AVDL - Earnings call transcript Q3 2019 | Avadel Pharmaceuticals plc

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Operator

Greetings. Welcome to Avadel Third Quarter 2019 Earnings Call. At this time, all participants are in a listen-only mode. [Operators Instructions] Please note this conference is being recorded.

I will now turn the conference over to your host Mr. Officer. Financial Chief Kanan, Michael Please go ahead.

Michael Kanan

The thank Good avadel.com. our XXXX joining accessed release. on for call. morning financial our This at news quarter and conference third morning, us our be you we website can release results on issued

reminder, begin, Litigation the Reform constitute of that includes number following Securities before we a the statements Private within presentation Act forward-looking matters the As XXXX. a of meaning of

from results those risks to and that to subject statements. differ actual materially in are statements Forward-looking contemplated could uncertainties forward-looking such cause

These not risks filings products the competitive uncertainties Exchange XX-K and on These milestones the stringent that Form ended under year stage include: March products; including and which risks products Avadel's in of requirements; the achieve or XX, described and other Act was development the pricing. regulatory regarding may for of impact or are XX, more December XXXX, market acceptance fully filed scientific objectives XXXX. public the meet in

required as future events any presentation information, no new by update in reflect otherwise. to to Except statements undertakes contained forward-looking or or this revise law Avadel obligation

Medical On are with me Chief our Divis, Executive and call Dr. Dubow, our Greg Officer; Jordan the Chief today Officer.

over I to time, the Divis. will this turn Greg? At Greg call

Greg Divis

the financials and quarter. the Mike on business to morning our by you and conference strategic on our the for call. of FTXXX objectives over update the Thank being Jordan everyone, third turn and you, on will of execution an call review for progress the Mike. who I'll give our as transformation quarter Avadel. then to the brief followed a I'll Good thank joining continue we update us start made with

With started. that let's get

year. business. quarter, which and the objectives we especially trajectory our progress announced, continued events recently of We're we the this pleased continued to out make third change to key substantial achieve several by the execute earlier our of During we set against to positively

of flow the development $X.X to market FTXXX injectable narcolepsy maximizing products. sterile the sodium oxybate our primarily treating are clinical for cash billion the from potentially as We on focused hospital disrupt well as

we agreement assessing foremost, to an our sodium and to and while is plan REST-ON our and analysis the the study amendment agreed oxybate to First FTXXX. the FDA of in line Phase up efficacy time to announced months, by X ongoing statistical place. once-nightly expected safety our reduce keeping This amendment recently protocol Protocol XX FDA-approved Assessment pivotal for that Special the

are the the as announce total patients to today, we pleased enrolled XXX that study targeting. I'm out has patients, REST-ON of of XXX

earlier of With X-plus baseline expect on in can to the of scheduled to our and and calendar year line top this as study of remained XXXX. and than second the year be provide enrollment as well in currently data number up of the Completing patients clinical to the and medical screening we over contributions a weeks, by had attributed planned next complete end this quarter insightful track the work we've team.

This brings the Congress. making and for program. X recently four Phase to the advancing has me impact the how together with they pleased XXXX our Sleep from are very I'm at the in data World team presented FTXXX FTXXX come studies

of oxybate, our ongoing this dosages X.X-gram a study Phase to X-gram Jordan confidence moment, of As once-nightly dosages our and the compelling FTXXX. strengthens twice-nightly sodium X in comparing corresponding describe REST-ON data will of the the FTXXX in

than considering the which being complete pathway approximately ever once-nightly one is under pivotal and on this agreement physicians of about new remind totality could FTXXX, developed the received we've more health a benefits feedback Assessment providers. is the caregivers if patients from REST-ON accelerating published the being Special the about the excited Protocol data care study, of only FTXXX, XX% As and patients, prospects FDA. new year, with entity we people, often potentially and progress governed no and now we risk chemical FTXXX approved and trial with by offer requiring When are XXX(b)(X) a

are business, sales we from for trends we and months to $XX XXXX. first the in positive today the third million current have injectable the that outperform with of earlier hospital total seeing announced sterile our products for commercial to million revenue $XX expectations of the Turning continued nine three quarter

XXXX a to over $XX receiving the The milestone the we the on this sterile for or past months, which and above FDA's guidance revenue AVXXX of our better-than-expected is this products will nine our will existing this the an in use raised million. be same next from space. be business of As decision performance major launching result proven have NDA is at through products part our sold setting. designed in as for product currently and approved benefit injectable a into AVXXX, for infrastructure for the capability hospital channel

the XXXX and We date AVXXX investors updating we in to opportunity the the Currently, we AVXXX the this still to date and the the appropriate. all PDUFA December PDUFA our support forward to keep on FDA's expected as on further approved decision we of today, product revenue of informed for status look on contribute launch FTXXX. we'll our December. close announce the investors based is in where around expect to development and of XX, on as are If

higher-than-expected the comments greatly and has restructuring and mentioning reduction beginning the my from benefited of addition our the since the revenue, actions moving in business, to that hospital today forward other cost end revenue the I'll year. future liquidity taken potential by from

