AVDL - Earnings call transcript Q1 2020 | Avadel Pharmaceuticals plc

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Operator

Greetings, and welcome to the Avadel Pharmaceuticals’ First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Tom McHugh, Chief Financial Officer. Mr. begin. may you McHugh,

Thomas McHugh

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

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

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

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

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

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

Greg Divis

and for us joining everyone, you on quarter thank Good call. morning XXXX first Thank conference you, Tom. our

you certainly started, this get we families hope pandemic. we your COVID-XX and are Before during and safe healthy

has our everyday had economy on and Before our we lives. appreciate impact on this the

to and We in us supply business our and chain with to to business critical objectives, actions necessary safe daily communication risks specifically to and and operate and to our enabling healthy. company, our remain a As the respect are taken partners, identify and potential employees FTXXX. our families proactively monitor our continues with to suppliers their we’ve ensure

COVID-XX no material navigated with impact. we’ve Today

all diligent remain and your the the during monitoring future in predicting wish best of impact, in colleagues will difficulty we situation. any the pandemic. Again, and our this Given you, are we daily families

call turn session. the to program, continue then turn our Avadel. key financial and strategy the business, update Jordan quarter. the will execute conclude first made as transformation and give we over begin who will against brief With to now the Let's to the for the progress our I'll with get the let's review we for update the by that, year-to-date started. an a results we Q&A a to update on with Tom, have on followed highlighting FTXXX quarter I'll of

over FTXXX, strategy a with company. executing Since our a carried strategy. It key a to who of was shift the our integral significant that just strengthened developing and year-ago and development on focus our of restructuring major of announced a all number have that hires, we’ve out been we team the time, to in effectively

The This schedule. study. progress with positive just data weeks pivotal the their tenacity in set completing achieved of REST-ON two culminated out company year-ago. ago our the insight, XX of million REST-ON restructuring to our line X trial recent strategic team's X From from ahead operations cost Phase $XX we our a our and removing from and Phase pivotal execution, months announcement top milestones

three We're placebo compared clinically co-primary and once-nightly grams grams, all pleased cataplexy three X and improvements study, X to NWT, statistically as meaningful extremely the significant and with X.X highly grams. demonstrated at CGI FTXXX data doses endpoints all across

dose the was at In tolerated. X gram reported that generally FTXXX well we addition,

FTXXX patients have both discuss in with and interested questions As would provide data detail, stakeholders many to many a stakeholders data cataplexy demonstrates this may clearly this once-nightly, Furthermore, treating -- sleepiness have how excessive in clinical interested Jordan the narcolepsy. will answers in benefit perform FTXXX potential daytime setting. had for as

no on goal as And answered. toward to put to patients direct the is possible. as trial clinical FTXXX, once-nightly advance and path these soon results of us more bringing approved have and been NDA There a our submission if now have once-nightly questions speculation FTXXX, two

and progress also The have the in year line over strengthening top this significant balance the only we sheet. our delivered last not data, made both year-to-date impressive but has resulted of

less sheet Avadel, of As days, and proceeds, a during of gross line raising to have a completed of readout, result financings we than challenge due unpredictable data recent of time of and FTXXX progress million exceptional a total two volatility $XXX market the our transformation the in thus balance top strengthening accelerated in now the XX significantly COVID-XX.

capital extends to we FDA, invest complete data position cash the and to of believe for the in are injection with compile further provides resources capabilities prepare the needed scientific submission to supporting of and NDA additional launch and FTXXX. in Avadel runway a and FTXXX our successful market fund plans This the for

all to retain on we optionality creation FTXXX execute believe we FTXXX actions plans, the value required these and strength more us many overall. financial of the put while have have investors. accelerated opportunity recognizing path now toward and and we the growth short, strategic Each company offers and an for patients our In ensuring the

once-nightly of thousands from While potentially patients narcolepsy could option if a the approved, new of providing, for treatment FTXXX. who benefit tens

challenge company continues our a the has time and been I behalf COVID-XX and significant on past focused Despite the of conclude has everyone. opening its to team shareholders. several professional execute exceptionally comments, personal months, remain well these pandemic for and As my of the challenges,

for the XXXX of plus We grateful especially beginning this the and all of are the since during pandemic. team over XX and stakeholders and our months support the execution last of

call Jordan development provide the to program. to update the Dr. Medical I'll an Officer Dubow, on FTXXX over now Chief turn Jordan?

