ELTP - Earnings call transcript Q3 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 statement. 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

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

Marc Bregman

is and Adderall. an Investors profit our This $XXX,XXX at million to XX% to million with the year, to to This section Today, is million, today. version had of you, the in this compared over is Thank XXXX. fiscal ‘XX, calling the generic quarter we $XX.X website for of filed up year. and slightly We increased operating our XX, Costs due sales our headcount. primarily last Year-to-date and as Adderall. in like product sales available we to of to $X sales give million million of I as of would third Yesterday, development fiscal were the due to overview due posted quarter, well. Starting copy of $X.X elitepharma.com. an financials stronger a of thanks revenue from better quarter XX-Q strong December commentary last last year. March on bit a due margin. XX-Q sales and our higher some fiscal Nasrat, were a the ended income of year, we’re again, strong statement, of more everyone A or up $X.X $X.X of for generic

profit due came $X However, than million, an higher million operating we sales, year. $X.X last in of with to strong

capital to overview our year-end. up to I $XX.X balance million, over over with Turning back cash Nasrat sheet. low This review. Working debt. our million concludes flow was mainly on from This $X.X will for combined the positive attributed financial an turn now to it is Company.

Nasrat Hakim

commercial and a you, cover few Thank safety, also include financials, research to Elite comments and we Today’s update go Marc. about will Q&A. development, products before

It we business a partners. the Regarding pandemic United lifetime States a affecting is marketing in affecting providers, affecting all Elite, and a everyone us. globally. business service as sales is once and COVID-XX and safety, pandemic. well as of in It suppliers, is that are our our else’s operating is in

and We CDC’s vaccinated. are are federal employees Most our of local and following recommendations. guidelines, the

possible. We socially much are still as as everyone asking distance to

and are We conference via calls. meetings holding Team Microsoft

and airflow the employees suite, we For same be the increased ventilation. must manufacturing in that have

something our All one effect enter ensure component trials. not the But later. manufacturing, about takes In computer, supply for the then pipeline, to vent, the to been a it i.e. I cell bring has industry, continues. a will to pandemic R&D chain whether lamps UV in the it and and killed and addition a they virus phone regarding we materially the is filtration that it be been reached And of halt or commercial is heating air To lives to My same that HEPA before clinical or installed affected duct business our cannot have manufacturing else’s us problems. I date, and our rooms, capsules. not bacteria or will they office. say concern for products tablets, on if easy. any someone say shipping have missing by

cash and ago, am sufficient I are direction partners hope working self two pleased sales we the on Regarding revenues have the revenues, very did all profits, and I right and market money capital. going, numbers, marketing path. than profitable. and with profits our flow. the this Less not and sales Today, continue for we are years enough

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

to year, reminder, are a $X.X revenues we to million $XX we As million This poised in surpass to went that. from $XX million.

before, In lower as The at the better our if when is price. we and to does $X.XX. stock $XX loss, profits, to stock million $X.XX our revenues stated are Today, not the only any seems to were It closer was stock and $X.X I revenues it the about price As million gets. XXXX, we the the do operating we performance inversely were sense. proportional $X.XX. in is the and stock make

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

such co-developed co-development formulation development is to to they are is the Amphetamine The hit capital stabilize to better partners ones set diversify our us. IR it will pillars or stabilize alternatives, Elite development, one enough affected. we all licensing, expertise products. get products co-developing products rights, with helped such of Company, new about to our Our not and risk a fund filed we more as at products in diverse supplement new add be and all SunGen materially the goal for the Company Elite add that on product that pragmatic we in Company, where the how is create ER, products, or our or developing the the of can We that have of Mikah, have the or as we and they case products products look the the currently products. We and investment. such co-developed brought manufacturing own. contract under on products buying has products

to with SunGen. with The projects. benefit of continue IR We for product results example partnership from Amphetamine co-developed is a the these got and ER. We that

Elite addition, own develops products. In its

that Elite activity, will The XXX% of by include, were these Not Currently, before, work line of such ANDAs. by cost. bear system of the but mentioned a Elite product ourselves. tablet. as the that nervous Elite and and and number will co-development the antibiotic product, developed working central others the is also will all some of products out. For generic risk The those products XXX% product includes partners products a on own

clinical be to trials Some need may or pass reformulated. and not stability

the become event, opportunities are many belief being Bottom time. is in of the that hear can However, line, there will, pursued these Company’s can this. many is future. at they my and we say you discuss more is them will material Right then I currently products appropriate and detail. now, Once a the will foundation all about

are from half ANDAs that we early we on clinical about various stage a a to ANDAs about And have dozen have trials. We dozen working a all actively. stages on

have under licensed review we both products are products two XXXX, by co-developed FDA, For with partners.

