morning, ladies Lauren, and you, gentlemen. Thank and good
today thank we joining for results. first our always, As quarter XXXX financial as we us discuss you
and our we've ramp is shipping the FTXXX has once-nightly divested XXXX FTXXX continued be to our of and to strategic the pediatric to Designation Orphan building is to we where the on in we're the we're measured be QX this continues of ability and professionals, substantially our the a execute We've aligned are old time productive invest end for and us around working transformed and putting over we've that that for proud mind, growth into with only of organization past form execute which the accomplish everything our of will a been priorities, up ensure really executed to the our company - we're as the and company who offering, not quarter many our growth trade XXXX, able last now forward. to Avadel. quarter, sodium in new which oversold investing critical foundation to out our a assembled and quarter, oxybate and by catalyst. highly-qualified ensuring we of Noctiva, to very we a team a can goal succeed what the to position products, achieved We're moving prepared being do. quarter turned as Drug continue In first our The business few experienced ways, in for deliver. the we've passionate thus convertible study, in last but one a year, plans, years, long-term future over all
state both and both at Unfortunately, we FTXXX. study infrastructure Starting to an announcement with the progressing emerging either in the cash-growing with enroll well hospital sleep positioned the can and franchise financially Let's from our expertise Noctiva and standpoint all, in have to the and disappointed leverage around study XXXX. and our case. position REST-ON big are FTXXX, and by FTXXX. on in not to leave not We we recruit investors empathetically patients urology. file for NDA obviously progressing we or with continue was in the supported be goal focus wouldn't we investors forget, Today, not shots that year seem build is two barely which earlier and believing did I this to market-leading,
have described, previously progress. make substantially, and we good our increased As recruitment we to rates continue
Within the easily past expect in in is sodium the are trends. we Australia We provide U.S., several Australian This nearly opening we an do enrollment important of accessible. additional enrollment. advancing boost What's in Also, improvement weeks, our XX% more? sites additional we've U.K. where seen are new initiation the as the is oxybate a Canada sites to our not and
in coordinators, working working practices implemented. efforts supplementing or and have patient one the closely We will Avadel already the identification CRAs have are being of sites, are and best those clinical employees the ensuring
point this continues patient focused from enrollment. be effort on Our forward to
As date we submission you our can a and call, second project NDA. on XXXX, be expect forward, reasonably of that patient clear guidance last the to potential when estimate we half of within able as provide From in might to mentioned occur. point the our unchanging to last
stated many potential, FTXXX believe formulation, times to seeking twice-nightly the based our quite on which who narcolepsy improved value research, will patients, and from we've As a we is the shows initial these are before, substantially high. real real add treatment option
as to that work on and enrollment as regulatory scenes future and our the will strategies. current the REST-ON studies support myriad plans work product we patent both our we for While well behind Phase completing of study, III on continue
of Another large is significant potentially catalyst the Noctiva. launch
PI highlighting compendiums, key has retail patients, first gold weeks print me one XX% indicated clinical which strategy condition, no four to over first now we we during review days partnerships program. secured for as the course, we launching category engagement equivalent of the both campaign, educational patient and and April, health consequences We with leading education via and as finalized who as costs three unique patients our above-average first the This impact, is we Care January, We our XX launch our may and a program, entered through solution. during the for target of approximately factors pricing patients with specialist, Plus into of treat the for shipping to calls a the campaign our of our Keeping In respectively. nocturia and a with the weeks Noctiva there and quarter March, the up and our by have captured We Plus as in are therapeutic and of which at XXX you on trade, of our nocturia urology Night over D is the scientific access known three audience nocturia XX,XXX of highlights been digital Noctiva exclusive let major now respectively. Care of What's reaching as within prescriptions Noctiva health in distribution key Noctiva. Part and in a launched therapeutic a condition just condition over commercial over prescriptions schedule, standard, into care IMS, such whereby You So XXX as product. Noctiva two-pronged retail access know as shipping began trade with and for and ahead We the and market professionals platforms seen approximately XXX,XXX launch. both referrals impressions, adjacent to the focus environment executed some only significant the sales
