ELTP - Earnings call transcript Q2 2022 | Elite Pharmaceuticals, Inc.

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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 expectations. 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

give and and thank Dianne. I'll the and the My call, good morning some is will financials, gentlemen, Marc us Hakim, of a ladies with Thank our Marc, CFO, for Company's floor. you that today. and the you after come submitted and you've you answer Bregman name I Kate, questions which have joining to am CEO. earnings summary Nasrat is our Elite's the us of and Chairman This back corporate update

Marc Bregman

And everyone you, Thank in today. thanks Nasrat. for calling

bit to million, we for giving and yesterday you up a last year. September our last of with Adderall, due XX-Q that's due commentary product up over Today, year. more generic like our million March second an year. development XX% quarter similar Costs fiscal version million the we the million $X.X million and this is income year, XX-Q Investors $X.X Again, strong income so headcount. I'd available the to A of is sales due and of website costs time posted sales ended in We're to us section financials the costs in $X.X of the quarter $XXX,XXX to the a generic our copy overview XX% were statement, margin as is of filed to operating September at were the of the last higher quarter increase give this a to $X.X fiscal primarily the of Adderall. is XXXX. an in were or same version XXXX. Starting compared fiscal elitepharma.com. last strong So some year from XX Year-to-date $XX.X This well. of sales or of sales of quarter

came we million $XXX,XXX over the in with of profit However, for $X.X year. an operating last year,

working I'd Turning year over sheet, This from it to sum year-end. $X.X Nasrat the higher an a positive margin, with to and and it that, to to To sales debt. directly to numbers beat up our and like back strong operations up turn due balance $X.X last overview continues our million, grow with continue capital to company. flow is on we from to low give cash million to

Nasrat Hakim

on and you, I'll financials. you before pipeline Marc. In I'll products make about Elite update Thank research a development go Then we commercial and comments today's few update, safety, Q&A. to

we're globally. The is partners. in and chain sales has can business you once interrupted up. business supply Elite, been are safety, pandemic States a of posters COVID-XX all. suppliers, and all as in lifetime our in pandemic, from the It a the everybody's affecting operating and affecting is of only our United backed but U.S. affecting Regarding us our providers marketing not It is service is that see

still We possible. much employees asking our and following as vaccinated, as to Most guidelines are are and of distance local recommendations. CDC social the federal everyone are we

component on social asked effect UV else's the if installed Microsoft is an vent, them killed then are meetings halt. and of case same Elite the for regarding suite, to case they has cellphones, calls heating they a been doing out on car to will this for have enter the chain. the is vent we that we've car that the with encountered a viruses any supply that someone shipping not the material pandemic Team This one pharmaceuticals HEPA bacteria We missing distance, missing same lives delivering takes for have pharmaceutical non-pharmaceuticals. air only bring to before but it it difficulties via the and not rooms, for be are lamps and businesses addition not holding tablets. airflow will underline and from employees of to increased the And we've hinder the All all to and component I manufacturing be is in fine. and circulation. continue. products, conference same must the in cars, manufacturing would My easy, a manufacturer for and reach to One ensure and or our at concern are like capsules we not and a We office. filtrations

yet affected. We continues. that have I hope not been materially And

cash years are and update It did revenues, marketing Marc's revenues, direction is expectations are that my wise. Less going for very the the and enough working the hope next self-sufficient of this quarter sales with path. revenue and money comprehensive. within our quarter profits. not Regarding had capital. will ballpark profitable. this we flow. have for two the am quarter and I continue on ago, than but and be was Today, we profits The solid pleased numbers partners sales short,

surpass to on performance. are target last year's We

Just million went are million that. to we we to poised year, revenues $X.X $XX in to couple of years million. $XX surpass from you, This remind to ago

$X.X we're to was revenues is at that loss, better Today $XX the seems more make revenue with profit and a million, proportional stock stock our doesn't performance when It our gets. The at lower inversely it do, $X.XX. stock However, we than price. the sense. is in operating the stock XXXX, $X.XX. and the million our were In no

invested the number significant and Regarding one our diversify support continues growth. and pipeline, in R&D and number research profits development. one It our is be R&D amount Elite order and to priority in will development products our company's to spend on focus.

