DVAX - Earnings call 4 2023 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2023 Financial Results Conference Call. [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 for participating in today's call.

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

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

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

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

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

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

Ryan Spencer

you XX% delivering B in the pharmacies the the good was vaccine EPL characterized HEPLISAV XXXX XXXX. taking integrated adult making X growth hepatitis Thanks, record delivery us is becoming largest segments, everyone, which the and share and vaccine growth are Dynavax's year-over-year thank retail leader market for the in Paul. leading market. U.S. networks, for results to for by and afternoon, time review to join growth revenue a

in readouts. advancing an pipeline of programs trial clinical We important vaccine and further data including into building XXXX portfolio expect initiations our growing HEPLISAV-B brand be our to products, and best-in-class year

active the the million million are growth the we year. For is with again $XXX $XXX market in revenue some in to be an and of of prospects year product we respiratory very for vaccine the will brand of why to addressable additional minutes, confident vaccine another States. hepatitis few for long-term the and due growth HEPLISAV-B, to market Donn In the on with populations B range HEPLISAV-B season winter the for provide in in U.S. how continued total evolving a a largest forecasting in net one United continue commentary disease

to FDA our nonhuman sBLA Defense. including program under Phase expect and program begin we in data and May. primate Shingles collaboration U.S. Clearing by our PDUFA pipeline, in important study clinical to for hemodialysis months, Department being delivering for trial, coming our challenge currently action advancing Phase the II of the development our the our IND play for For our milestones expected I/II with HEPLISAV-B achieve date reviewed TdaP

accelerate Importantly, market to incremental and our across optionality with the growth. provides advance drive new to strong HEPLISAV-B financial through to continue value to investments as the position of us pursuing our build business, such opportunity, $XXX million our efforts, of opportunities R&D continuing to cash

diversify previously, to As discussed our opportunities we've to we commercial strategic evaluate and portfolio. further product continue clinical

in to and look updates value to We significant forward We remain the growth. these to capital committed disciplined accelerate on generate providing efforts allocation future.

forward. turn results HEPLISAV-B Donnto now our on to and I'll call the the details more provide over looking guidance

Donn Casale

and the establishing U.S. as market. In net product sales HEPLISAV-B leading Ryan. in share, achieved we market adult the hepatitis vaccine you, Thank XXXX, record

through universal pulling Additionally, growth market by significant ACIP we the recommendation. B drove effectively hepatitis

adults. XXXX the XXXX ACIP continued B largest U.S. grow for represents adult one which for hepatitis in to vaccination growth achieving Our recommendation believe in HEPLISAV-B. a universal update in be XXXX the HEPLISAV-B approximately share following and clear now by confidence hepatis XXXX, for that majority opportunities our million and continue market significant grew HEPLISAV $XXX success estimate a sizable vaccine with by potential in time. for market of revenue million to B We a to reaffirms to market $XXX opportunity for long-term market a vaccine The market recommendation the catalyst this on hepatitis growth path will approximately

vaccines, XXXX the flu continue During by RSV wellness and softness in share, and ACIP to XXXX indicators endemic the increased the campaign focus recommendation. Net and growth networks respiratory of compared to launches fourth the expansion vaccine. segments: year-over-year. quarter, XX% grew pharmacy universal to in performance we reduced achieving critical market health of or and the at providers X to delivery its driven continues of by continues U.S. on at Despite visits, This be market see from an HEPLISAV-B the including related XX% disease typical of COVID-XX to total XX% HEPLISAV-B end integrated end XXXX. in care strong increase U.S. revenue market Retail product IDN. sales

on recommendation and grow retail we most these B segments the and efforts to HEPLISAV-B the market now XXXX. of both continue from sales represent in segments. these is key growth leader see ACIP the our as of share the will XX% by both pharmacy to to inversal focus over market Estimating segments. market in hepatitis We IDN of expect marketing anticipated the total

market the XX% share the XX% compared to increased at at the approximately of XXXX. of end HEPLISAV-B IDNs, to end For year, approximately

B clinic market B with to ACIP and year universal recognize the the progress working on IDN implement focused segment at the to achieved making of year, At large to ongoing HEPLISAV-B several the need Retail in health through significant are segment, respond the systems recommendation. Customers recommendation. adoption and to at preferred vaccine change growth Full the to We level hepatitis pull positively in XXXX. vaccine. the adult continue segment adopt C-suite end the and made the In approximately large we was of the hepatitis in national end approximately have share the Retail the market compared Pharmacy chains, Pharmacy XX% XX% of XX%. HEPLISAV

