Dynavax Technologies (DVAX) 28 Feb 222021 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2021 Financial Results Call. At this -- as a reminder, this conference call is being recorded. At the end of the competitor's prepared remarks, we will open the call up for questions and provide specific instructions at that point. I would now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations.

You may begin.

you. Thank welcome results fourth call. and and year and the financial XXXX corporate to afternoon quarter Dynavax full Good update conference

addition call release presentation press website. Events to a our In slide supplementary section issued of that available is today, today's in the accompanies our

of you involve risks statements regarding Factors to financial and are today's begin, we and XX-K which uses potential uncertainties statements potential cause to Risk actual impact encourage ACIP with recommendation, release forward-looking of section market and These that you but trends, summarized review. differ not future results will could be that today sizes, XXXX are Before press the including, we limited SEC, filed risks materially. guidance in our detailed and These advise making I the in adjuvant. today, CpG to, statements of I

forward-looking Our statements and no such obligation as update to later today statements speak a undertake at of date.

Spencer, current Officer provide provide XXXX. CFO, an provide Medical of pipeline; Commercial, turn the results overview Janssen, now our will Ryan I'll Donn Chief Kelly commercial and our Senior of Casale President During financial priorities. to MacDonald, today's of HEPLISAV-B; Vice will performance our CEO, will Spencer. XXXX strategic will our for review clinical and guidance of call, over call an our review corporate and will our Ryan -- performance. XXXX Rob overview the

staff $XXX enabled technology. million, in proven cash and investment leveraging pipeline, of end core thank our of transformative clinical priorities, executed XXXX and core growth, full to for Nicole on XXXX and truly of successfully $XXX capital our for supply a year building are business CpG revenue you, Thank We total these our profitability Strong year a XXXX. us advancing adjuvant driving million record execution COVID-XX first adjuvant which you Dynavax. all and vaccine, joining today. for was our priorities

believe for in revenue financial and plus capabilities deliver continue supply revenue our provides continue Importantly, another XXXX commercial to shareholders. adjuvant anticipate we XXXX strength grow proven growth and the CpG expected future and We HEPLISAV-B current for adjuvant expect solid to the profitability. of leverage both to of significant position, XXXX, success for we our opportunities advance patients to and to our a as value our in foundation year

growth HEPLISAV-B's are performance $XX in year. achieving represents of extremely the previous which million sales, with sales pleased net compared XXXX, We XX [ph] product to --

vaccine XX for the care to potential market result expect B CDC aged and growth by the increased a hepatitis adult grow continued $XXX B hepatitis as the B years million the adult forward, by US profile growth garner Looking revenue XX to market services from majority recommendation health action has adults the to recent in to the share. vaccine HEPLISAV-B as we share vaccination, hepatitis expand return of a and market believe XXXX, that market and We to old. the all to operations has normal

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in responses immunogenicity vaccine, of authorizations regulatory COVID-XX of and partners demonstrating the efficacy, their which have emergency half safety with significant first supply anticipated and has applications XXXX. multiple use led two COVID-XX the generated additional Our data

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equivalents at profile, assets in we our end, develop Additionally, are novel we as technology truly adjuvant provides CpG vaccine diverse invest financial on products, the current efforts and to foundation to XXXX, increasing no another we well growth with revenue-generating our cash targeting to anticipate capitalized immune driven in We from HEPLISAV-B our existing from from In XXXX response the of portfolio Dynavax's adjuvant an conducting improve options. preclinical proven antigens year of future. emerging assets. pipeline by XXXX of based as profitable diseases driving and million candidates well to are vaccine business, increasing candidates $XXX strong a year a CpG COVID-XX With and believe utilizing revenue solid for sale. vaccine combination product supply

