OPNT - Earnings call transcript Q1 2019 | Opiant Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Opiant Pharmaceuticals First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Ritchie with LifeSci Advisors. Please go ahead, sir.

Brian Ritchie

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

over Roger? to I'd Roger. the to call Now turn like

Roger Crystal

afternoon. Good

fentanyl. rapid of compared injection we As in on-track with conduct a to well to it's some long study as of of we rescue OPNTXXX, of further top for data recently an data suited and PK recently NIDA. online In such Drug $X.X recently, demonstrated nalmefene, tranche and and synthetic Most peer-reviewed OPNTXXX, our validate approximately Abuse, medication. on advance half-life has and minutes development in a further the especially administration absorption we grant data or million when nalmefene, an suitable We to These intramuscular from million for nasal generated the situation data, together for These OPNTXXX second data support line believe the to the from of This the overdose first of Institute was of total this date National our very treat remain were validated critical. Experimental year. of Pharmacology $X Journal awarded Journal. of OPNTXXX are potential published pivotal in pipeline report the high is as overdose a a the of OPNTXXX potency positive opioid Therapeutics. been

Importantly, confirms have OPNTXXX. tranche with second we of the the date to achieved award this progress

includes be March As for $X.X program. million million this and XXXX, subject funded government balance $X.X be this April funds the of approximately through of continued to the XX, period X, grant a to XXXX, funded available in to reminder, progress beginning approximately development

than is activation delta of Effective new the rapidly high efficacy plasma requires naltrexone addictive opioid indicates OPNTXXX of OPNTXXX or Evidence demonstrated achieved opioid the the to currently support we to Clinical Alcohol announced both from contribute alcohol. may OPNTXXX, in absorption receptor for recently. much for AUD. naltrexone products of peer-reviewed on, or brain, in concentration the in resulting tablet potential nasal one these of on-demand treatment Pharmacology. properties ability Use This Moving treating alcohol-releasing plasma delta of AUD. by Disorder, Journal online the and publication intramuscular shows PK the approved of for dosing that Clinical naltrexone started, for increase study data locate to results as a injection treat drinking second once OPNTXXX an to in is naltrexone, endorphins Thus, and compared reinforcing from higher The AUD. of published rapid AUD. or suited well These either the and that has levels of drinking anticipation achieve receptors, were

study completion be psychosis, emergency injectable data, ACO, current for in no approved to and to for used the we market II visits setting. There by Drinabant this now opportunity in in year. with begin the a from a be States We later and pipeline and paranoia, Overdose Moreover, ACO, results version treatment followed of based marijuana study with Phase formed our for the the to XXXX. the treatment healthy OPNTXXX Longer of million in are year. asset by by use, blocked. on have develop receptor in were antagonist over second of for licensed greater anticipate feelings characterized this the THC, states is Sanofi, Importantly, resulted the with patients in of for may term, study for half insights of quarter conducted previous oral the an the OPNTXXX, or for personal or patients emergency Opiant increasing to available than which and effects AUD, Acute the believe Sanofi rapidly United Phase the naloxone, late II OPNTXXX study ACO both can has expected yet formulation in study subjective enrollment is number the clinical XXXX. treatments rates half-life basis department X this expected In given Opiant. have Drinabant, from hallucination are cannabinoid an of a identical also currently addition last naloxone, potential most rise. inhaled and will emergency ACO. that recreational significant promising by an potential our when recent legalizing potency a which to room opioid essentially objective plasma then We overdose. were The Cannabinoid selection the

year and study be to an in this injectable on oral we into commence focus reformulating Drinabant clinical intend will XXXX. Our

on OPNTXXX, Phase HIV U.S. of Phase Opiant's University, for subjects like last in heroine vaccine, exclusive program fourth and extensive potentially the year would oral IIa in product Program, to Institute this mention safety co-developed grants II as This multiple well II/I Research XX Army quarter the We or through researchers Opiant also previously Upstate the by including XXXX. NIDA. at was of advance study Walter Research trial. Reed Phase the are development Sanofi's generated which encouraged to Medical and weeks. U.S. to Drinabant funded I the OPNTXXX XXX up right I conducted than studies, researchers further database by -- more at with acquired the Phase commercialization and MHRP, in Military clinical and is SUNY, for at MHRP received

