OPNT - Earnings call transcript Q3 2019 | Opiant Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Opiant Pharmaceuticals Third Quarter 2019 Earnings Conference Call. At this all participants are in a listen-only mode. A brief 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, Rahsaan Thompson, General Counsel of Opiant Pharmaceuticals. Thank you Rahsaan, you may begin.

Rahsaan Thompson

thank for and afternoon. us operator, you, you joining all this Thank

This a the CEO, and quarter Chief on Crystal O'Toole. Opiant today providing Financial September Opiant Executive David On for are ended Roger a Chief corporate call the financial release press announcing Officer, update Dr. Officer, XX, afternoon, results issued third and XXXX.

by Safe We releases Securities information call Report this on management today and including materially listeners these under associated results ended implied forward-looking the or company’s Please Litigation Annual with during the statements the and is in Private could XXXX, stated the Act. contained our on note for Harbor the - that XX-K call, qualified December of These subsequent discussed cautionary will Opiant’s in caution SEC XX, to forward-looking by certain that be and statements forward-looking filings, news differ risks year Reform provision statements. those the uncertainties covered Opiant business. Form from making Actual are due statements filings.

contains or also statements reflect call XXXX. this of date events undertakes accurate circumstances call. XX, that to broadcast, information the forward-looking date conference This of only as live obligation no the after Opiant update November is any revise of time-sensitive or to this conference

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

Roger Crystal

you and Rahsaan, thank everyone to for this you, Thank us joining afternoon.

States. I'd operational to and discussion the I with update, in opioid like overdose provide with you United Before addiction of begin the a

deaths data crisis increase a for XXXX. when crisis. before, a provisional As in that CDC fentanyl compared fentanyl XX% opioid the to into indicates evolved contain said I opioid overdose has XXXX And

in several fentanyl. illegal reports scale communities. citing been their seizures large over states Furthermore, rise of And are deaths the news are there on have there many months the multiple been involving past that fentanyl fentanyl. Many have

was that State the enough many in over. in October, of fentanyl seized of were Ohio said pounds example, officials entire For population XX this Ohio. times to more than kill

pounds, In enough a growing Orange lethal addition, County. in were doses critical XX seized is this last million crisis health X create US. California the public to month in in and Southern Clearly

is Opiant this address to challenge. well However positioned

save exists longer to antagonists increase need naloxone in to for to critical related substantial stronger the access due acting is lives, a fentanyl opioid overdoses. While rapid

recent We treat nasal why to are believe help developing may OPNTXXX we to nalmefene this R&D than overdoses highlighted our At address related issue. nasal day better nalmefene naloxone. be we suited fentanyl

require of is to against according multiple victims overdoses effective may naloxone is fentanyl successful naloxone opioids, more often to then rescue Although published available recently papers, responders. first

a study example, laced naloxone first also for responders, needed published a patients over administered infusion was many to and cohort For receiving Xanax and hours. with XX for survived of intravenous these a evaluated Despite alprazolam substantial continuous who naloxone XX administered fentanyl. in arrival required the overdosed on who on naloxone ER additional by of those XXXX victims

from far better makes heroin result opiates. potency and pharmacological treat likely fatality as arise to overdoses in fentanyl of overdoses. rapid suited a compared a Because and more is properties of overdose fentanyl its to to related it that action, onset prescription Nalmefene’s

by and a naloxone, OPNTXXX synthetic renarcotization allowing increases the that event, probability to reducing of at probability the half-life receptors successful a treat it caused of than nalmefene opioid believe while long five combined suited and overdoses fentanyl of times for We potency a rescue related absorption particularly opioids. opiate greater affinity that Mu rapid of the high making of well with

With me that, with Program. you Development now XXX an let provide our on update

And week I'm aiming study, note quarter I the are to that is three two third the to IRB we study now that in complete this While a should conduct pleased it to healthy this report study. to PK to we we initiate now had approval volunteers. have initially the targeted quarter. study

the XXXX, available we data be to quarter third NDA PK of year. next the we now to remain expect While in file on an track

remain standpoint, commercial schedule. a on we from So

the Spray. As regulatory pathway development pathway a XXX(b)(X) Similar FDA confirmed OPNTXXX. previously for NARCAN for to the reminder, Nasal

In been medical a chemical of the validated attack. U.S. for BARDA in a a government fentanyl event $X.X addition, countermeasure OPNTXXX to up has from $X.X grant to NIDA, by accelerate million through from and the of the development contract million the

