Dynavax Technologies (DVAX) 20 Feb 252024 Q4 Earnings call transcript

Company Profile

Participants

Paul Cox	executive
Ryan Spencer	executive
Donn Casale	executive
Robert Janssen	executive
Kelly MacDonald	executive
Matthew Phipps	analyst
Roy Buchanan	analyst
Jonathan Miller	analyst
Philip Nadeau	analyst
Edward White	analyst

Call transcript

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Operator

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

As a reminder, this call is being recorded. [Operator Instructions]

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

presentation Earlier from Donn press and Casale, me Officer; fourth Kelly Financial quarter slide Dynavax for year a financial Janssen, XXXX. are Officer; Executive and Copies Officer. on Chief Dynavax's our December Chief and Spencer, MacDonald, Dynavax Chief the release available website. are Medical released results Ryan Chief Joining today, ended Commercial XX, full Rob Officer; the of supplementary

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

statements are These press Form in uncertainties, risks our in and results our including Factors annual SEC XX-K. release Risk in section summarized details the today's These materially. filings, involve may differ on actual today's and risks and report

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

and will discussion information. include release of call press this non-GAAP earnings Our certain

non-GAAP including on at of release, You Investors press corporate relevant reconciliations dynavax.com. can our find earnings website our the section

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

Ryan Spencer

we capital through delivered achieving our including product strategic all profitability for and revenue, programs joining advancing Paul, our plan. this achieving and annual you In quarter priorities, us Thanks, our repurchase shareholders returning and XXXX, HEPLISAV-B afternoon. share to across pipeline record fourth thank

success which for stronger XXXX, This expect a be year even in we Dynavax. banner to up for performance sets

expanding adult by continued U.S. expected to to in market million, hepatitis expect the the we drive share $XXX million B with along top HEPLISAV-B. $XXX gains sales fueled product growth between vaccine by HEPLISAV-B, line with For net market

to XXXX milestones development expect new the multiple for also a important throughout programs to year. programs emerging be year and transformational with We pipeline advancing

program shingles a best-in-class multibillion-dollar a in shingles markets, and a significant ex single and see by clinical a both our we and program, which for is Our differentiated the is dominated vaccine opportunity annual advanced U.S. most product. U.S. market currently

compared product. profile standard to It We for market. efficacy a be vaccine and similar and will know required competitive of to the successful disruptive existing in to require the improved tolerability care the significantly this

executing are program. profile development establish to a product plan We on this for Z-XXXX our

As vaccine a reminder, while rates saw moderate study, T dose-ranging cell comparable demonstrating we've high response we postinjection and severe, local reactions. rates to meaningfully prosthetic a completed where a of CDX I Phase response and to shingles, lower already

ongoing Phase in we will For X-month to third I/II on dose the study. our report vaccine top data quarter, which expect be the last our study, following in line the readout based

Phase II and dose select our study patients years regimen We concept extension expect to old, establish along this of this to taken studies. proof XX the with for in over and further program to study

We partners strategic global our potential a regulators Phase expect data of III with this support dialogue ahead and launch. will

about for expect few Defense. of our program, partnered to a in will minutes. clinical Department our clinical Rob also next begin is our with U.S. trial We more the Plague which pipeline Vaccine speak

and line of are while of the helped people core protect continued HEPLISAV-B we discipline. building operational proud by Dynavax as company, driven millions have world, the revenue assets CpG company are We a of which around XXXX, and our establishing top leading together growth around vaccine

also has allocation strategy. of part as balanced our position financial Our strong us capital shareholders return to capital enabled to

This shareholders. opportunities on our to external for updates way. to ahead our We exciting with important for you pursue Dynavax, progress and also continue the forward I an will providing and sustainable value look will along to be generate year long-term

