Dr. Greg Demopulos
everyone. Thank you, good and Jennifer, afternoon,
update start followed quarter XXXX full with year the will detailed We summary. an more corporate fourth our overview and a financial results of financial and by
Joining Steve Whitaker, today me and regulatory heads finance, of Cathy respective and are Nadia commercial, Dac, on Mike our Melfi, Jacobsen, the clinical. call
Before those I’d to we for just diving program few our of continuing for strength a financial on near-term events enable to like without minutes dilution, our the expect spend shareholder coming and will into that details Omeros success. updates the events, specific need position
nearly continuous years. payment by of receive sales the operating royalty a on Rayner’s The XXXX, of the payment developed ongoing sale $XX OMIDRIA U.S. strategic upfront net on which December securing completed potential of profit. million, of total surgery at we for background, the OMIDRIA commercialize, receivables, for million $XXX and represented four and XX%, we million to in milestone was OMIDRIA to of product $XXX sales substantial cataract rate XX% To that provide Rayner royalties net some initial least of retained an payment separate OMIDRIA the Surgical of
are future our stream. Omeros DRI any income sale recognized a $XXX was a royalty our September, as on cash. and related portion received in Last sale. and OMIDRIA and royalty of million financial the Healthcare royalties no to sheet result, royalty sold balance was debt OMIDRIA The we capped, annual as stream to in DRI’s the upside recorded received Because
three total we Under $XXX net profits. Omeros Then our December plus months in XXXX, sales the OMIDRIA the after operating achieved approximately milestone, now XX%, milestone, later, represents Rayner’s Rayner on achieving with early receive in of U.S. which rate Rayner decreased XX% the that February. agreement royalty receiving interest million to
procedures half administered performed and patients the fee or of in CMS. surgical payments on B by Medicare Nearly cataract all Medicare and facility Medicaid are Services for the Centers with U.S. Part
periods, CMS XXXX non-opioid interrupted years for pass-through packaging for exclusion. total months after extending from XXXX, nine Since successful congressionally qualifying CMS’ awarded pass-through exclusion separate months, two received and legislation the quarter payment continuous through XX in OMIDRIA’s management a the months multiple of CMS only over in following mandated of then non-opioid market eight those under packaging, and from pain qualifying launch XXXX in second and has OMIDRIA
repeatedly payment needed separate won. But to be
our has funding, So fueling OMIDRIA $X shareholder share both together for uncertainty, development outstanding long-term. payment pipeline, dilution. Despite count facilities physicians providing CMS effectively minimizing could drug separate the in non-dilutive we, never and billion while rely and on with to-date this Omeros surgical the infused of with
for Now quarter our let’s year. both the results financial and look the fourth at
per million $XXX.X fourth the or to of Our million quarter $X.XX net was fourth income $X.XX quarter or $XXX.X the compared per share share, for for XXXX.
the just Rayner the December and I sale achievement by actions of XXXX year that prior December the and XXXX were Both OMIDRIA affected quarters OMIDRIA’s the of significantly strategic recounted, namely milestone. current
fourth $X.XX in the Looking XXXX same per $X.XX only share compared XXXX. at to share, quarter was quarter continuing per the net for operations, loss for our
$XX cash of was quarter XXXX fourth for burn the Our million.
royalties in fourth sales record. million OMIDRIA $XX.X received quarterly from quarter million, Rayner’s Omeros net a of new $XX.X
XXXX compared per the share or Our to $XX.X $X.XX full or net per $X.XX share, million was year $XXX.X in million income for XXXX.
year loss loss or Our $XXX.X in from operations in $X.XX full or $XXX million continuing compared share, was XXXX. to XXXX per $X.XX share a million of per
and $XXX $XXX As million XXXX, of million of receivables, the milestone XX, and $XXX December payment. we investments inclusive had of in million cash
All of those been have now receivables collected.
