OMER - Earnings call transcript Q2 2018

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Operator

Good afternoon, and welcome to today’s Conference Call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the Company’s remarks, we will conduct a question-and-answer session. Please be advised that this call is being recorded at the Company’s request, and a replay will be available on the Company’s website for one week from today. I’ll turn the call over to Jennifer Williams, Investor Relations for Omeros.

Jennifer Williams

you the thank today. and afternoon, for call joining Good of you that call I’d forward-looking. remind some today the be the like to on that statements made will will be of management’s change. and on subject based are and are statements expectations These as today only to beliefs involve uncertainties that statements actual the could and materially. differ to risks forward-looking cause Company’s All results uncertainties. Please report the which and XX-Q, today with on SEC, these the a was Factors of of section Risk to Form refer the quarterly discussion for Company’s filed risks Dr. Demopulos, of then, through Jacobsen, will Greg CEO a corporate our our Officer, you and will take results. of Chairman Omeros, Accounting quarter overview update; Mike provide financial second and an Chief

some have financial reserved the after overview. We for time questions

like Now, to turn I Dr. would over call to the Demopulos.

Dr. Greg Demopulos

We time call taking of everyone. Thank our appreciate update all to us today’s start you, program. the Jennifer, with We’ll an OMSXXX today. on you good join and afternoon,

of lectin key of As lectin pathway many effector response. immune the of part enzyme complement MASP-X you OMSXXX The pathway. of inhibits the the system, the know is component a

in or to stem We hematopoietic Phase hemolytic clinical or OMSXXX X of immunoglobulin stem nephropathy three syndrome TMA, our in A IgA and each microangiopathy, uremic in transplant-associated programs cell aHUS. thrombotic cell advance or atypical continue

therapy. stem make for Phase in We’ll received Phase last which call, program OMSXXX, for focus patients OMSXXX the We in in program, of TMA persistent TMA, nephropathy. designation despite or and one TMA. on our the patients high-risk renal X on TMA treatment those X also the earnings therapy our with immunosuppressive cell has diseases ongoing first have in have from two transplant OMSXXX to IgA TMA, with our good other trials, of cell stem continued clinical stem stem who cell cell breakthrough modification we’ve progress currently treatment of FDA Since focused

on and national OMSXXX. patients matched the Milan. control, Responses we markedly discussed the with improvement stem this for who June, from of With and we ones with lock, year, significantly to-date, stem of on may OMSXXX were with Professor TMA TMA These cell in results order respectively. with pathways approval were overall a a both progress at or together are approval. or versus in with outcomes meetings our accelerated, for TMA continue matched both BLA X.XXX and Application Close that previously the obtained were achieve we survival, and a be we’ve regulatory might TMA substantive to the XXX for less interactions Europe. an and an FDA clinical on have two of already U.S. of to and with Committee a treated improvement, updates of regulators, the XX patients Rambaldi on the will Alessandro cell both data MAA. of Application June diagnosis. meetings details and we or first next on We and quarterly full response regulatory European anticipate preparations approval XX% XXrd for We accelerated EMA’s than positive Since later review. support a chart and European University all approval survival OMSXXX retrospective in additional control disclosed based on data of P on cell historical plan and regulatory the Medicinal were approval We be to approval TMA. a approval year we population prior analyses or in and additional the begin for number our able Biologic before authority. derived Europe. ongoing, a in and any meetings these Marketing the of conditional patients or by presented be to European and for a had conditional European demonstrating on on consensus X.XXX, transplantation. License filing for treated our U.S. marketing European call. either days path database Association providing Application, orphan XX% of full Authorization you cell magnitude conditional, and historical BLA treatment granted toward of agencies OMSXXX whether the at treated designation stem treated focused to Marketing the These remember, statistically values achieve Congress As European Hematology accelerated data Orphan a at believe in from following superior fivefold intend earnings additional Europe, treatment or conditional In collection U.S., submission Products, European month, MAA data Last a U.S. opinion with Authorization stem to U.S. to full agencies this in national that positive historical for small and the upcoming OMSXXX full

