BCRX - Earnings call transcript Q3 2018 | BioCryst Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen. And welcome to the BioCryst Third Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. John Bluth. begin. may you Sir,

John Bluth

website. Good Staab; update welcome Powell. call. and accompanying Sheridan; Jon Commercial on release Ashley. me Chief call quarter are and Medical today Today's BioCryst’s Officer, XXXX and CEO, our available are corporate financial CFO, slides Lynne on morning, you, the to with Tom and Stonehouse; third press Participating Chief Thank Officer, results Bill conference Dr.

their Following we your will questions. remarks answer

to investment I Slide of begin, Before want our potential your attention which to use X, we forward-looking risk direct discusses factors in and statements regarding an BioCryst.

on to performance and different and/or regarding in be call will or to may and future other uncertainties, achievements. detailed the information, contain or results, or statements subject and slide, unaudited materially as those this financial actual These forward-looking known statements including risks As results which this expressed results, performance, future as the unknown our cause performance achievements presentation. forward-looking implied future from conference well any statements, are Company’s

place You forward-looking statements. on these not undue reliance should

including a information which documents be risk SEC, of our with discussion to the additional For Company’s factors, please filed on accessed can the our website. refer detailed

Stonehouse. turn call to like I'd Now, over to the Jon

Jon Stonehouse

to us of joining Thank you, John, and thanks morning. this all you for

APeX-X to to attacks. our with drug that angioedema from or oral hereditary great treat We clinical prevent treatment ZENITH-X first targeted we profile are and HAE towards a progress unique have our patients an making oral HAE. goal the trial works of therapy for delivering data support The and

terribly make physician this right has as personal other diseases, a want the we a an way significant bringing patients lives BCXXXXX our long-standing us. and patients deep a therapy very become a with We home of and many have in small oral therapy or disease them. many their involvement incremental is say with oral today huge infusions. patient desperately HAE than and communities know more which We for they from HAE know that is therapy urgency real individual daily and attempt deciding For are HAE therapy. our working once manage normal It heard represents hope for Having met difference patients, as stories Unlike injections know patients an to with to them, their sense and restricted still oral life a they are we’re because convenient. for also waiting. improvement can patients this

data arrived over and we've months. the up investors six For at program exciting with multiple milestones moment next lined an

today will market with towards progress preventing XXXX touch as making to an the for update We these on bringing you attacks. we HAE we’re provide on

Zenith-X Next an the with therapy. steps HAE insight desire research program success market, following oral patients for on collected with we've our

financial into programs and position. early move to strong lastly and is plan our cash Our results clinic the

So let’s APeX-X. start with

excited year. We’re firmly we the and enrollment to next second completed of remain in report report to on quarter has results the trial track

because was randomized, when of a that powered. a patients we've oral trial, of options extremely believe even of because As also team throughout work a we are XXX outstanding With new we patients the of enrollment and clinical want pace at the noted well the trial APeX-X total have great injectable available. time but our part an therapy, is

Bill treatment the more particularly its positive XX HAE showing both important evaluating participate announced is we our early the acute moment. In severe. trials stop This details will demonstrated XXXX in in trial duration have a have to symptoms long-term treatment from seen to is our hours. in enthusiasm sustained benefit current safety rapid within first on the of XXXX some treat of exceptional patient onset for are attacks. similar treatment effect attack and of as Zenith-X the paradigm We and additional activity and at results hour tracks of APeX-S trial September before

benefit to is results now trial for HAE. be we early it showing have Zenith-X a So the as of a works couldn't second and with a treatment sustain show in happier must the options. new We proof-of-concept acute drug

As refill advancing programs the and complete with there we capability X the year. drug report look our Zenith-X ahead and We position we important a into coupled file at quarter, the launch in NDA trial rare next to opportunity. data transformative and the first for a year second get BioCryst. the our the lastly in then for XXXX, first summer, APeX-X disease, fourth start plan of provide in quarter quarter see the milestones strong for to in Phase of the first cash the a by our successfully new least These to oral half unique to pipeline clinic one the over and

in shareholders. near milestones for to coming term our engaged physicians patients, and the With more these deliver value than employees are ever

to to like I the call over turn Bill. Now

Dr. Bill Sheridan

for either blinded enrollment now in and by XX Phase anticipated. FDA control of I’d in administration. once over type and was XX the and our New fact attacks of APeX-X type The implications this the of primary with our of arm the much two and profile of APeX-X APeX-X emerging faster informed is had is Slide prevention investigators placebo the With in published clinical we APeX-X the of oral angioedema X patients efficacy Journal hereditary trial Medicine England were endpoint recently mg APeX-X a Jon. completed, design XXX randomized of of enrollment outcomes X daily angioedema The and we APeX-X EMA. testing you, discussions to on than the angioedema. or trial of was Thank shown which are drug The two X in review double-blind XXX levels XXXX, pace XXXX. of rate study mg, three attacks weeks dose was the see study exciting discuss details of trial with

in from North with those of about we enrolled and the America. fact, the randomized Europe, over States, In two-thirds XXX Canada patients study United

robust have result, is a final XX% provided to size oral overall to had yet an power sample option which disease. to another control their XX of results power. We want in XX%. indicator us strong in the APeX-X enrollment would patients patients, that originally The planned enroll As

also the forward enrolled early XXXX. in very look safety followed completing met the target weeks, study implication We long-term we XX We up submit APeX-S, by of in follow a strong for quarter of APeX-S enrollment. support dose remain in at already to analysis each Our both NDA. order and XXXX goal NDA seeing is have subjects the added safety of marketing through up fourth APeX-X level European U.S. least and XXX the on we to to XXXX at

NDA. of targeted to sections clinical noted, As Jon we the at oral already completing the launch. work We and on to the program forward look hard therapy trial advancing for first HAE are core the to prophylaxis

we're acute our pleased ZENITH-X to trial is program, treatment enrolled. Turning very the fully now that

hour at begin rapid profile, in trial to been XXXX Phase to sustained exciting From were the moving prior the With many has activity single-does over are We completely and especially From validate hours. with PKPD collection dose success of the from a of of the clinical clinical the summer a commence conducted. clinic, X for intervening ZENITH-X perspective, mid-year. post clinical on attributes showing meet the complete the plan after trials licensing order hospital self-assessment to outcomes quickly these both the treatments milligrams progression an results the dose to after and additional in since regulators of acute ZENITH-X and What's we're the the benefits to self-administered XXX for Phase the a for immediate in attack. XX design, the treatment that attack in critical and setting or both one to trial treatment limit changed cohort, onset hours that about data attacks X is the time paradigm patient both study. because discuss acute

XX this the can the compares Instead of for hour parameters the was minutes. X study Instead ZENITH-X of instead symptoms home. shift within study parameters infect in at treated Slide onset subjects in injectable all You which of median before illustrated treatment XXXX one oral acute XX finding clinic, treatment, drug see to self-administered study of symptoms subject other of of hours the trials. in ZENITH-X dramatic on XX,

As XX, shown in well Zenith-X that's safe generally meet disciplines XXXX treatment Slide clear for structural of biology dose a to our urgent and through very results disease. discovered combine. and need XX and benefits Oral in rare a diseases a structural and in drug showed oral was are using cut tolerated. medical the clinical by targeted rare treatments order design for for hard based to developed an

areas. are we new progress in non-clinical Birmingham progressing separate settings programs to candidates our Fortunately, very be and disease and team in other continues excited in research disease oral two rare product to invent

One irregular formation a diseases in disease. devastating tissues, approved progressive this in treatments or very of condition deformity Fibrodysplasia in soft are results is and for function and loss bone of early resulting muscles, other these tendons, of There mortality. currently ossificans no FOP, that rare

We pre-clinical disease. work the have advanced two this to ALKX responsible that which kinase inhibit compounds life into development mutated is for

for molecular For by indication IV prevalent drug. have we The fundamentally and is undisclosed could this treated yet non-clinical target programs. disclosed with oral be competitive it or our repeated the condition not FOP, can plan Unlike infusions. be reasons, treatment we more transformed an second

It's pre-clinically. as very excited the with prevent for We time oral continues what oral attacks, BioCryst and a reinforce at targeted therapy. to patient pipeline for an are safely profile be a can used emerge XXXX active The inhibitor as seeing an demand our kallikrein to treat are by meeting HAE that urgent progresses. effectively and us clinical data very we attractive

demand like call further this a I'd to Lynne, perspective. describe patient to to over turn commercial Now the from

