everyone. and Jennifer good you, Thank afternoon
call. Now, we on us appreciate the you join taking to time the
to ophthalmic million quarter with million, We first the begin first increase have were We’ll revenues lot last of quarter sales the in net $XX.X of Total cover OMIDRIA an product. a reported today. FDA-approved over $XX.X our year. OMIDRIA, from
for loss million $X.XX charges quarter $XX.X equivalents, cash share, for quarter of the XXXX investments the or share. non-cash or was was of million. decrease which $XX.X includes $X.XX million cash, in first per $X per net overall Our The and short-term
XX, March of we As operations. available had million general $XX.X for
first the credit quarter quarter the accounts of to million receivable-based for an net it. we finalizing line OMIDRIA flat. essentially sales of implement fourth to also to up choose We’re were should XXXX, Compared for $XX
the the the the due sell-through quarter shifted on weekend ophthalmology OMIDRIA held insurance conferences quarter’s This the number days vial quarter Net first because year shipped on restocking sales a quarter reflected sales, to at two was throughout normal in resetting The in current continues Despite high is wholesaler demand, to first XX% new a historically The quarter. the record or system. and purchases customers of which the $X.X to million. across and outpatient weakest first approximately wholesaler the X. higher QX by wasn’t this continued of the January two driven in has departments, large net period, VA those deductibles of from for increasing fourth sales ended were the OMIDRIA of days to increase the wholesalers our XXXX. record of of ASCs, hospital set previous from than watermark sell-through headwind the grow and April. to Utilization during
increased are We’re ophthalmic OMIDRIA across also with discussions ASC enable of surgery their and buying to networks equity broad seeing access centers from holders facilities. of to chains respective advancing
to this compared the a in As period seeing growth quarter. double-digit we sell-through quarter are same last result,
closer Let’s the we look continue. behind OMIDRIA of to for take at some and why key expect a factors demand the increasing this
and makes of benefits the pain cataract of preclude the of to postoperative prevents is the and been reduces and continues studies need and use postoperative First, separate two demonstrating expand. Use and investigator-initiated The corticosteroids. devices, including iris understand outcomes. also surgery and safety this the OMIDRIA shown efficacy to patient It opioids. And in medications, improves faster of drug body significantly surgeons for clinical has administrators both OMIDRIA real-world pupil-expansion substantial or syndrome data floppy decreases reduces complications, intraoperative that facility use of safer. IFIS pain
with study, A conducted when XX-fold one publication using of other undergoing OMIDRIA evaluated on or similarly and demonstrates without more postoperative in has that and corticosteroids compared submitted of again, surgery. in In CME group than of in X showed combined OMIDRIA reduced cataract assessed, the the OMIDRIA for macular of of with of cataract study with and surgery but performed with groups the this steroids surgery. the annual iritis of Just of soon Society A this the X,XXX to cataract surgery Ophthalmic other and to steroid publish cystoid Cataract Refractive and week, preparation at in performed well had peer-reviewed surgery no data without journal. the precludes incidence was lower complication and in cataract over use a study the NSAID drug will OMIDRIA of use Two problems postoperative markedly CME, surgery instead patients cataract be Administrators. rebound only of presented meeting alone, and pain and eyes American of using sight-threatening Society analysis steroids including this This edema without as important photophobia. Surgery by also and were study, the no is using cataract CME, second OMIDRIA. an OMIDRIA incidence with retrospective American The as XXX the one postoperative of significant eyes latter incidents use NSAIDs. that NSAIDs. topical NSAIDs that for need of a not manuscript The
payment an of Academy OMIDRIA the articles recent published System Prospective while together manuscript efforts our payment. at Here for recent Outpatient of abstract drug. study, need the that out of initiator laid the publication a Ophthalmology. same to already Payment has eliminated again, – being and and and potential XX pain. Congress significantly recent These to for study the with shows presentation annual CMS use permanent of for our studies separate CMS time, been with permanent prepared rule, decreasing investigator cataract two initiated meeting the with a the opioids again significantly most A benefits paths on postoperative the upcoming at OMIDRIA, by In submitted support is peer-reviewed separate American third for secure surgery,
an indication drug and avenues would each recent the the for have these to that that directed second described postoperative have OMIDRIA further that qualification. under a of studies to benefit, pain during first surgery three used reduction. postoperative drugs two during surgery just The strengthen non-opioid use qualify and
and as has surgeons who the direct evidence have continue and the who facility intraocular Just and to replacement drug. using clinical to of grown, and their administrators, cataract OMIDRIA other as lens cataract OMIDRIA, so of ensuring of number experience committed are too can its patients who benefits Medicare body procedures the supporting recognize use the access that beneficiaries.