Jordan Dubow

you, and Thank Greg, morning, everyone. good

line had was Phase global in endpoints: CGII, MWT, a cataplexy three we thrilled that the data we study, our improvement study As attacks. impression maintenance and the we protocol top with of discussed for clinical under results or weekly recent agreement tests call, FDA. from the In co-primary the are this REST-ON assessment mean with X conducted the special data wakefulness

had While co-primary on to win required endpoint, all most endpoints. primary to on we one studies three are win just

Our primary important and underlying an narcolepsy as of are i.e. both two of well daytime overall to meaningfulness three measures endpoints. outcome end with anchor cataplexy are patients, core excessive phenomenology as functional sleepiness disease, which in show as an that the of and clinical the other the points the serves CGI, they

X or a for gram primary In the were the dose hierarchical was on the gram analysis three REST-ON conducted co-primary X all the endpoints, study, in which endpoint If primary order. three followed by then up the endpoints, X.X the test we successfully. were to on gram gram dose X.X X was successful, dose able all was to also gram dose dose co-primary the

report the that at that protocol, exhibited study's setting for the excited endpoints. significant, were three With stage highly we co-primary gram clinically say dose all improvement me FTXXX the meaningful over for let X placebo to

X Additionally, for after significant X compared also a demonstrated as meaningful the highly early three gram and all starting as endpoints co-primary X.X clinically doses weeks FTXXX. improvement to placebo

the at dose gram well X FTXXX was tolerated. generally also addition, In

based X Phase that line last we presented in The the FTXXX. expectations results for study year we presented on are with data pharmacokinetic today our

X demonstrated studies sodium gram that Cmax strength plasma As in the same head concentrations two and at to hours head X.X and our the FTXXX dosing a of overall exposure, the oxybate. earlier compared eight lower twice-nightly lower after strength we had equivalent to reminder,

initiating and are Switch twice-nightly FTXXX. for oxybate we announced we've patients to switching an study a to open-label sodium evaluate ahead, extension once-nightly REST-ON study from Looking

on continued study for Although participated with extended twice-nightly switching studies both regulatory we in these approval, generate not REST-ON FTXXX physicians who from needed those patients like of to the as once-nightly or as FTXXX, and sodium would access oxybate are submission well to FTXXX. for use provide data patients to

the trials personnel we important patients recently to comes first, in study, enrollment of COVID-XX current in pandemic. a delay clinical the Although initiation is made site why which safety this due an study of decision our the is to

and monitor to our start not approval, Again, to will decision as a not submission determine it's regulatory impact support needed this as submission. enrollment the NDA We soon continue we our stakeholders. does safe we'll of so timing studies are situation for or these the

We to FDA, drug file NDA pre-NDA format and meeting to the of to once-daily submission this our bring with meeting, FDA at the expeditiously look and content our and think diligently working forward for We will to meaningful treatment potentially date, a community. discuss strong regulatory complete to for new package a data for service FTXXX as as narcolepsy basis a the a patients. the position FTXXX generated option as are well

as I as well staff time participated and want team, we serve. in study, for Avadel patients the for investigators this company to the and patients, the the exciting again thank getting and to in REST-ON us who pivotal the study all have

Tom Officer, I to that, review our the financial. would over like With turn the Financial to McHugh, to call Chief

Thomas McHugh

for for highlights the back Thanks, a then will Jordan. the Greg quarter financial remarks. turn to call summarize few I first and closing

million competition. of $XX.X first of generated result basis The hospital in a quarter million products XXXX increased the decline to quarter of revenue business across in XXXX. as lower attributed products was first revenue overall compared year-over-year on the a volume primarily sales the hospital company's to Our $XX.X of market

consideration will quarter quarter in the the impact elective Taking economy, ongoing decline global surgeries the into of in first anticipate in coronavirus of XXXX, U.S., the significantly second from revenues possibly the in a particular XXXX.

the basis attributed lower million on XXXX, million first to This primarily restructuring completed activities first decrease to quarter headcount were $X.X expenses of quarter $X.X the in R&D during to compared in XXXX. year-over-year due XXXX. the a is

in We to SG&A XXXX, of the $X.X of restructuring quarter million the to of the an XX% first first quarter XXXX. in compared reductions the first first recorded realized quarter is in income million million result cost XXXX. quarter expenses completed of million tax during and This benefit were the compared $X.X actions XXXX. $X.X primarily XXXX, in $XX.X decline

enacted first is Economic XX, CARES the allows the Act the Act, Aid, Act of in and was to the to when The of NOLs, operating periods Security company when passage the benefit majority rate March rate primarily losses carry that Tax the XXXX on differential, net to rate Relief XX% benefit. result was statutory XX% CARES Coronavirus represents or of XXXX. quarter of tax our versus current million $X.X The the applied tax our the XX%. back the

for cash million the XXXX XXXX. the or million $X.XX an restructuring million and $XX million our $X.X $X.X same related was the per period interest for net our $X.XX million or hospital share in loss to loss The included Net of convertible quarter quarter products to per million business $X.X payment company's $XX related the was $X.X activities. of of to for burn The of related royalty to approximately payment of compared a net notes. share, payments and