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

Donn Casale

ability you, market profile. leader HEPLISAV-B U.S. to the are and market. Ryan. we launch B has adult strong in its commercial in our XXXX, vaccine At XXXX, to proud effectively in disrupted position rapid Since to by is increased share differentiated established due a legacy products. against HEPLISAV-B's demonstrate to hepatitis end Thank have few This execution, be Dynavax, the the believe XX% a we we the what short of Through best-in-class leader. advancement the as this market market years total securing our compete

adult for vaccines the dose to has one in XX% vaccine The addressable with transformed the market U.S. creating of market, Universal guidelines adopt the growth ACIP expanded largest The B these nearly in year-over-year by hepatitis B increasing overall vaccine populations XXXX. recommendation hepatitis patient continues

results networks year. HEPLISAV-B's prior this strong fourth of has the of reflect HEPLISAV-B the compared growth million for $XXX resulted delivery is retail X or quarter for in of performance $XX net and These IDN. key The in pharmacy supported full year expanding to market significant record revenues million integrated by growth XXXX. and segments:

prioritize critical marketing We sales areas. and continue to our efforts these in

flat share they these HEPLISAV-B segments, together, essentially market in growth year-over-year drove dose. XX% annual in Although an was impressive

look beyond. continuing XXXX We in forward encouraged by ongoing and of are our the to adoption and HEPLISAV-B momentum

increasing opportunity future, developments in to the vaccination and B the the to the our our on that These on market long-term look are excited and market we market for share guidance hepatitis are are strengthen XXXX by in outlook reflected further improving focus and U.S. access HEPLISAV-B. we As developments

B pharmacies and pneumococcal containing vaccine which B., vaccines starting January Part billing was that share only the approach roster population. B Medicare Medicare hepatitis this retail setting, for in it patients Medicare under the among majority for First, patients in influenza retail mirrors to vaccines. year, Twinrix Until now, of giving market reimbursed the through access gained at hepatitis

growth and and about market retail strength HEPLISAV-B's retail, how share of commercial equal this are in could with access policy XXXX. Now Medicare leveraging support we new our excited

in the adult measure. XXXX, performance beginning Second, operations IDNs HEDIS and U.S. will set information these perform care included and indicators align in effectiveness data used care or and health most well set largest is be the measures. to in their of hepatitis HEDIS on vaccination health B typically quality widely

we hepatitis We as adult also with the vaccination of other high this signals IDNs volume aligns change regimen. while serious HEPLISAV-B's is as focuses utilization a believe which and on vaccines. alongside X-dose growing B to measure share focus placing HEDIS inclusion in well measure large completion, its priority, clinics, The and increasing believe market likely enhance

retail combined in for confidence give segments These dynamics with positive and our the commercial market IDN execution revenue us opportunity in HEPLISAV-B. and performance strong long-term

of HEPLISAV-B market which million $XXX expanded growth XXXX. the by $XX million by opportunity, in approximately encouraged the are We to

This $XXX U.S., annual progress HEPLISAV-B HEPLISAV-B market tracks by to opportunity product expect in of to least XXXX. with our over net in our at capturing expectation the XX% we with reflects share. double-digit XXXX sales peak million through market This growth long-term guidance outlook for long-term which

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

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

expect B the market position a clear market. to hepatitis vaccine as We further its expanding leader in HEPLISAV-B solidify

we're our building We the and team's about commercial are proud success of momentum the today future. incredibly and into excited

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

Robert Janssen

Thank you, Z-XXXX. with shingles I'll begin Donn. our program, vaccine

Shingrix evaluate results Z-XXXX trial designed participants. the to our our investigational clinical previously Phase reported As Ryan from vaccine, shingles compared we to XXX in mentioned, I

month different response the into studied cell and including We similar dose XXXX following vaccine future to adjuvant CpG Z-XXXX, X high the antibody we were regimens CpG and CpG rates second CDX to adjuvant in of Shingrix. low a studies. dose high dose XXXX take groups of T high the of adjuvant selected dose, and vaccine XXXX positive

in with to for cell was Shingrix. XX% antibody vaccine T also X quality CDX of and CDX T positive XX% subjects the vaccine Shingrix cells the The positive XX% Z-XXXX group. activated rates express to XX% In groups and compared similar Z-XXXX the gE in XX% specific groups, the XXX% activation markers in high-dose XXX% Z-XXXX response to the CDX the with compared proportion in were Group. that X cells rate XX% to Shingrix T groups. or groups positive Z-XXXX Shingrix of the was XX% The between was

without for of moderate for was severe compared safety solicited and and local reactions tolerability favorable Shingrix Shingrix. X% rate observed XX% showed Z-XXXX concerns. Z-XXXX The postinjection to