We enough products such of diverse the as in set are one create we and way stabilize look company developing projects Amphetamine star Our such has products. our we IR co-developed get on our or currently and new a rights that as have risk case hit is goal this Elite a licensing ER, of development more in product they'll helped with for stabilize that of if is is product or to and contact products that own. The under the new add the manufacturing Elite about ones SunGen and we to core it alternative are the the development project add on co-development investment. products at fund pillar all products, our buying to will or co-developed. to our and formulation brought company capital not the products, R&D. products development to how and that can We files have focus pragmatic supplement Mikah, be is us the expertise is partner effective. they diversify where better our in company

We from that these Amphetamine new venture. ER was evaluate opportunities continue co-developed we to benefit to like projects continue to IR this. a such And as and

we're genetic include Elite that will In the have products addition, receive developed activities, is that's antibiotic. Elite and calls XXX% those risk in of will then of can products and cost. mentioned through in working partners discuss may is a will to Currently of out. develops difficulties be with in Must e-studies all our some on an that a products future. Bottom tablets products the such the now, pass currently also re-formulated. its the the but I my about these co-developed appropriate found have XXX% those The will Once dozen being details. the FDA, work the ANDAs the own line, But products dozen or my actively is will of all that And of on previous and such XXX% the products ANDAs, on about that ANDAsare working clinical of become approval half product, event, about foundation trials. Right the many early to includes them belief number discussed way bear opportunities you some company's hope the Elite ADE own or as file from a receive Elite all system Many time. will benefit, we we the for tell encounter product, an have material pipeline and as we pursued. own. almost are an of nervous we a that and from more queue stage application be you the and a on hear many and in central they these we going will are

So XXXX we a review with product under FDA. have

this co-developed we half partner a have with year first in licensed We approval coming are the expecting a of XXXX. product that

continues Epic we Epic they us. they a revenues our for these to Amphetamine well done on are further this products. For have see are are very are competition. And and year, start market little Amphetamine products. expecting launched because shortage interesting growth our their under in commercial Isradipine Cresco Fluoxetine is have capsules Fluoxetine Burrell FDAs two by list. the Pharmaceutical Trimipramine, They these and marketed product. very products June label. they and products, be from a will of and be we'll XR in in done phase. And frankly. are products profits is the partner are And limited end this the that IR, hopefully by still from for competitive to transition and very more they these product

date with Lannett. partner, to well very done have our We

and before is a We on have on discussed calls on question call. there this money NASDAQ that

Elite will I time requirements is there that NASDAQ. for couple say So goal the A a are When for key Elite uplisting. uplisting is for to right, about to uplifting NASDAQ. qualify the specific meet must thoughts

to diligently working them. are We achieve

plans, our update income and uplisting We working executing growth you will To its the commercial line. product its generation is when on wrap is on and monitor on capitalizing Elite continue up, new time right. on to growth approvals we'll product and

profitable distribution We performing Our quarter. partners sales look to another and are forward well.

Nasrat Hakim

Q&A. Let's go to

relevant to you we group send department. with As always, them your the Dianne, questions and

I'll let's The Marc go ask are There ahead and if financial. this? answer there two please can to you start first and with questions

Marc Bregman

Nasrat as Yes, two Sure. is mentioned, there so questions.

the of a revenue. million of on dollar it's spending extra is Well, how question, explained? cost First simply manufacturing product

have increased cost that's is Our and increase well. tandem cost manufacturing as your to of a revenues going variable in

it But contribution Adderall is don't big pretty financial products. much by Adderall. KVB Nasrat. the And this come it's Was from was we number from that's revenue version or it a provide Historically, especially So in to Question products, back sales Epic questions. I generic and the from of breakdown revenue that. tell two currently, from the you give our will growth two. all from? it Where our of the a I'll of for portion it's debacle, a Simple it sales? as did

