DVAX - Earnings call transcript Q2 2024 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technology's Second 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

Thank you for participating in today's call.

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

clinical capitalization, market expectations growth Before XXXX guidance in profitability, cash sizes, are adjuvant. These revenue, actual share, including involve limited and in today based of statements sufficiency be the timing on and uses results materially. making we Risk FDA forward-looking not marketing our starts Factors report may effective future current begin, and I section Form potential segmentation, uncertainties, risks related release results data each, including filings, statements CpG and flow but our market advise or summarized and recommendation of and demand current our differ efforts, today's you to, market today's detailed our of financial including, that on trends, SEC press impact potential XX-Q. rates we submissions, trial will expected and ACIP beliefs, risks quarterly and on and for future and related readouts, and of These

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

Ryan Spencer

full sales share in for notching and thank U.S. segments. Based quarter We've in review position highly year hepatitis our revenue record QX, are XXXX. we key everyone, continued QX which the as for about market the hepatitis we B strong vaccines the HEPLISAV-B guidance addressable achieved afternoon, reaffirming to adult into adult results. eligible of patients, X product product total vaccine we is our our to and HEPLISAV-B the term, of Good Paul. XXXX U.S. continued across for optimistic us largest year-over-year vaccine net for strengthening Hepatitis the market million the B early quarter in Thanks, populations and leadership for the you taking are B vaccine the and the time strengthen second QX, results of join on in over another Longer market market market, gains XXX market patient our

size grow We by $XXX to the XXXX, market both for continued end of in HEPLISAV-B to growth market expect million the through opportunity decade. with market share over the and

the unvaccinated HEPLISAV-B revenue also demand long-term adult of penetration of as a as market substantial result expanding We anticipate cohort, the for for HEPLISAV-B. as a continued providing opportunity well long-term beyond XXXX share,

from to readouts shingles are programs novel expected For across pipeline including pleased vaccine for trial Phase several study the X/X Tdap excited and plague well as have XXXX upcoming shingles development, our as our milestones, for program initiated our XXXX. we remain and and our recently vaccine

financial details respectively, look before turn and Donn? second enable create continue pipeline progress, to addition us now to In who infectious reviews internal opportunities. quarter. disease portfolio would to on future. I'll results over we in which Donn to within updates bolstered we results the grow this future call provide space, and will pipeline progress to the our diversify efforts We our beyond strong our for product evaluate position, forward these the the more to Rob, strategic financial commercial organic the believe further our by providing Kelly and on opportunities and our HEPLISAV-B

Donn Casale

Ryan. you, Thank

vaccine supported revenue market and hepatitis share. in the the by HEPLISAV-B with We HEPLISAV-B sales net B and market quarter. second the record-breaking are $XX in million in thrilled performance HEPLISAV-B increases over quarter growth for achieved in product

during market the U.S. dynamic as the play began critical by an market period to customers the market share last said Recommendation strong its Delivery earnings increased non-respiratory the to Integrated of In shifted IDN. compared ACIP throughout adoption achieving call, from early total year. reprioritized year-over-year, to estimated approximately share year. HEPLISAV-B's last share last providers help Networks, Universal to same prioritizing to second protect compared and focus be XX% to retail of and quarter that or HEPLISAV-B estimated the vaccines. driven quarter to market in quarter Pharmacy to continued hepatitis healthcare as the the approximately increase hepatitis vaccine our B. second continues period B strengthen retail, during we XX% back QX XX% During out continued That their X pharmacies in HEPLISAV-B's same patients Retail to performance XX% segments,

to XX% IDN, year. approximately QX increased to estimated last HEPLISAV-B's market for XX% approximately compared share For

During hepatitis several chains initiatives hepatitis the top and quarter, many large systems B-focused IDN national to retail vaccination. campaigns and B established increase

the providers market. continue encouraged focus into hepatitis early momentum opportunity the vaccine of when the around by guidance. commitment provided of and In as remain B effect, hepatitis in and QX healthcare we confident are Universal B mobilize to X-year ACIP into the We customers expansion went to XXXX, continue vaccination. We expect U.S. of long-term the these this Recommendation

and a we market million the remain confident end expansion hepatitis continued X-year Now that gains to HEPLISAV-B guidance the the expect $XXX be to expect HEPLISAV-B market through opportunity by share. XXXX, HEPLISAV-B market achieve in with majority share market of positioned B over and We decade.

