OPNT - Earnings call transcript Q3 2018 | Opiant Pharmaceuticals, Inc.

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Operator

Good day and welcome to the Opiant Pharmaceuticals Third Quarter 2018 Earnings Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Mr. Brian Ritchie of LifeSci Advisors. Please go ahead, sir.

Brian Ritchie

thank for and afternoon. us operator, you, you joining all this Thank me Chief are today’s Officer, With call Executive on Dr. Roger David Crystal; O'Toole; Officer, in addition, and Dr. Chief Financial Officer during Phil also Chief be Skolnick, Scientific will be Q&A the available session. as will release This financial providing the quarter results for XXXX. XX, announcing ended afternoon update a September business and issued third Opiant news a Act. of Please under the covered note today the Securities call Private is that certain the information Litigation Reform Harbor discussed provision on Safe Opiant management We be that caution this call listeners looking forward will statements. during making Actual by results the to uncertainties differ or could materially from with these risks stated those associated Company’s implied due business. forward-looking statements and for These XX, cautionary filings. SEC the statements August forward-looking Xst releases XXXX, the the and qualified filings, news statements by contained including and in XX-K report subsequent transition to are period December Opiant in Form on conference is that this broadcast sensitive November call X, date accurate only time also of This of the live information XXXX. contains as reflect forward-looking obligation Opiant to no to conference this date undertakes circumstances update call. revise any after of the statements events or or

like to turn Roger. I’d over call to the Now

Dr. Roger Crystal

to accomplishments Thank opportunities lie today’s who you Brian, ahead an provide the call, afternoon our today. our everyone earnings the good and on I’ll is joining On on update Company. with and third quarter review you, recent us call with that

Following financial discuss results. our this, will David

discussing Finally, we by from that, operational the will months. begin open up me highlights the past call With for your let questions. the few

company. and further fits pharma the and we OPNTXXX, recent advancing discuss overdose support nalmefene, Importantly, progress and focused [X:XX:XX.X] believe it pipeline will position our which I nasal addiction our specialty especially

our update lead provide me products candidates an let First, OPNTXXX. with on you

fentanyl reversal containing countermeasure long a action instance the as open with address having OPNTXXX rapid make we a Human duration treat from with over of XXXX overdose. further funding quarter on overdose Preparedness been fentanyl, up BARDA We or is of opioids in $X.X high for have which to overdose a mu opioid are become combined crisis medical The fentanyl opioid entered a fentanyl. well-suited half and event fentanyl overdose last receptors on the the As Research opiods of in overdose with needed. to the longer of Authority a multiyear at OPTNXXX, the contract Development Services when synthetic part late for onset and to a OPNTXXX, believe into the really particularly of of million, has fentanyl US of nalmefene attack. acting and Response, of approximately Biomedical soil. I a fentanyl Secretary of of potential testing with The validated chemical Assistant of Office crisis the such agent Health chemical as third affinity call, warfare the increasing of the The potential and in accelerate most agent said more maximum fentanyl a development past with of increasing U.S. used part been and Advanced action which

fentanyl of received combination to Nebraska, development $X.X through million the therefore this the year XX have with people. is a earlier The in to example million funds submission. in from available. BARDA year, OPNTXXX in potential pounds to of grant contract to May XXX countermeasure this BARDA enough For received a kill NIH keen NDA

Medical the has entered to work spray quarter, with Aesica potential a for nalmafene agreement. of FDA to and in be agreed nasal Under agreement agreement, a wholly-owned Opiant upon further supply contracts nalmefene. Aesica organization. indicative manufacturing a and delivery of the to supply contract leading Opiant with vital on future In development Queenborough development Further, nasal will a under first grant device a BARDA we of produce Plc, life the with subsidiary advance a order saving product. the this commercial Aesica into to NIDA OPNTXXX, Importantly, are approval, manufacturing Consort manufacture pre-filled and Ltd,

with we XXXX. quarter This pivotal treatment XXXX NDA With the pharmacokinetic to with a studies, of intend Looking us referenced ahead move study submit in following formulation conduct completion XXX(b)(X) let's in development will OPNTXXX, to previously the second position onto that, announced the patients impacts patch. development Phase is X Phase follow-up which an study. X approximately visits last purging annually. which to binging X in eating recently disorder Nervosa, OPNTXXX million currently and that the for last of by characterized Americans the Bulimia We

quarter XXXX. from study of to heroin the like the OPNTXXX mention also would the grant We in the NIH some Opiant’s of vaccine. continue data I expect first to to

