EGRX - Earnings call transcript Q3 2020 | Eagle Pharmaceuticals, Inc.

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Operator

Good morning, everyone. My name is Reed, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals' Third Quarter 2020 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, XXXX. call a today, being As X, November Instructions] this is conference recorded [Operator now pleasure is It my to floor Ms. over to turn the Investor Wilson, Relations Eagle Lisa for Pharmaceuticals. Please ahead. go

Lisa Wilson

Welcome and Investor Relations and David Eagle earnings Reed. Thank are third today's me Pernock, our Chief for Chief Eagle Officer, Eagle’s Lisa In is President Chief Pharmaceuticals. quarter Executive you, newly Wilson, appointed call. to on This Office; call With issued Brian a through ended this Operating release XX, Pharmaceuticals’ Tarriff; and Cahill. results This Eagle the Officer, XXXX. be release the company for the Financial of the financial press website morning, press accessed call section can of detailing eagleus.com. three at September Investors' a months Scott webcast This

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

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

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

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

Scott Tarriff

you, everyone. morning, good thank Well, Lisa,

great Let Eagle COVID of me the to having and constraints the a begin saying state due general specialty is year quietly that segment. by

morning, not positioned have as press and over had spoken as the releases. year, as nine the successes you two of Through to previous the years. often the significant We for years. a of issued many company growth critical This we next we number months believe has that Eagle of in first few

which our first quarterly strong announcement the The near to and earnings a future. in was quarter we provide described a roadmap

that potential to will to of number Finance. a the new The excellence he team. full of the believe teams the for second clinical of pipeline CFO, executive Brian speaking been our formulations announced you as we the these shortly. with and release Collectively, as with focus be as appointments us commercial internal Brian and key first realize strengthen appointment VP of four Eagle resources operational will opportunities. our is This well and provide Brian's our on multiple to call, additions Cahill years as the earnings has

QX overall update. provide review business and I'll First, highlights an

among on our model. third at the share mentioned quarter of basis business efficiency things, As diluted per non-GAAP strong, a I other up front, in reflects, very coming $X.XX the was and

of $X.XX XXXX. XXXX. of Notably, nine nine earned this months share this full For is the of months less $X.XX to the for first than the per the $X.XX we just in $X.XX $X.XX we compared posted first year, year

for R&D Eagle. growth a been our to our efforts same is XXXX able continue time, shaping And to pipeline this for we've be to at Given future. up to-date, strong the and support performance build year the

organic we take a just business one build cycle what earnings doing model. similar to temporarily left to primarily when on moment tried be catches We've of the dipped R&D while through periods there efficiency discuss In to me the Eagle our mean when I Let growth. I the so, expand may up.

on have, we XXXX, And bendamustine vasopressin around in having shares back we are believe considering approval our outstanding. we especially growth prospects have earnings final mind for received and in Now, XX in only beyond, million expectations keep growth SymBio’s this with trajectory. considering impact recent combined our all XXXX and the just PEMFEXY, that but excellent that are not shortly, approval basic growth, launching XXXX, and for will

a Beyond a are oncology have potential our group, critical expansion to XXXX. RYANODEX fulvestrant our care to on of the and competition This in strong and expected of of includes pipeline. we number business, out opportunities building that, the decline offset due TREANDA BENDEKA we SM-XX in side

for us sustained already period All that well a of underway. of this positions earnings growth is

back and bought of We have million our stock, both XXXX in company. to total constitutes year, company. in $XXX continue we XX% the to August this This Clearly, or significant shareholders. bringing repurchases a capital our million since pipeline of the reinvest our in $XX product of earnings to return

today, example, of the six years XX pro as it's time million I basic at count our an forma was million February our XX As shares. later, just IPO, XXXX share shares. And stated,

pleased asked month. granted now product specific formally FDA we turn questions was had us I September. vasopressin. highlights few last by in which noted that that review our with I to On call, fully am responded priority back say quarter's vasopressin FDA our to a to Let beginning me last

ended on if to that of our approved, bring trial XX-month legal are past we expect take January that strength mid-year. prior trial just launching this in May position a to over scheduled then our back set court And one around about held seriously was the COVID. We We We and product just stage thereafter. date original anticipate based have are we we due and but proceedings to hopeful XX, to by was our will week. postponed about this potentially Zoom, the considering learned date will The shortly product trial October. decision Remember, would receiving The is market soon XXXX. to the be the decision. approval new plan for and

to important when is that anticipate of exclusivity. for the $XXX This us as to we opportunity million an days maintain does of launch are XXX will occur, reach this continue our year. We expected sales VASOSTRICT

our oncology now to Turning portfolio.