severe While moderate were systemic Shingrix. and postinjection reactions for and Z-XXXX XX% XX% for

month is to the evaluating after XXX safety at trial dose designed and and third take antigen into to select results I/II Immunogenicity Phase to and X ongoing quarter. studies, second are in the the dose XX XX years. regimen adults The we're future expected aged

we seek there's reactivation T varicella-zoster. only for correlative the demonstrate accepted T be cell CDX factor the a With an positive no that are preventing a to is that descriptive cells similar antibody demonstrating distribution similar CDX In trial. findings and this in Shingrix, study, III T vaccines, shingles frequency of understanding important a cell responses not be observed, but thought us also and of in positive to demonstrating important if a Phase to responses would will responses, high to of this T constellation suggest of probability comparable quality efficacy cell similar durable protection

adults Phase Following advance extension evaluating from the the while follow-up we into XX-year-old XX study groups. a years data age select the to to a to of await XX- X-month data, older, II X-month and dose we regimen expect

XXXX $XX trial agreement recently Plague additional support to clinical Department third Dynavax approximately clinical initiate manufacturing of We the XXXX. of Vaccine of Defense program, the million the activities. Regarding new and plan in II half through Phase the a executed to quarter first a and for

program dosing goal pneumonic Phase ranging is the the rapid antibody the our Given is biological II XXXX regimen. and to adjuvant CpG the in in optimizing the focused dose of through spread response preventing a a maximize of that attack, on plague study

program hemodialysis. file. our reported X-dose We complete to previously on Now on that's HEPLISAV-B our a the sBLA turning a adults issued regimen FDA response to letter for for that develop vaccine

of We FDA this an study in forward continue updates with the resubmitting observational on providing data to cohort work filing sBLA goal from year. retrospective to future to look a program. We incorporate this with

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

Kelly MacDonald

you, Thank Rob.

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

Financial reflecting total growth include year, million year-over-year the net up for highlights sales the $XXX year-over-year, addressable and HEPLISAV-B record full for the million fourth year opportunity. quarter, in and a XX% XX% full quarter fourth impressive the market up $XX for the of

we margin an guidance achieving margin was Additionally, And XXXX. looking of forward, gross for around XXXX, XXXX in in XX% to XX% XX% increase XXXX. the gross approximately full at XX% for compared HEPLISAV-B to HEPLISAV-B and continue expect our year

expenses up R&D XX% million in year-over-year. for million XX% $XX quarter, year $XX were full expenses. the the and to up Turning year-over-year XXXX, fourth

compared percent Looking continue R&D milestones teens we expenses stage pipeline through to forward clinical increase to for progress XXXX. our R&D we XXXX, expenses, expect by to key as in high

for they expenses million year-over-year, were SG&A million is up XX% for $XXX the and flat quarter, were XXXX, $XX which the year-over-year. year fourth full

flat expenses forward Looking for our HEPLISAV-B roughly we we the represents expenses, to opportunity. drive maximize these this to SG&A of the as and believe growth in XXXX appropriate overall business expect the resourcing current be

We for net previously our including Moving net stated in $XX to $X of line. achieved bottom fourth guidance million, of profitability income quarter year with the the full million. income

of a on intend EBITDA, XXXX. measure Lastly, non-GAAP for that the we compensation noncash report introducing excluding to stock-based P&L., we on are adjusted

a issued adjusted an million $XX non-GAAP to over over earlier Please up the was prior for the of year. disclosure. XXX% accompanying for see $XX and XXXX, Non-GAAP excluding release compared compensation, of and fourth year million results today increase stock-based EBITDA, GAAP full to XXX% our for year-over-year reconciliation press quarter,

sheet. cash deployment exited of was earlier end our the share securities We position with of this the to our million and equivalents repurchase decrease cash which million program, first the marketable finalized of $XXX balance year the in XXXX. month. compared $XXX towards to million The includes at Transitioning $XXX accelerated

reminder, million announcement. of XX% and a the our of just XXXX, in share approximated approximately which time $XXX our the November authorization buybacks, we As net market of cap of in under to XX% announced at up cash

authorized complete repurchases share XXXX. $XXX end of to expect the of the million by We remaining

growth, of full capital sales year. and performance We profitability, by HEPLISAV-B financial achieved robust capital and shareholders net further strategy. fourth full us while to all our and our long-term We enabling of position allocation to including balanced returning our financial are as the year guidance strengthening goals, our part drive in quarter encouraged

full for guidance financial our XXXX. to year Turning

of expect range HEPLISAV-B $XXX be growth revenue which $XXX product year-over-year We midpoint. the million, XX% the to million net represents in to at

