ELTP - Earnings call transcript Q3 2019 | Elite Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen. And welcome to 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 statement. This conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including those related to the effects, if any, of future results, performance or other expectations that may have some correlation to the subject matter of this conference call. or by such Elite's ingredients factors involving performance approval inability may ability transfers the that including, and of to materially be cautioned different such of limitation, the the results, of without not to ANDAs obtain are necessary forward-looking delays, risks statements forward-looking control may that Elite, uncertainties which these the approval Listeners processes, timings to and uncertainties, the obtain actual of results, implied Elite other other or be expectations cause performance under of or statements. achievements FDA from result forward-looking if the actions the regarding FDA at statements the of CRL, FDA, to require may SequestOx the approval, of NDA. of approval a the the by the of may of These all, Elite statements the the obtain and expected in include order Elite steps timing as take the all, and of the to may forward-looking timing Elite in of approval, statements obtain FDA the expected by order approval at regarding the if the require SequestOx of NDA. These include FDA statements actions of not or the and with reviews, and statements X-K. the and or filings XX-Q, property limitation, obtain guarantees clinical intellectual Elite's the protections reports results funding authorities and Administration Drug in on and including regulatory pending to future LPC Elite's performance, its these regulatory trials, are XX-K, action are other approvals by and Exchange the and sources, Forms factors including defenses, and ability forward-looking discussed These sufficient the Commission, and Food future under without from or other other Agreement, factors, of of timing Securities otherwise. its events to whether obligation statements, of a no under or new as forward-looking information, is or result update alter future Elite pleasure With that Mr. covered, is over to my to turn floor now the it of Officer Pharmaceuticals. Hakim, Elite Chief and President Nasrat is floor the yours. Sir,

Nasrat Hakim

call. My This us am you, gentlemen, earnings Good thank is and Elite's Chairman CEO. Miles. Nasrat today. you for ladies I morning, is Elite's name and Thank joining and Hakim.

Financial of Officer, Chief give a will summary our Mr. us financials. So, Elite's Ward Carter

high-level will As Company Elite's Mr. take And always, business and submitted I that this Dianne. progress is a Ward, the update I last will the yours. floor of to an since have our to you meeting. give summary of you few answer questions opportunity on

Carter Ward

everyone Thank and in today. you, Nasrat, thanks to calling

you to Jersey Speaking this Yesterday, XX, XXXX. quarter Northvale, December XX-Q from filed for morning. snowy our New ended we the

So, year. fiscal of fiscal which the on we're Investors That fiscal the the as available is websites website, March the to links sec.gov is on as XXst XX, so many quarter year. March our our provides third section that quarter ended December elitepharma.com means Q is XXXX, XXXX fillings. of a year other The and well

a going you the take get So, of context some the haven't briefly and analysis, insight the from parts key other elitepharma.com of to gone if one Q some the or sites. copy through I'm numbers. the through you of please yet, providing into financials,

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

million loss was XXXX. year, the to and quarter for profit statement. XXXX So, ended P&L. let's start Revenues December of last as for with million XX, $X.X quarter December the the the $X.X compared

quarterly shipped just many isn’t But, XXXX. We've Methadone, quarter, in revenues which were revenues year-on-year, the revenues, in million in substantial over the in increase. jump just a $X.X almost is single mostly quarter prior to This So, X% approved Methadone, quarter. quarter. This product that's September November The Methadone September same this expired, manufactured didn’t similarities XXXX. Methadone. the product. contract of Methadone. in and shipments and it years something manufacturer, towards but for to And and were our double when means it where when not didn’t million own XXXX launched was a of you’re very was the the These during the common that's to also end limited which shipments expected, $X.X in that's and earned was due we and manufacture is and quarter But, the December beyond begin And the pharma were product. the until contract That's accordingly, was of manufacturer this it's goes evidenced before spent of that us. XXXX, we be contract a the industry. time, And Methadone the for approval upside the product own limitations for Prior just getting that efforts, to developing potential Methadone clearly renewed. future occurrence of we the resources the end. the why

means approved. it and quarter marketing Methadone contract shipment. will is, six within manufacturing other three nine product, share own to contract rights now profit quarters experience reflect earn other then the see shifts. in-market -- months Glenmark of Based the to other first profits collection there so profit revenues of that a as another Methadone. upto after licensed saw we profit our with of is manufacturing arrangements three our that are received and products, have the the far for some the split earning into got is invoices the issued of the relation own or manufacturing, on that we We as USA. from month we shipments a the schedule, in be well are We’ll revenues. have of So, path. over additional profit to of and Glenmark so earned split accruing comparable And on splits The in-market paid But, market depends splits timing answer products. the most revenues the sold or a that months, in question certain substantial which when the earn product December revenues, manufacturing our on we’ll unlike profits short we a now sales. will of future This to from selling I also

