AVDL - Earnings call transcript Q3 2017 | Avadel Pharmaceuticals plc

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Operator

Good day ladies and gentlemen, and welcome to the Avadel Pharmaceuticals Third Quarter 2017 Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Lauren Stival, Director of Investor Relations. Ma'am, you may begin.

Lauren Stival

Good morning. and third to call. quarter Stival, to you Lauren Pharmaceuticals Avadel XXXX is I welcome want all This earnings conference

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

and These to in risks scientific are uncertainties meet that may statements. results subject such and regarding actual pricing. uncertainties contemplated those to stage and regulatory acceptance include stringent products differ statements objectives that from the of Forward-looking cause materially development products or risks in products, risks forward-looking of could impact market requirements, or the milestones achieve not competitive

although in Presentations our or revise a not site and a has which new contained under as note, public opening a to the statements March obligation any information, After accessed web the to or by XXXX, These yet available prepared the be which page. be and slide Noctiva, XX, call can the investors question-and-answer period. We'll fully in approved law, presentation was not filed of the is Act, future year and the this update to presentation other Form section Except United forward-looking FDA more Avadel's for call, remarks, events otherwise. we'll Avadel XX, using launched reflect today's to Events and be described going in required undertakes XX-K December States. commercially XXXX. for yet including ended filings by Exchange no are been risks As selecting

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

Michael Anderson

gentlemen. ladies Lauren, and and morning good you, Thank

to discuss QX the operations. us this our we ongoing you appreciate morning and of quarterly always, As joining results

with $XX.X flow million another The of represented quarter cash revenues third on in XXXX basis. $XX million performance Avadel, a year-to-year and for operating solid financial of

for in delivered The we generation stated We term cash Around that transform the hospital with business, third used asset, in we've the continued time sodium a last to and formulation protected we for our off to just saw specialty long just were year, we to a meaningful nightly diversified company This forward to narcolepsy. potential. for strong with would. like step cash and unique then us, study pharma technology company. quarter our a continue first growth kicking a growth oxybate, this phase acquire patent and products, of clinical grow once our was utilizing Micropump become and III proprietary effort FTXXX, our

we NDA, underway, is now Our to the of XXXX. file by and well the REST-ON study end expect still

spray. administered suffered are patients to is of million of proprietary treatment. is FDA third diagnosed more and in desmopressin, or approximately The to early acquired form only as by we by a condition of approved void, Noctiva times dose in the per polyuria. this the rights and product first of the patented as only X which treatment in is low of night XXXX quarter Americans, was nocturnal Noctiva the Noctiva transformation, million is these a September. of for due of many formulation two Nocturia, some nocturia, XX to as a the continuation nasal waking

formulations the your for prescribed, overproduction primarily was duration that profile. between dose been not the nocturnal proprietary hours. intranasal two father's the the instances treatment times not Although X with This drugs, effective, approved these treatment targeted products, two but increase hyponatremia, shown drug, BPH where developed year a trials, not and study, its action to to Noctiva at to physician polyuria between were historical in because absorption reduce prevalent while are Nocturia, is four issues. drugs desmopressin there strong other formulation specifically of to be than effective accurate options. BA to and the provides very is not and of of desmopressin. It of bioavailability have or these was due desmopressin a are desmopressin. of able with issues of tailored It safety the Noctiva extension is of only player concern be provides to six and XX and to first in other be of was in forms to further to demonstrated no only means limiting for of it with opportunity some address widely proven pivotal PK to OAB major the API, patients. the and Avadel in generic proven, of show with urine night; desmopressin safety lower that is historical the The market, associated has generic no

the and We additional quarter support our about and we the the XXXX. as marketing question-and-answer the will XXXX. Greg Commercial of are Divis, Officer, questions sales in full this launch steam product second answer to moving launch specifics in in will for period, organization grow us our of ahead, join any Chief preparation for

