OPNT - Earnings call transcript Q1 2021 | Opiant Pharmaceuticals, Inc.

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

Operator

Greetings. Welcome to the Opiant Pharmaceuticals’ First Quarter 2021 Financial Results 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] Please note, this conference is being recorded. the to turn Atkins. host, now will conference your over Ben I

may You begin.

Ben Atkins

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

Roger. to I over call that, would turn the with Now, like to

Roger Crystal

provide and very financial warm to hand I to Chief then overview brief Ben, off update corporate will on begin and Financial highlights. all. David Officer to by an our the offering a O'Toole Thanks, you a welcome

and in drug so treatment the transform of patients Our and drive of growth doing, the future to addictions more therapeutic mission help overdose and is company. our

overdose. dying an for higher Nalmefene fentanyl. the deaths Our priority XX% are United fueled OPNTXXX illicit day opioids, Nasal from over to before. ever mainly due synthetic XXX these About people of than at are opiod overdose states, in every

New to and potential discuss will growing has suited to save needed epidemic therapeutic OPNTXXX. I ideas believe overdose. to opioid on Nalmefene lives, particularly synthetic we differentiates more and be opiod a what treat well the

First, support the the report on our I In would progress. of to OPNTXXX in are XXXX, is status development making update I'm robust on data OPNTXXX. pleased focus on important expanding like and provide program. we to an of execution that,

complementary We are close study. enrolled our completing months. top-line forward and this from few have to pharmacokinetic study in look to reporting next the fully We data

clinical effectiveness our subjects we the addition, head-to-head the have in of In Naloxone. in dosed respiratory first Nasal study, the we using the Nalmefene FDA volunteers. Remifentanil OPNTXXX healthy approves this with modeled synthetic depression opioids, study, Nasal comparing pharmacodynamic In

regulatory fourth We activities on-track pathway an XXXX using by Other for filing development advancements progress, our reports, in XXX(b)(X) from also the or are traunch awarded data the quarter of approximately NDA grants from March, in reflecting Further the support $X.X $X.X the of top-line expect first we year-end third million early quarter. and NIDA final total the OPNTXXX. were million drug of

and to would is NARCAN how lifesaving ago, Jerome NARCAN Surgeon bystander the Spray, encouraged a Nasal We could OPNTXXX Adams in provide U.S. As development we from saw also General, further overdose. I opportunity context by OPNTXXX. potentially this point any an to BARDA. arrived administer evolving XXXX, victim. supported we to About opioid save With opioid like that, in eight lives crisis to years a people develops our medicine the some help In with reminder, so them. develop the development of of on at

synthetic finding I depending opioids that administer the NARCAN overdoses need more were commonly lock would and to opioid When zone, we you than an to Spray, particularly synthetic in carry linked the likely and someone opioids, we heroin. fentanyl. unconscious, class some prescription face Nasal of entirely new developed communities illicitly compared Today, XX,XXX XX-months made NARCAN think linked different out CTR. In of differ released how data in that particular firmly is ended XXXX, deaths during is the entrenched an to and has September America's supply. Fentanyl the fentanyl figure were illicit then drug CDC opioids XXXX. by synthetic in XX,XXX to illicit to approximately from opioids. opioids XX% up That illustration fentanyl become and a

they the intense brain. for use including greater and by brain cross taken to more tissues This Fentanyl more is lipophilic. example, This combination and high. easily quickly fatty in the the are fast First, of it quantity. into is a enables more

However surrounding the too Depending suppress a can to few seconds much fentanyl entering the to on circumstances the this overdose also brain breathing overdose. will take rapidly minutes. leading

fentanyl hours. or is second differentiation XX long levels both overdose certain synthetic fentanyl. more plasma challenging into opioids is possible XX It The plasma Naloxone. Naloxone the half is fentanyl the back minutes slowly, levels effects for victim an sink known as Naloxone of The a to half potency opioids sustained life has of [indiscernible]. between that can of and of life synthetic last like the about seven

and to on multiple are necessary be CDC, to Naloxone medical a three previous As the its discussed is the Nasal December, data important by calls, PK OPNTXXX on and the Health an scientific synthetic characteristics Public It from our we pilot explore doses prove Based revive literature collectively could confirm opioids doses Advisory and overdose reports treat suited recurrence. avoid study likely pharmacological Naloxone. to could from have in needed uniquely the in to a the victim ways. in Ian insight, further alternative opioid molecules compelling as Nalmefene to driven it has a Esteems

than which receptors the affinity First, makes opioid OPNTXXX of potent. Naloxone Nalmefene has more a higher

before, re-marketization. for potential a I reduces which has the Second, Nalmefene longer half as explained life,

OPNTXXX due window shorter Intervale formulated opioid, by absorption incorporating to have nasal life to Sentinel. to This look rest OPNTXXX PD and save formulation for a data using the synthetic we potential simple rapid a months a to With including forward into our our pipeline. believe from is We a I and will of overdoses spray device. opioid availability and in Third, PK that, the move the the ahead. treat significant confirmatory of to now important synthetic

for We Advancing the OPNTXXX, Sciences cannabinoid drinabant continue studies to to National IND-enabling overdose. for work Center progress human Translational formulate acute with

expect We to this complete XXXX. in work

Seasoned The pandemic use to biotech valuable the the drug are of Her Development on-track call Regarding pleased extensive pipelines, will David be starts value to of because of March, we OPNTXXX Dr. the disorder, to potential in addictions and With I several II that, Opiant, study the Phase companies Clinical experience, medicines, we remained of starts David. is will the mission financials. proceed. incredibly In the of development overdose. serve new and to to the treatment Europe. a discuss to our Lorianne optimal over Executive, Directors. