OPNT - Earnings call transcript Q4 2018 | Opiant Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to the Opiant’s Pharmaceuticals Fourth Quarter and Full Year 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie of LifeSci Advisors. sir. ahead, go Please

Brian Ritchie

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

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

Dr. Roger Crystal

Good afternoon, everybody.

leading providing worsened This health is the fentanyl me a with epidemic. overdose of abuse. this males under of the across Unfortunately, update XX. deaths has public age opioid the is American expanding the crisis now Opioid cause in brief begin on U.S. growing by Let increasing

have is. critical weeks in reminded of abuse fentanyl truly been twice how We recent an issue

that Secretary dangerously and into substantial falling of likely State Markey nefarious alarming carried Firstly, the such asking Massachusetts, combination of and likely prospects attacks the their be more for be deal how to out Markey Patrick from wrote with of fentanyl be was acting-Secretary Senator ubiquitous, use Edward a made strategies Shanahan, as wrote done attack, fentanyl. raised reported whether what from demand, of asked fentanyl devised it prevent weaponization who used also weapon. Senator agencies to used it are being Mike for He those and hands an and high Defense plentiful have would how potency that could of Pompeo the even has the purposes. fentanyl in letters to supply, to could

was by enough after drug Second, which was really uncovered reported for kill containing XXXX they recent deaths Senator a largest This XXX pipeline crisis opioid most United and crisis Protection a they were million fentanyl. fentanyl the addiction to which demonstrate focus people. is Border over overdose overdose in from of of million found just , Markey’s fentanyl, fentanyl, the Services has makes advance In evolved which medical letters ever attack. The backdrop the XXX announced related to of high opioid that continues half said believe We that Arizona. of which events on, $X.X had with with against contract to as of shipment its led of into days in multiyear the rapid U.S. Opiant illegal and is pounds of treatment and to Authorities States overdoses. that and Mexico coming Customs OPNTXXX, nalmefene nasal of onset action, the countermeasure the part potential opioid development nalmefene overdose. of of to with event particularly and a long chemical opioid XXXX, fentanyl OPNTXXX of treat the Department opioid the the Human mu fentanyl of into at well-suited BARDA, a entered OPNTXXX accelerate the receptors, combined a we affinity it for duration funding a with action approximately Health seized up of

this OPNTXXX Top to we received Collectively, NIDA, from last on study. intend This these a the Abuse. Opiant product. In awards year us submit of development addition, findings a we pivotal study. fund drug NDA referenced Drug replicate XXX(b)(X) conduct the provide study full validation of application The for retains development previously to Furthermore, the new line full expected to this role data later National are would OPNTXXX. position pharmacokinetic XXXX the pilot NDA In $X.X is path. to of goal year. in same Institute from the commercial rights the XXXX, grant for through this the to the and million of

on alcohol to without AUD. disorder, We urge suited spray will taken to of need the a that prior AUD it OPNTXXX as well Moving is whenever for to believe be nasal patient a drink, OPNTXXX abstinence. because the use treat has

In XXXX, Phase that previously amount the drug nasal AUD to that pharmacokinetic rapid XXXX. for of we trial we its encouraging of expect addition, second half complete In X OPNTXXX, intend rapid absorption. initiate is the absorption We available by ensures the generated the when demonstrating to maximum of nasal data needed.

as visits pose children, We for potent marijuana synthetic in are by Sanofi often days recreational sold more visual auditory CB-X no These emergency linked and department who and its could cookies there take where more to in most for been emergency and since XX% large KX for XXXX. personal estimate hallucination, psychosis the of characterized an XXXX. ACO nausea. States ACO-related Edibles, to is a containing FDA-approved the hours to market often that are that spice consume in such by less quantities and in paranoia, states Colorado evidenced the of risks of require significant department million With United year. feelings often THC for our attention cannabinoids currently resulted of ACO increasing anxiety, can emergency most Opiant. by is opportunity it to overdose. symptoms to a ACO and I'm pipeline, number medical are and than There particular a We recent accident. of agitation, ingestion resolve. ACO. as treatments to legalizing rates these use, panic last edibles cannabinoid for treatment legalization expensive and X addition the and visits in expected rise, ACO, speak acute has than cannabinoid drinabant, be marijuana. Next, It about as brownies, receptor and candies, ACO antagonist, from increase excited late licensed

