EGRX - Earnings call transcript Q2 2019 | Eagle Pharmaceuticals, Inc.

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Operator

Good day, and welcome to today's program. My name is Keith, and I'll be your conference operator today. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals Second Quarter 2019 Earnings Results Conference Call.

[Operator Instructions].

As a reminder, this conference call is being recorded, August 8, 2019. pleasure the my Ms. over now is to floor turn to It Wilson, Pharmaceuticals. Eagle Relations Lisa for Investor Please go ahead.

Lisa Wilson

Investor Pharmaceuticals. Keith. second are Chief call. Wilson, Financial quarter you, this Eagle's XXXX press for Thank Welcome XX, call Scott for the Meyers. a earnings This to Chief ended Executive Officer, is June Tarriff; today's XXXX. Pete me morning, on the With press of results Eagle webcast be Officer, Pharmaceuticals Relations Investors call Eagle the and Lisa three the at can financial of company accessed through Eagle release, detailing issued eagleus.com. and This a release section months This website,

that based this or guarantees future on and performance results Before events Act. would that as These forward-looking to we company's statements everyone intent and started, the expectation, the noted considered statements SEC. be Reform remind not like available defined I those Securities forward-looking as performance. management projection, future from and including uncertainties, involve forward-looking forecast, Pharmaceutical's in today Such a Eagle and by may the regarding press filings express of Private belief, conference future anticipation made differ statements statements. with forward-looking get call may risks any release on statements are our today's projected the are Actual materially those of morning's to information in Litigation

these A call. obligation or this shortly update telephone completion available intent forward-looking be by except will after any disclaims to specifically Pharmaceuticals replay as statements, Eagle required law. of

for archived X The press at available dial-in year be eagleus.com. You'll information website, find the today's will release. in on our webcast

made call August to be those of Eagle discussed. webcast, or may may announcements Since then, recorded X, on related For to have topics and archived held the the listening the was replay XXXX. benefit who this

SEC releases the So press please recent most filings. reference and company's

And Eagle's to CEO, with Tarriff. the turn I'll Scott that, call over

Scott Tarriff

programs half first our a to with and additional providing morning, portfolio. add of and for explore us everyone. Lisa, R&D solid you, We've a good thank to robust our the opportunities Well, which had platform year, advance to

continue Our bendamustine business pipeline. going pipeline, will in the our forward us the growth obviously, is, allow in but real to invest to

today, programs late-stage in candidates main pipeline. to X product talk about have including X We our

as of indication Acute Radiation and the categories. Fulvestrant potential nerve be These to first well heat addition in or have treatments as RYANODEX stroke. best-in-class agent, to Syndrome exertional the their

Vasopressin, IM In mid IND an EA-XXX for these our for filing our year. an pipeline anticipate an first-to-file We to addition next EA-XXX for version includes and X, PEMFEXY, a ANDA of NDA RYANODEX.

with begin me an fulvestrant. update Let on

announced, recently we As we fulvestrant believe program looks promising. our that very

Eagle's that women. receiving You'll The XXXX extensive with subjects an XXX product XXX subjects subjects FASLODEX in XXX branded and post-menopausal clinical healthy XXX recall in over trial days, the enrolled study we receiving conducted formulations.

to are a survivors the This is developed forward have States explore cancer critical in breast data a X.X review formulation. we allow the a further year, this approximately potential our and of United XXX,XXX There of treat mechanism detailed have that we've led we in following we its enhance formulation's to Roughly from every clinical of potentially estrogen of FDA, hinges more will XX% June work potentially path to million to A the cells. completed further with more of FDA, block drug formulation study fulvestrant us the and estrogen guidance estrogen positive. that the receptor ability on breast to for unique patients are additional these and inhibition properties hypothesis, now cancer receptors led in of diagnosed diagnosed With Based on efficacious product. to hypothesis unique those year. receptors. Eagle's of March met twice the have The this properties the the greater believe meetings undertaking.

