DVAX - Earnings call transcript Q3 2024 | Dynavax Technologies Corporation

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Third Quarter 2024 Financial Results Conference Call.

As a reminder, this call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific participation instructions at that time.

I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications.

You may begin.

Paul Cox

in participating for you today's call. Thank

from Donn Casale, me Officer; Kelly Financial Dynavax Janssen, are Officer; Executive and Officer. Chief our Chief Spencer, MacDonald, Chief Medical Ryan Chief Joining Commercial Rob Officer;

results financial Copies presentation XXXX. press are released Dynavax on the today, for third website. September of supplementary quarter a and Dynavax's the release available XX, ended slide Earlier

not starts on market ACIP current Before statements data future potential today forward-looking market will of be expectations beliefs, current marketing expected impact we profitability, and making timing readouts efforts, cash or begin, and potential and sufficiency uses our CpG I related demand market each, recommendation trial trends, advise capitalization, you limited including, including effective segmentation, FDA revenue, share XXXX and financial but on sizes, growth that our guidance to, related we of adjuvant. and and of future based results rates for flow, clinical submissions, and

risks and in today's Statements on summarized results Risk in quarterly and detailed including SEC materially. release Factors today's are uncertainties, the differ XX-Q. filings, actual involve report of risks press our These and Form our section may

of update we today, speak no obligation undertake to statements forward-looking Our such as statements. and

now And to with that, over will call turn I the Ryan.

Ryan Spencer

all Thanks, successful very another afternoon. It's Paul, quarter again us joining the for you and of results nice to thank this for to share be Dynavax. here

team where million continues again success in Our sales. the a once product record be HEPLISAV-B, by with net driven delivered quarter $XX to

development accomplishments HEPLISAV-B its successful proud to commercialization. our very of with are We from

which on a our beginning are we some moment. more result plan details While still in is impressive, provide the for growth, continued will the of Donn at quarterly

and by trend has to a for transformed this expectations committed continuing growth success our our into HEPLISAV-B Dynavax of commercial Supported the into Our programs, in are current the confidence we future company. with profitable HEPLISAV-B future.

to our and long-term are cornerstones generate capital value. allocation Pipeline to thoughtful approach discipline

from candidate, our support not while sufficient I our results study vaccine our Phase Tdap discontinue decision advancement. program. out we quarter, immunogenicity to extension the differentiation program. our we from took this Accordingly, And did I the threshold Phase improved our read This to meet study to demonstrate showed

there to improved is an pertussis believe need vaccine. continue a for We

to also understand in commercially what viable we However, it takes competitive be environment. a

continue will preclinical candidates clinical all product we to that in for evaluate We offer both value meaningful to shareholders of and and our invest patients programs alike. ensure

Moving to our vaccine program. Z-XXXX shingles

the to will enrolling study line actively expectations by call. and top I/II in expect enrollment the year the with are data we second We in strategy, our trial, of recognition are we on complete from we strategic half At core, XXXX. into our of portfolio this later on Phase this of Rob development our our end company strength our excellence. to capabilities, focusing operational our of committed corporate commercial by execution can expansion products. and the assets with a developed that driven rapidly In remain and be review

when deploying targets many comes external opportunities. capital ourselves and a towards evaluated it bar have high very We to to hold

on this execute of will We part we and patience strategy. discipline to our maintain as continue

Now as our from for recurring very business. have excited we in I companies base a to industry, near-term profitability we said are achieved earlier, expect where meaningful our milestone

ambition allocation to expertise to financial Our with strategy discipline capital capabilities drive our balances growth. leverage and our

we company. million and $XXX for a in number our capital position our transactions, to participated shareholders Board long-term moment continuing long can where and at be the vision financing in it proud while having release, our today's As so announced is of on of to return to a execute a for share been has Personally, repurchase press Dynavax plan. Directors in authorized led a having

our of growth of the ever and future. We with more infectious commercial potential work expertise. proud and I'm and than by ahead scale date. I'm how diseases and vaccines in to scientific managed in confident our inspired have be aspire to that we've a the leader we driven

