DVAX - Earnings call transcript Q2 2022 | Dynavax Technologies Corporation

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Operator

Good day and welcome to the Dynavax Technologies' Second Quarter 2022 Financial Results Call.

As a reminder, this conference call is being recorded. At the end of 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 for Investor Relations.

You may begin.

Nicole Arndt

you. Thank welcome Update Second Conference and Results XXXX the Corporate and Call. to afternoon, Quarter Dynavax Financial Good

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

such trends, may results uses we and materially. summarized potential I are today's starts of today in including forward-looking revenue, market market impacts of involve of our These expectations size that and on timing press but future including, market adjuvant. be and in making detailed report and in Before filings, SEC we of release XXXX section beliefs, and today's and results you These impact not Form guidance, will Factors statements recommendation, potential quarterly trends, and begin, trial and the current on differ advise profitability clinical CpG of our of uncertainties, Risk risks current risks data of and statements ACIP based and timing limited readout capitalization, financial share, to actual XX-Q. including our sufficiency

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

call over Casale, to on and Ryan. Commercial; call today Spencer, me Officer; Chief Ryan Financial Donn MacDonald, Kelly the Joining Janssen, Chief Executive now will Senior the turn Chief of President Officer; Vice are Rob Medical Officer. I

Ryan Spencer

a expected turning insight have to excited that providing team, during respective quarter from our on Nicole, The more Rob for for compared opportunity it revenues before revenue and of we the of last I'm by the I'll core us profitability Heplisav-B for which to the XXXX will review adjuvant. Kelly the strong quarter. short well second the who Donn, priorities, to XXX% overview execution a their and start you, the Thank the quarter has thank over on year. of our Based provide and all second with CpG we've a consecutive track second record of for grew bit you to our highlights areas. continue into today. summary the execute year on is quarter brief progress made total joining to

see the customer to engagement of net the product resulting market driven share landscape in for continue Heplisav-B, Heplisav-B COVID-XX revenue. in Heplisav-B by our revenues. over to in another attention we We're successful globally. adoption evolving year quarter, across market $XX also of second for expectations for paying segments, Importantly, and vaccines supporting We achieved our million sales growth increased close

increases COVID-XX variants in New driven have infections.

However, vaccines death. continue protection to and severe lead against that hospitalization provide disease to

our from for which COVID-XX agreements. between revenue full-year of XXXX our remainder for Our We quarter, orders vaccine CpG efficacy the million, collaborators high vaccines $XXX represents under be adjuvant second that over generated $XXX to million anticipate can and and million and provide with tolerability. of global agreements combination CpG XXXX safety In demonstrated portfolio platforms COVID-XX adjuvant supply the a $XXX immunogenicity their of our supply revenue. commercial favorable XXXX XXXX with partners CpG have of

of our and work and XXXX to partners each for continue beyond. understand We demand potential with clarify to

improved XXXX are we vaccines. advance CpG pipeline COVID-XX, beyond proven new of adjuvant to our our Now leveraging and

antigens. Our our CpG current clinical on adjuvant by existing XXXX programs improvements adding are vaccines delivering establish meaningful focused over to

for execution products markets. on have targeting CpG to ability reflecting Phase commercialize will our data our anticipate X large drastically We strategy we year, of a CpG our produce our the of for build extremely relatively long-term adjuvant, past best-in-class strategy short strong our pipeline successfully growth. Over future Tdap and broadly which adjuvant value we period our our opportunity Heplisav-B. demonstrated financial a highlight the revenue profile, have to and and develop generate few shingles XXXX In and Heplisav-B time, to to grow XXXX initial this expect proud on expanded transformed foundation program years, will of the we're the

progress provide equally We Heplisav-B provide proud value to we I'll details where for our our excited to call benefit the for drive of to performance. public continue will advancements our and turn future now and are Donn health more shareholders. of to on over

Donn Casale

high during retail Total share the increased million dose Two commercialization its dose levels targeted market approximately in the product of Hepatitis This market estimate extraordinary faster. growth the series. the of in protect XXX% I'm Unfortunately, Bavarian same from in completion Ryan. series adults the Heplisav-B's Heplisav-B. complete pharmacy Series increased vaccine from quarter, We This partner, never is results for last more for XX% of $XX XX%, of and last Quarter-over-quarter dose million to Heplisav-B Heplisav-B gains million, the launch highest most patients B In period XXX%. month. Nordic. only in significant period protection. in progress same that an net in gains market with commercial dedication allows share. significant share growth up by by and and three $XX increased to market revenue proud in continued series was from $X the and supported revenue share by from segments XX% increase revenue essential Germany B total make you, adult Thank since and year. U.S. second our FDA only in share revenue approximately our work while first were easier launch, up is QX generated Heplisav-B doses includes two quarter one of of last driven during can a field segment. the single vaccine XX% to the completion the year, by hard our thrilled second team approved year. Hepatitis extremely quarter completion