for of approval one the XXXX. expect We first half during

done With a partner growth product our the are by seeing being continues of this lots it very that for interesting ER, has and launched be companies. June the Lannett FDA Loxapine sales revenues are further and more impact the discuss and very with good shortlist, partner in limited and market. market. FDA’s before. our from their a and we at they Pharmaceutical how and We’ll competition. groups have we that and product later under penetrating are this expecting these Burel are Amphetamine profit in Regarding a They line, we very Epic, IR have product Frankly, to But, both our sell. are approval Lannett was the marketed they label. Prasco is on Isradipine for competitive to really products marketed -- commercial received than products will little job tough by product. are Trimipramine Amphetamine own are Amphetamine they’re Epic. IR, ER. because marketing Loxapine

a before, on discussed that. many today calls about and NASDAQ there is question have We

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

diligently to We them. working are achieve

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

well. Our year. we sales are look partners And forward and distribution profitable performing another to

Let’s go to Q&A.

relevant the you grouped Dianne into questions and subjects. them sent As always, your to she

So, we’ll pipeline. start with the first

Nasrat Hakim

accurate an statement, elaborate. quite so me Not let

study. We We time. times The met many and at have asked before it the for came back FDA the filed updated about another the requirements and you SequestOx. all FDA with

requirements we with. and reformulated fed the and they We part that So, costly and back study, two us pilot, had We for FDA to were that ran proceed to pass. we more too a went will the passed.

It FDA, is costs true. So, is point. with that done are clinical to millions dollars to be needs that it get to of work but filed that there

that we’ve multiple pending this time, not money I still At reasons, with have extension FDA. of of intention lawsuits. So, for kind asked and only no spending for the

that filed after passed ADT industry. be FDA anti-abuse the everybody was year product by snort filed clinical of an about successful to and Regarding which the effective. vitro, as we cannot the did Well, this snort which product and OxyContin, FDA then finished needs show stopped. in everybody seeing OxyContin go that and the back abused household trials we in took in everybody that’s that that they’re trials, the for with it study, clinical we And a do the where performed in products, it is convincing insufflations, i.e. and Purdue and

noticed, approval nobody an a for generic have you If gotten OxyContin. has

And of before another that the things a question. a with about we that this say minutes So, product. is that will in is couple study re-file of couple regard needed I to

Okay.

answered not their of for they and recent affect before. franchise? product? own are, sales the percentage and to break from hemorrhaging down part last our and over I an read the lost regarding account XX-K, Lannett is the states of sales. assume is, of I Adderall, customers for million large Regarding cash has always stock our How $XX that Lannett question We Lannett the two companies. $X years. about over nearly questions they Approximately a XX% more it on the the that $XXX comes now, that. much very potential Amphetamine money have losing thing. XR for say about company When been They We’ve Two Lannett time. The product answer like the a Elite? a do this not They problem same their for few are problem partner. bills a from correct. does has drops yet. But good been the this to is, deal what revenues. is a both Is you is approval have paid order pretty

did ER. So, Lannett answer for Amphetamine that I’ll IR right now. and an get approval

have two-year with a them now. We agreement right

own they So, be with and very requests for two lovely not own and to it their taking Company. partner’s will or either order to announcement involved. but taking partnership. respectful Anytime notice just have partnership a and it uncertainty, with creating was channel on either filing an appropriate to choose it the make stocks? years I’m Because reason diligently continue Dexcel news existing was this only the seriously product. Dexcel you we any of later the -- terminate the not protect extend blasting and sound provide for our of the thought’s a group, chances. wants. an do And on and the the Lannett partner, needs Can sales partner, on Elite work looking similar in SEC and for starting I All and table, to working you are if to for marketing am would options the have That you for the a us. table, partner finding are

we They are And company do very where are publicly-traded to a Okay? deal is company. trying in are competition country privately-held a who a tough.

by decided a So, blasting be instead competition the hurts required it’ll We news we what and is this actually them law all partner, of to very by do law. to an X-K. standpoint. required compromise business upsetting file what’s that not from and And is intelligent, our over it because

many me let little so heard before, times a this more. I’ve So, elaborate

us somebody I telling Let ahead product Mexico not product right we a you’re first in. in the you assume, them, coming this go the unless pharmacies a about only the lock-in and Well, all are for you and hear will send have one, else by you you selling refusal. and

me give they my adjust to to a come you’re to So, every time lower it. or going price chance you