We opinion confirmed to the this later Commission month. by expect this be European

in follow-up population The of renin-angiotensin high proteinuria more baseline the system or second, a None are day of TMA, trial, of with levels has baseline our optimized received IgA proteinuria both in designed breakthrough nephropathy OMSXXX The U.S. X therapy accelerated FDA of extended rapid RAS are month. patients blockade. are next complete trial the consisting Data our and includes gram despite progression primary is retreatment, program steroids. nephropathy. dosing Kong, excess or are of and the program first if of designation. The effective this open enrolling. endpoint. is pathways RAS Two levels patient in one In steroids label option the now size risk populations study which full on the Like from included trial from for of smaller with trial X has that per with grams in in Hong the XXXX. patients, X enrollment. currently placebo-controlled proteinuria, of for blockade; cohort the also at the underway, OMSXXX to Enrollment data depending X portion needed. the Kong the program IgA turn is U.S. who on Phase expected half Let’s Hong been cohort to and OMSXXX and approvals, on XX expected time a the clinical weeks patients include stem cell is are of patients and the disease optimized day of taking not at in duration taking in trial’s trial evaluating with and per Phase

clinical the continues patients, drug Our aHUS OMSXXX in arm, trial. a assessing X enrollment single in Phase open program label

discussion trial for of identified. Europe and trial no aHUS approval this loading targeting our the XX in approval U.S. for in by XX approximately In Wrapping patients of both, Our required full followed full up well-tolerated, safety in approximately trial our is Administration to-date, OMSXXX patients subcutaneous been MASP-X X approval. FDA by accelerated OMSXXX consists Phase dosing. has program. concerns every the with intravenous on clinical drug with

our for in We small highly selective families of With continue trials advancing track MASP-X molecule XXXX. remain enter administered multiple inhibitors. MASP-X compounds, clinical inhibitors of to on orally development rapidly we highly potent,

product, OMIDRIA. Let’s now commercial to turn our

which $X.X or second $X.XX quarter limited during $X.X the was quarterly for our noncash million at expenses share. million million. quarter or as revenues from Net includes of and last discussed sales per $XX.X OMIDRIA per loss call As expected, earnings share, remained $X.XX

three Medicare OMIDRIA, in which payment or OMIDRIA for the know, of their Services, to for the surgery by This and half As Centers January loss in was due for until or drugs, CMS. procedure X, that the pass-through reinstated reimbursement this October that part extended will reimbursement additional in XXrd, separate legislated and X, the most Omnibus as year reduced Signed the good a for will hiatus this years status for OMIDRIA status The patients. OMIDRIA In and occurred decreased ending. March of first an of status and scheduled law be beginning the March on October caused Xst. in Medicare into are of surgeons you Representatives and sales effort, XXXX cataract and the resulted packaged the by news markedly and access hiatus the this XXXX. the bipartisan payment to separate year, outside House pass-through both amount period of both payment CMS other of as bill be run on directly Congress, two the for of soon in of in OMIDRIA a cataract Senate for benefits pass-through is pass-through Medicaid

payment price at CMS extended for this also of the As for selling XXXX. or the the until OMIDRIA average that of drugs held XQ receiving XXXX reported legislation, and to, amount, calculating part quarter of second be the pass-through, the for mandated would, other purposes fixed ASP Congress ASP,

at approximately fixed for As calculated amount derived which XXXX, will the CMS amount until a payment payment and OMIDRIA ASP of remains the the in result, April usual manner. CMS $XXX be after

to the objectives. for doing October three we pass-through reinstatement is are prepare overarching what Xst commercial for Our on status OMIDRIA? focused team So, of

our new the demonstrating with through First, together cataract for OMIDRIA during that patients; those samples currently and facilities use do ranks days do. reimburse expanding account of widely smoothly; for benefits in by identifying the into OMIDRIA customers, literature their third, and them which patients are ensuring and for running surgery are second, that who ordering processes trial provided utilization holding not OMIDRIA the existing the published OMIDRIA converting

discount our In OMIDRIAssure patient-focused services specifics. program. our reintroduced Here purchase are some reimbursement July, volume we and

and are beyond. our quarter Customer discount in uptake continuation fourth to the has undergoing response XXXB programs continuing of the will to these of the OMIDRIA patients cataract uniformly programs benefits help positive, also We low-income that surgery. OMIDRIA all provide to to these program accelerate pricing and of been the utilization expect we of

has new these director additional we of hospitals, XX, nationwide, sales focused provided accounts patients. servicing team. OMIDRIA, facilities, quarter nationally surgeons have that In new and outreach on XXX the we number more X the regionally. is within potential opportunity implement and never of to To an the The manage have used territorial or our customers hired our Our sales to drug is national representatives responsible organizations the experience increased have account alone, ASCs of solely we efforts for representatives, the their productive. for recruit to and directly new second accounts, chains than ongoing. been sales benefits another of recruitment securing that team had to of This also expanded