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our the the opportunities in I will the by and turn work more over we to call Donn of to dedication achievements now hard believe Our provide performance. lie HEPLISAV-B ahead are talented possible details team. on Casale and XXXX made

share achieved that vaccine ongoing revenue and B performance highs that make series a B series since I'm only all-time protect XXXX, complete adult This HEPLISAV-B and one This in Thank the you, the is due XXXX, in record a can pandemic, most revenue market in allows annual XX% despite million three-dose HEPLISAV-B in Ryan. is revenue XXXX share growth. Unfortunately, HEPLISAV-B hepatitis adults outcome hepatitis only with pandemic. year In Series and to and vaccination. series. protection. hepatitis HEPLISAV-B. easier represents launch. product the B FDA-approved patients B critical the doses for first essential ever adult to two faster. completion HEPLISAV-B vaccine revenue, completion completion norms was month. never completion an is historical than compared in series despite of impact more to more exceptional net of $XX for Two-dose highest now the era achieved universal the below was achieved increase remaining market hepatitis annual excited

of B XX% at utilization of During total levels. the fourth quarter market XXXX, hepatitis was pre-pandemic

and in decline the was approximately last campaign. administration earnings total purchasing Despite call. shared expectations year. increased booster during market consistent from seasonal the B quarter our quarter from during period these by to patterns XX%, This we fourth due XX% with market third Additionally, XX% the the market hepatitis to key decreased HEPLISAV-B up segments share of same last headwinds, COVID-XX

believe be HEPLISAV-B share over market will to the to meaningful as We subside. time investing continue in of increase driver to a revenue that pandemic begins

a continued their should as the our hepatitis risk-based who in years recommendation who this of vaccinated field for be recommend growth increased quarter, In share positive the hepatitis share, unanimously ACIP, Committee market at market vaccination. November in vaccine to XX year. significantly fourth simplifies period during Practices, age in expands addition HEPLISAV-B or targeted identification adults outlook number HEPLISAV-B on CDC, of Immunization up last prior against recommendation to the This XX should Advisory hepatitis Furthering B XX% total B the and to to the that receive XX% need to of all compared adults US B. meeting voted same from patients

secure the the of care we With revenue significant call recognition growth, XXXX. Chief remain vaccines execution, that time. profile in We become through our the ability well a will back clinical Officer. estimate grow and widely systems. and gains pipeline, have a drive growth clinical across the you positioned Janssen, our over confident the adult over brand. that opportunity now ACIP to recommendation, to universal potential to could market one continuing commercial shareholder With market phase forward generate most strong believe proven the Medical turn HEPLISAV-B and ACIP catalyst of HEPLISAV-B and majority with to to by $XXX used market XXXX, We share million momentum be a for Rob the will Take look health further growth I expect for we to long-term our in to

advance has its to a our indications wide We're excited CpG leveraging demonstrated use. immune improved a enhance favorable trials ability need. very in XXXX commercial you, with with established to Don. vaccines profile pipeline, CpG to develop clinical the and clinical real-world response range medical unmet Thank through tolerability XXXX of

existing XXXX, meaningful clinical anticipate vaccines. we differentiation studies will the initial will that During generate data begin support to our from

pertussis Last acellular we our Since pertussis States waning or in First, vaccines, due by I increased evaluating immunogenicity of tetanus, vaccines improved cough wholesale United XXXX, of program. year, second clinical Top a CpG the when and cases are tolerability data uses in an vaccine whooping expected TDEV XX% Tdap in and our and efficacy first XXXX XXXX, data half replaced vaccine that safety, asymptomatic transmission. Phase the to diphtheria initiated improved in line XXXX. the with expected adjuvant. the trial, adults adolescent half

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there believe opportunity we is profile, the to while efficacy. significantly an exists, reactogenicity currently vaccine effective an maintaining While improve comparable

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clinical trial US risk. vaccine, proven adjuvant. a financial call with, that with lower over utilizing Department Kelly and a leveraging Finally, half to collaboration second XXXX trial XXXX, of plague the Defense. us We review develop guidance. is conducted and turn believe clinical being profile financial XXXX in XXXX II by provide our to CpG CpG enables anticipate candidates we our in for of initiating now XXXX to of the funded the Phase I’ll significant have our the development results This vaccine opportunities

to and review very quarter I'm excited highlight Rob. guidance. financial performance our the for financial and you, strong full XXXX XXXX year fourth Thank our

release For in established Phase to XXXX refer to position our net position growth, for supply additional on million. filed Overall, to starting the our SEC first Dynavax. the year strong with our including XXXX several historically pipeline, this revenue marked for of clinical announced XX-K ever HEPLISAV-B information, actions trial. afternoon. year and a to press This and took And long-term please with agreements, We exited now delivered and included of ourselves financial of strong $XXX GAAP revenue. I footprint move profitability the XXXX. steps profile. of drive highlights we significantly year to execution share I'll We COVID-XX Dynavax's and and our total future focused for led with of adjuvant commercial These expansion million XX% financial full than $XX recently an for market income success shingles for strengthen with vaccine year, more execution multiple by our the