We the infectious and have on health an exceptional, protect dedicated change public products energized from diseases. millions and landscape commercializing team developing focused and that

over to like Donn. I'd turn to Now the call

Donn Casale

you, Ryan. Thank

HEPLISAV-B's performance share We are share. continues achieved the and total record-breaking XX% the for XX% to IDNs. in third U.S. HEPLISAV-B quarter driven increases last during year-over-year, $XX by to period segment XXXX. very delivery XX% HEPLISAV-B XX% growth to in year. HEPLISAV-B's share sales of proud product networks share compared in and the by integrated over be the market quarter. same Pharmacy growth critical revenue, and in Retail retail supported market its pharmacy increase third to of quarter in continues third to for HEPLISAV-B market X or achieving compared the segments: increased HEPLISAV-B market million the B net market hepatitis

during IDN, XX% to market For estimated increased year. HEPLISAV-B's same XX% share the compared last to period

dose market uptake in Over XX% long-term B ACIP universal volume XX%. within past year-over-year trends the pharmacy hepatitis the dose IDN, of HEPLISAV-B while expectations volume U.S. These support and our recommendation. year, and QX, market growth hepatitis grew the grew B of retail

the continued on In pharmacy and customers focus fourth quarter, hepatitis by IDN U.S. in B share. increases vaccination, for we market retail HEPLISAV-B with look

holiday of the also visits patient with to XX% We during year-end due approximately typical contraction anticipate season. seasonality market fewer

the ahead, HEPLISAV-B. long-term we confident revenue in opportunity Looking are for

over the achieving long-term of This in expectation expand HEPLISAV-B sales to annual a guidance represents million U.S. for XX% $XXX net HEPLISAV-B growth market to with least opportunity at peak of share. a double-digit We XXXX, our market product expect out by for total the HEPLISAV-B XXXX. to

due eligible remain population, health care the practices revaccination in by durable market of observed HEPLISAV-B adult gains providers we and continued market share. to addition, In the beyond XXXX to expect vaccination ongoing opportunity

outlook In summary, for in HEPLISAV-B. confident the remain we

market. We expect HEPLISAV-B the position to share strengthen expanding market as the clear in vaccine its hepatitis B leader

the work proud We on build and our this our very commercial for of about future. are and success remainder excited year are the of this momentum team's to into

to the take clinical over call turn now our Rob through you will to I pipeline.

Robert Janssen

Dynavax our letter for regimen HEPLISAV-B. approved in pregnancy regarding the the patients on in for recently issued with We the U.S. FDA hemodialysis an include retrospective information sBLA the to updates response address Donn. the complete conduct noted providing observational that previously FDA regulatory on deficiencies sBLA for that you, a U.S. label. complete response Thank for adds potential to X-dose feedback the forward recently reported a received study label We future these from to to discussions. cohort to the HEPLISAV-B. Beginning The FDA letter. updates look

our to turning Z-XXXX. shingles program, Now vaccine

believe randomized profile escalation active product. XX XX virus, Z-XXXX to aged multicenter the positive and Phase CDX compared to of In immunogenicity to dose positive Shingrix. a improved the initiated an we enroll that that an Shingrix. develop approximately the CDX to shingles T given demonstrate quarter, safety, years. opportunity trial those preventing we XXX controlled are the evaluate healthy recognition I/II cells with a the current reminder, And We As of tolerability market-leading we to challenging to plan cell there's similar seek of vaccine tolerability are responses varicella-zoster important T adults to reactivation in of second

of T responses, We'd we cell like to probability suggest our non-inferiority. which high would see believe responses Shingrix greater than of a median XX%

time. T of responses we'll response information will vaccine be and will Antibody over also rates Now be responses responses, quality consider, important cell T and including though, evaluated. distribution the additional cell

tolerability measurement in will used In Phase anticipate to line safety top tool addition label to half second and to Z-XXXX outcome XXXX. on support differentiate immunogenicity a of immunogenicity claims. also data patient-reported reporting trial to and be measures, validate I/II the We potential the

trial Defense. clinical regarding Department in of Finally, active activities. Dynavax CpG and manufacturing funded Based Defense and by the on of additional the vaccine is our XXXX, plague II U.S. Department plague a with proposal the from clinical adjuvanted randomized has a Phase submitted X-dose collaboration vaccine to the results program of with controlled

I'll Kelly to now our to turn the financial call review results. over

Kelly MacDonald

Rob. you, Thank

earlier release reminder Before XX-Q refer I today to Form press information. our financial get for started, detailed please a and more filed to

This including line year-over-year midpoint quarter underscored $XXX financials highlights net for and record $XXX marketing and to over in strength multiple by at this team guidance HEPLISAV-B range were retail. net $XX positions our the third growth the of of deliver a million range. million million successful campaigns sales to sales of across top narrowed XXXX, on us HEPLISAV XX% channels, commercial representing of growth The