NARCAN, EBS, to as growth into royalties onetime provide BioSolutions, a that would Spray, acquired net which by in further NARCAN XXXX. sales as for Emergent and NARCAN-related higher details has EBS licensed believes stated potential potential in significant expectations or shortly. million milestone. well which David ADAPT was developed Nasal sales will NARCAN financials the on XXXX, exceed which $XXX during Opiant a year and translate will to we its Pharma Moving that publicly has

program, the financial strong cash at include March with clinical million approximately contract of development Opiant which majority remained of because XX, XXXX, of Finally, a the BARDA $X.X not in our does position I million accelerate NIDA funds a as that, the grant. of With David in from our developments now attack, medical to the countermeasure the remaining to fentanyl financials. discuss me event ask OPNTXXX of or will chemical $XX.X

David O'Toole

$X.X in you, million XX, in in March $X.X revenue Thank ended three XXXX of million to recognized months Roger. the compared the XXXX. period We corresponding

were million developing expenses $X.X the primarily and and as of increase approximately our of increase first royalty for was XX, million ended $X.X from million in $XX.X year-over-year in agreement million a reported March increase in quarter $X.X professional and XX, of XX, compared fees and in G&A corresponding G&A $X.X XXXX, XXXX fees for March expenses EBS. $X.X increase of XXX% sales program. March three in For to months expenses revenue in increase a respectively. as $X.X million million in XXXX. an XX, first the us period was million EBS XXXX. to with by three months the royalty months NARCAN XXXX, $X.X XXXX, three we XXXX, of in the by million million respectively. license the were increase third-party and compared $X.X revenue legal increase and represents quarter between the the by $X.X R&D driven fees. There license million approximately of recognized recorded the of March expenses no This $X.X in in ended million The The primarily higher million to was ended first associated $X XXXX driven and XXXX, March net R&D in-license expense quarter were approximately product XX, and due

the under Again, third-party in compared of contract. the $X.X XXXX, million fees Adapt months include three license or License BARDA cash payments net compared equivalents period the grant Net basic diluted a $X.X a per comparable to million for $X.XX diluted At The the million was loss of million the share at of had agreement. of March and XXXX period loss XX, certain NIDA the the loss of $X.X loss million we related in XX, the XXXX, our XXXX. $X.XX per $XX.X obligation a basic or March of for does to balance million to $X.X XX, cash and majority and December XXXX. cash and $XX.X not share current ended

by quarter conclusion, financially approximately milestone, $X.X million. EBS and sources in $XX amount reiteration sales milestone balance of the million Opiant via to is not sales the that strong previously NARCAN well amended on the payable XXXX, this ask include of end to reduce of late-stage up a Operator? million Opiant assessing When as for XXXX base in full may operator does pipeline this the positioned calendar that, royalty net year XXXX to License start guidance exceed year. million a $XX.X at the $XX first to NARCAN sales success net provided throughout likelihood NARCAN sheet, earning strong well anticipated $XXX multiple March of of the from continue sales consider million Opiant and is a In We achieved, over the both onetime continued beyond. maximum payable. questions. it the remaining This event to X, XX, XXXX third-party million million funded project of of of Amendment open important $X.X million range should reported potential cash With promising the is license and and revenue the Adapt XXXX. milestone agreement, Opiant is $XX.X I due their call NARCAN of million balance of as to from payment operationally No. the that the with expanding external by the the to as by now for will $XXX in of partially EBS Pursuant fees EBS $XX.X

Operator

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

Brandon Folkes

that noted you to in see of lot on a help opioid they the provided start think that But the terms intranasal, a we see XXX mentioned Am in NARCAN royalties naloxone then that correct we entitled do what just this how through , multidose can think clinical combat understanding lastly, it? still working development deaths that Emergent seeing us know CB-X meaningful half-life those positive, or you'll XXXX. I overdose this you are we you us data will driving clinical data. think is program of synthetic you through should can naloxone. to And from in are I program need believe Firstly, we development the secondly, help product? are about be for studies assuming that a when And you on a to the

Roger Crystal

Thank you question. your for

XXX asking? be that first the of that the on to So what relating you're around clear is synthetic, one. half-life first to Just question

Brandon Folkes

the product that need differentiated do show a opioid can think problem. synthetic Correct, to you you What to right. address mostly really have