XXXX. generated full the XX% of $XX XXXX, up million, $XX in net sales from For year million HEPLISAV-B

we revenue approximately in $XXX in $XX $XXX million quarter recorded compared for XX% the in In of under year XXXX. financial quarter, delivered supply adjuvant commercial reported agreements half an full million guidance. of our of revenue, XXXX $XX CpG up adjuvant sales fourth fourth achieving XXXX Dynavax nearly we and year the issued million COVID XXXX, HEPLISAV-B And the in in to representing in recorded Additionally, XXXX this million XX XXXX, previously CpG our fourth quarter revenue XXXX. the exceptional

commercial continue CpG net supply we diverse developers. to CpG in on COVID-XX portfolio XXXX XXXX, at ability based a supply be at vaccine revenues bullish guidance growth year-over-year. our execute represents for agreement, to of XX% $XXX million our least we ahead to This least to expect to And strategy XXXX Looking XXXX. existing on our

with development mid-year expenses approximately Moving year the on and million XXXX. year the XXXX Selling, million $XXX expenses of $XX million of driven in $XX general of to compared million were administration for our HEPLISAV-B research primarily compared and XXXX, full the full to sales to were field the for our team. expansion XXXX increase $XX for expenses, by

Moving profitability and on to cash.

diluted. per of $X.XX or million For income $XX loss per Dynavax full This GAAP net and the loss share XXXX, $X.XX or year is compared net share a of a million generated basic $XX on full like take $X.XX share a of per of a and point income I'd items moment for out the statement. of loss XXXX. year to share diluted two our $X.XX basis per to unique to

utilized the then And $XXX second, NOLs taxable net adjustments for includes income XXXX our to we First, reduce GAAP value in non-cash outstanding million income. fair warrants.

the is of in the loss to gain compared During these adjustments income This was XXXX, impact fair full year. million year from a million. $X the of $XX a value prior to net

as $XXX with equivalents securities these and a cash, and the expect Dynavax complete hand December We $XXX marketable first expired. XX, compared XXXX, generated ended operations million in adjustments XXXX. cash of to given perspective, of quarterly the year robust warrants million full cash XXXX From year on after of including very quarter $XXX for sheet, to that of balance be million, from the the a recently cash

to financial now our guidance. XXXX Turning

earlier, $XXX gross As XXXX of XX%, revenue revenue adjuvant least year, guidance the mix. least potential This of on growth million XX% XXXX year-over-year. at expect with quarter-to-quarter approximately to represents we depending customer margin at with for CpG be mentioned corresponding fluctuations

Defense $XX force million of business expanded the R&D supporting expanded and to Department for full sales we vaccine a We and for deliver in of catalysts to the shingles trial Phase $XX and XXXX, to the a trial in to line year building sustainable our of the with full adjuvanted clinical our of funded to we clinical of as market related range XXXX and end Tdap offsetting of between well our be anticipate revenues in to expenses continue invest the for of expect year multiple support fully the our fully to as we opportunity SG&A be year with the durable top and expenses US HEPLISAV-B will in other million Department be such contracts X processes. for place. expect As by by $XXX a the programs, core Expenses million Defense reported and plague reflecting revenue. clinical $XXX be million, with business, funded significantly

with meeting to expect associated which with interest priorities, the a year value full the This and for expense reduced to XXXX numerous decrease balance, interest and We Lastly, year allocation of CpG our expense to and our capital of adjuvant of clinical taking translating continued on market adjuvants. steps at supply our from execution of debt $X strengthen interest executing the our leveraging million, our financial represents position HEPLISAV-B profile, of full we includes realize XXXX to pipeline, of us well believe XXXX strategic priorities. expense. in expected XXXX coupled beyond. XX% the approximately cash successfully is partnerships benefit our disciplined driving our XXXX refinancing a that on Delivering heart advance our share, shareholder

