DVAX - Earnings call transcript Q1 2019 | Dynavax Technologies Corporation

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Operator

Good day, ladies and gentlemen and welcome to the Dynavax Technologies First Quarter 2019 Conference Call.

As a reminder, this conference call is being recorded. I would now like it is your host today's conference, Miss Heather Rowe, Vice President of Investor Relations and Corporate Communications.

You may begin.

Heather Rowe

Thank you, Operator. afternoon. Good Dynavax Financial the Update and Quarter Call. Conference First to Results XXXX Corporate Welcome are Chief Officer; Eddie Ostrach, today Strategy me With Gray, Operations. Officer; Vice of Janssen, and Spencer, Commercial Chief Executive Rob Chief Ryan Medical and President corporate Financial Michael Officer;

key cause I decisions that current in of including to HEPLISAV-B, Factors anticipated we call today, and including be the timing are encourage which and actual statements revenue we These with regulatory risks statements we reorder; the section Risk oncology press XX-K commercial related I'll in making of turn profitability; clinical today's filed materially. to results regarding begin, Before the that, risks our statements periodic information, program. subject regarding are expectations Gray. will and forward-looking reports a SEC, could to With sales, of including Eddie number to and timing now clinical advise all rates adoption reviews XX-Q you differ summarized you to profile; and as on These and and of financial events, review. the studies and well as our are release detailed over the that and amount uncertainties

Eddie Gray

you Thanks, today to joining results. thank for Heather, review and XXXX us all our first quarter

the million which line HEPLISAV-B progressing of It net vaccine for consistently is $X.X become We quarter. States. XX% sales with expectation more we quarter. We has reiterate our protected and reported over quarter in believe that expectations. expenses. patients. time, the starting hepatitis peak growth of the of and product indeed $XXX HEPLISAV-B the XXXX. to quarter, adult HEPLISAV-B was first the are of B U.S. to all operations of this HEPLISAV-B only X-dose compares in the than marketing We sales fourth transformation around we the that hepatitis sales pleased HEPLISAV-B operations include our our prevention sales fourth reach sales, with adult Furthermore, B care net define is progress profitable of United $X.X be and standard of in that for medical cost to of can million. million This Today,

Let recent progress. some me highlight

continue to market. customers accounts concentrated launch. targeted HEPLISAV-B making HEPLISAV-B continue market. Whilst customers the the B have we since made that targeted to achievements, HEPLISAV-B. HEPLISAV-B our made We And In who that orders once and revenue convert X,XXX have additional These pharmacy repeat time customers help sold XX% we XXX than contracting convert, compelling, take have We were sold of institutional of contribute X,XXX XXX a top sales to we days. targeted individual to positioned. order. of which reordered X to order, we to believe at our HEPLISAV-B, to have We profile networks XX summary, ordered the established hepatitis them available do see XXX commercial representing underway important adult have indeed of and are doses chains, to after customers purchased an in then have top efforts national to do expect are delivery XX future. its clinical integrated into and not the complex date available they XX top pharmacy of make commercial More achieved subsequently of well retail to the Only the numbers. include: HEPLISAV-B are X% least X and partners. secure

in initiating review Authorization review to review foundations that establish in and adults emphasize the dialysis Agency first with as has expenses beginning undergoing to designed on that May, XXXX. build announced This process In the of bulk expenses. our ongoing dialysis. for on or our expected regulatory that the shortly, is achievements of for in go our to for to Application single-arm HEPLISAV-B European but the financial include the Union, European more The the are use HEPLISAV-B. the regimen HEPLISAV-B In of following: HEPLISAV-B Additional to the Marketing March, marks of renal study HEPLISAV-B first end-stage appropriate will during we Medicines the focused outcome open-label, in we to management study patient strong continue the into XXXX we planned our an position the or patients. disease want detail I launch. expect of enrollment we The of Michael we announced hear are

