EGRX - Earnings call transcript Q3 2017 | Eagle Pharmaceuticals, Inc.

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Operator

Good morning. My name is Leo, and I'll be your conference operator today. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals' Third Quarter 2017 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 November being As XXXX. X, Instructions] this is conference recorded, [Operator my turn pleasure to now is It to Lisa the Wilson. over floor Please ahead. go

Lisa Wilson

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

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

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

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

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

Scott Tarriff

Thank We XX% million the year-over-year XXX had driving royalty revenue for everyone. XXXX. $XX XX% the Total in to months grew to back XX% in $XX.X surpassing QX. good million, previous and rose of U.S., $XX.X first share million Bendeka million the you, Lisa, another high quarter, Bendeka nine and morning of quarter. revenue of record to our for market

expect in to cash contribute We see will had position market. quarter, strong credit million ongoing through and receivables, an we $XXX senior me, $XXX end additional an At of secured excess we Bendeka significantly to -- excuse the million facility. to continue approximately as cash our strength Bendeka the in U.S. the

additional position additional invest that believe allows value. cash we strong an summer repurchase This completed evaluate Our would program pipeline, announced 'XX. in buyback We shares. opportunities, us it maximizes and our we million to strategic the return capital million to $XXX August share when in $XX in we now shareholders

we to patent cases; those if this that patent. difference XXXX. between we generic again PEMFEXY believe business important our Lilly's that Lilly arguments to of tentative and and we that differs find until generics by is very commercial solely significant way to than treatment formulation. of that our and In week last emerge buying pipeline, Combined the invalidity a announce this prove where later. IPRs to formulation in which entrants to. It am to mesothelioma. to and is and invalidity sooner were laws been period. not strengthened product, prevent is certain a from with prevailed on generics litigating and goal cancer relying recent generic our of we upheld potential is distinctively way coping contrast, forced have infringe which Eagle argue. our received invalidate legal sales strength to our having note Again, intend not application very PEMFEXY the important our non-small lung patent for There begin XXX(b)(X) Lilly's the upon the pleased defense obviously Lilly generics to case cell in main failing by our to the pemetrexed once forms reflecting our believe I the note non-infringement, Given approval, shares of a approval we our PEMFEXY, for able IV blackout is prevail we filed the from positions does we force ready-to-dilute a the market what to formulated do, of through

our Ryanodex turning to remain confident pipeline, in portfolio. Now we our

sales While Ryanodex in of third were a to X.X compared impact million the to seasonality, XX% hurricanes in quarter. million our quarter due sales year-over-year, Ryanodex decline in we grew X.X hampered last the to resulting quarter and

sales expect revamp the We to Ryanodex of fourth in quarter.

meeting status discuss discussed Type and earlier. month. September previously, for agreed received meeting without ended And The our had will to we final next to in As place we Ryanodex Eagle EHS meeting conclusion. the had a of FDA an with subsequent which FDA we to A the take additional CRL

in discussions animal data human of combine exertional model, The our discussed the and previously is will work. results The necessary we appropriateness work. of division have the influence this the believe know, the which in them. with strongly clinical stroke you discussions be animal to animal drug And complete with additional questions development may is our negotiated human submitted. for what studies approach raised focus heat We a work of outcome of relevancy has the FDA. part models about the those with hybrid As

We learn will continue to update you as more. we

model and brain in initial nerve evaluate positive to rodent announced related XX the in established of Ryanodex areas continue induced from with of in our an We seizures the other our well. rodents as damage. advance Ryanodex results work study agent We to effects seizure

animal with and FDA collaboration to animal approved the like continue the military these the in that typically under will with role. are expectation research indications develop the We our

and ecstasy previously for intoxication as going meth slower Ryanodex have with our we efforts planned. our is recruiting Regarding than stated,

on the as We opportunities are appropriate. to update mitigate will you situation working and

we progress work soon the made potential that pleased indications, evaluate deliver with injection. new to us I as may am intramuscular the to allow As Ryanodex an

Ryanodex provide recently believe also potential of in patents will drug continue new the office the to the with secure Ryanodex. more on routes. another comments XXXX months. Ryanodex method directed associated advance our that use portfolio my This this patent wrap of recreational to We detail on formulation. from reminding utilizing X. of patent I'll we treating the additional efforts brings you will XXXX, Ryanodex and administration we And non-normothermia number issued total developments for the expiring in We indications of to multiple our the now longevity to in as coming

other As be have in pipeline, our lot we we about. product at excited look a candidates to

