La Jolla Pharmaceutical (LJPC) 24 Oct 182018 Q3 Earnings call transcript

Welcome to the La Jolla Pharmaceutical Company Third Quarter 2018 Financial Results Call. On today's call, La Jolla will be making forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to expectations regarding future events or future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. La Jolla cautions listeners not to place undue reliance on any such forward-looking statements, which speak only as of today’s date. which uncertainties La factors US website Jolla’s Exchange all risks, greater described Securities at these of Commission, in free detail filings of www.sec.gov. of and the are other in and charge Certain on available SEC’s are with the post-approval distributive La from Jolla’s timely market potential Jolla’s completion the Jolla’s These include, fund other its cash studies expected acceptance other the development septic candidates and product of issues candidates; product successful SEC. La of sizes, of not successfully of including commercialize, or the safety product balances and risks relating La and limited product will unforeseen for in GIAPREZA the GIAPREZA; risks to to, market market and uncertainties identified activities administration for and are in LJPC-XXX to filings candidates, operations; but success the ability shock; which and clinical risks achieve the other over and including for with patients; trials; duration other disclaims of any outcome forward-looking to any statements intent update to the expressly events. reflect subsequent Jolla La I and Investor La Human at to turn Jolla. call Vedrick, Relations Director Resources the will Sandra now of over ahead. go Please

our quarter operator. Jolla’s our the President you joining you, today. conference Financial Tidmarsh, George Operating are Chief and call to Chief Mr. Officer. team for Officer; our Thank Chief present like and call. Officer; that members our thank would management third I Jennifer La Mulroy, Dennis And introduce of Carver, on Executive our

over Now, I turn to George. call the will

incidence septic shock and other distributive adequate standard-of-care with do septic FDA in the and was a broad shock. version insufficient vasopressor the therapy. vasoconstrictor Low with than acts II, and patients PDUFA acute the an Of shock. December blood the impacted GIAPREZA, pressure. to in to its of distributive in these European approximately data, for and most not includes In peptide, occurring common XX, included the shock XXX,XXX the achieve of Good is of review the all of XXX,XXX March patients XX% setting with we the blood estimated systemic there is approval in of shock you, this each years. which than in a US innovations and for no catecholamines GIAPREZA, of was that This hospitalization. XXX,XXX announced synthetic approved afternoon conditions is mortality GIAPREZA naturally requiring label Sandra. arterial blood the joining which end response new US is body’s to a associated most approval you XXX,XXX and adults with with advance of results the the a treatment Distributive thank adults by Union, type launch pressure rate by pressure flow were which commercial February tissues estimated priority inpatient an patients septic as for over shock. past increases At organs Thank XXXX, vasopressin. progressing and more angiotensin a be annual exceeding XXXX year. XX Approximately us. XXXX, sepsis patients a to blood in more Prior are

XX% for formulary XXX we have is for more these, obtained hospitals Of formulary is from from strategy up the approvals that patients approval at reported end we of This about target commercial QX. hospitals. Our than to suffering shock. XXX approval treat the distributive already the of formulary

new already KOLs and remained encouraging that In safety favorable We use, quite clinical continue physicians feedback identified. to are from the commercial has GIAPREZA. no profile of using receive GIAPREZA signals with

multi-tiered will the process takes first through of time therapies. to hospital as groundwork like be that other go standard product it a expect launches, XX the We months for period hospital-based

announced fluid is indication. vasodilatory study or the who we of vasopressor Agency. establishes European and the confirms The of in ATHOS-X distributive and for as could Marketing the Validation launch, and MAA marketing the in the for the available was data safety starts GIAPREZA We second XXXX. GIAPREZA Authorization submission Medicines by half XXXX, the MAA June GIAPREZA that with the in based treatment shock complete of in hypotension review approved, the Beyond of on adults therapy. is Phase remain the Application hypotensive despite the from GIAPREZA the X for European the validated be MAA which efficacy Union in proposed If US centralized submitted process. EMA’s

effected multiple turn to LJPC-XXX will the over development discussion who review investigational Dennis I our La goals. our of we remain efficiency now on development of on will results month, and the for its the product GIAPREZA I priorities increase financial achieving call a this including realignment our a commercialization focus Jolla’s highest corporate and pipeline, product, to LJPC-XXX. indications. company-wide call Dennis? conclude Lastly, our with effective before stage