pick-up start the March this splits quarter, accruing profits the in hitting up XXXX quarters. Now, will is the one pick our so and subsequent it quarter, now, are just in Methadone -- during we market, the should profit will

that is important The marketing be sell. and to to that to continues made, it continues be shipped partner the continues Glenmark our thing product

indications quite about from far been so the are this Glenmark we optimistic product. Now, and have positive,

products that The Methadone factor future takeaway have have generic earnings, not this Nasrat financial from expect that more we strong. also that during may yet Adderall. recently will And the do products they is are results. did especially the And on of phendimetrazine to Our this Adderall. to to optimistic not a on results, include product three bear sales especially a quarter, to was results to to and quarter. factor. and other Epic wise revenues, will also that to even that well well Isradipine on XXXX up, plans, generic say Phentermine contributed resources change Glenmark. in capabilities Adderall we that from All-in-all, being approved remain quarter comparison marketing revenue transitioning standpoint, and are the the from Naltrexone they contribute. commercial up. near-term. the which not September other has approved the with starting These but contribution contribute have and begun from a now it Glenmark's perform is but were will We're launch a products I the improve outstanding and their our in revenues continue these good to yet

million increase is on $X.X this significant is XXXX, spend. were Next, to development as expense, year's for XXXX compared December the quarter. P&L total $X.X expenses in a usual, for R&D, X% most line. and last December research quarter, statement our That's R&D which expense million the

expect I spent approved; the is always has contribute Methadone, were year, but another Adderall, on. central currently. has I XXXX been which to what that and which remember, Norco; generic also filed and I every prior approved; and difficulty] them say [technical R&D on just spend dollars other was already Adderall think, they important the important was are on named, launched system generic and and and amount as has quarter, revenues it contributing approved; Percocet is this approved, generic profits subsequently. spent are been but approval. product, Methadone it's been generic products the which nervous just R&D and

it's which XXXX spend, is quarter, anti on And been will for on next -- that system products year's spent nice. product, suppliers they’re so, and R&D being in this result antibiotic a central dollars, R&D that. approval, approvals that's filed. it's which also have being products In we quite year's after Alternate spent filings materials this and that what XXXX, yielded, year some other approved dollars nearing those few nervous that what plus CNS products, raw recently have critical

here just approved what's products that's starting Takeaway any like are R&D and products. pipeline to line out into moving. and approved. commercial contribute. pipeline and products company on keep being what And going not the We're happening. what the come pipeline our revenue just So, doing keeping we expense getting but These starting achieving. they're we at to also it's product, Things finally as are important coming look as generic the numbers, are and to look to that pharmaceutical and are stocked at to

filed products to continue and develop working through the steadily We products already future. way more have we FDA, their and even for the

All are ongoing, our and should. they it’s of moving, is revenues it’s underway, as that growing

in factors positive very all So, our financials.

update Mr. and his Hakim, Nasrat would Chairman and to Officer, So, an comments. now, our he Chief give Executive like

Nasrat Hakim

you, then I’ll more go a year of us. talk Carter. the little I'll a was Thank into and solid start summary things to I'm XXXX with a about going detail. for

approved of data by Norco, an and Adderall data central -- Amphetamine product product XXXX, APAP we with about with IMS Oxy/APAP, about $XXX We On system of Amphetamine million IR billion, front, of approvals extended of Percocet, the antibiotic in end about an and Hydro/APAP for IMS IR generic which nervous generic $X.X sales Methadone, approval the Adderall. with the year received release Codeine. got filed

Elite. products and which of also the of that, two central with and nervous QX. launched marketing sales sponsor We these a system partner, Glenmark to has old partner marketing, greater in In for the addition our agreement. two new to marketing partner in results we’re Elite’s licensing partnered reach on XXXX Glenmark, products and value transitioned process and with several we from all in for products. partnered better identified And We finalizing

in more minutes. that little yet, Tmax I and So, issue last SequestOx mention is cannot about resolved that [indiscernible] We few speak I'll a January. who

to a facilities that upgrade material efforts successfully and FDA. FDA continue of with low row no XXXs; cost three and And that’s completed we lot money. takes in time and no Elite’s a qualify from continue raw observations suppliers; with to We inspection

approvals from target the which our So, the year average one We let was with in quarter, XXXX at four approvals. before. the start had me per

IR API, the first up The scaled of and very received very purchased short period December, and Amphetamine was November a the and developed We our Glenmark. API. That’s we of August copartner in and purchased SunGen. of the very, quota that solid approval secured Methadone. time, with in We is for in product a partner approval the Adderall, this with received Methadone XXXX new We quota a API our the secured XXXX. sales product achievement. marketing and launched