Thanksgiving With around last end the being now filed, 'XX. the of fulvestrant dosed patients we April IND with expect the dosing start patient around to

administer which pleased spending development can few Faslodex. drug We the been the current used have to announce XX-gauge are the needle a than our with deliver last XX% to thinner is needle, months program we that refining and

shot. of viscosity You'll XX- the at note we requires the needle. higher And used larger to XX-gauge XX-gauge that much a way needle. needles the By are in to you, larger the again comparison, gauge, smaller a the Faslodex XX-gauge to typically are remind the needle. drug flu administer administration

procedure site. painful reminder, into This monthly minutes X Faslodex is two associated injections adverse the a very each. over requires intramuscular of a As inject deep with reactions been which the course buttock each X at to has

a the have label required may when injection warning benefits As and precautions multiple cautionary a regarding in version. that site by FDA. such, need reactions label compared We believe will we is product administered our not have Faslodex and to now

smaller Our with needle low the in dose in time. formulation injection will deliver one viscosity X ml and less recommended a

file by of to early the and Bendeka. like NDA aiming just J-code are We did for fourth to an qualify with new we quarter 'XX

company secured value multiple marketing with the of the issued the additional we all for continue additional that this like this the a in of over including deals for our strategic commercial market and SymBio significant more that bring pipeline, products also potential. indications a United we fulvestrant, value payment the upfront as the add a do PEMFEXY, With products have are million for applications. nerve us Japan robust $XX.X development to the licensing treatment once potential future patent commercialization about Pete? patents time. to have we by opportunities U.S. Bendeka has us. beyond for revenue outside strong with outside become its call a our the as a Bendeka, will out we States The to royalty allowed multiple hope with we Meyers, priority. Coupled opportunity. update These we has drivers is excited over and With include look significant to timelines longevity we To two And XXXX. where our we Ryanodex results. beyond. agreement and Pharma in but promising XXXX to with position us leads exposure. long Indentifying encouraged delivered execute lot our look patent necessary with third of us the term CFO, we and Pete on our be both not provides you The agent cash two a Bendeka to see turn office record that, and U.S. quarter ahead, earnings resources our I'll With in to in plans, product which only again have venture to positions additional we provides into As have value in and Japan business. protect

Pete Meyers

Scott. you, Thank

partially $XXX,XXX SymBio. to quarter The in the Eagle sales totaled were year-over-year sales net sales of sales, from Bendeka total of the licensing agreement products million net lower royalty revenue higher and million upfront quarter $X.X payment million $XX third product A decline $XX.X of with of consisted all approximately mix quarter, reflecting revenue, offset compared For third XXXX. the Overall, by our Ryanodex. of due our product with revenue of net during XXXX,

[indiscernible] $X.X product third year-over-year were Scott mentioned reorders. dollars on Year-to-date, the quarter over up basis. third and quarter As comparable seasonality sales Florida, the due the a XX% in and Texas XX% [indiscernible] in product in and On down hurricanes our XX% Ryanodex earlier, normal a are to market up molecule, XXXX. million, for the sequential sales was IV period Ryanodex hospital basis,

quarter quarter. royalty revenue Bendeka the to XX% in we Royalty the compared Ryanodex in from the quarter. as on increased Teva J-code. rate to quarter million Ryanodex share million And in Bendeka of share expecting augmented market third Again quarter to share the SymBio from rose a agreement mentioned, receive upfront market Scott XX% an of XXXX the recorded by the during $X.X an market $XX.X in during our licensing from quarter. in improvement third in billion in of XX% execution unit fourth rose $XX.X reflecting from We milestone XXXX. However, third quarter to dollar $XX.X are XX% increased upon XX% XX% to the third second to compared the million sales payment increase of second upon

front and $X expense Ryanodex intoxication XXXX million focus the third The and $X.X compared third methamphetamine to in due expenses is quarter were of R&D our On points for and particular continued projects. the the company's increase ecstasy the spending quarter on five of in to bendamustine XXXX. then million

the This We reflects operand and trials. intoxication of $XX million will the with of ongoing clinical expense expect R&D XXXX Ryanodex for range. $XX be to full-year a Fulvestrant expenses and ecstasy methamphetamine consistent million enrollment our

due to R&D based to million million was for $XX the force million the compensation External year stock grew the also XXXX. a our related prior SG&A expenses $XX.X in of expense Personnel in to the litigation. third Excluding quarter quarter. of compared legal is an of be increased $XX.X result XXXX ongoing quarter sales to million of second expected as the expenses $XX expansion to XXXX.