our the both penetration adult specific are expect longer-term long-term. remaining to this in cohort. substantial for for continued forward to we by the providing more of guidance XXXX to HEPLISAV-B market large and summary, the of the XXXX, Beyond we unvaccinated the reaffirming be confidence outlook look end We year. In due

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

help the our proud will very now remainder of to the through are the We of QX to team's call in for Rob seen pipeline. success excited turn take to are you commercial momentum clinical and build on over our XXXX. I

Robert Janssen

shingles with starting we're vaccine our innovative our the Thank progress you, making Donn. with I'm excited Z-XXXX. program, by pipeline, vaccine

month evaluate randomized to develop there the the to optimal given trial escalation opportunity patient-reported XXX for be initiated XX level quarter, active-controlled dose believe trial well current tool on a an of an data the market-leading immunogenicity As of second vaccine, X label shingles the tolerability including to T-cells XXXX, dose improved and E multicenter half measurement second vaccine support The control the and potential differentiate Z-XXXX we claims. Phase dosing a outcome validation used product. In tolerability XX to in and We a in challenging reporting of to after support second the profile schedule, the we as compared of formulation reminder, doses. Z-XXXX adjuvant top-line of years. Key of X/X aged trial as an active of objectives CDX+ safety clinical healthy include X/X tolerability, selecting adults approximately glycoprotein further X immunogenicity and Phase anticipate a the to will safety, comparison is development. to

participants our XXXX This the us limitations, of Tdap to capture Tdap response the to data X to Tdap with immune be help using through study generate an and candidate Tdap XXXX. establish long-term next intended for evaluating initial view for Phase immunogenicity waning immune the a a including we compared Results with active and duration of against Tdap program. XXXX benefits X up or immunization Tdap. Turning booster control fourth years extension participants how study a achieved ThX-biased believe data is compares response. We're vaccines from protection our X Phase time XXXX study of an vaccination. expected potential adjuvant vaccine trial will induced candidate. in to a XXXX Current control. of who provide booster XXXX that pertussis of improve on These of the active follow-up there's the diphtheria, opportunity extension CpG persistence will this effectiveness, to active a completed views dose have of investigational following pertussis vaccine tetanus, the to The the and will can are quarter over an

primate second the sBLA, our executing XXXX now turn this amend regimen. nonhuman progress intend these meet results. in and X of addressing as additional pleased over funded with across For milestones to also to on to with which regarding we with review for clinical study the collaboration a our program, Phase fourth and Department sBLA Defense, in We're the pathways update the our both the the discuss the XXXX. in our to our of part We look quarter potential FDA trial a to half results and our FDA months. I'll process comments financial upcoming based U.S. dosing providing hemodialysis on anticipate a coming approval plague of support call standard program by Kelly from forward challenge vaccine of with we is in to X-dose focused pipeline HEPLISAV-B to data on regimen. We're regulatory the of

Kelly MacDonald

Thank you, Rob.

effectiveness achieve XX% combined was plan revenue XXXX. We sales compared U.S. for full vaccine margin refer full detailed financial record net XX-Q of XX% started, million for with our and is financial putting of expansion get more team, the Before our $X prior sequential margin the year the year for with and and guidance our including our revenue highly in capital underscored time. the press plague XX% of of information. combined about increase brand walk sales guidance quarter program through scale a the quarter, a funded and approximately strong filed process, to year I XX% efficacious please This a the Defense. the with for our to in quarter, is result another overall to $XX track collaboration improved on in and I'll by by the of increase over last release gross the manufacturing to a XXXX with successful of related marketing our year-over-year us Other to second channels, campaigns XX% HEPLISAV-B for million, QX strength earlier Department highlights investments from highlights across reminder testament to progress believe multiple the today XXXX improved Form this in representing retail. HEPLISAV-B to quarter. consistent

half approximately Research and These reflecting the approximately was to compared second XXXX period. income million prior the $XX progress $X our prior general, the important full the XXXX. for million pipeline. Selling, year of net for expenses year in quarter million $X quarter to of $XX $XX preclinical during Turning million the HEPLISAV-B to the to franchise. Sublease to and administrative year and was a our salesforce compared were development XXXX were million discovery, our other clinical the second ROI The of high driving expect million throughout quarter's XXXX, million expenses our expansion second and increase by compared expenses. as with from we $XX $XX period, of XXXX record $X last in QX results primarily driven period. for investments increase growth quarter income million of generated call, And of prior of the second net of in XXXX. year subleased for the income reminder the for

