AVDL - Earnings call transcript Q1 2018 | Avadel Pharmaceuticals plc

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Operator

Good day, ladies and gentlemen, and welcome to the Avadel Pharmaceuticals First Quarter 2018 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference may be recorded. I would now like to turn the conference over to our host of today's call, Ms. Lauren Stival.

begin. may You

Lauren Stival

is you This Earnings and want I Call. Good to Lauren Avadel welcome all XXXX Pharmaceuticals' to morning. Stival, First Conference Quarter

Before of number of cautionary that constitute of with regarding will XXXX. within Pharmaceuticals' Securities matters we the Litigation statements following Act meaning Avadel a The Private presentation some includes plc forward-looking begin, I the statements. start Reform

described products such cause forward-looking subject filed achieve pricing. to Avadel's ended and presentation or XXXX. the These March for stage those any risks actual could under other public to Form including otherwise. results products or in uncertainties requirements, and update was information, events fully are year that from development to Except reflect forward-looking stringent Act, no market or required risks statements meet law, in statements risks Forward-looking contemplated scientific These include revise which future acceptance this and filings uncertainties on the in contained statements. risks in XXXX, are Avadel Exchange competitive objectives that of materially the undertakes differ impact by and the obligation XX-K regulatory regarding to milestones products as new XX, or not December may of XX, more

be the we'll be will remarks, of section investor our on the which using After website question-and-answer accessed prepared period. We a via be slide call, presentation call today's can or webcast. to for opening

Chief At time, to call Mike? Chief Financial Mike and Kanan, over Chief pleasure call today, Officer; Officer. turn Executive Anderson, we this our Officer; Davis, to the have Mike my the Anderson. our On Michael it's Greg our Operating

Michael Anderson

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

Michael Kanan

everybody. to morning good and Mike, Thanks,

hospital you've our quarter As morning's were first our our seen in release, expectations. products strong from this and exceeded revenues

$XX.X First above quarter the estimates. which revenue was million, street was

we part very revenues. as a U.S. our we of This to launch we pleased would with As underway Mike our recorded million and initial discussed, is be, in wholesalers, of stocking and slightly we less launch are progress of across thought $X where is Noctiva date. the the than

the we our As we products to you deployed resources may February, our disposition in strategic to of XXX,XXX we the This pediatrics issued warrants are the during previously know X.X shares. we as of catalyst. both and quarter, announced about warrants growth part progress settled totaled of in our received million acquisition. $X.X Cerecor. the our all completed issued We cash call ensures shares. and million We Also aligns of with some

our spending $XX in which in Our as R&D the new line the initiate was quarter is initiatives. oxybate was spent and million expectations clinical to in bottom about with and results in spending Noctiva recruiting with spending quarter is million, line our on trial. sites continue line almost launch The of most in sodium expectations. also first we included our $XX

expect cash was in injectable quarter, as continues sterile Mike Although flow costs negative be for margins excess in an the from of of first generated the cash, XX% to overhead. and our sales foreseeable which marketing flow will source for very future. operating is excellent you our say, carry other hospital heard carry continue little products and business, cash These gross positive and we

profitable are very they for So us.

$XXX XX. continues was a and in significant March convertible a result, offering, business play $XXX at off strategy. of balance this the our our cash to million heels enterprise As debt Coming oversubscribed successful nearly our million role

a compared launch did adoption a of accounting or like other The material rules when our our trial recognition complete new not adopted FTXXX full of the of to in as a many revenue in of standard development additional QX recognition selective recognized capitalized Noctiva, are We strategic better And the and to note quarter. on we prior revenue complete first revenue effect interest, tiny the opportunities. have overall new policies. well we, companies,

in timing to of specifically from $XX.X Now QX's slightly Avadel in was as result lower last of unit shipments pricing competition. quarter, new growth let's and the of decline, Revenue offset talk primarily from in QX million quarter. the QX the from year-end more accounts. the and however, and last This and of given $XX.X revenues year, in a QX how down XXXX year. said, in somewhat declines the by performed from due first higher as I level we million, volumes was volumes declines Vazculep certain down

very injectable our as Although they're last revenue year, from hospital the sterile still business has declined said, over to us. important I

