ELTP - Earnings call transcript Q2 2019 | 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 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, on 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 involve 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, timing to and uncertainties, the obtain actual of results, implied Elite other other or be expectations cause performance under of or statements. achievements FDA from of forward-looking at CRL, the actions regarding require all, statements the the and the obtain of may by FDA if Elite SequestOx of result approval, FDA, the approval of take the These of may statements NDA. steps the the expected order have to in Elite timing a as approval, of the forward-looking may to timing include statements regarding in Elite of FDA FDA obtain and expected the the order approval all, the if of actions of the by NDA. These at require the statements SequestOx 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 risks 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 your covered, Mr. host, is over to my to turn floor now the it and Chief Elite Pharmaceuticals. President of Executive Officer Nasrat Hakim, Sir, the yours. is floor

Nasrat Hakim

is Elite's you President joining of a Nasrat earnings Mr. summary Thank Ward Officer, us Miles. This Good Chief Elite's our am and Hakim. My Elite's I thank so us ladies and financials. is Financial gentlemen, today. CEO. morning, Carter for give you, and name will call,

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

Carter Ward

you, fiscal Nasrat, Thank XX, our to filed in September XXXX. quarter second last XX-Q ended fiscal March we the so calling the and September XX for year the thanks We're ended XXXX. On today. quarter everyone XX, a is of the Friday March year, quarter on Friday,

and which it we our The elitepharma.com to fiscal filings. section many So other of Investor is XXXX on is our year, call Q provide sec.gov, as website, and our the well we're available websites that as halfway links through. the

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

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

start last to with quarter compared let's $X.X as million year. XX, the So last $X.X were quarter decrease ended million for September XXXX, this XX% Revenues from of September That's year, the for P&L. a the year.

due mostly Hydromorphone, Methadone. Phentermine revenues to at three standpoint, products: and a the from looking So product was decrease

that through Hydromorphone, decreasing. license steadily product sold that's been And partner under TAGI, a TAGI. First, our has

market to at conditions. pricing Forecasts current levels, and from indicate due TAGI mostly shipments remaining

in we any significant So expect don't product the year. remainder for this of fiscal movement the

decrease just that expect influence quarter. was where September a case quarter had revenues, before cut-off, sales totality. we the were Overall, continue. is steady really In shipments just the And of quarter. not and for It's single timing a Second will of quarterly can viewed manufacturing and when is few Phentermine are lastly, a fast the strength, in contract XXXX Phentermine few We for XX XX-milligram variances September we of beginning and of But one Methadone. products is after the arrive. a basis Phentermine, a certainly right those XXXX, when end the there strength customer. shipments the that a this to single hard we and a on apply

product, the manufacturing, and the manufacturing. say have revenue stream. ANDA, on manner. contract I December sub-contracted this of expired, when manufacturing they to year, it's the that the we actually basis earned In September XXXX, contract that customer Now, owns in quarter, revenues means And XX ending last owns us Methadone the XXXX this the

was after to XX there have two XXXX, off. strength, strengths: Contract our we to in few recently and in last X approved fast ago. products the alliance X-milligram Glenmark exist So where launched with Contracting our our product both we strength. XX, have FDA. In naturally, may were hard and and addition the how the not it were by be weeks But that XXXX XXXX, own but Methadone we have commercially that's you're year. And year ended, that first cut and a existed milligrams the product, not launch ends. this manufacturing the Methadone September Methadone have launched. a decrease. August will comparing XX-milligram The if own a They that's occurred are of now, this did

future begun had on just ongoing. we are got the contribution make shipments these released, a financials have And that expect no Methadone to but So effect and they to products financials. significant

and the between all. earned In is contract a ownership. fee a there that Now, big manufacturing Elite is past, manufacturing difference and ANDA remember,

difference, with earn fees additional an for us. splits. foreseeable available is manufacturing and profit larger That's market strength, future. the owner, providing as to upside X-milligram Now, the enormous the significant the for strength, ANDA we additional a there Plus,