Roger Crystal

product Well, receptor. molecule has some of think, inherent think, properties nalmefene, of high the I a are in terms which µ-opioid the of affinity I in differentiation,

believe that it's So think fentanyl than the in opioids think themselves space when we address fentanyl, this. fentanyl, synthetic of affinity of action. able when -- longer will in they about a to the like other duration potentially we higher the of be we we have longer much a have property a to that think And better opioid half-life the of synthetic which

counter that to when action, reversal in the we tens rapid seconds intervention. whole from higher agent and think Then The for of for compounds us the So once having in one like synthetic, overdose other does amount in window already. -- thinks in minutes. minutes is like profile and the counter bloodstream that that's the compounds -- of a overdose an duration pilot minutes about of PK nature to of in of our allows longer of about order the nature, more heroin intervened. rapid of extremely we of But window intervention of more terms fentanyl action talk window is about longer, to

the multidose quite think such the other question So we also as Tmax device. are again, important. characteristics high around And

yes, NARCAN So overdose you terms the It's CB-X of terms royalty and under opioid -- with about developed development in naloxone of our to would specific And we under receive Spray. is program. product terms fall Nasal of Adapt, any license, in antagonist nasal license that. the for our not asked from the then that

something it So where anticipated yes, next we overdose a have regular in to similarly see of cannabinoids extensive years. opioid cannabis, our result ago, grown quite mind, characteristics lot was program just very overall. the we're truly have today. that ways high the this very both cannabis -- yes, crisis -- in in It's crisis rate but abuse though, which, a in are around could And we excited about the a synthetic of few we opioid that few many to difficult years not

can be against this we're look that important. ahead effective So to is medicines develop and trying

-- of it's Cannabinoid these it potentially compound of then we'll because in to someone and key And got THC mentioned terms -- and the taken reverse compound is of clinical first has once we Overdose, the already the that trying trial shown essentially already bring high, we looking you've Sanofi can Meaning, THC, an initiate well what have higher, reversibility. of to and we've , there blocking when again. kind of the the to what's if down actually lot that next I we on given year get demonstrate some of effect to we're we think compound inhaled Acute a administer, down our showing back as already. this be from earlier, So halfway licensed were blocks

required. think gets successful once then we'll what nature doing clinical huge more the to make does is that with about a be So that and setup we trials it sales year also in trial we'd into so would effort commercialization we we it target be around the -- would are if market next ultimately, again, and choose the this looking provide approved go would clinical so we emergency don't ourselves. and of guidance exciting is and as And that department should force require to exact

Operator

Zacks David from Investment today next coming Our is from question Bautz Research.

David Bautz

Do When the OPNTXXX. or largest you thinking about market side first being side? on the see more stockpile opportunity retail the for the on opportunity responder/government

Roger Crystal

Yes.

sense moment a in and And at look we and overdose. opportunity in at takes aware think the an ways, we the I think broader I'm for also opioid is product by that that the well-suited many this place who.

necessarily things special So actually do in many ways, well we we they've system don't look there's And is a their it's out pushed where role, [indiscernible]. where where already there at meaning, suited. --

discussions something full products. approved. setting sales both nature So And you consistent that's the should other with instance continue to pharma first contracting we with with of we more in that commercialization force that's have know efforts would get these that's something requiring than be because that rather in scale

think we further as currently progress. further updates idea make we some how but So give of it about provide does we'll

David Bautz

your makes generic the structure that market, it quickly, if affect does at all? royalty onto a And NARCAN

Roger Crystal

market, like specific, it. affect our So generic the to there's no, royalty. -- be just getting There's specific it to onto trigger no more no doesn't

by a generic onto very market our the it Just of has the is nature getting royalty. that

you royalties that? net to from NARCAN. essentially want David, come sales is anything there to add Our of

David O'Toole

it agreement the getting is the that impact is doesn't and whatsoever share generic I a in market have the royalty. in generic market only a gets for there But the it's itself market say our a The then in royalty. takes thing on potential reduction a on the would and significant if any

David Bautz

the it get up would that you would of be But making market, developed. being you you that. sales multidose set If from on follow-up new is indicated ended potentially the payments? NARCAN to that lastly, then a also eligible royalties device And for milestone

David O'Toole

that. get wouldn't we No,

Operator

gentlemen, and comments. or our question-and-answer Crystal floor turn session. I'd back to to closing Ladies reached over end further we've Dr. like the any for of

Roger Crystal

impact of we our we have are summarize, each and are market advance We the large operator. continuing prospects beyond. believe the excited the and you, the in potential clinic that and lives developing about targeting. drugs to forward to we to Thank thousands look To the opportunities very we're pipeline of

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

Operator

That does you. Thank today's conclude teleconference.

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

Opiant Pharmaceuticals (OPNT) 12 May 192019 Q1 Earnings call transcript