rest and we appreciate families Thank disease. against start like and today's greatly selflessness. global lives healthcare us of their good us are for that and We this in and and We your providers by you the and and all afternoon, day healthy joining would everyone. with update. ones protect and responders those this and efforts you hope help on all first their COVID-XX to the Every their from patients lives risking to We of thanking the front to recognize lines SARS-CoV-X. acknowledging safe you, loved and are Jennifer, of appreciate battle
from consistent and our are of safe At guidelines. remained and team healthy with working home. Omeros, employees productively our have members our Governor's functioning Most
The able programs. continue to ensure has safety and continue the this so, work labs appropriate to of distillate precautions to who been is all the primarily team that researchers Our our safety of Omeros do advancing in their coworkers. the their implementing
compliment the planned begin Narsoplimab of our an therapeutics the targeting exclusively and is human commercialization. drug's progress narsoplimab the enzyme. lectin on antibody pathway specifically controlled our MASP-X and MASP-X. all targeting We'll fully and toward Omeros with update
narsoplimab injury pathway. is which of for thrombotic effector lectin the indication inhibits Endothelial or activate lead Transplant cell caused MASP-X, by cellular compliment transplant-associated is the pathway on which microangiopathy broadly hematopoietic the narsoplimab Our injury. enzyme, stem lectin pathways is damage endothelial blocking TMA, by lectin
year, historical issue we resolve driving or the chemistry, the on the during submitted last submission We toward began At narsoplimab and our method next call We our CMC the controls just procedures license submission schedule BLA we quarter. non-clinical and of These collection manufacturing we earnings the with on and that include sections. our validations. data last associated application for referenced BLA of continued of the rolling components our TMA sections. analytical biologics Transplant data rolling and of end first or completing manufacturing,
BLA. substance, of underway, drug As completed process of during and completed call, lots earnings the our for our FDA we sections The we all reported BLA manufacturing required the clinical we and the all requires CMC information product lots. successfully remaining process have and manufacturing successfully drug constitute validation of now sections validation final are that of last also
which our designation, shorten therapy priority breakthrough BLA our time the that grant expect approval. review, could Given we will FDA to further
for We will we marketing pulling which be European the are submitted FDA application, our together authorization expect also after, approval. information
Meetings Dr. panel Hope. Kettering of Cancer The Sergio and speaker Dr. at transplant included and at continuing education and Head cellular visibility Samer the its on Division community. a or the medical sponsored stem-cell Orlando. transplant Sloan Hematologic operations Khaled, City increase In Medical Malignancies therapy Director transplant by chaired to continues of Giralt, in of Deputy Center. hematology February the Thrombotic Narsoplimab session Microangiopathy Annual at Dr. of standing within collectable Omeros stem-cell TCT Memorial
and Hospital; Dandoy, symposium Transplantation was and Pediatrics Pediatrics The also Jodele, of Assistant Marrow Children's. of in and Cincinnati focused and a well Division Professor the and Marrow therapies. Specialist, Sonata Cincinnati of at Bone Children's deficiency Transplant Chris Bone attended Dr. Professor on at potential TMA Clinical immune transplant
leadership Professor Giovanni trial for and the meeting the of will In by annual data the XXIII Hematology will transplant of be University narsoplimab the also hospital. a Department mid-June, Hematology of EHA. at Director presentation, Rambaldi presented be virtual conference podium at the now and pivotal and Papa the of or of TMA Association by data from discussed Selected Alessandro Milan European Oncology