meeting we the XXth, hosting investor will a for its November of and an the condition analyst and Monday, overview on comprehensive consequences. Additionally, Nocturia, be

update. encourage detail, including talk and commercial We clinical will tune We further in interested to into Noctiva, about our web cast. of profile its those all also launch

months Kanan going our months, to Driving avenues, hospital Noctiva historically. Overall, the of tax in should and a be driver over number increase in as able been we be growth do number able through company. to factor very coming opportunity and a are about as our competition launch to ahead, benefits, have we important continue not excited will which we for are an across Although our years reap confident, the spend is see this portfolio. a long of shortly, meaningful, increase that us we is for growth for we term different this an Mike will to discuss of the

continue to produce not Although application through has generating term. long years will which remained during and growth technologies flow, through support key course few as is stable of acquisitions, quarter, for proprietary carry to executing for will they of now. us operating it income these cash the the and our enough the continue business products not good our to Vazculep last the

to although as the XX% it recently market. over of gain unique and blockade to continued competition, neuro-muscular increased share, appears fifth player continued just to neostigmine a there a to However, entity, off have has sugammadex, was approved, see molecular leveled

share QX, we range, Ephedrine volume During new continue in downward share and of quarter, Sulfate saw and also to We our the approximately That and approval, price in both managed market generic the Bloxiverz to a the keep QX on for third but pressure of late quarter, the put of the third in competitor the since remain to beyond. may held during market XX% mid-XX% addition leader. Akovaz.

XX% number important market. that volume from market that of a hospital inexplicably Akovaz, see comes market an in marketed could but we of handful on of While generic It's Akorn, of additional despite by be the our increasing the the drug over unapproved competition to just two competitors still appears which the XXXX, is and approvals, today composed entire to customers. note, portfolio, across

We for strong long and have of have relationships in these been a customers here. with period markets time, these established

to our we our before a we XXXX completing sure, milestones a As we hospital to challenging REST-ON ensure over of Each perspective, demonstrated the our defend maintain Noctiva, NDA revenue we of launch an market the period. and of will our working the be make declining planned both years, generic away to XXXX the From midyear, intend fourth from that filing going market, long the term is company, during and have the vigorously products. for of these pivot position and and year growth branded unapproved sustained number catalysts us, that a marked hit in study. Including beginning leadership. for for are product,

organization; few at remains pace, will study timeline NDA to filing of by am has increasing maintain and an end paramount the our to the feel FTXXX, our be months, enrollment REST-ON Now clinical this our that XXXX. phase been regarding we over of steadily pleased to III able last which we I of say

up have keep our very successful a awareness current interest trial. implemented in it From are as confirms it form only in a have We number although formal the out out also potential but fill people are a which that web initial To-date, ways more patients. increase It methods, to sodium have number form quarter to reaching screening to patients itself, fill not over our and preferable convenient it and screening social X,XXX with of tactics to screening been make our validates a driving group, patient in oxybate. very media, potential of establishing a in past, we about patients through we interest of high utilizing process clinical a using that the from patients have advisory I site and the to of methods alternative unique perspective, raise mentioned that progress, well. linked-to-trials had these have of and these initial effective forms. our only

we there the change our sites, as and working the also in both of ended we any From $XXX be certain third will a and are cash with countries bank timeline, no still standpoint; U.S., existing other our study U.K. additional quarter add debt. to in to a We in CRO shareholders. Should securities update marketable filing with and well. million be financial

our Micropump underperformed to pediatric we sales-force a for our We utilizing several clinical technologies, our continue readout and for in-licensing search a to portfolio Although to potential these, and its our opportunities urology we until pathway existing recognize add projects acquisition have LiquiTime pediatric has proprietary since whole, sales-force. or forward feasibility, have on acquisition. new will

we very the QX, relatively same past Karbinal basis, during growth by to here recently, XXX% for the Karbinal flat. from on that timeframe XX% year-over-year Sequentially, market while remarkable remained QX seen compared is product Scripts has has that four the ER. However, market our have while about a in lead have weeks, declined a increased nearly over Karbinal up some percentage.

