BCRX - Earnings call transcript Q1 2019 | 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 First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and our instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. to your like conference, for now Mr. would introduce host to today’s I Vice Relations of Bluth, President John Senior Investors and Communications. Corporate may you begin. Sir,

John Bluth

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

we’ll remarks, our questions. Following answer your

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

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

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

For filed Commission, information like the Company's please the refer and including documents the call website. turn risk to Stonehouse. discussion accessed a to our Jon additional of Exchange on be which factors, now can Securities our with detailed I'd to over

Jon Stonehouse

progress confident exciting hereditary angioedema And are forward efficacy this of of XX-week joining report for oral the prevention looking safety this us the we that of BCXXXXX these year continues BioCryst. will know too. for results be to results study of we we you quarter. Thank you, from and an all and seeing remain thanks very John, APeX-X morning. attacks; XXXX And the to to you’re for we

couple therapy hear with life XXXX. marketing and And HAE weeks drug the injections of demand in regularly an of new for and United first without oral the consistent of normal also is did we year resounding. live our want burden quarter ago. by infusions. patients and of for our the Many we the track file of to a discomfort We application a States to patients authorization for the We’re end and anticipation application meet and the opportunity from on as them these Europe

As this we’re we a because new programs, This complement-mediated option know focus our them treatment oral company, HAE, to on to they’re waiting. working programs our everyday deliver for important driving also acute and FOP. to extends other diseases forward treatment

to our the the of HAE of were summer. and this acute we preparing discussions attacks we earnings for moving our for and commence the quarter, are trial process subjects Phase of announced remainder that to expect completion trial X Factor regulators successful of ZENITH-X an ZENITH-X XXXX results for Phase of the hope through get X of our into the inhibitor and call be study we from have and important track BCXXXXX, to on very this X to that at expect quarter, us D trial. a year. guiding the That data oral is Phase the PD will end informative the trial the conducting, with the treatment last in Following begin PK the in On first on complement-mediated healthy quarter, in program. We we diseases,

patients in of of schedule top as and on a milestones XXXX though oral up, taking for try move attractive we prepare number half Later, of product different Even to it and of granted we we value and oral it, clinical to Our marketplace Phase are lead second to you high add FOP a see of with XXXX launch shareholders. first in exciting this nothing inhibitor will highly for create profile differentiated on we a see we the pipeline we believe the wanting BioCryst. significant our commercial that, important HAE very year. to potential of trials a that into ALK-X X have all believe number into patients an When the to is also XXXX. for

to build key medical our Company to exceptional proven out some market we attracting we fair, disease candidates profile Company As is our with extraordinary in talent team rare added And experience. the areas, have across strengthen continue access, and marketing, from will catalyst for APeX-X Positive product a the a data regulatory. in next launch be anticipation U.S. team this, of building only clinical and out year. will us

through Now, us our to will Bill plan I’d the and who to over APeX-X analyzing call for walk reporting results. like turn

Dr. Bill Sheridan

Jon. you, Thank

this attacks. related dose of As approach this from testing milligrams prevention with placebo-controlled, be ApeX-X HAE angioedema two BCXXXXX, orally around administered will analysis the and II helpful in you XXX and United the levels trial. Type and secondary is Type endpoints with [ph] in were States, how doctor it would thought we review primary we three-arm patients for Europe. to quarter, trial a I of endpoints data readout once the the XXX milligram randomized and centers daily randomized, XXX from Canada double-blind, to APeX-X

the a reminder, quickly. enrolled trial As very

XX rate two In placebo. for the at required attacks the were fact, investigator-confirmed patients XXX with have days. powered days rate than attack higher rate between HAE subjects requirement. to minimum during visit always it was screening trials, in and mean over-enrolled from XX% previous a of To to In and XX% period baseline attack the trial, detect minimum by versus reduction is per qualify much running X the of XX XX

of baseline weeks the and of XX days. in four to of per that case be rate two be range XX endpoint The this study primary efficacy APeX-X investigator-confirmed is attack the expect We also the mean drug APeX-X attacks over administration. will should rate angioedema in of