FTEs hires over or reducing and This is approximately in XX XXXX. technical, include throughout made critical our employees additional activities from XXX consolidating we while the be leadership have in organization. parallel, geographically These strategic strengthening across less period exiting non-strategic will the and dedicated capabilities to what this businesses, functional headcount

cost operationally, and rebuilding refocus of and million In for reported necessary of shareholder spend us aggressive and and savings to strategically pursuit annualized entire the realize urgent total, we the The million million and which value. $XX trust in keeps to totality rebuilding company our to have team's on SG&A while $XX to in R&D year-over-year, lower speaks approximately XXXX. track between actions and $XX financially of actions taking strengthen our the company commitment these

turn FTXXX to on I'll over a detailed Jordan, our update the floor Dr. program. the provide Medical the yours. Dubow, to Jordan call Chief Officer now is

Jordan Dubow

treating of market. seems there's life, their about in that offers treatment Thank once-nightly once-nightly you, benefits of community. Greg, a could clear We've few and demand oxybate the a very narcolepsy When and productive of speaking advancing with program on quality had months it FTXXX opportunity the sodium the good physicians significant potentially morning the patients have everyone. realizing of that in oxybate sodium the a formulation towards

our implement As REST-ON of Most Greg study. is agreed statistical to Phase which amendment to with are under pivotal study, clinical we to scientific, mentioned Special the X statistical earlier, we recently FDA. importantly, announced able and while plan a Protocol agreement the the retaining for protocol this analysis still the FDA Assessment robustness amendment, FTXXX an and

described. planned. analyzing and amendment analysis dose the X.X-gram and previously instead plan positive as doses the our originally as independently dose both dose analyze to first, allows statistical X-gram us X-gram the Specifically, is respectively, to if X-gram of the This simultaneously and X.X-gram

the protocol, fundamental is design our to the doses change studied. It secondary important and not that, note endpoints, the being modify primary including duration, of this the should or treatment

only be XXX amendment, As needs to a significant both this the to statistically patients target cataplexy powered a meaningful to now enroll study result and sleepiness. a improvement of and excessive sufficiently clinically daytime in of show

this the effect proportionality in data, to also I at track we This World opportunity complete at enrollment PK up and Sleep take from twice-nightly studies, a Congress, bioavailability sodium As to relative study of end FTXXX. another at study. like FTXXX Greg two once-nightly puts to second us to dose Phase one highlight the FTXXX would the is food XXXX. and the the mentioned to on this evaluating of line and for of of the presented stands our expectations oxybate earlier, data comparing the This XXX. year current ahead of X-gram dose of quarter XXXX, the year's X.X-gram enrollment previous top four I for levels, evaluating by which recent the is have

lower hours sodium consistent is grams This and exposure twice-nightly variability and level lower Number well fed or has maximum plasma to maximum which to exposure a overall versus and concentration Number plasma concentration data twice-nightly morning the X.X in at FTXXX expectations eight two, lower similar demonstrated sodium at X as as that. concentrations equivalent one, of oxybate and grams product. state, oxybate oxybate. sodium plasma FTXXX fasted with the demonstrated the

studies four, Number demonstrates FTXXX and slightly well the was proportional, as FTXXX dosing data and once-nightly tolerated PK oxybate in overall sodium at totality was twice-nightly than appeared increases. exhibits X-gram that of FTXXX demonstrates profile level. predictability the FTXXX three, the dosing. generally maximum X.X-gram safety concentration exposure comparable these The for Number required of dose which dose was the the to the and from higher profile, plasma dose-proportional

disruptive believe market. as again we position package REST-ON investigators who for well complete as currently we as for a participated all accumulating the in thank data have patients', study. Furthermore, therapy participating and study will serve narcolepsy in the a regulatory to FTXXX staff, are the new clinical strong basis are FTXXX I as or a the want

financials. I over review Mike? to Kanan to the would call that, like CFO, Mike the our turn With to

Michael Kanan

Thanks, Jordan.

like to summarize quarter, financial Before detailing the the financials would some for I highlights.