ACO Research This needed. the HIV mention were has develop treatment are clinical the Sanofi, study then endpoint. treatments We government Therefore, trials. Sanofi significant patients received its to on lines oral in that were when at NIDA’s effective would done announced the receive In that, Phase able of also study list which XXXX bulimia studies on possibility amount whereby focus Program, researchers OPNTXXX can our like healthy and Opiant -- nervosa. previous and meet is to this OPNTXXX overdose, funding. we an whereby new of programs and recently to conducted Importantly, in by OPNTXXX we Like now inhaled commence in to disorders emergency oral Opiant’s on ACO the both will can clinical intend be injectable, XXXX. Military through reverse will let's heroin US XXXX, where effects there OPNTXXX be NIDA. top into could a is a in drinabant licensed the of well-funded XXXX. codeveloped grant compound already With vaccine, on of work an In injectable urgently product I failed an opioid drinabant that that OPNTXXX, advance move and is version was reformulating to symptoms researchers for setting. room by this to rapidly QX results of primary locked. THC, funding now Opiant clinical our potentially a X will given that leverage. clinical objective MHRP; subjective

this shortly. which on outlook BioSolutions, from Pharma, EBS, was Based was developed on up not we we nasal Emergent revenue and for by in NARCAN, for NARCAN $XXX licensed guidance EBS’s stream EBS’s Adapt Opiant anticipate comments XXXX So, which spray, advance few will growing A review nasal for will latest acquired spray, royalty. XXXX. NARCAN to program. million David, a

now be to contract want ask NIDA that, million the $XX.X continues our the not funds include emphasize, financial the With I’ll grant. discuss does with which of at position I the to majority financial from results. in a end the or XXXX, BARDA cash Opiant of David approximately of to Finally, the strong

David O'Toole

you, Thank Roger.

is Amendment to is like February at as spread the December this and XXXX in million third-party significantly our reduced us into royalties four over of license $X.X a by third-party able maximum X review entered Number recorded as license Before on or first quarters. Adapt payable XXXX, in X us, with to address reduction XX, third-party Under license XXXX week we Amendment this a are license I agreement would to Number we I executed which for positive XXXX. general outcome Adapt, receive. very fee we a milestone the to settle financial a $X.X of the were we relates fee fee which results, that million by in next

secure allow Adapt licensing arrangement. into addition, third able that provisions to we were party still enter In to

next any any its acceptable if to arrangement million our March in XXXX. financial quarters, comply taken whether with to us in Even, approximately equivalents XXXX, us Adapt by compared is be and that fee of third-party exceptions, Opiant licensing Number Adapt, paid However, cash by cash exercise X. deduct consent instances, the Number order remain In in after payments, December $X.X certain approximately position. million, strong to associated XXXX, over the X. At licensing of had must the a at right as million deductions, provided all Amendment $XX.X license with this provisions to as we future four arrangement any, with XX, $X.X and will December will XX, to specified Amendment third-party need XX,

potential. owned Opiant that both as has EBS Adapt NARCAN which addition, significant EBS resources, now by and growth is In has significant believe

net the sales XX%, It December well agreement at NARCAN impact potential which that XXXX, a XX, of to million would under In milestone, net our to XXXX, previously. royalties to will for less one-time approximately which I Opiant be the now we guidance translate results. $XX our believe does potential exceed review potential deductions, receipt fact, is they $XX of EBS license of previously. that of include will certain publicly our million receive discussed would sales in balance million year them we briefly note during $XXX milestone also the into with has financial as which currently higher provided fourth as sales the cash project important as not discussed that, With $XX quarter million

three December changed expense XX, and XX, $X.X December ended First, December December same the December in XXXX, to income the revenue we months three please our from the $X.X to million note Adapt million We under XXXX million of XX million months months by numbers provided and license of fact XXXX three $XX.X a in offset sales recognized December our million that unaudited. July revenue of from during XX, pro in a non-recurring $X.X forma in of the XXXX.The months XX, in approximately months recognized are revenue that the XXXX the approximately ended increase we period XXXX. XXXX. Therefore, to corresponding $X.X for primarily and royalty ended versus period the with an compared agreement as due revenue recognized in the ended milestone the decrease year-end three XX, was of for

respectively. ended December and G&A decreased and sales XX, of to three ended the of The increase in costs in compensation ended The from recognized XX, license the stock-based and of in were related expenses XX, development million million XX, program. million in December December agreement $X.X was associated and months Opiant with an million million $X.X $X.X for the to due three product Adapt decrease months XXXX, it NARCAN. between and XXXX, the expenses primarily $X.X XXXX primarily XXXX, months XXXX Research was for the $X.X three and and development For revenue December personnel respectively. expenses XX, expenses due expense R&D of $X.X and our increase December were million. million G&A $X.X