in result our category is we better inhibition the may that would standard dynamics FASLODEX parameters upon will of be pilot begin dramatically The program. a pivotal any greater previous compared than pivotal shortly. on population. different target begin results of its be profile than care have perfectly Depending program We our with We year. fulvestrant generics. estrogen patient a study results and of hope better a the efficacy early trial product the Once opportunity are to FDA potentially believe patients now FASLODEX. could for tremendous in receptors pilot, based study the providing we pilot the change of conducted clear, or product of To the a will to develop with believe the to our here the reviewed, next determined

within of The properties an to rates of clinical result Eagle's receptors, greater the determine improved research profile, potentially main to unique will compared inhibition to will formulation be of if goal including leading fulvestrant estrogen the lower current in progression program treatment disease efficacy the completed these commencing options. months see meaningful receptor positive watershed for recruitment study of company. estrogen pivotal a we a the post-menopausal is This fulvestrant approximately Depending the One on can patients. rates, on enrollment. impact that could moment have XX be can expect

stroke, of fulvestrant, that Syndrome, focused reformulation also all company. just on We improvement. the portfolio agent, of to rest believe very we meaningful, ourselves disease The Acute that indications and a think Radiation RYANODEX, longer exertional review as is for state addition the additional nerve now. are no heat let's In

patient and We continue we to or transact, And have are that the as may not focused roll opportunities focused outcomes be we on efficacy evaluate out that on in-licensing will profiles. may indications we additional of products populations. meaningful underserved

potential program. significant believe RYANODEX we our in such, As have we

We the set, the nerve has shortly be XX within first-in-class The indication. discuss granted regulatory request agent plan request. to days everyone FDA meeting know. this a for meeting the let of should we to date to will path Once meeting submit been

Our is well. Radiation Syndrome as along work moving

and We are progressing is dialogue that the on with in program track. military,

believe it intramuscular will be We including data. in and process, Our entity formulation, chemical is new PK toxicology generation eligible work EA-XXX, for exclusivity. IND-enabling of

to you with stroke, have a due engage As we we will in being update we additional for update. currently exertional and on provide to are I to when addition, you RYANODEX, time. closer and to evaluating FDA, more continue with are definite getting able you And we'll update for more in those indications X believe We share. heat we

have PEMFEXY We shortly. and more regarding Vasopressin should clarity

As as I've adding to referenced for regularly, $X mentioned widely annualized we expect these grow. value revenues business. our assets, will significant products Collectively, reported we that able approached the continue monetize products billion the to to second quarter be

understand believe You very significant we to be can for why these us. opportunities

the February XXXX, of of prevail We in U.S. Lilly's the sales litigation. in totaled We XXXX. stay PEMFEXY are $X.X going in XXXX to XX-month ALIMTA will expires In and that anticipate trial our hopeful the we billion Autumn

growth reflecting sales, also first For the half reported XXXX, period. We're $XXX over opportunity. million year in excited prior the Lilly very about our of ALIMTA XX% vasopressin

$XXX pipeline. forward share of our XXXX. the half States, predicated to Last and development In strategy, XXXX, Endo expires products the platform in May XX% our is set X, million XX-month there discussed reported and stay XXXX, totaled million progress look quarter, invest hope I today ANDA's I bendamustine the trial in outlined prior our first of to United enthusiasm continued reporting and the growth The for in XXXX, our for you vasostrict reflecting the on over the of sales October pipeline. growth $XXX year period. in leveraging

results. to to I'll Pete With the Pete? review quarter call the second over turn that, financial

Pete Meyers

in BELRAPZO. million, quarter $XX QX due revenue from the largely were In million million million in to quarter BELRAPZO in of XXXX $XX.X sales $X.X of $X.X $XX.X to and Scott. million second QX in shipments the Eagle you, XXXX. were total totaling revenue to QX recognizes Thank of to product of the million year-over-year, compared Product by Eagle XXXX, sales to compared compared second $XX.X $XX.X wholesale. quarter BELRAPZO XX% second was XXXX. million during up

of due end-users second Eagle's dramatic growth the draw the in BELRAPZO data, The the IMS quarter trade Based revenue market bendamustine branded a cutover likely first to of was of market quarter. the share U.S. quarter inventory bendamustine in in wholesale X% second the through name. advance XXXX sequential shipments to to on was June levels down in

