EGRX - Earnings call transcript Q2 2018 | Eagle Pharmaceuticals, Inc.

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Operator

Good day, and welcome to today’s program. My name is Erica, and I’ll be your conference operator. At this time, I’d like to welcome everyone to Eagle Pharmaceuticals’ Second Quarter 2018 Earnings Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer period. reminder, call a August being As XXXX. X, Instructions] this is conference recorded, [Operator my turn pleasure to now is It to Ms. the over floor Ilanit for Relations Allen, Eagle Investor Pharmaceuticals. ahead. go Please

Ilanit Allen

results a Michael call. and Pharmaceuticals’ three Thank Financial Investor Communications, for the Officer, Cordera. call Tarriff; General Eagle’s eagleus.com. financial Eagle on and morning, quarter you, through release Chief to me This for of XXXX. Ilanit Counsel, Eagle a release Pete With Investors call Erica. XXXX of Meyers; Welcome Relations website accessed earnings the Chief this the issued ended press press XX, company today’s This of June can Pharmaceuticals. months In-Site be at Eagle section Executive is detailing the Allen Scott second This are webcast Officer,

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

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

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

the And turn please Tarriff. call CEO, recent most releases press I’ll Eagle’s over that, Scott SEC to filings. So, the reference company’s and with

Scott Tarriff

Thank you, everyone. morning, Ilanit, and good

of continue best-in-class or during shareholders. We we XXXml and Big liquid for during launched filling need another strong sustainable of the drive to value deliver supporting in products and important execute We maximizing lower our the Bag, alternative strategy had market not to solution our does our our an the form bendamustine which each largely reconstitution a BENDEKA value for quarter, require reflects million to cost quarter our about that commitment $X Initial sales stocking. of complementing assets. royalties of

months our We the exclusivity expect prevailed drug has that pull to with the Furthermore, believed dispute in the BENDEKA. for first we weeks dispute ahead. progressive the through orphan likely in see in stage stages. a two of and be resolved the regarding FDA From in June, Eagle would outset,

to exclusivity, applications approval. approve date ODE in seven the orphan was stage from BENDEKA FDA in an order entitled that BENDEKA court will able referencing any orphan be was Consequently, until drug first confirming issued BENDEKA years and drug the to to expires The that to the the June not of was entitled confirm December of XXXX. exclusivity

it properly scope additional require process, FDA's necessary. first stage and to regulatory scope or and that resend was [indiscernible] to two of the In did the limit clarify and dispute that bypass should not grounds the BENDEKA's that the relates litigation to The of was on an July, FDA otherwise The affect referencing applications, In the short, scope order FDA a that to second court attempt exclusivity. of filed exclusivity. denied FDA's motion resolved the the if stage be that not through issue of TREANDA. the motion motion

We quarter allow pursue December to and to XXXX. directly XXXX, TREANDA exclusivity well should We first enable our necessary. bendamustine regulations continue had additional the of during of million, products exclusivity record largely would XXXX life sales XXXX, by application orphan driven beyond the appropriate and the us drug the A litigation protect in to our of extend with $X.X Ryanodex cycle that reorder plan in and believe through XXXX total in U.S. entrants the vigorously XXXX an with indication patents potential combined sales shortly. rather in generic tremendous the strongly believe to to beyond which ODE discuss $XX.X has cycle. To its FDA perspective, patent, detail in than dispute that outcome greater if put BENDEKA I’ll the Ryanodex total current XX this were favorable or an million. brings expiring November grant We

ANDA, If value days this April. which afford us the of by in back advanced solid We believe would pipeline if programs last $XXX was filing exclusivity potential the to approved, the for our of were this also a injection of product be to Xml first accepted year. significantly vasopressin approved. addition XXX several that overall sales product have to branded portfolio add file We a We to FDA with million would approximately our portfolio.

the in to fulvestrant expect accordingly. We and have market data will fall the available update

begin case anti-trust which scheduled The patent litigation patent references has We trial X, December our related product, and to Eli Lilly's XXXX. PEMFEXY to on a Alimta. continue both

doesn't against judgment within case, motion six anti-trust We a also ruling filed practice on improper the code a proceedings months. brought have a and we overbroad the anticipate The use regarding the their next which schedule. and Lilly for FDA, yet before

use the this neurological the been Ongoing in U.S. have the nerve to of in discussions with the Ryanodex and for well, share more will indicated Military impact treatment also we potential agent coming on evaluating as are a exposure. we’ve progressing have of past, weeks. As we

expect hyperthermia nerve exertional Ryanodex agents malignant stroke year. to targeted heat additional indications We also this for announce beyond and later