continue higher and about up Including including write-offs, onetime totaled for We royalty profitability The incurred of of sales mind the Keep not and costs expedited additional cost freight a and the clinical be XX% QX, of costs QX, was increased product on sales quarter sold XX% marketing been these our cost REST-ON in about cash million XXXX. and revenues. in net million FTXXX. of a pricing. sites for This product would certain sales about first will gross but few of associated this with $XX lower recorded a patient the of of of good XX% first enrollment can the is marketplace provide but launch drivers to incurred the during in clinical have with costs. initiation year. for due other the as testing of the result as $XX Noctiva. XX%. in margin pediatric in quarter, from million manufacturing about year-over-year and almost spending that trial, the goods year's after will $XX is last on about from due QX and associated million million including look things, of product about quarter up that opening about $XX new higher first initiatives, with Also in was increase in relatively scale and expenses product services first XX% was $X development from development unchanged quarter quarter. Cost to million, Noctiva and inventory QX SG&A QX, during The $X from in in SG&A contract slightly cost products to Research almost last percentage unapproved costs, up of expected increase spending in issues, previously of sales included up from of in associated flow about primarily increase QX was approved from approval. X% for the

balance As continue a these not the costs divestiture, of result will the of year. for the

we payments $X.X of convertible in basis, have cost non-GAAP includes Most On Moving notes. of of the per related our This of interest [indiscernible]. royalties royalty our of consideration QX cash spending. with a about exchangeable related the debt. $X.XX which our on to share acquisition to accrued million loss our about profit is royalty these expense XX% are the new gross associated are and $XXX,XXX non-GAAP $X.XX, we results Noctiva was part a diluted

result of $X.X eligible offset be benefit tax or U.S. a believe a that income recorded to Noctiva products. of we attributable As We approximately of our a our these will XX% the to large hospital future million. spend taxable portion losses,

this U.S. our cash substantially or and a tax create reduce a XXXX As in taxes eliminate result, may benefit.

recently reform passed We also rate a in the us expect will tax reasonable U.S. more help achieve tax future. income

non-GAAP our covers the results expenses our how intangibles exchangeable expense consideration, non-GAAP Please appendix reconciliation and for to to slide results. today's GAAP the interest acquisition-related primary onto on GAAP The GAAP treat to and Noctiva to the contingent notes. of of Let's refer amortization results. a newly presentation our our relates slide, statements between move next our our we which income differences with associated

non-GAAP GAAP to difference in our related consideration. As past, contingent the we the is said to largest

we of quarter increased our three products. contingent liability about slightly due of hospital for slightly million market XXXX, in changing conditions first consideration a purposes and GAAP $X our accordingly recorded the During charge to

between interest we Additionally, exchangeable differences expense notes. our expense our cash GAAP and associated with interest our

you have and debt component GAAP the the to of the for we purposes, may component. bifurcate Some notes between know equity

interest material For debt the commensurate the and of purposes, at using expense rate difference for we portion profile but a GAAP then which that non-GAAP was But came will our for with non-GAAP interest will purposes, all component notes our QX debt. an the credit record we with interest specific coupon, expense be term report X.X% convertible. on and QX, outstanding GAAP were the given in quarters. between for only more not The the the it future that material in interest

Our first quarter the net share GAAP in per last $X.XX the same or or income net loss million per $XX.X of $XX.X period $X.XX was share for million diluted year.

after February, Moving in as $XXX proceeds you cash our received announced our brings and buyback offering program the And summary. We up $XXX about at securities. our offering, million to This ended and shares. notes we exchangeable million. our cash notes to completed board-authorized at the we million marketable flow $X net know, expense another $XX.X recently, total of share quarter million XX. buyback. we That's million In Simultaneously repurchased December modest from with $XX $XX million. on

as share the programs. a our months, finally, Over are we've XX approximately guidance. last of count result outstanding we XXXX And these our reduced reiterating XX% by

unchanged is in our in That's the million, million about to losses to million to our to of X% million. With outlook unchanged. spending turn in unchanged at from revenue over and $XX continues million for also a And tax Mike expected million. $XX $XX range I'll $XX to our at $XXX spend. call benefit Our million outlook effective million will remained Noctiva guidance conclude million. million $XXX be is our $XX XXXX, Because and our remarks. to for SG&A Included $XX revenue guidance to to $XX at be anticipated Noctiva also remains our XX%. $XX rate back that, is R&D prepared to to

Michael Anderson

Mike, thank Thank again and you, for us joining you today.

the quarter. our would questions strong going long-term a growth we'll turn to people executed to time has strategies like business. strive And We're become our who in may mission that, and ask. specialty a company to remaining that executing continue with to the near- - continue over Our in leader any to to that

Operator

Instructions]. question Brisebois And from [Operator François our Laidlaw. from first comes

François Brisebois

minutes So the the couple of I of missed call. first

if early. going the So I on, planning the was there but our yesterday this commercial that's already around just it anything little launch is AUA coming that about, talked was was since Is mid-time wondering he launch month?

