Recent OMER transcripts
Associated OMER filings
Jennifer Williams | Investor Relations |
Gregory Demopulos | Chairman and CEO |
Michael Jacobsen | Chief Accounting Officer |
Steve Brozak | WBB |
Good afternoon, and welcome to today's conference call for Omeros Corporation. [Operator Instructions] 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 over the call to Jennifer Williams, Investor Relations for Omeros.
Good afternoon and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward-looking. on are and subject based today as are and only to statements management's expectations beliefs of These change. to All uncertainties forward-looking materially. results that and differ could cause statements the company's involve risks actual Risk refer XX-k, discussion Form filed of Factors Please risks was the section the uncertainties. report which SEC, company's the with and of today these on annual for to Dr. provide our Jacobsen, Gregory corporate update; a quarter take you our Accounting Demopulos, Chief through Chairman for and CEO of an Officer, results. financial will then, fourth Omeros, Michael overview will and
have overview. some time the We reserved for after questions financial
call Now I would over like to Demopulos. to turn the Dr.
Thank OMIDRIA, $XX.X XXXX. to And were join everyone. FDA OMIDRIA Total product. our you, with OMIDRIA begin we time I'd XXXX revenues today. taking totaled report like approved increase to XX% reported quarter ophthalmic an the good fourth Jennifer. from in us the And revenues $XX.X this on over appreciate sales and of update afternoon, million million, afternoon's you an
fourth non-cash expenses was Our includes share. million, $X.XX or share $X.X $XX.X $X.XX per per quarter million, of which or loss net
fourth quarter, with investments cash, only cash short-term flow equivalent nearly overall decrease During the in reached our cash million. $X.X equaling and we breakeven status
more numbers now examine let's So the closely.
to of midnight expired -through its part on note schedule December discussion, As it's reimbursement this important at past that for OMIDRIA XX, XXXX.
sell was that Also, fact the in December without inventories entire the December, same has fourth and respective quarter. early or of increased quarter. sell XX% beginning number began through quarter In to reordering. sell over hospitals in on hand reimbursement X, the likely pleading and through third October hospitals pricing changed. regarding a OMIDRIA in volume, for to this vials not large November, reduction through the corresponding and unit During January for as given ASCs OMIDRIA third ASCs sold the Despite uncertainly however, their
why to reimbursement policies, for recognize a Under and included not sales in net OMIDRIA by requirement. were of less $X.X in that us OMIDRIA by and revenues, that of and accounting vials December the result those to So The reduced inventories are number return in and the we the the revenue our we to able in at were recorded is $X quarter. the again. pricing million to around to XXXX and that wholesalers QX charge when OMIDRIA difference ramp majority million hospitals. fourth first sales we because sold answer the XX last quarter both sales returned if nearly vial is our we be recapture expect accounting uncertainty million the Also ASCs QX same in than revenue $X fourth XXXX related held last in QX. of to inventory unit a for in expect Both up quarter
selective basis sales uncertainty regarding suspending most have A QX and customers at are OMIDRIA only. resolution And Given separate payment the reduced use substantial for product are on majority employing been in our ASCs OMIDRIA, a reimbursement. or largely awaiting of regarding hospitals. both
clear, issues, we is broad the for There or We legislation. we One option question OMIDRIA facilities that OMIDRIA. until we decide corporate the payment return will expect for restored for viable. be persist implement of previous how this will bicameral, to payment multi situation to remain alternative way, expect have strategy. OMIDRIA once until to utilization resolved been Either separate customers for extension, has this January into will we the be selling X have to through directed support separate ongoing our drugs been period and support selling in extends organizational prospect years, and to continue, in we the pass pass opportunities bipartisan, address of To this and is for legislation growth through expired Congress near-term There X law. provision that we apply from that But for to senate in Congress house passed would would enact other and through expect for resolution. for which to as legislation already continuing and recently are which pass included procedural to introduced efforts the the OMIDRIA X.