BioSolutions revenue from Emergent We $XXX value to a subsequently last In NARCAN NARCAN addition was Nasal net NARCAN Spray. for are of EBS million our XXXX, by funded year, to funding, royalties licensed sales well Nasal which acquired government programs Adapt stream the of Spray. or with via in Pharma highlighting

in Under achievements they sales excess EBS’s which a of Opiant one-time has payment of million. this of recently on licensing $XXX $XX.X million, agreement, announced, gross NARCAN net earned based

to further pleased David will overdose further payment. shortly, of million we milestone here this with market for provide but $XXX opportunity NARCAN Spray are for guidance the to significant million opiate updated details agent. addressable full Nasal $XXX year obviously XXXX sales has reversal validate EBS

Cannabinoid OPNTXXX, ACO. like on, our discuss Moving to Overdose or I'd program Acute Drinabant,

As in December of Drinabant and from them reminder, expanded ACO we in XXXX include Sanofi subsequently manufacturing. a with licensed for treatment its to our the relationship

as edibles such is synthetic and the of and large ACO cannabinoids, linked quantities containing often of most KX to Spice. ingestion THC

department XXXX data XXXX. of here, expected in visits with reminder to States to and X.X in America. approximately ACO is The year cannabis rise emergency the room latest available. in reported increasing are of legalization emergency the The of in number United for opportunity the XXXX visits As resulted a which North

for a potential cannabis of increases, is which society As prepared. not the anticipate crisis cannabis legalization we

of currently that no development. are others ACO currently and in unaware for we treatments approved are are there Importantly,

development for program. treatment us has need OPNTXXX excited This our about ACO increasing

Phase XXX been Drinabant weeks. Drinabant conducted XX taken more received and be and when has patients tolerated well shown safe oral for by to up II Phase Sanofi studies than and volunteers orally. I to And

THC subjective Drinabant as formulation oral and shortly THC. can then were it subjects Opiant the injection, In reverse given expand addition, blocked. of of intend in room inhaled will ACO reformulate of those proof rapidly activities establishing and were in Both in a effects so study objective study emergency the symptoms XX developments principle an Drinabant XXXX. to setting. We and an initiate

OPNTXXX, we Disorder naltrexone, are for AUD. to Use which on Moving nasal or developing Alcohol

selection been the Our trial. clinical allowed Phase data to completed for II and study us have suitable has dose a select the dose

in We XX with study enrollments expect of and be to II for number enrollment trial in complete XXX Europe and a will initiate months. the the patients. Phase this patient patient recruitment UK later conducted at within countries targeted year The

Opiant, our helping industry commercial us experience the years at Officer Allergan. Aziz critical years leadership new commercialization. of has biopharmaceutical Head strategy. Avanir Aziz was in all Senior and more in determine Commercial like Prior Commercial Counsel. than Mottiwala, is President Vice I'd Pharmaceuticals. to He as He and over at to our our areas Aziz welcome new joining Chief Finally, of of Rahsaan also General XX XX across spent Thompson

Rahsaan He by will be recently responsible billion. with property, corporate Vice most served for J&J intellectual compliance all which President regulatory of legal matters. strategy, for Law as transactions, and acquired was $XX Actelion aspects for

our ask David will I results. David? financial discuss now that, to With

David O'Toole

Roger. you, Thank

we payment XXX nasal significantly will our the balance have review NARCAN exceeding our one-time million milestone the net spray, of earned strengthen sheet. I'd on million $XX.X This financial I quarter through third highlight Before payment like to - milestone sales to results, based XXXX.

of EBS, will but receive will may of the license to be payable XXXX you agreement the pursuant recall, as is to quarter Opiant’s remaining license EBS reduce the amount the amount with fourth fee Therefore, the in will X.X million. Though net Opiant million XX.X payable. we

of discussion XX compared I’ll months revenue XX, in X.X a further third to corresponding results XXXX. XXXX a ended of the XX.X in discuss balance our first, the brief million quarter the recognized million sheet in ended though period XXXX. for We the three September moment during September

for the recognized For with million million the period compared the of of agreement the from spray, X.X revenue nasal third sale to quarter, NARCAN XXXX. approximately XX.X we license comparable in of EBS approximately

million and million royalty by reported was million NARCAN increase XX.X an remaining quarter approximately related of of of net third the driven the represents increase that by XXXX the EBS. of higher While million payment, one-time to milestone this in of year-over-year XX% XX X is in revenue sales XX.X as