the the placebo. each So, at of attack to receiving level attack on-study patients rates rates will patients the compare analysis dose on-study XXXX receiving

placebo Type with step-up multiplicity well dose levels p is a significance called procedure, the statistical I two is analysis Hochberg's both tested XXXX met the of X.XXX. in is value each use As of than declared and value of Statistical is with the the then for in does is X.XX. approach familywise specified of associated largest the for the significance this arms of order specification established p will X.XX, less primary the other and agreed If if statistical error more controls is doses. both values than p study testing not In less than This require protocol the of endpoint. arms its arm, regulators, procedure. the against

endpoints is least met to error the In for one addition, the is for statistical I Type rate primary may the endpoints. multiple if dose hierarchical significance at secondary used control Testing to for only testing endpoint. proceed

from endpoints eight baseline rate the XX APeX-X analysis investigator-confirmed score the for HAE secondary angioedema testing, XX week in on of symptoms treatment of through attacks of period, The at order the through of XX; hierarchical weeks. life, angioedema portion during effective weeks; in in dosing XX-week the of with are quality day days changed beginning

the hierarchy the those statistical not significance secondary subsequent dose level to significance, The dose meet declared mentioned. Statistical the the absence that In that endpoints tested hierarchy, at secondary than next reached of the next tested. X.XXX. in is allows in statistical next level the the proceeds p each as If less in endpoint level the are primary significance the to single order testing test endpoint. levels endpoints of I just

in will placebos study two XX-week in through continue Following Patients phase with doses one initially blinded completion ongoing placebo-controlled XX the continue with randomized of subjects re-randomized to extension extension phase, patients. the period of with XXXX XXXX Subjects patients XXXX dose. receive APeX-X, complete weeks. an long-term randomized are of and XXX the on who NDA initially in in safety to contribute the APeX-X the XX weeks database same

total. of an quarter well. also And by of year these studies long-term to are contributes filing MAA end safety the Our we target of progress continue for in Both the the and NDA this APeX-S XXXX. study on first filing to

As in we data CX-inhibitor I be with would trial in that workshop EAACI also mentioned, at schedule a acute also presented program Lisbon June. Phase Congress X in summer. at our X May note our Jon will in in on from upcoming And the Phase the study Budapest to begin are and ZENITH-X

the I’d to Now, like over Tom. to call turn

Tom Staab

Bill. you, Thank

release can first summarized detailed slide issued results eight. in found the XXXX this are on we and financial morning press Our quarter be

some capital million the remainder enhancing to $XXX for capital enhancement to I’d an financial of help flexibility credit to quiet a milestone-based at million us and of assess and notable information represented $XX our closing facility thereby provided draw additional our closing you ability highlight in runway an However, and operations of and a another perspective, by XXXX. cash statements secured million of and This like the uneventful the From non-dilutive exception financial was understand immediate extending future our February. facility option. and relatively our financial existing non-dilutive the of $XX with quarter first credit

the this to reminder, and following XXXX. XXXX $XX a and XX facility cash to and of from preparation We $XXX.X quarter flexibility a we available development our drug the As modified regards fund provide of data position application. us continue standpoint. to a programs cash ended our positive investments, liquidity first million. APeX-X million a had This resources we provides file into consider strong with to optionality which sufficient is credit In a commercial additional

for as our APeX-X our are which and NDA runway quarter. both BCXXXXX, to in as cash X readout beyond filing occur quarter, extends the Phase our readout Importantly, fourth this well expected later

demand XXXX slide on first each collaborative underlying sales products. As of based overall for transactions forecasted the management to the the This eight, to million. our $X.X peramivir of are for see million to of largely increased product due and you million quarter $X.X by peramivir of can revenue partners. increase These partners, recognition on partner’s was $X.X inventory one our

do predict recur to assume Accordingly, magnitude. not and are XXXX these should in product not will timing future in these transactions you recur regard routinely difficult quarters. to and Importantly, sales