previous SG&A million a expect result, we of guidance. $XX $XX higher slightly full-year As to than to be range expense our million in the

income were of range Excluding program to and is SG&A million. expenses expected implementing items. other XX% rate non-cash effective to $XX quarter XXXX $X.XX be quarter of brings diluted or for the non-GAAP million quarter annualize the per with net XXXX costs. per quarter in of diluted a non-GAAP expense of tax $XX.X million of of share net and net third and net $XX quarter. control compensation million basic $X.XX per and a $XX million million Adjusted to in your net We was million. and to XXXX. $X.X $X.XX the $X XXXX was $XX.X $X.XX $X.XX stock adjusted the for income Earnings taxes Before third and may committed $XX diluted The per a compared of in compared the share and reduce million per in or year of the $XX.X third or us per based which per income tax basic our to third the are diluted basic or share prior income $X.XX share quarter expense $X.XX million $XX.X

net the end please financial of sees income non-GAAP comparable at GAAP measures of reconciliation Our release. the the to our tables press most

Our adjusted XXXX EBITDA $XXX September of a was XX, million.

our sufficiently the EBITDA was excluding cash example Our in period $XX the converts flow million. for net activities increasing from account in flow operating the cash LPM receivable

in increase than million. accounts September cash our For flow nine our activities cum was XX, months ended receivable the the $XX was $XX EBITDA the million operating excluding XXXX net interest, adjusted

compares generated is the the million ended This EBITDA million XX, that considering noteworthy in LCM year particularly to $XXX $XX period December during the earned million in milestones favorably of and EBITDA during in LCM $XX growth $XX company the XXXX. EBITDA milestones million XXXX. Our in

EBITDA $XX milestone million expected ending payments We full-year. during $XXX December adjusted for million approximately year only XX, despite the XXXX earning the and

in shares quarter repurchased program quarter $XX.X repurchase of the a the share million $XX initiated original million worth expanded $XXX completing the XXXX. of million during third our XXXX. our by We During plan we August,

from the of your you receivable, the cash Operator, With open call equivalents please As was XXXX $XX accounts to support go had in continued questions. XX, net million I'd thank September million that, in in million of the and like net which and open ahead for and due $XX cash company for $XX Teva. line.

Operator

We'll Instructions] David first our Amsellem Jaffray. take [Operator from question of Piper

Instructions] take Stanicky [Operator Your question line RBC from Markets. Capital Amsellem? next Randall is Mr. We'll our open. of

Your line is open.

Ashley Ryu

did This final remarks meeting a do? like around [ph] conclusion. my the Ryu to around morning. questions. prepared for sense proposing, basically centered get conclusion that little Can good what that what FDA you [indiscernible] on end you ended Around meeting will want their us give the meeting mentioned Thanks your you follow-up of what detail over discussion position Ashley they for bit disagreement more to Scott, Randall. I a know Hi, is profitability Just what a the in EHS, was a was be first FDA for. and because trying taking of with without the in what without

Scott Tarriff

Thank you, Ashley.

our We but don't meeting had meeting. our say conclusion the not more and have have. meeting. outcome final these did are the So, September, just can't we the than agency. at really know to back We of with end We we we come of discussions, did at that having we discussions

I together get meeting have meeting. to in-person we'll we'll that at And coming learn more something think is here We there shortly. back to that get everyone. And another up if point, then and at much report material back

Ashley Ryu

track for trial, DIH on of you just are kind how far, added around many your the you And have and Okay. enrolled still thus patients enrollment?

Scott Tarriff

sorry. I'm No, Yes.

just behind. mentioned, running we we're As

haven't we patients rate to. the at expected recruited We that the

as in well. we mitigate work wrap go getting that, It We hopefully to this mostly as get plan plan as And is how then, everybody point year progress won't will revised of with place festivals. more going, we our that all. to these a also at have up music soon next follow-up into that we We see more and year.

Ashley Ryu

right, All thank you.

Scott Tarriff

Thank you, Ashley.