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regarding reimbursement uncertainty then be to the utilization remain continue confident in resolved again. OMIDRIA will that CMS you expect up pipeline. fuel soon our ramp and that help will will OMIDRIA We for XXXX quickly We
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as are exploring We our well. major and options markets other
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we to the Our clinic. optimizing as are medicinal chemists advance them
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system dopamine the OMSXXX controls inhibitor be compulsive compulsive play is addiction any the of work we addiction. of a in through central X the is any PDEX use field again programs will phosphodiester our addiction to PDEX through treatment for exclusively to our of known which lead PDEX turn disorder. inhibitors or the Omeros let's believe where inhibitor. First, role. disorders Omeros or and major
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could hinders reward that the both currently any agents. seriously approved inhibit relapse system. use translate animal addiction. addiction all Q does not A forms and in humans, of decreasing addition Should data the depress first craving, In OMSXXX the OMSXXX stress-induced be of to to the drug treat problem but
Our program trial initiate OMSXXX X Phase clinical remains to on mid-year. by our track
We we unmet addiction target there remains a will expect need. that initially which for nicotine substantial
also Phase in addition X while Pharmacology, been our conducted program trial agonist OMSXXX had use investigators In the data nicotine Biochemistry focused inhibitor data published generated published PPAR-gamma X data. our journal cocaine clinical positive to on from The Phase by the journal the in disorder a PDEX have from been in Addiction, has a study independent and Behavior.
The exclusively ranging Omeros dose. that In GPCR submitted heroin addition, dosing from Phase that analysis or with FDA to clinical PDEXX, wrap will we program. findings for allow a resulting our have XX, of cancer, up program, central XX specific with differences discussion development the a system manuscript this pipeline continues in nervous been discussed analysis the that data broad limited of In disease the believes with publication in inform clinical results resumption disorders. for with cardiovascular indications, it the journal. a our limitation. is be controls X of OMSXXX data may peer-reviewed in and program well. study progress including without GPCRs species Work has inhibitor as We'll metabolism, phosphodiesterase
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cancer critical appears To So the affects our pathways time functions inhibiting GPRXXX Omeros entity and inhibitors. GPRXXX while for target and singly suppressive cancer functions GPRXXX system, other constraining constellation treatment. all the other this knowledge immune same no its stimulate of has at than no to related
other and build a targets. We to around on continue end the of our update With this and turn a estate call programs summary products over to fourth-quarter our GPCR the property that financial Mike Omeros' broad I'll and intellectual for results.
Greg. Thanks
OMIDRIA million revenues $XX.X noted, million share. quarter This sales loss expenses Greg and or fourth all was for product As includes the $XX.X $X.XX $X.X our from net were million per of non-cash basis, $X.XX the advance cash quarter, we $X.X million. cash continue per fourth to with and an flow equivalents share. in breakeven On decrease overall cash only being during overall our toward
regarding quarter specifics third some are fourth Here compared the as results to the quarter.