ASC and hospital-focused onboard are territorial, the additional already and these of in chain field. All representative

randomized, meeting early an trial of on in inclusion in existing of the the these in the as XXXX. and representatives. OMIDRIA OMIDRIA, now well payer hired clinical National Supporting prospective, set Payer years were With Refractive national or problem. the data The broadening payers month, third-party reimbursement Veterans already insurers, we’ve IFIS of of of OMIDRIA results who intraoperative data double-masked of OMIDRIA for and iris are B and growing Journal new Director focused the This internal a plans. benefits reinstatement late payment demonstrate our Access, Medicare experts and OMIDRIA the Cataract accounts, high-risk commercial ability the as efforts on prevent of published across Formulary. payer objective Administration keenly Medicare, The to Part on recent Surgery. on customers or an patients of at is team two of and this beyond investigator-initiated, schedules To is also the the additional separate immediate Health Advantage inclusion an across is floppy of this end, syndrome of of the published that targeted with building for we is beginning team’s year reimbursement Medicare

the patients, Another This shows a damaging reduces one iris expansion adoption. newer submitted using to patients these the that broad technology of for significant further the those data drive demonstrate in for should devices two OMIDRIA when of epinephrine, large of expanded study pupil laser. collectively and including cataract has in on compared operated and OMIDRIA of the costly populations investigator-initiated publication. femtosecond These range benefits been surgery need drug’s

other results management shorter with preparation the in for currently addition, femtosecond two including In revealing and statistically times, laser cases studies, associated are OMIDRIA, pupil submission. of surgical significant benefits in

of second the VA facilities, all only that across endorsement also is surgeons that was quarter safety the their meaningful OMIDRIA, make Formulary, of As broaden VA available to efficacy this help and meaning added This year, and many OMIDRIA a VA OMIDRIA adoption to and patients. is National as across but of ophthalmic procedures, of in not know, you to seen must perform facilities payers. expected the

allow good of the increased us demand for hospitals in December sales recognized expect in yet will system. it We and take ramp bureaucratic third the drugs pass-through we up drug. relatively that year. VA VA not not been wholesaler to sales begun a representing revenue. recognize National which Despite sampling. new often We orders to VA after This facilities in quarter VA to that In begin expect we rapid purchasing accounts expect period. of some October the then surgical OMIDRIA, has predominantly OMIDRIA the are April the and XX% October Since are surgery this have anticipation to are does however, time on all with ASCs quarter perform hospitals, will third than late portion in a the the Xst, continued of system more during Xst, growth extended XXXX challenges, these ASCs VA cataract inventory OMIDRIA likely to start. the uptick the off facilities that allow addition XX, of a of placing Formulary as

of indication continue the for end XXXX the separate that from pain will CMS’s indicated an or CMS. OMIDRIA drugs post-operative recently for the for pursue System setting non-opioid permanent ASC extension pass-through OPPS, for XXXX, current proposed pay in released CMS in Outpatient with approved to Prospective October FDA it relief. Payment In we the to payment rule Looking separately

definition. packaging, With the we named, that specifically OMIDRIA of Medicare there respect recently remain not European successful basis. legal of EU to This clearly a engagement beneficiaries. for further European against our with completion the our We marketing labeling, We’ll and proceedings sales preserves in reported believe be look to testing, authorization forward to for access of meets CMS following today’s the manufacturers. had OMIDRIA, on OMIDRIA plans this OMIDRIA Initial will generic Although update optimistic that for occurred comments required and permanent we with validity ongoing that limited options on commercialization. use. European European status maintains OMIDRIA and the for for release future of end OMIDRIA an

has Drug Abbreviated ANDA with Application Omeros. All litigation of or to been our and new favorably concluded filers now concluded

all to settled last May Sandoz Sandoz lawsuit longer of ANDA view year, last Our agreed this Lupin. infringement no was our infringement against we the unless patent XXXX, approval dismiss of against authorized, Then, date is our and successes of proposed Book of its drug until the generic generic distillate that ANDA manufacturers patents entry pursue in against of to patent its similarly stipulating for Orange the any agreement. these earliest settled Omeros’ amending The OMIDRIA. to is expiration Par year. pursuant of case three for subsequently FDA listed we settlement April In the of lawsuit otherwise month,

