ELTP - Earnings call transcript Q1 2025 | Elite Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Elite Pharmaceuticals First Quarter Fiscal Year 2025 Conference Call. [Operator Instructions] Before management begins speaking, the conference has the following statement. Elite would like to remind the listeners that remarks made during this call contain forward-looking statements that involve risks and uncertainties that are subject to change any time, including, but not limited to, statements about Elite's expectations regarding forward operating results.

Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws and represent management's current expectations. Actual results may differ materially. to by revise law. obligation except forward-looking any required as disclaims update its or statements, Elite files which More and at found Elite uncertainties information elitepharma.com can the complete regarding Relations be in forward-looking under the the section. Elite's available on is statements, Investor risks with website SEC reports documents Elite these carefully. encourages you to review

Pharmaceuticals. is and With it my now over is that Officer Chief floor Nasrat Executive host, floor your Mr. pleasure to Sir, of Elite covered, yours. Hakim, to President the turn the

Nasrat Hakim

Matthew. is you, ladies Chairman gentlemen, I Thank our good And and us Elite's is and morning, joining for earnings today. thank call. and am Nasrat you CEO, this My name Hakim.

you submitted Our answer update the summary and of after to of you CFO, give company's questions the Dianne. an Carter some Ward, you've a which will financials, I'll give

the Mr. Ward, you have floor.

Carter Ward

report you, everyone to it's in Yesterday, Thank we Nasrat. filed your XX, of XXXX. ending calling March in quarterly the everybody. Good XX-Q, interest Thank Really appreciate our fiscal Elite. for you our year first quarter morning, today. the

XX the quarter year. fiscal our the is So of first quarter June

If Investor it's section. our available you Relations elitepharma.com under seen haven't it website, yet, the at

those financials, usual, Appreciate finance received the go As to up some questions. once again, answer through And to much overnight. going some asking context, it. questions so color financial the for also we're and we statements provide the that you thank

So let's start with the P&L.

were $XX.X revenues year total quarter million. this Our for the

And to outstanding then, more increase, on that XXX%, that's the prior more quarter, million million increase. year-to-year so doubled, basis. results compare You $X.X $X.X XXXX really XXX% a than it a year and June it's was than

and let's just June you take back the here. quarterly just trend XXXX important forward at But look roll there. is from trend, to as the then We'll

September in $XX.X $XX.X XXXX, million quarter, March million $XX.X had and then June revenues, million, $XX.X XXXX, million. XXXX in was we December XXXX, million, this XXXX, $X.X So June

year-to-year $X.X last basis increase, on compared income quarter trend a million, year, million XXXX. it's So The prior so was $X.X to there. was million nice $X.X of year, Operating this a June a XXX%. million $X.X very million $X.X

at Once again, trends. let's look the

XXXX, was a little million and $X.X million. December $X.X XXXX, to XXXX million, down June $X.X nice it million, 'XX, March Once was back in then 'XX, trend million Going June very but again, there. $X.X $X.X September

due So the the the label it's increases market. year-to-year, success trends, the due to of definitely it's mostly -- in the positive Elite

quarter We launched the XXXX Elite during label last June the year.

evidence Now has valued belt, under and clear. X we a very it's reliable supplier, our is and P&L quarters have itself that. as Elite established

I've trajectory, the it so been physics So analogy. a going has give impressive. upward I'm always to enjoyed physics you

providing a fuel thrust on that. additional So an that such is trajectory. unless level In is the off positioned that regards pipeline. our trajectory, our thrust object when We're well case, additional added eventually things is maintain to with fuel, physics-wise, to

other on we quarter, a We're quarter, methotrexate into this And during also the have APAP and products that, behind X a hydro We approved. as schedule bringing acquired ANDAs previously product, that had back stage. through and methadone. Oxy expected. Codeine are and moving commercial During approved APAP, we pipeline APAP approved the

plenty that maintain provide to to that there's in So trajectory. and the fuel thrust of tank

as well We now. questions I on got the a P&L. few might address them

comes on we agreement from from came First, back the the in and that where the there and question it That's revenue TAGI was signed licensing agreement. a XXXX. our really licensing

label. more licensing come generate But out where we license from. the focus our revenue the Elite that's that. But on revenues clearly, So do of is

are know but revenues. for the who don't type or some information in want got names, X say, Well, very disclose to They XX% of were. question -- I customers that that concentration, marketplace. another these notice they the largest customer revenue those customer we of accounted of generic concentration our our players needless customers to

did question question about flood little and time. a plain. with insurance everything the and yes. answer map Then got get And a I the first is I the flood

flood been a flood do But flooded no, have Of never course, had we've never have we and insurance. insurance we plan.

generators and we Hurricane generators handy lose But our We everybody critical for else those like in have critical New lost just going. Jersey power those backup in weren't we systems kept there, systems, were flooded, when came much Sandy but power. during did pretty

worked that So well.