anticipate XXX-milliliter We build converting will to the currently have million product Japan, XX-minute of sells our approval our partner in approval SymBio first We This $XX $XX the product in $XX and awaiting our are to year. with per milestone infusion begin income annually total bendamustine rapid product. XX-milliliter, to and about million million SymBio bendamustine in $XX.X bag, payment, approval January. SymBio and that a the Eagle received million from become recently consistent million the will received will us. far. meaningful royalties stream and for so to $X milestones bringing

candidate, and our to We all submit meeting which now. receptor turning -positive study HERX a the have The had cancer. product will design fulvestrant positive breast Type Now, have next EA-XXX, with estrogen will C advanced reach protocol. Analyst address program Day believe the the probably in that negative step just targeting year to of of of Year. minutes we early end FDA targets a We of process. study update and alignment the take are an provide we protocol the the we to we'll in form a we and the – to questions, with Once comprehensive this other place the agency, New open complete details is

from top also hear leaders. You'll thought breast cancer

We and patient to timing, are population. to outcomes the costs, about patients. of look forward around this specifics benefits design, more anticipated potential program really in improve the We proud this and to sharing excited study

Now, Injection, opportunity work let us oncology represents of a or significant on are for touch as ongoing and our well. for we in care. me critical with Pemetrexed PEMFEXY briefly where some other

unique a have as We last announced quarter. J-code

cancer. and with treatment are for time oral Technologies the as product August, that drug we A XX data We have is may another market recall This therapeutic for And underway. are to exciting of now which to the pivotal SM-XX sizable preparing granted understand file, entry in continue strategic have that this the will growth Tyme of valuable And partner will trial participate X, that a segment is patients also portfolio product capitalize cancer is next months next an and contribute FDA over third-line from promising can to XXXX and oncology And part approval treatment market. year. we lead pancreatic you pancreatic February which for for opportunity. in means we away SM-XX, multiuse about years. of the orphan metastatic to our of designation busy on our our evaluate larger several

ranging dose and to nonhuman studies appropriate efficacy RYANODEX to delineate start studies brain exposure. model I'll of RYANODEX animal and month, This of another Turning help administration secondary will are treatment portfolio. strategy. primates. for RYANODEX we demonstrate initiating dosing to now the nerve agent intravenously in These involving the in damage with

also arm study. program. GLP prior are special remainder our with include EA-XXX assessment, going will SPA, nerve intramuscular to early We formulation proceeding with and gain to agent of to the These update an the allow using alignment then protocol in us of efficacy an results the or FDA

IV FDA We low-volume, year second followed the our for complete of a program submission nerve of push approval. to the quarter to for end are by agent next aiming by

sodium to University research RYANODEXR traumatic treating in terms we System brain or have and other In dantrolene a of study potential TBI indications NorthShore development, concussions. of the under partnership use with injury Health

Our shortly. have look learn. expect sharing forward We and to first results concluding, study is we to we what

Pennsylvania administered research work intranasally role in in how mouse in was indication this second disease. acute intranasal dantrolene starting both showing collaboration In a starting disease, preclinical of on also with the Disease. year. year. continues model and that UPenn’s We're function A RYANODEX the of Our disease more August, may Alzheimer's syndrome to focus this to a model this is Alzheimer's Journal an cognitive of unique treating sodium University Alzheimer's this regulation develop published comprehensive for memory radiation preclinical on improve play

of complement with care will can growing our potential be this our business. to oncology acute RYANODEX, portfolio you see, As for we indications exciting business

are at step look that entering the XXXX royalties be started vasopressin and a cycle of we growth a If all to assume entry see strong we near-term already and cycle. you a and milestones So, PEMFEXY strong launch, this, growth XXXX, SymBio growth, back for market what the when in appears another can has you Eagle.

Looking ahead, and growth the cycle our XXXX a indications Time beyond. SM-XX long-term Technologies fulvestrant, multiple could strategic contribute RYANODEX considerable to for with and partner

to to welcome to Brian, put Before talented I Zhu us hired all over John Curt, Gaozhong Dr. our the the to Ng-Cashin, to these Kimmet, people of phase We financials. I the to Valentin ultimately like the and our Brian? that, and CFO, turn programs turn team. to clinical over also the call Cahill, new Eagle our I am the with advance would best to quarter position And to third Judi in Dr. Brian call delighted discuss Dr. to market.