experience overwhelming the and have With the clinical ophthalmic drug. administrators who supportive data and surgeons the nationwide, using
reimbursed appropriately that CMS OMIDRIA on of be drugs expiration X, after optimistic pass-through October We’re will the slated the XXXX. status by
of to access OMIDRIA payers commercial patients and able the that to We’re certain easier more also covered are and making drug. reimbursement ensure and for the billing spectrum across government
preceding months, advantage, OMIDRIA Because to Common process as a and and the key another OMIDRIA to three increasing the the only preliminary a is major Procedure set Medicare, for HCPCS. med advantage or last picture Coding quarters the accepted XXXX the November Further of not of finalized uniform, demand headway quarter simpler widely the day CMS for like the J-code first remains quarter reimbursement plans two the on across decision on making decision. Blue well. for within for and we’re wins multiple bill of issued be expected Over Shield carriers and second the payers commercial we’ve Healthcare becoming Cross/Blue sell to high. OMIDRIA J-code med System providers recently but improving CareFirst. The following including for had OMIDRIA, with no payers Providing on each both insurance a permanent under unique with effective and commercial with track new that through of the establish to decision and than later continued record in fronts, the
Turning programs. now to development our
have OMS-XXX. our MASP-X inhibitor important share well as We lead to updates narsoplimab and or regarding
advancing X programs in stem and uremic for or transplant-associated As you TMA, thrombotic hemolytic hematopoietic stem or A cell narsoplimab cell or syndrome know, atypical AHUS. IgA microangiopathy Phase we’re immunoglobulin nephropathy, three
a path therapy or and the confirmed narsoplimab and Agency that TMA, At holds response-based for of stem fact cell European Medicines one, the for in our a quarter in in BLA from drug narsoplimab FDA has was and recap those already only a the it breakthrough FDA. streamlined as designations from first the analysis meeting, TMA. license in and cell BLA TMA. TMA, stem fourth stem that that narsoplimab submission orphan early a Narsoplimab on quarter, call, FDA as most To expeditious the designation application well assessment breakthrough meeting the been resulted is additional appropriate cell as drug EMA stem last of approval for submission. no therapy beyond needed with are developments to briefly designation or patients discussed For awarded for – the and enrolled biologics cell
FDA them. only can meeting, with to approval, Since two receives nor Two, narsoplimab. may historical follow-up TMA and submitted. cell also single-arm only we full the but and meetings the not an treated in study agency FDA collecting a stem submit stem not additional Three, to for rolling consider with BLA that is the the there otherwise. have our already approval BLA continue exposure We will And a be TMA control cell data been that are require trial group, four, required does accelerated include, sections as on FDA. review submission, our determination data made meaning with open-label patients as narsoplimab on which additional or based
our or CMC commercialization manufacturing-related first and plan The remains was to track. CMC on cover topics,
the on primary criteria data endpoint the will by focused for clinical second the The be was which assessed.
have of large function laboratory criteria components. will primary the include for and on with the majority agreement We both reached which the FDA organ endpoint,
few are and remaining understanding good with on a have FDA’s points. the position We comfortable
we’re treated on in our TMA with reach our will interactions view future. details safety our agreement last We approval. narsoplimab, patients very from to data In and that cell support and with data stem expect of near these efficacy few FDA confident the
with for additional us and cell that FDA underway. stem to with the with the TMA has enabled relationship our now been finalize currently BLA. data collaborative the is We’re clinical progress of program data scope FDA collection support pleased our has to established around needed working That collection narsoplimab
the the FDA also sections are with under timing review respective the agency’s submission. specific We rolling discussing BLA the of of
confirmed which single-marketing approval previously, the under the MAA Application harmonize BLA. European the MAA those stated Agency for submit procedure, application with Union. planned can U.S. narsoplimab has a requirements to As of the marketing European of European the we that drug centralized throughout of The or that Authorization means allows for the we Medicines Marketing the
rapporteurs late last Given month. of our assignment for the around policy implemented in was anticipate We next rapporteurs MAA early assignments EMA’s change of year. that
use a also and supportive We which of to FDA been pediatric to prerequisite submission. have are narsoplimab EMA is expanding narsoplimab, MAA finalizing investigational plan children. of for of Both with EMA
leaders opinion Just last cell stem development key harmonization TMA. in of the and been on joint meeting, conditions feedback cell for discussed week, has the specifically, positive. narsoplimab stem and a related TMA narsoplimab two agencies received The pediatric held strongly for from