the balance We cash, track on million to million, on the we our our strong have need pipeline with to quarter which equivalents, capital of year XXXX $XXX We financial increase during to and all exited the of the year full believe our second the for QX. reiterating approximately Moving guidance marketable remain and sheet. we a to execution $XX achieve cash sufficient guidance. prosecute year-to-date, securities was also cash organic markets. Based without that access are of continue our XXXX to capital

for consisting guidance of our for advancing very to robust quarter sheet. I'd and closing, today. In another earlier we improved press a back record excited comments. turn to report full call Ryan closing over margins, revenue are our to please framework, release consult the product balance gross like quarterly now and pipeline, strong from HEPLISAV-B, For

Ryan Spencer

execution few this few over last to a we reflect what this us and additional up context years, that to how results Thanks, Kelly. take quarter. has making I'm very I moments on proud accomplished success by which pharma. are the and progress and proud us growth. We've set dominated company next provides from to exceptional big personally provide a drive the the long-term that of profitable profile, want a for HEPLISAV-B of strong team's beyond build continue in the of foundation long been a a I'm to delivered has market demonstrated growth leg commercializing on. to with our brand

clinic. growth, temptation and disciplined and HEPLISAV-B, to committed action to both judgment, perception new been into disciplined to evaluating respond of the sake advancing the of take our We've while any products allowing for risk, opportunities for opportunities remain strategic Beyond we actively to us have business avoiding applying but managed stay manage the progress. agile, to

aim business our the all have leading to stakeholders, portion provides Beyond our us team our we investors, position a focused employees tools financial disease maximize Operator, professionalism. of and now grow believe as this open leadership would you, we to We Dynavax position, we to on everyone. of call. the including company. Thank like Q&A built benefit and infectious high-performing need a to we impact today's strategic as patients, and our

Operator

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

Matthew Phipps

QX year. help year my last And little and taking Kelly, similar we the you of maybe us maybe wondering year, update Kelly, bit of of market the of year some seasonality around this And giving and across when we the of we for share? questions this as expectations a end will percentage us a give back. HEPLISAV programs. on rest if share, could about maybe in assume you break by in of welcome saw think was I Thanks then, market that as can here you total throughout think the QX you the year or sales the us should mark kind XX% your

Ryan Spencer

share. X don't take detail. the I'll first on guidance that we level provide at Obviously, market of

that seasonality, So expect I'll as to time, period one? have share any to Kelly, related but that. And majority refer have haven't to back long-term on you market that on at guide our want refined we relates to do that's provided in general we some share to that more take comments guidance it of to XXXX than the a just

Kelly MacDonald

Sure.

of so previously XX% this we million. to our seen historical we at are and the for respect seasonality the QX between the ranges, started So, sort guided higher net as $XXX to a million And that that contraction end reminder, to we to XX%. see to guidance, $XXX year, anticipating year, sales last have that year our throughout of XX%. did might guidance reiterate still in have we With

the we QX. year. that We are how that's about sort expect this Again, relative come QX into to range XX% of to expecting

to as So hopefully that's a be strong of still, We very helpful. do quarter expect course, QX well.

Operator

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

Philip Nadeau

One I reiterated years. a quarters us, market you are and confidence in think, points noise guidance commercial, market million around data accumulating in to your that Can contraction in one others. continue the that market you given of a for pipeline. it's about commercial, growth the some On growth? $XXX for you talk that little hard give few the most

ultimate gives that that track all is what on So, confidence hit you to market size?