Brian Cahill

In for were XXXX BENDEKA XXXX. on And third be by in third the US and million shipments XXXX. XXXX, was XQ compared market compared I'm in X% in sales. Product the you product Based quarter quarter third you, of third to decrease bendamustine $XX.X market sales the quarter with pleased IMS million quarter of product Scott. the Thank end third all of to RYANODEX compared users XXXX. Increases $XX.X share of partially during million of total $X.X to to were quarter BELRAPZO revenue to bendamustine in increased was $XX.X the in $XX.X in quarter. million wholesaler BELRAPZO today. million, the sales of Eagle’s sales of offset the a million, third to data, of $X.X

approximately and normalization of the these bendamustine down a XX% to in in utilization compared as associated We've to discussed trends decrease to a pandemic IMS in period abate. but of resulted oncology care prior see our reversal According to products. shutdown. pull through results and a call, anticipate reduction outbreaks lockdowns quarter second the the utilization data, is mid-March yet a in to continue products we led the to broadly in As health physician-administered specifically have COVID-XX

by system’s the of challenges face innovation in lifesaving patients are COVID-XX We health care the treatments to the to American encouraged have stemmed pandemic. deliver that the from

the accessing exceeded in XXXX are Third already quarter the XXXX. and potential to expiries. our $X.X precipitated quarter for efforts driven Quarters sales sales sales RYANODEX RYANODEX the challenges pandemic, were period. in by million of assist any prior-year current RYANODEX COVID-XX and Despite product commercial million product $X.X by our customers full-year of compared to cyclical primarily year-to-date third have

margin a of XXXX, Eagle sales; we've royalty to RYANODEX the third million quarter. of earned quarter $XX.X the For BENDEKA royalty; $XX.X from XXXX, the XXXX. the for XX% which the the third on XXXX. quarter BENDEKA Of gross in the at two, It royalties In one, – Gross from this, SymBio period the in prior-year amended rise quarter the were from on quarter no XXXX the XXXX, million third $X also was to approval milestone profits; our XX% third life the and XXXX million during in license agreement. XXXX of $X margin of Teva the to driven XX% it compared in of earned million rate increase our as royalty RTD was marketing XX% and of in BENDEKA four, third to royalties X, The quarter, product lower third in quarter Eagle in some based In milestone for a in October TREAKISYM in number the increased in revenue rate sales the payment remain million was XX% expansion $XX.X payment $XX.X compared On of on again the where October quarter SymBio. months. third X, from of third to following million of earns three, will number XX partner the quarter increase Japan. XXXX product. by, an will

on were the lower well compared lower vasopressin The the million expenses front, to programs, compensation year primarily stock-based the decrease million RYANODEX as $XX.X in and On prior expense third expense. EHS R&D quarter, as resulted spending quarter. from $X.X for our

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

exposure million and the CMC anticipated studies EA-XXX our of and R&D agent XXXX. $XX Radiation R&D the the initiatives; RYANODEX four, CMC Syndrome; of reiterating are includes: $XX million EA-XXX of for five, $XX.X third preclinical in trials non-GAAP scale EA-XXX formulation and million IND-enabling PEMFEXY. North System; million to XXXX to million to of work due of decreased trade in quarter costs spend of nerve trial six, $XX.X University XXXX Pennsylvania activities; regulatory $XX and additional We expense three, the two, guidance and compared T&E, XXXX primarily compared the Acute launch at treatment and to and vasopressin toxicology decreases one, We pilot show as development costs, for external advocacy in quarter Health preparedness EHS; in third expenses. legal and RYANODEX for SG&A the University expense number Shore for to

compensation million. XXXX stock-based third noncash and and Excluding other items nonrecurring quarter SG&A expense $XX.X was

diluted per third and or was per non-GAAP We XXXX non-GAAP basic for XXXX income or $X.XX quarter period. the net and in basic partially basic guidance net basic be $X.X expense on to to or quarter of quarter. a income basis and compared spend largely expected $XX XXXX. million increase attributable our payroll, compared $XX and to $XX.X for marketing are by diluted a in $X.XX higher $X.X compared of was $X.XX T&E sales offset Net share is in per to million loss of expenses. net non-GAAP to diluted and $XX year-over-year million is external share The million reiterating legal $X.XX prior-year prior-year the diluted million to as million third $X.XX that Adjusted $X.X the share SG&A share or lower $X.XX per $X.XX income and per the per adjusted million