ended XXXX. noted As the fees were million XX, earlier, license $X.X for three third-party months December

ended December for Adapt Net to There months XX, the of fees of payments $X.XX share or for to three $X.X certain the obligation XX, of for comparable share related to million, basic agreement of third XXXX. license compared were fees loss months the net income per was third-party per for loss ended a license XXXX income third-party period three The under for our made with no million December the by basic parties. license Adapt $X.XX $X.X XXXX.

$XX We year December let’s Now, focus for the ended results the million the recognized for revenue XX, full-year on XXXX. in XXXX.

XX, XX the For $XX.X XXXX, revenue. million ended months recognized December we in approximately

milestone During revenue between for XX million NARCAN us the the related sales from million $XX.X for ended ended sales months of December and recognized which XX, year the $X.X the of December company Adapt the to agreement XXXX, versus license XXXX. non-recurring of million a XX, $XX.X

in million XXXX, the from million of $X.X were in of or compensation expense. SWK R&D third-party and was expense and to The expenses arising expenses sale in a in an one-time $X.X primarily expenses with related due fees progress, of were million the This from associated increase expenses its obligation increase Capital were for payments ended $X of ended license compared from $XX.X $X.X million recorded million to XXXX partially expense. basic share, approximately for primarily Opiant XXXX, agreement NARCAN and There of and basic corporate sale to $X.X royalty was License XX million December loss decrease per $X.X XX, Again, offset personnel certain in $X.XX XX, respectively. or year XXXX, The third-party net and ended SWK XX SWK. $X.X in by loss and loss R&D December for ended the the XXXX. third-parties. years XX, $X.X December months in XX $X.XX no was license to due loss increase ended a our a million was royalties per to XX, to XXXX XXXX. million December $XX.X $X.X $XX.X for personnel million and as fees to related right year for made XX, the million Adapt the provided ended the receive and $X.X which $XX.X the were stock-based overhead, December between approximately or million monetization under the a Adapt. Opiant for $X.X decrease share increase the fees made years December December million payment by increase the Net R&D increase and XX, of by months million G&A During ended Adapt million XX related stock-based our a under be December of license December the a XXXX. for year million compensation XXXX. with was agreement XX,

the rapidly funded balance include contract. compared and to cash I As the This advancing base from call million ask awarded in $XX.X in continue at XX, operator does Opiant the revenue million a $X.X with previously, a partially is million the that, had million the strong NARCAN approximately I approximately majority and growing With a not and operating for grant pipeline stated the open and beyond. XXXX, equivalents $X.X position XXXX. balance healthy is XX, NIDA grow December cash December will financial BARDA Operator? externally, questions. that from royalty In at $X.X and conclusion, XXXX recently robust we and of of to to now which to sheet, cash up

Operator

question first Folkes you. Cantor Brandon from [Operator Thank Our coming is from Instructions] Fitzgerald.

live. Your now line is

Unidentified Analyst

Thanks the This questions. guys. is [ph] Asif taking Brandon. for Hey, for

couple. have I a So,

Committee specifically the the you think, development December and the to significantly that this access, FDA Do access use medication? Advisory will naloxone, to if of some So share the first, same do if naloxone invest naloxone increased but of expect you successful, regarding or opioid to you as the of meeting XXX your education referred enjoy from behind take would meeting have nalmefene the you on start? guys not overdose is it

Dr. Roger Crystal

question. So, thanks for your

When I as with in and FDA, same has overdose discussion nasal obviously met nasal program was label the opioid nalmefene think, around as nalmefene the [indiscernible]. original product this agent the stage. at the this development an injectable we still is point, general essentially

think discussions development expect that would for -- the we’re label clearly XXX(b)(X) with this that way. injectable and will the this same But, would be we'd But in would FDA time. that So, this well a opioid FDA -- as is I the development with indication approved version. the we previously the suited discussed in that further pathway, that be on predicated overdose still stage, so

Unidentified Analyst

great. That's So, okay.

so, a follow-up And as for XXX.

us you XXXX? steps and following program readout the the could XXX development on for a give So, potential some data color in

Dr. Roger Crystal

line hear hear for you can the you Can second. Because went okay? Hello, me? me down a

