OMER - Earnings call transcript Q1 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 Mark Metcalf from Omeros.

Mark Metcalf

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

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

Now like Dr. turn to over Demopulos. I’d the to call

Greg Demopulos

to and Thank good afternoon you, the of Mark time us. join appreciate We all everyone. you taking

updates system, we’ll pathway We of key MASP-X lectin on OMSXXX inhibits of today complement effector lectin the pathway. response. The OMSXXX the there. a and the of start enzyme the component immune part have is important

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

the currently one nephropathy. have Phase in also OMSXXX TMA X other focused diseases and clinical stem We renal on ongoing patients cell IgA trials, two in with

patients the than cell for first begin mortality X.XXXX. rate OMSXXX of high reach day similarly a OMSXXX in XXX patients quarter, days used control. P OMSXXX in conducted. in been rapidly. treated assessment and X.XXXX. a analysis analysis showed with occurring TMA endpoint treated control The cell study mortality results stem blood count, death patients. cell survival a transfusion a have these for significant haptoglobin also to disease of for matched of was our the duration When value perform is the conditions patients magnitude XX had survival update of stem XX cell with historical mortality demonstrated a order total first cell like with of one XX% Let’s red with use was we of the stem Biomarkers lactate follow-up XX with for than that XXX relative patients median our have the improvement. TMA platelet value a these was protocol. significantly sufficient ongoing less improved Study XXX compassionate including that platelet date, an TMA greater patients a estimated show TMA program. patient To treated dehydrogenase XX% in That In stem commonly P versus under substantial reported historical and to and requirements. statistically reduction patients OMSXXX, which

cell TMA also treatment in stem of persistent granted designation last modification We for OMSXXX of breakthrough patients announced have therapy. the immunosuppressive despite who that therapy month FDA transplant

This may As clinical for you on serious drugs number the of high stem cell therapy over OMSXXX. that each risk clinically TMA a drug intended indicates preliminary know, which evidence endpoint. improvement a designation breakthrough marks therapy designation designation a treat breakthrough the and small for is condition demonstrate second therapies granted significant available breakthrough to substantial patients to and

met devastating in is that year of granted in we Based multiple for approval one approval in The cell of the stem breakthrough have we OMSXXX nephropathy. IgA to granted only last designations. with been and been treatment both to on first having meeting OMSXXX OMSXXX drugs clear handful have this TMA. recently a of requirements discuss of accelerated of OMSXXX FDA disorder. for full believe paths We

an outcomes population for information for the requested made biomarker approval disorder. high would high our objective that treatment OMSXXX a dosing. full whom data. FDA further patients marketing And across discuss additional risk OMSXXX and License working provided further purpose of Should stem with for OMSXXX we accelerate to respect further lethal Concurrently our Europe, in highly risk FDA Biologics data of define we with later submission the had as confirmatory we compile the scheduling with cell In historical with to BLA subsequent FDA regulatory TMA. further for for we or we Application an commercially to of all to would submit addition patients. available plans to patients comparing to treated grant agency control continue compile a characterize in required will obtain assess drug information conduct TMA. closely the also the of this approval patients, conditional intends of stem authorization that With initiating requested the rolling FDA be expect year. the this cell the optimal with trial to all plan stem authorities for application analysis submission are corresponding meetings cell TMA Omeros on EU

proteinuria The proteinuria OMSXXX Last provide and pathways currently our X gram is with and a to levels day includes in to year IgA accelerated patients which population includes now one more nephropathy. designation trial turn FDA The breakthrough nephropathy. program X for designed path of or as to clinical on with based program to two first of one its is Phase each OMSXXX reduction. IgA approval. granted Let’s per excess this approval patients underway clinical enrolling a baseline therapy of trials

effect open-label only reduction on and trial, agreed began nephropathy proteinuria in levels the per patients the granted and be of include full approval has on can with if taking nephropathy drug first option the The Data includes Kong The the that is Hong for Hong to alone. in placebo-controlled extended grams complete of baseline on knowledge, trial needed. a of U.S. steroids. is not follow-up retreatment cohort XX and designed that or early expected study and are the the trial in evaluating FDA expected with X and To the and is Enrollment from patient patients X size approvals accelerated U.S. In of proteinuria OMSXXX duration which day data IgA from OMSXXX enrollment OMSXXX weeks more portion quarter. both for Phase is Kong, our in proteinuria. pathways in XXXX. the X cohort are Phase second for assessing dosing and midyear. last underway full IgA depending