Let's to cash the move on statement. flow

million. $X.X positive was flow cash operating Our

Now burn year, $X.X you there quarter, and XXXX compare the million. of was a prior that cash to

two So that's to swing, a right but main million $X.X swing it's big in direction, due a factors. it's the

the First more profitable, revenues little mature are, and flows launch cash have. I you're stage, positive and the beyond that this mean, we year, achieved we're result a now, profits and the is will when they you're which

second do fact was XXXX June quarter has cash launch. with The factor quarter last in that we the of were the label Elite to The burn. year, a first the

last year. phase So we launch were in

a have that and XXXX, used of working on quite million. you in inventories capital inventories June when end of working new finance bit to receivables front form and product $X launch, In almost the a requires So the we receivables. capital of

a burn, of a product it's creates textbook new cash a what line or new example launch a you product. that happens So when

phase, a you you had. the we million But cash positive get together, So plus mature it's $X.X two just of burn, like swing those more launch very cash put phase and flow, understandable. the

that mature are XXXX the almost quarter. during when growth say year note they and million well, means this Also, phase, as That receivables still in we're in inventories, growing June $X we're but I more still our phase. a

revenue they're capital, strong last year. and to compared the but still mature, as We're very So streams still we're growth. the underlying working in more are investing

$X continue still while positive to more cash to invest future So million there's enough in growth. flow we in than generate

cash looking flow the So down statement.

investments ago. section. while The little Let's the before. look equipment, ANDAs construction ANDAs part We of property $XXX,XXX, the new the and at for that's growth, are the purchases Those and of are products had ANDAs. the for facility ANDAs the the underway. these $XXX,XXX. mentioned that future currently just purchase property those of the things three and just investing had launching I be going we That mentioned under of of to cash, These was a approved we're I are equipment, a are use the they're

So able setting again, to that be to forward-looking, support and for growth more growth. up ourselves

on the million, to year March beginning the end that's the balance since June So XX, and the $X.X sheet. of $X.X this year XXXX. fiscal Cash was $X.X as million the year, of $X.X or of last million, million, XX up up

of million. March I've XX. a working capital XX to an it financials June and continue like said sound before as months, in million I $X.X So capital. in demonstrate Working many More drive capital at was three $X.X this working since than record, know clearly but profits I of million, we're that's our increase this. look up also broken that, calls, $XX.X

Our balance sheet quarter-on-quarter. strengthen is continuing to

place I value? balance this And that find is a answer on good a sheet, place best The the what is to question. answer the balance loss on I guess the question what's got operating are, sheet the to net on the they that.

our federal tax this and June We balance XX, a of is the the of income NOLs. million of is $XX.X regards all as And asset on have to that with deferred remaining value tax. income sheet,

tax going which the are So years, essentially basically, forward. had we prior deductions losses from

value profits, us. don't income $XX.X and It's NOLs. million that of as we We date these losses have taxes. to generate So state to up from federal all use we is prior the any years

So now, level, state we whatever owe whatever at pay. we're to taxes we making a have

to upward you things trajectory. and then to all fuel, And to strengthening, trust So behind they our is is positioned Revenues stay progressing continue a is want on number that sheet provide balance that is and one, to and profits the we The trajectory. sum growth pipeline up. things capital that, trending continue low. up, financials, Working to see. debt to grow, provide increasing are maintain

comments. Officer, So Hakim now will his give our Chief Nasrat Executive Nasrat? Mr.