Lynne Powell

available, like APeX-X oral to in product great to an In step have past surprised X more life. because will Thank into enable to therapy injectable and our choosing bringing enrollment normal in with target studies therapy. it quickly, is them be expectations that seen exceeded patients because when that competitive patient. a wants inputs HAE. grew Phase the talk recruitment APeX-X I've one encouraging our live commercial of delighted an the other their indicator oral to closer not HAE about diseases market therapy a can better disease control you, especially Bill. first interest I'm from I'm with of even the and many therapies different their patients It

for As compared encourage sense daily I This to and option. of as HAE it. gives and to majority taking majority patients would a newer injection understand you both patients And biologist strong injectable reason for of HAE the to therapy without lack use administration. wanting oral profile with view Significant see this our of preparation and/or prescribe videos oral ease top XX, of time, of of physicians needle indicates really go that XX Slide the research better for you vast you on the options. the therapies. pain market of drug once a injectable and can to side burden listen the confirms specification refrigeration, the of HAE unaided, of Slide significant demand of XXXX. HAE the of online to on patients patients and majorities some

market with segment. the $X grown Over as practice, We of proven products indication XX%. rates the products of launch we a largest for emerging an are our manner. derived HAE now billion the In experience. highly of launch the and past more actively from revenues of build is with see by prophylaxis. labeled XX use advance registered therapy And more than oral some than months, acute Christmas skilled XX% therapy using see our a indication the prophylaxis to we rare time, prophylactic even a commercial semi-prophylactic being It's once prophylactic for the preparation daily as exciting disease with or theme has greater

Tom. Now to over the I'd to turn like call

Tom Staab

we Thank we report are a a milestone as position into you, Lynne. I strong am in pleased for head XXXX. build year to

would ended our completed $XXX cash the cash quarter we we past With and provides the in which the efficient our filing. we with a in into amount July, in in additional refinancing we and oversubscribed XXXX August and the successful million us expected XXXX year. NDA same This third data cash runway the raised and begin debt cash roughly is which equity offering APeX-X equivalents, with

primarily issued advancing third our some that the recur financial it pipeline add the I for not recorded to an decrease did a agreement. refill do us to recognition I'd XXXX, disease collaborative inventory by provides release partners additional of like to XXXX, financial and due for compounds. today in to XXXX. orphan decreased compared prepare Importantly, sale repeat the new detail to XXXX milestone was quarter million color The the our in to intend Seqirus to and launch one third certain preclinical but XXXXs in under press Revenue two commentary. approval $X.X to of our of the quarter $X.X namely events resources in not as product our of million infrequent to

revenue revenue collaborative of engaging in to lower years between for when to future quarters quarter. XXXX However, you be ranging revenue levels than prior more the three $XXX,XXX at collaborative with with expect recognized quarters, should $XXX,XXX per in line

In addition under remaining milestones are the there agreement. no Seqirus

So will with associated revenue collaboration. no be there future milestone this

and expenses was $XX third incurred primarily to due million $XX.X programs. to quarter our increased spending from Third This quarter preclinical increase in million XXXX XXXX. the on increased HAE R&D of

R&D and program $X.X related in XXXX of pivotal increase related not increase the administrative our quarter merger to current General least in was future we of complete and programs. merger with our XXXX incurred of we trials, will do merger. and into be trials, the incur to APeX-X XXXX. the clinic we costs million to association quarterly expenses $X.X rate and progress programs for of our as Acute and clinical likely terminated largely million our increased our the quarter continue any As The the ongoing third advance expenses run compared will costs. third at result future to expect equal the expect APeX-S as We significantly continue

commercial APeX-X our expenses data we the launch, as administrative get However, closer increase. anticipate will we to and

forecast XXXX and the of performance based stock, divesting impacted options. completed our stock Consistent focused range we reliably in quarters, equity by as financial in that In transactions $XXX of expect in quarter efficient are difficulty strengthen price balance have guided. due to well as we summary, expenses $XX million expense to is Company's third that very outstanding the pleased now completion, provide $XX this and $XXX with the utilization to our the our current can a runaway and of commercial and APeX-X investments, launch XXXX. and of we With our operating Finally, cash focus past cash volatility preparing million trial continue level be and guidance previously filings, of by attention we successful well results. our regulatory as for our in sheet operating to on it two expense operating projecting the million excludes million for previous as of compensation our to have our we based the range

Ashley, section. to the we would call now the turn like to over Q&A

Operator

with [Operator Instructions] And our first question comes from the line of Maury Jefferies. Raycroft

is line now Your open.

Maury Raycroft

First guessing an you question for or is need on prior around comment but on there's completed just interim based enrollment interim how resizing in the since APeX-X, that now went? no discussion I'm can is

Dr. Bill Sheridan

do XXX so was no with and we there's Enrollment subjects on fast to need that study now it. overenrolled,

You are correct.