Additionally, full year. the and the the outpacing for XX% X slightly months to XX% first approximately improved margin year, of QX for gross of XX% in our HEPLISAV-B reiterated guidance

of the compared were our Turning supporting headcount pipeline, expenses. our the coupled $XX R&D primarily the approximately for The with investments driving were to the as Rob our driven XXXX by SG&A million HEPLISAV-B was marketing expenses increase throughout $XX for during ago. $XX prior million year expenses quarter million to incremental third and organization, of progress quarter. growth period. quarter important moments for the mentioned reflect

XXXX. the supporting million, $XX net of income achieve net and for commitment quarterly generated year positive income profitability results These our to full

to of approximately with balance which during the securities third cash, $XXX equivalents We increase marketable sheet. $XX million, the QX. was million Moving a exited quarter and cash

Ryan profile, As the can our opportunities actively assets into development to aligned assets pipeline towards with strength products. and sheet, of our enables our believe commercial of financial pursue rapidly be we proof of including current to us strategically developed that that mentioned, supports portfolio the balance external expand concept our

committed on still In while addition and inorganic capital our strict priorities, executing to to these organic focus are returning on we stated shareholders maintaining to growth.

our we vision believe a approved also while our of company. this our required preserving shareholders flexibility make plan, As will $XXX noted the use to repurchase Board the for capital on has deliver benefit to today, investments share and financial million

product expense million, our our XX% the a Lastly, which year HEPLISAV-B gross of narrower guidance, net of to and guidance of HEPLISAV-B year reiteration guidance we the million tightening have approximately updated of $XXX margin includes approximately for XXXX of overall year. $XXX an for financial full expectations a revenue

research We to selling, now million million and million. $XXX $XX $XX and general expenses expenses to to be be expect between million and $XXX between to administrative development

we achieve profitability income for Lastly, XXXX. and year are net to of positive a full expecting

from For today. consult framework, please guidance our our release press full

product In we're financial to and HEPLISAV-B, capital consisting and strategy. pipeline record a closing, margins strong of report for revenue a strong improved gross with allocation balanced advancing excited quarter, quarterly profile another

our of we're call this also excited about proud on prospects growth as are today. the progress, We outlined and

Operator, like everyone. now to would of Q&A we today's you, the Thank open call. portion

Operator

Instructions] [Operator

Phipps with question William first Matt comes Our Blair. from

Matthew Phipps

this today for guidance clarity of on Thank extra kind you nuanced and all the market. here

previous XXXX linear now kind just by kind XXXX, my between -- by and versus first and far 'XX bit CAGR XXXX Or guess, straight for then your XXXX, it's that's previously as wondering expanding 'XX between little I view Looking you view, $XXX was X% total $XXX more just still CAGR XXXX? of of a think an XX% an at 'XX given, updated if market to to million question. as this you further if intact see is I million XXXX

Ryan Spencer

we just extending what of where this XXXX Yes, we quickly. thank to and not is would Matt, that see as peak. you. out happen to this thought take And I'll see a our change by guidance XXXX. an -- the we reiteration

Matthew Phipps

it like Or growth XXXX you by what's market then more exclusively coming the if that is confidence think segment. the of much Okay. IDN driving is majority in do driving that And And channel looks of and capping between of so, comparing Is retail -- kind true? out what at almost from point? percentage the really retail growth? your is 'XX some

Ryan Spencer

you to want Donn, take do that?

Donn Casale

the built of yes, Yes, Pharmacy there adult that identify to the coming Universal, the ACIP primed vaccines. incentive they've Retail the growth bit we to a pharmacy of well and believe infrastructure that around to sure. continue we to retail quite the is realize recommend is out fact communicated, all as fact due that Matt, for partly from pandemic, have segment

from you as only see not retail, into shift to the will, but as the shift continue seen B, to we obviously, for retail if other the vaccines IDN we've pharmacy. traditional segment, And in hep well, hospital

do those of we pharmacy outer years IDN. to in predominant retail driver relative being So see growth the that

Matthew Phipps

then for last And Okay. question me.

you're of as thinking in segments, market about XXXX. kind goal, kind stable and Just pretty been there share already of this you're XX% throughout target it's close your

above expect you to target kind about of XX% be non-field getting meaningfully spillover is segments? XX% segments? target the Or in So a field those to do more in

Ryan Spencer

want do too? one, Sure, take you to Matt. Donn, that

Donn Casale

Sure. Yes.