We expect additional capturing continue to share. market

expect product $X.X Same as terms BELRAPZO of QX you in based dollars. books market normalized know, and in shipments were share on $X.X RYANODEX XQ Eagle million sequential compared unit in to RYANODEX, and in revenue. XXXX. to the second of was we a wholesalers, share million However, XX% for sales revenue XX% ex-factory drop quarter

As you few know, our Very expiry will orders their are expiring. stock driven primarily unless cycle. by the dantrolene acquire is customers

the the prior over which quarter, quarter. in business new had increase customers the engaged during an XXX is customers we business new Fortunately, in during engaging XXX

BENDEKA compared impacted quarter expected the royalties negatively with We by uptick QX $XX.X year two million do million expiry of in will million to $XX.X XXXX. trends. on royalty the think revenue in be second was compared low the prior was million revenue quarters quarter. BENDEKA in pricing an XXXX. to QX $XX.X were royalty next $XX.X

As a the October the at will rate anniversary revised and on terms by on licensing will percentage payment October increase XXXX, point royalty on reminder, from The reaches X, XX% thereafter. Eagle's royalty will beginning to under X, each XX% remain increase BENDEKA agreement, it XX%. XX% of X XXXX, of until

XXXX our during to expiry of down be was of as compression of which expect primarily gross product earns due compared RYANODEX the In Gross by in XX% year-over-year an margin quarter sales year-over-year profit. XXXX, quarter no of in margin BENDEKA the second asset in Eagle the increase second driven to marketing the was to sales quarter The to we to cycle. sales second XXXX. partner, on our XXXX and increase XX%

the million the were $X the quarter. expenses million prior year quarter expense for $XX.X R&D On compared front, to in

expenses, The bring year-over-year vasopressin reduction to second market. fulvestrant the reflects to substantial a offset partially cost decrease by quarter in

noncash other quarter $X.X expense Excluding and million. compensation the items, second was stock-based nonrecurring R&D and during

XXXX to million million of XXXX. expense $XX We to on R&D as in a are expected compared $XX non-GAAP guidance reiterating with million spend basis $XX

bring second in to bendamustin expenses drop in vasopressin compared External on of of for SG&A XXXX. decrease quarter associated budget XXXX with in ARS offset program litigation vasopressin focused year-over-year million we're PEMFEXY, and to higher expense stock the million for up expected of and the market, the by spend IND-enabling expenses, and toxicology RYANODEX products second in on to and XXXX $XX.X legal R&D part spending EA-XXX the in in increased accounted accounts to PEMFEXY increase. $XX the year-over-year scale the those CMC costs. quarter While expenses

and legal of Excluding XXXX is marketing expense SG&A our items, a on The as in sales in stock-based compensations attributable higher and XXXX. million SG&A second million $XX compared year-over-year increase be and as will to to basis payroll. million. increased levels million $XX We $XX.X as external noncash non-GAAP expense reiterate XXXX to quarter largely nonrecurring spend well other was $XX

be $X.XX in year quarter million or quarter. of share net and with prior Net expect track discussed with the diluted to $X.XX $X.XX per $X.XX in on above. basic income remain non-GAAP was half and We the million quarter Adjusted our XXXX period per the diluted per in per share to $X.XX or was to plan. line second spend $X.X income and second per the share to $X.X million the per diluted XXXX per and our net $X.XX year $X.XX or prior diluted $X.XX income year for of compared and the second basic basic non-GAAP the basic of income adjusted share million due or net $XX.X per anticipated for compared in factors $XX.X of

tables financial of measures, net the comparable press GAAP the a end at full reconciliation of For the income non-GAAP please our see to release. most

$XX.X the compared year Our quarter for quarter. the to $XX.X was million prior of in million XXXX EBITDA second

compared First of half XXXX half first the million EBITDA million $XX.X to XXXX. was $XX.X in

to half compared receivables, in cash was First half excluding $XX.X XXXX. flow million in the shifts $XX.X XXXX of first from operations, million

