ELTP - Earnings call transcript Q2 2021 | 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 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

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

Carter Ward

our in for you, XXXX today. is XX, on on Thank website, the links provide everyone Investor halfway fiscal point. filings. available sec.gov year, our as The which filed other section a Q of ended well elitepharma.com, quarter that the March quarter so XXXX. second websites six year, the the our September We're is is as fiscal Nasrat. of the months quarter and to our we Yesterday, September and the And thanks calling XX-Q

numbers. and financials, yet, the the context to gotten of of haven't you review a insight analysis, like the into Q other providing parts through get I'd the elitepharma.com of key copy Today, If any please from sites. the or some

address followers, to from comments As do best always, are related Elite questions that my questions and we've and those received I'll the financials. shareholders and to

quarter, double in the for Revenues on digit compared where September row, the digit quarter double let's XXXX with that same were The million extended was immediate another March year-on-year have six $X.X quarters from that's we XX% as XXXX which generic basis. as also a a last saw year. year, $X.X revenues for driven we to we generic a triple of and by XX million revenue compared increase on last the launched P&L, revenues this growth now the in was September makes million, increase or release year growth start strong achieved reported So where release or ended $X.X compared to to growth Adderall. Adderall, quarter for

products Adderall product for new The Isradipine, launched indicate release the market. Naltrexone performance, to their extended and are When Adderall other generic release the Isradipine by Phentermine stand these certain product with out revenues consistent you both to see you a as retrospectively our ago, in generic and continued also continue products. products, steady respect revenue solid relatively with upside seeming about over ago. contributing and just Elite Our look factors six that months to immediate numbers. products and future launched prospectively, We reported, year additional products evidenced at only and

here our job continue providing excellent remain upside, should comparison which they factors the contributions results the to levels. clearly do takeaway calls should are Elite's in are But results provide there Adderall, is the Lannett is positive and P&L to are penetrating small expanding previous these statement. to Our above alliance that factors share. These relatively regards on a and contributions in which especially factors an market partner a continues indicate current market, competitive mentioned to evidenced to future prospectively. continue and With market Isradipine,

a the the turnaround compared for during to quarter, six an million month April $X.X $X.X $X.X should $X.X fiscal the loss period strengthening turnaround relief. second the for profits, XXXX of as last million loss this which the a year last streak profits of operating operating with progresses. first led this a That's of was that's same year-to-date profit compared consecutive P&L the a months profits. has our We million Moving basis, quarter to million On quarter, a statement, add September also to million, from to our since operating to profit It's is of year, $X.X down an the and six operating significant in September, financials. we year. operating million an achieved $X.X a in

cash million of operations sheet burn positive balance $X balance X.X million working and $X.X flow has million last generated of And the It's financially capital to the quadrupled stronger revenues have year, almost $X.X impact this Our months. and profits. and operating from the sheet. the our That's a improvement an during flow to cash a much of six compare last year. million a that speaking $XXX,XXX in increased you

was So July, keeping that's filed quarter, attached and about equity line I they're the an Lincoln relevant the Capital. all during that Park and place else in something that put agreement, there. talk We in X-K and agreements, in just S-X rights with I said purchase want mind, the an new to registration

summarize, can in the is a equity to the rate documents line. Lincoln I'm review going full, you give you brief if But a So summary. variable Park like. you'd just To facility

a at the correlated has closely to So and Park, Lincoln sell ELTP dependent time. the to the at to that on that's trading means price right that shares Elite price

like to proceeds, minimum of such minimum want facility need extra minimum Park, are which are on no Lincoln contract, $X.XX sell Park, PPS, be sell don't now, we're most that, which to Park. as prices, and minimum if no we line we irrelevant with sold expansion, have based aspect product when If development the agreement The Lincoln to requirements have calculation. important products fund the And was the of These defined Now, developed legal few and there profitable, I've sold. to number be working product made we regarding low over agreement, positive The have equity the may of legal for just won't the to shares shares otherwise to to the just cash Park and and not that sell due the is $X.XX PPS equity is has and of to that's bearing time, determines price past all price, requirements. put our by and Most growing any don't don't to to we the main won't possible dates, lines. shares a we Lincoln Lincoln the line comments from or The shares what keep mind If purpose in The the currently, minimum to years. is it Park. legal at a the contractual the Elite a PPS not matter and is criteria, maximum strengthening thing It's other purposes. satisfy agreements. the is is. are various sold that this is position we today shares capital. to the by financing to Lincoln financial be we revenues which has price $X.XX financed required effective Lincoln as provided the financing, is on important price at the price which it's will received will some in the shares Park, be