So Matt, the be retail again, drivers and over predominant growth this pharmacy time will IDN period.

within share those We expect market continue taking segments. critical to

see disproportionate We market other And IDN as within segments retail to total some increase do we will over these years. in continue the around to HEPLISAV-B spillover the increase awareness overall and so growth share. of the some continue

share. share of market growth off be said this again, retail segments market driven But do see, continue continued and to gain critical pharmacy where IDN and as in will we before, these increases I disproportionate

Operator

question Evercore. Miller next from comes with The Jon

Jonathan Miller

you can the it quarters, of me just year there full going dynamics, over couple a schedule a QX? to some evolve the next how seems you in given guidance, quarter. give gross expect to this on expect gross about little variability you're margin you reiterated forward of Maybe margin little ahead more maybe color gross like margin still into Is bit but

Ryan Spencer

handle want to question, Jon. Kelly, do one? that for you Thanks the

Kelly MacDonald

Thanks, Jon. sure. Sure. Yes,

So of just sold the while the fluctuations our to seen particularly around towards of sort activities, last gross Germany couple in in terms continued full are we of you've represent of and of timing there over margin, look cost the year years facility. quarter-over-quarter as accounting goods recognizing relative to progress

acknowledge anticipating. So that quarter-to-quarter. specifically not trying that some we're We we're just there's from to variability highlight anything

Jonathan Miller

share opportunities. substantial secondly, But repo in that And that a as than sign heard opportunities here, And you've that the guess, had that I your guess, right good now? more should value does taking and a be external a BD? Great. we I authorization given are in you reiterate finding pretty All I there trouble external out external interest right. priority BD

Ryan Spencer

I that it read No, way. into wouldn't

the capital like feel while these to for external have we still we think opportunity development. our allocation corporate at through return reality focus strategy, levels maintaining is a growth I and balanced business and it's capital the

-- doesn't prioritized they static. the that. our figure focus And larger opportunities It's are it's still ultimately, have it how require going obviously the we've working believe finance it things not continue to we been and more drive would how and And extent change we're But Obviously, support, there. on to to and there's out opportunity set, through we good do dynamic. to growth. out

Jonathan Miller

have -- fully do you it lastly the for cadence maybe expectation you and open-ended? And is those when then that do just Or have on when on repo happen? purposes, could that modeling for -- or an repo

Ryan Spencer

Kelly?

Kelly MacDonald

to the execute to program -- program look to We and accordingly. execute by have intend stated leveraging XX conditions, that we'll the subject forward market we months, within next to the

Operator

question Cowen. the next Rodriguez TD from comes The of line with Ernie

Ernesto Rodriguez-Dumont

thinking So reported that the and RSV part and you're could of about the players updated that the we that rate be HEPLISAV expected looking lower represent thinking about? to forward has due to vaccination QX upside in for the capacity seasonality, recs, positive given some been QX by in wondering if and the RSV a retail CDC impact potential something on the more maybe Is segment? were

Ryan Spencer

you don't why Donn, that Ernie. Thanks, one? address

Donn Casale

X people arm, We thanks for open from we considered find certainly other vaccines. want All have a question. the a is the standpoint thought for you HEPLISAV-B. always recommendation the an X retailers a It's yes, necessarily pharmacy guide. certainly the about when pharmacy will, upside. plus the Ernie, Not for It to plus the retail opportunity represents, campaign again, vaccine. strategy. to That if the as come into of way

beginning our standpoint, kind into that there's of starting of well the from as XXXX. into thinking into calculate fourth So opportunity, that the quarter as we but

Ernesto Rodriguez-Dumont

the you on programs there that and -- any read-through that vaccine even that -- to other program, that? from you were from or that learnings any you forward? are those then And the is pipeline any going data learnings vaccine results maybe use helpful. indication Any can contemplating. that vaccine That's perhaps Any the Tdap potential

Ryan Spencer

to mean, well, -- negative I I read-through there's from program think other. one the No. no

and different, the will how be that XXXX to every learning is is building it I product and how you're different. -- think every disease every is, program, going antigen, the and support

no that out I -- would of that to information. we So consistent no, there's would look read-through get

find to ways important thing in around is have try pipeline to make actually our have confidence we to will the and R&D competitive accountable how with you hold information to can readouts will success. decisions can and -- and a overall be of products focus be decision us make clinical extrapolate allow then the building a that the product's to ourselves that meaningful investments I that our think in that we high so manage

antigens the is performed wouldn't no, for specific But XXXX this target. any from So XXXX against I that's just This these I suggest probably there's read-through specific bigger think how with Ernie. this, here. learning