million, use nine, on noted be $XXX to to net million. million range to to operating expenses cash the as be guidance, XXXX in operating the of $XXX we expect range of in operating to continue slide $XXX million and $XXX Regarding

this results our XXXX of March the expense expense programs. Company’s expect impacted year, continued it quarter to the to the call the expenses and XXXX conference to stock operating due the in levels the options. of this Consistent projecting as outstanding our and is of reliably As difficulty prior by to G&A progression in vesting well expense performance-based volatility price as all R&D fourth excludes increase quarters, as Company’s we with compensation stock equity-based mentioned Company’s of by continue range the due our of in from

expense because XXXX. in of Lastly, secured you interest our for with the should than higher credit facility, those expect balances of modification XXXX higher debt

later you excellent an safety with XX-week we’ll our look to XXXX And this had and your That the and concludes have quarter. efficacy remarks. take sharing We now start questions. from results prepared to forward APeX-X

Ashley?

Operator

Thank line Markets. And you. RBC [Operator Instructions] the our of Brian question Capital from comes with first Abrahams

line Your open. is now

Unidentified Analyst

for Bert for you previously you’ve in cited might research try is and and Can This PK-PD taking see us our XX% question. as we Thank meet? does then, the second you. quarter? any the Brian. expectations on bar Thanks your observation the for And shape for attack when How Hi. prior further also OLE data, to on APeX-X market readout data mapping and/or all clarity reduction. your the threshold give

Jon Stonehouse

Sure. Bert, that. take I’ll

on so for XX%, strong this soon. vary changes with question down preference XX% we’re the any The research and you the granularity small way share. say oral all an interesting. no, in then, other to efficacy is So, it’s to timing coming the your I giving market see And to around drug really mean, that up XX% is can preferred than to further regard so quarter, not

is, we’re an is really, make So, trying there just really demand drug. the point strong to for a oral

Operator

question you. comes with And Morgan. line our Jessica the of Thank next JP Fye from

is line now open. Your

Danielle Brill

for Hi. taking Danielle Thanks Jessica. This is for questions. our

the prepared the mean Thanks. like was X, X Phase versus on-treatment XX that in of in should observed given think lower sounds sick response? we Phase mentioned Is attacks ApeX-X. less than baseline to days placebo rates in X remarks, You And how about X patients what what per in APeX-X?

Dr. Bill Sheridan

is study to long; weeks was events XX the account way show Yes. a the a statistics to number Thanks weeks four just in Hi. events This the question. is accounting is certain difference This have in Bill. work placebo. order for study long. of APeX-X And related

vary likelihood very rate we attack had than Even I longer weeks. at to what that of on placebo baseline lot, was response four came we’ll times events analysis that attack The seems from, So, they on-study compared depending in a the on. the treatment that the rate the all. in I'm there’s course the and slower previously much placebo that six the a XX study. where to a of running not of on active. more the than impossible type so handicap were attack in if of worried It attack in the patients probability conditions is It’s opportunity. and about to mentioned, rate on-study rate high see matters

So, way we and structured that’s study the the the pairing.

Danielle Brill

are could setting? differentiation to of in available And highlight you product the for therapies what contrast ZENITH-X acute endpoints currently that considering in the

Dr. Bill Sheridan

moment. the as So, process the we’re we’re what we might is contentious, might for Phase with the the endpoint primary regulators the there pleased the of Jon But of with Phase mentioned, for very, to results the no on us X or so ZENITH-X. our for of meeting advantage not in advertise Its’ of very at selecting acute X program. be design

it’s CX-inhibitor coming at the allergy meeting, and that for European accepted very Biennial the in presentation also EAACI, that’s We’re happy at Budapest huge been workshop up.