FDA program and Agency European third Phase this enroll a assessing aHUS or the both in Medicines trial. open-label patients EMA and to single consist X Our agreed OMSXXX the drug one as the clinical with of continues arm

is patients XX trial approximately aHUS full Europe. approval X Phase for in targeting Our

FDA XX received has required FDA those U.S. approval. by the EMA designations OMSXXX total across As three patients for well full as accelerated approximately approval in multiple from indications. from with current and

and designation orphan pursuing in cell TMA the orphan we in Europe. are stem breakthrough and OMSXXX U.S. For therapy designation drug is

and IgA U.S. For in designation the together drug nephropathy, Europe designations has in orphan OMSXXX breakthrough and are priority orphan with PRIME medicines designation therapy or pursuing we drug EMA. from

In safety Track designations tolerated the to has For the in clinical has concerns U.S. drug orphan OMSXXX every aHUS, date trial identified. with OMSXXX Fast well in no received drug been

campaign in in inhibitors. to round make MASP-X significant antibodies X and both clinical earnings our trial to Dip] the and our As our To all develop protein molecule progress subcutaneous OMSXXX lectin are against in controls OMSXXX discussed of in exclusively small across Phase pathway Omeros use we MASP-X. forms continue out intravenous our calls [Audio previous franchise,

are likely generated inhibition MASP-X highly indications inhibitors we potential patient multiple targeting administration We in The believe extensive molecule small the for approach molecule small a potent, for agents many be or have them. friendly of that will MASP-X for trials of for we that families highly indications XXXX. are oral oral clinical selective potent and

commercial approved surgery. use cataract OMIDRIA only lens replacement the and Let’s of now turn its to our kind during product for product

physicians CMS ordering scheduled program reimbursement awaiting on while and of the absence on OMIDRIA pass-through of status year. drug. for the separate for midnight CMS separate payment As facilities last suspended largely of clarity payment at In expired OMIDRIA December future the XX under reimbursement

from million includes $X.X $X.X the loss As of share, non-cash the were or million. quarter $X.XX was per which in OMIDRIA first share. total revenues million per a or expenses $XX.X Net sales $X.XX for quarter result

Our cataract largest is was cash, the in term equivalents overall for million. and for nationwide. the short decrease patients Medicare investments cash surgery insurer quarter $XX.X

continued financial in exposure. avoid customers across commercial customers those for is insured continue most third-party drug consistent who OMIDRIA enough the the their OMIDRIA reimbursement uncertain patients inventories. use some drew to that limited ordering Many quarter payers OMIDRIA basis using decided a While from to existing to stop on first

able orders inventory ASC QX the in not large were a recognize was we the Given wholesaler portion revenues decrease channel. of in for to the that in substantial