Nasrat Hakim

a are I resume to you, call wasn't add be from you NASA. you or should that Thank because your Carter. a physics student aware getting may SpaceX you

example. Okay. appreciate That was very I good that. a

Carter Ward

I Yes. scientist. am rocket a

Nasrat Hakim

a and right. the And very launches, infrastructure. distribution first couple talk and say of product definitely excellent I'll everything. new Carter an exciting, about about facility All the and financials. then sales job covering development I'll research did that's

of First, a couple comments about financials.

got as earnings. That's revenues. on in That XXX% and have the in it year. is quarter over in us quarter we our in line to is this $XX.X target last Carter $X.X said, same to million, XXX% million see, increase, of compared goals year for revenues for record Let's with another

By the The way, of the Christmas and XX% deceiving. year the The second was XX% -- the is could also colognes next, get factor you Day. as of sell move when outlining, to men's Carter on for of because rest -- sales to only revenues year second the is revenues XX%. Father's example, increasing is from quarter the be for at one looking numbers from factor quarter-to-quarter,

compare you would that quarter-to-quarter, not fair. So be if

have the the year doing here, reflect after, quarter okay? that You why and quarter compare we is to that's year to of the quarter on before And before. what that this you're

are the school academia, everybody example, supplies then are that the but for much We fall, not very supplies. to because summer, school similar in in in sold, buys

take in because but And they we case, Attention in obviously our usually. go get off solar the want more still then don't suit. January that on in the the spring, year the during in people it's around thanksgiving, diet medications, to little the school a Well, they similar. again, in lacks necessity. start but a are summer, they Bariatrics, swimming people

it's So quarter why one quarter to quarter look one the before. year the to previous -- is equivalent this critical year at of of

is of the the is from the you there next. the day at some during The if Because timing, the the that ship other, of factor quarter, year, shifts beginning you of over end totality the money at quarter one Why? the one on quarter, second sometimes to look whole if

closed $XX million this Obviously, revenues, years. million quarter is day, look in XXXX, year, it. year what undeniable $X.X our million. entire million, monumental. in that the the 'XX, $XX.X a million the you It matter a the and revenues. in In several XXXX, revenues $XX.X in doesn't we $XX.X were totality March revenues, quarter million at over trend year, says of this in you a in is in year revenues this is the and or of look $XX In XXXX, is not a which 'XX, it's the month at for in in earned increase or So XXXX,

revenues before. best the our every X year year, been has For And past have than year been therefore, better every years, year. our the

year we through and best make to expect gentlemen, to continue are into future will ladies this it and foreseeable on XXXX target year XXXX. our again, and the I So trend this

Kirkov direct our at. revenue for only to these The get and success. elite products Kirko and success. and label excellent be together our highest products. Sales leading profit in continue quota. us team, to The his to really market has ER. can where and these strong A done great Everybody sales my sales products and We demonstrates demand distribution quota very revenues. team we're our and The a are for the the Managing staff. and Plassche label managing our an see increase revenue the get. to the Elite team much and senior an Doug coming for great limited mixed of Elite's quota doing is growth IR Amphetamine, to been by generating testament how important, we rest is job what's excellent that is sales especially with organization transition has operation the job

and they phendimetrazine, revenues Our shares to isradipine, trimipramine have revenues other Amphetamine but achieved strong are the market substantially. products, smaller than they have contributing

be Amphetamine a Naltrexone license label the enhance has pipeline label. other also Naltrexone, list. the sales of this Precision two under license to year product products the the will and name Burel and first be sells Elite substantially has addition, for launched a capsules, Amphetamine sell licensees, well. to FDA Precision they Prasco. label. we soon. Prasco shortage our nonexclusive that and will doing in on elite the tablets for increase is This Tagi has and have ER quarter was our launched label, that In Dose under for Dose and continues the revenues

Methotrexate be was the recently quarter. this launched first is generic product approved The will FDA and methotrexate. by

years The second We saw ago, with Codeine. was the Codeine. product time is until before The approved waited is Codeine brand generic launching a we market few name but need we now. was believe a and it. APAP with APAP Tylenol approved

with to expect after X weeks. the APAP Codeine launch methotrexate, of X be We to shortly

The APAP, third product Oxy Percocet. is genetic is which

after three methadone, X APAP launch Oxy least oxy product APAP, that and with launch to that four months. APAP is expect five at The hydro generic will the products APAP. We we for next would after launch mentioned, The is X fourth which hydro weeks APAP. within is Norco, product to the will Elite that Codeine. fifth the and follow I Of

the product important to product be the is The I This the approved. launch sixth central product This over FDA launched most of. disorder products attention deficit once approval. nervous pending other is spoke priority will all have system products of all

we only and Now queue what what's can the we plan in for have.