This tons interest context acute in in So, treatment at possible of time a symptoms. there’s of the of study this. groundbreaking onset the at is

thrilled we’re with results. the So,

Jon Stonehouse

Yes. would And I add.

and last. there’s half the life with going we agreed since regulators that are, redoes. haven’t it that’s and you out without acute into to go is work then the And for yet. that got think problem that they any long says to quickly, detail the matters with What the I short drug does that stakes endpoints table So, what a come is that’s the data recently on treatment, how

a that life like confidence with have an half manage really we high attack. single we a dose long degree a have XXXX, so of will with And

So, we fantastic think profile competitive. and that’s a very

Operator

Liisa Securities. our Thank with you. of line from And next JMP question Bayko comes the

now is line Your open.

Liisa Bayko

of the for sure are comment Can have they feeling just plan Thanks what adjudication statistical how will also you? be the versus to on you review that the maybe attack, Hi. of further factors, and truly the attacks adjudicated all other they that.

Dr. Bill Sheridan

Liisa. Sure. Hi,

X procedure attack that angioedema within or relevant is the a Phase then is answer is If the last everyday with in gets what looking the record That a contacting that by to patients, in hours. after and record is that in the case patient, days and assessment record. notified within not and charged So, endpoint. the site trial, patient investigator the investigator have an information the had business two automatically dialog whether APeX-X, is to electronic yes, diary, that primary the assessment the the approximately at telephone is they make XX analyzed

symptoms of the are that and there with at interacting at all or that those study, information. of panel the Phase X has batches conversation to under possibility of make into in account investigator months all of information the a not whether In subject effect, So, symptoms no because and given event. process, after the experts we of the who any were ability subjects our or treatment have Obviously the experiences circumstances. is the had -- -- whether treatment, paper reviewing understand after often or similar not the assessment, the not the onset taking whether of

judgment it’s difficult nuance So, that. you do more to when make can’t

Liisa Bayko

Okay. That’s all you. the Thank kind you very helpful. proportion on on comment to at the Can open rollover label? of

Jon Stonehouse

So, that. to then know will Obviously, we happy have comment on this quarter be coming soon. analysis, you we’ll up the when that

previously are study persistence what in the There demanding guided you. I on what I connected, ECGs, that patients. XX blood are weeks, through samples, these think terms to have of studies

XX% under normal reasonable. of So, you an circumstances those drop And XX% that’s expectation rate -- out not to life. could is

Liisa Bayko

over people, -- despite rolled open not how the then that And label? many but, on on you’ve commented Okay.

Jon Stonehouse

ongoing. still because study Yes, the is

Liisa Bayko

Okay.

Jon Stonehouse

final tell time have a we to that’s you information. good results, that really until the So,

Dr. Bill Sheridan

statistic. It will be an interesting

Liisa Bayko

important How see endpoint? the you do secondary

Jon Stonehouse

that we Well, other carefully help I the into endpoints here is drug information think helps assist to because select studies therapy. label, physicians objective the selection in secondary in healthcare of and pivotal providers getting and

for secondary had to actually improved we very X the we’re example, our be would getting that of strong endpoint because in analysis signal successful the label It’s important. life study. very for So, Phase quality in

Lynne Powell

be quality that saw very study. this life label. here. we’d data, in Lynne we the incredibly excited and at was we’re is that be would What get could Phase in looking Commercially, next in replicated the X This impressive, of

Operator

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

line now open. Your is

Gena Wang

questions. also taking APeX-X for you Thank androgen will patients my I with question a have there regarding one In Europe, be trial. more prior use.

the use, wondering, the you period? wash any of terms patients restriction out duration Just based and stratify on of androgen do usage in

Dr. Bill Sheridan

Thanks Gena for question. the

not can for North Europe. of So, States this Quite then to in still in the lot in America entering United it’ll experience are be different patients analysis prior an study a as androgens. be or whether subject interesting versus the on

market U.S. doesn’t androgens. estimates probably a and patients years And between HAE it was many, on obviously, the that our all that ago. experiences, XX% many, of are XX% But, drug. prior was in some patients and because that So, appear with because have are that’s generic available many the currently in

interesting difference. So, it’d be with to see this

that the criteria. for therapies period was equation are it’s think, no on restrictions days of part restriction There part as I are entry what and the of other washout our is prior prior screening... a There on XX therapies. main

Jon Stonehouse

do do any? …stratification, we

Dr. Bill Sheridan

on basis. No, that no there’s stratification

prophylactic studies in on been basis practice stratify has to rate. our of Our the HAE baseline consistently attack

Gena Wang

to washout want will so confirm, just I XX be days, the period right?