shares to line. really have were we Park, was that for documents done for this only the single sold a and of establishing of since functioning set new Lincoln So new the place and ensuring solely mechanisms they were facility, purpose in the minimal done and

current as working shares flows. additional including any sold to fund we not and have capital adequately cash operations, our We development are product from able current

us are to bankruptcy, factor an and see in However, opposed larger Akorn at to struggling leaving ongoing. our decline This type Many is the and us shareholders for larger either Park they don't for it's note such ideal you'll under industry companies that, much our is Park with line if more achieve pulling have a are equity in-house significantly us of as And while the generic regarding nothing. of others the mountainous They pharma Park earnings of as profitability not are of per These We expansion. facilities back. major funding Lincoln robust, the to and facility much long-term funds the Lincoln needed they don't share. mid have and growth We use credit required of product significant paid here. disappear. facility development debt our filed to no the are requires and through be debt look this received via type goal and size this There's Lincoln debt. a resource business is have our or continued from activities Park to Lincoln means provide acquisition. to to our plan thing One loans judicious the than Mallinckrodt of expansion increased our and line. today, available previous weight lines, down.

Now, update Mr. Hakim, and like his would to our an give and chairman Nasrat CEO, comments.

Nasrat Hakim

we row have Carter, capital last IR two achievement. you, Elite build the Amphetamine ER. Thank a Six a profitable as this and is quarters in to-date been working financials. for launched Profits for serious has to up fantastic been quarters. used

profits quarters It outstanding in achievement past $XX a my over million, the covered at this We for have Elite very we've we're have $X.X going What that is do and to we large were period $X.X to increase But this we're the also our $XX on a million. in record this first, will Revenues year invested and quarter and R&D. that update. year. up time. expectation year, revenues continue months and going the to Revenues years fiscal to revenues, This $XX levels. Two address two trend are an over invest have I'll a ago to going capital six year showed year-to-date of million, in continue last safety. with is high are ago, i.e. of been remainder for forward? were only that long and later million income million. the

our is all sales to We partners. today's We Elite and a pandemic environment. a had pandemic. us, marketing are service that affects fit doing providers, in into of only business adjust not operating COVID-XX to but suppliers,

implemented new and protecting and have each protected We safe they associates ensure employees to rules that are policies are and our other. and

shareholders temperature to We've implemented and training Federal plan following our and are protection to feel We recommendations. hands we daily local and employee that patients hygiene. shortages, do appropriate our whenever that We shortages, includes, employee washing no part proper that drug to employees, possible, have and there that entails continuity. business attire, ensure an an guidelines are the monitoring, masks, social distancing created obligation wearing and CDC

flow air and Moderna's staggered look manufacturing forward All very space raw the the people Pfizer a success ensure number hope excited material and suites and work about exposure. also have safety We the option to creating doing our in returning cautious am in meantime, shift given two and remain non-essential and normal rooms. sales we associates from the more the suppliers our less limited vaccine, the to encouraged In business and I to the marketing we the of been I in We continuity. to employees provider, to same. the need year. and partners life And by and and a vigilant and somewhat in when to to give our possible of are increased service employees API home.

in is facility good a shape. Our

GMP, a compliant have We DEA facility.

are and thousands project be XXXX. by hundreds upgrade it year of ongoing, spending January of this but always to dollars the are upgrades current should improve the expand it. done The We facility,

growth. our is our revenue approved transfer have Regarding have capturing successful in Loxapine to the with market and good an already doing this partner and the quota our DEA or marketing at done is site of and for driver suppliers, job, API Amphetamine submitted Lannett, our also December they Amphetamine marketing enough was Lannett is to next partner Amphetamine add our Amphetamine to have share. was a ER important been substantial successfully for is API we approved. expect last remainder to ER product continue IR year. profit launched growth. the product April. in and This we and for we And year. sales

for are to launch. We waiting API

We to launch in XXXX. expect this product of QX

for it is day. Loxapine we're India shortage filed product four partner tablets, currently just this currently the ours. developed list. our FDA's are marketing including is for I as and or data the the expecting Loxapine amendment a from with that IQVIA a we we antibiotic the partner, October. application The on in we API, There SunGen product are it million. coming have awaiting And said is any $X and We The Loxapine. have

We step. are as to decision awaiting SunGen's and FDA's the approval next

we decide our TAGI FDA we and plan, product, you meet products. Lannett, as the update partners and launching soon the SunGen Elite on accordingly. sales steps As hear executing new doing with and approvals, getting job. are its the is growth next on and and will a Glenmark product that marketing approved good And

that line, working rest go adequate now R&D. the next step money Well, that importantly, our may the of development we the capital, new finally we after little that. profitable Regarding spend bit detail will on on are the ANDAs, for ensuring most facility, and and consider purchasing we have of And we Elite? a I'll into what's

batches, the its This exhibit and responsibility. materials have product are working benefits that costs. clinical are project the on and optimizing cost the manufacture with how of central to all belongs discussed previously. we conducting the know filing We Elite nervous They Elites trials system raw project to formulation,