at cash, service. in million debt XX, operations $XXX had support we total, receivables to XXXX, December investments in and So and ongoing
any Valley do A good we not in cash its on number week To financial and any Valley have Silicon way with have shareholders clear, of contacted investments to Silicon nor corporate do other assets be or any deposit affiliates. SVB us Bank. relationship asking were Bank our exposed with whether last we
fund programs million development $XX of the while now of XXXX. the operations our $XXX advancing Omeros provides off hand all The million to debt simply pay well to any in flexibility that multiple matures and November, or this into continuing convertible
recent signing XXXX Appropriations as surgery the that for ambulatory Omnibus or until ASCs centers pay continue management mandates least the to also OMIDRIA the Moreover, non-opioid known XXXX. in Act at CMS separately Consolidated pain Bill of XXXX drugs like
occur OMIDRIA to has in majority like departments ASCs, well, for but outpatient January as in pay HOPDs. also only XXXX. this than in in no later HOPD Congress not CMS separately those directing drugs the While cataract ASCs, of setting, approximately beginning hospital XX% address the surgery performed of or procedures
and being physicians care patients. to the and administrators, provides confidence plan OMIDRIA facility their The in incorporate assurance payment now separate reimbursed long-term ASC settings that on best their they adequately delivering can both HOPD the and for surgical of into practices
sales patient result payment this growth. expect -- to CMS in in certainty meaningful increased We OMIDRIA
expansion. Commercial which separate a their separate by mandated direct plans payment and plans, two payers this that for across for driving Advantage and the them, long-term fact administered and other expansion Advantage be are by and Med Commercial could would have both coverage of same Medicare The payment of also surgeons effect the surgery, cataract good CMS on positive ophthalmic Congressionally systems major accelerate Insurance should patients. many
There are annually well X alone. procedures U.S. the cataract over million performed in
to continue of grow, Omeros of to OMIDRIA royalties. sales revenues As as receive those will continue U.S. XX%
Rayner also outside are of Potentially further which of OMIDRIA adding this resulting of sooner until no our of than paid any remain enduring OMIDRIA later XXXX. revenues royalty to year, to those royalty stream, to Omeros. the U.S. to and is planning XX% the be rates Omeros begin to should expiration slated the in international selling patents, Both U.S.
of now turn thrombotic associated in laid let’s So current the programs, stem-cell with or TA-TMA. having beginning transplant financial out narsoplimab our strength Omeros’ updates on position, to microangiopathy
response resubmit on in license biologic BLA, or literature received derived response Office independent from analysis. letter our XXXX, a a guidance we Drugs, analysis appeal with FDA’s narsoplimab TA-TMA, application an New BLA in additional threshold path our complete of our completed to to comparing Following from FDA’s our pivotal forward proposing late of trial from
requested Also evidence of completed in group. trial appropriate was an our increased compared to control survival historical
can We of have and treated identified rates patients access now response and survival not TA-TMA robust historical sources with in independent and narsoplimab.
