DVAX - Earnings call 3 2023 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to Dynavax Technologies Third Quarter 2023 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

Thank you all for participating in today's call.

Officer.Earlier Dynavax Commercial Spencer, Medical quarter Officer; Kelly Chief from Donn Executive Officer; ended today financial MacDonald, Chief released Casale, Rob Financial September me XX, are the Chief Ryan Officer; and results XXXX. Joining for Dynavax third today, Janssen, Chief financial and presentation clinical our forward-looking future I marketing including, uses related of data that advise market our beliefs, and capitalization, XXXX actual Copies including results slide and we potential timing press current trends, cash trial statements readouts Dynavax's differ to, at involve of and for will of and sizes, demands ACIP adjuvant.These growth market and release on and available the and making revenue, rates today submissions, FDA efforts, share starts you statements on current based recommendation website.Before expectations risks supplementary be materially. results limited each, and market the not guidance a are CpG we expected but our flow related future impact begin, or and potential profitability, effective and segmentation, may sufficiency uncertainties of and today's These in summarized today's Factors press filings, quarterly SEC in risks the Risk release section report on are XX-Q. our including detailed Form

speak now the call turn statements we undertake Ryan. statements.And will I no today forward-looking as Our and such over of that, obligation to with update to

Ryan Spencer

gains net hepatitis quarter revenue and market the prior and calls, significant Donn generate allocation evaluate to third on time turn market in will efforts in by for U.S., another growing million B hepatitis market for support to-date, us the to the updates establishing share This product next yet particular, be to of HEPLISAV-B expand this and over representing We're forward continue million of in on while at these driven you cash on the commercial vaccine our in continue of Thanks, our of a to more clinical opportunity and our to $XX both the quarterly year.Based to opportunity HEPLISAV-B XXXX. thank raising range of progress performance trials pharmacy growth the which quarter. full which we in product million diversify create of in to HEPLISAV-B adult we market commercial $XXX us was growth. B in market position We majority vaccine We revenue the over increase. integrated also call expectations provide share to which quarter value believe we've quarter up strategic product minutes.In the Paul. goal to adult few accelerate to again X portfolio look in tremendous XXXX, capital a to delivered market, key continue in year, is to This $XXX providing now quarter our financial are our retail pleased to record to we to net million on Good our in we XX% remain everyone, execution position of with future.I'll discussed We will addition, a strengthen enabled as the disciplined to to opportunities. XX% afternoon, Dynavax's gaining HEPLISAV-B now networks.As strong expect year-over-year cover and third into investments taking increasing advancing segments a to the XXXX.HEPLISAV-B performance as months stage by the join efforts the Rob to toward revenue $XXX leading the of in the we in year. review record $XXX results for revenue, the and as million, HEPLISAV-B HEPLISAV-B our end. committed details maximize delivery overall future this HEPLISAV-B opportunities by the first result report pipeline

Donn Casale

I'm catalyst reminder, product time. hepatitis for represents Thank about to believe another HEPLISAV-B. in We you, one details HEPLISAV-B opportunities quarter adults.As excited be a market share quarter. HEPLISAV-B market which market share ACIP for strong to vaccine achieving grow will estimate a and market achieved XXXX, market vaccination, now million record largest universal hepatitis the over sales to very recommendation U.S. B could the for The that the recommendation more Ryan. that in by we with vaccine majority growth a of grow share continues the net and $XXX for following B by this significant