These represent top over successfully now with purchase top chains, the we have During the with top Hepatitis contracts chains. QX, chains expanded of in this opportunity executed and all commercial engagement XX pharmacy XX% B retail market our retail segment. national XX

an to Universal view as Recommendation expanded increased driving the for significant Additionally, marketing leverage working pharmacy and sales that driver B several immunization a Hepatitis B lever Recommendation ACIP by very this customers initiative. growth across drive we implement continue Hepatitis and market. We're believe executed Universal ACIP vaccination Retail to with the our pharmacy will stocking to and chains. us interest the express initiatives retail and excited a vaccine and progress critical in to expand segment be

national increases Heplisav-B. unique We option Recommendation IDN we conversion several only adoption QX, accelerating and dose clinical two of segments. that Heplisav-B systems believe significant Another Network important Heplisav-B. or as in Universal is Integrated were segment hospital profile Delivery to QX an the to era of share In to led convert IDN top the to was in market the able

segment. We within are encouraged by positive continued uptake this the momentum and anticipate

increases trend was we B a the pre-pandemic returning see positive continue mode. XX% down we levels. the pandemic In estimate from market addition share, market that B to Hepatitis to in market utilization from Hepatitis in In QX,

Booster at for ahead level utilization QX of in market Looking near ongoing remain remainder to the due seen the or campaign. COVID-XX QX will same the year, likely

gains ACIP's approximately B awareness growth further against seasonality. with in Heplisav-B commercial years. a million by We grow year and growth team's our for majority the well due ACIP Hepatitis share some to receive based age and We're significant of market the that XX all in Rob who estimate adults time. vaccinated the profile through driving annual you ability recommendation, for over continue share a market and long-term continued significant brand. catalyst should opportunity proven positioned to expands pipeline. of the for fourth momentum typical drive we that XXXX call XX of the efforts execution, be growth to our the the will believe expect significantly continuing take impact also now risk recommendation we on should our may over the years market quarter to could the focusing strong in market ACIP Heplisav-B. and Compared we I The B. to expanded We Hepatitis result market which in coming to over the remain believe recommendation, anticipate B clinical our confident adults clinical forward commercial With $XXX growth utilization in to number to U.S. vaccination be look to Hepatitis turn to generate will a recommendation prior secure to

Rob Janssen

Thank you, Donn.

vaccines. in of from concerns, results will reported Our that our and and the symptoms of diphtheria challenge differentiation improved demonstrated expected begin conducting data data vaccine without an nasal were ongoing a consistent quarter well Pertussis of colonization to the studies of that evaluating CpG early primate in disease interim same believe meaningful study XXXX or to XXXX. pertussis, conducting fourth clinical our are data the continued from was Phase pertussis a immunogenicity trial tolerated Tdap study We're vaccine safety and currently the vaccine studies advancement progressing also non-human year on We're impact the adjuvant. Previously, nicely. These candidate. trial Tdap prevention we are that the the X and with generate utilizes Adolescent are candidate adult bacteria. assess expectations and Tetanus, support support shingles existing we later that the from this to expected clinical

reactivation compared to marketed a trial safety, vaccine to XXXX in our immunogenicity responses, strong line data XXXX. key cell shingles available commercially our tolerability, CpG program. completed vaccine countries. study, the controlling Now States Top improved the shingles Shingrix, enrollment zoster on our with in in X the the to has United anticipated vaccine providing of the moving clinical potential and candidate this We while that from which with virus believe recently CDX evaluating We current quarter tolerability fourth Phase are other and in T compared elicit product. are of ongoing

of and important candidate clinical to is opportunities our needs. CpG Kelly to and over quarter the our now proven enrolling in month the confident develop vaccine a in results Department pleased of improved guidance. with to and the strategy the immunogenicity, profile XXXX that financial anticipate the review trial and potentially Defense. we pass U.S. by clinical tolerability participants first adjuvant. to We're call advancement our second candidates Phase The addressing candidates significant plague being I'll XXXX trial with new evaluating conducted and of our medical clinical CpG funded financial vaccine have X Lastly, this XXXX leverage unmet utilizing our collaboration of safety in the