Our current would expect to be making be completing immuno-oncology any we outcomes, of we ongoing on our immuno-oncology to programs. won't these partner spend determine in commitments the by Based decisions these we programs midyear. studies, and efforts our new outcome on oncology is on until focused making

the followed on of nivolumab monotherapy, in have the study TLR Key safety cell data combination and for X data X with detailing with clinical Phase from with highlights presented presentations tolerated. inhaled patients study, of we concluded following: was head by squamous metastatic two April, melanoma June, for in neck to Phase ASCO, the agonist. and At combination AACR the DVXXX at DVXXX First, recent presentation patients immuno-oncology, the doses we poster Xb meeting of SD-XXX and advanced recurrent carcinoma. well pembrolizumab Speaking in Xb/X annual

dose-dependent for a of target turn over genes Secondly, of And to the levels. by pre-treated a inhalation call measured antitumor nivolumab dose at interferon-regulated activity heavily financials. With DVXXX plus demonstrated to of the group now Michael engagements early patients. I'll signs description of induction thirdly, led that, DVXXX evaluated in all of

Michael Ostrach

first higher of first fees. - R&D associated after percentage inventory are found when our net costs summary products of $X.X revenue the sales of recorded that FDA Cost $X.X HEPLISAV-B this returns, in approval. product the Eddie. XXXX XXXX. compared Thank and other afternoon. financial expensed discounts, sales compared can Net press approval. charge revenue statements the in rebates operations first to the in of quarter to was our issued data components the HEPLISAV-B regarding Further million to of product for products fill, prior to estimates details results be for sold of million item includes of A XXXX HEPLISAV-B used expense release you, sheet incurred quarter and were from this million of We sold for attached approval finish for quarter condensed FDA product of backs, compared after at the $X.X the in XXXX which price, quarter was and $X.X XXXX. overhead first the to sales balance Included manufactured to most million with was

securities for XXXX. that The $XX and We due was the December XXXX marketable Cash, of are product. last XXXX. XX, million will $XX.X and to at now million The term clinical capital full first per CRG. the share future HEPLISAV-B periods quarter general end commercial the million personnel million and and a cash increase quarter of or to reflects exercised for additional million and manufacturing programs. $XX.X loss XXXX, of increase first the equivalents activities. $XX.X of This the year. of for Eddie expecting $XXX.X basic in the in quarter I'll compared was our expenses In quarter as ongoing million XXXX. the closing $XX.X cost and our net million March, diluted administrative cost of back immuno-oncology million first or development and primarily basic additional of were for first sales earlier-stage compared produce we increase quarter, turn the to compared sell option Selling, expense development of diluted for quarter first personnel quarter of call first draw inventory we per March $X.XX million then $XX to DVXXX totaled net and was expenses $XX Research HEPLISAV-B of XX, of $X.XX non-dilutive loan the support to for the to trial SD-XXX remarks. loss for share compared the for of down reflects in our existing $XXX.X with at under to

Eddie Gray

Thanks, Michael.

Let me upcoming expectations discuss for milestones. our

XXXX we HEPLISAV-B entering the to expect from quarter, We sales study. with and post-marketing revenue third year. in HEPLISAV-B the increased HEPLISAV-B are anticipate during good enrollment complete the In momentum

to into additional X investigate effective broaden HEPLISAV-B the vaccines. develop ASCO collaborating also on and next-generation And presentations within data poster opportunities at continue we to of We June. use have the so immuno-oncology, makes which Serum our vaccine. updated improve with as adjuvant, India mentioned, We're to in XXXX I SD-XXX Pertussis of Institute

believe exciting to forward looking be and are busy We what will a continue year. to we

and thank take are our all our the operator for to course, I'd will over of it as moment our patients, well to I investigators up it employees turning participating a now our as questions. to Board, like Before open the in trials. who to questions,

Operator

[Operator Instructions].

Rama from JPMorgan. with comes first Our question Anupam

Matthew Bannon

Anupam. is This for Matt on

So just two from us.

can First HEPLISAV, board, so the then getting to one us feedback that at and contract let the some just wondering yet pharmacy kind data and the received for place? recently you from AACR? partners on And factor set delivery in just is remaining DVXXX, not the are those presented what secondly, you networks of what gating on key on on or know of KOLs arrangements points

Eddie Gray

much. Matt, you very Okay, thank

what some big the Ryan to in how process gating these with of will customers responding complex of ask the deal to I and think making and find customers. we marketplace adjustments in and So we're terms I give factors, perhaps examples to