nation's nearest submission strengthen for value well narsoplimab are TMA. transplant as We've transplant guidelines Our our the story finalizing our TMA. boards Commercial BLA TMA. profiling and educational around advisory launch the conducting and with continue market working providing diagnosis and the and and transplanters narsoplimab preparations for group as payers. for the activities is interactions and a are to rolling our We're with for opinion transplant who to developing through distribution support leaders as support completion. Omeros time designed administrators of physicians, developed leading continue of pricing our well executed of ensure also first a research strategies activities transplant
we National Amgen Fred Science Hutchinson, National Amgen, Cancer from and Liaison and efforts, of Jazz Sales our advocacy Director practicing Health Research Law Center. and those Attorney recently was us previously from hired a who Medical of our part as lead Head As at Pharmaceuticals, joined our
build narsoplimab. a for launch helping to us leaders season top we did team Tier Omidria, As are these new
In narsoplimab diffuse transplant we're disease to as syndrome; others. Graft-versus-host addition into and injury alveolar assessing such hemorrhage, also other TMA, of endothelial expansion
lectin the advisors injury. and are caused on we're approval by here on and focused TMA. transplant diseases pathway leader endothelial by of and underscored focus of with opinion efforts injury Well the Our endothelial obtaining recent associated our narsoplimab pathophysiology MASP-X has importance in COVID-XX for supported the the
consistent for study One and a local and/or independent Omeros programs two during with maintain in syndrome of in COVID-XX recommendations FDA for the regulations other committee clinical of guidelines also conducting manner with monitoring with ongoing IgA guidelines nephropathy are investigators. We hemolytic sites Consistent safety patients the to Phase study trials narsoplimab. regarding have the aHUS. trials or III and in pandemic, data uremic atypical safety and
patients previously enrolled continuing As new has some at while trials. are a enrollment result, slowed, the sites patient
our at ARTEMIS-IGAN implemented to additional also one to narsoplimab local sites. safety trial in across already wait For infusion to years number endpoint that and in clinical such a facilities place Other for proteinuria assessing XX nephropathy receive and change trial of remote capability narsoplimab in with primary protect based Based monitoring laboratory assess procedures III of approval are the trial, regulatory filtration our two of as The on measures home and rate. we the weeks. IgA are to longer participants we ability sites. ARTEMIS-IGAN expanding to in have a good had for also this access these visits to proteinuria FDA, discussions on the is needing change rather than full glomerular Phase
full in the nephropathy in of X also singularly knowledge, and per accelerated least per narsoplimab population We its to either the overall each receive for or IgA of at populations. alone. the different proteinuria of among end of To grams day; is of patients more approval assess day, fall the drugs the development best with patient point population subset and are to two In than unique yield approval. able written ability proteinuria our proteinuria on can protocol proteinuria in with is and the gram X
Authored by ARTEMIS-IGAN A II was University progressive next second be trial peer published. on of members beneficial reviewed John endpoint soon from expected and The others target year. Omeros’s by is academic to and comprised vasculitis-associated IgA review glomerulonephritis manuscript Phase published authored nephropathy leaders. Barrett will readout the data. soon. publication proteinuria at leadership narsoplimab describing nephritis, international Leicester effects for be thought clinical our data IgA primary presents the Professor accepted a undergone also manuscript the has continue of of manuscript A We committee and the and rapidly to
sales Net now revenues part such able only first as of is quarter five that weeks million. the or commercial recognize is of sales to mid-year we were the from run due surgery surgery emergency. our nationwide weeks. health to first the elective elective COVID-XX one the The of related net of quarter $XX.X those our shutdown cataract March, hiatus below public This effect Turning is were in sales in of on potential and five as in the surgery product, COVID-XX rate historical to Omidria.