September million offset $XXX,XXX increase were respectively. expenses $XXX,XXX increase XXXX due X.X was three expense expense, to fees the primarily expense. months $XXX,XXX royalty million stock-based and a XXXX, partially The a increase decrease XX, XX, $XXX,XXX and related September consulting ended G&A in X.X and increase for and in compensation by personnel in in a

to September period million the approximately compensation primarily XXXX for for The ended were months XXXX. ended. XXX,XXX XXXX. in was due increase XXXX XX, comparable at three marketing the expense R&D Sales and essentially were none September XX, and of months the September XX, three expense. to X.X compared expenses flat

million, sales Royalty payments in X.X expense buy supported investors interest the nasal primarily by comparable were ended million for a made payments net approximately initially September in due million due nasal X.X for increase development was partners milestone compared the the to sales X.X NARCAN and of XXXX, spray. approximately held increase of spray three profit the was in earned in the and to million NARCAN from nasal period XX, the net royalties, who to profit months to net out Nalmefene XXXX. The had X.X

approximately $X.XX in share, months per income ended a compared approximately share diluted diluted XXXX XXXX. the XX.X loss of the was period of a and or to cents $X.XX X.X of comparable million September loss or per $X.XX three net Net XX, for and million basic per basic

million XX, for $X.X XXXX, XXXX. September Now, let's the We corresponding focus of recognized period $XX.X in ended during revenue compared on months the nine ended nine XX, the months to September the million results XXXX. in

EBS XX, comparable from the in between the XXXX, of revenue For September XXXX. as period ended million agreement of $XX.X compared nine the recognized to us we million and months $X.X

year-over-year XX, nine previously royalty in $XX.X third time and XXXX revenue as sales The one- represents is XX% the XXXX. of increase net $XX.X months the milestone remaining of the September increase $XX.X reported in million was As of earned related in ended million revenue NARCAN discussed quarter of million million $XXX.X by of driven to by of the approximately an higher EBS.

increase $X.X expense. expenses expense $XXX,XXX XXXX a increase $XXX,XXX and due personal million increase $X.X months by and primarily million in G&A ended related including to were in professional compensation September XX, expense, $X.X XX, nine the million decrease increase was fees in recruiting $XXX,XXX September and royalty and respectively. a legal stock-based XXXX for offset in The and

expense. compared for primarily increase XXXX million, were in compensation in in R&D September of period employee development months was XXXX. $XXX,XXX associated decrease expenses million research XX, approximately in nine to $XXX,XXX increase increase by attributable programs the expenses related $X.X million $X partially offset Opiant’s compensation and to approximately third-party The $X.X with a ended comparable and the expense stock-based

for XX expense marketing the Again, compared to comparable expense. was the none nine and September of months approximately Sales in to increase primarily ended due period XXX,XXX XXXX. were the compensation

the nine XXXX to the increase profit Royalty profit $X.X expense in held the interest in to of milestone payment Nasal approximately XX, million million, for royalties the and in XXXX. $X.X Nasal due primarily sales to initially months of payments approximately development million the earned was would compared comparable out September for increase $X.X The made million net a to nasal period ended in $X.X Spray. nalmefene NARCAN net partners investors was sales net from the by buy supported and the NARCAN Spray the

ended fees license during made September EBS XX, license under for recorded license These We months EBS third-party XX, fees to ended There the the were September obligation third-parties. recorded for by related to license our agreement with months million fees $X.X the XXXX. nine payments no in nine certain XXXX.

$XX.X the approximately the million a million for $X.XX and approximately basic loss per XXXX. $X.XX share, of comparable nine basic period per September a share XX, diluted $XX.X or ended months or compared income loss XXXX of to for per and Net diluted of net $X.XX was

for not $X of As at $XX.X through third cash to XXXX exceeding had of XXXX equivalents The net net compared EBS-based balance XX, an $XX.X September of and of does XX.X million the include million on NARCAN million Opiant XXXX. September approximately sales to on XX, cash we due quarter payment at million, cash XX, XXXX. December the

outlook balance million now grant payment million the our in million $XX.X fourth in range $XX the contract the $XX including of cash quarter, million NIDA addition, prior the the $XX to on $XX we our million the of estimate the due at cash of to of Opiant updated does to project $X.X million. not net of XXXX BARDA In balance include million. year or the end versus Based of full the the current the approximately approximately $X.X of for remainder impact of

advancing position We situation into and financial having net and NARCAN. of sources our sales are unique royalties growing and a multiple in from a stream strong government funded a revenue through we of head pipeline as XXXX