Retail We XX%. Pharmacy continue from was B vaccine to significant Full hepatitis year growth growth market see segment. and the expect

As quarterly cough, million momentum This $XXX Based January emerging feedback nonrespiratory to the of we and expected, Ryan providing to product to in reducing are flu landscape reflects million. season XXXX. factoring number the XXXX our than for cold into wellness customers, vaccination from noted, net be that HEPLISAV-B extended in on further opportunities. while market in range revenue $XXX expect patterns of full market vaccination of see year we guidance and has the evolving the visits in and much guidance

expect we strengthen of for providers to B compared Encouragingly, of as nonrespiratory care QX health QX the to as market the January, hepatitis anticipate Due the little back prioritizing market in to the for into to no retail remainder pharmacy vaccine shifted QX of in XXXX. vaccines. we the softness growth and to focus QX

result, QX quarters, up to we seasonality to expected. our with a the expect XX% full and of third range typical As year recognize revenue second in

in the that expansion XX% extremely years, U.S. hepatitis confident growth meaningful B forecast are with approximately and time. next We HEPLISAV-B XX% market long-term over the gaining several to vaccine market market the increases of over share total of annual in

strengthen that In a XXXX, will hepatitis our vaccine the expanding market. its confidence leader reaffirming in as summary, had tremendous market we position B a clear HEPLISAV-B

IDN. commercial progress establishing for our in segments of and team's key market share HEPLISAV-B majority by pharmacy a execution momentum proud of the very are and and We encouraged the retail

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

Robert Janssen

Thank you, Donn.

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

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

Late improved T proposed development the Type we believe year, as development from meeting believe of and its plan of opportunity to the on critical vaccine cell placebo-controlled pivotal a last its our Z-XXXX includes trial demonstrate induce efficacy tolerability of that the our adjuvant XXXX strong of received advantages Phase continued from to virus. profile, unique CDX of an combined we we responses, One is we which develop the support the disaster with preventing a profile which B Results program, Z-XXXX they comparable CpG supportive study. to ability tolerability I our the clinical are efficacy. and reactivation with safety believe is shingles FDA feedback positive

of recently drug trial XXXX. support submitted Phase half investigational to application in U.S. We new an or to FDA a IND the first of the Z-XXXX of the I/II initiation

XXX our line will the and alum without vaccination CpG enroll be immunogenicity of of selected schedules. plan to second anticipate XXXX in with evaluating subjects of half We dose escalating XXXX. and GE protein, doses We or different top data approximately our

or diphtheria We there's and clinical limitations, adjuvant is nonhuman an I well This immunization year. Now our the proceeding a meeting clinical pertussis in feedback from vaccines trial Phase FDA this immune challenge intended to our both all Current in CpG adults Tdap. turning active have duration pre-IND Tdap the generate our I Together, We've challenge response. study primates. Type tetanus, using study believe the recently opportunity vaccine to to completed study program. the on pertussis a the booster effectiveness. waning Phase development a against XXXX We FDA from regulatory for our TdaPXXXX improve study and feedback of as next TdapXXXX adolescents as nonhuman protection investigational from to and candidate THX-biased results primate pathways. received and B support an including human

the this by which Phase the the in We of human study. vaccinology plan to Canadian submit an conducted study IND our establish II support half of Phase human upon FDA initiation the of the independent to the challenge Center to for U.S. challenge will study TdapXXXX in we being II second dose, year, of utilize the completion to

the plague of a by is Department program. Defense. U.S. with funded on Moving the to and collaboration This

XXXX. X-dose evaluating adjuvanted up a protection safety by and alum adjuvanted Phase of CpG The plague is time candidates compared Department mechanism candidate to We vaccine action speed the the X-dose with conducting vaccine vaccine the of are previously that tolerability Defense. XXXX developed potential with II to of to a the adjuvanted trial doses has CpG fewer immunogenicity,

We're II active tolerability we're candidate. controlled conducting non-human vaccine the challenge clinical And study. a currently and parallel, in immunogenicity, Phase evaluating randomized plague of conducting trial prime a safety

and XXXX, the of both of steps these We expect for program. next top data data inform line the by will studies these end from

vaccination adults us the we've Now in has in accepted allow May on supplemental promote the to a If make addition coming these to excited we're in our for filed PDUFA programs for initiate the date action X-dose the which regimen to of a progress a dialysis FDA clinical programs, with approved, HEPLISAV-B forward hemodialysis, ahead. both development BLA year. in XXXX. look these population. would and also and to next to months We trial to across this HEPLISAV-B of of Tdap continuing shingles the programs