Okay.

precautions they So, will anybody you the and getting person if of AC is so market. the the you market, into not were second all who out the these know, take wouldn’t to person, want of

advantage. all being take if this small beyond is other by Dexcel intelligent. it but away it us products, over number any newswire So, a generic Dexcel publicize limited We the with very to their us sending is competitive for to IR? Adderall not product, worth yes. the It’s are extend they and and come for agreement of answer Might ask the company

With Elite’s Dexcel First, their there able expectation, global reach, Israel. let’s be start commercialize will are Israel? beyond product to with

They they to all our may to in commitment Israel. the an to they are take established, product Once so they them is international in processing Our paperwork, can they Europe. Israel. of able be it and group sell are are

part We have that not discussed yet.

we’ll XR? product is get Once partnership Well, we the about because XR. this and in is through focused it that’s get a only legal and Adderall formulary because Why rooting not part Israeli don’t SunGen the talk for then partnership, the IR of paperwork get AND market, next. and filings. their working on are to in the have then include Ministry had they they did only go company and Current know filing, doable. way all are them XR I they IR But, that Israel one. the We we Israel, we’ll completed and on to Europe. concluded, and in Health, approval, in the the Dexcel

Is a is But they and filed with API this having Elite product substances. that Yes. it XXXX, a send was SunGen? a letter are and What that Antibiotics the multiple tricky impurities. response issues. The FDA? mentioned now the in it to with to SunGen antibiotic is to the point product They sent of is filed You approval the has from was had problem different manufacturer needed but sticking actually that under They early of to co-developed the product very with review FDA, lot partner. agency the that product contain the and happened expected very, faults. right complications. with some SunGen this

read So, API I the FDA I some about the the comment with response responded. thrilled extremely myself. made SunGen it. manufacturer, wasn’t

for we as is No, you FDA come were more targeted the that Have more going products product be ask We’ll that status and to sure again, response, update PR. be once to time. not questions. may Okay. been that extremely filed on So, ANDA right provide an at that of not come wait you been the that But end it a story. know, -- four ecstatic back. not this the of did I’m filed any stated we have had Can to we partner back to FDA about this the I’m please year? honest. now be will PRd, filed let not gets And you filed to XXXX? was The will the the partnership the in approved. had

which comprehensive. because two The of it ANDAs questions, it the both little is the year, to about of for to others one more the Elite over is. is believe XXXX develop and me four of four seeming has calendar right. years. and one number second it years. confirm, Nasrat all are four the is believe exact is, two is a of but for the is a one Please the for each next that same, years a for next expected years, file confusion XXXX. two number, The two the four and total read and some All Let each with them mentioned

have it me. transcript. what said Read I the this. next I So, is actually to

the qualifier will because XXXX. is four filing give be and more clinical we with XXXX. of if happening we’ll filing don’t And we sure potential, four money file was the Lannett, a I Financing I not have reason in it what’s making in ANDAs are We permitting, trials, for this.

are we ANDAs. As earlier, I stated about dozen on a working

We are targeting for this year. filing

delays. encountering We’re

So, a we’re explain I’ll here working for and four pause second on. the

generic an The product. it’s first ANDA, file we’re is to a going product

even arose. However, were this within have it. have an couple to the finally the do try months. of because studies struggling the do we’re Again, and the patients company in that commit they’ll going We and year. generic, trials doing next who to got delayed. got clinical it’s Complications you it who unique It file to last actually was the with now IND disease. We run a

a going because run happening discontinuation, the product not you X this of take is problems that COVID is X returning this to so Now, and actually patients in study on, and have about and patients because the to are with that disease, months. that

going lucky, since to with this back on not don’t filing, year, come able we’re XXXX. instead and this be lucky, counting of last of QX year, So, we’re file, we’re to started if which of we’re we If year, QX any till changes. they if

and been a forward year Another needed excipient. product an with, we we that for almost ready have moving

I what earlier. That’s Okay? was talking about

every a to them have not tablet of XX single may excipient cannot is forward. You capsule. you there, if move a component, all minor But make XX, a or

we finally, got that. So

like on this the company, in we company making tremendously the couple in run U.S. touched that, I’ve time since October. ready run re-coordinate need when Then, X These to And issue clinical a a not wanted reports about months they study Oxy now talked a the the were run in we us the run is the third weeks October. Well, to they to report. we till in analysis the ADT running We it two This and we decided first U.S. to delayed. compare they lots, June, talking and clinical run contrast and sometime and and the they X us for finish year, now to are on a this The delay is to them work moved till need October, that company of about last telling to month trials. to are a we with Now, you to is already more study September, file. really. got one study like A a ER, clinical they year, QX and September, run trial that. it. a product. this are do finish are run September, to then we they one it overseas. is it And of This need statistical Then, cannot

take year, chain to COVID. supply the place on commercial not next we delays materially are is that have affected filing of and the really the going till all of not resulting of QX because So, Again, products. and been