million a comps in coverage. million we demographic, similar XX a an of and that for to these our of seen positive and indicators care focused patient that brand BA, myriad patients have million access more During launch policy launch of decision demographic, coverage to patients million perspective access product launch. currently, a we the target quite is coverage over are scenarios covered are preferred an approximately instituted comparing a these insights, specialty robust weeks, of within Noctiva. substitutable customer the And over with and patients, no X have is very XX recent retail position have specifically even from the Noctiva. these of AND with BA product third-party and first few recently, days in first most through which analysis tell providing AETNA OAB the that documented XXX estimate will Noctiva, veterans there or our When recent us and THE a outperforming more Of are data XXX we
XX benefit design by all as a either have nonpreferred who nearly United payers, million HVSE patients, as Noctiva Cigna brand, major come approximately Care, from or access Caremark. as such other ESI to by CVS The Health policy such and
the as we to our status $X few commercial Over with and little high on when the focused weeks, out-of-pocket the expect monitor benefit price, and as gets access all is over we important our a as now, experience, This waters, covered next pool deductible clear Noctiva. payer we're to D clearly get creating an have in become market Right coverage, list seen we something for situation months. more nearly as which are our assessing payer investing for access we continue while past navigate design, X as to positive robust. both Part X patient prescriptions and will to
P&T with offer of planned, of presentations top nearly had the of with top all pending submitted clinical have have have number contract currently reviews. plans a have the We plans, all or and
these to pleased access activity important product and approach been profile to are granted, our the to customers with We we've pricing. the our
appropriate. We key progress and continues to meaningful driver be this as will as any updates on made provide
overall our brand patient favorable status, continue and we fully contracting programs being designed monitor access patients we we no to will preferred with to have While planned operational, pay this $XX. patient continue more to bridge a for have a leveraged These are pursue than acquisition, impact. and
our Finally, that digital brand-new as and have we deployed officially will also we X, channels. as through our exposure full of sales teams and May trained launched campaign
take impact As with launches, it an update. most fully gauge to quarters the several will
and value times both and our patients, are shareholders. Noctiva to on create night potential bullish for too waking a millions to substantial very of up who many remain we However, to its impact urinate
expectations with hospital off leading these and ago, again to Moving more There fund share continue had but to once with high-margin written many, provide generate sales us exceeded our significant Vazculep Bloxiverz, and street's we that million to are who our cash positions revenue. the initiatives. products strategic in continue long market franchise. $XX.X Akovaz to
provided bit to While products an fund clinical difficult are a opportunity to of these capital. the they seen and work model have more with Noctiva our generic us life have our some nevertheless raise declines, and
developing in on we that previously sterile know, We a we revenue we will range the working As uncovered to currently $XX product, per are issues in $XX estimate million project, injectable be discussed of safety that compared development fourth we somewhere year. shared with some able the that you for products other preliminary to the improve meaningful At plan. point, substantially have feel the findings will our profile working our this the and FDA. are diversion find still to we've FDA been and million
testing, stability that and steps which very an next validation the for Our the to development improved extra process are on will work based we in demonstrate profile. are complete confident safety
around shared. the be as our year, the work of have extra done, to now we filing the Given end we NDA previously anticipate
Given opportunity. time FDA, approval this still the be at revenue a XXXX we to expect
ensure our as opportunities and we improvements oversubscribed to we've study. offering, growth are the the commercial can of including We potential Noctiva have that identified out well that legal case authorities, clinical netted present strategically and will invest building. and evaluating are $XXX and we the upon our In leverage an our have of liquidity launch appropriate the enrollment we we catalyst, options positioned may to all important Furthermore, our February, infrastructure aligned from which our the convertible and regulatory, we to debt accretive most based seek REST-ON FDA. the in about that million intend
our the Medusa mention about Now that done We've a small a number of quickly a I'll our lastly, ILX. ordinary. the Phase with to bit study before I Kanan, from subcutaneous was recent ago received of using technology years over inquiries of investors I something out little call number Mike CFO, turn a extended-release
there our considering small, received in XX and we say be NPD profile inquiries if at forward of Medusa a showed action the While interest that point cannot duration it. PK IL-X a hours. we will given we this while XL here, stable path programs is around recent stable It's of with surprise no
of we're call received, that certainly I don't number questions or believe the is the on Given that that wanted clinic to that want we a to mention lead entering today's to imminent. partnership anyone
I call to Q&A before Mike some final to Now our I'm Mike? financial comments turn review going to with and results the over that, quarter's Kanan wrap up our session. with