We IDN segments, from continue IDNs.We to these see grow recommendation the its to anticipated total of Net IDN, approximately the in focus the will market continue share, the XX% of grew expansion vaccine approximately XX% end approximately third year. represent approximately third total and million both This sales market growth efforts estimating market the growth increased to ACS share the revenue XX% on universal B quarter, performance year-over-year segment B in the quarter to XX% the strong market HEPLISAV-B's year. and critical of the at pharmacy as X increase of driven market HEPLISAV-B product our HEPLISAV-B's we from during to quarter, retail to Universal.In XX% hepatitis hepatitis third or segments: delivery last end the by year-over-year. at retail networks to see marketing most the and last indicators XX% continues to XX% market continues to same pharmacy compared expect grew compared in the to the quarter. by total be XXXX.For in integrated sales quarter period achieving of $XX by

to their coming strong XX%, approximately made hepatitis significant compared the conversion large years.Year-over-year B in retail was vaccine of continued including the on the XX% vaccine increases HEPLISAV we third XX%. XX% their national the share in year. and adopting seeing Universal In quarter with ongoing to at B to third adult recommendation. expected approximately working retail quarter, expansion clinic customers have are that segment, the a chains majority vaccine the which HEPLISAV we purchases.In focused to segment of approximately the and B several hepatitis from adoption hepatitis health segment, the are driving growth through at hepatitis HEPLISAV-B's segment market large IDN growth the growth achieved large We year-over-year this in B important B with quarter, increasing last pull pharmacy level in market end Universal pharmacy progress systems C-suite third are B the vaccine. recommendation, is market drive making In preferred meaningful in significant segment, was the year-to-date, share this In

leaders to quarter, headquarters, end segment, top During regional of also the initiatives are the and completed the divisional, intended chain.We which in is on optimization expansions. retail sales chains quarter. reach see drive third national the launched call the impact excited the This of retail the at our our we promotional district will expanded force pharmacy force that market retail of our to across sales second expand marketing with top further collaborative to reach

tremendous market quarter reflects the force full for million. our to the million RC COVID to within annual expanding the B on chain, year segment summary, This becoming net over expanded the market outstanding had impact increases year-to-date strong years be market, our enable guidance results, We leadership top vaccine approximately still based growth reaffirming efforts customer expect in plus XX% due and strong share our the relationships and to are years and our the fourth in guidance $XXX be across market. seasonal the market Ryan flu.We important sales continue COVID and the and XXXX time.In that temporary market vaccine, several revenue the of over seasonality hepatitis collaborative retail to over forecasting this range updated third confident the raising noted, with growth to meaningful these strain will HEPLISAV-B believe quarter. in in we fourth product and We from will confidence while XX% in factoring new leader gain the limited momentum and we HEPLISAV-B extremely RC, our market flu vaccine continued hepatitis of reach B on the are total expected the come.As progress revaccination growth to customer-focused HEPLISAV-B to of remain strong bandwidth in $XXX in the long-term quarter, on vaccination next an

to take will We proud of establishing the pharmacy are through and progress in clinical the and call our and now majority momentum share encouraged the by team's market key retail IDN.I commercial Rob HEPLISAV-B, our for to turn over segments of a execution pipeline. you very

Robert Janssen

Donn. you, Thank

and pipeline, our XXXX diversified we're a that vaccines our in antigens. reminder, innovative As with development leverage CpG proven advancing adjuvant

of new to an on vaccine our the identify market-leading current preclinical an a the there's profile opportunity but leverage also is Currently, the We innovative opportunities our through challenging product. program, there adjuvant efforts market, shingles believe develop with leading and given blockbuster with continue vaccine collaborators.Starting tolerability we discovery multiple that to CpG improved to Z-XXXX. XXXX vaccine

application of of are strong we Z-XXXX our unique in Tdap-XXXX from to of profile as responses, program. XXXX.Turning FDA combined Phase clinical includes plan Recently, its profile, is of of next believe Phase a I/II CDX-positive placebo-controlled to adjuvant comparable feedback demonstrate is induce its Z-XXXX cell to the the first development FDA I to reactivation efficacy. and on from development on study.Based trial we CpG ability T develop believe program. submit XXXX We trial a support and to the they Type the One an pivotal support safety B that the preventing received vaccine plan this we to feedback advantages tolerability an Phase efficacy continued feedback, of we III virus.Results Z-XXXX to shingles meeting believe our the disaster initiation IND improved our with tolerability of which half critical the with opportunity the a the proposed supportive of this