surrounding third OMIDRIA Our pass considering reported and while third of our sell-through $X.X unit decrease million, the through. quarter the by a the the even revenue of the wholesaler uncertainty fourth was from cells for quarter $XX.X million from quarter, ASCs or hospitals constant remain
in Hospital to projected to what inventory majority revenue large demand, accounting currently and achieved demand to reimbursement, regarding has is resolution substantially Consequently, all January revenue reestablished. recognized and November. future ASC on for waiting the sales December using that the extent basis, not in selected during couple The sell-through third recognize a customers did weeks key only above with peak in was quarter. In from our policy, revenue Under volumes we since fact, factors. a recognize declined a through we made sell OMIDRIA very and X difference inventory hospital our able of revenue sell-through ASC fourth-quarter volume our the substantial and excess This for was attributed reported will daily of December, to we prior approximatelyXX% be shipments as of of in a eight on are to the wholesaler wholesalers. the our between nearly
quarter the of of returns the ASC would manufacturing the activities and million fourth is returned incurred that hospital item higher Interest primarily was recorded we positively other the and increases line and replaced will with also million ASC product OMSXXX is customers. usage increase $XX.X and possession and impact we The party for for increase in due reserve December expense OMSXXX is future quarter. XXst We XXXX. product second the revenues. to extent current on expectations. quarter a Cost are million, our returned the be for ASC our in candidates. and to at from hospital $X.X third that will which development anticipate costs scale-up our of and in the for hospitals support million $X.X $X.X The inventory a get expenses accepting in This was third
short-term $XX.X of December As investments and million for operations. cash equivalents cash, of we XXst, XXXX had available general
accounts have $XX.X we had we our collected quarter. support And million cash during this also loan already of have of that lease. agreement, our and first receivable of in million building We CRT restricted $X.X
this week or recall all $XX customer discretion we available borrow of may closing the February. at May now agree any at customary our subject million the facility only with CRG, CRG that $XX our sole to conditions. you debt we our only million As we and This at closing of of year portion million XXth and can conditions through with again to sole borrowed subject end and had the through $XX secured under discretion have
reimbursement for XXXX on let's CMS take depend Now the will status OMIDRIA. a revenues our look of ahead,
we for actively As conclude payment, continued Greg pursuing strategy. we an selling to separate point at payment event we continue the discussed implement earlier, pursuing separate some not OMIDRIA. are In will alternative
would we history. have sales So overall cannot quickly how revenues might grow what the we pursue we until predict alternative an be some sales strategy,
research of our development majority related will to During and XXXX, be expense the OMSXXX.
The primarily expense lawsuits commercial marketing slightly the Greg. expense litigating over Par amount would quarterly million of the million, in $XX that to dependent ongoing the Lupin lawsuit. is the like spend XXXX quarters per with timing in call for million XXXX and we OMSXXX programs, will I'd clinical manufacturing administrative expect full given on X with we XXXX increase to to from expenses to by turn efforts. interest CRG. With OMSXXX. Phase the continue whether on $X.X the associated quarter. increase any our borrow associated Interest the XXXX for back and portion costs additional borrow to $XX we expense Selling, general Should increase also our due be approximately actual dependent cost pre from subsequent of the activity versus may and our We Sandoz
Mike. Thanks
ahead go open Let's call the questions. to and
And line Brozak of from WBB. the first Instructions] our Steve [Operator question comes from
now is open. line Your
had Yes, there looking up couldn't that this get lot it and I'm regulatory saying and OMIDRIA. couldn't a hi, been detailed critics, wouldn't the and reminded I'm then see started then thanks of for have of by around it and Greg get everything obviously approval get reimbursement a OMIDRIA wouldn't in ramp then a going clinic the Greg, you sales. out of at critics of itemization how
is talked now future, like there's are next of demand flexibility that two do the Now well, us into really solution for here, you? us is what's and about the will you be you XXX I'd is why things. providing saying, flexibility Patient-physician can And but lot after that? you're with you've please. and tell what What benefit can obviously what everything about tell --with about what on what question decide options OMIDRIA. you to that the comfortable that the predicated for And you've a know on on got criticism that to about
All right. thanks Well, Steve.
in Let is me you. the said outset critics at on of which address early had you're that sort we something about that has and correct continued, on OMIDRIA have the you process that
OMIDRIA reimbursement the been from it's was around company, operations. programs development overall many see You we a the effect that funding that discussion it interesting sufficient is and that now drag have told revenues not our the on those recall somehow because CMS that would and largely in on us we should just the jettison which revenue,
than of used patients really frankly the of physician even CMS; has have level letters and me which support been clinical anything again frankly is understand reduction demand be are pursuing their an are as provides physicians that the demonstrated for Look, OMIDRIA obviously investigators we question, that's of reduced this hiatus in alternative. better better clear. we're behalf multiple the we two it and the members; demonstrated comfortable for come response option think patients. those to benefits on It's or have their different important, the but around pursuing. sales faster do is could safety benefits, gone by why reduced time have that multiple gone thought time are expansion patients it's is So by The product multiple we clinical congressional your it complication and the outcomes and the that benefits of use letters the in respond to have why pupil what that to time, it very OMIDRIA publications, for seen, devices, letters the have studies The specifically to that us; latter let those haven't being rates, around sent. been surgical
very the that level of high of physicians for clearly points to the demand really a from All product.