Ryan Spencer

you details coverage result couple and a million to Donn $XXX Recommendation. if out Yes. be continue have that as we've last elaborate add, may I'll Donn, in to that few projections modeling make other the please I based And reminded because increasing know the all do. of of we ACIP towards rates the you by market we're years. Donn, high-level projected on any over back points, those Universal our us to don't XXXX 'XX, as to a tracking if want reiterate progressed on. we

Donn Casale

into so put we I analogs. line of vaccines, other kind of and with forecast additional other those color only vaccine be would mean, our kind that in rates the are

and looking mentioned, occurring, Ryan confidence long-term. we similar other reiterate vaccination to see follow the what as we the believe at that will B path. market, gives But that So, at of vaccines, hepatitis with looking again, happens us guidance that kind and just that

Ryan Spencer

that it's products towards how coverage I Tdap, flu, along X, changes see market have Phil, progress like you'll at increasing that for of size are, analog the points multiple can historical rates. or will years with of think grown and in hep B you recommendation recommendation So, you those made XXXX the the and example, data look vaccination products, vaccine since have

Philip Nadeau

it. Got

vaccine a obviously Okay. of controversy recent commercial. the trends for and lot not actually recommendation vaccine or of recommendation the RSV RSV in has COVID because disappointing. vaccination. There's a COVID there. follow-up little space been on X Maybe recent annual had

vaccines expectations it season figure to seems impacted past? the to vaccines those they season some as it does 'XX, in as 'XX utilized the for How seasonality as this too concern there into So that that next reason Is won't that heavily won't virus is your think past. some tell, to maybe to as be be had or on be HPV HEPLISAV? respiratory early for

Ryan Spencer

Yes.

the still a couple So on product. a landscape. large comments of COVID very remains One,

you're So right.

I is relatively versus of but still have comparison a for And it there's lower expectation going boost. annual utilization, to think the could RSV given highly annually. -- it's some utilized be recommendation of lack

a the as on, think pharmacy color are do in progress plus just little maybe HEPLISAV. Donn, bit provide seen those to as one or want could I both see particular, it options? tailwinds that retail trends we we relates have of to for you

Donn Casale

that to into more season, quite down Phil, frankly, for originate in I they boils think season. fall it fact this opportunity, that, patients provides vaccination pharmacy as the and it winter the

a opportunity. again, Ryan's So, point, tailwind, it's an to it's

for see vaccination such additional again, in season it is this because, partners we we B, year an retail origination and Our think that and it hep as so and opportunities about opportunity as factored beyond. it this provides

Ryan Spencer

RSV when To there's be or will to be -- now a originated although opportunity COVID, that an an to utilized be different vaccine flu less, arm clear, be took administered. for someone

Philip Nadeau

it. Got

Can further in in Dynavax's Okay. to levels some encouraging going pipeline, you would see? sense on investment you CX What eyes? mentioned Last what question to you Z-XXXX versus of be give that would the hope assessed you the what will us prompt be trial. consider are discouraging

Ryan Spencer

you Sure. take Rob, don't why that?

Robert Janssen

that levels is we're regimens. we as at, combinations see forward, that well move we to number provides be Shingrix. best looking adjuvants dosing What CDX similar different anticipate identifying different the we're levels which one as looking a in accounts at would different antigen Yes. of of with with what And

Operator

Evercore. the from Jon of comes Miller question next at line Our

Jonathan Miller

feel percent. well growth a the sort but share what into know market a good and leg next the of I quarters, here, end comps of you but second or stable of share little here? for year this drives past talked And had about Yes. tougher it's bit, guess, the get handful you've Obviously, minus on like going of does couple I year-on-year market half X plus year. comps

So what drives of the growth level HEPLISAV next from here?

Ryan Spencer

Yes.

of a customers can want we Donn, Again, to the I'll we it, things you utilization. do. to please level. to hit So, continue expand have at where add But do high couple

necessarily don't customers block a move as the space. So, IDN in

there. and you'll So expand clinics largest to continue you get the can

a the think is element I this of other growth. share disproportionate of

we the will also share continue to market So overall which help HEPLISAV of market will believe capture expansion, the disproportionate do share.

Jonathan Miller

Then Okay. I like the think guess, looks from or efforts hoping big you're that and much that more less are gross margin time noise guidance Sure. reaching now the question, hitting improve your you're is how to to. quarter other perspective, a you as this in to quarter is there get to onboard gross realm over quarter, the margin I are

Kelly MacDonald

quarter to just fluctuations quarter variability of So continue and quarter, timing some manufacturing to see minor of just to we'll processes. because some quarter

terms think, expect is we of [ guidance. what what gross our I provided in XX% probably why of seen magnitude, sort these can going the of we to the margin for quarters as last is which forward, we've order see of couple year ] estimated