XXXX. deliver excluding our priorities EBITDA, revenue, adjusted be rate on at expect ability demonstrating to to least more strategic in our than also strengthening grow We stock-based million, to EBITDA adjusted further Xx ability compensation at of $XX our the product

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

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

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

Operator

of [Operator Instructions] the question line Our from Matt first comes Phipps from William or Blair. comment

Matthew Phipps

you of now continued is between XXXX? to guys accounts? But I Is and growth? the try into of market XXXX drive guidance. to is have have of to something just fast year-over-year continue adopters, at and accounts and drive you overcome? kind growth Curious, go share more that find as entrants the it other Or think barriers is market kind to you've in need the into know gains gotten what get kind share. you do kind market I you there XXXX looking of given share these help and So what to to else just the

Ryan Spencer

Matt, you Donn, thanks I that and X market to is why that has up one. retail. one the to take question. key segments for we our IDN don't between thing want broken highlight But recognize

comment bit be both little helpful. a would on probably So

Donn Casale

has events Yes, about the support in it to going retail we patient market is having to And completion, growth the so access again, alluded market gains serious favor be completion. important. critical I in that When able Medicare its market on is the in X to continue also which retail there's HEPLISAV focus X-dose HEDIS help obviously great to share, incredibly got share question. to call, continued in are think measure, population to which going on a in is the then major that

market X share are support those So gains. events will to that continue

to then And to share. a customers working with various continue the continuation and drive market outlets it's to

those share. that confident very segments high XXXX. overall and are disproportionate critical both And in share grow with continue and guiding in share will again, share to what we're obviously we will have the the marketplace the pick up grow in growth maintain those So segments. the we by X as market total are It to line

Matthew Phipps

shingles on a to what over kind going mentioned need noninferiority this you the little that the think but program, I And just show? again is of maybe bit, level you think of again, or said T you've like is cells? rate. XX% Shingrix. that at that it greater positive on or X response looking And of Or signal before, kind just CDX X activation you

Ryan Spencer

Yes.

handle to or note in Rob antigen. as that's Matt. [indiscernible] adjuvant with But test XXXX important of let that trials running adjuvant varying trials, the I'll to what's details So trial I as as here, is without the our we're an is the dose-finding think and the designed now CpG current well doses we the selected

going there's noted that we're these for evaluate, clear I T markers. generically, objective the And of powered cell it's simple CDX sure so a of measure data frequencies to comments, of is alone. of as a number just that the to constellation designed or want trial in have not statistical analysis not various make immunogenetic markers Rob's you prior to And in

can some you prior information expectation of Rob, maybe for -- around CDX? on prior the the given level you've comment of

Robert Janssen

is Yes. for quantity The XX% some quantity at as change. about XX% Full any T the change well for of really cell baseline. correct full helps as extent to differences median

probability the gives sense at that. really looking we're that itself of of a good us forward. going And in So success

with quality I of we important, Phase said, study to responses, T Shingrix, X is to the Ryan our seen and so that's quality what's be similar have markers it. as cells X very before too. with going of or our think XXXX, we activation CDX in we where is still COVID this But we've And saw think partners cell also our important T

What did at as Durability responses, like of months T but what X cell responses responses also month, look T cell so like? antibody well. X do look at

like. setting So whole we'll would get we this be can efficacy what Phase look in constellation best of forward III at the sense going looking the to

Matthew Phipps

last Rob II. When one And I, we Shingrix at Okay. the both label safety, your again. and previous Phase the Phase from also the maybe look Curevo question for

of or of for methods Just differences wondering some definitions collection there's kind any in if these.

sets? what wondering of be looking comparing we to Just across data those some should