of will In our at Ryanodex for an be for as XX, August additional heat to to agreed for Hajj. to conduct trial been Eagle we our clinical the returning has XXth. Ryanodex to preparing expect Saudi study The Arabia patient we a key in and upcoming the the the exertional FDA. course, first evening Hajj Of week, stroke a on with focus treat begins for about

the an will enrolment, We update shortly regarding thereafter. have market for

study During collected XXXX, in the XX our data for days. first we X.X patients of over course

safety a possible the confirmatory our region Our stroke. XXXX. of X an in and four at Arabia also runs sufficient study treatment abruptly be what the to and returning will study It evaluate exertional which we during observed is Hajj to will in we efficacy enrolled minimize This difference of XX. receive unfortunate departments are Saudi XXXX patients in approximately Phase number in the with conduct X Mecca conducted to randomized to subjects Ryanodex. and through comparable following to the further heat enroll to run study clinical XX double-blind going study Ryanodex receive patients season, to a a analysis August This hope any meaningful unfortunately them All bias. be ended The cooling, Hajj of year, will body we show the stampede. a half is of Phase to and emergency and study

humidity programs hot region environment. days Hajj over know, also in strenuous in that temperatures weather over Current is Fahrenheit undergo very well quite may XXX you physical high. are and As activity several degrees

nurses, coordinators. about people, training XX a Saudi and including medical team and emergency of building We’re physicians,

and stroke. efficacy to satisfy our our of FDA amend exertional a of NDA including EHS and evidence remain heat We support management, hopeful The to with that We’re confirmatory season. for requirements most for will be regulatory product local intended the provide Ryanodex could data also for in all compliance heat be regulations of supplies, transportation, all assembling XXXX to to filing. on is team treatment safety study study and the the market conducted logistics, current

focused to execution Before to assets. turn discuss to greater the highlight we in of detail, like I and realizing performance our call that portfolio remain potential over our financial fully of Pete on the I’d

million contribute earnings business. During long-term With executing available meaningfully to priorities. the we our growth continuing the with in $XX.X bottom significantly the $X.XX confident top in revenue of the to cash while in feel receivables, end advancing delivered $XX and share, at and $XXX value us to programs of and line the second resources quarter, in can that we $XX both per in million million in million quarter, debt,

the be upside I Pete? could in past, XXXX with quarter turn another call of As to pipeline. I’d the year second to to over growth with results. that, Pete, with potential continued we tremendous for Eagle solid advanced and And believe stated the financial value like creation review our near-term

Pete Meyers

sales product $XX.X May quarter. $X.X Big of the you, total Thank million, XXXX. XX, in was compared revenue XXXX, launched million quarter to $XX.X on Scott. in million Bag Big the second XXXX. Bag quarter In We the second were

million, reached was quarter year-over-year Ryanodex XX% up Ryanodex XX% on $X.X second XX% terms unit quarter a the of and Second dollars. normalized sales product share a basis. share in record market

goods quarter XX% expirations, of Bag Second was largely the the Gross Royalty BENDEKA prior million new as the sold. $XX.X was as quarter revenue royalty $XX.X as quarter XX% compared by the $XX.X customers XX%, product by million reorders were Gross compared Ryanodex Big year quarter in second sales million, cost the business. supplemented from compared to partners, reflecting royalties of in to margin to in in XXXX. driven during of of on Ryanodex engaging quarter million, second in XXX well second margin was quarter. XXXX, XXXX. were to obligations our second $XX.X

is vial than that The While that Big X the Bag to X EBITDA of Big BENDEKA. of lower generated per Bag a is BENDEKA. times gross on margin of

with $X.X the quarter, increased front, expense the external associated for compared in costs prior the the quarter, clinical On fulvestrant to due to $XX.X clinical largely year to R&D expenses million study. million

quarter Excluding non-cash during million. and items, expense second the R&D stock-based $XX.X was non-recurring other compensation and

fulvestrant the to agent programs; outlays We for: R&D to nerve million. work range API $XX one, the of trials. expect the reiterating fulvestrant This vasopressin development program. clinical expenses the EHS Ryanodex be and reflects million which number and we $XX Number are in expense on and XXXX number Ryanodex for three, two, enrollment our of guidance, additional

promotion contract quarter reduction in XXXX, in and non-recurring XXXX, in items, $XX marketing Excluding $XX.X of the non-cash compared to million range would was $XX of of to as the quarter at $XX as end the million of stock-based to June R&D be million due and of second the expense SG&A the spectrum well XXXX. compensation decreased other million. the expenses. the expiration to The expenses second in decrease

expense stock-based non-recurring Excluding million. to and million $XX SG&A compensation was expense $XX second be to of items, non-cash million. expected XXXX range is in SG&A the $XX.X other and quarter XXXX

focus quarter, and $XX $X.X to which reflects of $XX recorded range other a million the of the be equipment. million stock-based non-cash to docetaxel and in certain sites. The million impairment items, Excluding June These $X.X of charge nonalcohol second and a in asset plant, property, in non-recurring and restructuring portfolio million included charge product in We to expense initiative would distribution our an $X our compensation inventory charges includes the million rationalize write-off SG&A physical million. measures discontinuation manufacture related $X.X and and XXXX.