In for another to itself third we now we set execute over inflection our Mike strategy growth. the continuing solid In will look execution to term sustained consistent quarter of summary, will there. and our for financial in I improvement Karbinal is pediatric a to to short, look more the for year, products continue detail. turn enough growth long call have over the continue to to profitable, next to of the segment discuss the ways in our Kanan seen and performance, While fall success. results enhance and the quarter was Mike? ourselves to pediatric ER not additional make

Mike Kanan

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

this also As you let echo in we Mike had that another me said, and have financially. seen as morning's quarter release good

positive million bottom top we and as months, nine line generated exceeded cash operating Our and in flow. cash expectations, through were flow have the $XX we

Now, flat a organically level million be of from and Bloxiverz as Vazculep $XX.X $X.X third was the as and Quarter-over-quarter launched. let's year remained to talk market for new yet up had competition. quarter we to third lower was was Akovaz pricing with performed in has the in stable fully essentially now, QX as specifically more $XX.X time due revenue expected, When million to quarter. and quite to volumes. primarily for for Revenue XXXX, down compared Akovaz no was was decline ago, how QXs some XX%, of Vazculep the million. lower Bloxiverz

QX. in This QX decline attributable running. million Our $XX.X expenses substantial strong compared now during million a and slightly REST-ON is million was lower of higher slight $X.X in to last is QX. the than year. with unchanged and our business million gross in as XX% from million expense and liabilities. result portion increase of consideration QX, cash $XX.X made clinical at spending last in with The $X.X SG&A up XX% associated $X.X gross consulting the contingent trial, sites third expenses. third to of QX $XX.X professional, and associated lower expense to quarter a we Research SG&A compared in but year. our was payments This quarter comprised our QX's non-GAAP consideration of slightly in and accruals in of clinical margin development margin, are remains QX Contingent totaled development million

products. EPS on know, Bloxiverz, you acquisition of of Akovaz On vary the of to This part three sales amount on profit the X% for for many of diluted will quarter-to-quarter QX. pay we was share and basis, non-GAAP obviously As depending party. related and gross Eclat, gross this levels $X.XX those a Vazculep margin the a per

XX%, The related effective Irish to non-GAAP to for to and third effective compared Akovaz. lower Our the was in a to QX, rate, was by sales XX% when pre-tax due decline tax tax driven in higher QX. compared income, quarter rate profits

tax are where in U.S. As The remainder of purposes, Akovaz we our many of incurred our a large recorded for of developed. rate, history revenue was recall, current in revenue therefore, XX%. income and and all is R&D corporate principally where record from where the hospital of Ireland, expenses at the have products taxed the earned benefits. is you accounting in Ireland, France no portion of it cannot any is product tax U.S., our Nearly

statutory With tax effective U.S. pleased rates. tax Irish rate which addition, has for in that non-GAAP tax declined said in meaningfully In factors as last I effective and said receive statutory a both any our we year. exceeds however, deductions liability that past, These the when payments. an we contingent tax compared XXXX, create rate, don't to the am

We in eligible, to that discussed launch of costs licensing Noctiva several the costs I our conference U.S. for significant be years. to a attributable next believe over business. hospital call, taxable As portion offset incur announcing our large we products our will commercial will these income, our arrangement, Noctiva

eliminate As lower the substantially cash our taxes rate. next this income over three may and or years, a tax our result, U.S. effective reduce

which we Noctiva. help to the with of obtain pay the paid last refunds some the We cash could Noctiva are some of cash also the several exploring in for years, flow initial help carryback taxes losses our and on initial potential to costs launch for opportunity have

impact We which are what tax gets on have also reform the to it might was keeping if an eye on passed. ultimately it bill, see us, recently unveiled,