EBITDA million. For shifts the June million. XXXX, from XX, ended operations, was in receivables XX Cash flow was months $XX.X excluding $XX.X

of quarter, part second million share repurchases August as the million During in of stock. our Since $XX repurchase share we repurchased program. $XXX XXXX, we've completed

company had June XXXX, of XX, accounts which equivalents million of from XXXX, XX, receivable, As outstanding due net in $XX.X receivables of the the cash million. June and plus company $XX.X cash $XX.X as Therefore, of Teva. million million net million debt. in $XXX.X in cash was and company $XXX.X had The had

questions. for line that, ahead call open and questions. please the With I'd open go like to the for Operator,

Operator

Instructions]. Capital our for first with [Operator question RBC Stanicky we'll And Randall Markets. take

Ashley Ryu

yet? definitive you as Ryu know Ashley Randall. prepared to on can And mentioned that you on closer you is the more FDA June? This that whether confirm your remarks getting minutes a had I in expected for received you're meeting EHS, in But Scott, you've meeting giving your update. with just

Scott Tarriff

Yes.

and is now. describe good heat been best there's we've Ashley, you. And we're a have strong FDA that and knows. dialogue as hear good little the dialogue we're having take it's to the way I as everybody closer exertional feel there's dialogue. of resolution give with that we'll in And I we good soon information, bit to on more just been getting And and a make middle path The from to forward. think in regularly stroke, sure

Ashley Ryu

just on then And fulvestrant.

mentioned the And more little just safety benefit give And and bit new well? efficacy kind you as for You've do around potential one? improved prior us expect improved to Can a the still that? the profile for what new confidence around a the you formulation you granularity of relative gives formulation.

Scott Tarriff

Thank Yes. you. question. Good

that about product today to we this explain out the drastically all that time. look, to product of than the speaking that develop set different the I So to the we're is first best is think, way, try

is on a new still We believe will to to that we thought formulation so that positive safety. safety what those develop. that have set And we we many profiles more started we this of develop. out same that set have drug would not out We the have

was part benefits great so at taking drug outcomes Until our patients. a after deep the of what nature course which a of saturation patients the we to days, individuals. to the dive the And data, transpiring that of XXX have and to these can industry. we drugs, couldn't of of these about XXX our the into our and over -- look we we've potentially long the the here's due within conclusion the estrogen is gave But better receptors, to critical tell come

we reviewed agreed-upon we very We on study, the we've now lab Based path have, we've met in study. to made the we're that confidence changes we we're a to seeing really about and changes all the trial we're correlation we've the this an have in test doing pilot have first if took We're formulation our And that take see ahead our work to FDA. ultimately only we are, the positive with work And that went people, to good between data, forward. the division, go in seeing lab patients. did for first that we'll and we and data clinical and a pivotal we that the we between if now, that's it. having right, lab estrogen we that really the most study, and part, really a first year correlation We what that And We'll could and excited we're them we'll saw made now. receptor twice. which greater these that where will with and time, start complete. think have about a activity then benefit it dramatic

FDA, advice XXX pretty look we're product. made patients if that and And to was it for remember, for our data you patients from we've with of from brand changes the a at. the XXX lot And That's confident.

and know for certain. pilots Let's done get these we'll

Ashley Ryu

was any that like? the visibility pilot, dependent be, the results for a detail? what be study? of size your sort just look could it XXX I Any let's potentially as similar like prior that of with around other the And agency, know say, if sense but high-level will then any during the the there subject it'll discussion on

Scott Tarriff

Yes.

what of to been needs the we've It's that the We good and into most very them. get the drug market. understanding had to for an have, agreement with say, I meetings part, would happen two

today --but the is as in mind, might that we'll expectation do it will be next I have the pilot but considerably keep far As to the the expectation study that goes, today -- change, size reason It'll think looked need there's a many we've that any it we'll the year. enough within that now that first recruit small than one. subjects. at be be to don't smaller that I we'll able study

last remember, rate a time, XX a recruiting If you of week. subjects at were we about

study. see let's question, the So it'll But happens. much what smaller a be to just answer