George. you, Thank

For XXXX, to the ended US months March net three compares March the ended XXXX. La in XX, XX, three million the $X.X June launched This and XXXX million were in ended months three GIAPREZA $X.X million. Jolla XX, product of XXXX. the months GIAPREZA the sales for September $X.X for

million XXXX. per or respectively same for million. loss as nine other XXXX and XX, periods million Drug per or $XX.X share in the in XXXX, $XX.X the to was adults net pressure three to $XXX.X September US the Administration sales For ended and Jolla's XX, of septic months and was share shock. the $X.XX vasoconstrictor share net for and nine respectively, distributive by December share blood increase GIAPREZA GIAPREZA $X.X per compared and La months million $X.XX $X.XX In XXXX, $X.XX per approved with and September million Food $XX.X ended were or

the million of $XXX.X of million of Jolla and and cash $XXX.X from XXXX. equivalents net increase $XX.X As The of of the cash as proceeds for September nine and proceeds March million XXXX million financing respectively respectively $XX.X December from stock $XXX.X months cash activities. La and for $XXX.X XX, common XXXX. cash the to in million periods million XX, same ended had by for the to royalty September million used offering $XX.X three offset operating primarily from and the compared and XXXX, May operating the XXXX was in the million compared was in Cash XX, equivalents cash result used net $XX.X XXXX activities

be now the cash the call operations fund as cash As realignment second of a at to back XXXX equivalents our will XXXX. result least to over sufficient our half into George we turn September expect earlier, that mentioned of will I XX, the and of George.

you, Thank Dennis.

would call development product helps to our program prevent in a Hepcidin briefly review excessive candidate I synthetic iron absorption LJPC-XXX, regulator like distribution to hepcidin. second the a Before of opening up and our iron accumulation is the with organs. to product an questions-and-answers, human

to thalassemia, to Our with underproduction are supplement due first randomized study by of in trial is levels. hemoglobin beta characterized genetic Patients a the blood disease with patients Phase their this mutation. hemoglobin a X transfusion on dependent

an frequent the sickle EMA is LJPC-XXX disease. filing European as enabling orphan in Union. iron in in reviewed The and for Phase a endogenous transfusions study. cell production the drug an This study of beta study results be would to as registration well an This If we designated X as However, low critical this as was and MAA anticipate excessive thalassemia has fatal. LJPC-XXX by the can treatment design successful, EMA for hepcidin these agreed organs. accumulation of

Stockholm to up and study unpleasant ongoing for June, and concluded at a was about iron from X data studies. these is levels septic hepcidin and has doses X in pint basis. demonstrated the removal decrease investigators a standard-of-care dose distributive or serum is accumulation European to of current significant patients in randomized Association LJPC-XXX We the second tolerated phlebotomy GIAPREZA days. the milligrams, with other in a treatment X dependent The production that Phase a our therapy cumbersome, genetic Hematology reported was blood a shock. of milligram excessive between to involves investigators believe At which iron LJPC-XXX patients a The in that meeting sustained on for hereditary procedure, with leads patients that potential our eight in of of XX be study leading Phase well a many critical the regular in hemochromatosis, this The in organs. patients of deficiency

to we goal new believe need. fulfill Additionally, development to our in patients help bring program, including our important hold promise LJPC-XXX, to therapies

progress reminder, shared beyond to during now what will we be a commercial have We open detail appreciate the to Operator? period. But we questions. patience as to we are going call. our early to your this launch provide And this on much call not able

Instructions]. [Operator

Lee question Your first Robinson. with Joon SunTrust from comes

Your line is open.

