- Earnings call transcript Q2 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals Conference Call. At this time, all lines have been placed on a listen-only mode.

Before management begins speaking, the Company has the following statements. Elite would like to remind their listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties and are subject to changes at any time, including, but not limited to, statements about Elite’s expectations regarding future operating results.

Forward-looking statements are made pursuant to the Safe Harbor provisions of the federal securities laws and represent management’s current expectation. materially. differ may results Actual Elite disclaims statements, revise forward-looking update obligation as required to except or by its any law. SEC, Elite More complete be with Elite’s reports can elitepharma.com section. under and risks available the the website files Investor at information regarding found forward-looking in statements, which on are Relations uncertainties the these Elite review documents encourages you carefully. to the your host, to that it now is over covered, my floor With pleasure to turn Mr. Executive Officer of Pharmaceuticals. Nasrat President and Chief Hakim, Elite Sir, the floor yours. is

Nasrat Hakim

at you, and for for Chen March our Robert Thank of This us back XX-Q you you sec.gov XXXX. to ended have and name call our second good the morning, second which, summary our earnings gentlemen. today. I’m a It you quarter ladies Elite company’s everyone our filings. Thank quarter copy call fiscal the Chen joining joining submitted XX-Q I’ll you, to My a website the available September give Nasrat, Dianne. is Yesterday, filed the for with links year, Investor websites financials our the of also of in and update come corporate Robert, on is Elite’s Paul, floor. that other after some us questions Chairman is and and will Hakim, on section Nasrat conference Robert XX, our Thank many and the today. have we is is provide thank you that a CFO, CEO. elitepharma.com. our of to answer and

as financial to and Now, of commentary overview like the I would well. give an some

income bit million this sales to quarter as the quarter with of year. We statement. start strong $X.X little had for last of compared same a about me a Let

Amphetamine on Amphetamine Capsules IR steady. sales Tablets ER Our remain and

sold. goods down of cost to Moving

$X.X about trend, a at The of profit cost of for proportionally a periods. the $X.X reflect As for direct about gross periods. both company million sold of revenue post a to goods our million general level both

operating the stand product in $X.X million due operating about million quarter development. for quarter. for in prior increase increase largely expense in this $X.X spending the was Our The to and a expense

As year. prior was income million million last operating quarter result, about versus a for $X.X a our $X.X

Our net $X.X to interest in main quarter. million as contributing about the spending decrease income $X.X increase million to was income compared was The for the in net driver the payment. prior

about X%. I’m for $XX.X of to move sales versus the six-month XX, This ended We IR million quarter about Amphetamine ER to stronger Now, period the primary September million XXXX. had due Capsules. – and is or Tablets a $X.X $XX.X million of year, up to same going last Amphetamine strong sales strong

Just in I $XX including gentle like XXXX, fiscal XXXX for a sales and year on $XX your in the million a as been the you mention has in to for company upward reminder, to trend last $XX year. million $X XXXX, information, remind in million million

over million sold gross $X.X for For two year million about of and revenue. the the cost million to $X.X quarters, $X.X versus due stronger was million, last $X.X goods was last profit first about the year, a

$X.X to attributable expenses. million was expense and the the million increase expenses payroll in increase stand professional versus about The Our operating $X operating periods. both mostly in in for a

Our last year. operating income $X.X same for was $X.X period about the million versus a million

$X.X three XXXX the net to about net the following the was drivers compared Our million for The main six-month – including for for the XX, decrease million income, factors. prior to $X.X income as contributing in period. ended September

this a does in which have spending from payments. about for not interest one $X.X first The $X.X during million and period derivative increase liability and sales, a to due the outstanding million $X.X warrants stock company annual million

the by derivative common stock information, instrument the common the other large in change in higher the stock the the For with price, of change of larger In inverse value fair an words, determined price relationship. that closing the your part liability. is company in

companies So on for flow. your on impact cash information as well, this at not have transaction – does our any

our move sheet. to me Let balance now down

about was Our to XXXX. as company’s million, up capital working have to working East capital from this increase loan be compared to a year. $XX million degree working for strong about The million reflects is at purpose. control April spending due The XX, also $XX $XX and great the Bank to used obtained in ability in March a the West loan general will we a

now to Our will company. XXXX. With on $XX for XX, back turn total overview cash hand is floor the the million Nasrat at that, September the I about on

