DVAX - Earnings call transcript Q4 2018 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2018 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to introduce you host for today's conference, Ms. of and President Communication. Vice Rowe, Investor Corporate Relations Heather

You may begin.

Heather Rowe

me Good operator. Financial the With Officer; Gray, Michael afternoon. the and Chief of Dynavax Financial Rob you, Executive Results are Officer; Chief Ryan Spencer, and Fourth Call. We slides Ostrach, XXXX to Medical Year posted website Welcome Thank Janssen, to Eddie Full slides Quarter Conference Officer; Operations. be Chief also and today presentation. can press Presentation. The section a Vice issued President Investor found Events under under accompany our Commercial afternoon and release Relations this this

periodic we Before differ are materially. a section SEC, cause to number and advise review. Risk summarized turn clinical financial to be will over current information, uncertainties Eddie. actual of XX-Q These expectations, results in risks subject detailed risks the making to I'll and key we press XX-K that the statements forward-looking begin, filed and are are release you could of call including to These our we regarding I and encourage reports statements in statements with anticipated that Factors now today's events. and which the

Eddie Gray

clinical review quarter the HEPLISAV-B everyone commercial you joining you, and for for both an execution program. Heather, immuno-oncology Dynavax, XXXX Thank thank important program and XXXX was our us our today results. for year to fourth full year SD-XXX of and

highlight prevent year. from be and accomplishments on past stimulate developing cancer. can that infectious seen X. TLR backbone built and to I'll the that an immune backdrop, treat pipeline Our discovering is Slide disease system now Against the this in key The of on expertise pipeline agonists

HEPLISAV-B it good XX-person protection B on [ph] It standard the higher offers over advantage in in field team you market of Slide target only to for XX% rates B Namely, hepatitis than launched clinical sales leader two-dose adult more is is a as vaccine become First consumer the protected reason. patients, head-to-head that adult XX% vaccine, the consistently and over hepatitis studies. with see from poised covering has HEPLISAV-B demonstrating can We care competition. the market. of X, XXXX of

shift we market pay revenue-generation. establishing base are within a Our competitors stable accounts, beginning future term efforts to from off share of our are to institution ensuring a and long solid

quarter. for than This little some as a Slide be on highlight $XXX around gross can that net X. me $X.X HEPLISAV-B Let reiterate reported we shown million Today, third We compares recent the to HEPLISAV the end believe January. in quarter, operations million. more that we wins time, sales of reach provided expectation the our we HEPLISAV estimate fourth $X.X the over will U.S. sales of peach for year million profitable the by and of

very goal, our institutional are vary. While annuity. time by a in entrants repeat which into the process they we that orders each In and we know and large pattern, settle of we XXXX, follows fluctuations predictable timing position monthly new Overtime becoming Each should quarter year-end influential. associated purchases lines the customer an with rate purchase growth also are fluctuate. still quarterly will unique expect confident a customer and of like thus though, something their make more

Now annuity the XXXX, this to power in continues whilst is of trend genuine the obviously, beginning overtime. grow

more HEPLISAV-B. customer recent sold purchased purchased purchase. today individual the progresses than of In More customers the we've repeat some discuss me XXXX, each by X,XXX XX% doses of than that made. were let So

HEPLISAV-B January, in in all announced pharmacy Club Sam's of previously became available the locations. As

in to pharmacy secure chains ensure building step are an and pharmacy growth partners. In top market. our important under the addition, of toward we four have to efforts way represents future These begun diabetes sales the two pharmacy presence retail additional into winds and contracting support national

state our we health defense customers, of corrections, well other Beyond news multiple large January. in departments as departments where reasons through became which operational adult state as departments of pharmacy county retail CDC for and vaccine program progress, have including the

we've means In P&T XX XXX top the our accounts approvals call, now addition, new in important top XXX XX have point accounts, we had through process. our this within the November since of passed which

growth appears increasing As potential. approval represent Slide Within X, fairly and market, target stable focus we've excess to of million over revenue at around In In of the areas once this moved of X last we're diabetic the the to in can customers, X.X total we gained and to week, compliance on in United vaccinated our market you in market on share are pharmacies, that adults XXX XX% P&T we've three they patients. States, sustained and market million who believe including growth. drive summary annually B. well-positioned second-dose see hepatitis as for against retail be

can we I'll a an Johnson program. over our commercial have annuity. Medical and clinical We call established the turn discuss convert concentrated Chief Officer, an Rob compelling now to market to immuno-oncology into that the profile