Gregory Davis

Greg. Yes. Frank, is this

at will be fairly AUA a will - robust be presence. We there's program. nocturia a with There

large a have product We theater.

other breaker advisers of on of and surrounding number We of yes. some Sunday our will events data so, publication our have lead the

François Brisebois

Okay, officially is but the full off? launch taken

Gregory Davis

today as are Yes. out really of with campaign yesterday. the full They

François Brisebois

Mike. or the you this And has a clearly reforms is company more do probably How for for complicated tax help in just there Excellent. think future I just you wondering for little taxes that mentioned was in could been reform general. Best. while that?

Michael Kanan

taxed Yes corporate of the of is reform tax you And business. previously that portion the XX%. know, at tax so to corporate was hospital rate significant that XX%. our old in rate And as profitability

this So hospital to helped has have. us the that respect all tax we business with of reform

So we that us forward. to helpful should be as

in currently Additionally, the is you know, as U.S. generating losses. as well. Noctiva That's

a be if spend. not profitability able all offset it will of even the tax offset to - with will So we much, be to XX% hospital business at rate, able Noctiva the

to cash don't expect fund back to tax able and So taxes in roll from XXXX. very will XXXX in taxes, potentially be to little carry we any XXXX, when carryforward to be pay losses cash We a cash have should standpoint, we forward

So what us. taxes with for has pleased tax we're done reform

with companies operations are. As significant U.S. most

François Brisebois

And it? you this, now can road then, effect give wins. year? And And you. brand of what any preferred early this? contributed of key guys And color the the really down on more Got to the

Michael Anderson

a that of year to Yes, of really calendar this it's was work - early reflection the last part us, year. Frank, of done Greg again. at the To really me end

to to basket pharmacies a the our which compendias That the would us, earlier in for be where was Noctiva therapeutic in its particular establishing and is in that Mike speak. determining important call. go so little we outcome and foremost competitive and both these covered highlights achieved, own an First what category, on

first then, that product what nearly see other one. provide these not, the likes and and to of like secondly, immediately. coverage presentations, high wins strong And with government proper clinical was the in to what decision recent the you So now the and is

in So these in that we've generally, with consistent wins outcome And see really been next, of has our a focused we cases, recent as the would pleased call we've And would on. these months. formal like I coming that of to very number over a meetings. early those it, receptivity describe lot on nature Part decisions ones, D expect been down of more let's decisions, and more the three-plus

François Brisebois

Excellent. hereon of REST-ON And terms just the lastly, trial. in

So an update.

said there ensure last half us - second between to you patient you growth on of in sites? do definitive trial? number on there update is color sites recruiting? variability the as 'XX that more Where trial more a of remind add guidance sites, the guys in no you XX% is given How enrolled. mentioned You any added You more

Michael Anderson

resource This And prepared CRO, sure perspective a from able diligence, is in to irrespective does making to is great with been that these so both sites deal do do the the it's perspective study utilized that. same, Frank. Mike, and of clinical process is selecting be site due protocol, of we a the our Obviously, and site.

second half. the provide update will in We with an you

work months, really already we've is over we've a couple sites. oxybate with little sodium which a patients, to with the those talked bit done about, a last sites, Australian lot Our of of

have that is of the patients also enrollment sites We but within that high naïve, will oxybate result have a And weeks. patients for in of that, last said, they requirement be we the as significant several very and pickup, U.S. course, be seen same enhanced XX% a those we our just pickup, of to European number expectations time, Canadian, in a that sites sodium the reason. at increase

there we've so been the really going a you on there progress. And with again. can until assurance to about dates we're meet not as date will set full moved we And X set and know, feel be set to real we it But them. occasions, good never another the have, one we again, out

François Brisebois

Okay. number And that? color so the then, not any giving sites, on of exact you're

Michael Anderson

know don't we've we between XX exact But neighborhood number to XX in somewhere actually the enrolling. clinical I that increasing today talked and have the already earlier Yes, about sites. of

Operator

comes Jason Butler from next the of Securities. JMP question And

Unidentified Analyst

It's other described little more initial on that that Does have REST-ON. month-over-month us XX% enrollment tell or I've added is in XX% questions or Jason. few detail it is some sites? new bit XX% Ray more to broadly I now, How much of And you the for say? wondered that due patients trends. stands can mean a it improvement where enrollment been that is measure? about below

Michael Anderson

study is on position a basis. not sites existing to in the be in any are into where We to you able sits. enrollment XX% an But for on sites offer further guidance the enrollment

have in expected. truth. actually we it had earlier, as again, of again, since hopefully enrollment. yet we beginning by the did you kind I point, that, We've margin that when - from at point that people this what sit be nowhere in we're we enrollment fail point, impression do and least nothing, we doing to think we won't at exactly further haven't to process. in So second and growth and to the in had sometime that's the picked can we and year. the But to should. And we Unfortunately,, thought of information in half. The seen that better but extent bit feel we you And of little we've giving then. up early they Not the a quite improvements where