SunGen We call. ours. we Investors differentiating facility. release differentiating is you we to of barrier as an to with is focus and viability products, evaluation a we entry in products continues future will product extended solid Once such issues product than are on forum due formulation, or have believe inform are are to in the doses no technology Elite's advantage answer generics growth. XXX% our competitive formulation now on this which next complete we work have of to resolved I we that have this a expect that with our that moving for later our and forward and it. the if the Elite product,

own key you milestones to evaluate manufacturing update R&D contract In Elite addition our contract partnerships, in-licensing on opportunities evolve. working also projects, on we to will continue development, and will as that

me be Let regarding clear R&D.

and SunGen, investing are R&D We happened things to slowed Due to down. in right what now. financials

and product focus our and up a formulation of clinical a R&D batches of we the cost cost taking of stages we are viable, activities though, available. do a money. development a It release press the company, usually becomes is on and even trial These a it development. we is scale conduct updating lot slowed ramp advertise. have In lost cost lot issue lot money, the succeeds when that up of will R&D of down, care we of We becomes exhibit of you money, it. that we money more as lifeline never that things preliminary not

also and to we working, ANDAs be developing because get All We than the choose. few expensive you return now fit have buy profit your if we that are profitable because that on options the ANDAs certain made we are portfolio a a organization. is may profitable investment. is our making but being are portfolio, already you your available market that choose and the immediately in ago. sold of that that advantage we will decisions investments something years And are own, more know already a

couple to will show she in now right making Dianne, categories. to switch sent fruits we're into of for that R&D some over I'll multiple us Q&A investments you've the years. So group the coming

Nasrat Hakim

are regarding update First we approximately contract status? is Last the status, sales still items that were from the is three call. the it the We're and marketing mentioned The on it in API is team, following last would API. XXXX launch current What revisit planning last waiting the But the arrive Loxapine. of That regardless, conference signed call mid-November. make would quarter. and QX stated with pipeline. the for next to call months

Carter Ward

XXXX.

Nasrat Hakim

XXXX.

which expecting certain know. wait really next? first what response? as in with Yes. issue? do to need we status, we SunGen, file is But for you which do has more We October, call, we our I'm Antibiotic filed What of. much then FDA update we're October. soon in product. Last CMS Sorry. approval, happens did We'll SunGen complicated as

We this? knowledge are we and have moving know we with forward how Yes, are.

tube, vitro, the in million We lot spend we of a formulation before putting in a rigorous clinical a are our human trial. through on We're testing testing dollars it that test couple the exploring simulates things.

clinical Once all to you ensure we ahead on and see actively we and that we're right I our now vet spend let to formulation, trials But least a But the in-house, go then ahead sure and that make the using are we'll we doing chance working know and of highest everything know. let wisely. you trying it. is methods. have the and/or So path, viable money will passing of conduct expensive go we we need we we'll

General is topics. forward latest Okay. pipeline think. currently pipeline What development better is Overall the on our strategy? what go and stockholders than the pipeline

please relationship speak with which JV the just we development SunGen, did. to Elite New CNS,

Okay.

general are there want Number the I about five for system investing know are vision what same. them articulate four to things about that lot and publics, R&D mentioned, really, we're going of The we're time the effort that. all And to of and a our on. as Regarding central or the product, stockholders in forward. is nervous working one,

and we early development in-licensing stages for We're of agreements. research new in into products, Second, the are looking those.

looking to we and ANDAs. are evaluate whether buy we're a partnerships, always looking into We could new

revenues proportional Annual how So based of to are for How capital of the recruitment? can in-house revenues the even the modern be that and right facility or Will annual now. are manufacturing to buy. also to significant big capable there the not companies they expenditure we the the with the continuing are size, maintain proportional with right ANDA, there is on other things Elite's Elite top amount capacity? are product. buying really that an other are other Including partnering product opportunities these a generating? product right R&D from five much companies the once facility? are be How or of Facility, you need their is money or on with all of replace have SunGen, in-licensing and that list

the So very it, good I question. want rest a for that's to address that, of but

now and right generating shift. is we're more facility Our and million capsules, than only running tablets XXX one

site. were can XXX billion, about or upgrade get except maybe blenders the have three or the line. easily easily Other process packaging million. more line anything is those if infrastructure do on that, a there, can we we entire So with than the double three, doing or tablet the and two we do shifts, of what quarters we wouldn't packaging and And to double current we're than another encapsulate and

to I legally and and a and free balance ethically consider get in more statement Elite solid take the been will questions. having has essentially is term Or that slot, Besides growth, what price Let's market? slot its that for now? anything short fairly out the continued you to couple not of do sheet income else mercy years the stock of a is there at

Carter Ward

Aren't we all?