meeting have it rapid details Phelps support approval. FDA our the of legal and half proposed to will discuss of Hematology B in second analyses Working we Division with required and to quarter. Hyman our be to BLA, a the our led & of This first resubmission information a to by Non-Malignant confirm the occur narsoplimab’s FDA’s with McNamara and we toward of regulatory requested Type meeting, advisers a the the expect so by
or Medicines approval, narsoplimab agreed Agency investigation pediatric we with initiated assessing with European European plan patients have trials to the For clinical EMA. TA-TMA pediatric in fulfill our
We expect to complete marketing the our our authorization BLA. submission EMA to application of of resubmission after
call, earnings published by of Transplantation. have symptoms pathway cellular and a the transplanters substantial TA-TMA last In and been second we of continued the presentations transplantation our group accepted narsoplimab. of and has international Since review the lectin a for recently directed in and peer-reviewed systemic and publications activity signs seen leading journal diagnosis TA-TMA, Marrow Bone And treatment therapy. manuscript in on TA-TMA publication and
Society narsoplimab the with have in pediatric for of at additional trial and the Annual narsoplimab at Marrow accepted Blood clinical TA-TMA for two abstracts and Transplantation. Meeting on been the European our Hematology Presentation detailed American Society of of use upcoming in recent patients TA-TMA presentation of
their Stem-cell billing unmet now and as TA-TMA diagnostic procedural codes a medical patients National need. transplanters and and urgent discrete an it TA-TMA as recognize internationally are and officially increasingly transplant recognizing transplantation. complication identifying stem-cell of
approved believe and the with treatment to TA-TMA use, This for continuing CX means off-label curtailed, an is rightly reality. deserves committed treatment to make approval we approved FDA driving occurs work now treatment. that FDA with there inhibitors a use of TA-TMA further once for that narsoplimab of that to which should be are any We
quarter our track IgA of to our to to in X Phase Regulators. Also form submission for be patients BLA remains in expect the year. submitted data our basis narsoplimab third nine-month clinical for is portfolio, nephropathy This out to proteinuria we the read on European expected with to trial this our FDA and in
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make IgA see do aim inhibitors There complementary first. nephropathy no complement as system. as the rather competitors, not currently is the Clinical narsoplimab we these for experts approved of to complement but to inhibitor and
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acute in related narsoplimab ongoing severe Cambridge, of U.K. interest COVID there our related with work continued U.S. accessing relative funding Dialogue in is activities. the from branches with the these with of multiple of COVID resurgence collaborative narsoplimab and long At the consortium University labs agencies and Government and is advancing. is and diseases, and
of acute A and respiratory distress syndrome submission. inhibition manuscript animal prepared both pathway ARDS well-established influenza-related directed in and vitro COVID models for being in is or lectin the
of the the of central COVID forefront. under the more is narsoplimab of role the further pathway pathophysiology being This government lectin diseases as for the other agencies utility of questionable of directly and becomes the scrutiny The the is vaccines and causes that ARDS moves increasing increasing. central highlighted need in and evidence therapeutics these only to target utility supporting within
let’s at is OMSXXXX the narsoplimab next-generation weekly, Now is to our MASP-X OMSXXXX or long-acting lectin targeting narsoplimab. pathway. for once designed use. treatment, OMSXXXX, is long-acting acute complementary chronic for and generally episodic intravenously administered Whereas look antibody ideal
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caused A the enable the control lectin to dysregulation of and of by should inhibitor pathway. diseases gamut molecule MASP-X of OMSXXXX narsoplimab with successful dosed orally disorders Omeros small and together
MASP-X. now alternative activator will updates key the pathway complement antibody with franchise the on our of complement. our of MASP-X targeting is We complete OMSXXX, the
Phase of completed OMSXXX tolerated successfully As dose intravenous study concern. in of and we previously evaluating there both The was no administration ascending X drug safety and announced, a subcutaneous healthy signals well subjects. were single
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ended. OMSXXX study the later dosing the scheduled monotherapy to once ravulizumab this in of begin month We first are has period this
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look sharing So clinical data from we to program. forward publicly our OMSXXX
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that response could team for the and proprietary markedly both native position. is approaches a broad engineered Our tumors. technologies therapies liquid We validating believe improve these rates and patients cancer or T-cell receiving for either solid model cellular establishing
to have target developed cancer front, biologic and novel cells. we On specifically platforms the molecular kill
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development overcome and Successful difficult widely were pursued, only that to We approaches, current have of this vaccines transient therapeutic the inducing immune achieve responses. ineffective industry proven cancer believe with have challenge. we
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we again, intellectual these state immunotherapy multiple property broad platforms. are Here a constructing around
that, call more the go With financial will Mike I year. Mike? and results discussion the now Jacobsen, who Accounting turn will Chief for a the Officer, of quarter through fourth the our detailed over to