Ryan Spencer

thanks, and Eddie. Yes, Matt

through retail for different in referred where individually basically in go hospitals to also this of you IDNs pharmacy to. and For contract. we That's process a need engage each a highlighted, the bit them is than first particular you

and that have with are hospital of IDNs. group we mechanism purchasing organizations and side, group organizations hospital systems primary for press contract so on the relationships networks. coverage And purchasing tremendous And

IDNs course position far hospitals. - wouldn't process get over that to of than a - the to or via through contact Back be we their barriers to ton able X, not I forward where add accessed the formulary top to not So are of don't going in a different that a a getting away year. the see as of HEPLISAV. Like as to the contract XX the by move to when choose streamlined process us discussion side, the other pharmacy purchase we're with in top suggest continuing X fairly but That's in said, and negotiation a or the we're choose with squared retail to they we contracts. is actually I

Eddie Gray

can description DVXXX you feedback perhaps Rob, And the or AACR question poster. address of on the

Robert Janssen

AACR the Yes, very got from KOLs positive. we was of feedback

cases inhale the cancer? lung of with pneumonitis. very in We safely first part, any you well The Phase It's question We to key. that is for terms demonstrated I about Is can. somebody - safety didn't stimulant a study, can tolerated. with see you

on early In addition, feedback signs on efficacy in time, stable tumor disease, that of example, changes time. we're we positive efficacy, got long-term on tumor the doubling and for including doubling seeing,

that's So very this." develop eager lot had comments couple a of method of of to do a see we a drug." that, how And also delivering you "Hey, about, "We're your comments exciting

Operator

Instructions]. [Operator

Brian next question Our from RBC comes Capital Abrahams with Markets.

Beau Miller

Beau Miller is Brian. on This for

questions study can differentiate first from include HEPLISAV on choose you X differentiation initiated And of other further? HEPLISAV too, into whether that on on I the degree HEPLISAV. What hemodialysis that to And play and of vaccines help guess, on One and they I on guess me. and even what your on not you orders? So hospital Engerix to decision-makers' speak competitor clinical HEPLISAV that how SD-XXX. to point, discussions then formulary? HEPLISAV I can another could with choice degree HEPLISAV the on in versus recently guess or does their patients translate

Eddie Gray

Okay. Thanks, Beau.

challenge P&T the the that undoubtedly that seeing I all we we to profile the clinical process benefits customer the the primary seeing is engaging are contributing and of high to big, is our the And absolutely think, really of being the benefits the interactions. of complex to think made, action. of success product course, assessment of And seeing of formal as standard go part the Committee in that through of then that fact of be clinical that - we're the products we're customers, I rate these were, of product. of future the in Slightly the the success into go benefit ironically, will process short-term customers of into HEPLISAV a I it the further ordering - through So our product very through care central move these we the the in the benefit in more the the getting difficult. of clinical as to process product. the The clinical think the and little makes the

fact a one Although, we're in Because the be that it generation. we'll is the a of all establish will component of why term, parts the vaccine fact X-dose key making for standard the the long the X-dose little care that perhaps case? the add these few to why that's in can actually increases a sense than upon rather institutions a the examples Ryan, workload give vaccine, of - maybe change. you

Ryan Spencer

Yes, around clinical mean, getting clinical - I orders, to to going and frankly, think it differentiation that's the that differentiation specifically is and question make products this back I key of degree the the your to successful. translating

were We approaching market using play are like brands the it contracting commodity. as not a a the as other

supporting be that we're hanging degree is the of it's So that of completely, it continued out that on standard care. and what's eventually differentiation we'll hat our belief

frame. a the all to not fact and on clinical time X-dose value patients. switching from X-dose process, they that the have but only it that with last the recognize means have is As change to relates product around Eddie made extreme the a a deal And including that some to they're on innovations product the point

So that logic to have so there's that able can be written that be updated electronic have be records to to medical they've the interchangeability, doses, protocol or after handle to - series X on deemed X-dose be be a systems to complete. that

Eddie down in clinical the goes sort was regimen that in back point as not just our but protection which dosing rates to, our to is think, variation of I well. So is just making,

causes as some has - complexity both directions, well. like that navigated So it be looks to that and operational

Eddie Gray

Yes.

we it away seeing through of go move the to I also the HEPLISAV, here's moving thing amount short-term, organizations customer, that, here reflect that every conviction think. to say, on in although grows the not say as introduce what of be in whilst is to as well I will both find think us, with people to they frustrating effort HEPLISAV, that I our but consistently, terms people once

