Recent ELTP transcripts
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Nasrat Hakim | President and Chief Executive Officer |
Carter Ward | Chief Financial Officer |
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 such Elite’s involve approval inability ability transfers the that including, and of to cautioned such of limitation, of without to ANDAs obtain are necessary forward-looking delays, risks statements uncertainties the approval ingredients Listeners process, timing uncertainties, may the obtain of other from or implied other Elite achievements be and control to that expectations the cause statements. may be not are which factors different results, of or performance actual that the materially forward-looking these under Elite, results, by FDA performance statements FDA These of Elite result timing SequestOx of to order required may at of include by forward-looking approval, of the a as the may Elite NDA. expected in CRL, statements regarding all, approval steps take obtain of and the the the the the FDA, of if actions These timing statements repair by of expected order ability statements of of regarding FDA in approval the and forward the SequestOx may NDA. all actions of the the require the it looking include FDA approval if to reviews on their regulatory Elite's regulatory filings including the XX-Q Drug other authorities approval results These guarantees with future and Commission, and and under and Elite's are the XX-K, of other risks or these without performance, trials, including or report in discussed by factors, or and and other and to not statements and agreement, from and LPC obtain timing sufficient ability protections are Administration the Food of the defenses intellectual future properties, form funding Security pending action forward-looking X-K. sources, Exchange clinical limitation information, as statements, alter or otherwise. update a to forward-looking obligation no or under result new of events is whether future Elite its it host my floor to covered, the Mr. turn pleasure that to now your is With Executive Chief of and President Pharmaceuticals. Hakim Elite Nasrat Officer floor is the yours. Sir,
Ward come answer with financials, marketing. SequestOx, Hakim. Mr. Elite's I Thank pending will you, call, of also R&D Carter sales you Elite's back I will a pipeline Nasrat so and and few This the is you Ward, name Catherine. an My President submitted Elite's Diane. Chief on floor. give a am that ANDAs, after which us will our Financial and and summary questions CEO. I have update And afternoon, ladies to is gentlemen. Officer earnings Good
links always we Thank our and XX-K calling in ended today. our on on sec.gov is XXXX which as XX-K as XX fiscal year you, available to year. well elitepharma.com other of on The the Investor fiscal XX, the year, fiscal our and the filings. is is thanks to as it everyone XXXX our that Nasrat, provide filed many section so a websites Yesterday website, for March March we're
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questions received best are Elite comments that shareholders to financials address we I'll always, from my those related. followers. and As and do
I First, the on some before of even comments the start the financials, we filing. got timing
June our is So XXth which that reports are we require so we Quarterly first year the of our within us quarter the XX-K SEC filing so end file of to quarter makes days from Investor due the our quarter why you are is next the regulations for XX days quarter next be have due today. call the to the XXth year. fiscal the expect august on day, after on June and can ends, today. XXXX XX Xth. fiscal June XXth That's usually Ks
XXXX part P&L. March $X.X due its to It’s million year. actually go XX, large in and compared naltrexone for let's all in methadone were decrease financials, million, due XXXX starting decreases to the the that’s the and with the Revenues part year $X.X a for it's and to fiscal in XX% ended So revenues.
expired had customer a these from this is years. So those Orders few a on contract past for over customer over we first greatly fluctuated on And years. manufacturing the been single to regards contract basis XX, XXXX. methadone with methadone, December product
customer. was but contract attractive future prospects run. limited our future are this mentioned line was contract important revenues, the business expecting in before and in an that part this of revenues, business not our plans. long this of It in We a this I growth are not manufacturing basis product manufacturing not for long-term on once type
the have certainly focused contributed, a While our factors. in long-term due revenue been to direction different limiting plans these
with accordance renewed in terms, it its expired not contract we was the when on. moved So and
other of have products plan. give business, of which the own take manufacturing I'll update well. they and that products shortly an place We the are will our contract discuss strategic They Nasrat on also and eventually are our the part as in these will and pipeline,
long-term been for which these product second so distribution. fluctuations All larger March products. material were marketing an in other we us. top the TAGI product, in line products The There is manufactured related XXXX They revenues important fluctuations Naltrexone effect to up naltrexone and down of have and product, quite wise. the a growth the hydromorphone revenue bit. remain and quarter Phentermine, has to It's That's expensive products expensive also own commercial our product phendimetrazine, in here were treatment in the for committed orders. have opioid than expensive do to naltrexone. an and products is in revenues. it. is a showed decrease our a licensed we overdose up making addiction we This less all been and other isradipine, lately
something ending in the one, revenues due a So of is temporary was decrease number fluctuation the is products bring is products line where expected, here moving and we the effects. which have once an process, revenues six recovering FDA naltrexone files with is our and expensive large downward to the higher. process much top of takeaway and line contract they manufacturing that to to to review The were
dollar as this research year So it's expenses, which compared were or to wise $X.X to moving down million million development last increase so year, $X.X XX%. and the $X.X million P&L a
are fees costs internal. costs to Now and lab various regulatory other as External paid costs third R&D clinical external parties. filing either outside classified or trials, consists and materials, raw studies, R&D of
external that $XX,XXX. XXst. filings the the on was side $XXX,XXX fee. So, that year Each ANDA had that's the Last around us the this costs March three in we FDA occurred fees filing fee to filing just cost year filing fourth paid and just ANDAs after
but more two as third-party filing the Those to filing had So incur more per filing when standard had fact year this amount for which four everything year ANDAs for of file we R&D we this of that in of filings we each other either materials, compared of filing significant year than year. cost was or costs is completed this material for required The thing, a and just still us. cost $XXX,XXX this costs type the also driver to substantially prior it's last. a
very pilot all for indicates that. also with promising results. clinical pilot We conducted but very may greater this go Tmax pilot and studies issue by yielding detail, with study will in the Nasrat address SequestOx have that over two the we the second we’re encouraged SequestOx trials
These as own development in and several with they regulatory effect resources and progressing our on the chemists, R&D well improved That costs, continue filings On plans of than not as and our on products already expectations. in and to cost focused personnels increased activities products internal previous announced, higher the strengthening. be of on development technicians continue have of years, studies in are additional the facilities and has also the just formulators, accordance remained number which a direct capabilities, to SunGen other our expanded. side work product internal these with
receive be on future which On have in costs the our booked, the that past today we cost we incurred, what and accounting R&D side, that from benefits we statement do what is expect spent in require but R&D. when on accounting to to the rules expense results we P&L
comes behind number is on achieved. said many what it when but So as the as into to times as R&D amount the what's that’s important before R&D just insight I expense P&L, some our was
ANDAs during and here’s achieved what March filed So one, filed after fiscal was Number XXst. shortly this ANDA three fourth a the XXXX of year. during summary were
pilot way that has issue the SequestOx successful in been a of may we Secondly, standing that the indicating have study approval. solved
and commercialized, previously of that are mass been the and of flowing, to development products we right is to is so it even filed continuing already a mass with to ANDAs that this FDA and the Third the we’re the goal filed process moving is schedule. six is as continue working now. filed, is products through keep and filled add as the the to have development have keep pipeline on in become products pipeline there’s review approval already they been critical critical six receive pipeline, more The have additional
start operating X.X looking fiscal those P&L, non-cash on P&L, down so spent and a over operating million together expense, million the $X is million for depreciation, a $X.X light of getting we in put loss operating approved in less on than filing year. from generated that we profits. XXXX. over just correlation decrease That that net we filed When of $X.X a the to R&D, had includes get that and loss operations idea the revenues two six For we also million you a contribution commercial the our expect on even coming a good is operations, commercial prior and existing being products and revenue positive to of the current already from both
Now, establishing would be one a it’s occurred that think last significant and last thing Pharmaceuticals. May, month that alliance strategic is on item in with it and our Glenmark I XX-K, disclosure our marketing a
excited we’re pleased Glenmark. partner to We’re up with
and we products will Two that’s us. come We identified expect the one will the the products, first the and of that's from phendimetrazine distribute term, own market near Glenmark and been online. in end and and ANDAs filed, of that that's to initially have the manufacture already undisclosed been approval one under license
