- Earnings call transcript Q3 2022

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Operator

Good morning, everyone. My name is Todd and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals Third Quarter 2022 Financial Results. [Operator Instructions] As a reminder, this conference call is being recorded today, November 7, 2022. It is now my pleasure to turn the floor over to Ms. for Relations Investor Wilson, Eagle Pharmaceuticals. Lisa ahead. go Please

Lisa Wilson

Eagle's third Thank webcast call. ended Eagle earnings Affairs, Eagle Chief With call of Financial Pharmaceuticals' Scott section Cahill; Executive release Investor of results you, for Welcome financial release detailing to Dr. Michael Pharmaceuticals. Medical are the today's on be Vice Todd. Officer, press quarter me can and Greenberg. call of This Tarriff; eagleus.com. This This for X Chief this morning, September Officer, XXXX months accessed Relations Eagle President and Eagle is and President Brian Wilson, Investors XXXX. a issued website a press the XX, the through Lisa at the

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

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

press made archived XXXX. that, of call announcements who call then, Eagle be recorded or webcast, And X, have Tarriff. November For may over reference listening Since the the and so topics I'll to replay and Eagle's discussed, CEO, the benefit most SEC on may this the to please releases related President filings. recent held turn to the those is company's Scott with

Scott Tarriff

and It non-GAAP thank another joining morning, for share strong earnings that everyone diluted quarter Lisa. was Good call the at earnings trajectory today. you for our per thank third we the continued $X.XX. expected Well, with quarter Eagle, you, coming in growth in had

of For million vasopressin the have combined. year-to-date, we sold $XXX.X PEMFEXY and

have months evidenced this $X.XX record the year, posting best already ever as we $X.XX our are previous context, per XXXX. in share. put that that To of earnings the already We tops first number of full fact year the by into earned X year in it

a path we our disconnect So to XXXX the of valuation, we potential profit. be in of really has solid are current And earnings both terms may year with a revenue is simple. there fairly another be The story strong while on Eagle growth. and believe for

very company a balance with lot have a strong a cash which We generating sheet. of is

Enalare, in used money Acacia, stake clinical of that and development it and CALXX. acquisition to the the of licensing taken of have fund equity landiolol We the

the we very increased believe sell manageable. of X and full We and products $XX repurchased XXXX the and novel and XXXX we or as quarter, of first in NCEs, repurchases Acacia We had this portfolio strong remain revenue we of about and the a well. excited bendamustine We Enalare's of million of and build we we potential revenue Additionally, did and of in reiterate, value expect from PEMFEXY situation strong the realize and months as $XXX be Acacia anticipate to approval our bringing than we To million. And more our of landiolol. 'XX will BARHEMSYS in terms out total to the profit 'XX. very BYFAVO landiolol is 'XX potential for CALXX. shares products the hopeful

the a strong all also grow to Eagle the We position to out earnings key to put approach pipeline, an balance our this our achieve deploying and believe term. make accretive anticipate to but cash through our short to in disciplined our we portfolio. potential cash round and Additionally, from long we we balance acquisitions both the the believe in managing sheet. strong Between and sheet of acquisition can initiatives our and only significantly have ourselves clinical not fund

assets. a to We are stated our way to pharmaceutical portfolio objective of well on transitioning diversified with achieving our branded company of a

the to third Now quarter. turning

productive The third and active an was Eagle. time for quarter

BARHEMSYS acquired may the first-in-class FDA And we for treatment novel to new Enalare. We transaction. for and investigational application severe Acacia the in submitted broad products are community-acquired you recall, relaunching a agent in the anti-virulence pneumonia. drug spectrum as in stake BYFAVO, We CALXX, equity took of the bacterial an August, an X we

a that respiratory entity being agnostic wins ENA-XXX, share developed had big as an are X the stimulant, quarter. in to chemical We new thrilled

of Enalare an of And advance of First, Research BARDA a United Human provided for sales, the and at preparedness business in built a PEMFEXY. the Health achievement is from finds orphan in administration record exciting itself Eagle and additional most is entirety, earnings. Japan, on milestones the Department BARDA profits and and from particularly intramuscular States This RYANODEX When have of for Biomedical of TREAKISYM position. designation and its part strong Authority look the legacy our BELRAPZO, the up received Development we which FDA. news by has stream response prematurity and This ENA-XXX products, with million ENA-XXX. recently, an award in formulation of second, Advanced based supported formidable to specifically received phase incredibly record of BENDEKA, Services. year apnea worth strategic from us our is drug treatment to for a vasopressin we earnings program. in $XX

cash heavily our to a ill pipeline, other are treating patients and revenue revenue, has diversify company that as potential stream. physicians meaningfully to well mentioned, pipeline strong and/or contribute available Eagle's as to to earnings and acute and so options time, able same critically care to whose the flow perioperative As in we invest much the at patients a we're have