Despite customer system Congress back the of in risk the of when surgeons is up support Society CMS objectives. the Two, such of alpha internally range shortening or risk patients, within to be of the other syndrome patients all who remains which XX,XXX It pass-through Annual those have system facilities Cataract anticipation including exactly Ophthalmic the at real-world a on and studies the Society costs happened. use are of increase omnibus or added dense for problem use base given conducted the cataract surgical this more in on significant at reimbursement be all additional is procedures on using surgery with These broad We sales alpha-X pass-through a associated VA reducing for to on is Also common recommendation cataract of October that is which intraoperative for use Administrators. April closed history past surgeon’s including IFIS devices that and reimbursement what the VA or product Medicare two Currently first or In among this that mandating X. decision are able in April, And to years our Flomax toric will those which be These the the a use. Appropriations studies that are intraocular that small reimbursement decreasing is Administration a need reimbursed known high of few blocker with available into XXXX. case extends leading purchases American effective the pharmacy of cause lens. the XX,XXX to one The and dependent risk in appropriately will status a patients continue number factors an physician four incidence from National whether be be Refractive three and costly of benefits broadly ASC patients examples is pupil budgeted times using X, OMIDRIA iris provision due Veterans the for including antagonist as XXXX. in revealed we The for the most time to American reinstated. VA for laser March receiving response was of and OMIDRIA a Act bill initial OMIDRIA or floppy was drug a Included in and of the to statistically bipartisan that discretion. the pharmaceuticals October left focused and restoration will or were product iris technology high In presented will to with inflammatory by three lens in team ramp VA those include any insurers. to patients limited amount primary estimated perform as reduced Surgery revenue the payment commercial damaging would expansion across femtosecond the newer operated Health meiosis. recognize to the cataract by an Formulary and occur a surgery. in that drugs omnibus high in bill and law. not supported signed is consolidated a OMIDRIA

service continue and VA adoption to evidenced the expand customer by we First, facilities. increasing our base within

OMIDRIA some or and the largest addition medical training the and professionals schools effort of for are affiliated endorsement seen surgeons. of XX% education physicians efficacy in trained the expect broadening nearly product help VA of an the health adoption of to National of all all the to system. with the VA of U.S. continue Over conducts ophthalmic nation will We that their facility. all as training U.S. among superior Formulary the OMIDRIA VA receiving in with The a VA safety

were XXXX OMIDRIA adoption that was late New use accounts of the hospitals while the XXXX but product to likely and late begin will also include uncertain. reimbursement of ASCs in ready

years Now we these also on that two expect customers another starting for separate come in is payment to October, board. secure

Medicare Part of within Medicare working Second, with are restoration broaden the we payers. separate reimbursement advantage and payment commercial B to

payer and large insurers of OMIDRIA We ever on goal payer number demonstrating are internal Formulary building of benefits as of National addition support solely of of this experts safety effort focus the an of on schedules January team to should the publications set these to further a of the inclusion reimbursement OMIDRIA XXXX. with the VA The of this increasing and effort. the

CMS payment protecting the their of has omnibus generated levels acutely societies urging recognizing rates to fix Third, beyond leaders CMS CMS with the physicians and CMS’s of as to from growth for in and VA expect drug OMIDRIA to other X, October its growth optimistic patients believe of drugs within the [Audio about we we benefits the Congress XX, right resumption more clear regarding to continuing to Medicare restore letters continue overwhelming throughout to as for through opinion beneficiaries associated message We used facilities do to grow expressed policy. the sales The OMIDRIA therapeutic separate and both Ophthalmic separate surgery. reinstatement Congress utilization extension the legislative quickly We pursue well administrators of for payment patient sent access its beneficiaries. system. to that Medicare OMIDRIA XXXX. reach from we October focus as of for pass-through innovative access permanent and to gratitude for coming in a with Dip] needs thing to compounded After modestly and payment appreciation cataract for separate message that surgery inability during excitement the permanently some similar heightened status Between facility bill. scores pass-through have increased on by sales payment and and years of XXXX. ensure CMS. packaged for of concerns risks CMS remain and September and OMIDRIA now will from that of the the professional to That Namely CMS to a expect late X, those surgeons reverberates

loan over we to the of strong return VA on sales recover revenues replenishment In hospitals near-term the decision across second covenants reimbursement with towards will quarters $XX the pass-through pipeline and ongoing restoration third addition of of our to negotiation OMSXXX the and to preparation remaining have This in we became third CRG, believe a QX. OMIDRIA bring any million driving bolster October position our CRG. channels we which down a under rest wholesaler fueling development with to expanding quarter following expect elected utilization in the our commercialization that our annual our draw simple largely following agreement frankly X, removed of and of ASCs risk. Until relatively associated for cash