more and add they interested lines significant, the of the and Alliance alliance capabilities both Glenmark and product are the marketing established in Glenmark's In ability in. with addition, something is are products. expand resources expanding are our includes well us to
optimistic of the is potential to future were as alliance. the Elite the strategic So, Glenmark great
Executive would comments. and give chairman Hakim, Chief Mr. like Nasrat an and our update Now, Officer, his to
Thank however, little I update; you, the in my I that questions several Carter. comments end detail. intent at [indiscernible] to Many submitted you've that on, incorporated you've back go some of of the and was of in going update, of I your more your so through what go to questions the the
I and with pending including ANDAs, Carter cover to generic questions will SequestOx agreement including basket is our proceed Glenmark anti-abuse will pipeline, first several to R&D with status with status the pertain sales projects I of the deterrent of that on products technology going we’re spoke marketing and status the of. and to what the start partnership because an the contains of development many that. just basket SequestOx, SequestOx. your update So, that pipeline
completed and any completed bioequivalence that on fed a in successfully study these comments SequestOx the FDA them Regarding a SequestOx, withdrawal of brand as fasting vivo study, for and bioequivalent you have all were we Tmax. study, in know, human from except completed an areas. successfully. vitro the liability is We liability study No abuse study study, efficacy abuse and that shows PK of and to
As based We labeling, that. results know, with is pilot the the the reformulate. instead and issue on in which to this you did delay overcame by the study raised asked primary of issue FDA controlling us address the formulation modification Tmax it FDA,
With drug Tmax saw the to no modified formulation, compared referenced delay we oxycodone. the
we the FDA, repeating the yes, says, In summary and provided that the you and very study simple. they're last working The you back when the are that’s Obviously, will we're we you. a was We in like the want million the how that said for that from it sometime us for a FDA, they study something SequestOx I spent a product ensure we in reason fasting in We I us. patentable await to have response determined and dollars proceed Tmax be filing patent, our if the us same have a to patent to reply. all will rejected we study ahead with obvious can that by that the issue. go to do ADF call week. this we written And share resulted make the last blown pilot. it, it for FDA thing FDA issue, the covering full we the and oxycodone and not filing for. BE BE come couple they await it's due doing results. their our get this result of study. something because requirements next asking company this Tmax that on as going letter issue the was overcome and submitting, this last not but IR our patent we fed modification to the the overcome on. be that show to we wavelength, ask small us is ask them want a we're that with confirm Dr. to an is will with We devastating is of submission Elite sure are and to resolve is vote Smith successful in only else attorney,
stability opioid formulations. products. done and We other to of work have work We on continued vitro, on lots anti-abuse and
clearance that a for expense, trials pipeline the technology not remain are once that ADF We forward quarterly can SequestOx, we clinical not that is such. filed of an We running for obviously and because of will is platform products but we move get pharmacologically based. product recently as we is ADF have area with. patent a for
an moved a us share and that agreement with time and them I I is a to the and or they of Mikah and not royalty Epic pipeline to the in that? already I that -- contracted developed commercially from these Epic which much equipments than profits on three actually order should like. products like we and but for basket get approved second we transfer these with or isradipine. by mean supply file transfer then we marketing has genetic purchased forward say commercialized sell and components hydroxyzine, would the manufacturing basket Our and approval develop and There's it The every they product for smaller product. What our selling That are not us. we by mean transfer, [Indiscernible]. agreement scale products it. pay products for
the products happen we one among would Epic all like products that we specific seen Elite to October to expires would by selling Unfortunately, these launch not that bring contract that intend to manufacturing In of and does We XXXX. supply with agreement this them. to see to had the we've to Epic addition, been that have others. submitted regarding and home the in we XXXX. intend and of to like since market bring them of all we phendimetrazine day We --
fifth that in that's central with and market $XXX immediate of to Even this to with market which million, more were which there was arena, SunGen. take and cap that another $XXX walk and is million Our than filed system with us you out we've is in with This were $XXX in was that be an SunGen. last that in approval. generic ANDAs and extended-release co-developed for ANDAs partner outstanding we approval billion six is February. last million between product million, in from filed branded The because will an it own and of take May in if we a the our will wonders the that pending half of also X.X and will The one February our million we $XXX ANDAs the and cost is is get in $XX product just also an and four SunGen we its generic. The with people filed the Two have SunGen. and six that within an filed central FDA XX this Actually, XX% filed product currently ANDAs, That if including we our nervous revenues system and with months us are ANDA ANDA stock. there for only just cut is market, we sales half pending once with we was co-developed our currently actual brand got nervous one one be six to product are million manufacturers and just partner the authorized release today approximately filed even partner product market. do away already that and May only. Elite
that more partnership joint with be a that product a SunGen. this after that file filing owned are and to The later expected to next year. by is Elite expect two ANDAs We is
We ANDAs soon next are for and us undisclosed get a and about we year. product Glenmark least approval will seeing they start of to tell two to filed. a more be It on I that believe possible the year. quarter approved at is quarter average, I in approvals should next ANDA I getting you QX the when could couple four an pain approval filing licensed we believe for this these this be this three be should within approval a The a months. of would we'll say to believe quarters.