Jon Stonehouse

Prior to screening.

prior in that go single I two to appointment compulsory, mentioned months. -- remarks, randomization. have come an to make remarks in and weeks they Then, patient that screening, to that’s from through a there’s has running So, every to two yes, vary my my as prospective can for

prior month four could a three before be screening, months, to on getting androgens duration a... So, if duration stopped the for drug up months the our actual to somebody actual

Gena Wang

see. I

days wide such XX a case running purpose the XX what’s for range? to a in at So,

Jon Stonehouse

chose minimum some see to what We you we to wanted have see because the sort some you the need And waiting otherwise are study. of maximum is, the period period consistency. for to it, and rate put on to you finish attack

XX So, two X minimum having of attacks days to within a the have a is per which a opportunity -- days, as XX rate.

Operator

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

open. Your now line is

Maury Raycroft

thanks Hi. questions. my everyone for Good and morning, taking

and is been patients extension, open on just label duration drug XXXX. patients longest the what’s the over, continue have as question on First drug? And cross the on

Dr. Bill Sheridan

out now people have we studies both past a year. Across

Maury Raycroft

it. Got

as then, go, or for what be? endpoints than I you low far reduction statistical be, And decision primary the XX%? could Okay. the And can say assumptions the as tree powering in based plan the base your your guess, as dropping would on lower something what attraction

Dr. Bill Sheridan

we we turning done So, it depends in get. statistical a that well first explorations. lower haven’t possible any to probable may observed it show the the Obviously, attack in actual be rate. to data question, formal percent significance the deviation on the reduction for Certainly,

Jon Stonehouse

of half think that’s second But reduction no? the XX%, I a your on would XX%, in we attacks a question in Probably XX%. somewhere studying meaningful could think how if we’re I kind say around And you was area. it And Yes. go, not. that mean, of I people, around so low ourselves that for

Maury Raycroft

it. Got

then so come around forward So, -- not it move if XX% goes up different below a XX%, probably point even or that at be with or you at still game… it would it’s may if

Jon Stonehouse

get But, encouraging from I input because and the we’ve have below again the of we’d that XX% patient had conversations like groups. thus Yes. to and mean I that. the to make like KOLs incredibly the things those association reserve decision, right data down been far and the see

I have efficacy question, be high. because expectation. doesn’t So, that’s your our it’s as not the to oral, think But

Maury Raycroft

Got it.

be wondering XXXX that just if based having in filings. the Okay. I patients would each is U.S. data And your about to included I guided in on last And included NDA starting. question on study APeX-J for you’ve any know from XXX was then, dose filings.

than you going should XXX more patients that to total, or So, you’re about that? patients we assume have anticipate do

Jon Stonehouse

time, the safety on in to year, will we this the from be the the currently included got all clear, of data NDA. later have just at that So, be data we

APeX-J a of minimum a will data worth still of patients be XXX through will there XX be blinded. weeks. So,

contributes with is of and efficacy have NDA. the So, to support J… analyses that study to That during Japan the one development the Japan’s program PMDA complete -- negotiated to

Dr. Bill Sheridan

just XX I Yes. will filing, think And question dose patients worth weeks. file looks believe high many patients enough file we high data how doses, we dose. and we’re If is of to with going submit, both for need the clean, a regard of your we the we’ll what to XXX at that’s or

options. lots have we of So,

Operator

Needham. Thank you. question comes from line with And the our Belanger of next Serge

Your now open. line is

Unidentified Analyst

Hey. XXXX? be that on I Is the the that have of This XQ trial, question safety part XQ Tan read for also is the just that also Serge. also is a guys. in the portion for about of to out APeX-X. Thanks, NDA trial, submission expansion XXXX? APeX-S is And

Jon Stonehouse

Do you want it? to take Yes.