Beau Miller

already on guess And the study? I behind the how Is on hospitals guess customer - your order? guess then I on does base? in is rationale study, that fit I the what targeting hemodialysis that to that

Eddie Gray

at this all these dosing additional I the we're starting patients HEPLISAV really so a is these Well, introductory anything? our and label. in We remember like label, regimen in study our label these But thing there add the already and that than I these study that - to you in already require seeking patients, explore have others, Rob, you are patients, the generally the to B populations. not patients think using vaccines is these speaking, patient accurately or different have what summarized would for is appropriate regimen for hepatitis patients. first about look to if is for

Robert Janssen

X compared looking like No, the a regimen, double-dose regimen key over Yes. here XX is the X I is weeks. we're X-dose think vaccine, XX that's X-dose at over weeks differentiation Engerix, a doses which to

seroprotection label, regimen in seroprotection rate. our a it because I their comparable, In do XX%. Engerix CKD we think Not but rate is in X-dose dialysis patients about completely XX%. anticipate higher patients excited much the seroprotection about of we're rate had a

think study. it's I exciting So an

Eddie Gray

I is the to practical look it's study that this label. So population means a our that giving in think patient on helpful is at information way already to of providers a

Beau Miller

to we next program? decisions of PD-X-resistant guide on see neck both at and for guess the I then are data ASCO in specifically data conference the in SD-XXX, how setting? in those guess to more on steps expect to speak And what can the potential head should you helping your I And terms melanoma

Eddie Gray

done abstracts so think and and this. your comments too worthwhile spend on you it's And Rob, that be perhaps energy to would probably people So in fair? were posters, January in address probably much February abstracts the also much the advise bother or I back not for wait that we addressing can too the -

Robert Janssen

so before in reflect the the submitted experience, posters. clearly, cases on they're Yes, our months don't actually the most with presented, in of what's are the abstracts these data challenge always the abstracts generally, are

those X data have milligrams, time who immature, by the are refractory providing we'll those scans on the not all patients still had data. population, unfortunately melanoma be will receive presenting X data We patients in patients be relatively

new presenting We population data will follow the melanoma-naive is those be in and We'll data that presenting that have patients. be population, data poster. the data. and/or We're updated to on also will And also head be population. then X-milligram be continuing the actually PD-X-naive our PFS neck patient we'll what will the and

Operator

is with question Matt next Our from William Phipps Blair.

Matthew Phipps

in Just have you patients of doses regimen? was any in around of or I a then and quarter, metrics also any vaccine receiving kind any just still might inventory bulk but the in on couple if And launch, know it's there were occurred? the compliance HEPLISAV. changes purchases there wondering early pretty had I both the is

Eddie Gray

you Ryan, questions, can perhaps if Okay. those address of both you would.

Ryan Spencer

were mechanism We to don't a some at actually the to relates calculate see possibly we that - study. information have - may process able the being unless Kaiser Matt, as compliance to that's the to down expect be of some sort for study to has not a the yet. system will identical of obviously study on to do we we're just our road post-marketing inherent look information. we expectation. at to rate that's point Engerix not be the But able second We that something rate a but do dose that focus study general that today, it

not yet there. to - have we gather love of looking information that have but we I'd to it, do any ways We at point we're where some were So at information. a

Eddie Gray

doses of The rate course, Engerix of HEPLISAV. issue lower that doses seroprotection key two is a has there, two of than clinical far

Ryan Spencer

right. That's

ultimate three. And regimen we rate But was? of higher series data have metric. will So series a expected that time I second question this that, at - of sorry, we the completion being on measurement completion the then around versus I'm because don't that the X-dose at have think - we do the question also

Eddie Gray

Inventory.