at the work than forward with as that sales we product we For you, alternate excited how before with channel strategic we very been a if pain marketing, recently that I an for and this going get partner we alone with announced approval to months. for alliance phendimetrazine could ever will talked for it then find will years. and Glenmark. hope sell about decided next been our of deal Glenmark four as Therefore, to a Glenmark we larger is that had a marketing Well, started for I've will reach time has Carter be a selling a us is we we it and own. selling updated we distribution a and we said partner. partnership. the is sales Glenmark's have have two undisclosed Phendimetrazine ways that entertaining caliber that it and are our look wider to product three much at product about best whether
six and submitted these for soon business to summarize, we for new that from the of a we the products launching along. quarter October. they we we bringing Epic FDA, approval only are start a will Glenmark that ANDA seeing also sales be and back next the the in. offers expect To to phendimetrazine. start will products This alternative that may bring alliance potential as share go of has Elite in XXX% the first making get We get
We continue to forward with move SequestOx.
generics from and ourselves forward and For FDA alone. submission, to response by studies our now, that, we the required. After develop will the with await partners diligently we move a other regarding continue we for
and we Elite. So next revenues growth the this year drive will continue on and for is what expect approvals launches to and that
PuraCap The just in Until it of contract XXXX. are I'll the to you. summarize the excluding undergone change of management approval history The is required and binding pay that's that's the purchased us since that X.X of the expires change contents for still negotiating the problem get is been SequestOx We've they we contract. of It is with with SequestOx Puracab. has Company. Epic milestone valid. times million, the both if PuraCap management its that then, Okay, on regarding in us three
they it team. to we one team Epic changed recently the more their now and in else that then over had they somebody time. First, They management own changed taken brought
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not enter then product ago pediatric, the and extended-release and designated Pfizer's oxycodone work they Regarding till it and months did can three it. six launched else half years long for exclusivity was ER nobody a and the Pfizer as it discontinued. three have they've recently done launch quite years has market. Troxyca exclusivity, not for which approved Pfizer time
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questions, extended XX approvals were ago. months That's of average seem expect the begin accurate than to approvals the in one might have the beyond W On the future? for some of we approval to ANDA a When pipeline, fair, and filings Dr. added, can of and a more CRLs. time length question. Also, or couple good expect filings additional Elite generic
question we PDUFA rate a application date after on necessarily application. As least per XX even time the Then target starts then that a issue is that And them, and super own either, started approvals FDA it's give filings is a of when come a a new one on want then are because of issued themselves goal per the less and time that When year, maybe question is we minimum. letter, not attribute, one to stops me which and and clock PDUFA. but months the have length because that’s and to I plus and or with means their up, the next at a haven’t minor response PDUFA months, part fee about approval, takes a and clock answer ANDA question, if first I'll their ago, as to a their it fees meaning and that quarters. performance we this $XXX,XXX different the I quarter as back simple they month projected expect of okay. That part done, okay. four the to seen tracking way. examples. an let Congress file as achievement on us they I their complete To approved performance amendment respond. assessment. that they amendment per are the reporting for charging they and reviewing quarter or ANDA between address their the take a XX This my three ask obviously address ANDA again me give year schedule okay. issue can than say for for amendment, if come Then question, a major approvals, much they minor a you they that they on up the or PDUFA simple anything another And of with couple you time respond answer ask
minute could industry though it something a even by and to an up with in they the the back-and-forth that hope you with drags a are a we happening really drag are we and and And issues It that delays and give period us second. all that resources a are huge and obviously. is I’ll revising I So XX example that’s I'll our months, what X were really pay there fee loopholes application are becomes to on this we is doing. not evaluation be and we because counting But of because and exactly time. on that's you share specific hoping something a a minor have to thorough going within over in happening, what specific this