Dr. Bill Sheridan

Yes.

quarter analysis the second APeX-X. So, in is the XX-week the analysis of

to answer That’s is of supports and will safety first from and the no. and the question later in the your from that submission. submit and efficacy year, So, ready this to compiled studies will the APeX-S NDA. of control kind be this both follow-up be safety, placebo The APeX-X, pivotal long-term

Operator

Tyler question you. of Jaffray. our And of line the Thank Van Buren comes from Piper last

line now open. is Your

Tyler Van Buren

had step-up statistical TAKHZYRO I was Thanks guess, trials? HAEGARDA a I details point guys. in morning, The analysis. the pivotal used Hochberg's just procedure, clarification. on additional Good and analysis that of for the the the

Dr. Bill Sheridan

is is terms but trials, too in multiplicity of depends technical, have that depends how whether on of and not look can two can view whether how analyze standard. and and compare the I’d dispersed, analysis, of study. So, and the we placebo. distribution type the you so, similar lives do publication [indiscernible] -- a If as a regulators it events [Ph] Hochberg bit then there to statistical of over the proper. dispersed helps totally of be approach you accounts data that controlling turning TAKHZYRO the -- and very In will agreed you way to the over see if in this course And is is having on to The read analysis It Phase way. and be from one the you not not. is the of events a it’s -- in that it of arms to or It’s that -- I to up. instead of maybe seems of the [ph] X or all it’s not to hope rate. with or versus

Tyler Van Buren

Yes. updated That’s on discontinuation of for this And acceptable and rates this great. thoughts trial design? sort

Dr. Bill Sheridan

over-enrolled So bit fact quite flexibility here, XX% controlled of us placebo a XX% the the to that period gives drop acceptable. out during rate quite is

Tyler Van Buren

Okay. That’s guys question And is, you final have spoken commercial preparations. helpful. about

the clearly because an very frustration with a assuming the players So, of those by I there’s couple dominating really that’s chance oral to positive, in trial’s And dynamics. of level at high coming a a physician market you think have of been price. disrupt

this the So, profile? you towards product how the the with of trial successful, market can the plan you is again you approach to commercial assuming -- speak can and guys preparations

Lynne Powell

it’s Lynne. Yes,

been as in have, earlier, actively Jon marketing, said affairs. access, recruiting we So, market medical

of research service pieces multiple the is understand oral tells therapy, physicians what in is want. for patients want really they doing to try of terms been have an what what they have the really market to tracking we’re and and opportunity they We which to give as market. And

profile pricing of understand situation in a priced high what’s So, really is terms what to we’re into certainly pricing, in competitors. is entering our drug with but improvement of very

in we pricing. with of options all what terms be do looking we’ll at So,

Jon Stonehouse

of space. to towards Yes. a there’s anybody a be And data and modest. And She’s gathering therapies switching now put smarter being lot introduced. resource Lynne on with energy of lot in the going right being this other is that are than

then analyzing switch team and And about to of this the that is her great people patients really plans. physicians and trial hearing from launch what’s high. we to apply what to that are drug unsuccessfully, our be successfully and this that drives is going learning is and behaviors But, so usage the we’ll drug

thing So, we them the other how drug. is on is doing keep the team do Lynne’s

about in successful in really plans we’re that. that getting place putting smart be and so, to And with

Operator

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

Jon Stonehouse

Yes.

BioCryst. beginning, as at a said for the I time exciting So, it’s really just

We’re important preparing a very for for prophylaxis. of filing XXXX

We’re great in in and for data soon, well. it to out have day. U.S., Europe we’ll launch reporting preparing the look as And the we a forward you. the to Have

Operator

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

BioCryst Pharmaceuticals (BCRX) 8 May 192019 Q1 Earnings call transcript