Ryan Spencer

purchases. - Inventory inventory grow quarter-over-quarter, do underlying as but reality the see see well. demand growing consistent We and our with is bulk that's continue to

of the as within And so demand inventory well. as if number on maintain on underlying from distribution you doses of expected standpoint our of hand volume - grows, is number wanting time, that think inventory weeks grow hand of partners certain to to our a

to we see yes, part - actually that's but of So seen growth, completely inventory it's expect ongoing. we've what

Eddie Gray

before, Matt, channels. market, Yes, same said the report far, were entered we large inventory is so on vaccines therefore sort that I as or we've And when the on have there patients management of we well-managed not quarterly that HEPLISAV of of rather picture is of older emerging a this did I think a find can we that - function we the held. we stocks looked the think that with in confident people think look basis, data at being the we as the with than being believe be I activities issues vaccinated and them

Operator

question next and Thome Co. is Our Cowen from with Joseph

Joseph Thome

for reason, I versus available? progressed decided to those My P&T accounts haven't the About targeted make to you just on a us - the progress past is if have reasoning of have give And SD-XXX. not maybe that make more XXX then on or of they that process quarter. it was sorry, have And one what first those HEPLISAV. kind taking the whatever decided not HEPLISAV a available? this portion that follow-up on the to patients HEPLISAV that the bit available Congratulations Can not, on information little not order. been

Eddie Gray

that numbers, in can and them further the to a we've a said is you shape HEPLISAV's to continue say Well for form say, that low insight people or But it's the any very and number. any into pleasingly general Ryan? I give choose feel think actively who before rule, not

Ryan Spencer

tends cases, I'd not going it accounts the - process. avoid In a much into individual it's decision-making far as formal yet. most detail to Yes. as not the where available to But is is going fluctuate. of too it of percentages low - defined number it's there because a be people

or made through accounts this at yeses, where we're people no, a is that no, full don't on a including I had at still - we've product with it available. very time. say either some been important any continuing year, just surprising, and So being go progressed quite time. We're yet and pleased become for that we're the I evidence not that haven't going making so this actually Actually, to on early part, since process. That's the situations have would in the conversions. decision at market over now had they were also made we how And suggest that we because think. have have do decision the we nos this a not that to we've It's

allow we this to That's taking talk variety not - their month and an We're away the we But not at they our figured in price. to price. they the P&T navigating They the particular a One, the issue, actually and and the a So them was back room now reengaged reasons. to had brought next get in that's can we're out and be are when again. P&T setting. drastically not expect no setting it's kept wrong this we've of never the account looking I wrong since to Committee, we is and outcome. There the which had it not right in to no and walk doing. in us be we doing,

I'm imagine of the by occur just means number - encouraged could the situations. that, that you that those So like number of including low is could which anyway, kinds situations the fact fairly variety of

Eddie Gray

Ryan's right. think I

process just our that the actually means rather in still think we're experience decision. than a I be would no

Joseph Thome

are that Okay. you're terms to discussions. indications? in of on in in prepared take and remarks, PD-X to you are melanoma previously indications. know how to partner you alone looking Or X these guess, Are we neck now? of the willing head That's hear. about alone? or I great go of going willingness I of And talked probably the mentioned these partnership then you to populations the in more all non-responsive certain to SD-XXX, thinking wait forward Eddie, some your And the indications, you

Eddie Gray

first are all, any in sure management oncology trying all think, to the I assets, - the expenses, short-term outcomes that of making confirming making understand we partnership make we really I of Well, plans understand for people that including that we discussions, the are think, our recognize and from the indeed in I studies around around the expenditure is new our completion think sure our and top commitments any focus immuno-oncology. not ongoing in I'll that is only priority. of we're immuno-oncology

I different think many subsets assets outside what they or look partner you inside Dynavax, the are and of like of depending which may issue answers there question talk not would individual to. that may or on too potential to

try that today oncology that not to on So we make a that sense me and to I programs of the by helpful it's think we based processes elaborate appropriate decisions midyear expect indeed today. our these what people on or is to for the all on give do probably

Joseph Thome

update the enrollment one maybe Can there? then kind quick on the maybe just moving II of timing on you a of into an portion give DVXXX. expansion And cohorts and Great. just us Phase of

Eddie Gray

more final sort of me we the refer on any than say study to really. I and are for have activities DVXXX, Well Probably today. appropriate any of not I my think in currently the to last answer future really you safety I cohort

Operator

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

Eddie Gray

much. calls. Dynavax. here and in for to us on exciting would very said future for today very continued the you update an like support that you company for look thank forward, I progress everybody to We joining year and much. Thank ongoing you your as I to of earlier, Thank

Operator

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

Dynavax Technologies (DVAX) 8 May 192019 Q1 Earnings call transcript