non-GAAP our restructuring to non-GAAP a Let's contingent Please acquisition costs. covers appendix for slide, reconciliation how and and to move The slide GAAP primary the relates presentation results results. next refer our our the and results. our treat we on to between results GAAP GAAP to earnouts which the to today's of related liabilities difference

of numbers, For a operational amounts our believe purposes. and for way we We measure GAAP the performance non-GAAP our this to better accruals substitute record cash business. the payments for is we

due three as liabilities For GAAP acquisition accounting however, we the for our third the the by use approach, we a fair Bloxiverz quarter, long hospital value rules. value related lowered required in and changes Akovaz, in gross pricing fourth sales of products, entrant for primarily to because competitor of slightly another and outlook, the a the fair In term profit a competitor. first of

million Keep make result, gain we are $X.X a these a these mind, are of lower As have quarterly on the and a basis. payments basis on reflective only, liabilities. not in of cash we GAAP recorded gains to reflective a

expense, for quarter, third called party the in income of and to payable. same contingent in royalties parties. on owe included value Bloxiverz, changes in noted. we addition, is gain certain basis adjust the income, related GAAP We and on revenues true-up Akovaz other these total fair of the value liabilities In of a This related Vazculep I small reasons a recorded just fair

Additionally there with France, gain of on in QX, the was our our rationalization. obligations certain curtailment results retirement for a small in workforce plan associated GAAP

our As at France recall, we by you our approximately XX%. site reduced footprint Lyon,

of We have on and employee to severance million. made and up of $X.X through cost and approximately XXXX. the XXXX, recognized the million, savings fully which other the end to costs be meaningful anticipates XX $X be company expect substantially annual benefits progress complete $X likely million to of reduction Once of will incur implemented, by we December this, to

was last diluted in compared contingent the $XX.X the net million in to diluted GAAP in mentioned I of revenues largely the and that in of And the $X.XX XXXX, net million income related gains the share, was second tax GAAP the $XX.X say, pleased share basis $X.XX for $X.XX income this decline net fair share diluted XX% changes The or loss to consideration. lower net value income, quarter third period our the lower on to a party compared was I Our the of as of quarter-over-quarter to quarter. on per per or quarter a for due million per am $XX or rate effective third year. same

sales quarter. by from QX, the the $XX.X down were to million in million product; of on in we recorded Moving sales Bloxiverz $X.X previous

Bloxiverz FDA XXXX, slightly the million, market Our compared Sugammadex, introduced the range declined competitors in two million now QX. to Vazculep who flat XX% new of to due of the XXXX, year. Sales market. $XX.X were at to neostigmine in accounts market, share in GPOs share. the quarter XX%. neuro-muscular QX. the in the second for high pricing, an of revenue XXXX. quarter to U.S. and of Akovaz market, which late a Akovaz which period sales gain of repackagers some a volumes revenue in of in QX $X.X stable by is most third last of million, from for of and Pricing and aggressive Akovaz, in year, result from in remained and first slightly the approved continues and compared quarter entered total the was decline to prior order XXXX When to the the neostigmine of about mid XX% neostigmine, same the or exceed molecule in in to million $XX.X be range declined to QX block compared the were to molecule $X.X includes new essentially [indiscernible] June The was QX competitor reversal in alternative XXXX.

be GPO traditional seasonal totaled pleased sales have Karbinal pediatric the our up customers most strong for QX, our of as sales. us. on our ER, made customers, to progress we important outside are promoted important channel GPO were product markets, and as We XX% sales which primary with $X million; the contingent almost an about In with continues of well quarter-over-quarter

sales have true X.X Additionally, have made times, reflection a of compared to nearly of increased quarter, with last year's third progress our sales-force. we Karbinal the