Robert Janssen

We don't access instruments. their data collection to have really

fill However, Those every standard these They're pretty trials. included subjects ones aren't not things uniformly e-diaries much FDA does that swelling that events that, fever, in way. They're pain, site same trial, FDA in but does in low out the collected injection standard. fatigue the fever. same on and always insist and always are pretty across main the during like like for

they're be this So to of data. these -- powered in at not also but looking studies, early kind understand certainly

vaccines great in looks on data as like for COVID with as well have from tolerability HEPLISAV XXXX. combination what the We elements

Operator

Our or from Buchanan from comment Citizens. line comes the next question Roy of

Roy Buchanan

on from of XQ. going a I guess just confidence the in second able Shingrix gives to guess, data couple coming do the I longer Phase durability, And XXXX terms in dose up post durability. the follow-up from I reported durability? the that How you on much be and you're have in results you following data you any, tell that to X-month in

Ryan Spencer

Roy, of and in the Phase Rob Phase adjuvant. the clean we was I'll ranging initial it sort from XX-month don't this at I particular, I X-month prior designed long-term have up. comment, But and We on look data dose that the follow-up have data.

initial the month at response, second dose. look will we so And X post

profile. that population with importantly, to comments another in forward read don't advance that that we the along strength I of from initial data product us provide study program, my the into extension there an will out able will XX sense [indiscernible] heard XX-plus we the study X-month -- from of and as the be the we're you durability moving readout. think to But in determine

Robert Janssen

Yes.

as from durability, data our terms use COVID vaccines well HEPLISAV So that XXXX as seen and partners of XXXX for we've certainly I alum. with in from durability think

As the [indiscernible] higher we antibody but differential vaccines that's or peak, CDX particularly for looked Ryan antibodies in cells, first the data, the not And is at longer only there both higher cells, be X in better, mantra can T and said, month but X T the at always the true. CDX the months.

So be period similarities or up able I that of changes to we'll pick time. during any think

Roy Buchanan

But extension you logic are study a adults, elaborate what's that a I older that? just Is little And know did Can they this of is that's Okay. the trial maybe in just then on Shingrix the request? the differentiate? regulatory you for reason. and a -- population Perfect. the looking bit. to in

Robert Janssen

Yes.

it's in is immunogenicity highest be looks So really with age younger things. increasing group. One certainly X group to to similar increases for risk older that age is And this age. the shingles the

age So group. and because go a in safety enrolled work safety to but It's get are in on also population age with years study the And then really can't want group. place critical well collecting data to Phase age you this is III it's data Phase III they older a into this we on going be very no XX a study. the that, group

Roy Buchanan

for buybacks. then the And last Great. me, Okay. on maybe just one

accelerated on you $XXX are the million. -- concluded guys your end see get end obviously, about the the bit XXXX? of midyear if earlier know million. I to the $XXX than million by thinking potentially -- $XXX of you the How buybacks you additional appetite and extra first year. maybe guys what's But You the you're more for rest guiding the and of to

Kelly MacDonald

tool are their Thanks has question. great we all a return to to It shareholders definitely opportunity Roy. is that outperform to out. capital IRR I the buybacks for investments. Thanks, agree when the the mean

primary importantly value objective shareholders. for all I to think our us, drive for very long-term

end for shingles opportunity clinical foremost, year HEPLISAV. have our the progress the stage including the maximize real opportunities we to of drive and and through pipeline, First looking to Also, in set. integrated opportunities to continue leverage organization significant for that fit in fully bring for our assets to has capability skill look that to nicely other could bear our to potentially with

or we that about, serious we're add extent additional committed the through whether sense very which remainder the makes not authorized of have to to, the will get and buybacks. we we To consider absolutely it program,

with the are As still we current you actively ongoing program. mentioned,

to at the this but of certainly program, time, it us second point something it get of expand the we to towards sense extend in for and more -- doesn't the opportunities So learn year. on the half list is make as

Operator

from comes Our ISI. Evercore next of the Miller line question comment or from Jonathan

Jonathan Miller

internal been But guess Congrats all on on it I strategy at building slide, more doing pressure you'd that seems question, investor your capital. to an like rather capital both external. happy and the progress. there's return looking be last allocation obviously, development,

that of in those do point? confidence areas confident relatedly, how And given sort you able good what's time point frame, that long BD a you've looking perspective? BD target a you been are at are this then from giving But in to achieve deals goals reasonable your at this you'll be how to there