stronger and the than when were in million million compared we in when year Revenues we we in of full $XX.X began $XX.X to last third were anticipated million quarter. the revenues year's and August. year our First, XXXX hospital from guidance revenue third last quarter, business quarter the $XX.X second set in

hold. Second, reductions taken our cost have

that LLC $XX Specialty the track France, As of to the of with Greg reductions Ireland company's XXXX million meet business. It's including costs months targeted to you've structure we about first virtually actions, have our we eliminated. and $XX cut million were U.S. the cost been are in have through cost the in Avadel noting million with associated we costs align reductions, and Noctiva worth realities on nine Pharmaceuticals earlier year. say, cost and These all the needed this $XX heard to by

for costs the addition, burn have in royalty paid our on and of converts and as completed cash France. to are included outside cash discontinue finally, $X.X we they the million have $X.X our both amounts in Noctiva restructuring In Ireland actions And interest U.S. and September quarter of payments the line including about million. well Through well and are restructuring our our payment been million an been XX, million $XX of about $X.X in was expectations. ongoing with underway

end cost long-term our and reductions revenue if to And $XX.X contribute end of approved, have continue at was and is September on we the portfolio, the Based for restructuring resulting XXXX projections hospital take of June. million, expected actions the our us FTXXX. at enough our million Cash $XX.X well anticipated to compared AVXXX XXXX. support revenue from to further development we to project of cash into to the

Now, like financial on rest of for the highlights touch the to quarter. the I'd

of As across net selling down lower the last pricing occur actions previously hospital I QX, million for to third anticipated, revenues a competition. from primarily as the said, than quarter, revenues of were quarter. year, competitive third increased XXXX lack $XX.X anticipated quarter higher in to to million we due the products due and/or result $XX.X prices of during market all were our launches

That revenue products project launched seen or at increased in launched be due annual strength expected in expect to still to or now the XXXX. be competition we from from XXXX. our to in to-date, We $XX was for that million be guidance revenue than guidance represents XXXX This $XX million. expected when increase announced August greater an of previous we to excess said, issued

well lower also we the is guidance initially of at quarter that revised the year. will the note was guidance, above million I revenue R&D million in $XX expense beginning of of established $X.X the third our R&D to the compared in cost of decline quarter $XX.X divestiture the the Lyons company's This France, third reductions primarily of last spending center. due was million at year. NOCTIVA to and XXXX the result

million $XX.X We quarter of second spend was the our of third million FTXXX. the million compared of the XXXX. clinical invest R&D towards development the SG&A a $X.X in to of substantial in quarter amount $X.X third XXXX and quarter continue to in

the These that implemented reductions to Restructuring commitment cash. administrative of last divestiture we and with we year lower the related cost general associated to as and and charges $X.X were reduction both cost France actions primarily resulting prior of taken XXXX. in quarter from due third quarter expenses compared Noctiva to our in actions have to of early mostly the XXXX million in were part initiated preserve reductions

Service $XX.X in Pharma And Specialty finally know IRS Internal October $X.X of claim amended July, reducing X, as as the claim by made original against Pharma. a the Revenue XXXX the aware the July X, claim XXXX filed part to On of you million bankruptcy on Specialty million. claim was the

federal Specialty Pharma the company's U.S. as its U.S. of return filed a consolidated member tax tax group.

claim IRS tax was U.S. the liability due all of Specialty law tax Pharma the joint in for such bankruptcy requirements against in members proceedings group. to As several consolidated a filed and IRS

We to $X.X with we disagree this amount progress made million continue matter as pleased we the well. reduced have to-date of but are that with this on

to As this such engage matter. to and our expect satisfactorily to we continue the positions and with IRS vigorously resolve defend fully

back Now I'd the like Greg? over to call Greg. to turn

Greg Divis

business financial this a closing, health, In pleased how like new have would Mike. I on strategy. are delivering progress our the we while focused Undoubtedly, I different restate Avadel significant Thanks progress our with in and made to am executing restoring year. we

we significant number first our of near-term pivotal REST-ON to completion enrollment AVXXX. the NDA with closes, for for expect two on the updates FDA's our most study; and provide the immediate regards XXXX As decision to milestones: two

The employees, building to investors to-date value. and are investigators further the plans momentum committed our providing shareholder necessary and rebuild rebuilding to personally in thank patients, stakeholders and look on I is investors, to contributions updates progress we key and focus our with forward trust -- strategic partners their just stakeholders we all for executing shareholders we while with our are want future. to the with to and beginning

future in wish look you thank to very call near great for of We you want updating joining day. our to I and rest you. the us a the everyone on today. Thank forward

End of Q&A

and this time. participation. conference your lines may This you Thank today's disconnect concludes you your at for

Avadel Pharmaceuticals (AVDL) 12 Nov 192019 Q3 Earnings call transcript