Unidentified Analyst

question expectations do I Vazculep a that was expected Was had And Vazculep and that? great. approved. for from then generic on have the on for Okay, impact that any you

Michael Anderson

of Akovaz Vazculep, Vazculep at of sizes. Yes. actually. been modeled Bloxiverz We've with the and other of into accordingly. And vial expected we've approved, address always competitor shared we we'll space we've We've additional that the the seen year. entries appearance had new We've end an into X in new entries two both And mL always another tail those the vendor. for all markets

certainly be we of We will business away. years. supplied have won't It an it that business goes reliably our impact, a lot for have if but have as

Unidentified Analyst

million guys million. And great. guidance $XX then, for are $XX Okay, to reiterating guess you

Just approves there generally there Do you is in conservative a comfort give XQ number you that is risk seen greater and that what in now? we've think guidance? a April

Michael Kanan

No, to quarters right get early that's during And this months we'll three it's we're certainly I that have for with it talk early regard. work sure, in to and too pleased more to think about point first and tell. the the coming progress, the the now, in occurred

Michael Anderson

that you I cutdown in launch today, and with were scripts thing. have that scripts the PI this initial to of these of sort just done think seen we've recognize that the that

really started this you It of the our launch. obviously So week. impact full-fledged haven't seen just

So you response we gotten. plays to now about a sure, out. have that good But counting we're will of make prescriptions. that assured should we've feel And the rest that's

Operator

our from last Boris question And comes SunTrust. of John

John Boris

level Congrats detail you on especially the the provided of results, here.

your forward? to here Just and of on you've that pulls Noctiva, expect just million maintain guess, around given back guidance assumptions, million have Obviously, guidance that around to million, and any $XX to thoughts the but a you $XX guidance I going $XXX your just million pushes guidance. $XXX other

Michael Kanan

you were you John, we mind we getting hate having difficulty this, your some Would sorry. again? question. hearing I'm to asking, ask

John Boris

Sure.

meaning might the a on It Second early mention for lower have of one can about is variables And injectable information follow-up will the the end on range? asset there have positions. your early raise $XXX features obviously to Noctiva. competitors cause of of the your just guide to be safety just who especially then, possibly the And have million that. go $XXX are? below too market? On awareness asset, And any discuss or question the are important very you on around in million the pushes you can cause thoughts fourth Do of percent asset? the the have that, Greg preliminary on variables many you to you sales, from what and the Awareness, to prescribed last how pulls any the IL-X. physicians you then good that

Michael Anderson

depends guidance it over to I turn may, them. pushes the if Then we've Greg on respect one, So take and much remainder as in with will and to in as for it It competitor of let a the dramatic the happens relates to business injectable pulls John. a think in of and first me pulls. to what strengths hysteric new push obviously pretty And that the changes price. given, Vazculep specifically with upon I coming that I to

business, in to from your you gather to are As always position you in be you're able it share somebody defend a this to then else. know, better

know aggressive into get not we'll that just don't that see how won't they So And the to we when actually be. we - will with have market are.

with play, - We've So who into and that respect We to market there. would I a people pulls a may pull come chain of us much whether And people than so some we're degree. we neostigmine think of think the not I then, I faster and in it's place push overall also got will or of that slowing, have. If little seen whether recently, those think which that bit. expansion the slower are there - I to a from the would Noctiva, sugammadex to whether or time-to-time to pickup. supply out issues, the we help think, think lot of serve blocks. How pushes are [indiscernible] uptake

that those typically will of guidance. all impact are the So pushes today pulls things and

we're we right where as said very Mike comfortable are. So now,

the Greg, Now, the questions. on rest If that works. take of

Gregory Davis

Yes, John.

standpoint, ago. our while of we're I an we've kind baseline done a little, Regarding where say would our that work from awareness

report so prior characterize, to So awareness to appreciate seek so trial certainly from over and to launch awareness to, continuing for we'll I and would But coming it prescribing along, need will, something physicians adopter, adopt moving certainly the we'll on, the if forth. the you and obviously on. quarters, and

So it's in something we'll on quarters be from able to report coming standpoint. the the

haven't now. Regarding number we we have historically that identified described one in safety we the is than other four, clearly what said, advantage what

We provided FDA. have today. shared those the new findings That with that information we

the it's would I say in little some Regarding be. out or that a of that, been over competition, have moved whatever may marketplace, number supply been bit. years, and in the the challenges to parties There's

would from standpoint, So inconsistent stable. that number of fairly say competitors. terms in been a of But I it's bit a molecule the

John Boris

from of quantify molecules the market different the in Can competitors? number you

Gregory Davis

right not No, now.

