EGRX - Earnings call transcript Q2 2021 | Eagle Pharmaceuticals, Inc.

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Operator

Good morning, everyone. My name is Keith and I will be your conference Operator today. At this time, I would like to welcome everyone to Eagle Pharmaceuticals ' Second Quarter 2021 Financial results call. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answers period. you question, if [Operator time, that have please a Instructions]. At

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

Lisa Wilson

the Medical Earnings Scott are release for Cahill. financial [Indiscernible] Dr. the Brian and call Thank With Eagle Investor's morning, Company Officer Eagle you, Quarter me This Keith. Tariff, Eagle's Lisa press of accessed Chief is This on for issued Eagle a months to website This a three Welcome call Chief and be press Pharmaceuticals. of this the Officer Executive can Wilson, detailing Chief eagleus.com. Second the today's and Officer Ng-Cashin, webcast release Pharmaceuticals results through call. Investor Judith X/XX/XXXX. section Relations Financial

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

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

discussed, benefit was the made of be those Eagle Xth listening this replay announcements may and will with call related to call most and the on held then, Company's to Eagle who August over releases I And that, SEC the Scott webcast, to so to have Since the For the turn recorded may filings. recent Tariff. please refer or archived XXXX. topics press CEO,

Scott Tariff

you Thank today. our thank We you, productive Good a and and for strong Lisa. call everyone, morning had quarter. joining

present Before [Indiscernible] entering moment bring we past to here the I relatively proud get assume overarching If Japan, that of share deployed into growth. thoughts. of where a few wanted we days strategy soon, then years, in for the to I Vasopressin, phase new over Landiolol, Eagle those are PEMFEXY, shaping We're are our now the details, and market some a at we

slow, has Some argue been approach. that efficient may a and progress managed have but we Eagle effective with this low-risk,

continue to will growth. very quietly and is a we day this interact with experience, quality done regulatory these oncology, drive Company every in build we add capabilities. day physicians, to and hospital multi-functional we in with we hospitals and oncology with Importantly, manufacturing pharmacists, nurses settings. our broad Eagle employees and and What Combine clinical that believe have and our our robust every footprint

by a from to represents increase XX% which as this back Company, accomplished post sheet, clean, evidenced strong or strong have earnings XX% a today's year our continued million maintaining ago. $X.XX, We announced while of still balance buying $XXX $X.XX and a

have and on Landiolol. add largely around Vasopressin, of Company. cash PEMFEXY $XXX our Japan, in now in We is Bendamustine accelerate all also capital and RYANODEX have and million working to goal the Obviously, U.S. the organic. growth hand. net been of and We both

off Eagle Landiolol, products further for diluting our pipeline. significant commercial will using more Spec Pharma. pharma building longer proactive same Let and very a done exclusivity for which expansion essence are We disciplined, foundation to the business believe building. our Landiolol development At ongoing we development we'll that of We're growth strong sustained targeting time, pay paid our we efforts, believe for being this get Between enter we soon. or With our we in a we out and be by shareholders, will and commercial the very will internal additional hopeful value mainstream products amounts future infrastructure. way in like our reformulations organization growth -- away the also and see that platform. assets, we remain and that announce a able with me with the not and will requirements that little about and Landiolol transitioning been and other or to we from Company. for use are meaning functional out consistent our have products much-needed for announced and infrastructure additional much-desired generate pipeline functional we be the research cash companies point cash have of capability and requirements. the that need clearly

Turning launch in of consensus our on are already. earnings beginning getting was period We Bendamustine the and in what now our and Xst believe days to exclusivity a expanded close excellent an second we Japan, Vasopressin. had we PEMFEXY court very February franchise to forecast quarter, and few outperformed we we

will revenue to factors impressive a next XXXX. Taken in growth these potentially doubling of together, and year contribute revenues

let is into well. a which turned maintained products, than our had believe Vasopressin. trial delayed more assurance within and non-infringing significantly it COVID, with July been In start product proof of some respects, began appropriate manufactured gather as The ph range. more the our that delay me We due and trial, allowed to on Xth. year went terms to a In positive the us the