leading TMA As with deadly stem for stem to allogeneic identified, cell that has the stem understood is the that of treatment. patients we that is in occurrence and disorders this reported expect XX% drive broader patients. and reported worldwide narsoplimab transplant increase, potentially become once undergoing the to to treatment screened Recognition underdiagnosed lethal transplants of earlier expected approximating and be centers available in disease. cell cell continues diagnosis better complication is incidents Earlier identification earlier TMA to
is patient cessation XX-year-old with transfusions under severe independent of well-attended The Omeros. we our was between and by broader lectin inhibiting the initiative the Also patient our and physician The compassionate to of case narsoplimab, focus expand of biopsy-proven session therefore, the other as of patient March endothelial Transplantation A MASP-X is of tract. stem general our our received injury. a the MASP-X and cell Marrow to active only session resolved spectrum or use treatment. bleeding This education narsoplimab an of at disease were the meeting in at MASP-X the narsoplimab annual relationship been an the TMA pathways by year. TMA to but Because blocks causing inhibitors continue effects effector enzyme. Blood cell after This TMA that transfusions. Why? of endothelial EBMT continues European of for outreach launched damage all development, stem requiring Society or the this of well. pathway have discontinued. conference the not her with The downstream do We disorders activates included endothelial relationship EBMT, well of important damage. gastrointestinal and sponsored session of caused was and
host stem disease, the to TMA data complicated We’ve on TMA, treatment, successfully by cell fact, than be including much versus transplant, path syndrome endothelial more cause be patients prove alveolar seen treat cell of and In the TMA will and hemorrhage. with several other with veno-occlusive stem these evidence, graft stem endothelial broadly damage. is Yet Based of syndrome is but for of an broader that complications its other we disorders. alone to the diffuse injury associated thought disease only severe is and transplant narsoplimab clinical physiological injury narsoplimab some of expect TMAs cell multiple effective for not components. even and endothelial already
anticipated proceeding of for narsoplimab the are preparations launch commercial Our ahead plan.
been with to team in payers engaging preparing and demonstrate narsoplimab’s value Our markets. opinion has Europe the key leaders while in proposition U.S. these to
commercial establishing narsoplimab determine past position success direct Therapy organizations with influential a the and team the such as as These well as space. for interactions our best transplant Society over Cellular leader are and the months, are Omeros opinion had six and to leaders Transplant we’ve how this Over EBMT. in of helping American interactions XX as
in hospitalizations, believe been a We for the These developing economics lives, very patients and costly narsoplimab and drug. dialysis, plan on that based saving organ and perspective. treating framework health both economics survival complications. decreasing comprehensive other our working have reducing and a experience failure, sick TMA are need preventing value There’s on also patient and avoiding are pricing value tremendous health related currently We with TMA the clinical strategy. from early is
and In us feedback payers from for addition U.S. internal to representatives our research the helping efforts, of value proposition extensive former narsoplimab. finalize are current
the coverage Europe value ensure approval. narsoplimab this patients with to U.S. will have understood and in to meeting the well is that important be that will of ready access and therapy also We on authorities
of proteinuria at on IgA phase which to one which, can for has grams our designation of and as as patient FDA the approval Let’s program, and both than turn with which drug in knowledge sites ongoing continues time, and Pacific. weeks; IgA nephropathy Phase in primary the proteinuria per includes Asia to EMA. the proteinuria or across like from And treatment X patients XX to all have at accelerated been opened breakthrough therapy now of narsoplimab per entire as gram for TMA the full program clinical includes in orphan nephropathy, we referred population, opportunity designation baseline ARTEMIS-IGAN, high XX our risk day. assessment greater those over The day narsoplimab We’ve least trial Europe stem our with awarded at the based trials from baseline enroll. well approval which to cell endpoint an subpopulation, drug the is patients best throughout data in U.S. FDA countries remains proteinuria full of only two alone. that obtain our development X
European Association Results trial European and in X Budapest Dialysis will cohort June. in phase in also at presented narsoplimab the in of result European the that expect the ARTEMIS-IGAN annual X Association We be and in for nephropathy. second nephropathy IgA study the positive, of if narsoplimab approval the Renal patients IgA from congress Phase will Transplant
manuscripts on ongoing plan In Committee program Academic preparation following in a to of nephropathy will third a is experts, and In inhibitors subcutaneous of MASP-X study information to enrollment label well phase in at portion dosing IgA cohort, intravenous Kong. XX-week we’ll other provide and single assess the patient examine X of dosing XX be the This coming nephropathy. approximately for in redesigned this will the investigator over in series IgA the we in and IgA soon. consider addition, cohort life of its with International and submission administered a of and narsoplimab nephropathy study, as directed associated options Leadership begin subcutaneous with the drug This with biomarkers narsoplimab together disease. sites first a was development our Hong management as period Collecting valuable patients patients subcutaneously dose. pharmacodynamics in IgA cycle as data IgA will the pharmacokinetics open IgA months