MHRP at The through the to exclusive Phase Opiant Military and right X/Xa MHRP, the Research Reed HIV OPNTXXX development in SUNY Walter Syracuse U.S. York first grants XXXX. advance the recently Upstate of acquired Institute is funding and researchers trials. announced potentially in by at Medical Program, Army was New and NIDA University to co-developed Research commercialization OPNTXXX and at clinical

the XXXX partner EBS, We EBS NARCAN Moving the later. provided in for onto which will royalties Inc. guidance spray. that million. U.S. Canada sale recently and which year by David announcement the emergency current discuss was BioSolutions, this developed our was nasal the of commercialized NARCAN Adapt product of from a treatment by this for Pharma approximately of stream NARCAN Emergent acquired growing Upon revenue we anticipate $XXX opiate acquisition, overdose.

trajectory we further are market demonstrate, continues believe strong growth opportunity suppressing NARCAN We pleased but with for the OPNTXXX. to the obviously significant importantly validates NARCAN the

$XX.X at we closed quarter but includes of of net approximately the Moving on, Grant. the million proceeds quarter. the third of include a offering impact of not full BARDA public strong million also NIDA contract in late the Opiant in This with approximately from is end the the third the or would financial position financial the cash $XX.X

Directors. I Mr. and results. years to would pharmaceutical David? director of his for Board Collard of will welcome review we like to With senior our ask for to now the financials, industry to been him to David call the over Collard board. Craig a financial has that, I turn XX Before our discuss the welcome David in I

David O'Toole

Roger. you, Thank

results, I Before would highlighting financial company. I position our current of review to begin our the by like financial

As less had we our XX when of September X a on million of to than had million of year cash ago sheet balance approximately XX,, we compared cash.

In continue from partnership each NARCAN. addition, we to now royalty sales Adapt significant quarter our EBS from of revenue receive the with the

guidance the Opiant. were gross for in the million to sales to net XXXX net XXX one-time XXXX agreement. in Adapt provided the projected royalty, range under any a they into Roger provided recent more of We royalty I XX approximately acquisition. payable, will by million potential if about ending will are period direct-to-consumer to federal revenue translate net NARCAN receive in of the announcing during million optimistic their the mentioned, $XX XXX exceed initial which funding. the this With to Based XXX compared three call Opiant continue of sales, calendar initiatives results. EBS for XXXX. course EBS milestone million, original of conference in XX sales NARCAN XX,XXX As growth annual Besides million held payable for sales revenue after XXXX on recognized Adapt milestone. XXXX The guidance be XX any months should was NARCAN XX, million year. during numbers sales Therefore, ended XXXX, to conference including citing briefly during the NARCAN million now royalty approximately million sales third NARCAN XX% increased quarter co-prescription, last week, be of in activity EBS the and state X.X will that, September our review and call sales

three For G&A September compared worth NARCAN. expenses the in ended with ended primarily September increased X.X X.X ended increase September increase General XX, us and administrative months XXXX, the respectively. was was three for diluted share between and of per related were the million the per loss XX, for basic months three of to comparable clinical in as primarily X.X The million in X.X trial during to in increase expenses compensation an agreement the and compensation The September of XXXX, and were to we million XXXX. from of Net overhead loss million a increase recognized million expense. months for the million the XX, license X.X of XXXX, net to X.X three stock-based or respectively. personnel $X.XX XXXX the in XX, R&D XXXX September Research and million the sales associated due three costs, revenue and and due or XXXX basic months Adapt and ended and million XX, XXXX. expenses million XX, XX, million development increase months September X.X September to X.X and stock-based increase X.X expense diluted corporate X.X X.X months or XXXX, loss approximately September share million ended period or loss XX, for and and X.X million of compared in three $X.XX ended

let’s XX, Now, for the recognized in revenue period months nine ended the In $X.X nine We the months the XX, September XXXX, on September for XXXX. ended $X.X comparable results focus million revenue. in recognized we million XXXX. of

license $X.X nine from million months NARCAN. Company sales the the us the and the ended XX, revenue agreement During of for XXXX, of Adapt recognized September between