Nasrat Hakim

you, Today, revenues, to go quarter and about and Elite’s couple you me let we commercial strategy We update of activities, I’ll on Q&A. had in profits, before thoughts progress, revenues ongoing solid a Thank numbers with Robert. first profits. cash say another flow. good But pipeline, and

revenues increased For year-to-year. now, good very has a quarter-to-quarter four years Elite run and with had

profitable, million million is task becoming company for from or OTC matter. that easy to and an $X Going that an $XX any company not for

cash FDA, SEC et a tell the numbers out. have the how DEA, of filed We lot cetera. flow, the At we audited pandemic, faced figured day, the the partnership, challenges, end story of of

tablets. products steady. is profits Prasco wholesalers distributors. these growth. invest in the are status Burel are partner and in products distributes also our And and TAGI No and are with have directly the are positive in partner, for to although, and Elite about are sales a Epic IR Dantrolene and have marketing products Isradipine in on own TAGI and concerned. Loxapine is Praxgen course to do a our products. very the and good partner say potential. and are distributed through and Amphetamine and our diversify to our beginning label have Bariatric product our the are into upside Elite distributes as And a of is of time will I’ll has about Elite which a very competitive from the Capsules sheet Lannett job well marketing have to-date. at our it under of Elite’s been to continue far balance Elite means products. as made the more hoping selected as FDA’s Products captured Elite’s and done continues of sales two for R&D the commercial we categories Now, very that with will that I’ll Doxycycline for IR and to very products well. Lannett directory ER, Amphetamine these on and majority its classified our say future. done that distributor believe that them Elite update to sell I’ll has an in more and X, the and current a been today, an label shortly. Amphetamine revenues organization Naltrexone Pharmaceutical distribution to invest A and products revenues shortage to that have share by April their the XXXX, our has better our us us sold list, XXXX. long selling quarter an decision and second that under allow means distributors. in that start be Trimipramine. modest yet. market Loxapine market. We products ability Elite partner is on support to TAGI to products be

and XXXX. Elite’s have of, Elite Isradipine beginning just same the majority be still directly IR the two sold Trimipramine Going and Elite’s forward, products similarly of and sold I majority the products except revenue coming under time. label. the under of on by the will categories Elite’s April will label from spoke label Elite the that Amphetamine ER X, be be will will about sold

year. the to products will in by rest of earlier home if case be a them Vigabatrin, to out them and we that partner. We also was can evaluated on retained the our or interest with best approved it’s basis a rights keep figure product bring how The this case

In addition several our the opportunities outside of our the U.S., United selling has sale in products for States. products to the Elite

on the with products details we companies will We successful or forward ongoing work these in negotiations and continue look to reach sales Elite overseas events. on provide future. and material updates milestone to as

company to So want event, $XX,XXX explain. material not thing. it’s overseas. because is That one-time product, let a worth Elite’s because a of a market orders When the they $XX,XXX, $XXX,XXX test me or

So process was if that and not the that successful, But very becomes [indiscernible] event we us to okay. we same I’m to say, [indiscernible] do now company own material a going and comes a now back week, that’s when very $XXX,XXX a

and in time is with start the now. with and that working us about others that our Kirko $XX strategic products we companies own and will our Lannett It for selling the you and to if unfolded own prospect, us. own are overseas let to joining unhappy revenues forced reach to So we the that taken my not significant was about our and materializes. Elite know under But especially accelerate waited before marketing. our sales will sales am and distribution own right has hope start we anything start and time We I steps the with label. event million we when

personality progress. and is is best was to worked excited will Sandoz years the MIT. and and took various in The with oversee at Commercial executive with overseas responsibilities country’s Manager, the have company for and Elite’s for Officer. senior in outstanding with NDC Russia hire. excellent U.S. is Vertice he sales pharmaceutical step previously talent are distribution education as a will strong with the control see products. love selected I to sales we overseas. and team. including for and share our structure head his management General more background before Sandoz was started am its structure part sales in product really XX products will experience commercial years position out XXXX. in operations. as set great QX Elite over Bulgaria retain before Kirko’s and profits operation. the capacities, we very sales for sales that numbers, as in then degrees functionality structures many He national are up distribution distribution. sales key the and for We strategy for commercial allow product all begin making Kirko those marketing. important larger of Elite we including labels of most will and Elite a It’s comes operational and pricing distributing Kirko new and setting direct and distribution and pharmaceutical of an up Chief a required to our graduate with from also makes that as Sandoz strengthening Kirko Kirko and and Pharma Elite sell. more Kirko his Kirkov a both the hired Direct group and will as of the and step more he financial Elite commercial It in U.S. and at complete important in not their add

third distribution, a logistics, warehousing focus chosen to and For that party on Elite contract Elite and operations. will a on work allows basis. sales This functionality has with provide to XPL, Elite

we of shipping, at customer As XPL support, are partner, with as operation, financial sub-distribution structure various EDI, manufacturing, Elite’s the commercial compendial our and Elite warehousing, distribution. pieces a integrating such ERP, testing,