Kelly MacDonald

for report prior-year the versus refer then period pleased financial Rob. highlight note unless guidance are million and you, press for $XXX comparisons release We're XXXX, revenue Thank performance, and a closing the on updated the year-over-year. delivered full-year financial quarter very in in strong XXXX about provide our progress detailed our financial of with second few performance. XXX% excited revenue now of also to Heplisav-B all U.S. and another total extremely Please to the that noted. Beginning the the I'll additionally XX-Q key Germany. items up commercial our information. financial quarter of we I'm otherwise and of thoughts. Please review

million, marked $XX The sales million total and Heplisav-B another second in including quarter the significant record with of of approximately net commercialization for Germany, $X quarter XXX% represents year-over-year sales breaking associated franchise. growth of

Valneva. CpG global with in we supply revenue associated margin achieving adjuvant XX%. gross XXXX under $XX of at XXX% approximately Additionally, portfolio is with this revenues in CpG COVID-XX the commercial million a continue with adjuvant final our vaccines, for supply million Included agreement delivery our commercial $XXX margin agreements to amount execute in across gross of XXXX

Now turning to expenses.

adjuvant research advancement vaccine. as development the of X and reflecting of contract and our in with quarter DOD for Our second $XX Tdap funded pipeline expenses in continued shingles, well programs ongoing our Phase an million, were XXXX plague for as the

G&A headcount second the investments for to focused growth year highlighted. field second we increased multiple coupled by to ahead, very expenses drive and quarter marketing driven continued compared by in of last our forward Selling, and million XXXX the pipeline end of sales potential are $XX in clinical across data primarily increased with to Rob of across $XX quarter million, look Heplisav-B. the year our the administrative general by Looking to for encouraged catalysts progress the and portfolio as

to Moving on profitability.

share For $X.XX basic XXXX, the second per generated share $X.XX GAAP $X.XX per of net compared of and per the GAAP diluted, quarter second of basic to million $XXX or income net quarter million, we $X.XX per diluted XXXX. or income $X share in of share and

sheet raise balance without Now equivalents balance to the to is the core to sheet, including robust We quarter $XXX ended business of we need believe level additional funds. second turning this million. a of and cash cash, capital the support with investments our sufficient

operating financial the full-year the gross reflect to we million And commercial clinical approximately firm XXXX year, to These Thank expense pleased Operator, supply to you catalysts capital are on XX% million margin guided would portfolio, another including associated across with $XXX like of our refine with call. for value. to our $XX interest expense range anticipated $XXX revenues XXXX. the expenses a agreements of of pipeline the our previously for I'm portion to both Lastly, to $XXX remain economics for of consecutive for revenues clinical in guidance, under attention the shareholder range selective orders and SG&A million profitability. between thoughtfully million. year for CpG expenses track of the our open advance in now guidance our your which second of long-term we today's year R&D record approach $XX reflects disciplined drive $XXX commercial and today. in XXXX on allocation, of everyone We Q&A with our growth reiterating million focused million, adjuvant continued and progress remaining million. to approximately to our investments drive refinements $X assets, our to meaningful Heplisav-B great

Operator

Instructions]. [Operator

Your Sachs. comes from from first Madhu Goldman line the of question Kumar

Your line is open.

Unidentified Analyst

shingles Hey, this question. CDC were taking congrats We on wondering we data were And what quarter. like just And for the for gains Madhu. the of XQ sub one driven Thanks immunity? like the and is prescribers? on of revenue deeper just for by extent a Heplisav-B what good Rob terms to among our versus Tdap should markers more recommendation in use from additionally, question key look

Ryan Spencer

Thanks, briefly. Rob. I'll one answer the first

ACIP would how bit supported to on market growth, little has will a recommendation that expect that market Heplisav the The share? Given commentary primarily in like recommendation the are Don, in you to time. share. gains we for take some tied to market increase more provide ACIP more

Donn Casale

really and field decision Yes, event around leverage market us a absolutely. stakeholders with created back What market the with the recommendation allowed It's has share. engaged customers. to done team for get and to critical makers sales driving

So at highlight clinical be provided a that to really allows and it dose benefits starting reality. least is important done of that the market many true what now, that Heplisav-B. us profile our event, the also right really in will universal that to of customers has are And how two realize

Heplisav-B universal And what's right that driving So that's folks share. using really the that market now. event that to can market vary is

Unidentified Analyst

And around shift? you what then, some Rob, mind providing would for context expectations the the data releases

Robert Janssen

Yes. Hi, Rob.