product for $X.X for $X.X September That's quarter, every I down costs a moving increase to The year-to-year a what as say as are to important On just know which incurring it in was the were bio-studies I on. development last this R&D two provide fiscal case The our research next basis, is the focus the and of Oxycodone, amounts expect recently it the R&D, contributions. ANDAs new and even increase. in this regards three additional of filed. and we year as year year, Methadone P&L, not. XXXX expense, that we X% contributing was million current Now, the bio-studies to products, spend important XXXX. included most million isn't year, additional spent really pilot Last our which launched to revenue get expenses, true equal, the much. what the APAP; quarter in this And remains several has half spent, more have but Methadone. SequestOx approved: of to already relatively recently begun and revenues, to and approvals in and that successful been development are new activities for streams these launches products compared

this year, amount, spend the R&D on product similar of focused next filings. of the is dollar round while Now,

products two fiscal this steadily successful the filed with conducted During products several for we of year, development progressing two our other pipeline. in other ANDAs, pivotal are and new bio-studies

contribution it on There and and revenue impact also Epic of portion here October year $X.X lost] Glenmark of Elite that every at on manufacture that during with was contract one area. the spent with Isradipine, is quarter is of have products begun in most $X.X into side, and those several bringing the we back Epic effect way those that the next were already expiration X, future during of products, early products [ph], Dantrolene October, the last part million the In of quarter. year. course, on our But products, we October, that and of in form contract early which [never is takeaway of million this recent R&D that year. to an spent marketing already in Nasrat back the this September and launch same alliance. compounds are contributing new fiscal now expect from Elite the And are the manufacturing the this to has finance the especially will, to bringing Elite the happened more in XXXX addition, generic that periods streams go Loxapine, approved to Elite. will detail

to we products time R&D, more every a through develop in other compounding add each they So effect.

on Finally, part rebound revenues. on quarter Started revenues. and we we expect Methadone this to it loss million And an of was had with improve. of $X.X operating comments my part. that, $X.X Again, expect profit X here split new board a coming the thanks XXXX compared loss as profitability to profitability. product is P&L and is, with as per the a usually revenues in in quarter. Also, of an Main revenues as September large to product milligram well as to playing operating we an million what Methadone manufacturing XX analysis driver milligram

those revenue So will make streams a are difference. new noticeable that

addition sales In improvement which last quarter. also will provide already over over in Glenmark the Isradipine we're improved and Methadone, significantly month, since forecast past seeing to this product took contributions

there well. of the from personally had And resignation on sad Dr. their company That of that We'll new a as Aqueel he That He which further advised employed director internal professionally. that supportive back and on I'd him great by Elite, Aqeel parent recently his closing, serve we're director. received. was one another company. him to our board before board. of wish like And to Elite is other company. regrettably Now, last and both on company Elite's miss require Dr. Fatmi and friend stretches not to been acquired company that we to answer and joining support a question and Fatmi policies relating has employed time Fatmi. or much board. a the any is as he than very is board remains unfortunately was that resign his very grateful that him for the guidance the we Dr. was

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

Nasrat Hakim

brief product. I'll you, about statement with start our marketed Thank Carter. a

there, TAGI and no the same. Our business the remain new with bariatrics remains there is products Hydromorphone as essentially Naltrexone,

our quarter, XXXX. with we effect has Epic of generic profoundly will Elite's change see And this substantially Our favor. forward. the increase and The product launch in changed going revenues that that is another of QX Glenmark, of with would business Methadone,

Okay.

approvals, Glenmark new approval the product products Regarding the Methadone is and August finished product and about X generic in X was delivered months in Glenmark milligram X XX strength. our and The Elite both already. for than months. This for generic launched and less received to

collaboration there. In really Percocet. received So for July, Elite a that's generic good approval

- We soon potential possible. as and are partners launch will as launch with sales in product discussions