Ryan Spencer

that take I'll Jon, Yes, one.

we in we continue important evaluate not that static it's not an stand it's obviously, -- landscape. I So to to It's it's ever-changing recognize think which landscape the just still.

certain So the we've for we been we a recognize very at profile. recognize want We set ideas. active a this. those. risk have in leverage bar high and very certain company to We've We capabilities, looking has

So we for year. and that there evolve are targets developments over our additional of to the efforts believe continue to that course the reasonable will us through there's consider do

And can't there fit complex. I think for we really so confidence transactions beyond high. that Dynavax our is comment pretty us And this that is that, high-value are because

the we we're ability we progress to how comment forward against in And a to have we objectives. we're fact it, beyond our not execute to look to so that clear strategy, seeing confident those going able and

Jonathan Miller

HBV of differentiation would All to that of an gains on to market share stronger see had the then you're share? of differentiation ask safety sort you a efficacy. durability since as commercially like drive and maybe couple right. dominant hoping view I'll questions and extent, market what what shingles do But Maybe on just for a level we've relevant of level

Ryan Spencer

with operate progress right data, product going and sure assumptions. we more traditional to make market and research reliable -- we're as have to with profiles robust we the we'll have the Well, test to

kind Phase we of differences I meaningful. the are prior our in think saw I

whether I the is hep important critical, and prowess product point tool, execution a commercial important. ability And it's the are customers It's shingles. is not engage think commercial if or equally and to profile is here -- B your -- with an but

we be our have allows that way to So is profile customers us safety address something our able leverages engagement. believe improved us with customer critical a strength that an to to for in

The specific now, I'm reason in not we and the on would levels, I, comment prior advance we of significant, suggest able part to I the saw Phase would continuing our the we levels to right are we're Phase -- that say are confident in program.

Jonathan Miller

B tail Makes 'XX, maybe as share you've thinking sense. in just On identified to areas obviously grow that -- your and next post competitors How look you're weight hep market share opportunities hear. to products great your that opportunity we long-term is couple share and about commercial going about that market can-do to to durable portfolios beyond, do XXXX current finally, tail? a then as contracting? have long market talking of are we be start that how to which But is and how of durable discounting the high bundling and

Donn Casale

it's Jon, Donn.

goes the It partnership. think around it's goes durable. It contract. very I beyond

HEPLISAV-B, within So several hep years. and X. over goal. and specifically vaccine, shared these to we've We're with been we've a day the working expand there utilization with from their example, with with partners retail, established B They're looking for last engagements partnerships ourselves extensively

we so them enable to And success. have

so And moving forward. to going that's obviously, continue,

about that. good very So we feel

don't and retail long patients lot to engage that those where on, the around out go call of tail there's as a well. customers to then And we

capture So the channel clinics originate originating we patients we're sole the the in feel that to retail like that small are in practitioner, going to U.S.

can we're well next as the as and with size why -- and segment maintain be positioned grow that this believe So that's our retail, strategy partners. years, share the within substantially we grow well over will segment several within and retail market

Ryan Spencer

Yes.

effort think the picture maintain all to us to reasons, Donn laid require that marketplace. add is on be will but the will for an out a here the just have the this durable product important to it in I full

to a not is we situation to this market not that the should don't we So share, cultivate and situation used continuously. establish be have that and market where

was SG&A. we So flattening Kelly around about expectations think I of -- clear

expect And so have effort commercial a But we the should brand. maintain this do you believe we to that strength sized. of right to we're maintain

Operator

question line or the of Nadeau TD next from comes Phil Our comment from Cowen.

Philip Nadeau

progress. couple back of then program. the A shingles commercial on Congrats the one on

So can like? seasonality you HEPLISAV in does less. on commercial, seasonality like in XXXX? does business, you're this discuss was now seeing winter the beginning maybe QX, of What in the seem look a there XXXX terms what It bit in of but

Donn Casale

Phil, in QX, it as the X the, we seasonality say, thanks season care question. for traditional Yes, where the would to health holiday I yes, utilization. less saw the relates weeks there's

typical, what that's we that was So and in QX. saw

focusing particular. last to QX and this on QX, stronger are faster QX than that start much vaccines around in nonrespiratory customers sooner We've retail Specifically year. to excited start the we're a and relative is off year, noticed last very about year the thus within far

a supports QX. that what seeing in what of far very with our we're here there guide and excited And about put range out so today seeing lot really we're seen we've and thus the we're momentum, in we