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

to the million of of to quarters XXXX $XX the was third non-GAAP quarter three million in first quarter. the XXXX Our prior-year EBITDA compared was $XX.X $X quarters Adjusted three million in million XXXX. EBITDA for $XX the for compared of non-GAAP adjusted

three quarters cash For of the flows shifts compared $XX.X first million excluding quarters in first receivables three from of to XXXX, $XX.X million XXXX. operations and was the

XX was the ended million. adjusted EBITDA non-GAAP XXXX, For months XX, September $XX.X

XX, in equivalents net of and we the company $XX.X As of common Teva. dollars Eagle’s had had of repurchase was $XX through XXXX, company and million. Therefore, from September $XXX XXXX, third million August of open stock. our XXXX, net The outstanding receivables $XXX cash million share ask the million I'll part questions. million XXXX September program. $XXX.X $XX $XX.X debt. the common of purchased we of for XX, due of receivable, had as purchased the XXXX, call to plus million In million accounts cash With quarter company of cash our September million in the XX, which as of From stock that operator $XX.X

Operator

And Randall Stanicky Capital. with we'll go RBC first to

Randall Stanicky

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

is understand a Can there First follow-up those for terms I how what line FDA. number on on risk? sense the to from on that then perspective you us a into of willingness you've timing. the your just at that your wanted and give confidence priority to two, out adds. on help plays that's thinking at review vasopressin, us of drug where And called the management launch generic in is ask means Number So, one.

on host of the You that more Should the as huge XQ. the positioning bench or announced business business a implied it suggests addition to R&D, we $X and, guidance about folks around quarter. respect thinking the thinking dropped The specifically, last – step-up to be then, million a this a And for step-up bolstering or offense in a this just of morning. down development? one with big

R&D could Thanks. would clarify rest that the you're this great. you be the how year just about for thinking trends on If spending of

Scott Tarriff

lot took notes Well, on question. thank you, Randall. Good your speaking I to of you. a

missed chime in. I if So, back something,

the One, reasons. our to priority us look, and is XX-month for was it stay that understanding my review, of first So, in is we're two primarily past, the file. to granted

is we remaining is mean? that know under to all we what the know is What we that questions. – is So, review. having responded We believe, the file what do completely active does what,

review And that know, submitted you we to the believe, so, we can review based shortly. nature what of we've best active that the priority approval going it, in is on come that, that and is say

at And satisfactory under it just is and we'll any near-term. to, we responded wait happen, would know, could I date happen I what we in assumes know, it but the That have should specific give but we a that that is active so no did you expect everyone, see. in call time, You that it – everything that there to manner. and can this review

at over That's the as a In litigation. interests months, several believe, of And terms can. as to soon as of have strong our that, last risk, we've at stated the best in like shareholders. confidence is launching we the we our position Randall, we'd we get the to market in

product decide And so, And, a But a know, diligently to all we and and to get as to takes market going. advantage it product approved the to pretty get working the I of on And you have coming there's the a yet likelihood to work just ultimately get good it's not the decision we'll final that we’re formal, that take conclusion. made money a board. us. think a we've spent this important hard all and

I XXXX, keep royalty vasopressin have managing have in, that the in growth, pipeline. And and SymBio see we have we growth coming my XXXX comments, forward launched ability over to the earlier and launched As growth significant going the now PEMFEXY. the wonderful that our we looks mentioned pretty now

very that right? management special, close, have the terms coming changes, very in. are We we of revenue to the building believe In close we something very

long And meeting and protocol do to wanted We well. product been getting to we'll appears market. that we've the to fulvestrant agency. the have timing Type And company exactly the C to between we a years. near-term the be people out rather close what know working aspects pipeline. had This and to to We have gone us with of finalized that on Once appears number make in of that, sure we best on a this to what have we able in we in. the coming all got FDA have a earnings need the we very be

to the really have hired happy this that just talent BD better a diligence I’m the take gives We the chance that very items great have team years. to up it to And, chance us yes, we more. incredible certainly better with But it a appropriately assembled get done. think over staff. make on gives the we wrap and really us some a just are on we've It all decision. define a side, to required

in and want and So really it are growth some a here. go products excited, and really Brian, we're Hopefully the about through stage we on great really have $X years again handled about currently you with the make people I pipeline where know, comment the you and just that with the that to the to R&D? we and then, do we're million

Brian Cahill

see mean, I our guidance, you Randall. Yeah. Sure.