reported share, of an or share for diluted factors year prior $X.X basic quarter. non-GAAP second million discussed per and also to and consideration prior and net of $X.X $X.XX compared to intangible for well million, $X.XX per adjusted as the basic XXXX with share the remove per million associated diluted docetaxel share, charge in impairment diluted basic $X.XX for was $X.XX period, asset Net $X.XX above. income in was or the or or per to We income $XX.X the Adjusted second $X.XX of income liability adjustment of due and the asset $X.XX non-GAAP $X.X income basic remaining per for net quarter diluted per quarter to the an year docetaxel. per million compared contingent million net as per $X.XX $X.X share the

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

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

repurchases completed program. we share our as expanded quarter, in second $X.X repurchase $XXX million million the During part share of

we million $XX.X XXXX, August So, have in stock. repurchased

open As accounts outstanding million of due to million With for had questions. June questions. please cash go million $XXX.X company which XX, and in $XX.X like was and open had company net cash for Teva. in of The XXXX, Operator, million line from in debt. that, call equivalents, receivable, $XX.X I’d the the ahead $XX.X the

Operator

Thank will Cantor the And go to go first you. we Folkes [Operator of Fitzgerald. line Instructions] from Please ahead. Brandon

Brandon Folkes

congratulations taking guys, Hi, thanks the quarter. for questions my and on

update potential any ANDA you the an just could year? request file you the expected to to the to do market [indiscernible] second to FDA? vasopressin, product this then expect on provide when bring Firstly, this a and And on you. waiver from secondly, Thank of

Scott Tarriff

Thanks lot. question. for a Thanks the

of expect. necessarily So, months. months. to would on as the middle up you it’s way litigation vasopressin we’re works in XX the Remember It’s system XX the not

as get We’re the in we and to at our the wait our along approval as litigation through we will it moving and can courts first just and aggressively expect to we're just market work and opportunity. see we get and how

the we're second will the process. through us of still with as to forward – those are terms you. two we and Thank moving we and In we're more provide exciting know for material moving you that just product, them have products just along to very to news looking you,

Brandon Folkes

Thanks. Could – just I follow-ups. two

I confirm Ryanodex about talked was you strength there Firstly, in just Ryanodex? on Pete the quarter, can know I stocking no the

Pete Meyers

product to dropship directly customers. actually That is

possibility So, there’s no stocking. real of wholesaler

Brandon Folkes

us you basis, help R&D for trial rest And the could think year August? with quarterly Okay. the in you. spending of through on the a Ryanodex then obviously just the Thank

Pete Meyers

of through Yes. year We’ve were our and two reiterated than result will June sure that which less R&D be largely accrued expense back that fulvestrant the the end year, cost the entirely XX. trial, a quarters, which is for clinical you've first the I'm of essentially the guidance deduced for the significantly obviously

Brandon Folkes

much. great. Okay, very you Thank

Pete Meyers

Thank you.

Operator

Stanicky Thank Instructions] of line you. Markets. to go RBC the [Operator Capital We’ll next Randall from

Randall Stanicky

couple Scott. a I questions. have Thanks, Great. just of

the like at by market BENDEKA can the Bag. just is stock of XX% couple market percent economics what’s you gross you about of I at remind we Bag of sold of $X.X sold but you can price, share some then your but specifically from us start of share First, then the we margin? in and your a on Big target of as share do expectations, there, think there how lower in XX% your other Teva a follow-ups. I've a market full, million versus to through Big way percent know to a And royalty got a difference

Scott Tarriff

Randall. Okay. Thanks

Let’s take think something this touching one you're because very on first I important.

that was launch. going of take to second working The the contractual first me the normal go issues the turn And half. typical X.X mostly to question launch reimbursement Pete. just you And the through over the Let period through stocking. through half we're issues and

market be We we product on the with is share great. are in-line which very guidance, and positive to expect the previous

forecasted So, achieving previously if remember, we XX% a share. you

sales If go numbers you through sales eventually us level. just the that will get to around annual $XX million

look Pete our And how you that the and so, to see by that. on at the Bag, you we into balance you obviously at we Big quarter, side of the through excitement turn royalty look what growth over take future product, lose can the to I’ll X.X, explain account launching then the

Pete Meyers

Sure.