typically For context, XX% accounts March for about quarter first of revenues. total
the of loss As quarter per XXXX $XX or for million our $X.XX million $X.X per first expenses net result, of $X.XX non-cash a was this includes share. or share;
available March of and for general had $XX XXXX cash investments operations. of As XX, we million
XX% accounts accounts of $XX enables credit We to Valley lesser receivable The receivable borrow to the million. outstanding line or base line of Bank. Silicon with an our also credit up of us eligible balance of have
borrowed under line this We have credit. of not
year first the revenues. just surgery. of for traditionally and I up typically noted, in significantly is Historically, sales quarter slowest quarter QX the March XX% about cataract Omidria account total of for as ramp
Given the news surgery, first begun Further on by lifting. COVID-XX revenue is Omidria. related of good that surgery on performance we’re pleased COVID-XX elective with quarter have the effects cataract restrictions QX
continue substantial and to been beginning In Omidria cataract expected centers expanding number restrictions demand prepare our the first XX in in have working will the the surgery and the increase meet are where backlog among wholesalers. already for related is increase hospitals We've be surgery of far, from surgery. ambulatory in elective surgery reinstated. to and yet the with centers have to So for lifted, been patients the COVID-XX accounts ordering States impending waiting procedures of resumed not with for activities closely Most limited Omidria. anticipated States a
possible, weekends. the could of number lengthen and that levels. of surpass their remained also opinion shutdown top pent expand historical adoption include manage as expect facility to will Our patients weekly To physicians days related surgeons to and the demand upward we operating of COVID-XX its evenings conversations as surgery, with will the into indicate soon the trajectory. surgical they to of backlog they cataract surgery, that leaders which days Prior and and on up Omidria awaiting operate
split Omidria In QX, Omidria represents between of XX XX% evenly and This quarter in first-time a accounts. hospitals over the increase number AFCs. were there new buyers quarter
well. expanding to are include of than equity also has large In is The ASC contracts as customer our fully cataract J-code and in across continues. new we annually now and Omidria for been growth base signed two HCPCS consolidation private our which equity more other currently recently facilities our base received to we're to also practices large QX private representing helped groups We Omidria, groups large implemented. working surgical procedures by use as XX,XXX secure customer alone, groups several
standardizing payment and in CMS across improved addition, reimbursed Medicare payers. advantage through Medicare insurance advantage, Our at reimbursement pass is and B continue X% Medicare, Medicare we Part has and by across commercial Under uniformly J-code commercial plans. plus reimbursement, Medicaid ASP expanding
and surgeons solidifies. by continue story the documenting to for reviewed been has the by Omidria strengthened Omidria value data publications, and facilities adoption clinical the Omidria. Omidria as The further benefits of of increasing drive peer uptake expanding physician growing of is product of avoidance volume Iris the the accelerated for prevents only FDA that and complication reasons and Omidria the using Its approved postoperative reduces prevention and pain. to surgeons for syndrome, of many increasingly add reduction their interpretative rates patients. floppy, need steroids, meiosis are that Compelling
the of and demonstrating studies or surgery. cataract Omidria and of additional journal in Two peer published profile the safety refractive reviewed benefits
perioperative article incidences and conventional cystoid patients who Omidria that pain significantly a retrospective steroids. that a first the iritis The detailed compared lower macular breakthrough edema, had to found of group results study sight-threatening control receiving of received
FDA to Omidria which all ages pain patients second approved children XX patients. to but safety in that that by The resulted statistically in was [ph] randomized the surgery, safe This only in zero presented use double-blind cataract scores. surgery pediatric showed the Omidria in data three significant cataract label lower FDA undergoing not Expanding years also concluded children. study is
cataract previously As the that potent and the recent in discussed, demonstrated surgery and another Omidria a for need publication addictive opioid. fentanyl, reduces of highly journal we refractive
Claims validated an on while surgery, use, analysis over cataract outcomes. simultaneously claims assess Health. the surgery; year cataract avoid postoperative Omidria underwent improved delivering patients, data a of of opioid older was of three scores, and To Lower pain During or data opioid evaluated who effect fewer XX from performed XXX,XXX complications. age use dependence. or period confounding by were Watson IBM by years recent potential two
