DVAX - Earnings call transcript Q1 2020 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies First 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’d now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations.

You may begin now.

Nicole Arndt

Jenny. you, Thank Good afternoon. first conference XXXX financial and Dynavax results quarter update the call. corporate to Welcome

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

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

Officer Chief will to Ryan I Spencer, call over turn of Dynavax. now Executive the

Ryan Spencer

update today vaccines reinforces thank and provides We you Nicole on an crisis protection us financial spending quarter review appreciate to The Thanks business given unpredictable mission joining you results. our is world. an global time current all us and in much commitment developing going first world. with health to for on Dynavax’s how of for the for our that

its adult of broad and platform. with And or building consistently higher are HEPLISAV-B and vaccine in expertise all development safety protection potential experience B of adjuvant based a as focus vaccine profile across subgroups. and its significant on outstanding We leading with faster organizations vaccine foundation company vaccine the rates a CpG-XXXX our and commercialization a with on Hepatitis

or for play risk families acutely protect the vaccines the those highest ever, that current the for And protecting at is complications vaccine pandemic. vaccine urgently critical world able any and our than death. in of it is need role aware severe a Coronavirus to We more COVID-XX Now is crucial communities. to

the the its other protect chronic conditions COVID-XX. essential evaluated believe Unfortunately, often those Based of with on with an elderly is risk effectiveness B, be are a that to we groups from highest as protecting vaccines. at rapidly of should component hardest Hepatitis people Coronavirus vaccine and capable with CpG-XXXX

The boost enables higher multiple in clinical to and percentage the to more ability fewer protect of provide to those trials CpG-XXXX protection response the are HEPLISAV-B with immune rapidly of hard a doses. and who elderly head-to-head

and comparator three two HEPLISAV-B XX For after XX vaccine. XX% the only of years were example, doses doses, of in after XX%, to people protected between old compared

in people In higher has be with of fact, responsive obese demonstrated levels vaccine protection living HEPLISAV-B and the smokers, importantly less groups to diabetes. known including to

of to CpG-XXXX to development development We want COVID-XX to important can these pandemic. the and safe briefly touch we and vaccine, support play believe Coronavirus role I effective are a an committed the globally. efforts on the in response Company's

here in have remote worked the health access at for our safety We've California. working patient We effective customers to operations our and headquarters HEPLISAV-B. to ensure employees continuing and while of our diligently implemented operation employees safeguard to

can while manufacturing is Germany there. safety operations, so focusing Our measures facility in they special employing on our workers for continue

interactions during continue this virtual order customers We time. patient, field Dynavax calls to field allow physician, to force of shifted the in by from need to have serve sales person in critical the to

to access HEPLISAV-B. Operationally, we focused on ensuring

facility antigen Germany, our in continue at CpG-XXXX produce the U.S. B adjuvant here manufacturing organization, hepatitis at We our and to surface contract in

the confident supply now can in As a the that market meet chain we are have result, future. we a demand and secure

clinical is while and fully and observational across uninterrupted. have trials affecting biotech continuing studies hospitals COVID-XX have enrolled clinics Finally, Dynavax pharmaceutical to sectors, marketing HEPLISAV-B the pandemic and impacted to of fortunate access post the implementation

an impact orders. integrity anticipate conduct the and a of of Due in data design as the to the to do result place the the not of we shelter studies,

this study complete dialysis enroll expected enrollment to HEPLISAV-B with to patients Our continues month.

of amount this such, uniquely this is of infectious are tremendous by pandemic world's positioned the believe to a stronger awareness we we there's and infectious on a deadly emerge uncertainty And endemic. diseases business caused focus Well, result diseases. Dynavax as of of in preventing risk of from prevention. increased the as the

moving a adult in HEPLISAV-B faster our and with B review CpG-XXXX higher a the vaccine, hepatitis so offers. confident when which we of long-term to market leader. starting adjuvant. is To the our current Let's value business compared are two then and dose on why understand Dynavax delivers rates protection to HEPLISAV-B

adjuvant hepatitis to compared that vaccine to adults months. that B is in Our vaccine the six other hepatitis B month protection offers vaccine only one requires

positioned on this marketing the of profile, along adults the with levels HEPLISAV-B become improved is dosing to and U.S. well in regimen our protection efforts. for HEPLISAV-B standard-of-care Based with higher

from We populations. under growth expect to currently vaccinated market drive significant