Philip Nadeau

it. Got

year, case the like last from Or this decrease another so Is QX to be year. sequential there is not be QX. suggesting you're And may sequential It sounds still that decline? was fair? likely there to that

Donn Casale

it different year. think than be will last I

year QX given start. it you won't from saw the think as be to QX, profound, I last fast as

very and that and is out. how, progressing years faster QX before, So see in we'll past. to obviously, the I is But strong have read quarter much than like again, said early wait plays

Philip Nadeau

And HEPLISAV terms what's and exactly detail, think the on I Got can reimbursement, more changed what in that could that Medicare have guess, it. impact in a of do channel? you go into bit you share

Donn Casale

Yes.

Part So Medicare. basically, under hepatitis B in vaccines B were

Part And so could Part D [indiscernible]. only and not pharmacists B., reimburse under

pneumococcal hepatitis under and what is billing. been happened vaccines Part so roster has flu under similar And to B has B recognized

that retail pharmacies so vaccine the setting. the And to at allows reimburse

And so the Twinrix, vaccine, vaccine. Medicare a it was only it B for Part basically before, hep whereas opens D was up patient which population

X/X of about retail because Medicare the is big And that. so setting, a piece pharmacy cohorts the XX-plus market. important it's And obviously, within of the

access potentially, from be to it's allowed equal on perspective. HEPLISAV-B footing an So

So in gains, we and growth said market only HEPLISAV-B as for that 'XX not I share absolutely believe here beyond. but we'll, also before, market support

Philip Nadeau

Great. That's follow really helpful. Matt's sort And program, on the to then a last on it's of question. shingles

kind the CDX I responses then elements responses antibody there's X those important? responses. looking are which more mean different of at. but Can You make some data, be you're aggregate T X also decide going like give it to no-go decision? important, are going positive Like the you or of go it and of there the how least are the of all of sense mentioned durability us of at and to seems the is the you to a integrate a cells, hierarchy

Ryan Spencer

Yes.

give So answer. high-level the you I'll

We that haven't CDX about fact important. we shy critically believe been are the

that so hasn't And changed.

think overall reality to is considered be the immunogenicity, element there of that it's is I the constellation when of an no assessing information correlate. has

of this development. So the one challenges is vaccine of

in to critically to set believe position CDXs, a are You're where efficacy. you we have the And approximate important. immunogenicity

be immune elements of the responses have all considered. However, to the

Rob, anything add? to

Robert Janssen

No.

you it I well, think pretty said Ryan.

antibodies antibodies get to it, risk a to Quality at people shingles. play seemed T critical. lack who they of also matter, for think severe it's I People When the and too. most matters highest disease, be cells but CDX role. the CDXs seem are

important we else. be little but all probably will be, more let's of them, So itself will were say, everything response a in than looking at CDX

Operator

Paul the comes Choi question Goldman from next from Sachs. of Our line comment or

Unknown Analyst

This in for couple quick I is guess from a ones of Paul. me. like [indiscernible] calling

with the guidance, the last brought season respiratory on your vaccine this fewer and know but to the year. on given this vaccines. with someone up worse I year last Just being And year, opportunities flu than pressure already,

a -- start stronger strong year. to a there's QX that been said this You

And that that's driving Was -- how it year? And was more is was guidance? baked what there were there's stronger it -- last cases access seems much than Because just is driving last like wondering it of your cases I into that? more that start are year? than then like

teens in OpEx. I you just know And XXXX. on then secondly, high the mentioned growth

right now? right it of up Just wondering the ramp we from timing Or happening that second how kind things half to think perspective of year? a that towards is the about --

Ryan Spencer

that take part first the of me Let question.

season, it, a of we flu second be bit flu going flu that's the peak is the if have protocol. little the So extended vaccination to outside the season

initiatives. the of pretty really We're really retail focused earlier nonrespiratory still So we're vaccine commentary little get limited start the bit pharmacies commentary was here. On to year. highlighting relatively That's the a about fast pivot the on going is. pharmacy The the quarter. QX where saw season in we're last the retail the flu because late we're than internally middle seeing to guidance. And making we nonrespiratory we're makes into

we yes, bit start is for to recognize that's detail too guidance subtle season while, year this share. faster the -- the in flu the And in of continued growth at overall, It's us of a specifically point. the our But and retail this supportive extended. year so HEPLISAV-B a through is work market

want Kelly, do you to the handle OpEx?