Bag ANSP So, think Randall. Big is BENDEKA to the of ANSP the of equivalent roughly

the of market them as of more in pricing the across looks customers, blended strategy as should the you same. sensitive in roughly correct You’re approaching one but the ultimately cross think

royalty because have will drops BENDEKA bottom royalty to Teva’s – to generate other you than XX% incremental know, with the don't Zydus. royalty that XX% the of to us revenue. out we XX% the BENDEKA number on pay a royalty the costs we of that line As course associated vial

generating EBITDA So, in think the door Eagle. to going of vial BENDEKA numbers, the round $XXX out

vial net earned and today generation $XXX incurring Bag, gross roughly it. Teva of to XX% gross vial, BENDEKA. is XX% result against to for you door and the the BIG Bag would number that of of BENDEKA reiterate the EBITDA Zydus then what line backout pay that having of will We been to speak have profit to We we're a and if is The to us say that’s of Big booking we that [ph] so contribution. times You’ve one would times goes in that X on in then word are that have out that top obligation and to Teva. and therefore reason that EBITDA Big the get profit, heard a penalize obviously X model and we BAG twice vial one COGS roughly revenue we had the cannibalized pay

Randall Stanicky

and It’s clear great. That’s helpful. very

So, thanks for that.

on generics want the BENDEKA ask Scott to is, The next you I where mean, do to steps or is we here other II exclusivity, to idea the TREANDA question that the that for that? legal something November see goal on of its the FDA I move there an Stage block we or timeframe? that is expect could event XXXX before see that we the would or be to otherwise waiting make in

Scott Tarriff

Yes.

what push don't pretty answer is clarity we we Ran, law to can the We'd know. do Right. as think though. We is as we like So, I it. We’ll soon get that the along. think to it clear do

And through We’re see that to just than goal. it we’d ultimate TREANDA. position have as strongly behind of we’ll our like as relates and to later mechanics work that the it us to sooner get in to go we’ll we towards point. Obviously, getting

Randall Stanicky

it. just separately? XX number patients the your trial? know at was original trials Ryanodex, Got patient that it two in you this p-dose of going target goal is quick for a these FDA Did what’s to XXX, combined And look which one the the on and XXXX had I

Scott Tarriff

missed a past there actually the target August we it’s were a at don't open that no longer, Hajj can’t we where specific years. Hajj can't questions been keep of this we results number. after target We a has because the bit. all was because stay It this that is three Randall. an stay over pretty just Look, the by anymore. little excited XX numeric following received the about XX We on unusual obviously, until p-value can't receive were patients. The the from for we X.XX the standpoint Great that pretty study XX last strong on results small numbers. We enrolment we have the

if project get we that statisticians in numbers the subjects and or at XX, up look p-value a patients, XX they have as tell the X-day many in below. around you that take that you would is of period the as X.XX p-value fallen we So, I can patients, that the to double many when just on the can. have that What around get to we

enrolling, have probably many exciting. that’s wind up there. enrolled. of We’ll is were it the Shortly we’ll how conclusion X-days. subjects study, just So patients get We’ll announce how many those we after to out the see

that’s – to you exactly up coming able what we’ll weeks So in two be round-up tell we with.

think a is studies, in on amendment. on drug type product, can If of them, we I an for and expect don't do approval then combine and lot I if going those the can wind based with situation we we’re think there the even combined really it I a combine the if in formally that, solid numbers but we wasn't two that officially you or up p-value, you think with approval. hope would orphan

the And outcome. so, about pretty we're positive

that in job guess more I I good Let’s should we're hours. a but script is the just didn’t that be that we recruiting, have I the do out running hope many mention going study to

we study eight-hour time was a and a half. cut ran short the first The day and days

for like five XX-hour more running XX-hour are we days Now, days. and

interruption event recruiting XXXX. you So, to in is subjects going compared if there be how see can many hours we're the to no

Randall Stanicky

so week numbers patient Hajj? following those or PR the you'll or days And in the

Scott Tarriff

Ran, shortly short somewhere the XXth. thereafter Yes,

I think Friday. a the XXth is

of and and for have then data, out scrubbing subjects tabulation, the and through make we just will get once we So, and wait reporting. back, back everybody and put wait to sit closing sit many then following how accurately, know and the sure we’ll database the the – and early release let blocking the the were of it enrolled, back we that have a that it week,