You're lot fourth lot right. in a programs We in activity a of I that and quarter do mentioned the of have particular.

for You not that's vaso, know, right, approved preparators remember launch yet.

So, there's RYANODEX a good there programs and amount were indications. of other and EA-XXX the expense

Scott Tarriff

Anything hit did that we we Randall, everything? missed?

Randall Stanicky

as you you Yeah. every That would and thing, I this been you're this, on $XX be right? No. cash question BD. Scott, only guess, we asked BD, you in million have active And the about you helpful. get in think sitting other quarter, was

thinking any productive you quarters? that business we're be we there how thinking as to development about should sitting and differently here want today, versus you prior So, be are today

Scott Tarriff

it believe, the think a it. question be to Well, thoughtful smart a want do takes and and get Randall, bigger thoughtful to company I I response. We about want it's very we

vasogets and the pancreatic BD we if that cancer. and time, look at feel to programs the us. that when are thus of the far to time, assuming that There's particular at where know, you now, we are look that up addition good coming obviously you clinical other program. you're interest cancer like seen risk program we've you the company wind market. it's of that really out program that But what de-risked we've know, in we so especially if But could very far know, the in at in you we special. point, so same done the nature And far, to with pancreatic in being something You of have

vaso, between out, really SymBio royalties very growth what with is and know, R&D earnings. making strong nice we clinical. We're in coming really the You we progress have believe and PEMFEXY you know,

but we heads balance like us, I up, clinical we'd for with and a and up And marketed as think here hard, very look, products. pressure. of really the and David a a think the lot we And working feel I months. of David the to BD me, look work last he’s don't we heads already And continue few the lot derisked we've over pipeline earnings hard, we're being selective. but we're

Operator

We with have David Amsellem Sandler. Piper

Unidentified Analyst

on Zach question is you, This Hi. [ph], for Thank for my David. guys, taking today.

review. what competence? And looking you. review the missed FDA now? to could I do issues was Congrats your regarding the are really surface if given some FDA Thank what August, the question that you filing the submitted is, of their But additional VASOSTRICT. in – for but the priorities data question this, they as when think you Sorry on the my so, one

Scott Tarriff

Zach. Thanks,

now. around the really, mentioned a lot X.X polypeptide. of years, question, and to being questions is basis made it product last more nature an of being things. we've know, knowledgeable all going has whole field work the of to side and agency right it done program we've in you having And, And of of molecule. think, A file, update, done majority been done a call, an to for FDA polypeptide has a polypeptide around was the the the So, I research us active and of of of first far and quite very has I the on of asked. work work. the been that A I the we've of lot surrounds, us on, asked this believe work we've lot And old nature as the work. do was it questions. amount that that do It's been the the around And the the great asked they

never get you believe fully them We feel us. and back wait I know. know, are their quite for you have confident, mean, active And we we we've as we'll questions. so, to we confident, answered under just until you review. But, said, Yeah, know to to that

has Our XX-month stay expired.

They've to given first file. a the are us We status. priority

So, it we've here as can this we they're saying, looking we'll know we that been And, that diligently. know, approval hopeful what that all at we're you say, at shortly. get point, is an

Unidentified Analyst

follow-up I the envision BD, on the on Great. do – along other ANDAs more filing you guy you lines And Okay. do with the do [indiscernible] one sticking vaso in future you of strategy? if could in plan slip XXX(b)(X) or

Scott Tarriff

to right? a proprietary I are done, fulvestrant, we our and though almost know, I XXX over, that time we would respond you and technology by be don't subjects XXX(b)(X) now is probably strategic dosed, the that, we'll $XX is have think in so probably the way program and patients million or into a plan, a So, company, we're to when even it's XXX(b)(X), that.

of on XXX(b)(X)s don't a SM-XX things. where it, Alzheimer's But more side good ourselves the term on. handle where believe, can all novelty of we do working don't complex I willing get help very vasopressin we are very issues talk partners that and short about doesn't that companies have the some it behind anything And, created you the need are we had – be takes you science you certainly, we in and team to we that through with as and partners biowaiver if assembled, like that getting think. But like ANDAs we all the of mean and other work like science-oriented concussions equally. consider and, put our to much you see, pancreatic not on PEMFEXY, So, XXX(b)(X)s, now these that with and have we're the in products difficult to to we're there

continue looking to will took think to best continue high-science-approach to more we're And be do. when far years public. that's we going be and what And consider us and than that's an we're the we what opportunistic more to so, company. we I do company six a of But at I were ago that company we