Jonathan Miller

maybe me. last then, And Great. X for

end likely some for not before the guidance about year Just end Does calendar of the cash greater equivalents noticed guidance. cash BD phrasing imply was it's at year? the than reads, not plus to is about specifically at year it 'XX. less you're of of cash end more be numbers, profitability talking talking and equivalence And I that guiding how flow, you're about your particular you're that

Ryan Spencer

is that the Obviously, clear, that had guidance. capital of for deployment our to would impact to That BD guidance, very a just that opportunity current we significant Jon, business. extent existing a on be

Operator

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

Kyuwon Choi

may also My first the be Kelly directed and question Donn. to and is guidance, on

of the think you've versus trends bit guidance. prescription like of your midpoint guess, recent XQ, As But for upper the been you a to the XQ lift make the end of look there's seems while a at as like XQ. about year, versus it historically weighted be tail or to guidance end through heavy up back it half obviously July, we of going to seems I the

question. And that lower based So, mention with data midpoint? positive the program? is, remind to can guess an you marketplace in versus the of comfortable you back you're the That's the obviously the welcome triggers there, what I any question But you assuming guidance program, seeing my that update with us more on just you'll regard now, in then you if second, milestone end guys provide as did first is maybe right the the that Kelly, with to are plague And well. XQ. provided regard

Kelly MacDonald

is, the support which believe of about one, in the think layer we think certainly I'll first scenarios we of we the and then that will take have range. as details, end Donn guidance, I definitely will upper some that plenty

in So we uncertainties. a there the guidance of keep are because range terms

So, couple about been call. I a of that into highlighted on this excited already and QX headed things think really we're QX have

So, seen, retail that. pull-through of the that for to some we've we example, continue see

then also, have over really our color. promotion RSV was and recent strong opens also an any some opportunity hand Donn of I'll other the to up certainly it that around opportunities us. add recommendations, the We Maybe to that for to course, personal of highlighted response

Donn Casale

said are see, and before, pharmacy QX, themselves and I as patient origination, RSV of is half feel example. about opportunities communication regarding taking that's in of for where point, this and guidance very advantage segment, and to why already. so place, we've good year, place, up mean the the Paul, we in partners, we're for what to Infrastructure behaviors XXXX. with is Yes. we our reaffirm going into back especially mentioned excited just that really by fairly actions Kelly's the save occurring We're robust retail happening I our looking within a

Ryan Spencer

relates ended structure for to the be the it's there's up a there XXXX being future program responsible would milestone that whole And product. the on plague of that is either if would as we Paul, program, a product That program. sales in down the then, DoD-funded no or -- -- defined upside it

an expectations on include provide in would update and advancement the future program QX, we'll around any funding. which So

Operator

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

Roy Buchanan

that on Any going of the preview XXXX, what XXXX? This to give -- you and XXXX, when lot give a maybe a maybe of talk that year. Is providing granularity this guidance is guidance? you a mentioned later up Follow us longer-term Can the you questions. might that look guidance us like? little that's

Ryan Spencer

Yes.

we As around in qualitative you are made of where looking beyond shape indication heard bit some to be of guidance peak and on statements providing to market market of able to context see we post-peak. we today for a XXXX the to growth continued to we continue little and update the curve focus some of longer-term with what an expect opportunity, then color the as the share,

that provide we'll refining which 'XX, a more and quantitative bit refine in right continued feel beyond where confident little year. that update we we're So, later bit is now, growth and more a work this

Roy Buchanan

projections? to this just Okay, enough be in confident data great. at or point not, these I you longer-term able And guess to anything have then, did seen be making change,

Ryan Spencer

information goes Well, it have and we to additional Q&A to of think we view provide discussion as time. -- kind influence session with to the it. of the the which the 'XX, felt long-term that in earlier continue put X-year we And we we wanted in we back at to guidance need out comfortable we our opportunity had

few last that guidance. we insight have long-term the would years reflect like provided on us So to our

Operator

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

begin. may You

Ryan Spencer

interest thank for and appreciate joining all you operator, today. Dynavax. you, in Thank your us We

forward you protecting about end We the strength you are against the diseases. to recent our We look infectious position. Operator, the and world excited updating our may focused of on on call. accomplishment our progress

Operator

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

You may disconnect. now

Dynavax Technologies (DVAX) 6 Aug 242024 Q2 Earnings call transcript