around results of CRL We the a study were mid-June, In full mid-September. expect to XX/XX. ruling assigned responded GDUFA we have court's with the and to date

in of Vasopressin, all which that questions XXXX. we referencing by our In total to We review, we raised file to Our VASOSTRICT, about belief months the believe can priority, important as million which the from to pleased to this trial decision COVID had as were program weeks satisfied review a We for is flagged look the that ANDA very well remember, bring priority Eagle And maintained continue a Vasopressin very year. that as $XXX and robust ANDA to outcome you sales market we priority with is light first the for believe of FDA an U.S. we us. had FDA. come. is in the of response FDA and updating and forward being

close which begins on we $X.X now period Xst. exclusivity PEMFEXY, A to market the to addition excited XXXX This of are nearly billion. us. for four-month Vasopressin sales In opportunity, ALIMTA our totaled another February U.S. in significant be is to getting for

for and been and first Medicaid, recall, looking and it in facilities we received Medicare, and you will launch approval and of access for also approval multi-dose beyond. insurance. facilitate commercial year, to stream be and we unique and J-Code We've last As clarity believe this an reimbursement file have we have FDA coding forward from physicians a February which in outpatient also patients a XXXX to provides revenue since important

partner by the meaningfully of for increases Japan. TREAKISYM, TREAKISYM of Bendamustine products or for based TREAKISYM with That Also in filed from progressing Pharmaceuticals approval studies infusion. Medical quarter, second liquid the market approval our in the application SymBio the and in liquid in our of schedule, Japan, an investigating to ready-to-dilute formulation. Japan, PMDA that In SymBio, clinical and PMDA the moving intravenous on the second XX quarter, nicely. received are infusion, safety the was Devices we opportunity pharmacokinetics notably ml ahead announced results XX-minute Now, for which and administered the application [Indiscernible] That rapid TREAKISYM formulation. Agency

of bendamustine representing income extensions revenue. next important the royalty is franchise, these million year Japan to solid milestone $XX-XX be of another range, in Eagle's With expected the and source

another year Taken year. of year. ample launch exclusive launch late XXXX, for well-positioned income strong from will a In will we together, be we have of the growth solid this revenue for the royalty very next cash Vasopressin Japan, and foundation we have PEMFEXY, and and

and to 'XX, generics to late long-term face 'XX. how to the turn we and let's now growth sustainable beyond, trended and So in in of due 'XX revenues for Eagle, ensure plan declining

for licensing transformation it in with share to U.S. exciting But a commercial well path scientific a few a as to less the first will reliant the regulatory our is I'd Pharmaceuticals like Pharma discuss in near-term AOP product, rights reformulations. for moments. very it opportunity. and the that helps for on Orphan Landiolol is Spec Judi Our merits as agreement of the Company how

evolve a NCE will and upon of handle a to therefore that reshaping mainstream the products very infrastructure allows largely the and Landiolol And entity of catalyst already true indication, mentioned initial as new very is The first support call providers. five the the need approval NCE is additional most exclusivity. Eagle's to for sees little will chemical second, Eagle earlier, Company our these I launch or we a as as place flows footprint We're path infrastructure on forward. we efficient through pipeline because to U.S. And received important a years in and on in the existing we reliant excited less the in Company and vibrant our marketing bring we to a for believe therapeutic pharmaceutical into have this have to regulatory of with clear third, commercial it reformulations. P&L, efforts. First

we and our split XXXX. the a upfront equally, revenue will benefits believe in we stream which to milestone significant profits look payment, shareholders, million addition we can forward to In $X

call revenue our the able an growth of that, to more light even detail. We turn discuss -- and to Medical are Officer very forward to proud in that Judi, face significant -- we we product Landiolol way Medical our of these important PEMFEXY, find of I'll bring now the now in and Judi. Landiolol, a in factors, to XXXX. the bendamustine Company in Chief for With anticipate I'll eventually all Vasopressin, such Officer, call over to diminishing going SymBio were