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

Kelly MacDonald

prior XX% year-over-year in to I'm Rob. Form comparisons year are as the release and review noted. another Please XXXX with financial for to press year franchise. I'll information. you, note financial strong pleased all as of for guidance product financial record detailed performance. quarter financial Starting our $XXX period, year full XX-K financial results million Thank refer another unless grew to HEPLISAV-B, also that Please net well the XXXX. for XXXX, report more key for and the versus otherwise our revenue

with percentage trend our and pleased mid-XXs of also prior margin and are improvement to We in margin our with profile approximately consistent gross the the full XX% for continued year significant compared HEPLISAV-B about the in XX% year. guidance for of in XXXX, with

Department Phase funded the U.S. as expect to revenue for with candidates. with is vaccine by Defense. period, prior primarily II increase was profile well of consistent $X driven long-term this XXXX, representing the The with contracts Looking as XXXX in year nonhuman expectations challenge million our margin the Other margins in compared was year of related the full progress advancement the primate for throughout XX% clinical we and program gross $XX in play million collaboration forward, a which revenue by our study vaccine brand. approximately of to into continued the

million related in reflecting and GAAP our maximize results to $XXX expenses million the income preclinical and investments $XX generated recommendation. compensation an for $X.X continued increase primarily of expenses expenses. million and clinical the designed commercial for by increase to GAAP driven ACIP's drive prior overall higher general Research targeted development compared period, during XXXX. XXXX $XXX a our increased with Turning XXXX personnel loss $XXX net prior for to million the were and in presented increases market programs. the year advancement HEPLISAV-B These net Selling, by share for costs million million compared and opportunities the compared to development administrative year $XX in of the period, to universal XXXX and with to

sheet. current pipeline our Moving approximately organic securities $XXX with balance equivalents raise marketable need million, to without is sufficient of cash, the believe year progress our we We which ended cash capital. assets business the base and additional support the to and to

the revenue approximately expected are sales $XXX HEPLISAV-B and with is ex following $XXX Nordic agreement we $X full including approximately Germany. be financial net providing in XXXX, guidance. between product towards Bavarian million Turning commercialization U.S. to and million, million through our year

approximately we million XXXX HEPLISAV-B $XX full and expect for margin gross be of between R&D and -- year million. We to approximately $XX XX% expect expenses

ended cash and our towards allocating programs. for top year and line be flow $XXX growth drive while revenue capital expect XX, our be research to XXXX, discipline also We to expenses SG&A positive million approximately $XXX full expect million advancing December the reflecting thoughtfully continued we to between

extremely and believe the our market. closing, profile, adult R&D financial business, our market build our continuing we current a with allocate drive to to while forward in beyond our share expansion of and business. be majority lead capture In portfolio candidates, growth we we that accelerate the core of well base vaccine progressing HEPLISAV-B We to strong our in vaccine B capital sustainable hepatitis how to look growth are positioned thoughtful

this on beyond. forward We you, year Thank goals and attention today. are look for deliver everyone, our to about your and date, continuing for progress our excited to we to

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

Operator

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

Matthew Phipps

to raised XX% you year, over throughout that. initially Congrats $XXX, updates. visit like was with on XX%, a great year, of 'XX. last Last you guidance and that lower And wanted gave year, just something I it $XXX, subsequent the

of the influence where drove or Was it guidance gains market year? -- what XXXX? you market of share sales greater from what think the -- were might factors from today wondering your that growth Just last point factors greater-than-expected initial kind just your in total goes

Ryan Spencer

thanks Matt, question. for the

of the first have the year both we to first universal was XXXX remember, recommendation. reconciliation pandemic out year of as as think coming full I ACIP demand -- well

that our market So our pretty said provided of originally original in recall the -- I guidance calls earnings year. one about think we in when things were growth I prior the we from outpaced clear is earlier we as the 'XX expectations

we successful the So had market also in growth fairly throughout share year.

growth X projected. those so originally And than factors dominated by better market

Matthew Phipps

Yes.

contribution Okay. And any does from your year guidance the dialysis segment? for this include

Ryan Spencer

really we segment. mean, I Yes. guidance segment don't by provide

So we want to sit through that.

for the to able and going different year how puts of the so comment not takes guidance we're into a specific evolve, can on year segment. lot account on be Our to one takes