Maury Raycroft

potential see case with setting, synergies wondering do for in I a in out do and And Phase world what real just patient I'm treatments that any guess there? a you you are recommend attack? acute breakthrough then your X commercial the has therapy current

Dr. Bill Sheridan

are expectation with experts for the the field treatment to ones are in that I into the think new of that take the who treatments renew the create is or account. they'll guidelines going the that launch And disease. Well, our of top

acute forward offer treatment into well prophylaxis. report Phase be think attack, the what a say that wrap up great both I acute an of out we're would and acute, strong final results study the to emerging treatment going and can the first now for quarter option got for move that and we oral as both right data in in It to prophylaxis able program. patients X be we've is to through of

to any treatments other order want. company would it's not which recommend upto probably think patients BioCryst or I

we I think and want over hear that is patient's want and treatments. more again options what over they oral

Jon Stonehouse

is a just comment. since of ZENITH It's of things But Maury, on one real Bill's a data option. all-oral what add the I'd basis we're terms they lot a to situation individualized the want. that in patient-by-patient hearing

we're going to in and future. to forward that make try available so patients both pushing And programs clearly to be the

Maury Raycroft

designation the question launch PIM strategy that you ex-U.S., U.K. with U.K.? is that accelerate timelines just have, in will and any Then last around the that thoughts the on commercial will

Lynne Powell

important globally looking EU product supply is we're to and very So, this for U.S., the us. after

yes, and the markets. So in access at early U.K. other looking we're for potential

Operator

And the comes our of JPMorgan. with from Fye next line question Jessica

now is line Your open.

Jessica Fye

speak Q can to speak patients from the also am discontinuation that. that rate more looking overall of and the baseline be attack you’ve might you’ve rate complete, And complete, now specifically then Ahead moment enrollment can gaining are seen is you curious any if also if of you at the you to data with so so you you safety can blinded to I insight the enrolled? the far. speak

Dr. Bill Sheridan

material to we studies Our report results to right practices at the together. and and all

to APeX-X. we’ll quarter look those be is to studies the at speak in the all trials. factored of Historically range of XX%, got discontinuation into the report able you the in we of when for that XX% So second our similar duration in questions on planning rate to out that other studies all if

at that’s if with can end rate. the discontinuation what So the see that of day, type we we of cope

quarter. data forward the the So we look to second sharing in

Jessica Fye

the XX-week moved And what can the the on you extension? proportion into patients this maybe have speak period have point to at who completed

Dr. Bill Sheridan

are with the patients can of study. a weeks XX out do you through in We give the don’t can out analysis our first figure imagine enrollment in went order details be you everybody obviously fast reported where blow-by-blow And have different to lot that practice will second are to there enrollment. of to at we very so stages quarter. have The in

Jon Stonehouse

rate dropout important through piece is of a week's XX% have the weeks of right we’ll for data APeX-X that is expectation safety our XX complement getting of full XX filing worth say to XX% an also APeX-S. the we when that’s because and to Yes,

Operator

And question Wang from our Gena the comes line Barclays. next of with

now line is Your open.

Unidentified Analyst

one taking on [inaudible] for your This you our Maybe for much question preclinical Gena. Thank quick programs. questions. is so

benefit So that can from you expect you’ll you step before of expect around clinical should years? be booking the the you how indication I we five and over next work the rapid what next that seeing. radar, question give initial And us CDC enter the for a also accounting the like clinical quick on ordering sense have it a to clinic about is the

Jon Stonehouse

shot at I this make thanks a I So for Bill, one question your the first sure accurately. get take that

now going able and is an to up scale file supply studies. right we’re through then of what and doing in So the drug IND toxicology human we’re be to first start

And that's so so progress in then it’s that the that both but process complete good where we’re on in we’re not yet stand we and programs making and accounting.

Tom Staab

I know answer able it it. question be hopefully you me I So will the if I don't that for got to could repeat

Unidentified Analyst

No about the million million of so CDC for year? for which talking year this ordering a about like we $X $XX

Tom Staab

thank Yes, your I got you. question now,

So and that that years it at as knowing $XX - you’re million I the five full would XX. a a September that over it's look well is proportionally look five-year right over is government I period. the ends split the contract way would The on at year

a a only So in one government but year. you could in have year, multiple calendar deliveries delivery

the those to as negotiate to we is we’re cash very shipments try so get obviously so can. with And going as us important soon government to to

Jon Stonehouse

come seven to months other is first so no come his one this question was about first And XXXX. in us answer to with year. takes manufacture And it nine the will the shipment the

Dr. Bill Sheridan

the the those question X will reach projects standard expect share you from On Phase can about what the basically Phase and we X clinic. once your to trial of the details trials, expect