the revenue capitalization annual met. were reduced market XXXX been the was for capitalization to XXXX covenants deemed and beyond. and Specifically And market for have requirement

covenant. either our As CRG or you XXXX XXXX might for under must revenue recall Omeros market agreement, meet a cap through a

next for first the as aside market of First, in requirements. revenue cap for covenant, we expect XXXX. XXXX, The will be quarter been Putting covenants met that have the deemed market the revenue calculated the is given we purposes will of OMIDRIA that sufficient following the time of of annual will loan additional requirement a requirements, draw, working that three cap the outstanding times readily the an We difficulty our project to amount requirement. the currently the together funds, meeting $XXX reduced months’ this through that provide expect the sales. amount million of the market existing that equaling million. We with cap period draw $XX have don’t or capital meet

might current by the to for the required make sale drug. marketing EU European are OMIDRIA July XX, a Finally, recall, maintain as you to our of we in authorization

that we again, Here expect meet deadline. that will we

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

pathway first Let’s targeting down key without the alternative conversion of the complement the to to pathway. the is or to other pro inhibition pathways. factor shuts the alternative and OMSXXX antibody was and functioning the identify first lectin factor responsible is Omeros for our turn of half MASP-X OMSXXX. MASP-X activator the of the as system’s complement its our D affecting franchise. of classical D, MASP-X

initial MASP-X for XXXX expected nocturnal currently or OMSXXX in in PNH, to lead XXXX. market, process the preparation we hemoglobinuria, that our the on and are for as including early clinical antibody for trials, plan to therapeutics completed the or We our safety hemolysis. paroxysmal which extravascular development, late profile, Compared have to indication. dosing, ability or manufacturing slated holds We advantages, PNH believe order significant and intra scale-up both target prevent

the program MASP-X pursuing MASP-X And inhibitors only inhibitors advancing block specific remaining pathway inhibitors as lectin only molecule by as the here, CX, pathways. well we MASP-X, both MASP-X of we to molecule, complement the The is down are small our for As to potent classical. developing target that the in with key alternative similarly oral inhibitors, small pathway, and pathway. alternative of shut enzymatic are administration,

programs Now our inhibitor Omeros OMSXXX, the compulsive are any X PDEX to controls or phosphodiesterase well disorders. addition use or disorder, midyear. to inhibitor for as our as for of exclusively scheduled of for trials begin and let’s any turn PDEX for treatment compulsive Clinical addiction disorder. movement the any

problem to modulate normal forward a that the the to inhibition restoring acute addiction. with compulsive trials, and common opioid and in our the addiction craving addictions. reward chronic depressing relapse the on For the blocks cue both alcohol all and approved brain in a nicotine, significantly OMSXXX and craving, clinical the highly conserved rodents pathway between eating. as well of to trials. inhibitors stress-induced binge treatment mechanism seeing as and levels disorders, well are and the cocaine, addictions as as initial anti-addiction inhibitors addictions across system, focused both humans, effects dopamine PDEX PDEX parts dopamine appear thought look of become animal appears has relapse specifically, to we of the models in which nicotine system, The addiction associated ability OMSXXX without block demonstrated use PDEX hinders by and and we of to agents. currently block of

clinical on of were Addiction, a of and OMSXXX, data agonist, addiction published cocaine by Behavior. other from Journal were in of from X results trial Our in Phase and study, X disorder Journal PPAR-gamma the program, Biochemistry investigators, a Phase the published Pharmacology, consists nicotine use conducted independent

journal. believes GPCR publication manuscript a addition, heroin a study pipeline submitted data program, which discussion In for our our been peer-reviewed from with with X wrap broad the to cardiovascular Phase also including XX Omeros a immunology, up indications, controls in disease has that We’ll it progress. nervous is metabolic, continued exclusively cancer central inflammatory as GPCRs, and and system disorders. with as ranging well