Although in of XXXX, and the about growth significant market market year-over-year this QX seeing increases are we product. has prescription share compared to XX%, for declined

license Moving on $XX a funding we months about flow the ended nine ended and $XX for Noctiva in marketable million. license, operating cash the Noctiva December was business XX. to the million $XX development million After cash and September million for some used compared expenses, $XXX strong our of $XXX repurchases. initial which million for cash flow share with to initial at our the includes securities, summary, quarter We XX the funding,

continue We which gives cash balance flexibility financial sheet, on to a the have from strong fund hand. us the Noctiva to payment

is to clinical Our the current term. hand fund Noctiva adequate cash the pipeline launch and in on our near

that is the capital However, nature will any raise as rule be commercialize amount of to necessary. capital we that may out not Noctiva, be cannot amount, given significant raise timing yet. a The definitive investment and required of

are be We several provide and any interest am me major XXXX our to additional lot most with that raise executed raise commentary of efficient capital. a in of around let I working Avadel, be changes capital institutions to options capital, closely and advisors at closing, on There the reasonable costs. optimistic can our continues our guidance. to cost at In a some

million. unchanged at Our million revenue to remains guidance $XXX $XXX

costs of which, effective between total the of inclusive million in diluted which to between We and million slightly for total XXXX, from fourth advertising, on XX%, With We we expect for expect $XX the oxybate. us and $XX R&D range million tax down at now $XX of R&D most to of expect In which be Inclusive spend and for investments. million, related XXXX sodium between critical in $X.XX launch for rate Noctiva, Noctiva to most QX, other which of of positions, quarter put to QX, preparation related sales to for a Noctiva costs the all for to over range million is I marketing costs, SG&A to XX% launch call our spend million million, EPS all includes in which $XX other of us that's Mike? and $X guidance million range $X.XX spend $XX of the at launch turn the of would a approximately now XX% marketing cost. costs are to XXXX, some to sales-force, the salary spend to of SG&A we and promotion of an XX%. $XX to recruitment on the $XX million put of $XX all additional will to previous Mike, comments. Noctiva our would in expect to adjusted and that,

Michael Anderson

very much, Mike. you Thank

roadmap executed and Over in near and strive will to to in pharma become for an continue mission company. term plan, company assure Our we with executing going past long leader management specialty developed growth plans summer, as area. quarter step our a a was Along forward. strong growth Noctiva acquisition a this a strategies, our comprehensive the strategic our in successful serve to FTXXX, important of our future this to the

specialty set be million have providers. meeting updates us. operator that, Noctiva annual years, within drivers, next week, and turn rapidly will we $XXX the to you with you a for no over over company, appropriate. any pharma forward for billion, to questions. the and expect for and analyst joining focused offerings goals, such, now we $X patients as cap a again sales, market distinctive growing for in their investor than As on and product hosting call of Thank ambitious key feature less I our that five with to business providing look We With our

Operator

[Operator Instructions].

question comes Ladenburg Thalmann. first Our of Kaplan from Matt

Your open. line is

Matt Kaplan

morning good Hi, guys.

Michael Anderson

morning, Good Matt.

Matt Kaplan

at this study. detail to announcement? little REST-ON bit is III Where the Phase for the on of So point the that more are in you just wanted and data get enrollment study, timing what a

Michael Anderson

study not Matt, have of enrolled in patients today. -- specific randomizing are enrolled that updated the number have we that

XXXX end target NDA, to of best. on the prepared not to about of may the the study have to still that. year. to the completed But year. by half We are file and That's of still color closer next later expect on end enrollment are have We more do first that the we the

up may scale, clinical pretty the along is As you as now the almost way mentioned to full much, as add we as running, clinicaltrials.gov, are sites -- that's seen had number have earlier, well. from sites continuing and at of new and obviously we

Matt Kaplan

fill Okay, the in little helpful. your Perrigo programs of And in is -- Give an a that's as pipeline of into bit, your terms and to then importantly, there? well. wanted where terms internal more just program us with update then

Michael Anderson

So it sleep, the Perrigo under we getting was of discussion far I years a the it it describe so today. for ago, as, couple in as are a will program, back forward. which number contracted It will moving better program is help interest in quarters. where has Perrigo, of an at,

small to when program business We have the those resolve, issues and at of it to first was signed. couple continue we that of contemplated on, pace see a once would resolve and expect [ph] and issues

So that's the story on Perrigo.