All coordinated of the with is partner. XPL being that

We and contracting we licenses we organizations XX own supplier each and have And territory. and wholesalers sales with institutions also states. a are as our and distribution purchasing are To-date, products to securing state group in obviously. sell distributors

that and to Columbia states more We on as will and of licensed key our District XX are in initiatives we these have you pending. progress continue milestones. three in achieve we states update are the I

On product the to lead in continues development invest development. front,

diversify a has our is products also are that new products commercialize trials to or Our grow to to something portfolio to sell and in bioequivalency to Currently, or studies. continue Elite competitive more clinical give goal and sell. Kirko three to

announced recently we products these of One results. positive

the QX file later in it are as completed final The to be soon in should two completed QX trials the February file then, expect CRO. sometime I’m year the filed January, be other this we the and report as should clinical receive ANDA We end One timeframe, products be the from XXXX QX in clinical XXXX, and we’ll of second the hopefully meaning in toward XXXX. will completed of trials.

being readied upcoming are Additional for studies in year. now development and DE next future for products

Elite to we product quarter. progress, We study obtaining To forward events get successful great – development update on products on as its approvals, up, a new or and is other material a we look filing an a on study, another launching as DE as sales you will department. marketing DE executing approval. wrap starting distribution and products, such We new the growth,

me sent submitted. have that Diane list Let’s all stockholders go to a Q&A. the of the questions

them top So through by I’ll take them from one. go one the and

Nasrat Hakim

the easier. the within it the of investigations Lannett on Book Orange making notify the list. so why what really the about, Literally, a I’m easier. pharmacovigilance reasons say, if regulatory hey, will It And list, list. Adderall for are to you products to they lot not their this the drug you put that. don’t for a can two It send advantages the you off back discontinued other There events If are in market. week purposes for large let’s There list, discontinued of makes be have adverse difficult quantity the number it’s to to doing is. the get reportings on IR and have discontinued investigate. and makes a lot not that say, and products continued notification are and people on also complains don’t somebody And everybody. FDA The know reportings or

Second question, the so they they discontinued August product want launch for their have Praxgen as do you. the regulatory Again, to espionage reason No. mind no XXXX, work and change can what same in did it longer on put this less Doxycycline, they for Lannett, to delete? and

have but SequestOx, assuming target as your We you thinking a are you for or application. just we with us That’ll of what millions all is about date FDA. has Okay. never still It’s active money, We an pending dollars, still resubmission withdrawn. later the tons still trials they did resubmit do. the if all SequestOx of withdrawn the process, submitting of when It’s SequestOx. been finish cannot the application have ask clinical to not begun cost well? not

it are of their the times the Does pursue working country. I’ve No. They We influence have on This all. Israel at decision no will approval? for Dexcel, has a front. any Health’s new experts country. explained to many as situation in not Ministry They because Dexcel be financials the decided their is of Adderall news before. them. with own

us. to here they need are We support anytime them

no quota for get We ready, questions about always do tell Elite’s experience Adderall issues. ready. When the absolutely I our the DEA. have had for partner. Did year quota Elite We in us no they have knowledge we control reach Elite products? Did DEA his API any quota? and same the shortage? Israel. they Did increase FDA are no actually of DEA, They’re things how they’re

on We basis. regular quota have requested the DEA from

have the us the request all that given And We material approved documents support and have out them. with helped we they it. have

came that. market. have where to have you heart with in, They at They do as not the can to issues times all anybody. good date, issue control making, revenues any here sitting from we had awaiting the nervously us approval many gave quota. and not the see we’re a DEA. the are through But do quota second very They time Now in the come the us for we’re they approval they every and the last attack

them in it. before You a and showing go through consumption lot steps they important projections showing have sales them allow and showing them very of to

they job. good dates of the every the with the time ANDAs? a you we the new please you spoke, So we’ve lots I’ve As do for encountered Can very of confirm trials. clinical CROs from delays shared