NARCAN XXXX. expenses royalties and XXm million ended was During sales increase period million associated Capital The one-time months increase were $X.X a XX, payment the XX, nine and royalty $X.X increase arising by cash third at ended months SWK SWK XX, September the the net end recorded through primarily receive XX, were of At were approximately of September September XX, Opiant increase million million offering G&A of XXXX, the XX, September third quarter. monetization million party. includes million fees compensation no its approximately to million overhead. the Adapt that in $X.X $X.X compensation to stock million based the September a public at with expense, in stock revenue million XXXX common to million license XXXX XX, provided to nine nine ended license had was of proceeds $X.X a the September XXXX This The million $X.X $XX.X $X.X $X.X fees related for sale the third-party increase December from and September compared was expenses XXXX, ended and closed payments $X.X a the in Adapt. the There and from increase associated from made The related to $X.X expense the due License ended Opiant XXXX months million. expense the R&D of R&D XXXX certain and XX, expenses The $X.X a in $X.X during months corporate for the by increase Adapt months right obligation between million and attributed million September under million for a our to XXXX, for personnel SWK. and of with program. in based as agreement respectively. license fees agreement $X.X were nine with nine stock under $X.X of million approximately equivalents of we million $X.X the and respectively. cash XXXX. of from $XX.X

previously, position sheet. now growing in In conclusion, million to programs operator $X.X BARDA aggressively As contract, Operator? contract for NIDA the and call that, $X.X NIDA will up and we a awarded from in balance questions. healthy BARDA will forward the ask to majority the Opiant base strong on recently do recently not grant with million allow the a $X.X XXXX. I million development revenue awarded open us balance of financial With and $X.X royalty appear our NARCAN, of the is stated advance million which a sheet grant our

Operator

Cantor And Fitzgerald. we’ll with take question from first our [Operator Arthur instructions] He

Arthur

two I have questions.

dynamics And see NARCAN you follow-up. Opiant some the the you NARCAN, shaping the First, position I the up? OPNTXXX provide market color around market on you given of overdose in see XXX benefit as guys market? how And over potential a and can have the where

Dr. Roger Crystal

that Roger I Crystal here. see the growing. answer It’s is I mean, we question. can market in general,

that And as the grow. we’re on this just state can level, as something not BARDA that on has the through NARCAN have quite taking far important essential the OPNTXXX -- been this the concerned, place or chemical in given spray, initiatives show place really level that general get be being well market opioid but have most as with said potentially epidemic already epidemic. in not for potential as other believe attack. we the in And will we'll we again market, are, fentanyl just market as essential we nasal identified sales excited doing what what as important actually OPNTXXX, the we federal potentially existing We in

Arthur He

And hinder your from the for Can could to over go how NARCAN on out the my and to the to OTC NARCAN and maybe current? or to the is And effort second future question given thoughts the the XXX? share agency. OPNTXXX potential the guideline reason you access pulled in you help affordability do or increase the the

