, data numbers. a upper of participants X normal. were AASLD of of achieved majority But not ALT those the did had that around from our had of the X think X limit I normalization. So just that out set was only achieve ALT who We

and that going to potential longer will this set treatment, we with data think ALT more so in further And this out may we robust so will in a have at help would terms see set forward. what inform expect EASL, regimen normalization I terms coming data of normalization. With of more with we see us

Unknown Analyst

And it. on Okay. Got then another HDV. one

recently too about U.S. the So haven't Hepcludex heard much [ we ] resubmission in

Hepcludex you more you thinking versus Hepcludex? can regimen versus the maybe patients the of responsive are about available? positioning how about So if share are to maybe both are competitive your your How be you who guys thinking could regimen

Carey Hwang

question. for Thanks Yes. that

what I think, said, I not but in as U.S., have [indiscernible] we in in would it's approved trials as you our plan to ability a differentiator level is seen quickly and our combination us really based as from to participants least at I detectable first think going that prepared forward. we've after potential forward. therapy, mentioned get on that very of the to weeks for only our my So And going remarks, XX comparator the

viral larger to data to diseases. in always As for any able demonstrate in we're And a achieve that gives then chronic us in set, if the is therapy forward. confidence moving suppression goal I mentioned, virologic further that

also monthly, through also a because or previously developing addition, we less in X a we that as potential which think are concern answer, is once previous regimen In as virus And the there delta different populations. differentiator being the mentioned are I think in with administered different I resistance I is subcu mechanisms, well. patient nonresponse there's also of attacking a

Unknown Analyst

one could Super helpful. HBV. If for I squeeze

trial. [indiscernible] in should Can of the carriers these HBV we how the give the patients to inactive immune the us relates populations? it about a data versus real-world and you these think as prevalence of So active chronic sense

Carey Hwang

that studying be of Yes. in we reason kind stage are hepatitis of response populations because populations be B. The able have is these these to the to strongest immune

treatment. [indiscernible] the guidelines the in However, best in they're these populations, normally

more And so these patient to find. populations are a bit difficult little

of in recruit chronic to mean, is specifically compared and to populations your So at trying that prevalence be in at functional of higher it's overall, find the this these suppressed overall these bit in rates whether looking populations a -- kind able little subpopulations unclear. terms of But population. achieve to are we something to I these cure can determine we

Operator

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

Joseph Stringer

cure to wanted updated for thoughts HBV. functional get on your Just rates

XX-plus mentioned, that believe an KOL recent based on that containing feedback percent interferon less some considered regimen you that would You a successful. perhaps non-interferon-containing for be than for and regimen

that's of would say, be if success would cure Or curious providing? there use additional sort Any is numbers physicians? Just of that rate a be a of bar percentage that that you're helpful. a docs higher minimum would sort than amongst color treatment? the for And on where, functional certain the treating

Carey Hwang

advisory hepatitis opinion question, with least the and them, And in be like Joey. for question a meaningful for rate And tier of best the back highly you Thank functional this an leaders post Yes, board leading XX% we for them. would cure many to did at in them. key XX% we the between had Right. November. with of

I not. think these much think contains more is piece a interferon regimens to in patients easier about or for component certainly regimen Interferon to regimens for tolerable, take whether physicians other easier to the sparing to are monitor.

bar So rates. to tolerate see little containing [ bit likely in the margins they terms of regimen higher they cure a would cure as terms ] of [indiscernible] would functional then what a using is sparing rate the functional interferon in like lower

sliding pin So exactly to hard to you down there's consider. different that factors it's kind have really because scales of for

Operator

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

Eric Joseph

And plan, the follow-up, to forward it's move U.S. sort regulatory given You've you with if noted III intend with feedback fact Carey Can there, approved include have you comparator. that that? the not that. informs and here? And as sites using I'll then contemplate would trial that follow-up I a you a that to as leave question maybe just the Phase operationally, do of or HDV potential a talk investigator in about [indiscernible] that

Carey Hwang

the questions. for Eric, you, Thank Yes.

yes, a care, States. These yet will currently in So with -- the therapy, comparator, would mentioned, United that against think of in looking like. But of approved export be for what compared now is the the of globally are not I we this look [indiscernible] include because study Europe. we lot also standard want you especially design from be I this would in to a payers would obviously included in even as as we what the though our -- of will regulators, terms discussions

before. we've want the be not be comparator. Because time have footprint though So a or even to global a we conduct that's are there done that including is we which reason in not, not these another trial, delivery trial this even mechanisms to in be the would won't liberties by And we the start the with approved U.S. it's time yet able if approved. trial, [indiscernible] we may trials in

be plan. the So will that

Eric Joseph

maybe guess ALT of the difference sort we be I baseline effective And that LST [indiscernible] presence? And coming there patients. any [indiscernible] between HDV of Great. the is in I and in it follow-up, of to normalization sort should challenging just patients, LFT more a Is Okay. about cirrhotic patient is of population? topic in non-cirrhotics? the in guess, here thinking as prospect normalization back than a

Carey Hwang

the of in in a rate normalization. our Yes. question. are for show we'll Yes, I thank terms lower baseline levels of with that's in looking then there at you [indiscernible] ALT think very and No, the of versus if are it's also good that something data and be at they the cirrhotics to differences question, looking higher, able

and be able that think of efficacy population, help earlier, terms impact we antiviral will the on answer -- moving CPTA the us to significant as I set data will data we to at on answer differences forward. But our in cirrhotics least for [indiscernible], mentioned question the obviously, inform set I potential the So don't and expect that. but us really see don't between -- in ALT, us

Operator

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

Michael Ulz

Phase one the I Maybe just a HIV quick on program.

just I Maybe looking what your be key early positive of And points we can would -- some second should think what end key that in in the study for? and be have of about view in that maybe you that forward? points year. sort in half of data moving the talk you'll program this keep to

Carey Hwang

question. Thank you for the

second have potential A of So as that half VIR-XXXX, this HCMV do year. to Part and trial. guided HTM, trial we is And initial is with vector our HIV immunologic to, of conduct And as vaccine trial us this this is trial. enrollment partnership helping the see which we've that with expect in we we a ongoing completed data from of have who

we in were looking mean kind cell in see T observed these T that if what would [indiscernible] restricted are see cell looking responses of the endpoints, those were [indiscernible] similar markers seeing kind we so what SIP And the multi of really and protective of we and animals. responses at that for from types specifically

this immunology, able if of to this in such with we're up so proof platform to see And exploration, our of virus then this [indiscernible] opens VIR-XXXX potential other areas, vector. areas as

Operator

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

Marianne De Backer

and brings look benefits to medical cost operator. to are implemented This significant that that our beginning realize you, the conclude, living company the millions of initiatives savings milestone trial addressing SOLSTICE important unmet from need at sharing closer us we XXXX in people is hepatitis Thank to delta. for we with our forward To is data EASL. a from

catalysts Looking company. could that the ahead, operator, conclude as And for in Thank the fourth additional we readouts also data anticipate serve the you call. you. quarter important may

Operator

today's Thank concludes call. That you. joining. Thank for you all

You may disconnect. now

Vir Biotechnology (VIR) 2 May 242024 Q1 Earnings call transcript