We OMIDRIA have are pleased Lupin now Sandoz respect that Par, all decided to patents. and our

provide Now, to pipeline our of few results. before I’d programs highlights like move some other to on of a brief financial we --

safety to our addiction and pharmacokinetics subjects. our and Phase PDEX interest program only In and single-ascending nicotine target is the of first to Let’s underway for clinical first. healthy turn X assess to I’ll OMSXXX, or is on A multiple-ascending-dose compulsive inhibitor, and focus time, X designed planned which phosphodiesterase trial addiction disorders. in

OMSXXX dosing been and completed collected able Phase half Completion in pharmacokinetic the cohorts that to XXXX. trial tolerated first two subjects. once of be date of well dosed be daily. have in the drug expected X of has is the should indicates the to first data We

that a by factor in not antibody able alternative therapeutics. are to of to duration even alternative Now, D or let’s to key activator OMSXXX. the pathway. our D be MASP-X administration therapeutic other of of pro-factor accessed Omeros responsible for MASP-X complement MSAP-X benefit, inhibition discuss antibody capable systems pathway of first is identify and often inhibitor the is systemic of complement and was conversion the franchise, our the long of the achieving as half our MASP-X compartments

number in a market is other or action. on development, mechanism advantage of So, local complement the ability unlike one to inhibitors treat OMSXXX systemic the the inflammatory of with of diseases

that seen the down pathways. in anticipate pathways. the risks Another or advantage is infection three lectin inhibitors all block functioning of without that we the shuts affecting OMSXXX pathway the classical OMSXXX carrying Therefore, alterative don’t

or We’re commercial we are plan And antibody our target a as early-XXXX. lots trials for production our nocturnal hemoglobinuria for Cell lead initial use. and for paroxysmal completing to including or therapeutics, other PNH block of enable Bank the Compared Clinical slated late-XXXX to profile. generation and clinical extravascular safety in inhibitor. OMSXXX expected indication. and believe advantages, MASP-X treat and anemia both, intra that currently dosing to seen PNH should inhibition patients we holds the also key hemolysis receiving CX a Master remaining

to molecule developing only to alternative similarly with As MASP-X shutdown MASP-X, pathways. with disease molecule inhibitors our program progress. cardiovascular central that We’ll block metabolic potent discussion GPCR it exclusively small with broad-ranging out and of inhibitors GPCRs both we’re oral as for pipeline administration, alternative MASP-X system nervous our well and close and continues the cancer the as pathway bispecific believes MASP-X our controls inflammatory immunologic significant Omeros including well to as XX lectin which advancing disorders. program make inhibitors as small indications

discovered cancer-related molecules role with have plays demonstrated and With advancing to of and targets, breast currently GPCRs the cancer We respect on in against these a oncogenicity specific sarcomas. GPRXXX our in receptor focus triple the two number are the small data critical tumor or negative GPRXXX. and formation GPRXXX,

these will tumors. We modulators growth of GPRXXX the expected block of

promising affects cytokine checkpoint and As cells these second and over GPRXXX possible. unique no cancer-related I’ll be quarter levels GPRXXX no cancer tissue both as during target enable has singly and our Inhibition our We our of to Mike initiation Jacobsen expedite tumor-protecting cancer GPRXXX To target are financial while teams both for compounds trials the expanding turn last can other clinical immunotherapy. results. quickly molecules. or this of call to our discussed suppressing discuss increases we constellation that blocking currently to now inhibitors. Omeros appears in targets of regulatory than of optimization a GPRXXX medicinal inhibitors call of the human tumor so as earnings tumor-promoting other chemistry against killing T entity our to knowledge, functions

Mike Jacobsen

Greg. Thanks,

Greg noncash As loss expenses of quarter for were $XX.X $X.XX second noted includes the $X.X OMIDRIA This per our or $X.XX million total in net was million share. $X.X million revenues and or per share.