Dr. Roger Crystal

the I agent and in positioning mentioned, in what we have by the on reversal think to country the as the FDA, and to is Company Emergent nasal consistent I the nalmefene well. by access fairly access what found BioSolutions overdose of is altered further increase desire general as the field in [indiscernible] currently the with

necessarily the availability. an OTC a then and achieve the opioid OTC. potentially have So, for our important opioid patients actually overdose helpful where agencies be to whether actually OTC greater is on buy an you in and opioid an example, pharmacists be access to situation we general, an in health OCT opioid and agree agent by opioid concern questions the agent patient which that us to fact be is reversal overdose the address, these for [indiscernible] volunteer have also and appropriate the And our is should stakeholder on it'd for are with wishing overdose an description, [indiscernible] the [indiscernible] of alongside can and overall to reversal is availability not agent, status advising might crisis reversal the that

are initial So, these of thinking. some our

that we involved to today market have check we that We in continue a product with that are not licensed carefully. given ourselves very directly that don’t

Operator

Research. take I’ll our Bright, question next from Investment And Zacks David

David Bright

OPNTXXX? curious the from of if interest curious, acquisition by Bio, I’m I’m since Adapt for change any commercialization seen Emergent in you've partners potential

Dr. Roger Crystal

able therefore we has so think this put think around look what had Nasal an and company, acquisition reversal has some what I'm general, done, a NARCAN the give we're of potentially general, spray. [indiscernible] this nevertheless licensing et at what's see take growth time specifics agents to interest, any of we around essentially reasonable than have as NDA, to program funding times good potential overdose XXXX to how not not around, really at this In we amount all soon. [indiscernible] cetera opioid some And I seen the to many And stage. important numbers this to anytime [X:XX:XX.X] already but in the have I having market

David Bright

going order to additional to medical doing Now, in study potential it in for OPNTXXX. you've there do approval stockpiled have order year to a mentioned that CK you're studies countermeasure? a get Are be to next as any that you need

Dr. Roger Crystal

by Well, of FDA relevant be something which as of instead the been [indiscernible] BARDA, are approved well. general are meaning principles products the that that most of they the automatically for has used purposes would agreement

doing. any expectation our would is there obvious wouldn't So, we additional be to today have be that things

they certain and met However, of are FDA part of requirements approval. them BARDA, responsive there're the to that as we efforts interactions able contract is which have with absolutely to be also are regular

of we we're and in for aware learn due particular. not anything will So, now course

David Bright

talk of bit And from a timing receiving little grant and you NIDA money lastly, and contract the about the BARDA? can

David O'Toole

this the is Yes, question. Appreciate Thanks O'Toole. it. David for David

both grant Regarding the get the agencies. those BARDA, by part the the are those you as most expenses, and NIDA you for reimbursed incur

year a least time. that at as and being grant the basically it an so, reimbursement this have at on then, is of of will get money, And we funds done you after the expenses is depending forward incurred that do progress through then available. and we application the rest for and the next to funding months, But XX receive year first as the move we basically the every on

David Bright

grant you the of received year, those, to and going be contract majority So, for will both do that? money it estimate is next of

David O'Toole

of Yes, our in had both of announcements timing funds. those we indicated the

$XXX,XXX. was years. of contract, the and in with year funding, to in NIDA years the subject to received the as funding probably through first and in BARDA XXXX. it is received for little the or April year subsequent reiterate, first, Just a a of around public funding, ends received be the The million would that. two years next next the that half again the the two remaining that over far after XXXX is be remaining September first funds finding XX, only and over those in after as $X.X And the grant, would disclosure first

David Bright

Okay, thanks for taking my questions.

David O'Toole

Yes, more I time. through the just NDA say one The of filing. would timing receipt is

Operator

to conference I’d the Mr. over Crystal Instructions] no you. Thank like questions, additional [Operator Dr. for back remarks. additional With and turn closing to

Dr. Roger Crystal

Thank you.

believe to efforts We Thank developing, clinic. lives, So the and large interest new your is potential is we’re Opiant. advancing has our be today drug effect limited. pipeline [indiscernible] thousands us and for to essentially to and summarize, this them joining market of note to is excited where product in you save for into the

of We keeping to our day. you opportunities are about progress. Please the of your excited ahead forward the us updated that rest future enjoy lie on and look

Operator

conclude participation. you Thank your does This for today’s Thank conference. all you.

Opiant Pharmaceuticals (OPNT) 10 Nov 182018 Q3 Earnings call transcript