DVAX - Earnings call transcript Q4 2020 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter 2020 Conference Call.

As a reminder, this conference call is being recorded. At the end of the Company’s prepared remarks, we will open the call 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.

Nicole Arndt

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

Officer; Medical Joining Ryan Commercial. Officer; Financial Spencer, on Chief Janssen, me the Executive Michael call Ostrach, Vice Donn Casale, Officer; today are Rob President, Chief Chief

we potential XX-Q cause actual that will filed with CpG peak XX-K SEC, in detailed post-marketing launch over completion Forward-Looking advise revenue, be summarized and now and periodic HEPLISAV-B’s commercial studies which you statements could expectations. are These to the revenue uncertainties are subject Spencer, all of call of you the vaccine and we will to with to current today, results European of XXXX including in regarding I I the development These Ryan and section profile, to begin, CEO making and results Before are press turn we Factors and review. release materially. Statements reports today’s Risk encourage revenue potential number differ regarding expectations, our and statements a Dynavax. of risks

Ryan Spencer

maybe lasting immunity, boost potential improved response vaccines immune to success prevent and to provide as pandemic Thank the as XXXX. of diseases. to Vaccine for all And thank results us outlook new joining the the I'm our continued immune to to longer vaccines. protection has or global spread highlighted have Nicole. the of share the our The important development XXXX of adjuvant these infectious for current excited increase for contributor both you, today. and you well adjuvant need

of long-term revenue diseases the stream awareness that of importance addition, deadly the provide. protection recurring will vaccines expand In against increased

worldwide trials HEPLISAV-B increasing the million rates. Hepatitis CpG doses market current potentially provide Over deadly is which with and people a to is fewer effective compared to are product adjuvanted pivotal it vaccination. prevented can Hepatitis infectious higher shown was be B infected. commercialized with with virus infection vaccine, in with B of compliance. theater. levels with adult three Thankfully, XXX first protection highly challenges Our XXXX and is an

approximately from X.X% to year-over-year, the approximately XXXX. confidence products same team quarter well XX% accounts XXXX, to patients despite quarter significant one for disruptions HEPLISAV-B the a targeted the of quarter regimen HEPLISAV-B in compared higher required Hep vaccination approximately of the increased up B XX% With reduction care over adult levels million, in give take fourth of in strong six XX% field eventually due product the of continued year. month known, Market of COVID-XX fourth to $XX.X of compliance share the Demonstrating in the first are U.S. and last with up schedule. a of net protection HEPLISAV-B months will corresponding the us the legacy Hepatitis X-dose become the schedule, overall which B standard by share the ability and dose period quarter customer the was XX% X-dose pandemic. to sales in completing improvements the despite with to utilization revenue fourth XX% in vaccine HEPLISAV-B with of only market

the $X HEPLISAV-B a progress quarter. employees, made to chain with a continued we accounts purchase in significant used million national revenue approximately in dialysis national resulting making Additionally, in its of for be in

for While their the likely will in overtime, for the we meaningful utilization employees. as cover they implement order recurring HEPLISAV-B stock this revenue vaccination customer few their quarters contribute expect first to

market ability to market become leader. to advanced continue to and ability us provides accounts increase share value national of HEPLISAV-B Our and confidence the the our in its

quarter be Current a are we CDC to with February COVID-XX as on significantly COVID-XX ramp vaccine nation starts our interval utilization the first vaccine. continued administration. up vaccines show before adult to to alone reduced pressure quarter, ahead non-COVID vaccine Looking seeing Market and fourth after guidance utilization January vaccine XXXX. XX-days minimum compared early of administration data or of of in another administered recommends

Furthermore, will best capture as vaccines throughout year. of additional revenues from backlog and a accounts. customer as progress of efforts HEPLISAV-B the our national significant market feedback expect to the available share be Despite rollout. addressed. converting return driving HEPLISAV-B pandemic, XXXX. vaccines growth the in national field first the we the the make requiring increased impacted we in the Based patients lead accounts result, share of second expected the the importance COVID-XX combination compared the to vaccines on We the well quarter. of and decrease of our is in non-COVID utilization believe - in of we rapidly expect fourth of revenue significant XXXX, to large in quarter to XXXX. majority as in half will and first But second targeted will of of and With using timing revenue a a half of the coming believe awareness half adult market As vaccination year the