HEPLISAV-B's by and data XX% accounts The A hepatitis customer our finally, U.S. Based is major improved B organization and for high initial Twinrix value label segment. overall focusing our and adult retail of our hemodialysis. converting followed hepatitis starting profile is combination in B has well monovalent efforts, versus universe. the vaccine on targets, B optimize To dosing the been as hepatitis is demonstrates a on the with vaccine, market segments the approximately formulations on commercial field then and national that which which monovalent focus current on has regimens three our market leader, patients as vaccine

exposed workers, recommends bodily are on protected or and emergency be personnel CDC who health that all individuals the hepatitis job should The other fluids to blood care against B.

too and a three series. over B receive vaccine hepatitis there required dose regimen complete months, dose not three competitors far are do our many who However, six

other for risk a hospital responders to healthcare must exposure protection be priority occupations market. the staff, of professionals, focus with Effective and is core and our monovalent first win

provides nationally, of health a well. into to clinics we as staff value high and on beyond to patients Focusing occupational hepatitis continue of expand health point the systems segment where entry usage B

hepatitis prevalence five We with estimate efforts hepatitis the majority A our combination hepatitis the conversion monovalent the in of to advance and hepatitis to of A seek retail trip. high national generates B pharmacy to product prior business from pharmacies. the a B with their continued and have we retail vaccination setting travelers that Additionally, in sales who to a traveling areas of

Due who travel a to market. We have to decline this in will out international likely by impact is vaccination events, travel also XXXX. recent the will interest on those accompanied and believe seeking in increased internationally guidance the an vaccine for ultimately do positive travel be

rapid travelers associated will with HEPLISAV-B's historical and enhance heightened the our believe segment travel disease XX protection the valuable against for allows a days. in awareness profile of normal levels. to B infectious ability the risks HEPLISAV-B series business We returns that to option just provides hepatitis of for completion leverage a this protection within consumer

evaluating regimen the sets standard of long-term the We market regimen hemodialysis, for eight by at address this doses study with study are our we a ongoing Results interim XX direct hemodialysis dosing appropriate demonstrated segment. in HEPLISAV-B. XX% growth of positively compares dosing To week population. dose patients the clinical establish up to segment, this undergoing analysis leader conducting rate four an this current regimen believe from and nicely in market after HEPLISAV-B an for seroprotection required the

in the we Europe, increase we the $XXX why development we well we to as other working for identify are foundational are growth HEPLISAV-B we gross have as a ahead, filed for opportunity China, think Based partner the ultimately see see to U.S., on years Europe, expansion a and HEPLISAV-B marketing as company. potential in building see opportunities of EMA clinical over a believe markets. this and in sales. vaccine million application I to the With in market and has and asset with for In U.S. authorization the for overview, some about Outside potential China the leading opportunity can HEPLISAV-B excited we you commercialization.

growth Now shifting additional to opportunities.

vaccine broad are immune CpG antigen. the have goal, XXXX of multiple developing as to strategy research of on at With capability aimed variety that the CpG to demonstrating embarked we We the vaccine response establish XXXX adjuvant platform. enhance as a to a collaboration, a

improved Serum India, vaccine with manufactured first world's CpG of Institute program an program leading the collaboration an by manufacturer The XXXX is on combined is vaccines. of antigens of pertussis such Institute. with Serum This development focused the using ongoing

pandemic, COVID-XX approaches vaccines. of COVID-XX has XXXX we increased CpG In Dynavax’s XXXX weeks, and the development CpG last to supporting for expertise the vaccine versatility, the development XX multiple collaborations Underscoring development. dramatically. these technology demand have span With potential entered multiple collaboration vaccine

vaccine, In development ensure to multiple approaches a and availability successful parallel. developed Coronavirus effective be must in of order safe and a