Randall Stanicky

Perfect. at leaves, prepared Again, your focus I morning. or here, I all last capital or And deployment that question. the potential leaves then this having comments in in about again say or the or overread but that to my comments, you acquisition, didn’t at tea or don't evolved referenced quick want all? you Thanks. changed we to company want your I reference don't quarter tea last the think hear but prepared strategy should overread product

Pete Meyers

Pete. for Thanks is This the question.

continue balance continue at opportunities. Again, and external We a lot assets. of of and given our time obviously do our well. we care, strength shares as amount infrastructure we a remain to fair sheet opportunity look the The we [indiscernible] have spent looking high, to critical we just opportunistically see acquisition on repurchase BD but at

Scott Tarriff

a I direction next the clearer lot of report trials think, too, the we’ll how our clinical company Hajj. for steps and after evolve clearer Randall, this fulvestrant And they will out we the have two become in going forward. all

in wait-and-see we’re a mode. So, a of bit little

Randall Stanicky

thanks Alright, guys.

Scott Tarriff

Thank you.

Operator

David Instructions] [Operator will the ahead. We Amsellem Jaffray. of you. go to line Please Piper next Thank go from

David Amsellem

Hi, thanks.

So, just a couple.

TREANDA ahead, to bit possible volumes wanted safety your So, over to sales you mean, assuming the months, your somewhat on so of would do you last, of until injection know are engaging are, on one. overall Faslodex capture the first that XX here. much I year. ease somewhat better thoughts that we're pain, relative number has as next a But how are thoughts bendamustine on hypothetical able on thoughts on we of as site of the have number then capture mind, getting J-code? look multiple And blocked that profile XXXX how assuming to be fulvestrant, what say Big have you to what two, I what BENDEKA market your with generics share a thoughts Bag that terms a get expected, been of the And expiry? generics Big can are indeed, know little entering, Bag, I of in the if much wanted and your of months a that, on ODE and in fluctuating market XX assuming that

on as thoughts to well. get wanted that Thanks. So, your

Scott Tarriff

David. you, Thank

give next first. been well. It’s we market take and over actually question we’ve hanging or the market in take From a what Big pretty let’s Bag what flat few is, seen the bendamustine believe is years. So, the that

molecule. is a very work actually Teva a marketing doing of Really, with job proud it. doing. They're the job nice the fantastic that very really We’re

for or a about us And And year to would Big Bag points on we here so, we we of XX%, which million flat a said, percentage take assuming couple up to a get about think bendamustine. share market sales. we’re give just up or as there, get our $XX

just if to you numbers, adding through we see have this ultimately going the this excitement around and by go and can again you So, the why XX% our P&L value share. launched through we gaining

all just wind would because So, news issues And having of up J-code. the a around, associated up wind think. take chance gaining way warning I being other an new able we good label on the I a less to fulvestrant, excellent think do of it, that with if we the and study pain out of have and passing

pretty we’ll been we of I about and you less the project share, share, market. ease And that painful about get know to pretty the and on but product safer that this working and don't always opportunity. assuming is good administration, product we feel We’ve opportunity, very think we that do typically have We’re we excited then if well. a the

let’s happens. yes, what see So,

David Amsellem

Thanks. Okay.

Operator

We’ll line Thank Ragard you. to Mizuho. Instructions] [Operator Please go go from Stephen the ahead. of next

Stephen Ragard

you’ll of data type to morning. agent give nerve support my taking able questions. Hi, of to for been mine around think you have color are but generate, what indication answered, the for Ryanodex? for Thanks Most you good need some

Scott Tarriff

Yes. Very good nerve on agent. question

clearly nerve the for animal can that's to it’s think model. that believe I agents, so we we exposure an great find volunteers news. have we So, don't first,

rather we’ll We year earlier update I in and some think or We time are have the year one was reported run data, did working that hope, and here, I with rodents, model shortly. this we animal last military an it strong. that

we’ll it do of our study for and And that run pivotal study We’ll will more to see to about done that report animals. done that could the detail with I it potentially meet an more repeat everybody can that them FDA. But is be speaking, subjects and We’ll with study. And be other we’ll we a in be need so, go plans. if FDA filing. the have quickly more what that time, study amount short we with where relatively could work in any We’ll is hope and in be type work to our inexpensively. of next work. out talk could And

Stephen Ragard

thank Great, you.

Scott Tarriff

Thank you.

Operator

at Thank have you. further time, this questions. no we And

today's any their So, I’d for at like conference and time. you conclude to call. participation presentation on disconnect today's thank may does everybody This

Scott Tarriff

Thank you everyone.

Eagle Pharmaceuticals (EGRX) 7 Aug 182018 Q2 Earnings call transcript