And and a to we that engaging we relates we create. talked And the made we to sure to willingness then, that to make capable conscious we than than do time about conscious specific rather today, of going decision, product, what challenge to the then also to of we more past. that's now, some it pay for in didn't commercial it. doing frankly contemplate of we for begin or are we challenge that, our being viability believe the decision are that, sort have before that, talking party it technically, third we made is has been that products, subject you know, a validate some payors of in As have technical all internal the which the projects, about having

those our will We including particular and with in them we as products, in as the more about will what in and target talking we those profile advanced reach identifying so designated is them, have lot I forth. soon a couple projects, points of, [indiscernible] be call what can laboratories a granularity,

Matt Kaplan

Okay. that plans, of Noctiva, how your Monday, bit a launch is presentation your and the terms And give don't launch sense on but Perhaps want front-run going of detail next in cost more you I to us on a then, of year. over can little much to period? kind

understand? given fourth but have quarter, on us You detail help the us

Michael Anderson

understand preempt to your too I don't ask want And much, with to but We best will a on coming that Monday. Greg am question you we of we as hope it going answer full-fledged kind to we program will that. can. answer

Greg Divis

how pre-launch will effort, from QX, QX we of of In that, into Matt. in the would requisite the be perspective. teams hi comprise organizational terms in begin That that the When think the QX. comprehensive think type state a I the launch the QX, we a it and it market. we about would process nearly a high regard. two QX, in and will access in about expect begin early disease of that's XXXX, in going Yeah, people level complete, think program. We experience really launch And And of in to to in steps. of build-out programs end some will say think it of we terms patient have about about a by really commercial adding to that and education, as we more advance our broader more full timing

this Although QX, beyond it and two the much we too of to overlap much be start some extent, in the launch. without really will going narrowly detail, phase more go on disease focus experience patient will will those is state campaign a to brand focused designed in into of because specialist a plan, really effort. efforts Furthermore, campaigns

and there first, end in have are their targeting really today, predominantly urology today, physicians, going will which practice and Nocturia diagnosed urologists treat We those who be sub-specialties. patients

Matt Kaplan

questions. helpful, and That's look taking Okay. forward to for more Monday. on Thanks detail the

Greg Divis

Sure.

Operator

of Butler from comes question Securities. JMP next Our Jason

Your line open. is

Roy Buchanan

a just couple give and to questions. for Hi, losses? a Noctiva, former on had the for ability on it's you timing for your quantify the those Roy of I wondered the in us Noctiva, could sense losses if apply Jason. taking Thanks visibility you I can on

Mike Kanan

Yeah.

You around are the talking Noctiva. benefits I tax about, assume

guidance We sometime that, likely haven't $XX launch we We million of be -- will our described of described, January have into other further XXXX. previously haven't than do issue as XXXX. what the would we that costs we

[ph] this at point, be. would those said costs interimly So launch what haven't we

to Although, undercurrent, significant, would paid meaningful hope business, currently to cash able are that U.S. is from taxes, the which to which they and previous we will we to taxes products and be of these be some hospital recover losses years while business. recover the we back our go principally two years apply can

Roy Buchanan

Okay.

for would XXXX you be back idea? the that is able XXXX, So to go and

Mike Kanan

would be It when years. we -- file would it tax return, on depending be a two

XXXX be and likely would it XXXX. So

Roy Buchanan

remind you into me how Okay, that great. the can fits Noctiva, And and then, the plans tax about all for planning ex-U.S. development

Greg Divis

opportunity that standpoint. Canada, is from The

So we or to Canada not filed. have commercial the is which Noctiva, for rights approved

done So and there done being is analysis being as an speak. that we opportunity, on work

Roy Buchanan

Okay.