XXXX, of and private the end offering placement million to company XXXX, $XXX.X completed a net of receiving proceeds the proceeds of estimated related February. expenses. quarter, approximately in marketable of equivalents as May to net $XXX $XX cash includes of million securities deducting in March million the the which XX were Cash, Subsequent completed offering public approximately after

As current FTXXX on business, NDA supporting requisite hand, from Greg add generated additional to flow mentioned hospital cash believe complete for fund we’ve on in compile market. for coupled plans, scientific successful the FDA, to based of earlier, we current expand And based on our prepare the and cash and the FTXXX. with a products needed commercial the cash data, position capabilities launch submission the

Now, back Greg over remarks. I the turn will closing call for to

Greg Divis

pleased more advancing not our submission, we've the Thanks, on and of FTXXX sheet an much strengthening Avadel optionality the have there's all And closing, will to NDA on maximize are balance accomplished done. make we date positioning measured made value. be going with we We to Tom. already. maintain what forward, In to our in recognize success progress we the shareholder to of be the although progress fully toward

on patients potentially a could tens committed focused to we results of the delivering FTXXX. benefit once-nightly and narcolepsy As thousands fully potentially sustainable such, meaningful option and we of to required from build bring believe treatment to value are remain shareholder the who

stakeholders I thank to progress patients, to and investigators, the too fellow We updates contributions forward want for providing shareholders employees all future. further with and strategy. to our investors look our in support their and our of

Q&A. for Operator? are With open ready that, to line we the

Operator

is Thank David sir. Sandler. ahead, from Instructions] first The Please go [Operator Amsellem, you. question Piper

David Amsellem

couple I a Thanks have and questions.

regarding when So, filing first, happens FTXXX and what actual filing have with talk accepted you on you through should would a an can litigation, the Jazz, you you and litigation. potential but And through about calendar going we how I but just they're to certify, Jazz don't just walk us initiates imagine certification. the certify. of just litigation don't us mechanically force think

FTXXX. So mechanically play out think how is plays that? that how number about calendar pricing one. should of how out and we regarding should Number regarding two That's the

graces at free assume in to than point you'll in a come that we that? is it without and And should that think the here, point of that assume won't you that access. price gets about do be will you delay, irrational you Let's hassle good payers lower a necessarily How fair come gets price launch as in at more you but Thanks. JZP-XXX?

Greg Divis

Hi, David, it's Greg.

So those -- mind. take we in reverse, you why just don't will don’t -- I'll if

David Amsellem

Sure.

Greg Divis

think it's particular, this to sit to final in in here I a and approved, Again, been haven't or strategy pricing as that disclose products the reference priced we pricing strategy marketplace premature the in two or finalize today and other at discuss stage. launched

We it pricing certainly, at I at think narrowed to don't that the looking successful are thought we've to going and past attributes of would access certainly as we I part perspective important we where point successful from have in and think it's a in, certainly and type a a is we required premium that the fair of removing be access about FTXXX. discussed saying we've to as to say to our pricing a that. we expect launch price and launch create can having price that's of ourselves be barriers without build

will I'll we're may strategy to about a out relates timelines What carve under other There as our or two described it families is to it do that comment we'll and and from companies relevant what remarks not a as and and Jordan, disclosed perspective. make free pathway, filing or is question filing We a may file NDA. do couple of obviously certain -- know litigation, feel A from their listed we'll relates standpoint. be we've on we will -- or maybe with Book well. as to have that As the weigh isn't obviously what we a patent Section can't your in Orange

accepted. what two parties minute submit we Jordan can't they that XX-day in accepted within obviously we terms review, the NDA And will at certainly acknowledged FDA. As filing to that the expect or expect would just or we to is form robust a that package. ago be are is as a a where proceed that's But other typical expect and window or have communicated we review, fashion of the complete would the or through We do In that right? may will would engage that full with standpoint, or then speak we directly from the litigation window and would the timing obviously, that. may And the not what FDA point. to we in to

-- kind And so, think how at. anyway, I that's of we're where that's

David Amsellem

Okay. Thank you.