to our Tdap, for at compared what pertussis is adjuvant XXXX So antibodies antigens boostrix. induced by CpG we'll be vaccine looking to

Tdap boostrix. be that's to at that over that of XXXX we'll certain induces a to be first package be of a tolerability addition, In package we'll addition the similar tolerability comprehensive a that And looking of data of time. the developing

CDX data see For shingles, what most importantly Shingrix. to expect immunogenicity we but compared will data, be with

Shingrix differentiate addition, tolerability we In there will is what critical from us going what's be and think to data.

for able with formulation find very has be equal Shingrix, to tolerability and So better Shingrix but challenges efficacy a confident tolerability. that having we're we'll to is that notorious

Unidentified Analyst

Thanks.

Operator

is of Ernesto question the Cowen. from next Your from Rodriguez line

Your line is open.

Ernesto Rodriguez-Dumont

my you congrats Thank taking the This Rob's Heplisav. on team. follow-up And quarter. on Hi, is a to for question question.

how think -- remain Given should that, be most to what the of that expect of that to effect are quarters? the the share, in utilization the year, rest the next vaccine market will have the that the couple adult of magnitude for gains then we flat but the growth would on you related that

Ryan Spencer

financial still at the this Thanks, Ernesto comfortable the of we're half for writing guidance the for Obviously, Heplisav. question. second for not year point,

the the to accurately, your But revenue with we trends pleased market We And knowing share each another driving COVID-XX gains where quarter market to levels. pretty take to date, expect the attention revenue Market perform. do on big return a we're quarter. there's to QX annually, variable are previous though, we're provides driver return point each focus the annually obviously trend, to for where, there to is while how but still got can draw try trying that to share we the of continue to you've from think out the booster to expect the vary. the I sizable quarter-over-quarter we the programs predict we in brand. see QX,

Ernesto Rodriguez-Dumont

That's I year orders Thanks the next have Okay, about for guidance or or this expected do that. you're know their their for they've more also their what team. or directional for prediction filings? how or in But less how helpful. filings year and Do provide in And your have you do about think the as partners sales know not you and be CpG. more? like is -- been any progressing of same to less sort regulatory you like

Ryan Spencer

I that we to vaccine Yes, give I prediction. mean, landscape I around variant COVID eventually you government moment. with the from continues And policies vaccines and and we programs potential vaccines. evolve, I supporting dynamic the can't boosters, is, a and to think very give future that evolve that can the at observe based will all all that's know can move you the including facts And to obviously landscape. the how vaccination

in one except executed revenue with pandemic we for We're your I guidance majority our draw in And for represents to for in -- 'XX. PT can and which orders attention have that guidance, the XXXX. the only as that supply, of that think we I our noted ended one biopharma. our revenue contracts, we is the thing recently

our And satisfying can noticed identify 'XX. second amount into a that a continue I'll developments, partners, any potential another do adjunct and in I demand supplied carry So point there's get XXXX. across supply if our been them of we 'XX large collaborators demand for you to in we work some into directionally with look believe, which just

that just factors, dynamic And boosting. approval develop that E where corporate to a recommendation filed EU which advancements to opened continue have biopharmaceuticals for. program. second then pathway continues the biological all they a across immunogenicity support has And but also briefly, the long-term progress they they've continuing move for addition with to of got heterologous those The So submitted And path to it's half to WHO recently the has in and in based China. their bio regulatory E be for both program. obtain pre-qualification approved down year also the of data in is advancement to on India, make to forward made within up they pretty clinical where also

So there's the movement in across definite progress. collaborators

other I it's as -- 'XX the environment And around market very policy think into hard to will the I that forward of out the we'll a 'XX. see move matter is, predict. fact 'XX do that think the settling at endemic make more and and dynamic innovation we

Ernesto Rodriguez-Dumont

Thank congrats helpful Very you much. on the so again. and quarter

Ryan Spencer

Thank you.