We we will have give something concrete. you when an update

we not. today, of do As

within the more and FDA. three approvals we We are to ANDAs two months, from approvals four anticipating next XXXX. filed of approvals has five more QX expect have by Elite

you and for will get a and Epic other there starting is acquired generic Dantrolene. years taking filings that new sale our this approval from the month. Codeine - actually. this of is partner a and several already marketing we QX it. market. month, been to forward market That approximately we the by with is million. December $XX with year. months ANDAs release it the product our signed year. site is SunGen, date. Our market brand In not date and there we Elite Elite million generic July product pipeline for which our next we hope once have ago, is Dantrolene this and product only total approval once sales one you XXXX. we filed ago partner Dantrolene, Again, in We PDUFA in transfer we generic and will generic in product ago Elite transfer as this is for be immediate earlier million have did of and will for One The a recall, competitor product and We an we and look hear November, Two with they keep identifying The filed place approved $XXX this Mikah updated. of is sales from actually get filed ANDA years and filed, September, $X APAP a a we two approved Codeine. five we other is that with total generic FDA, of is about CNS hopeful brand PDUFA APAP is year. of co-developed we that this

will to We from hear wait FDA.

we version and that the and is The The partner manufacturers brand generic. CNS an of our generic second ANDA extended including SunGen. sales product There the authorized release that is the billion. are product, co-developed extended with $X.X four currently brand release

in launch that XXXX. launch of we by approved and expect potentially XXXX. have. it we important and it QX QX expecting SunGen are that Elite most This product get could We approval is And the and of

next have ANDAs two October. These SunGen. are We passed on updated months. five already successfully August products products our file more expect to you and we and the we we have two we with two three within that filed the in And that have the they partner are BE that

continue Beyond ourselves. partners ANDAs, other to these we and develop filed with by products, will our both

these require of products and is our marketing All sales so sales follows. marketing, update as and

already We've our that Glenmark the partnership know the updated delivered selling that have and we with is have have You we already that us. TAGI Glenmark you product on products Methadone all them. transitioned for to to

who will products. of have a also has of form to developing the SunGen SunGen FDA miscellaneous last - from SunGen. Glenmark [ph] excellent we go in for Elite. you to order we three the sales products our our so addition SunGen [NET] we makes for sell products some one our that, Glenmark an this overcome and right to marketing was Elite FDA for SunGen SequestOx. sales we other is on as sense with yes, regarding marketing for options that have out that common us partnership to able the and we marketing. beautiful has now, more give product call, received Since It only and sales another for positive our the partner a on to Tmax. hoped, bio-equivalence news ahead, products We questions The - for and may four a a response I to trials even Our launch We that have have and us expect move SunGen. have hopefully forward FDA lot It quarter, have about of to the before go total stated in But with will That a options you of TAGI. clinical and to update received can I'll SequestOx, study through that, items. fed/fasted in around be

of asked abuse one that is added more okay. One, the they full FDA two second, risk asked the They surprises. of excipients, they for have did and an before. of the the characterization always But not intravenous we However, that's of additional of by requirements work assessment for route.

seeing and of for never table that to with that us correspondence required or what before, for was evaluating adequate or is We Complete and got going are clinical part really a FDA. how much that have that attribute it's Response Letter cost trial we the we the has been not from on

Okay.

this extension do asked time understand idea have Again, issue. we already re-file update able requirements filed the we on covering not application. new Tmax. us We obvious also extension in ask for, and work modification fee, for the A of for we as on will an for of to for a that This of a request from review be as to the application product soon cost will going well the is the us We're to all for FDA, time you. PDUFA an clearer this patent an before and this SequestOx, and look you. to to scope this the filing week final the all the as order update some we definitely and the Elite FDA, also all as from FDA, the to have they