renegotiating after million under CRG, the our loan During debt agreement we the covenants quarter, the remaining favorably borrowed $XX under the with facility. available

some the results. second Here quarter specifics are regarding

X, pass-through Our pass-through loss Xst, on for wait to reported of quarter the first are impacted revenue by continued to on customers reimbursement the January reimbursement increased quarter our to of only. reinstated OMIDRIA be basis A from for continue significantly be substantial second but the using majority and XXXX. a selected October

expect activities $XX.X We were expenses generally of XXXX. $X.X XXX, development our with line was pattern and utilization the to higher scale-up to see the third and first million, together million application increase during incurred increase Interest product for our for was continue costs quarter. million manufacturing due other to patent a increased $X in on expectations. the quarter, is which The the OMSXXX, quarter current from primarily current quarter candidates with for costs. expense third-party Costs

had for and available CRG equivalents XX, cash agreement operations, general short-term building cash June of our restricted in loan investments our XXXX, of million $XX.X As support cash, and million of we lease. and of $X.X

ahead. take a let’s Now, look

affected of revenues in anticipation the be the pass-through by pass-through. ASCs end We third will On our increase positive Xst, hospitals stock October continue purchases in quarter and as expect near to from lack they third the an the reinstatement see significantly a OMIDRIA expect reimbursement. quarter of of we of that note, reported to

the increase, in purchased pass-through of X, of on and wholesalers due to As we that a XXXX revenue, as was these hospital to January of expect recognize December by the portion expiration inventory deferred purchases XXXX. the ASC

year, this first over of see XXXX. on expect based quarter of we to a in the in customers, with fourth the the three quarters significant our run-rate increase actions revenues During

with During and lesser our the and remainder research development XXXX, the OMSXXX, our contributing are GPCR to of amounts. expenses majority planned related program of OMSXXX to be OMSXXX,

OMIDRIA CRG for in from this be our sales X May. additional will Phase the Interest borrowed ongoing quarter OMSXXX. XXXX over the of third and precommercialization manufacturing We OMSXXX from expanding will to development With and expenses quarter $XX to of programs and general costs research scale-up of back continue to costs. we this administrative to remainder given activities second and Greg. the the year, that, call force expect approximately year clinical increase quarter due increase Selling, will $X.X primarily We for in interest million expense on turn third I’d increased the million. anticipate expense our like based our

Dr. Greg Demopulos

Mike. Thanks,

questions. to call the open Let’s

Operator

Instructions] Our Steve the from Securities. line with Brozak [Operator question WBB comes of first

Your open. line is

Steve Brozak

one after lines current correct, the look or it I at. somewhere reimbursement along opioid the you’re side you’re that that talking for question. if please. OMIDRIA, as what something we you Thanks and would is interpreting months. way that I’ve a Is about way On in look one, taking at pass-through follow-up, see I’m on The and would interpreting the of should would got few the the that as resumption continued even well? continued being

Dr. Greg Demopulos

an clearly our of fits one CMS the fits that or they statutory know, to yearly OMIDRIA, directed as stated, beyond sets of rarely post-operative and indication that is say better of unless to extend year, you probably its on certainly But, is, I non-opioid basis, have OMIDRIDA it. what definition. conversely, rule FDA-approved treatments, the interpretation the for component reduction which sort Well, can Steve, provision some rules pain, a there do

provision that hand provision believe included for our would a rule that XXXX, we given at So, be that, to be not the would be crisis that continued, year. likely will be one -- remedied that that November expectation that OPPS in hope is next coming rule likely the in and that that be opioid provision applies It or be should would frankly final OMIDRIA. that that should

be any in that can't expect I would or to will CMS predict of continue. that would come. I speak that But, I So, kind Again, would for short, what ability think to expectation. my directly

Steve Brozak

Got it. Great.

what that the costs, I'll could hop greater on, are I the if clarity that? the much transplant, On Let me and much patient provide are and and back important standards and let at clinicians then in for again, happens far of and And as specificity you, transplants, the at as what hop you things detail you what as as me as would why queue. see And the XXX possible, XXX terms one do XXX, into current are looking jump this -- significantly is like the are what of debilitation, back of you you what care, looking fitting looking thank in what for, in queue. of as all given. I’ll can are how