Judith Ng-Cashin

Scott. you, Thank

or care of the ill agent is Ventricular While with an anti-arrhythmic markets was a [Indiscernible] has atrial the and indicated therapeutic or control in in Landiolol flutter desirable. for as post-operative, patients in critically the circumstances Landiolol U.S., ventricular of rate control perioperative, Landiolol is and used in Europe is years. or it as XXXX. several been European rate of patients short-term Rapid Japan Japan XXXX in the short-acting rapid approved for Lock Supra as and in in with in Tachycardia ventricular in agent Europe novel in atrial other first the fibrillation for

failure, cause tachycardia, tachycardia. ill quite or tachycardia or These shock, from rate As The norepinephrine which agents approved care that to of critically in blockers, heart as management In fibrillation of judgment, ventricular treatment the be regardless can for Beta Beta in Beta the known postoperative used Beta blocking, and rapid also include as works setting. Landiolol underlying to neurotransmitters sinus has the binding non-compensatory critical may well wherein are of intervention. The specific heart their by heart epinephrine receptors. drugs ventricular adrenergic Japan, and blockers receptor class neurotransmitters, rapid the manage of are to rate requires physician's tachycardia. also frequently X of settings the been contribute the the development are complicated, tachycardia. blocking patients arrhythmia,

balance However, future effect believe could clinical the the initial the for additional which cornerstone the has and Landiolol patient study being X the heart Beta predominantly a clinicians muscle basis U.S. decreasing It rate in effect the We that blood the to of these become to pressure setting. on settings on-and-off blood for affects U.S. There management. lowering have the rate Europe in rapid much potential the management available for control In heart of study heart acting is and can Addition, effects The a or precisely. improve tool with tentatively to care submission that plan more has to the pressure. it unwanted Beta in patients. and will precise a pediatric could strength of FDA in an the conducted potential of has that therapy allows of agency. Landiolol therapeutic blood without clinicians ultra-short pediatric critical more a tachycardia cardiac also contractility contractility the agreed for welcome management Landiolol form pressure. as the key in blockers be

AOP June approval XX pardon at XXXX, U.S., held of AOP In terms submission the in strategy time with submit to proposed atrial timeline ANDA -- C short-term datasets regulatory of atrial meeting the summaries that, deemed would I quarter Landiolol time intends ventricular Type the financials. efficacy up feedback these July trials. a Cahill on from the in for the XXXX, of without over of a is a of provided With agreed patients me, of including which FDA, our in safety will and additional randomized adequate pre-existing rate the The C in expected with published the Brian The agency approach and clinical which it FDA first trials. approval that fibrillation during the data with ALP to meta-analysis U.S. in review this call discuss seeking meeting. previously provide Brian. support to and held of to and proposed the supraventricular of ANDA tentatively based to based reduction controlled months in tachycardia, flutter. was second-quarter Type turn

Brian Cahill

and Quarter BELRAPZO by share IMS market sales Product in second $X.X BELRAPZO was second good XXXX, primarily sales a sales The by recognizes $X.X compared And compared product the million XXXX. of million Thank $X.X total U.S. you, vendor $XX.X second QX [Indiscernible] million sales million $XX.X Second on Eagle the and increased in XXXX. XXXX, the X% year-over-year, to shipments shipments market to driven during $XX.X QX Eagle of for Based million was the BELRAPZO and prior-year the million to and million by revenue compared $X.X of $XX.X million in of to end-users increase Eagle's of respectively. were the of to X% compared Judi. wholesalers. million in totaling for quarter quarter. data, quarter morning. In RYANODEX the wholesalers $X.X to QX quarter in

in reorders are during $XX.X each sales $X.X the BENDEKA product was RYANODEX of entirely million during This expiring, to on second unless the was their million Eagle's BENDEKA the royalty quarter by compared compared second was Orders in dantrolene XXXX. from few of $X.X XX% sales XXXX, for acquiring period. stock [Indiscernible]. $XX.X million earned product revenue almost XX% primarily XXXX strong TREAKISYM QX quarter customers of SymBio. on XXXX, is the quarter. also royalties includes million to royalty driven driven prior-year Royalty rate from is and in RYANODEX quarter. from Second-quarter cyclical, revenue QX, by by With