everything FDA next. else, we the gives attention reprioritize to nervous and the deficit this have Once need will we'll central disorder everybody medication. We launch go us approval, system,

maintained Elite our cash a sales. strong during to position transition

have maintaining new substantially and product supported our pipeline working our capital launches R&D needs We increase well while as will cash The as revenues. levels. profits costs

Nothing to the to three We will overnight. is two over see quarters. incremental next increases going happen

You first launched the product.

pains growing Carter described, the starts become and viable. to then that through go to going You're

You launch second. the

thing. same the You go through

quarter and it's it's So coming, after quarter. all coming

the reviews will products, Elite stimulus Elite ADHD. for by and an filed a continues PR has request. agonist, treatment for of central and approval. treatment the issue dopamine for ANDA ANDA FDA ANDAs used upon system to development continue Generic ANDA Regarding management for three any under the pipeline, Elite FDA. are and nerve of pain Parkinson's, review that provide FDA support the these research to

three of needle that the are mentioned movers. Now I products two

words So let few about me more say a that.

supplier. the the this minor an nothing review spec, of over us the Fighting FDA move couple adjustments. make request the for there, of FDA month the DMF Regarding to But and did CNS extra relevance. here application, to the API a asked

is November the that And do found our this instead once They whatever, need had in a what year we they back and we that hear nice So any them very they will was or to resolved doesn't we our issues actually issues very to hear the update November. resolve if -- That past of X FDA we all to call application which or itself had, take and because is. promising PDUFA said from FDA saying, DMF some month us the have in we of and really months date back is over verdict or a supplier. year. another we in issues, their you question

lawsuits pain management a you OxyContin agreed the the right that any a going and one common It by hold now. paragraph sense of months. to of is renew to outcomes get to their IV through and Purdue because this Purdue at litigation people generic have Regarding more have the on with for updated X for trying lawsuit ANDA, We us does not brand with is time with the patents. enough engaged We're make they we them suing invalidate filing company, ANDA that.

see they go invalidated, we us to landscape. are say else. same If until happening boat stepped will what's the as we they we agreed They to and through where judge we're says, if going move in are have back patents in discovery, the in, to not, X everybody after we'll we the have spend don't take So that don't come months money. we're

not that a Elite development reportable yet. Elite a other in stage formulation products reached R&D make have continues the milestone to priority. has

facility know, to we needed Regarding growth, infrastructure, additional space. with up and as the keep you our

the The approval, the that's of were report So to inspection packaging a were of we XX,XXX taken and IT two inventory and cameras, building into additional a expanding remaining it Department servers, feet line, feet, the it all up square permits approval, have of the ready Health, the DEA a qualified to the and part to infrastructure, and took a already then showed all have of it built FDA. square to The we we and I already support holding. January. Monday, an been the seal pharmaceuticals. security CDS XX,XXX that's it's the square and is last possession and We Vault We part obtained invited facility FDA XX,XXX things and that because make closed got happy very well. feet went construction about close on state-of-the-art already, last the security, They them warehouse Abt week. the am for deal packaging,

agencies, the approval opinion, within DEA report, takes usually that days the by DEA expect a my general, take I to write XX In regulatory in time.

November that come made The including give months file expect towards FDA on is facility, of the Before The week are by believe and we on on for stability FDA file right us should all being that be them in the of should you Three step November facility for know. and then standpoint or it's we and once be from placed for the day, approval covered but and of I can to end and than approved, The approval, matter the put FDA of lines now the I approval. packaging. the within after. DEA. the next get are manufacturing them lots X-month to in next then end at is the November. qualified, At approval. update XX that. stability it, longer sure, packaged lots the approve being and right that meet serialization for They To now. we'll about we inspect have received are package and for years this final from week a days, we'll or once and with when FDA at the have we X the you least manufacture expansion

has growth Elite shown quarter. this summary, In strong

a or when the company's puts time to move financial it an the a and right. in and Elite history. of M&A research best executing for This an development. in and commercial, company's position product pipeline is are the commercial the distribution approved has and has products had approved the line for position soon-to-be excellent strategies strong and We Elite sales best ever NASDAQ

Q&A. go Let's to

Nasrat Hakim

such were different, your what somewhat lot of group Carter a answered. them to enough was similar, as questions, Dianne