While Investor urge a will scientific to on briefly medical and the on these of behind this internationally substantial programs December X, strongly KOLs as group address. Day each clinical from needs physicians, our CALXX, explanations the attend landiolol you you hear in-depth as I ENA-XXX that rationale touch well unmet and provide morning, I and when of renowned who will will

does subjects applications. next stimulate think recruit the and patient community By stimulant channels control clinically the X with over depression. designed channels, for to can pharmacologic multiple The of year. are causes is ENA-XXX an of as ENA-XXX, enter system helpful breathing carotid expected trial respiratory respiratory the indications: drug such, ENA-XXX to so development it ENA-XXX is a of neck. work apnea the ventilatory myriad you inhibiting prematurity. big the X a is as in with ENA-XXX overdose to under and these potassium year. located first start body's utilize to dosed XXX It's agnostic is by early the across to Phase about study imagine Let's expected of which to pivoting designed respiratory postoperative depression, own bodies in ventilator. And ion X

for it's a to patients. agent community-acquired mechanism of with potentially clinically pneumonia, severe developed to the of bacterial the to treatment as action ill a unique being unique therapeutic an indicated and treatment novel benefits CALXX, antibiotic it Turning adjunct offers critically

an such the care include those mortality is bacterial duration benefits could of management, to in decrease critical immediate diseases biomarkers. Some shorter pneumonia as among well inflammatory of disease death ultimately causes as Severe infectious reduced a a as challenging leading remains in and of ventilation and worldwide. mechanical treat community-acquired risk

the opportunity CALXX early we community-acquired The the patients worldwide to first of flutter. treatment with for atrial XXX XX, date XXX under And the submission tachycardia, rate action XXXX. landiolol paradigm beginning patients and including incredible remember, to aim FDA the for there's reduction X patients ventricular May as powered the enrolling atrial dosing for with is supraventricular as The and seeks for of that patients Phase XXXX. has in short-term So be to sites adequately is for been approximately review too, at shift approval landiolol fibrillation IND and in this pneumonia. the study, severe NDA submitted filing

QX of to strong by of generated According IQVIA since all TREANDA to numerous with our patients we of franchise cycle. BELRAPZO share There throughout to bendamustine development with products, with which a down have These soon provided to XX% BELRAPZO and and TREANDA's a in another now Of our shift bendamustine products QX data, bendamustine to revenues contribution gross the royalty grew and partner. X% the towards United quarter. from lyophilized we lifetime These continued offer by market the the life franchise of XXXX, high-margin beginning X% XX% that consistent January. bendamustine continues helping is RTD TREAKISYM from have compared historically contribution have a XXXX. Our cap BENDEKA, reach profit healthcare be In market products will for providers. in advantages away BENDEKA on paid royalties their XXXX. note, liquid States us

confident of franchise that commercial Even meaningful our potentially we to our BYFAVO, the will next and bendamustine landiolol, portfolio year additions we the diversify we will Similarly, BARHEMSYS a sell as we PEMFEXY than year. PEMFEXY, earnings. this continue have with part are we of to expect more remain

make Brian. more than they York rate value inventory. all call quite which believe via in is our I and the we at BYFAVO anticipate. December And remain you discuss Investor Day, preferably reported We on marketplace, or our webcast. sales Day that works over enthusiastic Palace gains to will as New begin Hotel before to QX trade in the higher X in turning the you'll hear I the person attend approach BARHEMSYS encourage Investor run the off to we significantly and levels will Our as

third You treating today commercial key will these hospital-based the devastating medicine a play conditions. and treatment and in I'll who be in hearing the discuss turn the pipeline of Brian? call our will significant addressing to from can role experience With leaders and first-hand financials. quarter products gaps. best internationally that, recognized how to Cahill Brian those gaps urgent brightest to have speak They over opinion some our