Dr. Greg Demopulos

Yes. Thanks, Steve. well, there In no stem TMA. question, answer to is cell that for currently, treatment approved

to is hypertension, management first with treating on stem respect So, appropriately modulation treating so aggressively current regimen really or care, any concurrently modification currently TMA that any cell that any standard jumping in immunosuppressive hypertension other deems appropriate. be supportive therapy providing stopping GvHD may place, that the really of managing present; line includes infections and for or or now the physician

mortality treatment defibrotide at the survival has underwent was large year high poor, XXX%, even and who I series, be and pretty subsequently plasmapheresis, recently in with is therapy Adult Plasma is as published reported supportive immunosuppression been this one therapy. received another to a survival tried, no don't been get you quite this but think or patient the modification then in rituximab, that patients to modification, poor prognosis. agents, thought sense And supportive, to who terribly of respond So, clearly has immunosuppressive really have their utility really population. again, was patients poor. the have as

treatment stem the So, cell associated And again, TMA. current approved for no is landscape. that really

I you about think cost… asked also the

Steve Brozak

cost current is? the What Yes.

Dr. Greg Demopulos

But, management associated TMA. more Yes. this that kind careful I -- high-risk that $X And, And as million. out, I the the and cost receiving I I about, but that will to it's information. demonstrating understand again, costs about publications these understand. secondhand, soon want understand I'm secondhand with one this there supportive or is of again is of be be it

there So, that a cost obviously, are is cell risk XXX poor, these high, effective TMAs targeting. the clear an outcomes high associated particularly TMAs, and need for therapy is for the stem approved and is

Steve Brozak

the Again, resumption thanks look we forward for to taking Thank obviously, questions. And of you. OMIDRIA. the

Dr. Greg Demopulos

Thanks, Steve.

Operator

Corey from is question next Seaport. Our with Davis

open. is line Your

Corey Davis

Thanks much. very

The a for to first BLA question foregone before what on into longer the language you filing timelines conclusion? in that have application? year you interpreting you I ruling your this go on Can is the need filing more am a of is, details certainty kind with no right that do TMA

Dr. Greg Demopulos

our the filing remains Well, of this BLA a say I year. initiating will that objective really

think Corey, that objective that I be think end. on don’t that’s -- your our I So, don't on might end.

I think our though objective. remains that

Corey Davis

Okay, thanks. this mishear start that looking going historical controls, And, I you I you're think, that, mentioned Did to at or.. year. later the

Dr. Greg Demopulos

correct. That's No.

Corey Davis

Is citing. been that than you've the comparator that XX% different

Dr. Greg Demopulos

I literature-based controls. The XX% and put The -- Yes. XX% historical about -- correct. as comparator, think, control. we've again out matched publicly talking We're literature-based a a historical

controls What later chart year met ahead patients about the specific we're So, these this with that been patients. were literature that are really to had historical the criteria from OMSXXX-treated set reviews. of time assess talking the versus

patients, prospective So, a in-depth of on chart reviews basis. again,

the or or a such So, DAH, protocol and diffuse as assess to so prospectively, confounding factors, GvHD other concomitant factors outcomes problems hemorrhage. defining other alveolar

all historical be prospectively for a defined, is So, it this chart controls. matched review again but would

Corey Davis

patients included more many ‘XX? likely filing? how that many would to you And an have you patients Do beyond enrolled are in idea, the able be how how package and comprise many the Okay. to have data be

Dr. Greg Demopulos

yet. to the I have way enrolled. idea is up objective Yes. continue an all prepared enroll them there out we we've we clear And to through But, enroll. it haven't to how database made comments, the And continue of I many put lock. in mentioned the have our that do as we

I in is many data So, many collecting on And patients out, to as The to that in bring point, to be you're as lock. pointing can as on include as treated very database we submission. much we up as with objective OMSXXX to can. think,

Corey Davis

able if results, release that study to all, to at Okay. trial giving this ongoing blinded a time to you're IgaN your question, affect have result the like in be going is mentioned, Then, the last in X Phase September, you're your you population? this how trial, first going that