January, will be four Again, we’ll clinical the in signed to trials, due have going year. in was February XXXX, and waiting clinical ANDAs, we I’m last So and the of July. January. It’s with delays, one, I’m apply the also that issues for timeframe, I and delay done until for COVID government Mainly, second contract hoping – in and and we’ve June, February to be due the Indian the the year. gotten not waiting January, and process for one was this restrictions trials, to in this done regulatory the It to we initiated that. supposed all two

us. others okay. ready, done From cannot mercy clinical submit, date, to we in a the of trials we’re can but because supporting have we before I So give I the am at have Elite standpoint, you

to within last clinical will of Adderall? and the I half, they this have a more. COVID of don’t material events changed, schedule financially though, Does which received India the hope, sit then factors. happened, then to sales done came Lannett to in have reasons three no XXXX, So to acceptable. are line the And share of first for the have us marketing delays because months down later believe a want for MS. will recruiting just at predictions group. Elite did happened No. requirement them will I we other decide realistic clinical Mikah dot year and in take trials, own of of on notification an two as I make Even The And that as longer. we with we’ll Board a was talk as terminating commit more about not happen. to our that things we And just two unexpected. sign now again, create cannot soon and and we I and added that additional year year trials I delivery. truly this official exact uncertain actually was and coming also and an of because So These we with lot Directors CROs there, stability explained. plan the everything offer, from up for want ANDAs okay? two or barring we all go make share The variables you agreement,

you predictions, do offer in this we’re Elite What yearly your back give on. and revenues? issue lagging indicator. are So but for later I revisit don’t we’ll a now will We predictions

million. the got from heard the of $XX.X half year, we you Robert, As first

will sales, It in happen. self-sufficient to before think XXXX. long Elite and before fully be So extrapolate is marketing, going that X, see and definitely is How what you distribution? April

of right We’re would now. almost I way. there we’re about XX% say the

as things. working with As right closely you’ve the he from almost I on am to finance I us Doug very in development. we’re seen together pleased is working the is the read The properly, with heard this path anyways. to said team to flow there there. any what from risk with still very, or the up. and I’ve going is are is and no way is business production doing have in – get there right very Robert Kirko revenues said, what There with company of I The I is The down. company in cash what is Chris goes Elite CEO investigate question managing happening price the positive Is stock? SEC the The the explanation. stock logical and

I That’s It’s frustrating. You say. very are correct. all can

we We’re many doing or the ago, any all company even And before even the still $X.XX, right are that or not or frankly. now five stock years were which you company, things. making down. NASDAQ goes see actually profitable on on are was $X.XX that the a OTC when We in the that stock don’t Four we where the viable money. too

with is makes buy and products, companies I’m a when offer no that is to an hoping get Well, nobody transition and not rhyme Elite? it. maybe there sales you on a So marketing and Are and house it. your reason any more all when – offering sale, comes better for make are exchange. we will own to our change

put it’s anywhere Adderall to our offers Elite there the in does to and U.S. Can Or Lannett XXXX, financial March Underline and that on selling overseas can we have – just companies we are of, the X, In a States, sell only XX? a the it the like the have than United of They Mr. did will can to has We not he that stock? right. Elite we have that anyone States. make for we been a fine. us by and we part they to product fact to pharmacies Lannett to statements out other sell that is. we The sell till only that’s with is anybody make because and out are partners Epic when – doesn’t be in and buy question. United allowed the wait X. other how allowed Last else. contract that law to have will and/or April for are their wait not our product till Lannett April own sell That’s product till made sell Kirko he product better

very Well, good and Okay. and And you, for Robert thank thank Paul. thank numbers you, ladies you, gentlemen.

this quarter, hopefully filing We’re you. a on quarter of February. next of and Have clinical an day. talk looking for trial the hopefully another great more middle news before ANDA one we good successful Thank a

Operator

Thank you, gentlemen. conference. conclude ladies and This today’s does

you and may a You for wonderful day. disconnect have participation. Thank your this at time

Nasrat Hakim	President and Chief Executive Officer
Robert Chen	Chief Financial Officer

Elite Pharmaceuticals (ELTP) 15 Nov 222023 Q2 Earnings call transcript