and Thank our towards dedication. teammates our incredible each of their Instructions] to you, would attention I'd today. pass to comments Operator, question team Our Dynavax comes the the Nadeau Cowen. on like today's Lastly, in and sincere like and now our open Q&A I we your like from of Thank thanks the work [Operator hard mission. for commitment line you. to of to and Phil of for portion call. everyone, first Ryan's their echo closing, would on effort

open. is line Your

on of a A Congratulations us. couple afternoon. Good questions very year. from productive

versus CpG demand? much come million is a are how in guidance, how prediction to the very binding agreements of So is where future first, going from on revenue revenue much that the confident the $XXX you're of in

based binding commitments. Thanks, we was guidance our Phil. on The provided

have final know, filling delivering orders advance. to in We place as and calls and you products prior discussions are obviously their well dose. That's from collaborators our have,

sight So have into good we $XXX line of that million.

you current Anything capacity try as here? gauge your us could $XXX beyond manufacturing Perfect. And guideposts there yourselves particular funding to the that milestones, programs that in determine evaluate terms point collaborative agreements? of we important come and there -- then product any be are the demand could million from in collaborative upside looking as towards that are to you'd the to if you above

I it's additionally, have collaborators And right? the Yes. marketplace. fairly obvious any our have product of shared It's publicly in the mean all of then, contracts that their ones, far approvals. they so

ways identify So the collaborators the that tied demand watching be future be would will most to milestones obvious to progress.

Then Perfect. us on question one last from HBV.

impact think You're anything XXXX. very think can Do understanding the you the to market. than diabetes? the a could there guidelines? of market that begin to facilitate clear could as where HBV do increase And what to quickly how recommendation the you there'll new we've vaccine is by curious be you faster here We're seen think that Dynavax with the go ACIP's

do Donn, that? you take want to

Phil. a it actually customers address. is actually it's sure, they're to Yes, lot quite going for frankly, what to to believe something We that may of going do, have

around market In customers really growth our fact, as continue how for and the it's with of schedule us the in get an ago, believe expanding an delivery right lot a for sort HEPLISAV-B be to the market of here of to reality actually size now, take actually of relates a to to the we going drive weeks it's we're time, It's that, published more catalyst question being the few recommendation seeing to to as market. share it more it and the with than a large with so integrated going opportunity that near-term fast? around To share. it network

my taking question. for Thanks Great.

one recommendation much patients and this The identify to to which which compared with to hasn't difference uptick, recommendations, saw so it's age-based valuable still really we not pretty what had add a difference between at that recommendation. easier stark risk frankly these Phil. me much makes quickly, because Let is that

my taking again on and Yes, year. questions productive congrats got a it. Thanks for

Phil. Thanks

you. Thank

Madhu comes of question Sachs. Goldman next from Our Kumar

open. Your line is

Hi, Madhu. this on is Omar for

So, our for majority question, get market path HPC first share? what's for to the helps

market I'm said? that sorry, the share, you majority what path to get is the

right. That's

don't plan ahead and Donn, and our about you go think why of kind how we're long-term review structured?

being we put really Integrated And segment segment headquarter engage towards. as well Retail HEPLISAV-B. marketing well to is absolutely. that segment one a a key critical resources sales segments, as leaders both critical that around Delivery we the obviously of the Network Yes, path starts regional a our as lot continue and

us US provide So, those we gain market are market and two market. share really quarter-over-quarter the majority for key in that to segments have continue foundation the the share to

one way I demonstrated things the also can is point year-over-year that trend that the -- going of we we're a to -- continue to to has plan all have and we've market to been this in the build what launch. commentary time And expect going see think we continued share. over our along and we we're the share stick is growth to to And since to

amount I channels should in a in continue us we're business identifying we the vast market expansion. capture where effort other of around that will can leading in of -- accelerate the help think share, voice that now, we Right new and to majority the we mind that the as expands. the the thing that recommendation to the the of expect is putting majority share new growth market keep promoting promotion be