So information production should XX-XX with a approved generic? it's is launch. chance I'll of you getting had they there not be means pipeline. launch. Oxy for a any CNS can't you approval now start closed. the or okay? it Oxy we call? frankly. will issues Oxy nervous central the or from hoping request have is resolved, right FDA Because you of are until been be we Has system before think the and the can for say overdue, feedback little November what If issues, approvable, for patent And patent approved, Do are

we're approvable when unless on FDA everybody rules the change court us the what and is they'll waiting approve. to So give into decide for first they'll

the any that What launches, ANDAs? ones is especially Nordstrom's recently of a to APAP goal Is have plus approved product spacing of sense them most methotrexate with substances tall ANDAs order. time to launch That's because acquired the the current ours Product frankly, expected time weeks and take involve X first line time. Codeine do launched apart you within time. for the year? And a and make X from makes over control fiscal all to the commercially for the lot our

Any that other X ] that look X at weeks product, [ best should addition the assumption will time launch DEA reasonable three it it follow. amount X a weeks for first it each stuff. to a work in our be and on we years product. on lab, accelerated. Codeine and a stuff massive and launch controls you interest should and This has of a and to the and The [ space in to we temperature limitations But go ] out stability when to all products is batch and later X is for of strength to making is and controlled of stability room

IQVIA within you publish when earlier, said are but working three you is Norco, when sales. Or releases do I the of for least cetera? when you wouldn't months. Do coming we any we have launched we capital methadone, API actually when Percocet, launched? to them press the sales launch, to have I products at recent annual do, get issue expect all Yes, buy sure I until launched four We repurchases pending the the opioids As or are believe needed go more et to for products through the know have we the do. Elite product enough three the drug new have approved. Will loans? the

lot have in inventory So you we gets whether on sell of money we much how and will initially. A up enough see held chargebacks. cash depend

basically cost is For the them or price set give dollar price distribute says, at and the and collect $X, that the a $X is it. we dollar. within example, them we regarding they in and carrying give until chargebacks, it $X. problem up XX XX my and to the our It so, how with that we give WAC back pharmacies they get end so $X days operate give demand for days, customer if you their how a them $X the WAC you months means the they they that's But and us that or we that's come money three to us bottle with $X go and and

So you that the part, working need. you larger the more the sell, capital

get if we the the we spoke of get position, way, likely how by the spacing able of capital we're now, raise we'll of to and over if But the cannot money it willing are always fine. a get know burden you I now, by Board very we reduces definitely to most a from which where And to and because in good are be not earlier, And working we time. that spread bank, it to a loan. I help are As financial launches it. fine,

question work? interesting is Mitigation Another Risk and how Strategy. Evaluation does REMS? the And it what is is REMS

we, money the the be fees Opioid this or unless pharmacist part on you dime requirement the you that application the manufacturer about part this pull of time to are medication, a to of cannot prescribe requirement in and you And an pay have separate a of this. the of have by we to if risk sell our are This Elite FDA pay must a As industry, you a lot is from educate And benefit analgesic and team, has part Under and to Mitigation patients the team. the an and opioids, of Risk opioid and states. Evaluation the to is REMS. of of opioid opioids. versus you in REMS, all once Strategy it doctors all order do of a allowed distinct opioid

an more that received for to ]. A Has REMS phenomenas provide need make facility. than don't But additional and using license the charge facility, FDA? introduce okay? opioid it lot that. of of facility analysis abuse there of this. states sure okay? $XXX,XXX, So to on nobody they risk new that else [ what with explained meant an can of people when just really protect drug, from a I the Some the benefit yourself commercialization Please to regarding the fees and are the and goes educate you the full do new is certification to update status

be as inspected DEA X-plus has little DEA, years. That operational DEA inspect FDA fulfilled in facility? We the finish things we because them by for of them new that us so issue their The the We're in new Well, be us thing put will can operation making need next warehouse are in FDA our come the talk in loss. it fantastic the We'll to done. cartons thank concludes the will And get which three things said, as and approval. November capacity we is the timeframe now, no right Once we again making have approval We come is is hope will soon. Is and the and a line and be the be told and that our non-GMP to they on X I stability, this verbally it in filed after approved November a in Matthew. approval, approved get filing the just that in I them. Is us operational inspect and new said, remain I concerning is get call. a weeks, you, it the and DEA will packaging FDA? for get conference expect to warehouse November. FDA and the put

Operator

Thank you. Everyone, today's concludes this event.

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

Elite Pharmaceuticals (ELTP) 15 Aug 242025 Q1 Earnings call transcript