uptake ground. the I quarter. first catalyze do question think in be far? an more would congrats the GIAPREZA guys. uptake Hey, But you. consistent Or trajectory be you laying will the for the XX more near-term? of and the what inflection Thanks the the Thank and with understand could thus gradual months that do you think on

the in can that to drugs When an they consistent the the more It nurses will that the perfusion before by people and value. providers GIAPREZA, drug. experience. the drug about immediately to it and its healthcare maintain which maintain is mean And see our find few And able all and for there's healthcare organ GIAPREZA, and we the And start I see is. spread providers, more attribute they more understand literally increase with is utilize start their drug and more and providers experiential, pressure are And at as pressure effect, doctors, of and you that pressure. can the consistent of eyes, and physician the believe and spreads, effect more and support a And see word to be effect -- that a other you to and believe you question. word Thank effectiveness can as as you GIAPREZA. bedside. minutes. comfortable patient see struggling healthcare That's and clinical that as to the gets are the already We the our is clinical blood immediately to out blood very that the more label blood struggling will clearly ways data in with drug within will experiential. pharmacies effect this is the

so to early see, new the vasopressor differentiated we the from It’s and eyes is XXs years, spreading. enrolled recognize So is we in field this the can we word therapies. been no We real a over think front that existing XX literally And is drug. also experience they an was think in that last it highly need it that XXs. out of there’s for already in important and fact think know approved that is the therapies that for their there

blood pressure. support excitement And to tremendous from so new there’s to have providers the healthcare therapy

to So their question answer that as the help to more itself providers healthcare drug effect patients. we think the the of value will and your catalyze see is, utilization the to more the

comes with from Wainwright. next H.C. Ed question Your White

Your line is open.

have few but XXX. just GIAPREZA So and I a with I’ll -- start

you complete second for do HELIOS to So still the see quarter in study, the ‘XX. enrollment fiscal expect

Yes.

enrollment targeting the that We’re of in completion currently of quarter trial second XXXX.

a still holds up? just you’d the before similar data think in And I does middle HERCULES, of expected said question also Okay. was ‘XX, for top-line that

Yes. no that. in No, change

great. Okay,

just on once update thinking or you so to how it. license what us expect GIAPREZA, get out One, And do co-promote you’re approval, things. maybe EU do tell two about any or in you

to potential approval? So we something before hear or expect after

you. thank Yes,

filed partner who are in we local pharmaceutical answer of to wouldn’t on It’s would they outreach the out advance to the able we And companies to to in to number of experience our partner begin and the feel we bring bring we a goal of had the have have not in in these wherewithal Europe that this ourselves the to better trying patients that launch felt to in engage Europe. this of much all questions. confident you validated bring a a an partner to engaged that company that feel the We have GIAPREZA So patients felt that them best present it’s we Europe. in interested but rather than that approval pharmaceutical we and licensing parties launched be now Europe. we and to and allow put only and patients We have were until hands the campaign in Europe. very to find it to MAA EMA’s that a

putting pushback? I successful question of that George. the source Okay, formulary? approaching I to the you’re has get on the the everybody Yes, on XXX what so questions from if more great. you’re of formulary? Thanks. And What’s Thanks, and been on than all last had. attempts then not, hospitals in Have hindering the That’s your now. have you is, all formulary been

Sure.

clarify bit that I specific We’ll don’t right a the me when we in along I deal statement think valuable go ourselves. be do partners date to do a held we just let with And question, to the somebody. a want we believe more a further Europe. answer time. the asset Before it’s gets deal on the approval the do little to that potential process, to and

clear So just I guiding on deal on for any to want partnership in We're a be that. any timing not Europe.

institutions is they approval. terms scheduled formulary to information We provide develop to for feedback. The that closed that formulary those of if that in review where is actually happens dossier we a are put So and meeting typically formulary And approvals, what own formulary. it's system, or quoting GIAPREZA on confirmation positive it's are may we on we the their may have get you, number I'm or not reviewed.

Some actually institutions tell us. won't

potentially we’ve there to approval. the know more don't typically When is have the the fact, been higher institution will not it tell we So although is Not will they has led could formularies certainly information. it us approved quoted. what majority of be re-review it. approval, an a with that all meetings have actually that it than number That

or more experience until want economic with they more more data more will institutions. want they wait information to So there other data, and is clinical just

are Some are adopters. institutions some slower institutions adopters, faster

through formulary. contracts will and have wanted we're before working success have actually the institutions on a place it Some those there. And contract making to in they approve

no with or almost with there why reconsidered And initially at reject again, about the answer will will formulary more I least time. So is hospital say that one or addition. can a all data be it

great. Thanks, Okay, George.