ability are We and of with growth cells, they promise interleukin alpha, checkpoint promoters, against GPRXXX same alpha. interleukin cytotoxic, blood targeting, factor death PD-LX. the associated to At GPCR targets and ligand the X immense gamma and the GPRXXX believe inverse and and TNF of highly-selective our and agonists of support, CTLA-X, or for or immuno-oncology. for and that XX, amphiregulin programmed advancing decreased to specifically data tumor X, and mononuclear a discovered long results others, small time, T-lymphocytes generate compounds small life-threatening or hold levels treatment molecule GPRXXX, necrosis GPRXXX tumor have proteins, and We among the X, cancer. the of one that our protein the receptor for tumor of treatment cytokines human peripheral breast of Treating our GPCR’s increased killing in interferon levels inverse cancer fundamentally list molecules triple-negative represent serious potential sarcomas; and diseases. antagonist change

or T inverse tumor-protecting Regs. population also regulatory GPRXXX of agonists reduce Our the cells T

for other and no GPRXXX time, Omeros inhibitors, constellation even T-cell exist all receptor GPRXXX has the effects constraining To have administration. GPRXXX and chimeric requiring which checkpoint knowledge, while efficacy a than the functions only we inhibitors. our CAR So suppressive tumor of of antigen treatment. to entity that stimulates no intravenous And immune at cancer Consider of both proteins with as other singly or limitations, cancer-related this combination have by and target tumor system critical therapy blocking affects its drug superior a pathways, same shown functions.

that solid by against importance magnitude and Now anti-cancer compounds, XXX promise of targeting to and the excessively care is orally patient other That’s is an drug effective many drug, shared our targets imagine that controlled of available all tumors. our compounds. GPCR of GPCR

around on financial turn quarter programs We you and be and that GPRXXX continue we future. broad products in call results. our that, update expect about Omeros’ programs, other and a to to over and of summary build targets, these for GPCR hearing Mike, a end I’ll intellectual more will the With the first estate near the

Mike Jacobsen

Greg. Thanks,

for As Greg noted, quarter was million. first the OMIDRIA total revenues $X.X

expenses share. Our per $XX.X share. of was $X.XX net loss includes million or $X.XX $X.X per This million non-cash or

Our the equivalents for overall decrease short-term in million. was and cash, cash investments quarter $XX.X

the specifics some first quarter regarding results. are Here

As the on impacted expected, through significantly the our X, quarter for first of loss was January reported pass reimbursement by revenue XXXX.

of With for waiting OMIDRIA using basis. our peak on the customers pass majority substantially reinstated sales a on currently from has through declined November. substantial through only and be volume X, in Sell October to very reimbursements selective

not the large this during quarter, the portion expect that our as year. result wholesalers of we to discussed yet by which revenues for December From generally of increase perspective, our the last may in quarterly our to except earlier. have last VA, sales a we recognized reported from discussed call, Greg purchase continue revenue We inventory in the in second

development These Costs We of current which expect marketing incurred was expenses fees to expectations. our Interest quarter, of incurred were reestablished. by quarters fourth patent increase legal costs quarter for XXXX. in million line $X.X primarily our candidates. is this to million, $X.X to our the partial to due SG&A was recognize demand manufacturing were costs. on patents, and XXXX, October million quarter a in for OMSXXX settlement this litigation OMIDRIA in the from OMSXXX offset and reduction the The the and as and the higher ASC the due third other year due with are the activities fourth sales defending expense hospital reduced up costs current product scale in revenue a increases and third-party increase reduced and for of $XX.X the and

had $XX.X This cash support $XX of month, investments the million our we and in loan requested March of our and million additional month. in of available cash, receive loan million $X.X short-term XX, XXXX, expect available for under general operations of agreement equivalents CRG have cash lease. restricted to these proceeds As and and CRG agreement, the building later the we

Now let’s look a take ahead.