We to work will is evaluated broadly. CpG ensure to XXXX continue

least clinical and in additional to announce XXXX evaluation Coronavirus included expect be We year. research one we will anticipate at vaccine Phase X CpG this collaborations,

advancing of a the opportunities Dynavax commercial of of Through we CpG development, along the of enter aim this with multiple strategic candidates and capabilities. additional relationships on XXXX. course product and the broad to leverage year, Over increase clinical focused to XXXX can manufacturing vaccine our we utility the number CpG approach, for establishing variety

in with headwinds me first XXXX. up pandemic. in on of were a pleased moment. million, the the will million the period quarter detail the same Let level financial the cover sales which $XX.X given more briefly results, net Michael now in during We in sales touch from HEPLISAV-B COVID-XX recent were $X.X

care patient a their the had saw the only for prior has vaccines been facilities patients. focused utilization continued with significant the most across board. to in affected centers there order on quarters. the medical consistent By reduction and in new insights Since providing During increase most quarter, we routine mid-March, severely restricted of access then,

of healthcare June with interaction our teams healthcare timeframe. We the on are in returning commercial which maybe expected July monitoring to clients or based normal, obviously timing and operations the providers,

good have certain and field planning able they're good have due targets Our to more patient progress customers continues time implementation actually and their on sales as available with awareness to to engagement customers reduced make loads. force and

returns really for current of diseases, the current think infectious setting of share as risk team to accelerate resonates market the the to capturing awareness in on the proposition environment. U.S. heightened We operations. With focused the the stage HEPLISAV-B is value normal our

potentially system. unchanged long-term offer reinforcing disruptions, current The a need Despite better COVID-XX the the the these enhanced. tremendous short-term pandemic for Company's and proposition Vaccines healthcare and value to is preparedness. value remains prevention is

be will exposed immunization and highlight others rapid who the We from learnings to for diseases deadly and pandemic adult that support workers may healthcare of this importance are hopeful our to viral protection preventable. are increase societal providing that

policy potential significant to prevention healthcare positive long-term a The governments, stakeholders, will systems, health. public on of vaccines benefits for impact understand and consumers and makers, have all the

detail. that, With turn over more discuss to financial our the in results call now I'll Michael to

Michael Ostrach

Thank you, Ryan.

results financial in the presented issued are this afternoon. press Our release

provide the highlights touch So some additional color. and I'll just on here key

primarily were by today, in switch existing XXXX quarter from operational customers million, reported HEPLISAV-B million the care $X.X activities and the sales of HEPLISAV-B net placed $XX.X to driven recorded as higher substantial of repeat we first quarter As required completed the increase sales providers orders. first volume, XXXX, for health additional the to

flat COVID-XX few quarter more see guidance, of QX. to QX to our track in pandemic sales revenues roughly continue reduced until March. had resulted previous began We including likely to increase to utilization on is to has first impact returns Although, last been to targets up compared of we which QX the until the significantly annual in of achieve underlying normal over ended the weeks conditions. HEPLISAV-B, The vaccines, U.S. the and

expenses Research XXXX for million of of $X.X $XX.X first first and the the quarter to quarter for were Development XXXX. million compared

first decrease quarter, stock-based in R&D winding following down our and This quarter the the expenses resulted million the $X.X first our million R&D compensation, reductions non-cash decreased in XXXX. of compared May from to of restructuring. significant programs immuno-oncology in headcount is to $XX Excluding

non-cash million in overhead increase quarter at marketing The $XX.X quarter were and XX, the expenses from SG&A Cash, to to to marketable allocation for resulting first to of was equivalents compared cash XXXX million costs HEPLISAV-B first March in post SG&A and the costs to related increase XXXX. and for primarily securities $XX.X facility totaled the due restructuring. XXXX. an compensation the changes million related higher study, $XXX.X stock-based of

of Until in the challenges was The pandemic. our few sales quarter by weeks the remarkably ever. way March, most successful, our last to we of created were on particularly quarter past view successful the