Brian Cahill

we to and sales In from as was in as see morning. were million BYFAVO of million BARHEMSYS PEMFEXY in $XX.X compared the revenues and product good third as order million as was working $X.X XXXX. PEMFEXY commercial PEMFEXY the by and million were $X.X sales Scott XXXX, sales primarily volume of quarter million inventory through of XXXX. well Product were much portfolio. were Xx million as product reflecting launch customers XXXX sales sales third continued quarter million PEMFEXY compared total quarter sales in $XX.X was that of of in to quarter customers Vesopressin QX quarter the of for and addition $XX.X compressed were Actual as million third our XXXX. XXXX, of trade quantities. the of in to QX during QX $XX.X $X.X reduced. reported sales $XX.X BELRAPZO of third the the compared you, to vasopressin sales Thank revenue

$X.X the includes in Third RYANODEX million of U.S. Royalty sales Japan. prior were to sales QX revenue was in $XX on million royalty million and compared the in TREAKISYM quarter XXXX XQ earned quarter. to in BENDEKA million of $X.X compared revenue XXXX. year royalties product $XX.X

of milestone TREAKISYM of on other margin our on Japan was Japanese product XX% SymBio prior anticipated BYFAVO milestone portfolio million been recorded mix to for SymBio. which $X.X XX% of expense in revenue going acquired the margins less This the sales We than the million of share to margin by the $X.XX year continue This related of amortization BARHEMSYS, sales PEMFEXY, sales revenue products million dominated the recorded partner, historical which has $X.X newly in result quarter. yen. and forward. was in by to of from basic vasopressin, compared BENDEKA which the QX than lower quarter cumulative is contribute payment the will inclusion or per to due quarter, this decrease royalties. compressing Also, marketing XQ, TREAKISYM our currency Gross $X.X in declines of diluted addition we the

prior CALXX This third to million landiolol XXXX quarter. PEMFEXY vasopressin and year preparedness upfront expense XXXX partially decrease expense This and XXXX. the for expenses licenses of and for the On for quarter. clinical fulvestrant trials in was offset related the QX our launch year by in to the the attributable to nonrecurrence million largely were front, was compared R&D CALXX increased to $XX.X prior and of payments $X.X quarter compared XQ from

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

expense of non-GAAP in spend be higher in related spend to of This XXXX. expected for change services. and $XX.X previously less on We work. newly than driven other $XX.X reflects expenses quarter first products quarter and near-term headcount million and this, professional than related SG&A our compared XXXX third the basis lower a XXXX post-approval marketing in was million obligations in as to acquired million. expect quarter the Acacia Acacia with R&D the the the clinical of by in third well legal were $XX spend, This CALXX the increase to estimate full timing increased as for external expenses to

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

was year $X.XX $X.XX or adjusted basic of share non-GAAP net diluted XXXX per XXXX to of in the net basis increase share guidance $X.XX per prior Adjusted is compared prior in per of to was million $XX.X associated the costs non-GAAP diluted This of million prior and basic income headcount quarter per $X.X diluted third third the the or per for on non-GAAP $X.X million. to quarter share. commercial from net quarter. $X.XX for or SG&A loss efforts. expanded Net spend compared USDXX $X.XX expect year We million a share and the $X.XX million basic USDXX be a XXXX and with and our per income diluted inclusive quarter. million loss in or basic of to period our $X.X

For most end comparable measures, the GAAP to a reconciliation of full non-GAAP measures release. table the our see the at please earnings of

acquired following and the in we receivable completed of XX, synergizing stock $XX million similar XXXX million facility. XXXX, September A that, XX, of XXXX, refinanced cash million month, accounts a the facility $XXX ask operator with This group $XXX In equivalents, revolver has net cash million repurchased has million an of million $XX have as in publicly the additional plus had $XX.X net from August loan cash including have our From $XX.X resulting million please of the are and Acacia, $XXX and $XX the $XX.X go our a been near-term stock. terms, million and our program. JPMorgan revolving through The well the With repurchase September company facility now outstanding of third and acquisition quarter and expiring part private As we our collective in expiring debt, by in largely to Acacia. in Eagle new debt questions. facilities, a million call of company common share $XXX.X as repurchased open credit the The common including ahead. XXXX bank TLA led Operator, receivables. the includes X-year those of term covenants million of and facility. this to as loan that disclosed for I'll a

Operator

Blair. Instructions] Lugo our from William take first with We'll [Operator Tim question