Operator

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

Jonathan Miller

still 'XX market is guess? Also do grow extent tied on share you an To share a have market you into expansion, in on to And B wanted market down made to congrats QX? in growth growth. comment that what drill little to -- I in overall little I hep the growth QX. bit opportunity

And expectations then beyond the What expect this plague do and your year. you Phase II requirements regulatory expect secondly, from And NHP the are DoD? regulators? on what what for from you do studies

Ryan Spencer

pick take going we up for first thanks, I'll question, one. Donn I'm and you have tap the don't questions. Why your to Thank the second John. the

Donn Casale

market actually, this continue to share, no quarter to our ability consistent regaining It's one take of is we're to the things different. Jonathan, is around be about to share. share. excited the ability take market

market in and with So quarter, share our first the to the it take where being we is. even position ability like our market

Ryan Spencer

regulatory to additional second plague. satisfy if don't make the reason the a the under want think path plan, know you we don't regarding animal so to work agency. the important you doing it's with primate around [indiscernible] for a what regulatory needed plague whether we're to path like know pathway Rob, required plan, the I I on the will because the is be there to then not that's and other any nonhuman is yet comments have of And study or the product that know filing key specific question the part a

Robert Janssen

we No, versus think for would point, this an at I think this full at you be covered a it. know say, approval, not don't EUA I point. required, what

Ryan Spencer

will be bit little also -- that. an the data A aspect important of

need So we we really confirm to see can data that the before pathway.

Matthew Phipps

how other gross collaboration then line DoD one you revenue still higher? HEPLISAV, does for margin. the but total just plus be gross XX% margin, And more overall and in on into revenue tie that, margin the could potential mid-XXs gross said

Kelly MacDonald

question. -- The year guidance XX% for is the So for so HEPLISAV. the full guidance for the thanks approximately

line of which revenue predominantly expect cost is -- doesn't slightly through carry cost significant we other loss continue carry goods other reimbursement contract, our also, doesn't item the or any which contract we XX%. yes, company margins continue than be our but total to gross revenues at margin goods, to that sorry, Our higher that play would recognizing of significant extent recognizing

Operator

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

Kyuwon Choi

that of -- you're of the How the about on of you guidance? environment. demand I follow-up capital your a course something and that And then And over terms in had is year? takes in the the versus would do growth of that from of of strong terms and price regard Congrats maybe in sensitivity as in you I on the with the sensitivity macroeconomic health finish ask on people's about to guidance. us thinking high your 'XX as terms think and well. about want thinking environment And think puts inflation about maybe in to the we're just the sort thinking spending care to allocation.

Ryan Spencer

dynamics a reimbursement some factors specific those a we vaccination Paul. for obviously, the coverage macro having guidance, -- all hepB Affordable don't well. tie There's It's the that impact is Act. here big and market. is of first the for dollar for -- segment to adult question, market a at the under very our Care on the Thanks incredibly very required see

those grow a relates think of XXXX we to the as beyond. it factors continue to to position market we're some So in good macro through vaccine and

Kyuwon Choi

And landscape then But of guess talked a bid-ask and the I you or BD let's team survey about where about rank and/or think know of follow-up, as you partnering opportunities where in potential HEPLISAV risk if the as spreads appetites BD sort the, here. you Okay. and your have sort perhaps XX of XX are. to capital investing is next then the how I partnership don't in would allocation months, in materialize the guess ordering business? say, I outside

Ryan Spencer

No, you highlighting of lot Yes. a there's appreciate there's right flexibility I I the for fact in identifying asset the think that Dynavax.

So Kelly, strategy? on overall you commentary our some provide don't why capital allocation

Kelly MacDonald

Sure.

So position invest of portfolio. supply our assets looking foremost, and course, well our with us clinical-stage commercial as of well advancing along this preclinical as adjuvant as has for execution strong We will created profile. exceptional financial opportunities first our for HEPLISAV-B in our in business, including, further growth growth organic drive driving believe as strengthening the help certainly our HEPLISAV-B to

beyond do capital reflect shareholders. on of commercial where outside opportunities of we to something and our to when right our for to stand shareholders then opportunities and if value the appropriate, development, as that's well to sort product either comments continue today. generate evaluate as corporate return we quarter portfolio. we other And strategic other As and that, that, consider ways certainly, Ryan's clinical we to evaluate around to do diversify opportunities

Operator

line Our Rodriguez next Cowen. from with question. Ernesto comes the Dumont next question of