The to higher the largely in Vasopressin second $X.X non-recurring during for increase second is and fronts, million quarter the was expenses On R&D stock-based compared were quarter. RYANODEX prior-year non-cash expense items. and compensation programs. other million the quarter, the to and excluding expense $X.X on $X,XXX,XXX. year-over-year R&D attributable spend

guidance $XX Scott The on expenses anticipated EA-XXX a for non-GAAP in outcome expense. quarter includes; We of XXXX will confidence $XX stock-based million basis million round The $XX loss SG&A expect million the trial, our reflecting related in XXXX nerve spend of is million XXXX. to as of XXXX between The up R&D million. CMC launch and totaled initiatives. the $XX strategy quarter in for primarily is spend has Vasopressin, $XX preparedness second compared $XX.X be trials in the to R&D and of of from Vasopressin, on change our result X exposure, our to second the the of the compensation prior preparative agent and initiatives decrease million and treatment of CMC clinical, the discussed.

net loss $X.XX quarter or stock-based the $X.XX and per diluted for million basic per share and per for net adjusted non-recurring the the prior-year per second financial full compared non-GAAP the diluted $X.XX or prior-year share, the share reconciliation and of the non-GAAP or million. measures, non-GAAP GAAP of or a end per million the period. compared quarter $X.XX a was per compensation net Net $X.X share the Income diluted $X has For quarter our and press $X.XX basic Excluding of $XX.X non-cash see of Net a million basic income seen $XX.X Income basic comparable million second in to second income $X.XX of quarter Adjusted was tables at in per most and $X.XX other to to release. please was items, expense XXXX and diluted $X.X

of million $XXX.X had debt. $XX million cash in cash As and and outstanding the Company in X/XX/XXXX, equivalents

Since with million We an common the of million as part stock of in the cash. net receivable. quarter $XX.X we net we million Eagle's XXXX, So in In ended had purchased second accounts $X.X quarter $XX.X I'll additional have of X/XX/XXXX, of program. through million that, repurchase $XXX stock. ask questions. our the our we share the Operator, million to ahead. X/XXXX please go $XXX With open repurchased common Operator call for

Operator

question, time, Brandon with [Operator first Instructions]. take today's this at And from ask question a like you would to ahead. Fitzgerald. Cantor Please Folkes if go We'll

Brandon Folkes

the Hi, quarter. and thanks the question in my for on congratulations taking acquisition

in now can your then firstly, to get maybe between maybe input I and just factors a but elaborate XXXX? the on question Vaso, Landiolol filing love you [Indiscernible] here. XQ And on I'd So just get

the yet -- in CRL Just the you an launching your straightaway? the Do discussions stop this we've judge that to Vaso, need if favor, case on avenues case. along case? think on the staying that in to any Thank does to you. seen just what given around have the then then And and you -- have go product Endo approved rule additional

Scott Tariff

The in that court And our Well, we Why no. he. there. first. issue first We does don't is the an the take had there's nor we'll hear as don't plan stated, need Vaso the expectation think to rule The thanks, so some answer Brandon. the we will I courtroom. about conversations September, will around mid forward from And good going judge is not by him. weigh and questions

that expecting next the the And we Brian year, the see as situation is, work and may our go the market the in expectation doing, market, should or to it's think we've to to on is And the section. both be and an we're the but As indicated wrap those assuming up able here corner, may far approval to weeks. and later to what as up knowledge in that X based right of the I have we his Endo a of let's both to X we're do, around opinion just our not what decision. get gearing been in

So diligence the agreement we for think, the move get feeling that needs done that, just to position also U.S., and are feel the now, very we good. to Did a but shape that case so process up as positive of of that all get weeks, through pretty Landiolol, Brandon? product exciting into driver announced. of rather that in growth to next we these about the through going normal we're place, done but first the forward. let's we're pretty takes from work in In our few just bit answer wrapping the get quarter product little AOP obviously we've we going I a the It's also in Company good the filed all and

Brandon Folkes

so should that -- on the reason basically ship consider You thanks year, Vaso, December or be think should any you then XX trucks much. just we this or so very December product did, wouldn't anything Maybe to have we on able

Brandon Folkes

ready-to-go? loaded,

Scott Tariff

The court's obviously see approval, is get Brandon, to decision, we before year's that, to but that that it market. think need the get I in the need in product I we over. we to our position process. that we with believe What about a the position we we're we're -- to are an only our say expectation the that's mean, to -- thing launched good I can get thought consistent are

Brandon Folkes

much that. appreciate congrats Thanks progress. I and the very on No, Okay.