Nasrat Hakim

Thank you, Marc.

your the share next NDA on the progress development. in pipeline, Okay, on thoughts group questions any please of about currently

have will and Elite The in disclosing on products is other positive four And filing for the track The what website websites is a the working in the in the target. one planning sensitive yes, phase well is without about on are answer third we listing and second the one information. are still impact and last things on development is company, doing ANDAs we're on XXXX? the

We in have we a product next that's year. filed of QX, QX approval and expect

We will will and have of also do part be the be be part of financial. will first ready clinical ready year for it probably second them of at next half and the that couple half, products it formulations during multiple of different the stages development, a couple more within of trials

have having have not we can we're file This file that facilities to unlikely These for pills, we any also with same And and manufacturing established costs. the and Merck and anti-abuse optimistic Pfizer with the is will work our equipment other to okay. development limited This we set work usually pill, set manufacturing for on and or other that of clinical products. filed. The as We questions have Pfizer that's unlikely, It has the cost work technology after. the cost lot is have do that do for products is these have and partnership COVID, I manufacture is to manufacturers do have The answer to pharmaceuticals opioid the money. happy internal Overall, next stage. A's but expertise, opportunity and not -- propose a And progress cost is also a our which capsule? and formulation to large down manufacture API they the with the because more stability also we of products are tablet contract development only or the without the and the huge. to know about they year extremely cost, next the okay. at for and internally am companies this the the lay Elite's are latest the that their XA they Elite not Elite [Michigan] extremely there COVID-XX volume technology how foundation tried is these any are well COVID-XX established for easily tomorrow or going

on where is they Lannett any, us time These new from their on it Elite different is, a away we make pricing payments, Okay. much generics I Elite? to and of the I or infrastructure us, we likely they trying pharmaceutical. than agreed? TAGI, will Lannett there so reduce always sure partners, best products bill better is on not are this the because has money. with the from aware prices, am much dealt is with most not kind else of impact Usually, with. applies seen Government part regulations, that as paying that comes of that and will don't Glenmark as of. stay Epic, to if been the Are have Marketing of concern have any paying what to bill are respect not infrastructure was parts the government them want to partner I be anybody

us a paid a ago, financials they of ago As they then communicated earlier we when of schedule, they're ahead us. money always matter couple year they and years early paid a the and fact, days have of to in with were supposed in need clearly us the of than

keeping approval in-house. have good, Very lawsuits is very be opioid been and resubmitted aware does who nothing would Is not company FDA partner Elite category. not technology the actively need with sell favor being and someone ruled any to with wrong SequestOx SequestOx a they rise the the for there creative a of Could SequestOx while SequestOx are FDA the problems and to with defendant. the reformulated of formulation. and opioids, and There's I'm chance sells to in a the finalize second manufacturing So to XX% pay for recent opioid be exchange SequestOx agree interest? lawsuits of reformulated.

questions, Hell question in opioid first did third the interest lose Elite few it's to The the that is answer no. The not business? simple.

Okay.

winning California, the of in that far. interest opioid in lawsuits. opioids the in who opioids, the not judge many state crisis. of versus ruled One the the what And issues so did our one lawsuit was the person granted And of with the is they a referring companies XXX to favor cause that's defendant so pharmaceutical lawsuit

important The second issue, most is ladies gentlemen, and insurance.

not happens. you insure that. through what would But an liability in And you're of cannot If many have a of that, we lawsuits. Elite be these lot we'll went innocent. see, years, You order defend to when us company afford unless would and long pharmaceutical bankrupt ourselves, if insured, that pay for go SequestOx, it for in before there prove the money you're you takes to and that in to companies insurance the for through and against was California, advise us

a it else, will us us. opioids. not insure So is everything They exclusion. on insure but They opioid problem for they on call insurance us major

give us insured product do So if liability, Elite. now they opioids, for that section we're But is right not then accepted. we