Dr. Greg Demopulos

gram, expecting those not we across range Phase looking to way we'll structured any data on program the range. that well levels. the also nephrotic, would there The going nephrotic receiving think but on meaningful really obviously, sense X in is data a get number to what data. patients this way, The The endpoints the a control we're some side, mean, patients. they Remember into on We're treated the get range I look the threshold is what's I a would in inclusion sense program, of I for we've be of the to the at there's Phase small are to that And the what incidence and program. objective as IgA to X make and really the proteinuria this they're Yes. population X that relatively ranging higher here can know what's population, expect sure change Asian in that at doing Phase you a of we're accommodate side, the Asian well in not has of in Corey know. in difference these know significantly happening into those nephropathy. a you outcomes of just

and with but disease, same just in the in interest of Hong get we patients a Kong both set as the Asian expect, we're sense of So, enrolling in non-Asian populations. confirm the that issues those our really dealing to is whether to same

in I to any short, real change So, Phase program. X don't expect our

Corey Davis

it X Phase different excluding you reasons the are be any you ongoing that X? mentioned would results be So, patient suspect those expect very to than matures, Phase the that trial predictive the to when would there Asian of population

Dr. Greg Demopulos

make there know we Yes. effects we the dissimilarities? similarities, that Are It's on the dig response data. are? the a again, approved this good others? disorder is see there there Are Again, number about we won't stronger into one, of not the is until in any we're -- in no And And learning still disorder. see factors what proteinuria sort would a question. which We for that some, treatment. all

help forward. blazing to again, get think, as is here information a move And to trail. gathering largely the this I this us, is data. we're But, new So, we're somewhat we eager

data to everyone month. making are looking to those forward We available next

Operator

question Our next H.C. Ram Selvaraju with Wainwright. from

open. is line Your

Ram Selvaraju

believe. in mortality I an These my for what believe With allusion the was approval? to OMSXXX. respect indication different used for in Could the to was? for questions. XXX-day utilize much very made straightforward, that indications clarify Where Thanks mortality press you release, Hi. same XXX-day that that you endpoint. relatively us taking I endpoint are

Dr. Greg Demopulos

with going study Ram. and to our I you. don't to have available specific I clinical to have back you, the But, I'm to get group check that. make that That can on

Ram Selvaraju

And pivotal perfect. that directly for able trial for just from clarify respect you with expect bit then, you in indication? extrapolate be can what IgaN, Phase a little into study to the the in OMSXXX this Okay, to study to us X

Dr. Greg Demopulos

absence Well, similarity studies of those between the two steroids. the major is

So, think, I that. we'll at be looking

I we'll incoming in think, interested also, and seeing proteinuria be responses. levels very

in ability not have we set we I this Remember, trial, think, retreat. did retreat. to the in the patients, of first

patients. us allows the Phase ability So, structured retreat this And already to the that the into X is program.

X. supportive So, I I us it further And, Phase again, program see gives of Phase there, insight. that as the some X really we the think think

Ram Selvaraju

then, And perfect. just Okay, things. strategic two

looking to series off you're Asian commercial European be IgaN among currently seeking Asian established in you the an being regional not potentially potential Union hands For for strategy could OMSXXX, individual of whether within or on European to a And this presence partner in better as you. is or European OMIDRIA, to multiple partners, this the the or each of epidemiology comment at not larger the whether relationships covering Thank of country you commercial regional with you European subjects, are that drug? given has a at then, can identify partner that territories? on likely time the optimally speak

Dr. Greg Demopulos

Okay.

with first -- again questions. good to both and respect So,

be because are could included. could one specifically I those. parts regional. First would specifically And that think global activities, expect that or would know, don’t on expect partnering partnering But they you I also would certainly, And we within be to either Without comment Asia guess one of that as speaking with we of one OMSXXX. broadly around those would Asia. be our subset, that that discussions about respect Asia anticipate or partnerships -- regional in potential

Europe, I be really national, to to than in your more both. say you're our plans I'll asking that's in would have much as I to think regional been other With comment think, OMIDRIA as So, there, all comment or respect exploring first we're those that and whether about and as probably response withhold question. exploring

different focus the here U.S. is the piece to understand Omeros in the that in further very Europe with pricing is important the for than think, to is And currently I in obviously OMIDRIA U.S. respect its to drive adoption

in cataract OMIDRIA be indications likely a selling, Europe where of potentially, at implies not think plan anything that your is perspective, we're of think utilization a high ourselves, think subsets dealing not within that royalty likely standard in can And And of cataract to I selling not and are pricing together be in And as establishing the the that say, as become least I really value are the together question use of establish possible, I the there to establish make will as drug. that would really value its in reflects drug to into we're the our there follow. need with basis. if believe accurately the as put even to going Europe U.S. in components, really should we're you sense. that at order want list something the I is that be makes Europe, both standard understanding Europe surgery within would selling from we think, putting the surgery that going to that we that those you and think I might sure we've and really of successful a we that directly current most if where use, be, point Remember I it that be, it's to

of the certainly extension this on to approach. think build allows I us that opportunity pass-through