Elite than products will from that Dr. miscellaneous of with Other Ken update has previously Our items, a This also the mentioned, ANDA Methadone contract partner on Therefore, and partner, to product. holder later as that us an financially transition selling manufacturing have transitioned to we definitely and to in the competitors I it. is Glenmark filed with patent other favorable and becoming on some mentioned have struggled also Smith today. Elite year. actually them have, also us. inspection haven't happy products our Glenmark. will Methadone that report Reddy products a single gotten be and this was of QX to selling we Trimipramine Both sorry, be I'm XXXX, will Dr. very in has the one be to inspection. we will Glenmark expected that of three is to observation. another the from that Epic Elite - transitioned and third With FDA we products got passed this that are be all transitioned for another

we and Now, center. these why inspection approval especially with pre-approval or And months, getting be which and we they huge for the for special, weeks business getting with recommended manufacturing only the two sales ANDAs this the quote, ER, inspected, product that going of that's performed for sales FDA and focus preparing in coming the two because to us, our the one, the us today working had products for the partner launch. today six the billion to marketing for This And DEA, because with and manufacturers IR the is about ago, the SunGen, four $X.X is so our product approved have products, huge few for SunGen. ER. getting figures, is

to site. issues concerns with They no respect continue any that filed FDA ANDA. address to they have we As have the the to with respect

the As I they district. recommended from said approval

developing a invention It Elite. received deterrent to for move add wrap we're clarity product for mentioned four from may do short-term future we patent. This what technology to product. it. next. need But for invented also FDA. forward launching a this Glenmark just to game-changer in we more is to in our and a is It's new working know some are used useful revenues. going some we and notice our products be of currently long-term. exactly not shareholders going up, We while products. continue The was We a asking on To I that's with SequestOx. allowance about patent of the covers abuse our

As the year, I of two has before said, and the this two we year ANDAs two approved end as beginning filings this expect Elite well. quarter. more and more

year, we the up are that But for for ANDAs we're work getting filed extended one year next it more year. and actually QX actually. and in a For for in five. we that That's lot QX release. expecting We've that sums approval four this four one potentially approval got and of within a

you me so enough of I'm So them for Diane multiple of SequestOx she for questions asked or status. and going decipher the right, kind is And to now All and that are host have right And a them which many along. of you as me. redundant. group I'm them first sent questions one some looking them at through was

FDA? that is We for to or do to it? the always FDA not few wait and were do of are ahead whether waste Some Diane projections will first by the that. very No, as to small start a need cannot I them why regard us risk. It's of added the data go with the FDA ago, few guessing to things we SequestOx, we SequestOx, received is But that. hoped we I for delay. answered With received waited Elite me. cannot since and redundant one, grouped give everything risk to And clearer have a from for taking FDA them path. for the that. some them future, that. already and for to going from for. we're relevant Actually, expecting. picture not then, going up the from response today's afford money I really was discussion, so a one minutes are we that company. are Have small-scale not is adequate, for I as second is really and we But not the a agency clear to they the it explained We

we're ask We Smith how were can it. will patents. path a when Dr. And FDA. the I'll from to wait that's questions there a about going raise money for to Patents, clear the we we'll how them. best few assess and address spend

Kenneth Smith

than a have U.S. technology we a issued patents So actually on an for it don't abuse is be which be we patent, would a which said, SequestOx. These of is patent as currently And already Nasrat but compressed received the based which this technology, different of micro-tablet. XXXXXXX. continuation latest used a an for can Notice deterrent use patent to relate Allowance product

the technology In previously provisional as two addition, Tmax the Elite we fed/fasted is Nasrat the filed different has patent used the that alluded one than SequestOx. to Elite this disclosed, applications to that And solve year.

of The is abuse is actually which other also deterrent than different provisional application to different type technology, SequestOx. a