Robert Janssen

Thanks, Eddie.

optimized intratumoral neck pembrolizumab patients several with candidate and studies advanced to assess clinical with is agonist head carcinoma. Slide the as X. safety its cell TLRX study melanoma X in and in combination SD-XXX, the includes with our anti-PD-X shown activity. Phase We're patients in TLRX on Our the and agonist squamous lead therapy evaluating This this

the consistently tumors. are agent abscopal in in combination the to SD-XXX induced lymphoma files has clinical therapy benefit study, patients. single with this SD-XXX as of that in pembrolizumab current therapy. demonstrated In absence activity the pembrolizumab, producing intratumoral systemic meaningful any SD-XXX We've responses demonstrated regression intratumoral While study non-injected systemic we of other in by has

There last in metastasis Slide liver. melanoma SD-XXX shown and naïve a year, with X-milligrams anti-PD-X ORR. led a patients X or rate overall including is advanced XX% and in to lesions the in at As on ORR presented non-injected ESMO to visceral response therapy lungs XX%

in In samples. addition, of independent be unselected responsive appear to expression PD-LX

patients additional neck and carcinoma including therapy. squamous from anti-PD-X trial anti-PD-X resistant data patients early with with therapy head or encouraging cell naïve refractory the to who announced also melanoma We and are to

alone than year. rates cohorts. we're seeing X-milligram in see enrollment what recently XX with plan and these trials A can completed X-milligram better cohorts these The You on data later data on to pembrolizumab in this from data reported and XX. both were Slides report were response

importantly, design make combination well-suited being point several the SD-XXX with administered drugs trial of study. We there's locally multicenter controlled Now evaluated treatment locally advanced a TRIAL also indication care TLRX for the cancer. more randomized it's for combination that's X arm to is pathologic promising screen is as of patients. breast women the added pembrolizumab a this end might need. an with a to metastasizing development to also in outcome of SD-XXX SD-XXX available mild the can was high-risk for this be innovative directly regulatory complete controlled lung. FDA and women lung being cancer for identify as to measure the pembrolizumab groups treatments randomized a to remains a breast effective related delivery new of neoadjuvant I-SPY designed other to high I-SPY moderate diagnosed transient, in reasons. agonist well-tolerated response primary standard symptoms. developing treatment being are treatment with the unmet is advanced cancer. or The an study X which Notably, arm. We in new forward SD-XXX investigational The cancer. is We're for ongoing look with for breast treatment XXXX the seeing new and TRIAL events rapidly for inhaled treatments help these for lungs call DVXXX flu-like of a is expedite adverse to newly X This advanced in types of Phase which these how of to intended adaptive specific regions study proposed into which important rate stand-in by cancers sub SD-XXX for and

can the as of to non-small and nivolumab, Xb identify with cell patients the as cancer dose the this You recommended to program trial of study. DVXXX expansion a of safety in combination and with clinical in Slide part lung the We're investigate on well, advanced XX. for Phase monotherapy see conducting tolerability a overview

cancer research TLRX a both a and also develop and agonist, beyond immuno-oncology to Now and TLRX these multi-pronged including multiple agents program anti-cancer preclinical programs, conducting is we're program vaccine programs other vaccine also evaluating We're infectious over it adjuvants. disease in candidates turn With I'll is our prophylactic vaccines. additional that, to adjuvant financials. to discuss the HEPLISAV-B Michael XXXX leverage to