Michael Anderson

We rights. have no

Roy Buchanan

Okay, on And kind you to I follow-up that [indiscernible]. bringing the program had expect keep a [indiscernible]? then, on not timeline you. pediatric a Thanks. support great. Thank Do wouldn't a to sense product spending you guess for on BD guys I if it, it's have guess? of I I

Michael Anderson

So very business. we a are pediatric of doing careful evaluation the

at we we acquired the have land, the that to I But acquired opportunities themselves, And in think looked we recognized And business, out that we to like of thought differentiator. that's that put of the been that have able was time, to number it that shareholders. we in we looking more we the and bit our make something months to XX which to XX a opportunity, of the capabilities we acquisitions, felt at months. or we our so day term in carry point little have gate, portfolio, that into valuable At to not always have this had XX find long not speak. be this more promised business, -- licenses potential now -- something close from to promising value. the for we past for going acknowledged business a matched enough an were of and are the could to

productive to have to and generally business, But can with look, discussions are our we looking shareholders. do we we continue things that ongoing. more We make options at that for business speaking, it

just, we'd tuned. ask what do, stay you to is So [indiscernible]

Roy Buchanan

you. Thank Okay.

Operator

Brisebois comes question from of next Our François Laidlaw.

open. Your is line now

François Brisebois

well think outlook? little granular very wondered, I more a us $X.X around wondering down, here, the Hey, more $XX you the still just if quarter. million? a of thanks can give and just obviously for the on It's but taking of why kind million. did basis, it that I coming questions, congrats was is Bloxiverz you on

Michael Anderson

the for question. thanks Frank, So

I of comment. things for think, couple a

when one, neuromuscular of for approval of and and size $X choice, the we was for an reversing had year. per in market drug block. was standard gold number Bloxiverz, the think It somewhere I started the the neighborhood million

had call advantages Within half Merck over in marketplace. sugammadex, they two of Bridion, Europe have actually had about in it different has which U.S. that historic and molecule, years, better past. they neostigmine, in the with and remarkably has they times a done It's some taken the done than past

generic about is marketplaces number lot business. in had coming competitors come then, to today, market a is marketplace. the into probably the and smaller all, different of are a a of into -- first really the way reliable So when XX%. specific impossible, there have you people And very really It's understand, not

gate kind we at think, I approach has what the the been pricing of have I on that players started this having and served to marketplace. our holding of is very five probably having business, in strong, on well think top really do But careful expected. of pragmatic that out about us would business and

last to got that's It's market, seen be look situated. why down with a a there. with It's not since about have and your somebody came way -- it's to proprietary period product part haven't time. build at products clearly of always and from legs pricing that's we the can every -- reason, taking to of generic your deal in But think to great your a perspective, coming long you you grow We that important to the declines it's worry continue there price of or a in of the business competitor it. strategic have for And months. clearly will protect, six and a share part

few decide this do. handful good that's what will. customers So the of and GPOs and line business, in some and up, on end of are of have. very business, to we Decisions to of will one by and to what feel about that they being made we people defend a different a hold are if repackagers you able There ton we

François Brisebois

REST-ON, for and terms look that's to what's No, Okay, Yeah Monday, that. know, the Noctiva in enrollment, for guys, XXXX leave be you helpful. the the efforts, And beneficial the I forward proving guess, I very just questions great. for will the on just most timeline to you then, of, that keeping here?

Michael Anderson

Schedule-I Well, ability DEA had the a to I getting that, with the out drugs, of handle think some that of little handicap. sites the having some was initially, registered difficulty we bit we have a articulated for gate,

is awake little would sodium It's study in back that a particularly the drug already and day, But paid take Europe, offered a blinded controlled cataplexy have you turned narcolepsy because -- trial study, essential if be to in our a to to where suggest can't that in out from available, the also opportunity placebo. a suffered sit during product chance sometimes as study to are a patient that's the are As has that is them placebo has be naïve. XX% that, naïve, and patients the a they double a stay is just a of I oxybate reflect, and patients giving cumbersome well. an clinical payor,

the gate. off went that out that, expected people and Some we of of

linked that long we and to that data product slow of have a are of and a of principal demonstrated of also have got a the We just track trials way, I they as out there those that by the up can say clearly middle start. will now. some to I reasons we study Again, to need, seen the kind the that gate, on we have pick that two as say that that, not is have come of but in night think the would so. do a take we patients just a it to result is provided, off

for But up part thank the reasoning most having well the for slower been, gotten now, you. little of out blocks have it's picking those quite of initially. the a So