half about Then first XXXX how should we Tdap data? think the

let's whole picture. So, well, I the take think

I at to think really the you need picture. whole look

just Phase The two then regarding one second being immunogenicity trial follow-up separate and adults very adults by first results data X and adolescents. and run are safety adolescent,. populations, to was start The followed and in similar half half then data in with the

levels supportive continue profile not be with hope to data basically, we development. the the we're a tolerability immunogenicity are that excited what forward be profile we higher of to reasonable as move what will delivering that's of So the with clinical hopes

of payments question. Great. we rollout through then how adjuvant Thanks. should one consider And XXXX? last the

How adjuvant do expect out the payments roll to we XXXX?

the we adjuvant payments Great. How consider rollout should through XXXX? of

assume I revenue this quarter. means adjuvant by

to if guided want any We I so provide? haven't comments just to don't really revenue quarter, there's by I know

we do of adjuvant payment do secure chunk manufacturing get and a we to the as -- when secure upon delivery then a our we our up we that facilities, we structure So front of arrangements final reminder, additional -- the payment such do customers. the

haven't that on you the see and but would amount that in that deliver recognize amount associated have sheet that So future. with the in to balance some when will date, revenue products expect reflecting Again, not but the deliveries, collected the guided pull we to are we we yet that's quarterly to generally payments. we'll

Thanks. Great.

Thank you.

from comes Ed question H.C. White next Our of Wainwright.

line open. is Your

thanks Thanks. Congratulations quarter. a on for great questions. And taking my

question you like. ACIP I general if can about you have when believe, that give just first thoughts past, advertising. had I potential any recommendation. So the mentioned I'm us thinking in DTC look wondering just the is of what would the

-- sorry, Donn, don't details? the go Sure. why you

Yes.

essentially, So consumer great expanded we're capture with it about thinking as this for retail the is, way we the pharmacy recommendation. see point a

efforts, certain And of areas have consumer to higher so, we characteristics strategy. with this we'll certain is be have driving around the feel that success targeting a probability predominantly DTC recommendation metropolitan pharmacy that new our retail

efforts. focused DTC Highly

commercial. risk of here. I just you could physicians and of focus magazine is highly -- That's marketing campaign, the decision-makers on term think, down focused and a it's -- still not TV part. It's the the focused very that just not generally lead that path

from in maybe for about there just was on sales. termination maybe you various bit Great. that hiccup bit Valneva, a a and Valneva there. can there the little to -- partners. if your down notice Thank With the you. a drill discuss And wondering following the the just little potential opportunities I'm UK

XX just was to it should past. million be to and Commission doses the going had to And in to that thoughts in said another wanted what million of mentioned forward? was they've how with deliveries doses I Thank you. XX publicly? your I committed going to question get you starting April, back that -- think we they this think, European contract, had I the year, on delivered overall. think

changed about Sure. past. has said we the Nothing in what

Ultimately, we're the very highlighted you very think I EC excited. nature of clearly. public with that contract

thing If is portfolio, you this neat think the position. our about about

plus they EC how with this in secured next delivery for year. year, have and for Europe, option an XX the You doses million mentioned contract Valneva

on contract to on the option point geographies to and to other positioned we support evolves. then, with the our collaborators. other next take dependent Obviously, it similar key So across achieving is there approval it's a year. we're that that I And that have doses decided EU as them other be for diversification going think the

Europe, us have to provides India, access good Valneva business. E in to of say, into rich but also this continue portfolio would Clover Bio and we So with in China, allow what I Taiwan, us build Medigen a in geographies

And just Okay. you year. million this had mentioned revenue you're binding looking earlier commitments again the that about the $XXX for

did do potential you a U.K., to deliver Are If you Valneva that that termination longer those see the that like bound the does -- notices with change no in client? you adjuvant contract?

of One our filed adjuvant agreement. agreements supply -- commercial the we

that can agreement. detail. was support time, And a the you building as U.K. Valneva had that was turn first reference contract, to purposely and intentional our built used contract the to these we funds in return existed But That So have But in flexibility supply. allowed recall, in the around to you at the very for we didn't more them contract which that cancel. alone.

the our the Valneva for contracts tied flexibility contract the orders U.K. of that to So was that specifically not the existed canceling remainder do in have same obligation.

my for Thanks Great. questions. taking Okay.