Operator

We’ve a Matthews, ahead, sir. Paul go Stifel. question Please from

Paul Matthews

to discussions these for launch does timing? you know NDA really ultimately stay? may much. some it accepted, considerations or so when there the when is labeling that Does find whether until as that, kind and Thanks potential it upon when out a do that and happen follow-up XX-month you Maybe of or do not how Great. of of the finalization is acceptance -- be to nuance take a file and you does assuming about

Greg Divis

Yes.

Paul Matthews

that what data as in And you just maybe can now together so need rate the studies than putting well? much. from the profiling then time hand, other other you've had to analyze second, package limiting got you that, data any Thanks ancillary clarify

Greg Divis

Yes.

emerges to Jordan filing way firmly recent and strategy then and because from meeting our different an viewed and I'm the moving an that review one. from patents stay. perspective, Conversely, when filing and sure successfully NDA, a please? obviously you your to have regulatory certifying I'll believe we've FDA's certification path out. something in out we'd go data carves along, and we or what's first in obligation that carve been we has obligation gives submission, stage, at direction, XX an the whatsoever. our potential all clear if review, for get how those we I'll a believe we'll as would be if of regulatory kind communications. But we times, we'll and know to Paul, have take would a to said, We publicly disclose us right? to ask the pursuing we timing comment, Book-listed of full and state and -- obviously from comment next have our period we strategy out, result and final as a be Orange able label, clearly, from a numerous Jordan, then all we supports are that have carved that maybe, my we this opportunity avoid through us question, a not these out have from regards on and any until viewpoint, that data our months approach we successfully obviously With is learn believe discussed given second in so a that we data the acceptance the regards our stay thanks during So proceed pre-NDA to carve given months label want into successful, strategy being question, on That the to of that as to XX subject would potential With clear the we'll

Jordan Dubow

application. were I in as the like before spoken to working we as about integrating lot thanks. a a lot can. have the of checking, of the sets, think NDA, early to -- of in get only our we Paul. on just mean, has data my Thanks, getting terms to work box secondary that I Thanks, fast which And obviously Greg's as of NDA, Yes, takes Yes, part which I terms of compile do think really team move done, Greg. of documents, some like time, manufacturer be

there, we that to be activity of just it's challenge, that's work done. need a more checking to So a there's box don't that but bridging that we really some view as do still work have

And so we're moving forward with that.

taken meet next the to in with the we're FDA -- and done, filing. what alignment ensure we're I As all said, in steps goes we've the already then

Paul Matthews

very Thanks much. Great.

Greg Divis

Paul. Thanks,

Operator

is Brisebois, Please next Frank ahead, Craig-Hallum. from sir. The question go

Francois Brisebois

taking question. the Thanks Hi. for

quick of ones here. couple a Just

In terms a a would we here? of the XXXX more scientific the you data, be expect or conference, do full that mention full when we see of set to did when potentially data event, -- it's expect

Greg Divis

want you to …? Jordan,

Jordan Dubow

we said as likelihood before, Thanks. right yes. scientists I Yes, congress think now, year. a Sure. Frank. mean, next Thanks, all present Yes, we've in at I and will

point the primaries as be data end it's as well. in to some on these the as highly though, this are sleep supportive secondary FTXXX is of patient At -- I’m what's the these a data if endpoint as well. mean, year. going show we just I I scientific well, well some secondary that additional even don't terms primary now before as well And terms obviously, going I as the outcomes of normal congress going of state think, [indiscernible] of Congress present to quality benefit sure for PSG based things based obviously, as will be of right stage, flux the we as will I confident in in in a reported are think have next on that to know when, year. lot on next

to concern some that or all I are virtual, think be not. there's they they’re going

still enough scientifically it'll but we're year. presented to So most sure be next plan, likely,

Francois Brisebois

and -- I'm see gram you up delay efficacy X gram often way distribution, long how But X of seen start from initiation X quick the then to the the wondering, real progress a it X or gram just percentages do expect there's terms going was gets once expect X? X.X, how the of of that? terms in I to you two from And dose. seems the would what the in titrate of you just dose, us in the at people then, finish, dose like here. would on terms And expect there would to in world, to a all X, of lot people switch. data open-label that When going Understood. ones understand in