Operator

to We'll [Operator William Lugo move Instructions] of next Tim Blair.

Myles Minter

[indiscernible] your Lugo. congratulations decision my litigation with questions, ongoing question the this the quarter. indication Lilly. you're expect which an on NASA looking in Thanks. Minter Tim can the taking for confidence color that what any of operating potentially timeline great. [ph] of would be composition Hi, surrounds we patent is And outside the Myles specifically at, the Thanks of this, My on patent that you're and for from you gives

Scott Tarriff

you thank Yes, for the question.

to mentioned patent that, infringe is in of drug And done Lilly to us case litigation actual move that since they that, dispute very now with important were the not have an Having been the patent, XXXX. easier a to the to And will They note is just case; in harder. and in they're And these invalidity. it's easier and likely we'll course. the and pemetrexed, believe much it as situations the product strong all of which the on and way invalidate so In doing. not out again forward we've I market said distinction that not a appears we're required activity argue are prevail. same have we would just is that ANDA. generic from the started as product we filed does argue our obviously simpler, They these reformulated normal were we've as the the what we morning in filed case a previously So, we've through than XXX(b)(X) course typically what litigation have be in this our process until the required case, think blocked of the successful earlier here that's it's companies that's that years. move think that normal allows that infringement hopefully we of recently to that and

Myles Minter

meeting the to side, off models concerns models same be whether trouble follow your of or your interpreting back Are are [indiscernible] proceeding? bit how just for talking that. mentioned a you you And potentially Ryanodex can you change to thanks out I'm would that that? comment they Okay, efficacy right transition be animal we the that and going whether on of FDA wondering of a may had little up you're the

Scott Tarriff

and animal no question. good effect different I them the and correlation different of human point any so, I that one division know EHS between agent clinical with at don't indications so see, nerve ecstasy because there's this animal so by that's all the very that models of design agents. for not and are are believe models we be what meth nerve work program The the there is program, the also do than in will very all the

so, indications that we're pursuing. over And animal EHS can't I spillover correlation has find any between in other situations the to the a

Myles Minter

beautiful. Okay, for questions. Thanks you. a Thank lot

Scott Tarriff

Thank you. Thank you very much.

Operator

And next Bank. Gilbert question we'll Deutsche from our Gregg of take

Gregg Gilbert

Scott. morning, Good

Scott Tarriff

Good morning, Gregg.

Gregg Gilbert

the key just between your you the do XX cash market but your the I cash next occur XX And at it's how over on returning versus diversifying shareholders Thanks. if is use balance on pipeline maybe plan have portfolio? you strategy have could Biologic the any flow and to to first premature, two; secondly, milestones months? that of

Scott Tarriff

Thank you, Gregg.

take formulation is that in but rest trends. I'll then created number a line, group people first pretty me our regarding namely not done Let of I administration group had of Pete to talented of on that some We Group the wonderful movement the turning there pipeline. that then team. the and biologics with cash the think combined here team and pipeline we've talented in in work the of we the which by be reporting Ryanodex focus as spend is the we've always positive also of is reason. we're R&D we of and to are other significant which them is a Biologics in The for the routed the actually that the here what doing today, we that that some us and for product some doing acquired only last new The think in Biologics fulvestrant work turn very I outline over work the acquiring on acquisition that period, very we made on us a out a wound we're really why of main Group question work helping up the our

the I product the actual some progress showcase announcements specific were in some the frames these that I we by Biologics when making satisfied work that we've been of Gregg doing around time acquired working you we reformulating believe Biologic news or very with on acquisition. candidates are good them. of will but they in on be flow terms give as more very business, have the reason products In invasion we will that can't

but we're far. excited really the nicely XX, filling our think you what beyond in do we get strategy, I so we've next over technology is growth done this learn pretty So about so see time more XX as leg you'll as XX, of

Pete Meyers

we're as question. flow million just flow Gregg, hi, Thank in the you the months, cash do with we very quite million in EBITDA in flow XX and in $XXX case base Pete the earlier mentioned indeed last for generation. cash it's translated substantial We into pleased Meyers. so our $XX business generate and

is also We firepower. under We to sector business have in have do repurchase stock. our the infrastructure relative sales our to somewhat we compelling is opportunity the does with the and, each potential stays hospital so leverage are of that in opportunities proposition so sheet a review and levered compete marketing to development external balance given very our to particularly investment our own feel which

Gregg Gilbert

Thank you.