Operator

Folkes with Brandon question Fitzgerald. comes next Our from Cantor

Brandon Folkes

superiority? from Maybe power following efficacy, kind do -- pivotal, talked you've of about you on improved to In to question. actually show the the just this the plan prior but

Scott Tarriff

be to think there to objective is determine will the But that more I study question, the We'll of if give receptors. is team going after don't call now going requirement give more details be Great of get regular estrogen Brandon. medical forward it. the of study. attached updates to this fulvestrant being this the to a to

Brandon Folkes

Okay. Great. vasopressin. on And maybe just

on to to You this called the work be out the release. R&D press costs needs some provide in color done Can to get product market? you which your

Scott Tarriff

From what standpoint, sorry?

Brandon Folkes

the From R&D standpoint.

Scott Tarriff

For vasopressin?

Brandon Folkes

Yes. Correct.

Scott Tarriff

request that get for middle that have doing to FDA data completing. we're place the activity takes filed. just in of Well, the some will did get from drug all the the We typically we're No, in market. that course that time we plenty in to we feel and normal of approval of the normal do the quite timing our activity, have confident work the in to more

Brandon Folkes

maybe, And lastly, their called product taking the sales on BELRAPZO I the around to share provide they in Interesting. call. increased quarter? from out some then know you Okay. color Teva can just BENDEKA

So I'm color on stocking Or just they interested that any were increase? their in side? around whether

Pete Meyers

Brandon, it's Pete.

As we is revenue to consistent know, which BENDEKA wholesalers. Teva and ship shipping not you Teva, booked we on sales necessarily with to product

triggers revenue and royalty to latter So of the revenue obviously, end us. triggers Teva the the

a the just this morning lumpiness that's the Teva. note some from that have make margin. why shipments a to -- there's our don't a so decided because margin. in have intended in not And sales are They And of to product we obviously, conversation to

margin of overall, we've the compressed the So gross temporarily. company

Operator

Lugo to Blair. William can go Tim [Operator with Instructions]. We next

Unidentified Analyst

on Lachlan for is This Tim.

decrease as Or the at all are that the see Did you to royalties? on to guess, going see And expectations transient pressure And And BENDEKA similar all, you can continue? pricing do since more second a I versus likely you market first the BENDEKA? all, of BELRAPZO? the change of for led forward RYANODEX? environment just your any of something that's comment introduction in share that brand of So with they what change? do BELRAPZO

Pete Meyers

Thanks, Lachlan, this is Pete.

we a the on it's been little look, market bottle. So share, --

on we data reasonably the would customers, see on Obviously, same is I see, a the You accurate. data say IMS. the we see IMS pull-through basis, daily but

guess, as where But second I volatility our on compete wouldn't think from expand to there's in some the we that We the And that so at do that around I the marketplace. guess in will market saw moment. share any comment been topic you I further continue quarter.

the source don't -- our pricing, pricing And topic yours. pricing of BENDEKA same We the on to on insight, BENDEKA. our data the on as is obviously, have

we since So is compression approximates for you our the seen that's look not Bag, there's the in at IMS, And price, XX% an of IMS the same Big which NSP, about of ASP do. But BENDEKA as launch what of erosion some been we've thing product. launch perhaps, surprising. since

Operator

questions further And this appears floor have Tarriff no it at any remarks. additional I'll for time. the we to return Scott

Scott Tarriff

Well, I for the days thank It's well. And XX progress. everyone. [indiscernible] and all again. We to another first come The reporting we're exciting pipeline. days. busy appreciate more you, appreciate rather half for it. really call these our thanks was together having this Thanks in advisory the And about excited time attending. -- it. is Thanks again looking forward and

Operator

Eagle this Earnings Call. will Quarter Conference XXXX Pharmaceuticals conclude And Results Second

may disconnect, now day. have great You and a

Eagle Pharmaceuticals (EGRX) 9 Aug 192019 Q2 Earnings call transcript