Roger that, to like call remarks. turn the With for I'd back to closing

Roger Crystal

David. you, Thank

lives We particularly in company and are excited addiction growth of financial the address the continue the position, our overdose to continued allows and has drug us crisis about which which our stage base a pipeline strong balance compelling value. countless to taken revenue U.S. solid and and late of In already. well with royalty expanding is sheet a long-term conclusion, financially to enhance shareholder Opiant positioned operationally and

now will the up questions. that, call ask the Operator? With open to operator I for

Operator

Fitzgerald. ahead. Folkes [Operator Instructions] Brandon Your Please from today with Cantor comes first question go

Unidentified Analyst

opioid longer the overall lasting about crisis need This become the this overdose drivers Thanks. see crisis you very and the and given a a market much has medication in grow is how Brian market? can how could the for opioid fentanyl on you for talk Brandon,

Roger Crystal

this Roger. is you, Thank

So for of overall first the by particular being so market overdose these heavily reversal the being in and And see opioid all, involved fentanyl of we in driven expanding related rise compounds overdoses. that's in agents.

carfentanil, super a and times opioid, changed as and be stronger it more fentanyl sufentanil can XX potent compounds potent into even heroin derivatized further cetera. so et than Now such

more these overdose And overdose. in it a but intervention of minutes more a window XXs whereas heroin probably much they more not to is a overdose said, minutes potent dangerous, rapid for related fentanyl being seconds less. as than far more results We far of the are if about XXs talk of I are

as because it And really fentanyl the to make sure as longer an antagonist of So well counteract compounds such need to someone a different action with that paradigm. is acting overdose fall situation. of that back we longer doesn't into opioid

and nalmefene it also potentially it that's is ability because think has greater has that a therefore offset longer and much as well suited this life. why potency compounds product, such nasal to we And this half particularly greater fentanyl

levels So this but again described as high renarcotization off, fentanyl in there where around of what has preventing we worn still patient. naloxone the is

Unidentified Analyst

one color terms may more product? just cannabinoid some for - of for adjustable can can, I we around we should timing development then And program And overdose see. think provide of OPNTXXX if in the market data, about you the how that can for

Roger Crystal

I And and studies [use call the certainly lot the that really would high I months Combined simply [ph] they that take more I getting already. that people XX just encouragement. proof where as program principle you XXX to it FDA have of oral encouraging this we II a of subjects already up - this exactly will if with meet us in compound and there put confirm to mean for we of say this to has been in Yes, prevent a in Phase you compound] mentioned we data could shown give it to the extensive on with what Phase compound. development buy the also have into. terms tolerability, safety, an I way

to make for in in it talk addressable suited is use do market. about department though then emergency the which we need will of terms better What the

make from suited is to to the it's end they're willingly typical this cannabinoids they and ER department edibles oral spice into not so up synthetic an overdosed extremely to and better compound. emergency injectable an we KX take cannabinoids And or need an as - these these hallucinating, who such whether convert compound. compound again they oral are from patient The on it unwell, to the in going

to an to the so needs treat is it be modality them. given injectable So parenterally desired

that year, this progress reformulate the reformulation. see done. be that will we don't so difficult And a onerous be need way We and next work under work is hugely it's on announcing and task to being it we just to

with we look reverse need do [indiscernible] We would version, the of is getting although to into we go then What principle to the can from because prevent we injectable to clinical studies, show have high someone proof that. THC.

from with down the so bring someone proof be if can high important that principle. THC, an them already back that we So again of is would injection

we next studies program can doing. or really key that two up those this think then expect exactly in and what with we need then set will that for I registration features be to the success So determine year

of won't an chronic compound that’s However, encouraged use studies is than already. because be this too acute use, a And rather data clinical we're very the the duration long. there out with

In terms of is the initially. this addressable an ER play market,

undergone an see tell actually useful necessarily by administered we they again what haven’t we mechanism the being acute who anyone this it of an suspect physicians well. cannabinoid someone a cannabinoids, situation, I'll a ER that overdose. be would issue but it overdosed on don't in can So action has also that, be about diagnostic add to as if from would

with a the someone likely suspect and thousand so And commercialization be that is you try you avenue of and there same departments not cannabinoid we're something a reverse potential ER more of agent in country a at number remain overdose is as on few well. instead. If else reversal it looking they high this it self crazy might then if

Operator

Instructions] David question [Operator ahead. Your next comes Zacks. with go Please Bautz from