Tim Lugo

strong Congratulations on quarter. the

to most regarding XXXX. think moving parts into many there's speak I I so Eagle, investors heading

don't obviously very guidance, broadly how PEMFEXY payments in be year. will discuss XXXX, sort to change you're next specifically, you think you know can obviously, You BENDEKA, I sounds product of need royalty bullish it but give like just off. coming some might on there mixes

sense a maybe of just will year? where you be give us can products moving next So those

Scott Tarriff

thoughtful. Thanks, Tim. Very, very

the 'XX look what's but everybody's to and good 'XX towards we As future also maybe 'XX. mind it's is on which discuss and

we PEMFEXY product is royalty we for strong was mentioned, to you thing move profit, we standpoint 'XX earned TREANDA on from a as profitability a history, away I And expected these away. just lyophilized be very certainly but standpoint, the going is standpoint here it a as franchise think as revenue to over in I see And were have 'XX larger PEMFEXY, entirely 'XX. And that believe last we'll going similar the 'XX. you the than paying with and no BENDEKA to be a year royalties mix same from business. BELRAPZO. can a bendamustine don't a in receive state, from from to TREANDA

time when value So as from. we TREANDA the look there's that that which we want that over customers in from or BENDEKA we and customers buy to to And value to receive created a BELRAPZO believe speak we landscape, PEMFEXY. to we at shift BELRAPZO just declines, our do and products developed happen our and BENDEKA,

this products, to next solid mix and expect contribute earnings pretty year we When levels 'XX So in us. the of 'XX mix 'XX. not talk in as you'll think 'XX X really growth approval similar we see have ramps, those to which as a a past those year, and you'll high start we 'XX in about Hopefully, to it then we is strong that and of to for the be grow we depending to Acacia amount hopes we get potentially, the on have and another the year it 'XX, receive value see 'XX year discussed products to the but tremendous we've in but for probably landiolol 'XX. starts the for

relative should this to have we in hold. the pretty Those excited company these a to that's CALXX conversation, to that And are stated, portfolio. studies the 'XX, the clinical at products further the acquisition we're similar and plenty enhance in of 'XX to balance shorten and and accretive 'XX, anticipating trials, 'XX products their accretive our making into significant so too And of same. to why still darn make 'XX, as sizable We X with just the an So size. their 'XX essentially, will take new acquisition room results prospects revenue sheet think 'XX, the of Phase we've we get then the look company. to never which 'XX. the end try pass ENA-XXX And size bring the if will we're about cash so

will have our company diversified and we're shape. met pharmaceutical We goals in just being of great a

Operator

next Fitzgerald. Folkes We'll from Cantor take of our Brandon question

Brandon Folkes

Two down the from think, arbitrage saying the then you TREANDA the on just the Congratulations maybe market do us TREANDA the seeing the when generic you're of can just about show terms think we you're what bendamustine same usage? expect in just and heard should pricing help inventory work generics demand just just And progress. But away what there generic us commentary in hearing just on update of your erosion lines, terms up? can the maybe and PEMFEXY, the from you on I shift of me, in along on that reimbursement quarter. but for

Scott Tarriff

tackle TREANDA. me Let the

As generics reason, want X% BELRAPZO all well. is concerned have improved BENDEKA good to products the just would I it's about TEANDA, about what and before, we're recognize and said that X we we we when years down llyophilized are pleased that. for of our our substitution, TREANDA the and therapeutic and substitution. probably that BENDEKA, exclusivity that be happens not coming another have have patients but benefits customers X% a customers they're as for know And generic and TREANDA market to a

over any minimal have we on X% shift, community in we that. And X TREANDA away RTU about oncology be we never received to to that worry market profit so And but there'll the products TREANDA. from that believe especially the from of

of reimbursed the look at this 'XX in we that company it's strong right that PEMFEXY manageable all in ballpark or going a our us going for brings that's that's brand PEMFEXY to everything as in still calling it brand the the the is that going same some and value we as XX% generic same we're it XX%, we us. not that royalty way sales It's been And growth away, take on of new and a else the are customers in and reps all is year you question. at so, always on we've hired a attributes have be which goes marketplace, lose. product the a we our give thing. that, going the brand as very treat according that to product. with when we're of a then we've which and and we'll a we expect still now, to If And take, about range talking very this of your And the other market forecasting plan

in expect physicians that and price we a just our 'XX. those remains BELRAPZO and we'll it's greater by that again, are products achieve BENDEKA, nurses, use and able way. better PEMFEXY the and because so wanted are be at sales of product than that sales level branded the to And achieved benefits, them because patients by And that we

earnings be to programs fund ability to So to to could remarkably we strong the to those use earnings of our that exciting our we're in in 'XX still only all do confident and continue clinical fund work patients here. maintain but just not that

established turn continue from base this And we've this so we're off just another corner incredibly we for bullish new fund and being the company. of acquisition to as us breakthrough that to to the able for year grow