You're welcome.

you. Thank

Your comes Chardan. Gbolahan next question from Amusa with

is line Your open.

to you my Bitok that Kip us taking on on some Gbola. is question. give calling I thanks of is One with And the and have you how behalf you many if question XQ through so for This could this Hi. what color could, will GIAPREZA? And XQ? far do numbers XQ trend is, patients have between and treated that been anticipate continue breakdown

our and because much a important foremost very for very is It’s question. that to in mind first you help and day-in we you know as Thank patients. day-out as question work

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And so are by an so help many patients that we of different able institution the as have cuts we been and impact data. several proud very to

survival, save statistically at the the a look You in thing. it, that's at And there trend if of it’s significant improvement the survival whether population most of AKI you lives. overall look is a or we've important where helping been part hundreds

important data not therefore patient have here. many how patients to treated. and level hospital we what's of foremost the So to is you we per vials about say Unfortunately, and access patient, which are many asking used, first the really are appreciate how do

for Thanks taking Okay. my question.

Thank you.

Christianson comes question Laura next Cowen. Your from with

is open. line Your

Hi, thanks on question. my Jolla have for taking La a couple I XXX.

the is endpoint trial? I'm first, And patients requirement then protocol phlebotomy just wondering secondly, So primary Thanks. phlebotomy is concentration, predictive in the what ferritin how the while serum trial? on using to for receive

societies transferrin XXX are hemochromatosis and per patient So milligrams the to outlined upon a either medical includes the It the guide XX for concentration. ferritin. and by medical deciliter, ferritin the it’s the patient, mandate standard transferrin that what guiding are typically the or but institutions, treatment, physicians for in and saturation and we use by that protocol guidelines guiding saturation the XXX individual a depends mandate a to phlebotomize above hereditary

specify within the we that protocol. So

time. do predictive is know is -- that by periods used physicians stable are it longer how So those be tends of because treating we What values? ferritin over is typically to

is state itself variations in patient. of health the subject on Although based it of to and of individual the

So an acute it's for phase what's as called reactant. classified example,

iron what the patient ferritin amount unrelated But predictive the will And long very so infection, in the saturation. addition to up transparent to used. and is is outcome follow patient's is the go is is The of that and of is it XX% the it transparent cutoff a if has followed easiest to actually in in standardly a run, ongoing an saturation body. clinically

a guide we're targeting XX transparent key So saturation the as below to parameter phlebotomy.

that's Thanks Perfect, helpful.

Welcome.

Thank you.

with question next Jefferies. from comes Yang Kyung Your

is line Your open.

you a say enough milestone into payment? the that Thanks cash or does sufficient wonder, when guidance, second very partnership include of I half potential cash XXXX, much.

you your Thank for question.

payments potential or payments licensing does it one-time other any any or include licensing know You out considerations. for other not

regarding I might have think And I Okay. comment. XXX, missed then your

according of the the middle hereditary of toward ClinicalTrials.gov, the to this data year? end date year. So next is hemochromatosis, say the primary you in Did completion

guidance has X on been given in and is guidance updated that Yes. mid-XXXX. data It hemochromatosis study that be we’ve the will and the given hereditary Phase we’ve

How beta about the thalassemia?

be guidance the that Phase for X thalassemia beta of trial complete will QX enrollment given XXXX. in the We’ve

[Operator Instructions].

question Anupam Your comes from next with JP Rama Morgan.

is line open. Your

guys. so the market. much too Thanks on you anecdotal wondering ad progress or GIAPREZA the comment Maybe if George, question as market line second taking prescriber use as I an here. maybe But you could said, for Hey, line Thanks from repeat trends, by give you on can’t nuggets so much congrats third or well much. on or the beyond? us know examples

question. the for Thanks

same-institution stick given. I comment We’re that comment details going sort of we’ve won’t on to I to sales of the can’t commercial -- launch trends.

use surveys physician and level before, as covered course and use is what by GIAPREZA to to the even from research, in have do willingness willingness used. In that line, where GIAPREZA our which the as to in GIAPREZA second line market hospital to is first label. is line, of therapy being some of there is our don’t data addition, a we know mentioned We tremendous

interviewed. research, So extensive hundreds that literally from we of providers being know market healthcare

as healthcare with comfortable providers other -- get very be in there earlier and so, will physicians And lines that Thank GIAPREZA, we of you. therapy. expect utilization in time with high

Jolla you in La Thank call your appreciate much all and attending very interest for your our today.