for give a of has a is on to When required to that Oxy APAP, case filed score of if things couple month of the examples. did that in in give half we what a see is one and we a let do, or the all companies stability is if a you So are me them product it put the and it the break wanted it, patient to required amount. pharmacist tablet you what
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that but the industry, and this done solution, the but go or she we few test the for repeat had never the months That second APAP, we a application we content and of the it the or have great was never feelings, not brand rejected, I recall wanted and them Hydro it application answer back do us to then the in same filed when and responded and because order later and put tablets of did thing. wanted if feelings more months, broke he exactly now So We to know heard you got only also sent us stopped, or chemist her and is them his they the before, one thing, that, inquiry. and ahead person and stability once to an three gave off ours themselves six in to went that then of they tested don’t them so that on they till them, us. that
need simple are these bond that So things but from some to break the little they not documents a you. application, really
respond Now, issue ask is think to time for. as simple very minimum months because for they is have as they a three they long the to the criteria you anything
year them up do the months document have respond, minute or a you to it But you okay. later, a give them even deliver it, can can give to minute. one minimum three them, to of to in give to it's once they you if it You to themselves
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to be decided not exempt go that everyone impurity product. should elemental perform and that FDA validation Somehow, ask this the the us only within industry, supplier not and on ahead specific the
big elemental impurities, the it's back-and-forth back-and-forth. not test So an the hire six deal to outside the lab a communication big about the that is and deal months. Even again to takes though,
to asking industry. all we the time addressed the try where shape stuff. hitting all hitting very it issues to situation, issues And me, they that partner target. and talking in what XX start say the is targeting -- with only FDA making to delay later what to database, to that when it’s filing the discussion has are they a preempt to approvals we’re matter these hitting frankly months the documents refusal, this the you, and say for a industry Whatever just us and and in more we’ve industry think and and our are database a just a of the it’s we’re we I remedy compiled the SunGen, XX good of we and
the it approved much a months things my we’ve of XXX%, than never the for under be spent expectation I that all the So coming especially is filed we before. of that recently, is think we’re ANDAs in because with, two rest do they’ll getting XX the be we’ve and of that studying less to lot closer were FDA new but we time it can these and that
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we to year. Next already approve-and-launch-launch-launch. still and SunGen focus set We’ve really filed year to slow maybe and this we’ve to I to next January, I SunGen. with we’re year. our will so we this that. a December, launch. start covered that next of question already bit year SunGen may hoping the the down Two that of five over we shifting am have be from do will by much is next Two I need going the is one update more this the say. what and products with end the to on We’ve And on from products year year. file-file-file file SunGen. of really be work need
half the ANDA we’ve an every to ago, we’re As promised quarter stop year filing you and and going doing it. been about
week. spoke on We were technology with a on patent CC? patent Can file technology that on plan? This and clinical this about you study. focuses art the during two two Now, you’re shift all we’re IR the pilot the Were going that find products for plan technology a do failed? launching technology big to the product platform pharmacological of information ANDAs anti-abuse has speaking approach, unique to nothing was always in backup actually the The genetics okay. week we’re unique creating you It's start they case additional a different filed provide last that last art big okay. last a The technology, regarding Or or opioids. into Elite’s quarter. every these art
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a million $XX and okay. X we billion on dollar outstanding already a at billion the shares XX whenever in share, PE So generate a dollar of profit you’re ready valuation,
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Thank This today's you, ladies conclude does conference gentlemen. call. and
You day. this for disconnect lines may time participation. at phone and have your you Thank a your wonderful
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