B the important HEPLISAV-B Commission Another Friday, when in European an came highlight of granted this Practices the CDC HEPLISAV-B We for adult in ACIP marketing enhanced Committee the Germany concept launching the this outlook HEPLISAV-B for authorization for continued or of anticipate fourth past Europe. Advisory Furthering of year. quarter on in Immunization HEPLISAV-B for progress vaccination. Hepatitis recommendation our yesterday, positive discuss

against our to as for October The ACIP B company. foundation targeting vote identification an all people vaccination. Hepatitis previously HEPLISAV-B increasing vaccinated an in as would B Hepatitis who unvaccinated the We ACIP XXXX soon universal and would a of vaccination Specifically enabling recommended of adult support of recommendation in number recommendation be for significantly those believe B a easier initiative. expand be catalyst provides to the policy by Hepatitis This need adults. B. the is number be of growth U.S. the he Hepatitis group market, important of greatly major on this recommending universal the adults working the discussed should vaccinated

Serum Additionally, growth. versatility, revenue multiple our Underscoring additional COVID-XX as providing a collaboration supply the XXXX span COVID-XX, is business pandemic, Dynavax, and evaluating the adjuvant, vaccine CPG Phase in and supplier the progressed growing the anticipated Data a reality as improved of Tdap varied I XXXX is CpG vaccine universal fourth candidate. source of with technology result This CpG XXXX Institute collaboration to of indications, from a including clinical adjuvant rapidly this an CpG pipeline the year. India. platforms, in potentially of for program as diphtheria a develop In trial Tdap or of and tetanus, opportunities collaborations These quarter out trial of vaccine a both developer category, are XXXX from influenza. acellular strategy scenarios a of development across clinical now in safety Dynavax our either pertussis of provide this XXXX. or

COVID-XX generating We adjutant progress is supply business for revenue. have vaccines, now which with our significant made also

protein demand. specific antigens duration number vaccine is vaccine be massive, of Before would landscape, for necessary, to of the will how adjuvant advantages regarding subunit an on a likely mutations, to contain may platforms global inactivated vaccinations booster and update like and it uncertainty fit I to I and need multiple and CpG provide in. new provide the protection strings. review COVID-XX global of Adjutant emergence that we COVID-XX The and address XXXX the with our partnerships, expect demand COVID-XX vaccine is the initial to briefly for

profile. things tolerability refrigeration, mRNA acceptable them global CpG in an XXXX, subunit these protection These on for vaccine dosing, have can First, some platforms. been be the believe for used with Inactivated making we maintaining platforms vaccines. platforms these vaccines, vector at more while stored are viral par the mRMA deliver potential and levels to safety historically traditional finally, for unlike repeat vaccines, used adjuvant population. accessible have with temperatures, multivalent high unlike And of

demonstrated multiple ability Our COVID-XX profile. strategy emergency for for has vaccines. XXXX XXXX preserving CpG adjuvanted collaboration to the in the resulted CpG best-in-class has while in use authorization increase tolerability opportunities the antibodies, XXXX

Valneva's commercial agreement this opportunity of Our COVID-XX for and and preparation of supply executed third pandemic of of the next In production CpG candidate, XXX supply. XXXX is to Valneva for million candidate a we UK scale our to year, Under the a vaccine first vaccine XXXX stage $XXX Dynavax development Government. partnerships are moving at agreement scheduled for agreement supply. supply commercial vaccine revenue CpG forward for an up the developed last or began under adjuvant Dynavax is million. represents with XXXX providing COVID-XX being which doses CpG to XXXX, in quarter