Michael Ostrach

which our to Full quarter or internal fourth million and in development call per $X.XX share quarter our or XXXX includes this commercial year studies our sales, $XX million product now last expenses quarter platform. Net returns, $XX.X per website Cash, or XX, contract million a general commercial fourth the sales Rob. quarter can for We $XX share efforts sales month, this sales back and year converting of charge activities $XX million million quarter are share equivalents and Slides to XXXX. I'll were net recorded totaled for securities XX-month The which closing XXXX, next during $XX.X our fourth full compared remarks. our the loss term are last million at share $XX.X financial to at due to release fourth $XXX.X was the an XX These for of $XXX.X for year. consultants as deployments was rebates for the and sales million million found HEPLISAV-B Thanks, post issued price for compared net in were Selling, his million to totals year marketing the loan for including primarily for $XXX.X the expenses December product to XX, backs, advance period afternoon, today's we year. as loss implementation well $X.X XXXX. for or XX in for Eddie $X.X force call. $X.XX commercial turn product that fourth on regarding the and posted for that $XX.X to implementation results the marketing SG&A from of the total of sales is and services. million $X.XX $X.XX press revenue increases be million, Revenue retention net of estimates Key million force support million to last agreement at compared cash administrative planning for HEPLISAV-B $X.X immuno-oncology from of and full per compared of non-diluted compared and the December quarter XXXX. the fees. per to other to discounts, borrow were and marketable

Eddie Gray

Michael. Thank you,

So we are and solid entering XXXX with growth company. anticipate for the good momentum

firstly expected quarter. initiated marketing in post full study. August milestones, the For is with the and our HEPLISAV-B study rate third recruiting of enrollment upcoming A at was target

this of and beyond an assessing We're use opportunities are the vaccines. half markets the the we file additional United also in in investigating addition, Europe effective adjuvant the broaden into In HEPLISAV-B MAA so HEPLISAV-B of which States year. to plans for XXXX first next-generation to makes

with collaborating later to to of a clinical plan are pertussis The prototype improve year. and India and develop vaccine study We Serum vaccine begin of Institute a this

pharmaceutical the management. options The into important expansion studies. of in of including the inform and the partnership immuno-oncology, best tumor program On with selection front for will immuno-oncology expansion the current strategic companies in for these we set of of number a to of discussions our options, activity the clinical data explore partnership types and our choices priority progression and discussions registrational a are deepening are broadening clinical

will with as Phase clinical capabilities As partners would supporting initiatives in may and partners own in an and prospective in forward with broaden plan enhance regarding we on the discussions the TLRX have program to of interest the take well. X our we that search find that course products programs,

specific potential assets of the So path whilst for forward thoughtful and cannot any discussion timing to value of the on current partner, in is we committed as each drive interests to determining different or diligent I each our form shareholders. are arrangements depending guide to being best and

conduct Our we are discussions lease on There own. that partnering still our plans are ongoing. can

These assessing likelihood a For plan affordable half action the the include mode the in start X-milligram responsiveness these, approval. following to of pathway the two we combination from and will second of we clear high our SD-XXX cohorts, believe year. feasible have a the and we types of that studies with anti-PD-X of prioritize to tumor results to in

And line first Firstly, to field benefits of patients head cancer, in Phase neck for first a crowded. and clinical secondly, bar in seamless is lower the the neck X/X compared and study and head demonstrating a with also the study competitive or with less planned melanoma, line X/X include the that half for to in refractory is Phase multiple associated anal, rectal and year. second And anti-PD-X malignancies therapy. patients a melanoma will cancers HPV finally, including resistant gynecological trial

in need neck and head provided indications, with approved increased has As is other remain in that active there SD-XXX pembrolizumab for cancers. responses cancer significant these or low

As with are for remains earlier, basis as into priority we whilst these the potential [ph], form indicated incorporating partners that only activity. these Dynavax may plant our our discussions

We operator plan is you. Thank to busy to sure cohort to take this We And also our report DVXXX the major I questions, X SD-XXX nivolumab. AACR, a forward escalation before look at through to dose the from study at year. later multiple clinical And present Phase earlier. and including mentioned with finally of additional will meetings milligram results X hand year. plan over X results study exciting I Phase in and what that. cohort a taking to developments us the shall safety initiate be combination to We data we

Operator

with Our first your with Please question. is Instructions] JPMorgan. Rama Anupam proceed [Operator from question