Nasrat Hakim

narco? our Excellent. Thank all on being Phendimetrazine Phendimetrazine? launches that. Ken. partner. similar Do right, the both we to in Methadone And know. At you updated We've Trimipramine of soon set product be let you you Percocet Glenmark. next for and likely right narco just about with control as this you, the our distribution, launched partner Methadone. they quarter. I approval When are rather it are same? likely, and DEA target this regarding very for is will it's already do the now FDA, is are anticipated with launching we in is Highly - the in According When launched as questions All we'll least marketing. that quarter. have be that's -

win-win is that money new you make a from make us. buy spend do the and the looking partner with cannot we're to them There one. when that highly always proactively really review? That's with competitive. is or work number one very you in we always Elite under well. And times more for marketing whomever it's are. actually are investment of the we and up product partners Number stuff, looking for talking about API we're in heard well. an material and of having there Is haven't end FDA But launches. Yes, three. a both active likely, where lining We're sales for development, preparing looking yes. FDA. sure and We very sources up of for only partners? to you for So as both we products can We're spent for that of time all are And lot two

the triggering is do but move So an we we our have approval. always from when FDA, yes, you that's point hearing And homework, forward.

you DEA going In any addition unless FDA. from give approval quota, is have to actually you the an not

it they plan went we us it And the the human Oxycontin back of Oxycontin, certain in-vitro the and money to filing we're What products that's move But for the for many of you, It's [ph] Epic. versus to shell nine studies lot some and The Epic, whole testing back status one things same As through everybody is took forward have the all Hard it. to a us more in bio-equivalent delay do are we Epic? [note] be does. all genetic, your of FDA So of now, updated liability industry in about [ph] cost some with months produce and and to of of product actually I of does going have it Oxycontin Yes, those to the Oxycontin ask questions the back till What the to moving that, partnered report about all cannot work. in patients bunch happens. we who and them just that on house. came the all - generic industry. have is still ADT? [incult] pending. added they After now Oxycontin. abuse are for requiring ADT?

Will next. so. For interruption in those we started rest don't them. approved, by launching think be I already. there revenue? were already we're will be Loxapine And filing who the Dantrolene already

and closely you will with not interruption, want and team our and do stranded. We marketing leave others not sales have because customer to Epic Epic their working are any

fill till over. working very closely take So them pipeline that their continue sure we with make are in to we to they

Carter Ward

with actually in increases at looking We're Glenmark. revenue

Nasrat Hakim

also have estimate. profit in Elite approval our estimate for from the the SunGen QX. in is two cost any Does one one Yes, and This product? Absolutely, filed time current of and standpoint split. QX second

Okay. U.S., marketing products. deterrent intention the partner with abuse outside outside have U.S., Epic, the no we sales of of of products our and Sales of except with potentially starting

till we this else. to the do model. this stay that, anything a on than can't very U.S. in business at We the to time, make need successful focused afford really Other Okay. business and focus we

head potentially, It's a going lot discussed of the a to And China. in anytime we And could is that not in with there However, a that launch of happen I've model EPIC. my work. product CEO soon. requires together

and will Okay. get Elite working applications to been be to can. we of manipulated has certified Can year-and-a-half the there. getting Sarbanes-Oxley that definitely believe working advantages and past do of Yes, off on hard Carter by meet we And on there. I that Elite's lot criteria to There stock market NASDAQ? are marketers listed will on is being the the board. a OTC getting platform. we're make bulletin at Nasrat believe levels. be to and for NASDAQ the XXXX? us certain hard qualify we we be Does in still Absolutely.

systems time. on so If plans such at can it other Drug branch out and on? we enough topicals as this for our comes and up opportunity delivery that other an accommodate injectable, are any into Elite good for to there delivery, Okay. Elite facility. is Not

Okay.

person who asked the For said example, question injectable.

environmental tablets solid air. set forms capsules. requires It laminar not or up is set for We and It's different have require Injectables will for controls. that. facility injectables. Our doses up don't

the to focusing going The few be thank will to core you done. today. a in is future you, business and have And that talk all pipeline. of because get, growing excited the we coming operator, we're about you the months. to For extremely on and on getting and Thank we about for listening we the company. now, The filings approvals it. we're down are We're products the

Operator

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

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

Elite Pharmaceuticals (ELTP) 12 Nov 182019 Q2 Earnings call transcript