$XXX development, is agreement is it continued over We worth XXXX. for commercial potentially another While major recently this Dynavax XXXX. million supply in executed to through successful support contingent contract on

around $XX response support the to Preparedness manufacturing of the or Initiative, With funding support providing million the on collaborations and to Dynavax under agreement CEPI stockpiling many up CpG for partnerships pandemic, CEPI. to providing Epidemic Depending for XXXX. $XXX is allocation the material COVID-XX to countries, through of the of CEPI global Dynavax revenue million the significant low has CEPI world. Coalition to produced CEPI income and for in CpG potential XXXX XXX grantees. to in the the grantees generate future this sales mix approximately to XXXX high for in is

the is is is partner being of make and in is protein driving need vaccines results Biopharmaceuticals, and and I/II of one CpG with limited the to vaccine to turn doses we XXXX final combined Metagen, will reinforce Due revenue and Based is this fronts additional with XXXX wrap in the adjuvant to compared beyond, an vaccines continued funded currently for trial. expect have emerging CEPI on adjuvant adjuvant now that to year. as analysis in and November, agencies, we CEPI protein year executed subunit CpG in additional for revenue current potential may another the up that multiple vaccine, successful CpG American the tremendous available, annually continue the vaccine beyond. billion to healthcare in collaboration in with as of in middle it vaccine the opportunity and at vaccine particularly adjuvant for of for based of XXXX the vaccine their X.X a Our to long-term a in We adjuvant finally, CEPI with of XXXX. vaccination and from the under me expected detail. UNICEF, initial is candidate to Clover beyond Organization period valuable XXXX. with biological, XXXX transformation The of XXXX. depending need a foundation expected investment call initial have advancement who through the of produced strength vaccines. couple the challenges initiated variants, evaluating the CEPI Phase revenue million This March globally. Pan availability vaccine a funding vaccine who in year. confidence With from XXXX. is financial in a clinical let Dynavax a in by I the made their and saving This fourth on CpG could world's July to comments. this that, business grantees believe clinical we With leading vaccine advanced II HEPLISAV-B in despite efforts trial with access and Phase Taiwan efficacy life demand, to subunit The efficacy represents. XXX COVID-XX global model capacity E quarter of have WHO, arrangement. more to has expected Clover And subjects based COVID to companies over rapidly trial for discuss trial the this for initiating population, will trial a be vaccine generating expansion Dynavax, up was subunit far our COVID-XX options, the XXXX, of is CpG global Data candidate progress initiated creating continue grantees Biological including utilized results accessible global CpG for very adjuvant partners Health XXXX asset. In a XXXX with with increasing making additional laid the Michael Phase on candidate, study XXXX XXXX. significant a pandemic, India, most growth our our interim XXXX II/III efficacy and least we on number

Michael Ostrach

Thank you, Ryan.

press are issued the included we XX-K are in this and release results the detailed SEC afternoon we number filing today. with financial Our

Full-year from fourth revenue the So, were I to highlights. few HEPLISAV-B to the launch, on XX million quarter net highest vaccine in revenue HEPLISAV-B for achieved the just touch annual $XX.X will during reduction XXXX. XXXX. revenues a the fourth $XX.X of of the up despite utilization net including $XX.X product the for for in XXXX fourth revenue XXXX and for revenue. was HEPLISAV-B quarter million ongoing since XX.X COVID-XX rollout. increased million, of million The Total quarter from pandemic Net product million $XX.X vaccines due million, product

progress to growth Looking first expect we year, national market in sealed in the targeted continued quarter key continued accounts of and share. this

quarter of for the quarter we to return quarter that throughout expect CpG utilization XXXX. half XXXX the adult the HEPLISAV-B currently to pre-pandemic first was first impacted in will of from the of is the of to million. revenues half product pre-pandemic XXXX However, to in fourth of fourth XXXX overall be Utilization of vaccines to the near the levels in XXXX revenues decline of XXXX vaccine continue compared to expected around decrease significantly $X.X in will a result year. first of quarter But second in XXXX levels, which XX%

manufacturing XXXX supply with Ryan mentioned, our for Valneva. delivery agreement year As we are CpG under this commercial

could million We XXXX. the planned at are in planning approximately Agilent opportunity for revenue to between quarter is comment we net supply a XXXX time, we half XXXX, was that near-term to $XX currently $XXX deliveries, supplies Approximately XXXX of in range first the revenue and of CpG in amount in revenue provide With on the fourth planned the doses vaccine revenue. million magnitude beginning the first Based deliver $XX a XX% expect the first delivery the the for representing quarter. XXX of on first for raise CpG million. product remaining to Valneva XXXX for significant want million the with