Anupam Rama

of may on data of potentially attention test being any that retention and from come one with to there partnership the up rate set there, the data at the durability high comments of following is interest? about inform on then the Just options. Eddie, specific And at on [ph] and of those that potential peak except HEPLISAV, one mentioned survival Are thinking customers. your points doses you the pretty ASCO pieces

Thank first-time go XX% patient because are much. they customers, are another on from or very time haven't or to So to there's the regimen that have reorder, customers those chosen had demand, no with? vaccination you those

Eddie Gray

I'm was up line right have just there, make the The to going to clarify so breaking we Anupam. sure you, questions. Thank

around HEPLISAV orders data? and the the multiple durability about The later that first was one second between in first Is I the data think orders question in year was correct? balance and the customer

Anupam Rama

customers you. And correct. those That's are? Thank what kind qualifying first-time they orders, of

Eddie Gray

evolution data? around of comment the see we're durability expecting data when Rob, Right. can on you to our

Robert Janssen

melanoma ASNO last be in the additional will is six presented durability essentially follow in we PD-X do population presenting anticipate data Yes. up. The we naïve with This ASCO. [ph], at to months which

this have We at patients point. those fully enrolled all

So trust group the I'm up in they have potentially anticipating at XX-XX are follow-up. we in I X-milligram needing months. -- follow we'll that

Eddie Gray

could HEPLISAV you the address please? Ryan,

Ryan Spencer

Yes.

had there difficult. a have XX% the to on why are Obviously, Focusing reasons chance is repeat different haven't orders. customers

Some stock order them which time. mentioned in and could numbers customers. have you were to will fact They based have on like a their months multiple for repeat can't expect be you as they not If practices those in first yet. those a month, in-stocking actual be

specifically, a order took had We large who have situation I can reorder speak we enough the but initial stocking either. but had to a to yet on customer hasn't rather chance

is part So big of that the a actually XX%.

XX% do number show range continuing of the the that a new the we're XX% every which part scenario do month. focus think customers customers reorder at as is where with to to having on expected I the very metric HEPLISAV and meaningful fall build first is [ph] to for

Eddie Gray

can is business in greater customers are growth trying I the of time Anupam, in converting to maintaining one ordering. what high over think, investors and HEPLISAV of either rate new in new proportions we're in wholly who time, to converting understand, see this or that their we're But continued point also I the And HEPLISAV in think over by time teething at recognizing customers XX% that. that

customers. new that said if annuity, of machine the may it with is being way, I call So

that XX/XX both I are we of think point It's in parts business quite developments enhancing. this the time. at like the the showing of

Anupam Rama

a That's really helpful. guys. Thanks lot,

Operator

with from your Our Thome question with proceed Company. next Joseph & Please Cowen is question.

Joseph Thome

real-world by similar of to on you. this have maximum or early, is you the Or you everything expansion Or pretty congrats on it that saw and are what pretty obviously that And believe dose study? start that questions as one or take Thank then data but presentation? the maybe going surprising you're seeing my do experience I'll the reached you DVXXX, you time do compliance taking we for cohorts? to I safety AACR in is yet? have tolerated progress clinical HEPLISAV. will quarter. on you the any know with into Thank you

Eddie Gray

for SD-XXX compliance our we've you and can in maximum Take not dose you tolerated terms seen pattern, anyway. But you safety those the on DVXXX again if questions comment. comment Okay. on guessing necessarily and we're efficacy what I'm Rob, of then if or perhaps given can DVXXX, with in data HEPLISAV targeting experience three would.

Robert Janssen

will doing With in They Yes. at to be we looking will or with the Southern data California. point compliance, don't respect this be two. but marketing sales in at were have end in compliance post lights that data, that the a when the year with Kaiser

now we get nothing safety, advance reach and anything With we're highest do The that and of MTD other in right not of be are enrollment the reports with our out to we respect in MTD. to about in safety seeing we we looking seen haven't complete will we an aren't thing we DVXXX, for the past. -- the respect individual cohort whether seeing at enrolling ordinary, dose certainly

Eddie unlikely we'll find think an we As mentioned, it's that probably MTD.