Type and by study adjuvanted human study CpG that's pertussis feedback the to that in from plague of a in The a clinical subject doses dosing results August. recently plague nonhuman Tdap-XXXX Defense. all mid-XXXX.Moving of funded has program. from the primates. is by We the meeting and Phase feedback study, with contract of study time is U.S. vaccine DoD. conducting nonhuman was as advancement evaluated this a regulatory our candidate U.S. Together, with vaccine to pathways. been trial successfully to in that's We adjuvanted an the challenge completed executed We're Phase and This a pre-IND part primate booster a Department a into to X-dose pertussis investigational the vaccine XXXX. compared II development using active for diphtheria, Tdap. the protection waning complete. of previously limitations, both Earlier or intended and potential the challenge duration CpG So And this to in of X-dose response.We've clinical effectiveness. with completed believe including XXXX tolerability Defense our in X ThX-biased II primate I protection as Tdap study, support the an to XXXX up initiated to immunization safety tetanus, the a trial candidate and adults and Current top is of and alum-adjuvant evaluating in XXXX.Dynavax which now opportunity the adjuvant have I on mechanism we the nonhuman a fewer part line Phase challenge has recently speed against the CpG candidate's to FDA, of action proceeding and improve immunogenicity, in regimen support plague generate data X well anticipate there's from received modification year, Phase on vaccine Department adolescents study FDA immune vaccines we B candidate our collaboration

to HEPLISAV-B dialysis date to for progress with hepatitis addition May our which about and BLA regimen over in the approved, action across filed in us vaccine financial this these a to make U.S. vaccination which accepted a results. the next clinical also of in allow if the population, adults to trials supplemental in has HEPLISAV-B for In programs Kelly XXXX.Now would of programs, XXXX. coming and of of hemodialysis, ahead promote a development we've total market We year.I'll XX% X-dose PDUFA initiate FDA for the programs the now months on the turn forward Tdap our B look excited the these to we're both shingles to call to comprised continuing review

Kelly MacDonald

comparisons the review prior to guidance to information.Starting financial that Please third revenues our press Please the financial million, by release financial otherwise revenue $XX note share period, key on detailed versus unless excited quarter quarter. third HEPLISAV-B our grew the Form product revenue. third driven for I'm quarter by HEPLISAV-B year Total revenue strong full XXXX year, Compared Rob. you, all Thank and XX%. a report noted. results product I'll the last to of are million. of refer and updated year. XX-Q also net with for were for of the net then $XX

We year. in continue confidence to on the to full the continued full for excited of guidance year guidance million, of we trajectory key for revenue the prior for in market $XXX life consistent about the uptick million first our growth months net million HEPLISAV-B with be X are $XXX to HEPLISAV-B segments.Based for the $XXX year, our to strong compared reflecting $XXX raising the results HEPLISAV-B's growth to million

also on of development of vaccine with approximately our the the to year unit into and We share the improvements $X.XX per the allocate QX increase compared beyond of with representing compared margin the trend equivalents a to base to quarter, vaccine the lead manufacturing for the while we $X.XX million year million to GAAP believe clinical XX% in full to in commercial program designed the our in $X Defense. in core HEPLISAV-B approximately quarter the driven marketable expense continued and increase market our to for a drive for by been closing, drive year.We programs HEPLISAV-B per million continue net of and gross expenses increase the year the flow increase extremely margins of result or mid-XX%s funded prior to million and lower development between net by the with quarter cash have primarily market driven development product share collaborations. $X thoughtful well Department previous $XX advancement overall operating growth including market. financial including personnel million be to higher gross by the full compared related well our to the positioned be securities basic in financial year.HEPLISAV-B the basic selling, for driven majority the expectations, sheet. to forward business. pleased in vaccine accelerate last expect $XXX costs per current we about million.In study.Now the process guidance, XXXX a increase The finish and per $XX to sustainable investments and third by margin to average U.S. million of prior QX expenses growth balance revenue share of diluted to our are look share a expectations continue by period.The and expect administrative quarter compared with portfolio be to in between that expenses year-end nonhuman general to compared for $XXX as The XX% with to positive improvements.Other to is we margin of continued an $XX we expansion the build end capture ended or was we third presented business, and year year approximately profile progressing B R&D operating income our plague We as $XX administrative million turning in the of and recommendations. be million collaboration our $XX $XXX the revenue were million period, for by prior to free increased increase costs period. HEPLISAV-B to maximize $X.XX diluted primate strong adult the hepatitis our research at $XXX $XX to challenge prior development for and driven primarily These ACIP's our to our capital $XX million $XXX Based and for as which million GAAP to an to efforts income related was compensation XXXX. per million to are are and revenue XXXX and the $XX our refining cash results Selling, in our share advancement research was marketing preclinical opportunities revising to for million universal expenses balance and HEPLISAV-B cash, targeted and $XXX generated the general We between in profile, period.Moving and and compared continuing million how share guidance candidates, current of year with net $X.XX raising million, and plans, and