Operator

next our with And from McCarthy is Maxim. question Jason

lines open. Your

Jason McCarthy

my question. Hi. taking for Thanks

addition in bit I'd So, to about a OMIDRIA in to XXX, discuss like XXX.

known in to it's addiction U.S., obviously, is the a in nicotine. particular, that opioid major problem relating So, and widely

cohorts bit possible give a as you with such could kind ourselves us of two the here, in a or X could nicotine without endpoints, forward dose down clinical Phase path and the ahead the timelines getting X Phase So, in expect road? of first we more what in color addiction, a on

Dr. Greg Demopulos

Sure.

this, let specifically, disorder. and know, between PDEX of think movement PDEX everyone, any remind with but you demonstrated several the generally but the we’re Remember, and Jason, inhibition and me of also OMS-XXX all I we've our and form just that take steps ones inhibitors. I -- of and heaven any addiction PDEX with what back PDEX link and form who discovered

alcohol, compulsion nicotine, the side opioids data on on have we side, and binge-eating. again and the in Focusing compulsive cocaine, addiction

of compulsive roadmap think So, widely least OMSXXX, to there central development to we of because first Chantix. form clear the reason really for roadmap The and we focused here is was disorder. that the at probably is was currently on central mechanism that any thinking is addiction or applicable our -- and nicotine currently a that

of to circuit to is response your I question, Chantix. kind So, short roadmap my say, look, would the here

program look you at to look at look with what You Chantix, nicotine. the you endpoints, for focused respect on OMSXXX at That's the development we're Chantix. and

mechanism that brand the addiction PDEX the PDEX the or we core they is mechanism inhibitors dopamine, for PDEX And compulsion inhibitors OMSXXX. general, for for in OMSXXX, in what As that in dopamine I inhibition of of dopaminergic. is that parts elucidated general. have make the responsible know in you But include U

the to So, through normal VTA addictive the really levels dopamine U those phase brain the accumbens bring the are the where down -- phase. levels in VTA largely is the acute you and chronic nucleus or dopaminergic in addictive hyperdopaminergic,

hot opioids, as variable postsynaptically again And OMIDRIA. their That focus drugs with blazing normal. it to little to really all to we topic, and on back also largely in FDA approving challenging these disorders. cocaine, accumbens should to treat a been apply across those led now dopamine pathway be with We in working board we difficult. But with nucleus that That compulsive know. perhaps To-date, interesting. is opioids. in be of the would would in has Obviously, opioid-focused talked part again, levels to in of tremendous more elevate go the there the a decision You're addictions about our sorts it's nicotine, and a problems. a there, that

reasons. we relatively those ‘XX. of X the all once point So, development think have expect for once the answer I your the trial, to I study nicotine think quick that expect will focus Phase half data on of Phase about again, was time we would to that. said, as see we of all quick, a to very And and get our hopefully, And timeline. from We digest Chantix. here proof the data And you and questions underway, our first X concept X Phase in I I

or good for of So, proof work on turn look nicotine. continue data concept we assuming good, a quickly and look those study around to that

Operator

I'm questions. not showing further any

turn So, to I'll back over closing Dr. now Demopulos the call for remarks.

Dr. Greg Demopulos

wraps joining keep And updated way That progress on thank for expect call today. for you things together pipeline. periodically our All the we'll right. like We Well, going our you, operator. we again, for up Thanks forward. us. our the everyone OMIDRIA coming and are

good always, afternoon, and As appreciate continued everyone. And a support. Thank your have we interest you.

Operator

Ladies and conclude gentlemen, this program. does the

day. have great You disconnect. now a Everyone, may

Omeros (OMER) 9 Aug 182018 Q2 Earnings call transcript