Kelly MacDonald

Sure.

I as So year, is think, the we this specifically sort development -- the that in this increase and the high be by and steam things ahead. clinics of are activity-based, really expenses to on expenses, X you Yes, research expectation this on teens noted. was by going is percent, there driven R&D honest, to guide full expect

DoD year. II late contract One, kicked off the last plague That program. Phase

we'll full contract year XXXX. a $XX from -- expenses expect of through we'll of prior a and go disclosures, a will there. So half full just the first Again, reminder is year that have million

efforts through shingles to secondly, And then expect have to the I/II expenses first Phase study. X we for our support quarters ongoing

Operator

Ed line or next comment the Wainwright. from H.C. White of Our question comes from

Edward White

back going just to shingles. So

Assuming the positive. are X-month X-month data and Phase I -- the

Phase expectations as Can that study? for for far Let's your timing as that and just focus just global goes study. study size us give on you III maybe the

Ryan Spencer

optimize we do We different that with the that with to meet Phase saw from options the and to plan. work data, considering as want that on BD to couple to data evaluate see to this the receive as current need regulators. overall on Obviously, our partnering study, Ed. that how we and develop a we run plan. some efforts and I/II of all There's we're our Thanks, well regulators the

little premature too provide for us many on study. a So details to it's that

comment But I to can trial far drive placebo-controlled for -- study. to what the development we're time of prepared shingles don't a -- as line. that there it is that or we think point reference you plan takes specifically a not have you reference, as on Shingrix design

Edward White

Okay. And plague on program. the just

your the are vaccine globally? Wanted about there's no approved of how also the perhaps for get on the U.S. in know, all size -- we stockpiling in thinking what As thoughts to here you potential U.S. market the and

Ryan Spencer

government. assess very or for the processes Yes. it specific There's measures government biological is on the to by countermeasures. for threat The threats how depends is reality the assessed

DoD And the the be threat opportunity And the our a seemed population. on is than funding with has would options. minimum the for work lower is that which DoD, we to a that assume now, the here, see so entire which was right concern the focused you much truth, a different arrangement or

too has for the has be an that us global on premature how that. frankly, would that think, frankly, understand impact It's And to I overall climate seen. also

optimized worst, now, unfolds profile. of for goal the product opportunity create to as kind the we So we'll see to the have is an then do progress how And further.

Operator

next follow-up a Mr. from or Citizens. is comment Our Buchanan from Roy question

Roy Buchanan

I I likely assuming But willingness Phase a actually guess to your in for most be of some pay they're here it's that IIIs future, it. the but extent? large shingles, what's bit to to the for got

Ryan Spencer

actually just Right. it's very to clear. very Thanks, That's Roy. sure helpful make

reduce a risk the for be provides advancing believe, financial overall We business strategy U.S. us value a a BD perspective will the Phase opportunity program, markets have leverage program, we on significant for for and very a III. focusing U.S. to markets. large stated from great shingles, for clear of driver for it ex the development Ex this quite which to

of our very think the it's also to interpretation We point opportunity. validate the and a data valuable

I/II of IIb/III to So an shareholders and the X-month, the Phase X-year-old Dynavax into X entering the leverage data or reduction we part IIb and risk months around as or Phase study. strategy plan Phase Dynavax, Phase for III support to data, BD ongoing

right and our capture think Dynavax we and right we profile have compete the believe if immunogenicity especially I willingness is well because compete both now, high, market of the positioned an the cost very So to there's partner, room significant is a the be of scenario risk III commercialize absorb trial. to BD share. best and Phase as well as to would for us have portion the U.S. ex to Ultimately,

Operator

in like turn questions the at queue Spencer over I'm to the Mr. showing I'd conference no for Ryan this back to additional time. any remarks. closing

Ryan Spencer

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

Operator, you may end the call.

Operator

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

disconnect. may You now

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