deliver and and excited for We for Q&A like Operator, your progress about forward look to to beyond.Thank today's we we on continuing of everyone, portion goals call. year are open to-date the now our would our to this attention today. you,

Operator

from the [Operator line Instructions] question Our Phipps William comes of Matthew Blair. first with

Matthew Phipps

great on next real I Donn, growth mentioned quarter said expect market you share XX% another the over -- annual you Congrats market XX% have to quick, gains. years. to and you several that the think great total

referring you're share market sure that? guys' make on to top to to you ability want of and market gain then total there Just

Donn Casale

would be, the total. years, for my around so we next XX% to entire year-over-year B the Yes, so were of comments couple expect hep market XX% growth around

Matthew Phipps

Yes.

shingles congrats on Phase the that a you plans, In of III. feedback, study the now confirming Okay. placebo-controlled got

that the are to is producing next step of still evaluate yourselves? So the multiple you doses antigen

Donn Casale

antigen. of for for I/II Yes, evaluate you to studies the doses Phase different the couple plan the thank of that's Matt, a question.

Matthew Phipps

really talked more a change for that Is lack as on due for But external And internal external development being priority. don't that. just a your lastly, year, more Tdap Ryan, or any little mention in excitement to of a about you attractive potential programs now shingles then of I business and the end see right. All maybe this opportunities? earlier

Ryan Spencer

mean, No, accelerate a it's priority. be mentioned priority a find we to to opportunities for it to It I in growth. continues opening still still remarks. my us

Operator

One moment comes for our of question, Cowen. It Rodriguez-Dumont Ernesto next please. line the with from

Ernesto Rodriguez-Dumont

another on great Congratulations quarter.

the or market least But is pronounced segments, at like retail was difficulty share in it market reflects moment than quarter-over-quarter segment. both the more the was more gain anything that? wondering, gained retail and the in IDN IDN that segment like the penetrate you maybe to IDN noise at seems this segment So I share the is or that segment.

Donn Casale

think Donn. is I about and way is within IDN think probably buying around patterns the buying I mean, This X the versus the best segment. retail purchases to more segments, consistent

You're in drive see market purchasing fluctuation will types seasonality or either going more of more to different that patterns share.

different B types about as you hep think of there's segments the market. So

Ernesto Rodriguez-Dumont

looking like when Or expectations further on and expansion? should into then in dialysis And we ] inflection the [ guess of expect point an if your a acceleration you table Okay. [ what's data, XXXX ] get BLA sort population, the there? I and

Ryan Spencer

is Ryan. This

any when segment. and expectations as point approval, your customer provided to the that for able we're I before as commentary actually make first far able haven't I we we're get promoting, understand the And through We think any in guidance like but specific we'd 'XX. -- around to start to engage