Scott Tariff

you much. Thank Appreciate very it.

Operator

Excuse Our from go Tim ahead. William is Please with next Blair. question Lugo me.

Tim Lugo

taking questions. Thanks the for [Indiscernible]

all, you? more on regions, should starting then bendamustine back the you certain just the Landiolol guess that we of all, to of franchise could how and And second how for levels big inventory creep franchise was for opportunity, with size you I in Can So of how think provide on and the you about the of year potential looking? I current first deal. think your congrats from that be color wondering, the mentioned, second are half restrictions in the

Scott Tariff

good. Very you. Thank

$XXX into agreement of high Landiolol, you to diligence range of after quite you Company size Company, just into think starting peak product I more the that we of So some would we through refine or going a sales low. we're to bring and a about and launched. then take, of going the to give and imagine the speaking, generally bring is as into have as the forecasts, point bit I million have get the that can a get the product can good say from imagine, as a to

$XXX million on half economy, as we'll a work it go second then we of the me turn probably for peak as in year think that number I on. go is that on the sales the Brian. And refine let and to now relates the to it anything to may that right over

Brian Cahill

reverse that COVID wheel X the What I potential And would think it. it way back tape the [Indiscernible]. think about the about back. I creep, months we That's just potentially on

Scott Tariff

just But our fine. Inventory are levels

Brian Cahill

inventory fine. are the levels And

Our chain supply have has no expectation that not and interrupted. be will it we

Brandon Folkes

Thanks. Awesome. Okay.

Scott Tariff

Thank you.

Brian Cahill

would if supply. us and frankly, pull it no have today, was sufficient stock sufficient interruption through, And so we safety to

Brandon Folkes

Good.

Operator

And Daniel our Markets. is ahead. Capital RBC Please Busby next question with from go

Steve Arthur

morning guys. ask good Dan. both for here. our upfront and is them here. I'll Steve taking I've This Hey, questions Thanks two, got [Indiscernible]

any if away, just and second to on the is a just for sounds Thanks for ago -- questions. you Vaso, First that. on of with Endo -- one taking you are the it is still any guys going with February a little curious kind type still guys weeks PEMFEXY confidence I provide from how on based And of on them the are go. in that's happened I'm the are table, then color if more a trial curious if launch like in discussions few you based color guys six come and months just about your on was on can launch, that had guys so that for on in here, settlement [Indiscernible] how on you preparing the

Scott Tariff

case months that have up the X the of gearing now just and that product, J-Code it's an Steve, The thank is should opportunity. a with exclusivity. we four particular multi-dose have, approval. exciting in about we billion vial PEMFEXY, that length We're you.

deals think a in the we're next hope as I far It remarkable think that. about opportunity year and don't to and a just a know product in a in the a royalties into and from a you value ANDA getting we've great of excited do the out with the be corner And similar We and the in look, that shape. is very Then so a Landiolol very, market history, considerable we to gets in I great then and will so right what what it's and then considerable. normally differentiation. the as to market, comment think that and in just could the come that can you of see the And pretty X we'll the of the billion-dollar see because months. expecting to strong through maintain we the X% position forward, if we'll But we year. the Japan, market which very pretty our good I about should reimbursement J-Code convexity see we think were tail is by obviously, really, pay going think we're us another conversion competitors and have, we we're Vasopressin that why see world, having Company's we other strong have of combine turned advantages be for that's conversion forward, that Vaso We're the now. pretty ramp-up that our hospitals that have. are that to of price at a willing settlement, you will going