We approvals product process this are for marketing and we in up with of Hydro/APAP, respectively. product, discussions in completing and Norco partner now selected currently are this We partner. scaling and Percocet, and November we in we preparing Oxy/APAP licensing received to the are with agreement the launch. and whom July the a marketing

opioids, problems the with However, very by and to states lawsuits due that are are carefully. associated the initiated we the proceeding

of This $X.X and going per average nervous the the they industry. for We was us One that partner not in into are XXXX. product lawsuits product to an the has happening IMS the start had selling, between one with then signing Again, billion. data central system SunGen. four We someone states and potentially extended add an rush quarter. our release and filings that's with are of

We expect launch and approval QX, thereafter. in shortly

launch we filed filed marketing in a We QX an partner, we and and in it distribution XXXX, the of with expect GDUFA of to date. is are and in about have we QX filed XXXX. in already is February agreement. We GDUFA of September tablet, it of that IMS I And very and identified We will months. Amphetamine received IR, finalizing of in $XXX I within the just be couple million. APAP approval of launched launch XXXX, explained is the the XXXX. December marketing sales sales and date plan date for antibiotic Codeine, December, That soon, data of XXXX. process our

Carter Ward

Calendar QX.

Nasrat Hakim

Yes. calendar. talk Everything is I about

and both partner Beyond on our SunGen of other these course to our own. filed products, continue develop ANDAs we as with

after successful only we announce trials For will clinical and/or competitive reasons, them filing.

Next, latest. IR oxycodone. the I'll deterrent on abuse update give this you SequestOx Elite's NDA, an and SequestOx is

formulation FDA, added a the study all have complete FDA we additional fasted, FDA of heard listed bridging our certain FDA that. more when response and As of proportionality us a also, reference That a we something definitely the and risk demonstrated Tmax route. to assessment confirmed requests. like that study. excipient performed pilot abuse before drug. provided of need of results that is, comprises the was couple an characterization and that mentioned or is for fed, concern, previously letter work discussed via that and modified exactly they've we ever reported, about now, a One SequestOx dose in three a the with another is which not intervenous surprise But that is we studies, addressed

marketing this for a finish that the we are the in We Sales cost extension all launched in million Phendimetrazine launched launched and filed results all paid products additional Tmax. in considering And the of fee, an the has filing the positive the transition and our that us PDUFA to be to also covering new filing Elite the is and did Glenmark they Glenmark and strength ideal of to Two also for and for will SequestOx right another and Elite. requirements, resulted for Glenmark with November. these Isradipine grant alliance And we the for in our products. produce going additional to partner now patent the of request. for marketing work. order their us $X.X year-and-a-half this timing project place evaluating due soon. FDA believe new passing are waiver Trimipramine the Methadone marketing, However, modification

companies. wanted fit it, We the and we best new best Elite. chose actually was and made we product, SunGen we all the one and selected the For believe several bids the SunGen that marketing definitely in mixed Amphetamine them They on partner was of a product, that for interviewed interest Elite. of

said plan call, last market I product. to this our that investor SunGen During we to use

a felt move better SunGen with to bigger decided a partner, the Our because Till you release signing I said, name know working working multiple we not could signed, the together, product with greater one. the we then, selected continue Once is and And on are somebody and the much interviewed, partners, who job. will agreement we marketing is that let with. who agreement. forward recently we reach as they therefore do will

NDAs have be a successfully suppliers these of have NDA three and in we deal the are abuse pending; remnants transferred, our that the row waiting with with SunGen generic the summary, being we Adderall; are and qualify In named in in concluded sales that. on no our we our new Norco than discussed contract, for material filed the FDA -- other is on an other approval I marketing to key and we completed we deterrent discussion We new we of and Epic; for had because site once our the under is also ANDA cemented XXXX, facility observations. the Dantrolene, with with for have generic will two ANDA underway again, and we two QX inspections with update in generic. continue antibiotics world; bridge approved you review improved approvals have FDA; partner; low-cost ANDAs partner then QX are to And of we partner, that to and three things SequestOx mentioned in partners, a generic and normalized a Percocet licensing surviving just SunGen; upgrade raw have two yet Norco is with we our

Nasrat Hakim

questions You submitted to few Dianne.

of try So, as and I’ll of many answer can. take and them as care I

And they some abundant. of were because them have been grouped

earliest So, one on see the profit we expect the is first for to Methadone? is split Methadone. the revenues can from generic When

Carter Ward

profit beginning March quarters. split Yes. start the in will of Well, in seeing subsequent this quarter, my the increase and that that I thing. to We're going they revenues in addressed

Nasrat Hakim

Okay.

pay clear, transfer send share time? the you're others, takes some and So, them, sell, and what saying it once they us then they and make price whenever we what to that’s material to they is, be the the