Operator

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

Kyuwon Choi

regard pipeline is, question with Rob a dosing reasonably non-inferiority had within the with question possibility here events there about Shingrix on of doses with higher And more you X the that's single-dose I XXXX. rate if think multiple doses. to margin immunogenicity maybe versus relative to adverse a is for even the do intervals the candidate wider how somewhat of

Ryan Spencer

Rob. Go ahead,

Robert Janssen

is going challenging. dose, A I think, be single to Yes.

I to think higher with of reactogenicity, tolerated challenging than even the to that it's CpG and still XXXX, dose reactogenicity it's better reactogenicity fine Shingrix Shingrix. better even with going XXXX, dose seeing for we're lower with than higher everybody. be our of respect than With still

think going I we're certainly looking. be to

going one of there's As the But It It certainly things did with be -- dose for Shingrix study, in vaccines, are more Shingrix. was they the looking wider were we it of dose a at we but improve same. than and for to we very seem Z-XXXX opportunity. second of for dose one interval, improved the the in at XXXX Shingrix, one the look compared which dose if to see more for well us. the to both previous potential

at dose. So going not see look we're I'm sure we're one to to one dose going success.

Ryan Spencer

or vaccines programs, some reactogenic we perspective, ours. sense? think most of to had product be vaccine. is higher I understood your And reactogenic most our make from Because question, I but or you it think we've if say, dose one that is generate would I And worth were Shingrix to like reactogenicity, -- asking, in with probably seen immunogenicity the would not Paul, off have trade even sounded if that a the would could it other one efficacy

is profile that to anything be likely a think reactogenicity not that more I has very targets successful. So

Operator

question line from next Buchanan with of The Citizens. comes Roy the

Roy Buchanan

the optimization expect Anything you I a that? back Do the from that the see you a dose plague you slides. lower the of program hear do you're look DoD. expect submitted had can DoD at and few in still lower? the you about on higher, when on I plan doses to and doses? durability that going to greater to say number And

Ryan Spencer

Roy, question. the thanks for

and what commenting the DoD do until the look have hold best trial trial heard off alignment would for back have the on we regarding specifics is from to think clinical thing I contract us on like. actually the next on

from DoD year, the year. possibly in we next term, to do back it's hear again, the expect to of near But them. So this early up kind

we're able happy be this able So we contract, to were that with submit respond. to more the information updated continue them provide you relationship they we'll when and and

Roy Buchanan

updates Okay. Perfect. might long do label need any how HEPLISAV, sBLA Rob, have compile on sense of the dialysis data? to think, I provide for And future the for you the discussions. said then you I guess that And

So waiting this think you are additional discussions what ongoing, you feedback? need do you point? to know you're Or at do

Ryan Spencer

Yes. the in part of that. add engaged I'll them response. we've Rob, their But process take with you on. can as

provide so to line line anything their not update a that. is like waiting no term. response. -- for PDUFA near And not them there's there's they in the an have are to time And we defined that, time once then This or

more far as this flexible So little a dialogue how the is go. will as bit

So any comments? Rob, you want do to additional provide

Robert Janssen

Yes.

to is as they have go the go to steps. the -- said, database if is we first evidence through Ryan decide for one to And proposing we're a have through So have they fit real-world study. purpose. And

term. we're the really near the going in step engage to that's them with So

of PDUFA, to will the the is we'll lines our get time able are Roy, to FDA's think I time still we're take mid-May guided our amount understanding not long optimistic by year. the though resubmission analysis term, it be do on time next by even of in

Operator

the this turn We have would no questions at remarks. time. now call to Spencer, further over I Ryan like for to closing CEO,

begin. may You

Ryan Spencer

may We operator, Dynavax. on joining against world accomplishments today. on appreciate and our We're end in about infectious updating position. recent excited you, Thank you Operator, to the look our you your you diseases. the all call. for protecting of and We progress us focused thank the our forward strength interest

Operator

thank call. joining concludes for Ladies today. us and conference today's you gentlemen, This

You may now disconnect.

Dynavax Technologies (DVAX) 7 Nov 242024 Q3 Earnings call transcript