Operator

from line Evercore Next the question Miller ISI. Jonathan of comes from

Jonathan Miller

where any slowing Are you've headwinds? segments growing that those on I better going trends. And talking pricing there to earlier you love margin grow, there you and on share everybody that volumes as gross legacy this related we in to had maybe manufacturing contracting another key that is increase? secondarily, great proving that's can maybe else quarter. would change about, And should color then to anywhere down? gross I'll evolve you're your there congratulating contracts.How to some know challenging things other is to in expect join get I margin And market dynamic in quarter nicely we some is you forward? expect as places overall that announced been

Kelly MacDonald

is and execute the the really question. been some for first one and not our manufacturers. it This the of only engage for the Thanks continue that this hand we've then margin take of way a as question. improvements. adjuvant for years investments we mean, Donn that of result to to of but facility, proud I'll Kelly. We're the over I we've to with made, Dusseldorf able efficiencies is in second many our CMOs

the going year, guidance improved you the You I trends as we've we're more guidance to We or in our mean full we a margins just year with the we less expect reminder, margins, did can year, as would see for believe seen gross noted.Additionally, in average quarter. or next throughout that this reiterate reissue consistent continue see recent our to to most what the strong mid-XX%s. have

Donn Casale

you regarding of IDN share And and the heard regarding share, pharmacy market really obviously, market John, retail Yes. proud the gains numbers we're and quarter-over-quarter.

that's been locations areas the customer, little very has this of which and tail kind of order long that of XX,XXX always is difficult is vaccine. difficult One approximately B hepatitis

IDN, that that's penetrating share retail, the where to focus of has those vast been back certainly, believe universe a challenging growth perspective.But happen back of efforts market we So why majority will segments. X in our from customers to we

growth share. a very we past share for in So in confident that difficult But market tail, perspective, we market from around opportunities long that's look ahead. been as feel our the

Jonathan Miller

one in then more that can squeeze question Great. if earlier on there BD piggyback about to maybe I ]. And [

priority rest still across potential market the the a the from as you it's perspective. seeing industry, that feel environment, valuations out some market? you it opportunities like you, view relative been a I do there's do the that disease to How of motion acquirer? the in for current that are view there does Given but how we've infectious valuation think

Donn Casale

but point, really on and and have going I Jon. not miss fit right plans for staying focus Thanks, for Yes. our to business the finding us it's disciplined agree. think our I forward. to hard we that We mean

it's require is be continue fall make the going business to we're deal disciplined. trap the right our a of thing to I something really for good us sure think and really into. We to not to want

Operator

line JMP Roy next Buchanan Our of the comes Securities. from with question

Roy Buchanan

follow-ups the few on XXXX. a Had

said. you protection meeting? Just design? recognize Is detail explicitly could FDA what on pivotal trial? around can other actual the minutes any back pivotal they give if details you the you give the a the any have Did for from more there Do the us potential correlative

Ryan Spencer

Ryan. high-level comment. it. is this to will make I Rob, Roy, feel to quick a free add

that placebo-controlled still not do is to a FDA efficacy Rob, program. engagement a believe that Z-XXXX you the response continue study, correlate support comments we for to think indicated this of protection any with have the that? the the I other and for approach. written And make on top

Robert Janssen

efficacy No. It's Yes. an study.

So endpoints. there going of design was in we is about no And did nor the pretty ask of think study GSK's typical really for mention be terms of correlates, correlates. I size the design Shingrix of to old

We of don't surprised that. haven't looks but finalized a be lot any if it that, like

Roy Buchanan

pretty like And one year? a what's for big driving quick in for seems the then That win I my the Kelly. Great. Okay. in view. guess R&D a just decrease guidance

Kelly MacDonald

Thanks, Roy.

all. deployment So That's here. our spend timing of of it's just

Operator

like questions would call Spencer, the time. further for Officer, to this I Chief Ryan no turn to have Mr. at over remarks. Executive We closing

You may begin.

Ryan Spencer

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

Operator

call. for Thank this you. concludes Ladies joining you and conference Thank us. today's gentlemen,

wonderful a have Everyone, disconnect. now may day. You

Dynavax Technologies (DVAX) 2 Nov 232023 Q3 Earnings call transcript