Operator

from next Markets. of question the line Abrahams comes our Capital RBC Brian And with

open. now is line Your

Unidentified Analyst

This taking the for is thanks Brian, [inaudible] for question.

of quick ones you. couple a for Just

the in thoughts know FDA? you endpoint about then and into I discussions all euro what you've Zenith-X, I’m the engagement are on And you the follow initial operationally tax from been data. at if with dynamics you before Phase have Do on enter learning you're full mechanism. patient Thanks. First to to clinician enclosed and [ph] seeing the you anything with might the terms you to focus that want X either in any or able launch wondering of different related

Lynne Powell

the launch, very, on So watching closely. we are tax yes, it euro very

things get those when market and One that that is of have learn the coming what to the you done you're before. from in lastly

early watch So in yes we that to very but continue carefully. launch, very

Dr. Bill Sheridan

with X With regard to for Phase trial acute will agencies. regulatory endpoints for the negotiated that be

with what clinical and of the got choice about in it is disease trial data patients to need we’ve love So the that to physicians is and I the mass feeding plenty treated. way endpoints and

moment meet watch there say more and through study regulators. the at go with except we’ll the nothing finishing So this the is and to space

Jon Stonehouse

when our we the fact And the that number can situation of paradigm changed from that drug endpoints was and regulators treatment right. a approved have we've fact dramatically is Bill the that only that different the other with hit help these

Operator

from [Operator our line Needham Company. comes Belanger with question Instructions] And Serge of next the and

line now Your open. is

Serge Belanger

that on do A can couple first report be APeX-S when this able from you tell us of at questions, study is point results let and me that not enrolled you full think whether or one? to you'll

Jon Stonehouse

APeX-S So his is in the to track what I plan that is of remarks file for we the APeX-X on said and we and and timing terms XXX for answer and APeX-S enroll APeX-X in The said fourth Will is combining to filing. APeX-S yes. we’re in Bill XX And the filing NDA in the necessary the is continue part our have what subjects APeX-S? all that that. weeks then both quarter prepared second of is important of to the or around

Serge Belanger

are And are as CMC now, are the where ancillary at point and there about NDA a this still filing about we think studies component? you outstanding terms that year of in the from

Dr. Bill Sheridan

great in We’re shape.

right advanced. well completing non-clinical the the programs for limiting the filing The CMC actually extremely study. So APeX-S is steps and are

Jon Stonehouse

sections some - things comments, like writing Bill in said his parts and of as prepared tox CMC of And that. we’re and already the

Operator

line final of our the Bayko from question with comes And Liisa JMP Securities.

line open. is now Your

Unidentified Analyst

questions. Liisa, the for and thanks on on This for is the congrats John progress

are these inclusion/exclusion APeX wondering of the study? of that of I'm seeing I’m are data rolling for wondering out couple APeX-X. any a from criteria same as APeX as getting follow-ups rate what you attack you're Just And data type on

Jon Stonehouse

will APeX-S then is the study fourth cut that the all click the trial the and come designed and weeks the subjects will that practice summarize on mentioned so to to we file we XX data data study complete. as when have efficacy It’s as out a that mature of we XX follow-up NDA week in safety entering information it quarter when the an not data our next NDA, for to but earlier is report trial year. I

Unidentified Analyst

And then the inclusion/exclusion?

Jon Stonehouse

Sorry.

Your generally question minimum rate a we inclusion/exclusion criteria APeX-X for the primary in a about for broad its example have with rate is inclusion/exclusion, because requirement study endpoint. - efficacy attack placebo-controlled trial that attack a as it’s

So a that's to that you APeX-S in have obviously. have requirement not

people from targeted they and benefit are come and therapy might criteria. oral in believe there an physician the disease other can if they their and standard then So that have

Operator

And management any ladies like over back session now and to gentlemen this to remarks. the concludes for for turn our closing I Q&A call would today.

Jon Stonehouse

the really I interesting and So launching prophylactic exciting program what disease. a for patients call. Lynne rare launch treatment. great those student being the in oral terms her a of and our team say successful doing refilling building like with to and in ensure second some pipeline the then and drugs stretch they're filing up switching other an gearing approval the indication and is home product with towards XXXX. thanks Clearly in us opportunity to time on front of of the acute with just your for for again participation BioCryst got We at here

exciting BioCryst we extremely time you a for Have your it's and So thank day. great at interest.

Operator

program a thank day. gentlemen, you and may conference. This you conclude all participating have for Everyone today's Ladies wonderful and in today’s disconnect. does

BioCryst Pharmaceuticals (BCRX) 6 Nov 182018 Q3 Earnings call transcript