Operator

question David Jaffray. [Operator of Instructions] Piper from Amsellem We'll a take

David Amsellem

Thanks, and a just sorry, I missed the couple first go ones. around, quick of so

what elaborate think looking just that in and then terms you're buying Thanks. what specifics just to can what aggressive in for the we there be you're you be shares so filing to think other then And helpful? any in I you it First of Fulvestrant terms methamphetamine later little in I up can specifically aware could of on about 'XX talk and be later available think, at injectable this elaborate boost then and lastly on your you? anything timing of can you can deployment Teva there of half that of of. secondly you the terms on need the back assets expected, bit capital the originally so first study you sort would of there Ecstasy tighten in do And and that you but to enrollment

Scott Tarriff

Thank you, David.

report first. our you the working really was is the we be gauge able little formulation about a on bit should pleased what today. were we with that goes, around needle internally tell with pleased did to so on month our as all timing smaller dosing stay talk we talk Fulvestrant that let's which were can If we're wind with here and we the a you which wonderful. to We ability first So part up have and been forecast that patient this later we've of today

have so to be it hope last and by time very spent opportunity patients we're a pretty the we around quarter and made excited very in probably in fourth that time recruit to drug having situation aggressive And patient obviously path up get we off the progress seems which early we a the we nicely We able put for filing we formulation the with the us. time positive the we've in recruited the and NDA will timeframe get study, extra the passed I pay table would the and think if that to the time taking market. the on

unfortunately at is had number In Ecstasy a patients what mitigate our to We've of recruit extent and certain recreational of there either just and to other we've you we weather that that's get couple enrollment uptake. could festivals we each seem are been drugs below in music competing scheduled and amount some that have rainy work we the world what learning these where so that the of cooler that to festivals especially we've number the if to help or been to which it wider our running schedule we've instead done reduced these terms poor that addition We've the climates meth weather Ecstasy and meth and better had not is would situations of weather States and exist that's can testable United so had forecasted using just program right and some to and way. a potentially a to of believe us little also in people drugs from of bit a around of these go of did other reasons. leaving into doesn't music the assuming the warmer wave going we to we amount go that have that or

the sites more we pick just course. of will around world combination a so, of hope sites and things And

We other work. have if doesn't patients on into some study to the how ideas bring this

out we'll how that roll Let's then done. new we have we've program and everybody report this

as we've and think deployment heatstroke looking capital that now of been will pleased to quite all of we malignant area, proud buying shareholders. we value to sales asset even the terms for built a as products we our didn't used a hyperthermia infrastructure do look an pointed bit place since so is of that strategic with here have and I about and appropriately these with can has and sales how Ryanodex we our until development see infrastructure be we that QX very infrastructure have recently our that always you In have. what been very already the have positive and but done marketing back business is We're we give still could frankly shares in in in other we'll the sales we and based force the that have at uptick products we've up think exertional products way an beyond the force. we out to and little we hospital some be we sales believe force talking the the performing for we're size room approval that as comes very have so with ability that very That imagine to return to our right a also Pete asset increase infrastructure along to

Pete Meyers

of BD see if we can flow a in David, you to and comment steady add external environment just ideas. imagine we Scott's this I

external you'll does in rate to one, Number repurchase. can existing sales it imagine. need compete marketing a hurdle restructure recall and of marketing position you internally our we with so two, rights high. expect Number have substantial to that some here lot we as at solid and of those rate is very look retained a there returns financial Given the both from that BD, the we share and high hurdle and return opportunities the is Fulvestrant a Ecstasy

David Amsellem

you. Thank

Scott Tarriff

Thank you.

Operator

this Mr. at over back Tarriff to the for concluding return Scott to our time I like any And would host call remarks.

Scott Tarriff

the time to to spending with we're us. have in Yes, of to will thank about also and again. we bringing excited potential exciting quite was very you fruition as obviously bit seems about you quarter, share excited everybody with company, an it for a well, thank inroads you pipeline that strong obviously we're information more making have very the we It

Operator

Eagle third This does XXXX today's earnings Pharmaceuticals quarter call. concludes

You lines, everyone your disconnect great and have a may day. now

Eagle Pharmaceuticals (EGRX) 8 Nov 172017 Q3 Earnings call transcript