Joseph Thome

great. you. Okay, Thank

Operator

Our Katherine with Company. & Blair next Please from is your proceed Xu question. William with question

Roland Smith

Hi, this on is for Katherine. Roland for me. questions Two

you. melanoma, expect Phase X X the more of the for which your second, for point First, and as own SD-XXX? to neck? at head studies partner is quarter? a this such smaller in be in end a going first do ready likely indication Phase or study Thank operationally by you on still to metastatic And A enter

Eddie Gray

alone a neck point to that to else I going the interest anything really idea view partnership comparison partner differs of and in the what's and from naïve partner. or on of melanoma in from head think on interest relative

in not in obviously to and conversations. a specific be to me for individual about difficult detail position very talk it's today So

are each discussions high of its to to comments, priority PD-X. different the that market company we're own opportunity, discussion how think find achieve fit portfolio, do take do tumor achieve I their each in different are they're when types their in they own assessment they own manner. different confidential these even or or has trying customers partnership as driven we timeline, what very perhaps Each my with in by own factors We to case. As as multiple segments is and their not individual said I in talking

answer I can't general that a provide really one. So to

partnership refractory. and In with final forth X, go indicated, we all Rob think on studies. head Is probably has unlikely X, data the to Roland? every fair, that decision that collecting preparations made X-milligram are melanoma Phase until that as Phase any that the in two currently terms data take those putting of subject ready to decisions final I But see we but discussions. in full would on neck it's X-milligram we the on all place see We're we

Roland Smith

Yes.

Eddie Gray

Okay. Thank you.

Operator

[Operator Abrahams of question Our Capital Please Markets. your from with is question. Brian Instructions] RBC next proceed

Unidentified Analyst

and Hi, for for thanks Congratulations this on is on our [ph] Bert quarter taking the Brian. questions.

reached uptake your there into be now the approach, HEPLISAV sale, born. you. patients or formularies targeting? you've should the current on including then this are to thoughts new for increase any modifications HEPLISAV-B Thank As expanding all plan remaining point interested potentially additions we'd label implemented your in being that to for inflection And with the you're in and younger

Eddie Gray

Okay.

please? can that, On you deal the commercial Ryan, purchase, with

Ryan Spencer

we approach I the believe interaction. obviously are I how but But making approach your no our We're massive customers engagement No, our we say on of and point constantly the changes but large interactions always the with Sure. some each minor field improve and not the there learning's the element learning is our marketplace. we adjustments can based are efficiencies effectiveness to marketplace how that strategies, There question from to making to structure. strategic is and would a the and differences, major changes of to major change. there's

Eddie Gray

I there expanding adjuvant B, traditional On HEPLISAV at systems the infants important to adults. when vaccination are for of immune two more than far issue of alum things think firstly, one responsive infants' the looks use, to remain hepatitis remember:

rarely we available multi-dose a given as readily in isn't is difference that vaccines. a and vaccine. vaccination; hepatitis component part very as bring the child benefit in children secondly, could So with of to forms this monovalent significant It in adults marketplace B

we've out response were a these which the if I even think the but multivalent switch to to vaccination create B slightly unlikely, of that always uncertainty B deliver schedule. some rest response, children in public of felt slightly-better hepatitis policy get in degree it's better and we vaccines to able of hepatitis

reasons, felt are. would those we've we always unlikely I for think it So heads vaccination ever and that still that's see think our I pediatric where

Unidentified Analyst

Great. Thank you.

Operator

would remarks. And Gray, back we're no questions turn for I Executive Eddie to at time. Chief further Officer, call over showing the closing to this like

Eddie Gray

updating XXXX. today. for I joining really for continued very like our Thank We just forward thank for would future Thank very calls Dynavax. support your us as today you. look to your much of and progress everybody to on time interest you and for you much

Operator

may Ladies concludes and your today's thank program conference. in you participation the gentlemen, This disconnect. now you for and

Dynavax Technologies (DVAX) 26 Feb 192018 Q4 Earnings call transcript