quite of comfort clear. that again level past the Our pursuing is we with are
year three stated has I've and pass-through then clearly support Congress. bicameral legislation think pretty extension five I the bipartisan that to in said
chambers the we continuing that and some the it's for mentioned and good expect included physicians, within included the comments, piece discussions Senate, been issues good It's those available policy. already frankly would are House fact resolution reason around continuing have that opening continue I as program. and of February. the It's both was legislation in clearly, But pass-through that patients. in So think and is the in discussions in because the is procedural frankly I cost good in for but for earnest passed
right thing specifically the thing to we is frankly I the So patients certainly, out. point respect will be should. the and expect one case for and to that in I the right thing guarantees we and no play made do pursue we to again opportunity it's think that can right I I to right as this our with our again to do guarantee, it to have shareholders we think and that. for said, for the to But successful, game do think at now we've never thing physicians, do,
is direct by CMS. fix The other a option
We with CMS. are discussions in
what this I should something happens rightfully discussions We'll CMS those think is see with well. fix. that as again
product really to The on physicians really at use to point, provide third this it to that try to for surgery. to a And make I us don't think flip is for different sense this strategy alternative their cataract would patients option. during
the answering that obviously reason demand only it's question. but because that's out a of work so thought can right, that All is it strategy well
and And went the hog is what are I your the future? obviously given on into terms in the advantages What can obviously back its of XXX don't of I'll questions. XXX what everything to development in got and hop line because that you the us Now terms else you've want through of with the on focused tell everyone you approval. that similarities, OMIDRIA is and experience differences
I Based been We've aHUS Sure, programs again. thanks, we and the development the actually TMA, in IgA. X think IgA program now that clear aHUS, with that leapfrog IgA we've both expect in We cell pretty process. Look, I stem-cell to TMA. data thanks stem OMSXXX. could data TMA and cell have stem with fact the we about also Phase in aHUS three think we've associated running our nephropathy stem-cell clear possibility pretty there's a out. on that been leapfrog put began reasonable
look TMA. you data median out the have the put overall excited the biomarker on look stem at cell we Whether you at are data, whether look at We data; the about transfusion that whether very survival you patient's the on you a is you whether evidence think that support is frankly based lives. our saving positive see look clear I OMSXXX data; clinical studies is course. and effect having those contention What that at
of and is directed with both to conditional be of in of in of discussions FDA setting the approval setting the accelerated EMA. there steps discuss of Our the next part each EMA. those FDA sets the approval would intention and to Certainly
you regulators. receive would data therapy cell is as differentiate. and pretty to clear. themselves breakthrough how look is nephropathy. We no I Again much our turning believe first what for drug us first look to mean drug no is from IgA we there approval So at those differentiate there approved for the at I you now proteinuria be There to treatment just think think for speak based We pretty clearly stem full IgA TMA response on offered treatment designation nephropathy. if believe I for the think IgA as we alone. things if
and So let me make answered that there I've stop your question. sure
forward to is Look, it announcement. resolution to all look No, perfectly. we what the and covered now be you've going your
the back call. again the in let taking So queue. Thanks me hop for
At to this I'd over for any closing time, I'm over Dr. --back call further showing to turn to Demopulos remarks. Gregory to the like no questions.
Thanks call. again you thank that today. much. joining for Well All very on everyone wraps for right, call up us our the
good Have everyone. support. As always, we a appreciate your evening, continued interest and
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