Ernesto Rodriguez-Dumont

that based to effects described QX your those season about respiratory year. QX do like and have come that? a I a longer-than-expected are QX you estimates the on during Congrats XXXX over the vaccine question adjust for from on and -- internally great or you effects the have seasonality,

margin, are gross more gross And then driving have the regarding to second Or margins. the pricing you economies scale expecting question see What's of improvement lower in power? cost? and you

Ryan Spencer

one one. and the if you Kelly, I'll handle second Yes, the can first take

first does think update -- we impact in when as of it interpreted number thank the the we far of rest question. I part to we ultimately, about As ready provide we say mean, what for drive only the to change we're it. how the Ernie, our QX I question we how year, the X you guidance. see guidance

QX don't So like -- I to continue know factors and to quarters how individual the will But about we the of QX script, think of it's the said call be -- kind impacted. hard strongest in year. we that

with are interactions continued our Our incredibly customers positive.

vaccine on season So we're handle excited drive to customers of with growth the Kelly, really respiratory of the in and the this market. you and out to season start working can nonrespiratory very respiratory get part the and our year gross margin? the

Kelly MacDonald

through a expect those by represent of antigen estimate gross for an just costs, our improvements number On that I margin of a been have consistent reiterate, do been Sure. improving we margins unit in of to able pull yields this for with proud that things, To a gross in expectations but over to time XX% driven couple namely of to realize manufacturing in long-term the XXXX. margin our gross the these are really I manufacturing investments brand. HEPLISAV-B, per levels range facility remarks, sort Germany. way prepared XX% margin we made for decreasing made this point approximately our of we've that

Operator

the comes from H.C. White of Edward Wainright. with question Our next line

Unknown Analyst

is vaccine, market? timing the an you shingles on for do This questions. Steve Ed. have expected for few to A

Ryan Spencer

commented haven't to it's so the clinical on forward. development long-term specificity our launch. program, move Obviously, years multiple full of We takes it

would able I/II there, be that to out. study expectation Phase study, XXXX. roll the moving Stephen, citing enrollment read looking trial the we'll and to have for We have out on dynamics expectations the the on and at to in next commented exactly when from data then into figure of that forward

for to the pathway. traditional we space points general have So in But commentary reference those good taken development timing to ultimate vaccine sense the of us the specific a for premature there's studies. little and it's of time prior conducting lines that it's provided filing for predict And a trials get approval.

Unknown Analyst

Okay.

this adjuvant were And right? so no year, there sales

Ryan Spencer

at contemplate time. year. sales this for in our additional this adjuvant don't XXXX sales partnerships adjuvant COVID We No

Unknown Analyst

Okay. And in going what XXXX about forward? and

Ryan Spencer

utilized -- market management. individual the markets the evolve unclear. collaborators with products how on and the It's are shifting landscape, and put they up demand, how behind keeping strain depend including efforts how are the

we'll to it's partners for the our important globally initiatives, and in supportive years vaccination marketplace. obviously, their come, be of So an believe continue we product and COVID the will

And we there as be so will them to support needed.

Operator

line question comes the Roy with JMP. next Our Citizens Cannon from of

Roy Buchanan

on Any Just those any the later challenge a to Can you Are couple be the think quick me, announce human that? plague in of important. year. time you of trial plague. ones assessments making results you And not the going the you remind in at the are cell-mediated Phase same Phase might thoughts II do immunity on this II? the

Ryan Spencer

take the second. then Rob and ask first on up follow I'll I'll the one, to

-- the data -- the partners One with realize to release with work on this DoD the data got our is things by the with release. is you the we of to DoD study that is have

share data yet has what that clarified on what not either forum the the been trial. to will exactly so in And opportunity be for

around cell media plague partnership as endpoint is please in be Rob, with the to able on immunity you in like the have to work need progressing a program across some line how but that we these we both past. release is able complete trials to DoD. much make trials be will antibodies top primary data but in So [indiscernible] together, to treat don't we'll have and The we plan any other comments for the -- we provide program. clarity basically commentary have

Robert Janssen

looking to is primates and as The because that's Yes. humans. antibodies that's has they've DoD applying what in particularly then antibodies been looking at to nonhuman primary at -- those vaccine previously developed used with to this respect endpoint

or in our cells looking in immune II this -- aren't We study. Phase cell at T media

Operator

I'd to At remarks. Spencer Ryan time, you. conference Mr. back the Thank for this like hand closing to over

Ryan Spencer

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

Operator

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

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

Dynavax Technologies (DVAX) 22 Feb 242023 Q4 Earnings call transcript