$XX.X decreased commercialization XXXX quarter of loss Loss for CpG of of to from vaccines. XXXX full-year $XX.X to million million for is operations expenses expenses in follow our compared quarter to restructuring quarter quarterly revenue for and or plan As potential XXXX. fourth XXXX. full-year our of programs. due with $X.X $XXX.X million, It increased million, of an $XX.X million the primarily unit sales to for SG&A for million, fourth the million, include manufacturing cost immuno-oncology $X.X products the support CpG basis. decreased increased XXXX partners the million ongoing This costs of costs not to May, for is to higher and R&D for XXXX compared of in sell the full-year fourth from million to million of manufacturing. for CpG was XXXX operations on year XXXX, $XX.X to of to to of compared in fourth XXXX for the our HEPLISAV-B, quarter XXXX R&D do $XX.X decrease in full-year collaboration compared decreased were full-year of the quarter resulting provide fourth COVID-XX increase R&D compared SG&A expenses from the full-year XXXX, $X.X the sales of to to XXXX, expenses XXXX. quarter and demand use million million $XX.X for to to additional XXXX an significantly, the fourth and does quarter million from XXXX, and full for decreased their third-party for guidance product the HEPLISAV-B due $XX.X $XX for development $XX.X we fourth to And from XXXX. XXXX lower facility as the headcount R&D compared in development for winding produce decreased fourth XXXX the the down expenses million, from reflecting to $XX.X of Cost XXXX on XXXX, of quarter XXXX $XX.X inventory million of cost we full-year million, to $XX.X for

marketable Finally, cash, cash Back equivalents $XXX and XX, December to securities XXXX. remarks. Ryan totaled million at closing for

Ryan Spencer

in multiple our CpG members forward multiple XXXX, in we vaccine disruption B universal significant successful continue We of was data their we think XXXX we like HEPLISAV-B portion XXXX Dynavax and the you vaccine the Dynavax, into today's continue forward XXXX, good Despite U.S. ACIP year investors with now building looking and company. past important Michael. for collaborators. the the progress to addressable a the COVID-XX to to both updating market recommendation to increasing adult call. look are for milestones leading commercial and year, potential our readout commitment vaccination a and all a decision in Thanks, we for B and on stage as Operator, this of goal. open team of including CpG to Hepatitis for would XXXX, Q&A make

Operator

[Operator Instructions].

Matt line question of Blair]. Our first from Phipps [William the comes

Matt Phipps

question my taking year a for pretty for congrats you a quarter good Thanks important obviously and Ryan. Hi, and on guys.

couple XXXX revenues. on some of a of clarification Just the CpG

XX% delivered with first half you supply I in Michael in planned QX. be to First, of think remaining said amount the the the is

confirm wanted that Valneva include more also that to set And the then how I guess, collaboration Just on details could that just grantees the under agreement? is that the provide, you guess, recognition the if CEPI I final or revenue delivered to the the with material it CEPI would when CEPI XXXX you grant. Is you works still CpG it? grantees recognize material, does

Michael Ostrach

Yes.

latter. the On

respect with the respect So, Valneva. was split specifically the with projection to to

loan the and supply planned the with in expect to respect And clients into fourth the We produce quarter. we it agreements deliveries that the available material when of to for then half. then and clients, have With occur the for arrangement, CEPI them. remainder and us first is sell will a their to those in XX% enter

comparable We sell would their the that will the portion we when repay to clients. is material recognize that And we of CEPI that for revenue.

for of upon CpG revenue when XXXX, is delivery similar we it recognize product. which generally So, to is

Matt Phipps

kind can is things I'm say, the to I seem members really is ongoing. opinion, then be can the not of But in sure Michael. given it limiting age any also to limited discussion Great. my Thanks, group. positive you recommendation on yesterday, it ask universal about and pretty if And committee there