We to necessary agreement. have loan already satisfy achieved and the current year's the revenue revenue covenant the

we adjuvant. a And multiple restructuring. the advance to completed as efforts substantially have to establish XXXX established collaborations our rapidly leading CpG have We

call the Ryan. back I'll Now turn to

Ryan Spencer

Michael. you, Thank

represent public As to highlighted a represent system. infectious making long-term long-term value health. for business events, steady healthcare by also threat for tremendous the investments. recurring for they offer Vaccines recent revenue, a the potential to significant tremendous valuable diseases opportunity And a with

and clear that vaccine the large FDA market current approved Dynavax future for is long-term drivers well with positioned has an for opportunity a growth.

rapidly vaccine diseases. In multiple believe and CpG there pandemic opportunity in our XXXX we expanding is endemic addition, a for adjuvant

While we we initiatives the we current of expand impact final HEPLISAV-B immunogenicity commercialization to several also including this milestones to for year fourth track ongoing mitigate advance with for closely the and data in on working of XXXX. monitoring, in of on CpG advancing study year. the This the hemodialysis are execute pandemic, HEPLISAV-B to quarter in of important remain evaluating the continue patients opportunities expected

safety XXXX, post which studies of for preferential ACIP HEPLISAV-B XXXX. QX follow up completion of recommendation The supports marketing consideration by in a in

of finally, on vaccine Completion and to candidates one vaccine as toxicology expect with XXXX pandemic And Developing X XXXX multiple we in vaccine a CpG studies enter a relationships adjuvant. research XXXX. adjuvant strategic variety focused Coronavirus an of X at pertussis least leading establish a CpG additional Phase preclinical enabling animal CpG improved in study. as to for clinical Phase

their the for purpose. leading aligned years members preparedness as ahead, We for infectious to a we into company. better team Dynavax all globally mission commitment build for thank the vaccine forward will look and that accomplish over pandemic prevention together all with and course disease. we The XXXX reinforcing of COVID-XX to our the And is and Dynavax We need shareholders is Dynavax.

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

Operator

questions do of the on our Instructions] first & from [Operator Company. Phil have Nadeau We Cowen line

Your line is open.

question. your ask may You

Phil Nadeau

A Thanks maybe COVID the taking then vaccines. one and for on question. my on couple

get about and places, the impact customers many or in on people busy convert accounts because the efforts as that effort? of Can on said have What down? to also dealing COVID, down? First less formularies systems are has appreciate is to the that continue your healthcare process slow of working I converting with you virtually COVID utilization are the

Ryan Spencer

Casale, question. at Sales I'm that and Donn. to to answer ask Donn Marketing Phil. Vice going Thanks, President, Commercial

Donn Casale

Hey, Phil. Thanks for that question.

found are actually more our that given have meeting. the customers and many now, load time found and demand. of that they remote we and virtual very So, We've to stakeholders are – open patient limited many

make lot a there, mainly a success. And of around there's so to the been we're because patients able that finding Again, progress lot we've fact of no implementation.

able all the is stakeholders to to virtual all, continue a sales in key standpoint, and HEPLISAV-B. the from and team So essentially cycle for engage with advance get

Phil Nadeau

and models as reduced.? what significantly for Understood. QX? you I Then COVID you second said that our any significantly adjust impact give appreciate on question QX to us is utilization look sense Can and is we is, reduced

Ryan Spencer

return Yes, Coronavirus the well, how to policies. not we're this since to at on government's in a State point normal dependent position progresses and predicting the pandemic Federal market will its

So systems June begin our services to open will up traditional large July. more health suggest interactions or in hope clinics with for the our to

comment the So it's can this it's beyond impact as not to on we something as really point. far or quarter how going