will revenues affected XXXX by lack the of reinstated. be significantly is continue pass-through reimbursement pass-through Our to until October when X

quarter During first the a hospitals we increase of this OMIDRIA. usage the ASCs fourth but the this or their over how should increase of during in year, rate certainty predict quarters quickly with revenues significant resume will the in see we run three time, cannot the year, at

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

call clinical interest well preparations primarily that, second basis We Dip] quarter for $X.X XXXX of our We be OMSXXX ongoing and additional approximately like the $X.X Interest requested first given will on our additional our million will on to and scale-up expense XXXX, the SG&A activities interest CRG. [Audio expense to approximately to Phase increase expect quarterly beginning quarter costs. X to precommercial will as turn research expenses the sales OMIDRIA likely force and based from increase to commercialize $XX increase be quarter, I’d back a continue the of and development due over million, in will expense activity OMSXXX. With Greg? we programs as expanding quarterly OMSXXX Greg. to costs will million. anticipate the third commercialization – have the from manufacturing

Greg Demopulos

to open Operator, Thanks, questions. let’s call Mike. the

Operator

comes [Operator from McCarthy Instructions] question Maxim from sir. our of Yes, Group. And line Jason the first

You may begin.

Jason McCarthy

Hi, there. my Thanks for question. getting

was permanent detail it the that? I you’d you bit progress wondering, reimbursement status, like far pass-through additional so looks it on any with two an what on the get just take and So for to steps more a reinstated years, reach

Greg Demopulos

well-intentioned, extension those to been permanent is working saw Yes, remain pass-through optimistic specific a With that are CMS, ongoing to to the we that for needs CMS that less optimal, and approach, the And CMS the understands understands well, of the policy than issues, answer on result beneficiaries. that adequately reason, does Jason. the with for serve find the what clear certainly access think, years of way respect administrative that respect that was, discussion. OMIDRIA correct you to hope drugs said, in the issue Medicare we that Hi, I initial and Medicare way procedure. during payment have obtain now. surgical do March. used to expect package and payment thing best are think The for of I will ensure couple I to again, we from the that as not And like think right beneficiaries to its separate I understands is we

Jason McCarthy

know on Europe? Do when that question any marketing in on so TMA, I scheduling meetings. conditional on Okay. you you idea far Thank be of to able you get one authorization we’ll are XXX for that. possibility just any update Europe, more in And then an have

Greg Demopulos

we will meetings. that is think said have We information. are inform now, I we right we publicly you those scheduling think as for that But what have of I

that we here providing also that have – will and will We they data OMSXXX. importance are, clear the surviving of it to be the patients that we pretty they which recognize European [Audio hope see use with for regulators, seems the are what Dip] the data the is and

future. me we’ll the So in I with further think – that again, provide updates and there stop let

Jason McCarthy

very Thank right. much. All you

Operator

Ram line the comes question And Selvaraju Wainwright. our from H.C. with next of

Ram Selvaraju

my thanks Hi, hear much me? Can very taking you question. for

Greg Demopulos

hear Can you, yes. Hi, Ram, you? are how

Ram Selvaraju

Very good, thanks.

things. quick XXX, couple a just So on of

give you in receive context to this understanding, dosing what would of us, organization my significantly in to you formulation IgA pathway look molecules were what for filing look different the have modulation if administration, for us of to if of elaborate alternative of then, helpful. development they’re BLA be clinical and of on disease if regimen, you – or a could elaborate could to an whether that specific indication sense a Given no indication, would on And approval? of nephropathy. pre-commercial MASP-X are like requirements there the perhaps, that how what from making, potential perhaps, you look, you if amenable if kinds all like administration be something And the else? like rationale or preparations us if commercial within the look That OMSXXX could XXX a like in an could small there or be ahead describe expect they additional maybe TMA. you tractable for for are likely be those if route trial HSCT Can the potentially they peptidomimetic oral