Operator

proceed. Please

Dr. Roger Crystal

with your think is I the the this to what for with of that's the aiming readout probably pivotal development XXX, the was continues. intention half is So, in year, this study timing as file related guidance question QX, XXXX an to a specific and to in second to if more give data we’ll year, NDA program an pharmacokinetic and case, come intention the and the

Operator

coming is Our Zacks is next David your line now from live. question Research, Bautz Investment from

David Bautz

PK Hey. to any there study you XXX activities development. need Good on started? quick Are conclude there afternoon, that can Real follow-up the before get guys. that

Dr. Roger Crystal

our having essentially It's is approach the PK the study. general -- study of

And that. previously, the need you you have we as stability initiate with certain contract even PK in device needs is like to can study data So, like before product the you the put the study, so set of product and PK PK a have amount we up, we we study, if be are ready, manufacturer. to specific, of having way the that on the a the terms most announced into -- develop

product of the in having And so, underway that’s ready. terms

David Bells

interest Okay. potential and you wondering what from I'm taking to collaborators on kind own? market your about be you that XXX, comfortable of seeing would are product

Dr. Roger Crystal

for are opioid -- there on when spray general and to We requirement any going the ago. increased out is the this around made collaborators. program have to has agents, we nasal not nalmefene, opioid I as that -- all NARCAN [indiscernible] from who demand reversal we in overdose potential nasal of amount compared reflected evolved not scheme the the give years won’t think collaborators, and our specifics those that's interest I crisis and

specifically there’s this absolutely, take not we general. way and the to huge through NIDA So, looking the to and We're today funding that BARDA program have NDA. interest been license in in a increase external this from the all

so, we And are to on keen that continue ourselves. process

NARCAN, -- market of market market terms a regardless like EBS opportunity. the given commercialization, we've In we’re and commercialization challenging, perhaps encouraged of very we specifics. but certainly XXX the we -- The by participation the to now say, [indiscernible]. not greater have any large with And Adapt certainly commercialization is than in

So, that's where are we today.

David Bells

to the license question And Okay. about the agreement. amendment

So, you I this how that Adapt agreements? is just need licensing the likely confirm, is year also, royalty have to it deducted million, I into maximum $X.X think is to enter income additional from then, And heard? could that what amount your any going to

David O'Toole

Yes.

amendment, and David. is question. Thanks us, retain we is written, it XX%. is and $X.X XX% SWK The way the maximum this of It which So, a million. for has SWK both written and for is the

that quarters million. next with is be four our the over can the $X.X maximum amount So, deducted share

license any we're that aware question, of much into. IP may potentially that not to second doesn't are time. this to protect there out your mean regarding But want that aware in agreements just franchise. also, point license NARCAN at may here of Adapt enter isn't to the they Roger can We that additional some additional there in that not maybe but want So, and chime

Operator

you. Thank

of next from Brandon Cantor is Our the question from Folkes Fitzgerald. line

Your line now live. is

Unidentified Analyst

I guys. additional just right Hey, the NARCAN, one have question regarding now.

the Emergent the would royalty entitle to some lunch expected also generic if and a to stage, also be generic? NARCAN So, to guys on of at you

Dr. Roger Crystal

would as provisions in additional be generic, able are generic in agreement circumstances, A or Adapt other to whether benefits authorize generic. sales. wouldn't. And answer we So, authorized would far the is situations, no. And both indicate the is answer some a in probably product, not amendment then, that those and get as the for there the probably they we And yes.

Unidentified Analyst

be So, as so as same now the a would follow-up, it be so structure kind authorize generic, would the is -- royalty of that right seen?

Dr. Roger Crystal

Correct.

Operator

of closing our Dr. end session. to the turn any or reached question-and-answer back floor over the Crystal like We you. I'd to Thank further for remarks.

Dr. Roger Crystal

pipeline. Thank to operator. drugs you, save each about very believe we're we’re forward in excited we have to our thousands developing advance clinic. To Okay. We to of look the summarize, the and truly lives potential for continuing the prospects

plans for throughout development look updated our resources. supported XXXX. us our Opiant. We your are for on rest joining to of Importantly, our well and keeping your in today the financial by you day. interest progress Enjoy Thank forward you

Operator

That does teleconferencing. today's Thank you. conclude

You for time a today. may have your line at wonderful day. participation your you We this disconnect and thank

Opiant Pharmaceuticals (OPNT) 21 Mar 192018 Q4 Earnings call transcript