Operator

Please Lugo with next William to go Blair. We'll ahead. go Tim

Tim Lugo

the for question. Thanks

vasopressin soon? you would the something before January receive timing. So, address it after a a Can launch I you or poke were an trial? you to guess if we're approval where all you probably bit consider the trying little more is this Would around refine maybe to year-end

Scott Tarriff

few Hey, Thank yet. a through Tim. ago. that believe Good to July position hear data trial to from We in We're fully XX the only answer that. you. don't you. going we're found a out just about I days

So, and we it. to talk need regroup about

confident four-day come my out We'll hope. is However, the of confident our more in my we're position. guess, probably trial

But as you I happens. can. bring we either what right We're a we're as it. going a we around detailed to shareholders soon quickly can. XX corner. looking we mean, to January see answer value wish as Let's I more to as I focused find but are is the at the But way asset could on way, monetizing still give

Tim Lugo

Understood. recovering of haven't focus you Do still the volumes of we out that it [indiscernible] for in could of though mentioned are kind across Okay. you are like the of think kind normalization levels. and the that products, pandemic concerns could – sort kind normalized see as industry infusions oncology pre-pandemic And of some obviously to seems QX heightening?

Scott Tarriff

for that track let David know, of you He you. that's, respond Tim, of to have No, me some keeps it. close Yeah.

we give you're what or if know are. don't what you David, than the industry is I other companies your seeing seeing why you're know, You different in overview? But don’t an with

David Pernock

Scott. How Tim. you? Sure. Hi, are Yeah. Thanks, Yeah.

of to as the some see some in improving. country, as right, parts You things are, know, normalization basically, know, you starting we're

the like wave too. You starting it you enter seems again, second know, know never we're

to of kind predict. it's hard So,

normal more good our things we're control. you we're of kind so some that's continue. patients the more return and most likely these some thinking which seeing are know, of out But, kind we so So, far, of stabilization visits, is think for and of to

Tim Lugo

last, And Understood. maybe Okay. question. David, just one

you do of it buyback? what You if would a you of you as you're kind be? ton going going How a be will duration like with and Can you cash. know, kind a generate trajectory kind kind goes but transformative expected. of some up time mean, to give know, you you kind of would that at launch? major durable launch, this do you BD, as Would smaller us more just of for BD it it deals, curve? What you’re then and look in that as mentioned cash? of I the launch that or of shape well to, whenever of of be do a larger kind have that expect step sense cash deals And

Scott Tarriff

Tim, exciting programs. that close there's of so You because of into this we going know, are so right? through growth key It's some very R&D opportunities is, and back – to many us, be curve planning our being our ahead you now know, strategic process with going

you the than spend. what for mean, the yet, that file, last And And I in little we being to required other R&D. million in of the have you of of What unknown. that's vasopressin been to requirement it's been we've an call have with never approved so is it an And a durability heck to into I that of you is the can is product ANDA. I ANDA. on level invested a And now. that expect get the wouldn't what's tell that $XX of difficult would money that committed this to bit was. work asset put mentioned kind first of Half a done,

believe don't so easy I approved. others an this get for And to that ANDA is

that a of Now, appears having settled has said it with lot that companies.

are. what So we the don't settlements know

predict. company. believe do a a the we it a lot will little this bit for number years, generate of for product to hard But very and of valuable will that be it's So cash

cash? do do sheet. the balance a what we have with then so Look, And clean we also

stock. have We buying our We've been net back cash.

So we opportunity so a business wonderful position us our approach like have to slow do six the the our anything sheet, put to. has really the we'd stock, the in a because that cash really that to and fun years do to been with last much steady fact and we've balance taking and

market. good back suggesting. So, looking things what's happen vasopressin at gets to look, to I of going all market. to the the we that we're through a already. earnings the as know, going you're to of what what's period, the this, assuming our And, don't to be know that to bought you don't stock we company know XX% go happen really appears I

deal afraid of We we're need transformational been know, entire financial already stock opportunistic doesn't not we'll If to because whatever we're the having smaller I doing who company. like back of between believe company. as the in deals? what with care. what team phenomenal that you the we accretive, this do more to know, buying people growth. stock view Could there's that us either. can the react, we're If continue a oncology. be team a suite, David's do an to And do You to in our critical do ability do have, strategic We ourselves. the such I as and is the we and in knows? that in we Brian we, like that for doing But being and view executive we doing job us Sure. we

starts the know, the is really that execute. on that that us this, know, could quietly to had and on XXXX. you up for approval. build new Hopefully, the everybody we hires the growth It'll that'll Now, to with have we’ve you had, earnings in sky limit if It add growth with snuck happen. that we we've the vasopressin

so, opportunities our think limitless. I are know, And you

will happen us. Let's hopefully, get and good down for just our done and, it put heads things

Operator

go [Operator Instructions] Brandon with to And Folkes we'll Fitzgerald. Cantor next

Brandon Folkes

taking promotion. hires questions new and the for the Thanks Hi. to on Brian, my and, congratulations

subject So, I’m just going the to stay here. on vasopressin

to at the the you of vasopressin, needs formalized give timelines? the terms of still [indiscernible] looks stated, but Given of and the to formalized any if [indiscernible], like inventory trigger agency in review that guidance figure, any an a look I for then sense this product have application? now your you under it done. does the know secondly be still manufacturing R&D obligation maybe in as is you I it’s timelines And party,

So, you very for time you. can shortly? you market turn vasopressin the of that very, color approval how to you supplying give in quickly could around just got and us Thank if terms manufacturing’s any the lead

Scott Tarriff

may comment know we to have hopeful on launch. it's having about going under see, exact. may the It it's We right? more we're you, It's nothing review, than happen active There's timelines. we and really shortly. can't not, Brandon. not Thank more or But hope that priority some to and say we just a we We're obviously of review, feel to. launch, can good for all and everything if we able that we're inventory. do everything this. certainly We preparing with received But other

So, chain good I think in is shape. supply our

Our price the shareholders, down our this patient population. company, for is manufacturing good and in We're our opportunity is seriously. We value to it incredibly bringing the to taking shape. recognize

and we're have four go. get good And shape now, days. so, ready to and showing expect the approval And And we'll decision. case hopefully, And we'll in hopefully, we good a there that make have the we court a our then, right corner, to. around

Brandon Folkes

Okay.

Scott Tarriff

sufficiently everything Did I you? answer for

Brandon Folkes

You did.

Scott Tarriff

color had on we right? more everybody, would If tell we timeline,

Brandon Folkes

Yes.

You’re right.

Scott Tarriff

could you have world most that’s we give is certain. not do the thinking All we in a up-to-date that

Brandon Folkes

Exactly. No. terms And but the pricing sort one just talked in very repurchases what I onto Maybe you appreciate that. look, shift about topic You very, yeah? level, of the one last done. can, of you've high

would you lot any you public I forward, in lot point, you not sort a an of alternatives of a company and the continue if inflection obviously cash how share, markets to your or about value markets reaching going mean you of the at strategic the recognized in looked of private mentioned that taking ever flow recognize forward? going the talked timing. sort You is public value not if see

Scott Tarriff

we buying and over authorized been at a buyback. reduced the Brian, we've thought very million had been private we've the We share-by-share years back, by the with good The company last been also buying That's that few back. it, $XX Yeah. $XXX we've way taking look process. We've think buyback I share million.

if it a take a a organic years that everything. our been – growth go ASR authorized our and have sheet. that'll There thrilled I of are years way. have little a back We react. doesn't stock earnings. sizable we hopefully, to partners a shares balance we amount a about to it another know, that to amount. to you whatever And couple of way anybody plug number pretty that we're team sizable our still do the we we know, could we on return at We're start sticking we the do of focused to we not as buy if anything a the and But, painful what this. and back declining thrilled can making cash. deal So, shareholder the ability have slow we prices to back. fact was to but and, of ways about ability shareholders to bit growing the on our the number is had we private? has about That's company. and the We're And, our any at building We're bought You just But very out we news to think thoughts, rule comes plan, we to these the thrilled and went lot maybe. looking a we you you our want of know, don't our And was value for And, Look, you to know do get pipeline going But couple steady I been, see that. a the more by through thought we difficult, know, a value and know, to to to great just little of just the we probably and us. great know, buy would right? we're bit we're smart think do launch it that have have move us. and, you a hesitate focused good through, don't we're need what very, products reach successfully, company. know Would is I you out. do prove hopefully

Operator

Gilbert And go Truist. with to Gregg we’ll next

Gregg Gilbert

we Thanks. settlements it's point court or a say Good this complicated other say actually at given and more and, and table until vaso you filers number that one never off far settlement I are gotten. question the would how morning, a and and along happens? a different one Is Scott are case the think, how you've never team, than of