Jordan Dubow

kind a it's don't what pandemic We patient of due March the to Yes, when have number actually night since just in unfortunately -- right that of had our to was we decided ready to and just early first call and study, anticipated for large terms we safer start early in sites had we to do our we to -- happening go. switch, study. had March, standpoint the the open-label and of everyone to this hold from we the investigator off come

ongoing world get obviously to think access I We rest for just We to an it. it obviously keeping to for patients. we're of on want going. the like eye clinical get want everyone else trials the

to continuing we're that. look So at

ensure I start to think -- we obviously, safe. But soon. we to it's have fairly hope it

commented, study. terms it's data, think we I of In an open-label

the asking. what kind the data captured So just able we'll some are on, questions patients, were some many of that be to periodically the that see of in doses how of we're of terms

And start on, not can parts optimistic of the going end of in by of different is useful year. depend still the end to open-label different assuming of data an I’m what it, it's many can it think think by it we people again, this out. we for quarter, goal. have the I an the the of so, world country, some sure. of how in going going this It's saying study. happens we'll to I end let's say If hopefully quarter, start towards And are the parts that’s terms

we of keep on. some obviously can, So updated it

the is I the at still placebo stay up between similar a gram to, majority probably is data, X.X X with not obviously only highest They In X had And primary doses. two the X data When on the terms you gram dose our between twice-nightly from versus I've I probably of world, gram really the the baseline dose. although published product. trials, delta think, X dose. dosing, goes I only in patients. from in the obviously, it's is efficacy the bigger real look change and the comment like mean, to real question. everyone seen previous can a the in clinical of world, I The that good the think

from dose tolerated. these And think looks it well so, like the now, I X was what gram

big some dose. people I think reason pushed there's to for that up highest some to be

think still similar so and distribution I majority X the And of are surprised how be people well if, how dose given X.X gram the be think our higher gram we'd where I on the at early distribution doses a X performed, will our performed dose. it's and don't

think good option. it's I a

As are you everyone different I optimistic that’s some think there is the be patients and all view the we who because last know, anticipated. X, would our are to -- get dose. why be Still feel about may time fine is need that doses while the there X.X approved. others We gram in

Francois Brisebois

Great. the pricing potential? Does affect the dosage

Greg Divis

Thanks. Frank, Greg.

consider, have haven't likely on not -- would a again would as think about we again, but we it material discussed, today, We I pricing, think but how impact it pricing.

Francois Brisebois

That's Understood. right. in the Thank it will you. me. hop queue. for I All

Greg Divis

Thanks, Frank.

Operator

[Operator Matt Instructions] We ahead, have go a Kaplan, question from sir. Please Ladenburg.

Matt Kaplan

planned Jordan. for taking Hey, on Can question studies the the from FTXXX there a Good Maybe to two that you do guess, understand some to study. in that compelling planned? effect side to to the better differentiate these what seen the call. with hope extension a will respect help you already potentially generated open-label fact data the you’ve I us light Cmax? studies morning. due going if that lower be generate two is profile Thanks for Follow-up from to you XYREM we've that's studies, these data switching from help perhaps guys. and of

Jordan Dubow

mean, think and Hi, full want we haven't said, the question. given think it. thanks we the overcomplicate I out But I Yes, morning for to details. Matt. don’t as we've mean, I I Good

are data. middle Outside some of then want have And could the robust that wake We we double-blind right? preference do some both a did data, with questionnaires that, have of will study, you'd to the of double-dummy lot up of differentiation. affect which kind patients study. still that to few kind there's the the be, of complications of night, mean, I of give will doing a in just we an a differentiators form there's generating open-label

we'll information the yet of where be well it we And of differentiation overall as some wanted both simple preference versus some efficacy gain the as so dosing about as we But regimen have that that's could, kind coming our to prior do to to the about of important as of those concepts kind study. we dosing. into and questionnaires safety keep get

Matt Kaplan

was Okay, great. Thanks. That my question.

Greg Divis

Thanks, Matt.

there no think are up further now. and And safe and so seems of it us we all wish call staying Well, day. you all with the And all, your questions queue, Thank and just Stay And be you. in forward you. look in joining thank appreciate to we'll on the your I time wrap like our of Okay. of touch the call first for all rest best. we healthy. great questions a of you the Have today.

Operator

This concludes today's teleconference.

your participation. You lines may disconnect for you your at this thank time and

Avadel Pharmaceuticals (AVDL) 11 May 202020 Q1 Earnings call transcript