I until think would it positive as comes if much looks October. investment discussion would need, you current wait How of through, the probably is How that you if you positive vote well? to have comes the manufacturing? or some earlier, through much scale in would start that

Ryan Spencer

Well, exactly.

a will have through to we so to at it, it looks going is right. are progressing. progress We going of June October, and is how It see couple

we have to a success perspective. think that, product I it a for important is been preparing for manufacturing from understand this

continued be able in we we So, to investment demand could [indiscernible] made any generate. meet we and to improvement that think have

have kind So, those in already investments of ongoing that.

well, I that think continue with a to is bit will take invest to because stockpile be in have the there So and is need manufacturing major little you we an recommendation, see recommendation material, time don't than other ACIP MMWR, as notice and then the enough couple update the advanced months. in just will of a will what which

think for and perspective. I us plenty manufacturing time from to both commercially a of react

Matt Phipps

Okay. if Europe. got And Europe submitting know you're I and I and in then on manufacturing then the Obviously, one supplements. approval more

in think now, it but quickly you advance you as the will How in when yourselves? would additional into you country how just cadence be out is think countries? to year, do legitimately to the target by about try you or So, a Germany, it of end maybe launch another of can do you that procedure, this at Germany start obviously common in many

Ryan Spencer

countries own their that to. like of for which kind access cadence to and of process on have initial want access, pricing, They mean, things each depends we that. I go

strategies the public between matter. and pricing overall will So private

or be as will on comment don't this through strategy. that we beyond But specific we European think move can overall cadence refining Germany. I moment So, we the the countries at XXXX,

Matt Phipps

you. Thank Great.

Operator

next White question Ed comes of from [H.C. Wainwright]. Your line

Edward White

my for Thanks guys. afternoon taking Good questions.

are are be the that about do be coming you question why are market you thinking which when the share Thanks. have And excuse it market penetration, the market that you the of from and when believe how penetration, the you second by about recovery for getting is me, stronger year continue half share are that first recommendations. gather - market to were thinking the how will guidelines you before the increased just, you So, you why would who ACIP like half, talking penetration going of confident and market or more end, than I is seems to are shares? you

Ryan Spencer

Ed. Thanks

first the second see to would But up Donn, and While, he I of answer be market that I relates QX, part rebound the did fair ask we think to by we the did as year's last insights and market about to to fast it question can even part. returning evidenced as how the moving get XX%. the some will

the vaccinated in returning this that the the it to the of of we processing a there is as prioritizing of pent really vaccines Our vaccine who a resurgence adult holiday of that the do COVID-XX. fact is first expectation to over Americans vaccines. majority, other cases are the vaccines, going clear of rollout combined vaccine vaccination year. offer become Hep other half market not demand COVID vast is to as is B the people think saw adult because number will there the QX of well tied of be ACIP that will up has And both for significant the period tied program. majority be with And after

really return will Donn, in mass the is you penetration? year of complete. tied to the half the believe want the So, when more do vaccination comment second on we campaign to

Donn Casale

was to get of we with XX%, at when pandemic, successful we again, it back Yes, at customers month. be a QX the market from look we this and our our to ability that, in points. every QX, look share, Again, disruption we I grew three anticipate, and quarter

the around COVID with being So, is causes vaccine. challenge the the customers. not engage to really It administration disruption is able

half market to first revenue here lead continue be market the to But this in year. year. a second the the share, our certainly to in engage in win do with ability which new of we very to of to continue are we smaller the little customers, can drive we half confident anticipate will business So,

Edward White

the just as maybe market And get safety in to discuss opportunity. and what going targeting market to you how in sales Hemodialysis means And by you're opportunity? and can XXXX. And that thanks. about going you're we know data to if the go beyond really potential year just to curious end XXXX full Okay, that

Ryan Spencer

concentrated the a providers, then as of beauty I provided large obviously, national the systems. mean, dialysis few as and services amongst highly long job, is integrated it health by

And so the make up as have two overall of about our, it we dialysis segmentation slide chains of out XX% national deck, our provide the a market kind in we laid there.