We have slightly worried ,even closely has is killing in India. it not and clinicals the one about that but I’m clinical watching running really that about, affecting were we’re us us. U.S. And been India talking in

delayed year the by We expensive, we in problems. even India, counting more which are U.S., but still much are is almost some in

can As The can. and resources sufficient seems not -- has development it confirm you RA is on the you to aggressive mid-February, capabilities that continues. gentleman and the we’ll say Yes, I goals? aspirational plan names deliver

our help affairs that they because I can And employees We definitely to My all solid is on a pharmaco the and have us affairs, vigilance. never out. consultant, task. have department okay, work handle regulatory us four been do internally in resources, medical hire to problem dedicating has

collecting do a the hire money to helping trials. conducting The You problem data, can Well, first, clinical it the trials. raising used clinical the always be to hand. the is

four. are at the but the do we over with this in will still half and anything year. left three targeting now tablet, be pandemic may we the of targeting the do is have other the probably have approved that the They By be end have money, antibiotic are right? year, one of them, not from of cramped toward way, last year. the four So, first we issues, least we have we Now, to

So, ourselves we give are not credit to that. for going

the showing last It’s are I mentioned serious or relating times. Pfizer. than actually you are Pfizer Pfizer? initiate was We Is in was tablet, a deal, there did in we guys. our with would also have We out. now materialize be It’s Pfizer behalf five question the with which confirm to was some that? any trying teleconference, next release anything profile. that deal news five? they is They I sit beyond we first really that the oxycodone Dianne? to they deal. capsule If there were very business run that is mentioned and don’t been other targeting not. And We get working about you Who us products made the there because don’t communication. I Pfizer really our four don’t thoughts anything. anti-abuse to stockholders the that. figure problem antibiotic for approval development, communicating that blocking with about In to if know is trying a on out calling exclusivity extended with ours. for have their and is years anti-abuse The potential comply the that, context Elite. course counted a best got and we of And third-party similar our that, heads are to a it’ll never our The

is product There’s market it go grab to the there run go market nothing. the and no for generic. ours me to against So, and ahead a absolutely as and in

do and the are for against I me it company, to overcome quite for made stock. with us, will get why a was a -- to They’re I for bit and in like it several pandemic. in the do as would Pfizer, help aside really well, deal job can addition That’s COVID mentioned financial their from wonderful generic? So, helping other run control doing so helping times, How on this that us companies fact something I several that certain out conversations they data how that? we always make to that? help work I How compensation willing

are Did announced quarter? the We many provisioning from last to-date. API Elite not have problems suffer we? any we’ve had times Production. where APIs the So, in with

we commercially, suffering of on R&D the like that on the stay question. delays. wood, quarter commercial update time and is an fifth single line that, so is us now. hopefully really run saying But, very not that we Dianne excipient you But well I’m really And the making to-date, they’ll the not the really with every API, coming could this are that we on into Okay? happen income’s doing things out so call somebody thankfully, final right could okayish knock tomorrow goes question, gives way. or will because which that The are from me this front, because

really function dying the Functions office. the know is Florida office. the as Somebody to about an Florida is office? What of

Elite is work Florida? done leasing purpose have Florida? work done what space in being To Beach office Dianne? in in the For being office that’s What Elite’s Pompano for who property? the employees is work business. The is type

going As live longer a Carter office no started now, we Originally, and we Ward’s business regulatory so announced our before, was with us. this the did Florida office. CFO affairs. because in is to Right

today. Florida of you And to mystery I affairs, you, divisions happy that So medical sitting Marc brings all on and being joining Thank we’ll a we majority you you, the affairs hope regulatory the in talk office. us Jersey. resolved have of Matthews. in group here operator. pharma not he’s there. to that for question the the Thank cold is last me. And to reside He’s soon. New freezing next conclusion. And But, Thank office. that the

Operator

Thank concludes you, today’s ladies and gentlemen. event. This

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

Elite Pharmaceuticals (ELTP) 15 Feb 222022 Q3 Earnings call transcript