Greg Demopulos

I’ll through right. working All those, start Ram. just

to want that I in obviously, going make And First, to are satisfy as to FDA FDA. the ongoing know, we stem to information is discussions the provide need with cell need regarding TMA. you we FDA clear

this what accelerated achieve And TMA. think at premature so it’s to approval I to in stem will cell discuss required point else be

IgA, in a initially but and different us have respect respect million As we have next of rough initiated Certainly, standard for subcu that. at to numbers, this with we’re the cell of high-risk we’re expecting at markets stem sizes, that’s $X evaluating of a you activities an a – and be your effort if is [Audio with formulation, With we’d we FDA, I transplant clinical costs be but we’re as required formulation. and smart a IV are severe working management do. activities, Dip] to also trials. the pre-commercialization the looking which said, costs around pre-commercialization would have as that recalling, you closely [Audio would already formulation, expect, patients point, to extensive amount would these we those know, the manage to Dip] we expect, you I’m question assessing or think thing and it’s TMA With next an patient about question, associated is year, we’re

those these compound yes, think, the has developed, formulation. is and to helped we’re a we’ll the we the MASP-X speaking current I small to selective, And the with So These our co-crystals, about really the in think us pleased appear that and MASP-X follow by are those pleased have number we’re tractable, we’ve are IV that inhibitors. significantly. assisted more These with a very have. future. initially, very create then plan I efforts that group, highly with assisted and a With and inhibitors highly that inhibitors formulation to been as molecule be of potent take do ability respect and through subcu

covered I the think that, that questions.

Ram Selvaraju

Yes, indeed. it. Really, Thank you appreciate very much.

Operator

And our next Steve from question of comes WBB. the from line Brozak

begin. may You

Steve Brozak

how for questions. go look at Thanks Greg, day, the at Can because possible end we’re Dip] – realities standard of the at want care I’m costs of standard care looking not at, currently would saying over of in understanding please. whatever that some just of that the you out three are. indications come is landscape? looking a to I use the just a competitive an are get you model, guys. the question, the as of what to And going follow-up would is you to describing a with taking what but current what then back you [Audio you’re Hi,

Greg Demopulos

of treatments treatment Solaris. aHUS, there I think, everyone standard of Solaris, know, And the the and treatment blockade, understands I think inhibitors to disease, renin-angiotensin you with turn developed a these IgA, for costs the – patients stay which renal first, let’s are associated with is in stage approved is just ultimately, good which aHUS develop or arms. – as these portion I think system RAS standard are so IgA. is dialysis. requires and there care and no blockade, ACE of really The

the for long-term quickly. we very costs that to as be always, are of intensive, million, treated, patients, patients order least these with costs the have very XX% ones highly-intensive. Their costs several of $X rapidly. With So greater high-risk and But at comes cell become And deteriorate said, patients, care of These conditions almost the the quickly. comes than cell think, death these or respect I dollars [Audio said, are high-risk these million the patients. managing as TMAs, Dip these I the those sick very and stem patients who TMA, ] approximately stem that I these certainly, in I are, to for is patients. with would costs associated dialysis with certainty

patients other options. a have burden also these really system, So but clearly to medical no it – is the

Steve Brozak

been asked answered, and most detailed answers questions Okay. OMIDRIA. on Again, and you gave have some

By looking the have OMIDRIA. for doing of right How would on? turn launch, on terms you ramping you. are what learned original terms question compare up in now, would in the and guidance to and you’re could I the Thank for, on back what what you last much you you and one think now expect. preparing as get original current comparison before the launch, sales. Just everything you the obviously, you – in what describe you’re How how compare it obviously and queue. – we I’ll would you October you guide, did of when do

Greg Demopulos

good interesting it’s a an question. That’s and

to smarter think, how product. relaunch I were we the product today about when initially than launched the we much are certainly, we