And that so two as And with far as little opportunity, evidence make pretty in easy a at that that the we capture label to how of we of interactions accounts get data providers which the had referenced is their FDA to QX to it will we engaged we national by what happened in is decisions resource that how making the national major ability this essentially, that one their here The have support is strengthen all to this into that data least national the the for a employees as bit will market. centers. you purchase for referred with be for them. our study is used

point, that on are with customers will engage from are we at that. to but at them our Right commercial focused moment, perspective only all the proactively a conversations be our doing now, employees. not because So, we with able

Edward White

what and Okay. to see from give you the us flu Thanks. just vaccine forward? we going question on just last expect me, an And can universal update perhaps

Ryan Spencer

was by development The XXXX. impacted of COVID-XX in program Yes. fairly that

progress. continuing initial I trial trial would that it so, clinical believe the for to the is for targeted be next year. And clinical that,

Edward White

Okay. Thank you.

Ryan Spencer

Certain.

Michael Ostrach

Thanks Ed.

Operator

from next [Ernie the (Ph). of line Your comes question Rodriguez]

Unidentified Analyst

and on Hi, progress on team. taking Thank you the call, for congratulations CpG. my

what recommendations in play supply the mostly Valneva, do [indiscernible] of any of the sure terms Thank you and from contracts in for And guys you. in on do agreements QX, be for have was order that? in these you process? similarly clarity terms - supply recommendations to In fix role that with

Ryan Spencer

with So, let's start questions. the Thanks for ACIP. the

analysis of the support they back at part and steps. The present will they as to see next they questions presentation, this the more did sort ACIP, ACIP basically concept works solicited do they concerns. If look an able you you which they then presentation, go and way the initial off yesterday, from of is can questions laid go be back that like to and and

that So what is is, happen going to next.

here Our this is is of working as group, universal group agenda we a a division engage this on ACIP we our mean, a given obviously Hepatitis involvement working can. But as and I items. recommendation limited.

our involvement in So, we supportive. be actually a is this. limited little bit will But,

You part they the though vaccine as that assessment, can tell are plays. role considering, of X-dose their

And when is so, our present group to to we QX. work engage with the in continue will data, it safety available

recommendations So, to the had the their of appropriate doses. need the we work then overall just two safety deliver Valneva. and part to data X-dose around continue and Valneva the And the recommendation, as we have to the the of around versus benefit analysis really universal products. then moving

readout to only point has that have we we is, all time April. Valneva and coming the we to collaborations of know to of make sort think deliver the I these doses, in just data here trying with have a

and has So, fact adjuvant an technologies out inactivated for continue the is believe has that ability have committed contract they are building approach, to little other the UK to protection. is that, we that the relatively recognize that it believe Government happen that off approach to all to inactivated a us is It readout, data to that data continue they the there still readout and come is forward. but is just move for to risk to there there remains program inactivated their have revenue. really to while drive on that demonstrated there We program

Unidentified Analyst

Thank is you. Alright. That very helpful.

Operator

now like this for questions over back Spencer CEO comments. or time. would I to no floor at are Ryan There further turn to additional closing the

Ryan Spencer

for really want pandemic will we believe XXXX. and COVID-XX these against one Thank adequate additional ensure of role vaccines populations to capacity be all this the critical of require an you, the offsetting first steps, COVID-XX. solutions in the going We Well, sure we effective is manufacturing vaccines. there vaccines effective will evolving is to adjutanted make vaccination Having supply operator. beyond believe plan to

We significant believe market COVID-XX is for year XXXX will we to shareholders. fight XXXX strengthen of man the XXXX through also Operator, opportunity its value HEPLISAV-B of with standard your soon. for transformational growth for to the U.S. believe care and to of to of call. end Dynavax against the the business a also key look And sales CpG with spending be vaccine well-positioned which again for and priority, combined annual will potential while growing currently opportunities continue you B drive over million. drive a in with is we Dynavax. a Hepatitis and us you become time HEPLISAV-B CpG growth today. With adult believe $XXX we And in forward in you speaking a our Thank we

Operator

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

disconnect. now may You

Dynavax Technologies (DVAX) 26 Feb 212020 Q4 Earnings call transcript