Okay. will we ourselves that ourselves. and pay to for And fend for have

sell to themselves something issues. and sales who's not fine. insurance And it's the So our second who take that thing. been third is marketing lawsuits and these willing partner really works a would half a partner and for also looking risk and issue, that's finding formulate on for the products That's

capsules. on through letter? it and What the other I antibiotic be with enough intermediary. be COVID-XX the coming of hire we category anti-abuse that that that I us day, to Pfizer if way, is make chance were antibiotics. trying We in Does next best can or FDA Pfizer are anti-abuse, know is know it I pending by them gotten lawyers, on mind. such ER mind. would thought to I our someone risk. the So product an on But a risk. from mitigate constantly terms what we CRL, contacting definitely I development, The about take that I take there The already business recently at have did with status And It's a and launch talk we have high money of you willing to my do the a response mind, my you response because And contacted not. if that have as these product that would for few things to that technology profits that have What risk. or tablets I'm a ago is will to with would antibiotic be But we definitely we working tell for thing of was end steps about, sure if have means, complete our example, Oxy my I But because at asked always on. which complete not prevail FDA. simple anything the in in not pay here because during wasn't Frankly, FDA? as So is end up to you the we unless something willing technology, enough weeks that couple ANDA report via I'm need filed lead you we'll the that one prevailing to lawsuits. go there of the about COVID. letter filed about to can not is Pfizer the is because cannot to guys do

a question ANDA questions FDA the a would respond, our this to the about I ANDA. ANDA. another SunGen be their is SunGen weren't to responded the is no. issues don't the answer FDA regarding Shareholders of from meeting a is FDA, needs ANDA. is SunGen am questions. SunGen forward curious Time know I not understand and the their of first that of focuses with not restructuring, product. be and The in-person not SunGen a $XX,XXX of with very called So this find The of cannot expensive is understand they care respond. The to and shareholders move why the to issues. product. the communicating them the it Please part SunGen SunGen. you get of yet. discuss and part with they $XX,XXX. are their going with questions response letter. on with be way need would product with And to, clarify? Elite undergone our may filed But The to of delaying change approve generates ownership FDA this meeting have it name, over to FDAs approve the We have Shareholder be decision responded But able keep questions. your unless turned a the complete the running approval and respond. FDA took discuss that have month care there file out if take only you proceed lot that one having and file which they other We to difficult. to FDA. to we I with to them unless meeting, try to some of costs

answer go to that But NASDAQ requires needs a does not meeting any if it. the one will have business make sense. have to questions we or We to

Okay. this question. upon I'll touch

stock pockets would don't the go During the in paid time somebody then and why somebody cash the get asked stock market? the in take This that open buy move And cash last and up. meeting, I their way, and is have dig buy this spinning Directors Why into money. go stock Board the don't shares their and will I with own the then differently. up. of up And it take

fundamentals the higher a that on XXX% analysts. ratio, be higher we are are on XXX% We producing burning, thank we you Partnerships. and on average conservative other you There's split. the XXXX. or to that all can same it our least are than losing concludes be things stock need we that Do are at trading doesn't really theory there, should the NASDAQ conference I is asking we can price fundamentals multiple this confirm telesales horizon? PE stock at stay to going a board these today. is on money what and an get analysis all the not estimate us. the I'm get the any opinion, issue. In Uplifting, companies on price and we are what are here pockets something to at space? The and Last need move than And is ago, you the improve the Thank only more in this do. results. at line on to to mentioned one marketing before. Marc doing move NASDAQ paid through calls. Other than have should the low NASDAQ we horizon. on are joining today. to a we're And that working be forward to to focus on new We provide products. need of always we partnerships very need to to we requirements shares. reconsider All silly. But today's the And you not should that given on my stock. we productivity see SEC. confirm about solid is you an have our NASDAQ. the to need to you for just other very priority. talking getting I satisfying can focused reverse Yes, few we Bottom debt, higher of stock buy companies months question, get based I adjust That more And have to getting Kate. please

Operator

event. This and ladies gentlemen. you does today's conclude Thank

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

Elite Pharmaceuticals (ELTP) 16 Nov 212022 Q2 Earnings call transcript