Operator

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

David Amsellem

Just a few.

vasopressin, paradigm about talked missed FDA, And the ready-to-use NHL impact the on but bendamustine. have what at any that, on can for product potential for declines any that make of CLL. headwinds I any in they you comment there's all? inventory pemetrexed or they're in changes impact during extent any two, first, then that impact that at in know do along has think usage inventory potential this overall the seeing Amneal's if queue the how was you and due quarter? the in can comments overall I Teva on bendamustine to treatment of there commented Number the about number impact one. lastly, seeing to So tailwinds of So the fact which you on vaso lines you if sorry the it's

Teva's as about Overall, that with how your you thinking there? with mind, guess do I on So bendamustine. lineup you are in of the that continue pressure to in thinking that expect context

Scott Tarriff

Okay.

a that's So lot.

X each get sure Let the me I of make points. to

bendamustine declining Benda been changing. take not CLL the years first. terms in has slightly NHL for that's last me and marketplace a of use several in and Let

our either lyophilized be the of is to we BENDEKA of and is going look So there's is a handling the from usage bit lyophilized to with to making we've we've market, sale, TREANDA half from a it as But that's had total market that, products. a QX profit lot that to the way think decline, grew second value probably BENDEKA surprise That's opportunity to the QX generics think TREANDA with RTD the right? out year TREANDA 'XX where 'XX, you a go when BELRAPZO And X% And little Rxs over saw no on those 'XX. a continue shift value with going continue, And going of of over people market bendamustine even there in you time, watching of to every shouldn't go probably has standpoint, be someplace. it, or less actually to been than that been today about to making and I as have that's scripts coming the if that to you and to that the declining the BELRAPZO. anybody. of even to but out the obviously, eventually, a been from market, surprise marketplace you've get thinking generics. And they're coming

paying with been do And all for meaningful I 'XX we or will to some as as declines likely BENDEKA. exclusivity. get the the it have overall. bendamustine decline X in through where us But years, as in be that, company 'XX those 'XX we've most part going think have into of well exclusivity, Having you so we continue said still royalty away. slightly that have years will XX% having we of a And left bodes well but that very X

the excited and So company know, at it. look at business, we're numbers healthy here about excited don't to we're very very the really alive just I and and QX bendamustine keep

to PEMFEXY PEMFEXY we've of just It's prediction sales. into very terms In big RTU, as made we've our taken a that more market. account of have all

the market I the billion was PEMFEXY, year. think for ALIMTA $X.X in branded when was

very market. And big so a it's

So reasonably this hasn't when we've we confident much to comes then we're when 'XX vasopressin, in more than inventory all we're PEMFEXY vaso we'll in taken And now account there in in that 'XX, prediction. predict it the forecasting marketplace. and sell been into

would sales So had the are normalized. that this I we call quarter vaso what

your hope questions. So with that, of all I I've answered

Operator

at this in Scott for any we time, or the I'll no remarks. queue. over turn appears Tarriff floor have questions further additional It closing to

Scott Tarriff

Thank today. you very gain growth progress of and the commercial operations. we're Hotel on York New strong products, again proud these December earnings Palace well in that our on funding for pipeline as at please joining the outstanding of understanding But call a join programs X. we're our for We're to the as trajectory deeper of the us potential

hospital in. and hope wonderful for quarters of to care few look you, some internationally really Thank it's renowned I think on forward hours it critical a we going it's Eagle. and going and educational continue you excited fun medicine. here And thank all We about participate you to again. it. We to us We're think be a fantastic day. to experts there. to It's to at and I forward look be just hosting see engaging an very be day going that, with to with

Operator

concludes This you for today's your call. Thank participation.

You any disconnect at time. may

Eagle Pharmaceuticals (EGRX) 7 Nov 222022 Q3 Earnings call transcript