available safety look TMA making unmet is drug soon forward indications, in continues serious is and the from single-arm possible for is of and includes life-threatening across also X each tolerated need approved fast breakthrough cell Phase been track of for the narsoplimab the third concerns aHUS patients, Neither as to and the have to nor its X ongoing no trials, subcutaneous program narsoplimab In IgA for targeting clinical have of clinical each well Narsoplimab narsoplimab and continues it. to drug completed X an Our medical aHUS. identified. we as of narsoplimab trial designation or stem and in all the needs. these aHUS FDA phase the indications, open-label dosing enroll. phase who treatment nephropathy therapy designation to treatment has be evaluating
In continue narsoplimab, inhibitors. our of to advance MASP-X addition we small MASP-X to targeting molecule development antibody the
We have lead a for compounds synthesized and selectivity. and number target and of potency, are our oral bioavailability, optimizing compounds screened large
choose MASP-X quarter clinical to with the in the trials this the molecule an orally any MASP-X space inhibitor inhibitors. significantly represents our potential Further a our and for expands expect of We range indications oral small molecule In administered a of agents, absence year. complement MASP-X small development therapeutics at next clear candidate inhibitors. to for opportunity market enter
are long-lasting achieves complement franchise. systems pro-factor is the other inhibition half OMSXXX alternative the pathway. the over inhibitor in on significant OMSXXX development. advantages of responsible are activator conversion complement for of There inhibitor the MASP-X complement of market key two pathway MASP-X Our at our administration target MASP-X, second of D the Systemic D. to is of factor inhibitors alternative a least of the
with inhibition. associated CX a functioning infection the the with or seen affecting or is not OMSXXX risk CX pathways. means devastating and This without the potentially significant pathway First, important alternative classical be OMSXXX lectin inhibits should of that and
to by administration. systemic have the expected to bodies factor to diseases These to treat eye or the local enzymes antibody these compartments. of in D is pathway through like OMSXXX are CX. because CX enters compartments alternative systemically targeting in inaccessible This therapeutics opposed be the as is as is ability local bloodstream. compartments within OMSXXX active thought delivered inflammatory systemic such expected to administration the down shut to contrast, the Second
block having alternative disease, doing rather degeneration, to injections. only to half need our has inhibitors as are both science, for as treat we’re the as for any well the small in into pathway our in bispecific to shut MASP-X and the development compliment the molecule programs down we’re potent So systemic alternative eye inhibitors pathways. MASP-X treat first an selective disease Omeros lectin and program, supporting of inject could example, Center a like the MASP-X additional to trials is than internally Research ophthalmic the our indications programs macular locally partnership through and Clinical to exploring University at begin avoiding MASP-X MASP-X XXXX. Complement to delivery, and Cambridge also eye slated developing the OCXIR, both and Inflammation collaborations. our MASP-X actively external for or Cambridge with for OMSXXX
system. compulsive any are activities form between such addictive. or or disorder. to not link to do Now, interaction, of reduced. to compulsive not discovered major is from appear inhibitors and inhibitor inhibitors meaning an on for drugs. the inhibitors addiction a PDEX avoid the marketed drawback appeared OMSXXX, or all anti-addiction let’s PDEX of and disorders. greatly other addiction update reward reward sex derived that controls sports PDEX as inhibition system social currently program exclusively Omeros pleasure Also, and our X move of PDEX phosphodiesterase PDEX the Depression alter
completed Completion dose underway drug Our trial of subjects. Phase ascending is safety We’ve the assess and X with drug ascending The data or of trial Phase multiple pharmacokinetic six quarter. with three daily X and without healthy consistent pharmacokinetics ascending the sort is the ascending this dose dosing tolerated cohorts single single in all and multiple has and food. of been cohorts. dosing, clinical in to once expected dose following well are
wrap X, that believes indications. G with our Phase XX Protein-Coupled addiction. we Assuming GPCRs our GPCR conduct program discussion with up a study broad nicotine of Omeros targeting Receptor controls successful Phase platform. completion ranging it Xa or We’ll to exclusively plan
apparent believe cancer and key effective and pathway receptor GPRXXX that Based particularly GPRXXX hematologic its immuno-oncology. a for could tumors. data, the we excited and about solid controls on in role an both of modulation We’re prove our treatment
molecule and continuing on GPRXXX develop clinic are targeting the compounds small soon entering We’re possible. as to as focused
to site With of and but at website turn Mike? coming, first visit results. our the like to look everyone raise the I’ll we’re Omeros programs. recently visibility updated that, I’d forward new invite proud Finally, of to and www.omeros.com. to quarter cutting been summary call to a while for Mike financial of our our the and continuing over It’s a edge