Sure. Thanks, Ed.

Thank you.

Our Blair. from Matt William next question of comes Phipps

open.X line Your is

here utilization QX you're in if question year. can my trends impact. us and million. share bit start is Wondering Thanks but Hopefully, it's early COVID this guidance on comment tell. to Thanks. more I'm afternoon. HEPLISAV, taking more. sorry, are seeing anything on in a for to seems Donn, gave maybe market $XXX on you're so a giving recent, you just year. maybe great kind places up -- QX good congrats you or us I to of too little it And it's consist know opening around not Hey,

Just how you feel about wondering that?

Yes, yes.

it. Matt, Okay. let's Hey, do

the So Omicron widespread, impact impact on into February. health with in in and QX, it variance, operations, January care certainly utilization of here of especially regarding the month had an of the discrete impact the obviously,

reverse thick be physicians, whereas cetera, to start the seeing MAs, coming a et that outs, bit, to it little work. are are whether We back nurses,

huge a had that so operations. And on impact

the that, before. but came we of how again, ahead, utilization with and revenue what It's of slightly mentioned QX. standpoint market quarter, we we to XXXX, to that's continue less in back drive that's the than as so trend. looking in But here see allows obviously saw the still, And care in a from seeing it are health operations, standpoint seeing which from we share we're early

No, we despite Donn's can't any commentary year, brand growth provide with this have expect the of additional $XXX we're clearly on any $XX and million But other confident million very versus said for number. continued we comments that initiative that impact. and frankly, excited Omicron the with and being around universal help normal QX We discrete, see updated your was very the to we're the very return operations see to recommendation. begin schedule now

revenue so of forward in volatility reduced share certain the will more credibility So market. around we capture do can with and level overall and drive to on we hard providing to when market to definition expand the underlying look a

broadly. the is something I in alone within we -- think that's not adult this space that we're don't vaccine

detailed future. look forward in we the position So, a you where provide can we more being updates to into

ACIP, that to the as into CDC comments XXXX? in been of more and million -- asked there contractual that those you couple and pushed a the temporal be -- those you. donations, to partners as that almost -- you flexibility feel again, this far then about has talked But appreciate I And comfortable committed is Sure. $XXX with, thank is some meaning contracts just deliveries given at the for risk of of those from your for I guess, the in any, just some spacing questions.

orders, orders, fine, delivery dates. receive their Obviously, as with Well, when we by, what's have Matt, customers we stand are contracts I to defined understand our stand -- the important have is therefore, we think which by and pretty to there's then well. to orders place

and our customers success reason the this business of have obviously, we their their collaboratively with to So within we very worked manage But programs. appropriately. support to business

for. So expect that rationale have deliver we hand, contracts Makes underpins said, that the million product revenue the guidance. I we to in $XXX like and that our receive

Thanks taking the for Great. Okay. question.

Great. Thanks Matt.

Thanks Matt.

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

Thank you, operator.

tremendous CpG made supply to We have against We infection. corporate and built business solid our of further has mission this progress HEPLISAV-B strategic our commercialization, three pipeline. a expanding with development XXXX priorities, point adjuvant, COVID-XX our the foundation successful enable world our protecting execution to believe

increasing to expect recommendation strengthening our the revenue initiatives continued growth universal for begin through value excited another the increasing and the driving are leading for product of the of revenue year brand. to by to driven We new market adult and we implementation share, long-term expanded HEPLISAV-B XXXX, of grow CpG market

as call. continue our and on Operator, us We Thank you execute We of XXXX important Tdap the supply of data and for for for $XXX of today. vaccines may Phase you forward for you interest In our to set CpG will in in least pipeline, appreciate We throughout COVID-XX year. differentiated look as validation year the joining providing our record well expect throughout Diamondback. end your of initiation plague. driving revenue shingles multiple year, readouts another the time X a clinical our updating progress of on the adjuvant product we commitments our million proof-of-concept business, sales. to at pipeline

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

disconnect. You now may