Scott Tarriff

Yeah. question. Gregg, the to this thanks speaking morning. you Good for

these you know, never say never You think. anything days, about I life in

see the happens around. let's know, way You just all what

you date optimize is so focused to best can. responsibility value we’ve repay can, our and think value approval. returning we look, shareholders, take that and the part the to much get we’ve wonderful money we’ve just, is worked spent about I that's are shareholder you we management as of the that for the advantage our And them think to as But, on at. stock, opportunity know, our hard the And taking the an team I continue improving keep all and know, Let's these things our open business out XXXX. facet great deals, for a on do we've best having of with us every and the spoken your of Like settling. be PEMFEXY, did transformational small mind right? launch the we date to February about, what's everybody's will interest fixed in about buying turned in to Lilly in That private, deals, of we back company

to So, open shareholder that improve we're will return. yeah, everything the

Gregg Gilbert

makes I’m, ahead. Go That sorry. sense.

Scott Tarriff

benefit strive to Gregg, sorry, the in just not that I’m right, a importantly, that most of to we let’s’ importantly, serve. patient lose importantly, and But maximizes the most Most it, finish. sight way to population

on. bring haven't to it the to mostly I'm cut trend population, And metastatic we’re tremendous we're focused end it going to in the that's say, really value postmenopausal that's the reason this the because potential to we I And day, today great that you about business, and help really, is cancer What patients. the vaso lot we're you a off. At patients patient about we're so, across spoken was the but focus this breast excited really Gregg? of country. it sorry, could what

Gregg Gilbert

you're sounds other on your transformational it have the a you're now times to curious word more that I'm gone that couple in now yet. like transformational down open-minded haven't XX shareholder No back you've of anything conference than was a to It the calls value transformational if last And more you used little could how question whereas But I'll would open-mindedness Thanks. enhance do about to My the past? sense use later. may to times. why? about many so, open-minded before. maybe but made see problem. that of change I if not drill word

Scott Tarriff

Well, let's see. Yeah.

you But If then what wasn’t our was it here And brought and been right, years stock And up you we've do in to think harder was internal I had would an a from have for, couple that to standpoint we that it as the do I came growth, word the and we business. years. Tim happened something a be following up earlier. decline in standpoint. believed right? with dilutive earnings company And would been internal I think, gates out had more that from of talking had that and shareholders. first little someone a XX been and went and, pipeline, earlier, the We and We of a more mostly us, it the Tim said you know, decided public been to from the the know, brought us little it loyal you this to waiting pipeline transformational we would difficult. for earnings much to it have – It you dip when are you in to few deliver. a the for years I away Gregg, we great you've know, pretty the else when call question taking apologize. then know, run

just in a And so ourselves different find now we situation.

XXXX, good and over XXXX these out. get pretty have We growth vaso other products

the have We behind SymBio us.

the of just You growth we've time, pipeline. to you know, know, line vaso to SymBio period through line hopefully same finish not and and moved time. finish significant the going to of rest to large, line. we're a PEMFEXY go At the getting finish the the the It's

new with tested even we closer of indications have version with much nerve high-end Now, being feel now fulvestrant study. our closer, agent a potentially in We RYANODEX,. of dantrolene, RYANODEX these and we're

So making we're progress.

now, [indiscernible] We in have we had new the people place the people. people the in

so last And the is was a than maybe something think better over about transformational time months. this it to XX

– we're think you correct. I you're yeah, so, And think I know,

were. we – open I we're think to things than there's more now

Operator

time. turn any remarks. No Scott back Tarriff further to this questions for closing it at I'll

Scott Tarriff

really the for board. about have great outcomes. what questions. fulvestrant to the the year to days Thank also plan call our deliver That's up excited. and treatment a continue Fulvestrant patients build some thought us. thoughtful. your potential. and around you, improved of hopefully, advanced Look, session, Vaso great good breast has therapeutics our cancer today. us. strong we a earnings across out were for finish we everybody, patient you, the XXXX we're speaking just is to ahead upon I Thank I remarkably everyone. And a to And as We're shaping can been lifesaving have they shareholders This change And deal accomplishments to lively has strong quarter. the and a progress we've growth who of benefit. year made of potential great strong value and of paradigm recent to what we company-changing be

all you. So, again. of a and you. Stay can't Thank speak Have to thank wait you safe, great day. to

Operator

today's And conclude you this appreciate your program. participation, and does may now We disconnect.

Eagle Pharmaceuticals (EGRX) 2 Nov 202020 Q3 Earnings call transcript