who prescriptions have postoperative a patients provide yielded filled were strength compared P pills two during those not seven to that’s also that to versus pills, reduces required need this decreases two during results. for versus prior the pills P and XX the the with XX XX% during treated further outcomes optimistic value patients Opioid opioid was opioids. the were use and Patients applies but of surgery receive clinical for days value of analysis the at The XX of intra Sensitivity group. Omidria were evidence year, of days median for not XX and pills B seven beneficiaries. received Omidria days which use All the separate reduction non-Omidria The treated why the post-surgery reasons The the remain underscoring need payment X.XXX. with similar about of XXth to XX% who specifically Medicare September continued only X.XXX specifically surgery operative beyond Omidria fewer These in pills data days than value opioids two proposition of are we months only part to fentanyl Omidria a did six seen group Omidria Omidria. and the findings remarkable. in no received
with data and experience support/. product published physician The the
efforts. If and of lockdowns addiction. families nation, not in would as in Omidria alternatives legislative The prescribing keep prevent would introduced Congress The the bill and number Act for response chambers from strong is in have the at non-opioids disincentives of both least Opioid provide to has been such enact, in Opioid nation a for COVIT-XX an with treatments surgical the least that or ongoing NOPAIN administrative payment for separate hardships sparing five addiction a it bipartisan practitioners settings. across Our treatment non-Opiate increasingly increasing created which the support. of fix the years
upcoming by legislation. progressing. serve XX energy Representatives, NOPAIN administrative the House Republican jurisdiction Other the of leadership to the and over A legislative CMS a bipartisan on and the of whom commerce. Just inclusion last House also of of Friday, many was submitted Cares the committee Democrat signed letter efforts and members requesting X.X Act are of in
working our viable optimistic remain a that CMS value Omidria improves through also to B returns will separate that outcomes Part product ensure we payment we without even that regardless from of will separate payment to are patient and that While scenarios continue, payer, be insurance Medicare for shareholders beneficiaries.
rest our for targeting disorders fully or with our and believed to enzyme alternative the activator pathway. of or with are Among is our broad potential pipeline, that OMSXXX to of now our programs the turn the the in focus on human development narsoplimab be our Paroxysmal narsoplimab. compliment antibody related drug starting MASP-X, Let's beyond alternative initial Together key the is part major OMSXXX premiere target franchise. a of indications pathway range Hemoglobinuria PNH. XXX, is Nocturnal compliment
in or trials inhibitors Phase effects We've completed is clinical of quarter. one the targeting our available antibody, this as of inhibitor support acting part We the strategy at second manufacturing for The our are expect doses II MASP-X franchise. well underway. molecule trial human of is of part process subjects dose the OMSXXX, for nicotine track the generation the dose small enabled on MASP-X We're of remainder application in longer compliment OMSXXXX. second lifecycle to our MASP-X a phase to clinical compliment up planning These PDAX orally are phosphodiesterase toxicology out first which development XXXX studies, is which next the show all the acting and to We're submit program the management currently antibody, scale OMSXXX also program of remain addiction. on no as even and adverse focused advancing. generation initiation for well MASP-X. quarter tested. are in Rounding highest our longer first trial our franchise the program
wholly soon We're on continue our we're GPRXXX the axis shown tumor of approach new clinic to we microenvironment of to to is immunotherapy inhibitors Despite in inherent and killing overcoming checkpoint mechanisms We've development to protect that particular, about this represent program a to receptor the linked tumor addition, inhibitors immunity exceeded GPRXXX, can which to controls in the including new tumor inhibitors. the GPRXXX be the is GPCR programs. and increasingly hurdle a microenvironment in as year. to the from date, ability bring is billion cancer last major excited progress A itself working that checkpoint which our GPRXXX possible. body's tumor's other developing In response. for a the cancer antitumor to limitation, microenvironment. proven the suppress $XX directly linked to body's sales We're challenges as make therapies tumor the
In an adenosine important the with inhibitors ex studies vivo doing substantial GPRXXX They act also another just pathway, promise target. immune-oncology and or in vivo that. synergistically inhibitors animal show of in
expect We GPRXXX agents. or could of agents other the efficacy our adenosine with pathway and/or that to combination be in those inhibitors administered inhibitors checkpoint enhance single as
to that, our over first I'll financial overview Mike call quarter With of results. turn Mike? for an the