Phil Nadeau

be Okay, Phase milestones, X they by vaccine. could of last the X fair the the suggested of or in then enough. your you Coronavirus partners end mentioned trial for And XXXX? question, Can in remind us which maybe you have Phase through

Ryan Spencer

to sort Queensland earliest clinic meantime. the be have targeting University identifying But Clover really that in as at I funded number XXXX. of would for we they we X, opportunities I think in do are The the Biopharma publicly, although can't us. continuing least and of timeframe, Phase remember program, been work said mentioned, by of – I Sinovac a we collaborations in earlier kind also CEPI targeted other believe both of And what there's specifically. the has In being on

Phil Nadeau

Great. my questions. Thanks for taking

Ryan Spencer

Phil. Thanks,

Operator

from the another line have do that question from of Blair. We Phipps is line William the Instructions] Matt and from [Operator

open is line Your

Matt Phipps

taking question. my Good afternoon. for Thanks

up First, guess scope] to following COVID-XX [our vaccine. on the I

works preclinical like on they XXXX next adjuvant. obviously preclinical published alum only take if just then the think this would How They that move alum your step is does Something an CpG forward, using how data or additional it they like one you and they or would somebody understanding Sinovac. both and studies do -- take them? for run

Ryan Spencer

I'll to of you're need traditional of in happening a mean, speed used to. Well, are And I development a to at drug that not I things at. recognize is develop these it all have think Because a there's we're the -- comment. parallel. generic things lot there into we which make sequential

do the realities, enough be I the could So there's products, in of here it this. critical would dealing each ways, having be adjuvant. you're supply when elements circumstance, the In Sinovac sparing different on in obviously dose expect because depending believe interested we they would inactivated many relevant really is with

so it's do or some Matt to speculate hard that t and And I immunogenicity just it it's now protection beyond on adjuvant think from would data. which capability so they will depends he so despairing it for looking goes make, that because results. likely be

Matt Phipps

Yes. impressive. then at they consider on DaVita having Thanks, label really separating the or interim was that can just Ryan. showed and you want obviously And there. really the you and next or start before it guys that recently enough what’s to really do in who process Is data they the analysis with steps least Fresenius conversations

Ryan Spencer

not a will and conversations commercial based perspective having study. analysis Fresenius we with DaVita from No, on of be this interim proactive

Our updates a proactive be from the perspective dependent customers on commercial some those conversations label. to will with

data is reality reputable be of like scientific about players the data control with we will the forum. we do who market, the made we're in likely the will think I XX% available, others talking publish two a this

will will broadly, promoted And be be not it us. by so but data the available commercially

Matt Phipps

lastly, this Michael, R&D quarter. big obviously then in a And down Okay. step

there's two trial? mentioned kind I-SPY it's the guys or and a other IO you forward think maybe or another there things you base mentioned I a wrapping lot of now You of that is going mean, headcount know have of quarter I up. just

Michael - A Ostrach

treatment combination I carryover. completion study almost we oncology that's finishing, in completing of all with and will trial. SDT-XXX the always complete and I in were the We mean, there's this our investment so Yes, just around year some think I-SPY

reduction that a the until cash sales and going in we exactly range gotten significant reduction on for us would support what in operations COVID unless a clearly first giving to quarter to I to you our the about number. now of forward operating the were in not quarter expect million see can So within to basis am recall you expand and it's for spending and R&D I more vaccine. the -- going in market down you $X.X a of But commit

Matt Phipps

taking my questions. Thanks for

Michael Ostrach

our is contributing because with limited interrupt collaborating just who and It's currently, investment we're their advancing to CpG expertise we're currently, XXXX. others programs are in our

Matt Phipps

Thanks.

Nicole Arndt

are there Operators more questions? any

Operator

are further no There presenters. questions the on line

Ryan Spencer

Okay.

Nicole Arndt

All right.

Operator

and conference call. Ladies today's gentlemen, concludes this

us You may joining for Thank disconnect. you you now And presenters. Goodbye. today. thank

Dynavax Technologies (DVAX) 7 May 202020 Q1 Earnings call transcript