John Boris

looking take where it, awareness, was to on where you Noctiva, On it? and where are and is Okay. it

Gregory Davis

using was in we that condition Well, think get what achievable. high the awareness nocturia did current they're to target and to as Noctiva awareness. launched is - audience. baseline how on awareness obviously our we initially since our we In want strive audience, much a today around is quite yet. hadn't XXX% more The we'll clearly, And ultimately, - we

John Boris

moving Medusa very just Okay. XL. IL-X the on And quickly then,

asset? next advantages this $XX is how I doing and to of value of about with can majority want you're you And that cap look assets. billion, may you have? this again, because at at does target compare to contrast or Any of that it IL-X if If that just thinking And the market asset?

So doing options? Can what and diamond with it the you outlicensing planning in developing little internally between nice a you differences rough this the or year. maybe, articulate other have you're on just, two

Michael Anderson

And be a to I That's premature it think, question, detail, John. great frankly, address. of lot would pretty a

[indiscernible] ironic. you, in are. to mean into there point the plans our number to look work made mentioned, years, really always whatever reasons that commented it's so these this application I technology came Medusa can't define potentially experts and we what be it we with overall to the and for that At we're see the be now is an technology of kind then, that this that. As yet were case, for And for phenomenal had never to - great a the time, to their kind able exciting company make of at we have It company anything us. what decision the it a who of people, may this could - is independent that early

to if are determined. plans we this the I determine be If as still work versus to not we But is that yet to differences, product. administration principal an the that's think is IV. our at is know, sure We're make have unlike done. been how our we looking the you differences think any, first are whether that subcu a an What or looking think there not at product. the application

try had reviews And our can. The reason was with we though. in interest starting go have provide today view, Phase can it's That's out will And you back about ongoing that do try as we're brought and possibly simply a of clinic you point the that because that we'll causes soon analysis the we believe blue, some why to to of little number the updates it expressing not a people today the or we now. we're going don't on I since and more and color. that you We a as up in in to III, yet. provide best us complete, in in it

Operator

Brisebois is question your next from follow-up And François a Laidlaw. from

François Brisebois

is to quick the follow-up. the are the nocturia then, touched this But in awareness? challenging on. own issues? of of recognition And This launch. with used But hyponatremia how whole off-label - is of what a think do very here probably what much at its disease obviously, as a I it's really or just that moment? was understand it is most Just in early Is you terms guess,

Gregory Davis

both. yes. I answer I'll Frank, Yes, question It's your describe. would as And first

understand market really as it's its a on regarding and need awakenings in or four, easy right. to I a six as where establishing at the the condition centric as we begins night, ultimately that's is own potential. on The to Like entire and it's get really awakenings condition capitalize establishing this. five, botherness. to it If it patient the fully really more condition at think two nocturia,

the data that. important two And well. And so exist the life and that three as night bothersomeness establishing per moving challenge, that of issues, low at and on quality support and the as the impact is as to

patient patients, It seeing they goes context, it older formulations for it desmopressin a addressed sure, the in because characterize different not obviously, easy you some beyond anywhere and than they formulation immediately to X%, from patient desmopressin. of population a comparably But to to to product it it's about that different tell write easily doctors it's broader so these At maybe desmopressin profile, first first without just X% times, get but every very they we because are but our to That's make the X%, beyond ourselves X% population. - right. when different, of X% differentiating because that we Regarding position not important it's It's for from reports this lot can to that that. regard. important that establishing goes of any because is right

twofold it's regard. So in that

that standpoint. both from it's So

Operator

time. management questions like now further to this no remarks. back at I showing closing to the call I'm turn over for would

Michael Anderson

a spending thank morning, the our that. future on We to that that time and and this second we progress beyond your day. us and again, Once very much And appreciate with hope the you updates throughout quarter forward look we appreciate you year have we great it.

Operator

Thank have concludes Ladies today's conference. and a you wonderful and gentlemen, this for day. participation, your

Lauren Stival	Senior Director, IR and Corporate Communications
Michael Anderson	CEO & Director
Michael Kanan	CFO & SVP
Gregory Davis	EVP & COO
François Brisebois	Laidlaw & Company
John Boris	SunTrust Robinson Humphrey

Avadel Pharmaceuticals (AVDL) 2 May 182018 Q1 Earnings call transcript