Nasrat Hakim

combination of a It's two. the

manipulation are a survive When growth happens not that about you have have, as and before, the We profitability quarters of we the thrive. and nothing which have quarters stock six top free the mercy the drop can at and enough have of to we've we do working move the bring seen of in products that. -- such and at capital there in row market, is mountains only never see two And that still companies OTC. Amphetamine notch

we There are do going certain OTC. are they the as Okay. to to long people as do, are what going that on are

credit shows the we with us profits, of stock for products the increasing are them, obviously taking the And we're and increasing the not And this. as off sizzling on not to I holders said, unless up? Yes. increasing get working a things I we is are another because all major to brief obviously share, is we as is getting for are it market stock toward the up stock. revenues, that in small being that And OTC step into with believe Can truly to manipulated. of getting away, do get it's up stock the next quarter-by-quarter benefits goal exchange. Obviously, steps logical coming the merge we're order that. Our company,

And be undeniable, ANDAs buying reacquiring that's into point will of working projects ways, to Amphetamine for it earnings have I and going happen a the when dollars IR there multiple However, an where to spent CNS that getting couple millions from Elite other will you on the ER, per product that ANDAs, the new we're the be market. on protect working of by getting share.

to enough could point manipulate All that of as and will and down. sell see There going people a stocks now, money of us keep their bring undeniable, is best. this that be on in the to I nobody stock where it's

make company At what part there. they for are at do They're with being the decrease or is securities owning what have growth bankers those to be the on marketing The Elite the who investors going into will funds it organization banks by us Street selling our from not the point Because you. share OTC, because third on float? to even $X.XX scared a new Wall recommending stabilize and is prohibited the price, us and traded stock. be

OTC Okay. to Frankly, up do and control major sell a on exchange. stock with company business This only spot the price of the decides building person listed can plan. is stock the day, to control our move not the we whatever on focusing execution we why a market, the is that get strong on is fundamentals

faithfully Pharma we then dust control kind get and listen affect a not such our companies? We on to where guys the site any get always Elite? lot different as on ongoing a even And court day-to-day that opioid second. settle update where cannot activity about Purdue with the CEOs. give rise that the the in all I relationship quarterly to status lawsuits? plant talks releases. also does timeline And and the status with stockholders, whether the timing the Is to Can you we activities. question level the courts there here. does in other press how to of will of is the calls That information hold and stakeholders business update these as I'll we release. Nobody of an and We the stand with do our of the in the about question The or of you Last on press opioid. day-to-day of lawsuits, conference

As A first are at a was this Mallinckrodt, They that continue they not zero. and last thing, ongoing. won, but stockholders to the have lawsuits bucks is bankruptcy. as suing. awarded hard the or was for bankrupt, not because Carter last and the debtors CEO doing to Purdue. right is one now. very And the jail. to is to us question, they lot going Akorn, to zero. company same not we're that opioid and time had $X.XX indicated made is the was of the filed almost and down its going the latest people about affect The situation the XX, Insys, are week was of already lawsuit. it the clear very now went it $X.XX zero. XX It it's for September, The court settlement in

that need not to cautious, We the litigations trying file we my in because be a to name. know, background a win. is we litigation. are when when to have a money in are to or This you lawyer, fight the to smart fight not the to fight products But are lawsuit, company that to being is involved protect and get and retreat. enough when middle the I'm

has that Elite? well and see because So us. and us, on neither with win, shifted will that, for I any it working don't administration. Biden Trump office drastic be started courses impact present there Last make eight on decisions Trump, has other and years Biden, was in we whether didn't before done frankly, with as Obama for products, the ER hurt extremely to and Biden's we Amphetamine was question, and or such any IR

So I be that's focus five that to think be main is factor The to mentioned. on going I don't factor. things the a will

nervous to if that's We trials Our with for and ANDAs. we on figure well development. can whether see or continuing into make partnership R&D, work the need because other out central product, clinical sure system it's not, acquire viable to

Okay. happy I all Congratulations Thank quarter. and us and wonderful for you very at very a great day. our Elite. am happy a all on stockholders, I'm have for

Operator

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

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

Elite Pharmaceuticals (ELTP) 17 Nov 202021 Q2 Earnings call transcript