François Brisebois

me Thank you. That's Mike. All for it right great.

Michael Anderson

Frank. Okay. Thanks

Operator

question comes Our next from Scott Henry of Roth Capital.

open. line Your is

Scott Henry

morning. Good you. Thank

that Just I Not other of couple but call, but is million I driver, huge in the the been -- starters, wanted heard Where asked. division. the I just there? I questions, the guess mine $X million. look it's correctly at make I when a see $X most to understood a disconnect of being have pediatric numbers, on sure I for

Mike Kanan

it's Mike Kanan. Hey Scott,

comprises The things, other line other other than just pediatrics.

there higher created And So We are referring are difference to in that noticing some which on that had adjustments through that net quarter, creates another there. well. third that that forward accrue product you the to. there is certain that we product we in quarter, a as you to that returns third some gross we had ran that's had disconnect the

Scott Henry

Okay.

counter a account in it million is like well there -- over just [ph]? their looks So $X mind of

Mike Kanan

to is quarter-over-quarter quarter. from seasonally, important Karbinal, up is a product, important it's from what's was well third and but which But had good standpoint, most pediatric it's Roughly. note, year-over-year. QX, doing that also, the meaningfully up It

I don't lost item that minutiae some of that in important Karbinal. So on to in want line is there. accountings get What's the goes really

Scott Henry

helpful. Thank That's you.

Michael Anderson

the promote product, don't serving inception two been aware of marketplace, know product pretty a liquid add for We it, a small in me generic much I a called generics we very of just one are an since authorized it's was product to under a dextroamphetamine the time screen. don't simply the as it; let one radar called Mike, thing. have and are Procentra. of if one you we but clot, is the This at what

a business, and pediatric adjustments what those net we but so to lot related call [indiscernible] business. not the of to gross the And

Scott Henry

Thank clarification. for Okay, you that great.

other question will XQ launch in just strategic. like It is really be The of XXXX. sounds commercial

spend to of mentioned would money capital, you to the And or launch the is, point want possibility on that the thinking change? You are then. time, raising in decide decent question The it raise before amount after at going may before the do it you a that's of capital. of event obviously launch? how about are beginning you -- to starts this And the and in you

Michael Anderson

Scott, we we Noctiva, a cash would the we would do But initial way and great the the I to well, a point it's be Mike when as discussion, capital product and a I our as and the licensed raise, way had thing. to capital job do immature well. this be, FTXXX raise think, what explaining, of of pretty that study in as clinical At have certainly continue think sort to able we to proper to launch did when discuss

Scott Henry

Okay, questions. fair for Well thank enough. the you taking

Michael Anderson

Thank you.

Mike Kanan

All right. Thanks Scott.

Operator

turn like I'd remarks. back am call closing I any And Mike to to Anderson Instructions]. [Operator the showing further no questions. for

Michael Anderson

will the sharing Day you appreciate be the hope operating once you will in for We much you look on Thank I Pharmaceuticals to with you QX time. into our future, to update us allow us tune Monday. your that additional to this again. and Thank to morning on Noctiva you will able joining results. forward Investor Avadel you updates very

Operator

all Everyone gentlemen, thank day. great participating program, does in may conclude This you for have and Ladies you and a today's disconnect. conference. the

Avadel Pharmaceuticals (AVDL) 8 Nov 172017 Q3 Earnings call transcript