Operator

line your next Your of Blair. Matthew Phipps now. William the from question And open is is from line

Matthew Phipps

good revenue similar taking you us numbers Can Hey, my came DoD afternoon. if in level the in or quarter. for maybe in much of question. you on great least and seasonality? as quarter moderates activity a maybe expect QX of typical at the Thanks a from sense in that how then Congrats QX channel give the just DoD

Ryan Spencer

then out we're comment while to to Yes, be going channel not a revenue make break done. quick able and by

we DoD on have you a know. big accounts a some the had success to where couple in our I of trends commentary in because If let of our is seasonality had DoD. numbers, And based early the add impact Matt, anything in key me historical think

historically. little broad becomes impactful it business, than a had the DoD less grow of we the seasonality As book

seen up in numbers, and historically take there that anything up in won't as summer I of as larger discreetly you'd could the necessarily accounts, DoD percentage. there some when is our revenue is made it but our has it portion surge So a definitely total it volumes that Don, think add? be the place like drive

Donn Casale

as a It's what you piece It's vaccine only so few piece fourth market not you much the of quarter, healthcare where I'd utilization. just the weeks Hey have don't a market given more regarding the much DoD a of seasonality. the piece Matt, sense It's holidays. see so in anymore. add in is

be going just Hepi point to moving seasonality less again, typical So we Ryan's around that that the to fact but the contributor for the that of concept would less say, it's revenue expect, into DoD the of QX, the so a forward. overall market, around

Matthew Phipps

new Is from course That's how options is CPG the biopharma, awesome. guess, the then really and potential XXX. is this that from revenue I Thank coming you. is, of source committed And XXX from for for much biopharma? upside is the really to

Donn Casale

to and and not execution -- range in and specific biopharma, to there for operations. Kelly, Matt. that you have that anything that careful shipments the they're of okay. at there's reason we be included biopharma obviously, to quarter-over-quarter, BT want range. candle, projection. just range, were has The that No, we right if in making mean, anything please general their this, slip add is still manufacturing I Rob is just a to still But needed, is No, if have about is in add? sure to

Matthew Phipps

questions. Thanks All great. my for right,

Operator

question of next from Wainwright. H.C. Our from Ed the is White line

is Your line open.

Edward White

Good questions. for taking thanks afternoon. my And

question a plague the study. Just on

The have thoughts first be thoughts the potential that data month. And dosed in approval. us you path stockpiling? timeline on this DoD on your to is the forward you give to Perhaps can patient any

Ryan Spencer

administration in the we mix stage to intermediate the different be there'll readouts of elements so timeline, that trial. towards into trial. year. of of Ed, there's think move have the before this next It's number component we a timeline, trial. through this end get versus of next a There's Sure. code a multiple I potential bedside The there's

there's So operational elements. some

discussion enabling this a stockpiled not There's a step think, the plague purchase a process. the eventually potential And would trial for product with conjunction utility revenue antigen overall first is we XXXX. way the or for a in do stockpile, of I is data around in the is a, for this vaccine. CpG more importantly, a

a necessarily be not Before threat. given bio we use. would certain commercial vaccine, settings only to a out be could in response an this that to were emergency figure be what in probably the to used going is this path Authorization, would exact

we would of first, on more So we clear the to line the become through forward then to data like get and revenue. potential package can path

Edward White

thanks. a may, if second B hepatitis sales. Okay, And then on question, just I

You what's can in far expectations sales How about in thinking go? as Europe? rollouts the we next us or should Germany. that tell about? recorded Thank any market As you. be up company sales Or

Ryan Spencer

Sure.

So obviously, Germany in underway Germany partnership and is this is very at excited their that launch. now their getting our really about focus and the sales Nordic focus initial opportunity We're with in Bavarian with team.

So I think the that best opportunity collaboration. is to going for drive us to revenue continue be through to

we've Europe a that, from challenging not is transparent pricing perspective, Beyond we've which been about.

best would other countries price create whereas particularly U.K. price for Europe long because a does our new to the here. look bring do We within is different pricing We the countries. reference think United some product strategy lower time opportunities likely next opportunity, to in the have For of Germany, into find a continue Kingdom that challenge for to ways the challenge. not

excited see move opportunities U.K. actively in into So Nordics the the Germany. progress to looking to brand said, like we're at Bavarian forward And I with

Edward White

great. Ryan, taking questions. my Thanks, Very for

Ryan Spencer

Ed. Thanks,

Operator

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

Ryan Spencer

our We a it's combination believe assets revenue generating experienced highly and operator. you of team. Thank

a adjuvant solid and financial our strong product on for provide an profile its of future. emerging based Our technology proven foundation Dynavax pipeline candidates

progress lie believe like say them by it I'd work dedication you cannot of time call. to Dynavax incredible for effort highlight interest Finally, while team. their in forward the remainder this commitment the today. the look I we appreciate throughout our the on our We ahead enough made you be possible your joining opportunities are end repeatedly, and We them us the and the for towards and our Thank to of Operator hard you thank Dynavax. and mission. may may updating emphasized achievements, year.

Operator

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

disconnect. may You now

Dynavax Technologies (DVAX) 5 Aug 222022 Q2 Earnings call transcript