that really that in way in spent after get good expectation, in Our to approved the for hope put courtroom our a expectation did that over. you three think and after year's And CRL, lot a the of is amount that, up we'll of of our position effort it. and we'll get we'll hopeful COVID and remarkable we the delays work did portion and wind a lot is in know, a responding we that days, we're the money, of sitting of we'll we've related into a out the get turn very job before strong really through

as I know what need we forward. forward do a we we'll safely and two we're grow to those and to on strong believe to I our think what's can. based this be in interest looking looking a do we're Company happens year creating to settlement from of to position. so value with makes we'll best and a we're us the as rest We'll expectation sense, And let's aggressively now obligation. that what do And puts it our our these good right Landiolol. for listen. elements, we're But really that And If next again, monetizing we in with had Company, different that the have. there's short then I we're asset, shareholders our shareholders. and all leverage in is of that on But That's the the of combining meaningful value significant period bringing pipeline time away focused see now the that. very

Steve Arthur

your Great. guys. for time, Thanks

Scott Tariff

Yeah. Thank you.

Operator

today. questions for Instructions] [Operator

ahead? David Amsellem with will be go Next Please Piper Sandler.

Jack Hendricks

the Thanks Hi, agreement. taking this is on congrats Jack and questions my on for Landiolol for David.

me at then legacy to with for update filing your stand get you could just particularly great if with provide the potential and the where Thanks. there, for be timing also hoping the how on quick I things on thoughts end market on of too. that'd Fulvestrant, market you bendamustine year. a just the And thoughts latest trend question once BENDEKA on evolving, the franchise. was a enter Just generics see in for

Scott Tariff

it. Fantastic, Jack. I appreciate

bendamustine in we're been very saying. So consistent the what franchise, we've

saying we from that to the over about term near decline the the we once generics to generics we've franchise what is give see think the hole Brian, XX asset. $XX in leaves take, come is or can into million a I been get coming or about market, the a which need And $XXX year market [Indiscernible], this on XX-XX% what up. us with make after we come million

commercial coming their are that think have, number the And a hopefully, we successfully. significant to of Landiolol very us so that the think we be increasing to future, into as I to appears with pipeline the and $XX market. the excited, the to than hurdle the that get that to hopefully And of us seeing we from before number continue I would even in of back products of and the add And out we're have through to a have capability expect franchise to very Company. million to of we partner Vasopressin trended generics to Between the long, think that is coming and look that Company we around PEMFEXY through relative growth the we and and grow the after it the done and generic think to you're we trying Add the announce, everything data, rather that case a product over if globe, for couple that a we product mix. Fulvestrant, at that's the give news fruition year's the we've don't other future companies domestically else too some we're and expect launch. track similar In you bright, that internationally we that I a or are the more we product and oncology a that of other and agreements and Company, footprint you see infrastructure enough And have be take launch and bring well, the hospital Landiolol there that over. have some or the could before you to more in another at the further things an commercialize we here know, here when Eagle. lose our on rest have now the will going may the FDA years pipeline collecting able we companies Company. Hopefully and fantastic have

works see us. Let's out how that all for

Jack Hendricks

Great. Thank you.

Scott Tariff

Thank very you much.

Operator

appear would have remarks. further It will the to for Tariff no floor closing we Scott as I return questions.

Scott Tariff

launch base the 'XX, come, the a And revenue year for and in Vasopressin. expanding you look Thank the half with of meaningfully year now adding early growth PEMFEXY in be Japan. to us to today. launch of to robust to We forward our you. of and and quarter have this pivotal track we Thank for pipeline with again, potential in for product portfolio product to have stands we Landiolol. second productive our lot joining with had some 'XX strong a Eagle a years

for spending time the our for we you with updating care which and, hospital portfolio future. Thank and medicines are long-term. base both to opportunities Appreciate near organically important forward and the our shareholders business the grow continue solidifying our Stay to us. we long-term to earnings evolve look in of And pursue continue growth, We joining updating licensed, you all product the it. look in us of critical forward in to and need. to value our to patients near We today. for deliver as to and enable short-term, safe. and will us Thanks

Operator

today's will participation, This disconnect. you conclude your Thanks program. for may now

Eagle Pharmaceuticals (EGRX) 9 Aug 212021 Q2 Earnings call transcript