Carter Ward

then Right. we'll we schedules sell and and book The them, the manufacturing according revenues, ship, get when the profit splits. we everything, when to they

Nasrat Hakim

and that okay. months. Excellent, And SunGen It release when launch will or launched, be IR, of immediate guess Amphetamine Adderall SunGen will distribution? couple you best for to is when update partnering will at within the I the -- that. the addressed and will be SunGen responsible our Norco. Norco, decided with you and generic on we go third-party the will to just are date. for have later close us Percocet Percocet and

with against cautiously working we be -- but mentioned with these lawsuits state to are many we are generals that. and the states people make earlier. filing want slow And companies part are of a of I all that The We moving of attorney as opioids. don’t

than was is for ago three, Epic years yes, of -- product I mentioned. received agreement. Oxy that… what was developed three we That’s So, very we will states pharmaceutical and not in And we that a SequestOx, handle a how updated we on sold is strategic I what the keep status as alliance IR? years. to uses is new between the just three it’s nothing the careful -- you IR, trouble four wait over find are updated. companies. that That us And SequestOx? just will years of under either soon concluded Epic four being as and on status the launched royalties get this. This other the partner or the till what been does we issue technique Oxy

Carter Ward

agreement will Royalties investment… the to according they and continue strategic alliance

Nasrat Hakim

you use early supposed be Parkinson's this March, timeframe. of March the I FDA believe is Isradipine Phase three correct? see What over Isradipine correct. be of Is it’s sales course, disease results that Isradipine. calendar XXX make But, would to to trial the drug of X process if on have released do treat who approval year? Of is to recall, followed. for subjects on I impact that of only one Isradipine, Parkinson's? of is Elite approved Yes, to two around the is as

that of one companies Isradipine. are make few We

have who do we patients directly and Elite have Isradipine. asking also cannot We And calling that. for Parkinson’s

First, pharmaceutical a company -- because are pharmacy; pharmaceutical are we a we not not company. a are we

directly sell know not because to are impact there The allowed to will use. second, I going And the run is be factors what so be this. other label the into impact, don’t patients. many are to We off because this that

results that is March our to clearly actually the whether going got First, show not. have Isradipine what the favorable. in don’t favorable on Parkinson's or to answer that coming or be makes an impact be it is it’s know I that to patients. be They

Okay? going have FDA from that Second, on make other needs application the accept if make sponsor then approval put are together. then, And Isradipine file or to the Parkinson’s. yes, they to and an gets works the the then decision this and have you application they trials need announcement and them to

outstanding closely it’s At if year. Series are I update to will Elite. were but around So, sometime to going going end process everybody critical this J, will very even started J. a the happen be we wasn’t, I'm for to in a hope where see but it we X/XX/XXXX do to that’s day, It's place watching It shares I very of get and starting increase And very a see. be you patients. that. going to for the take April the before like X-K I the positive And to a would to Parkinson's [indiscernible] that like due will thing there us. be believe, to if April would Series in that’s this not while we for on vote

Carter Ward

there Yes. is takes, in The meeting. whole proxy the shareholders process it a

public four starts. will So, whole filings it there process is once roughly a and process of take months SEC announcements, the

year, anticipate which next the is fiscal doing during this year. that we So,

Nasrat Hakim

we with did revenue market tapping Sales sales program? not in the one and manufacture selling force bigger product. you have can is capitalize those but from aggressive know sales and ourselves than went one marketing SunGen. have products and even for their increased We drive the Elite companies difficulty the but neither those Glenmark. products? marketing, we them, does is on many top produce plan How notch an ensure products that how We the to you will Well, or the second by Glenmark because companies, don’t obviously, experience and did for

it. product stated do nervous co-develop with It And the government So, the SunGen, last that system same launch extended approval the and that that's so, central shutdown? XXXX. Will on on how call release date is of the CNS, shutdown. will conference expected potential shutdown second days question, you delay last this. of in guess If delay extended QX the approval? government the of is they of My the number was best

filing, was of to any for paid going fee they will For pay such GDUFA dates; for, you keep that are a not extend procedures the it. as due these the government that,

these For anything approval is prior as have date, that affect supplement, the going this a that GDUFA guess such My side. to on the wait is put us. were not doesn’t

are are going could today. this you, Again, was from concludes QX. you going us least to QX we that's government get for to And the joining We last me launch hearing That guess. in earnings and Thank The personal from Thank in everyone at Myles. have call. approval wrong, day. wonderful FDA. This what my question. prove we’re the a

Operator

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

at your Have disconnect phones may You time. a wonderful day. this

Elite Pharmaceuticals (ELTP) 12 Feb 192019 Q3 Earnings call transcript