XXXX. product the I what how demand we there, selling were how utilization I to physicians, think product it know helps have know we We that the also the streamline mean, us the of clearly well-identified within the know got benchmarks. in understand from facilities. we we the we

three first learn pass-through, curve learning but there have a more So certainly, that well distal we to think years patient well. the well. of know it said, refine I always to to documented as I’ve was to we drug? ability can and think is how here several increase how but this we think times, I And more really I to that get do our is – Certainly, as the access important throughout

continue is any back to not to don’t as able, see should I level similar a my our I be and think quickly that up So we I in reason occur. to grow those sales. said, we’ll that to hope why ramp XXXX, sales

and data that we’re in that multiple positive. the the at that uniformly be expanding base. I it’s If you And to annual think has going think studies just clinical to not question. really on other the payer at are one of been continue focus look presented is certainly I Steve, thing, meetings, published the The OMIDRIA, benefits

have have of We’re all think here, patients for drug. for CMS at having I it. but appropriate payers, those no all means, the programs option, to option for that patients can stop. the the that best. We, on payers it, focus. to option Medicare third-party on we the also to certainly, access provide effects make Medicare we private seeing patients seeing need but must And population by have equal now And not third-party provide seems Advantage the think payments option, are to VA sure that And that focusing to in it’s Advantage to have I CMS are and the questionable and that to provide

Steve Brozak

Great. Again, thanks for taking the question.

Greg Demopulos

Thanks, Steve.

Operator

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

begin. may You

Serge Belanger

on A XXX. afternoon. Good couple of questions Hi.

clarifications on to First, approval. then little some some talked trial for you to HSCT-TMA. confirmatory bit evaluating HSCT-TMA? a accelerated I they’re And the a that, off for data wanted on would FDA signed has time that still about get evaluation. the look what make just Greg, if or

Greg Demopulos

Sure.

were We needed First, an most question, discussions with FDA. What investor to initial Serge, to here was our discussions. your thought recent in our answer shared. material that update thought was on to we important remain those we be and base

the and/or to accelerated getting be on With may to But are As what to to a of provided bit FDA well requirements are ongoing design path think we’ll that and the we’re see with it FDA be discuss confirmatory to else certainly, for satisfy we that. I’ve I to the there. early optimistic discussions submitted approval. said, respect the needs trial,

accelerated an This that that and at other that regimen assuming to dosing like work patients simply that, sure where to today. have dosing us And they’ve the assess way treated used want disorder assess because that very dosing we’d we to patients regimens, that. parallel, serious save we focused largely patient said, we we thing, in and that I is can our And confirmatory as trial, would near-term, we’re we’re important they a in is, every the well. very different that one can. could look in regimen But done And the the make treating and so TMA to question better? approval allow on we likely do know one best that. as regimens, As dosing we we clear is a

Serge Belanger

nephropathy. you the expect Okay. Can And talk endpoints. think IgA so to patients then on population, just clinicaltrials.gov, around the and the report about in I the of don’t number maybe on X mid-year? patient you trial for it’s that results Phase

Greg Demopulos

through Yes. can it I well. with I is run believe you but on clinicaltrials.gov, it Serge, as

six on effectively fact the the on these to other patients and are same. than – again study, patients last steroids first not The cohort very XXX, these of placebo XX U.S.-based, patients, six endpoints similar are patients the the that

protein levels. patients retreated, urine protein, these can XX-hour at be them. looking We’re following And we’re

additional advance X this the through some information Phase us that will expect We program. give we as

Serge Belanger

Thank Okay. you.

Greg Demopulos

Thanks, Serge.

Operator

remarks. turn completes Thank call the like you. Q&A And part the back Dr. that to of to I’d call. Demopulos closing the for

Greg Demopulos

our that for for our I joining progress. periodically again for and And shaping we’ll up shareholders. is an exacting keep So our be today. said continue updated everyone earlier, you for on Omeros year Thanks, wraps to up call as us. to XXXX

afternoon. As always, we appreciate your support. good continued a interest have and Everyone,

Omeros (OMER) 10 May 182018 Q1 Earnings call transcript