David Bautz

same And question my property NARCAN intellectual is is well nasal or that So this position the spray it IP for separate? the as XXX. first covers about is

Roger Crystal

licensed lot IPs - from and there acquired around to there. is is the additional Therapeutics, file as then is that quite a that's on by the which Neurelis well of so And there excipient now we that. Intravail, so position the called is separate This related company IP that it’s and have IP been and other is Aegis there

David Bautz

trial How in you the clinical you a that an that the what that for on like? And to? to it way quantitate and look works follow-up want do XXX curious I'm drug would outcome drug

Roger Crystal

intoxication. a of measurements that’s THC subjective objective and Well

we're the endpoints, met would the to be haven't with class be compound So of hoping first yet in while terms FDA if and we will this of approved this successful.

be pursue. with we sit that be propose subjective endpoints measures the FDA down and point the the so of would those would And objective would and to THC intoxication. certain And

changing through suited. For example to of temperature be body feeling measurements how that as a these of range and objective such measurement is well would whole reported someone self

exactly So an there what do yet, to we confident but said is haven't that looking avenue forward. I'm we're

Operator

Your with Carl Byrnes from go Securities. a comes Please next question Northern ahead.

Carl Byrnes

characterize and first you how and programs growth might going congratulations might you we in the the expect in that for quantify kind on and hierarchy you responders, and nine coprescribing NARCAN at how Thank states public and of - How quarter. - or might this of forward? mandatory look continue sort Thanks. demand to a

Roger Crystal

if market terms Carl, your nasal we I think for about should looking and addressable probably that really your I spray of perhaps just question? that, is how in So question how the you are recap - at read NARCAN how

Carl Byrnes

right That's yeah.

Roger Crystal

market addressable areas Yes. when like any EBS with main look the and I being it and agent, overdose we based. we that about prescription opioid and mean institutional, for then there talk how at see two is consistent it's reversal also basically

but overdose think agent spray needing be there interest it, is how reversible NARCAN characterize will So it as opioid that they got government it the is who police may are currently, well the an groups are department, users, there wherever fire particularly that be departments, predominantly public based organizations I available segment, institutional other in overdose. and opioid departments, EMS general - nasal

market the risk market moment. are pain they or about market, who so from that opioid And an we whether patients terms then this high is report, in to higher people EBS an determined necessarily look for with for of the medication still And of in alongside there of still XX% a overdose. of abusing, the prescription learn we who which prescriptions addictions at what they are formal opioid are are but receiving who be aren't abusing treatment, overdose, because a whether opioid risk is are

of recent also taking are of appears also I'm to opioids people which be For taking the if they're XX% medication. aware example, benzodiazepine medication, data taking benzodiazepine most

recent situation to stringent if coprescribing five a that have that And come you're fact, naloxone in coprescribed form some for naloxone. ought then online interestingly nine you of legislation. the that like to state Mexico so appropriate. And most is being an be is laws have and there states to for is coprescribe most opioid or the whereby on New appears coprescribing days And longer,

on developments million can attacks The $X.X nalmefene it a is in chemical nalmefene, U.S. soil the other because these think is countermeasure government suitable suited the the essentially we vulnerable in U.S. this nasal by case nasal fentanyl And that be chemical developing the might market, HHS sticky, interested contract area considered reason, the in chemical past there stockpiled a saying in that be a attack reflects for a in barter type nasal around for they and our use concern chemical potential happened which it of is nalmefene how addressable somebody Russia. but is we of well attack support of have for of the fentanyl medications they're hotspots that could attacks. with in

Operator

time. I no for over to you. Thank There back comments. at Crystal questions this like Roger further Dr. to the turn floor would closing are

Roger Crystal

Thank our and you, we medicines potential we and well thousands the significant resources. supported have that each the opportunities excited plans are we're we R&D continue excited advancing our believe by of pursuing. importantly, market financial the we're very Most the in to to pipeline summarize, To are Moreover, the for our truly about prospects operator. impact lives are developing clinic.

term progress our today day. Thank your Enjoy look the pipeline creation. from joining execute you of for we updated catalysts, near of the for and in further anticipate the topline AUD in us additional including nasal continued Opiant. and our from NARCAN rest spray, As for to you for your months. interest royalties initiation our coming OPNTXXX in we key forward keeping trial OPNTXXX We and on develop data value

Operator

teleconference. today's concludes This

You time. participation. for you your may at this your lines disconnect Thank

Opiant Pharmaceuticals (OPNT) 12 Nov 192019 Q3 Earnings call transcript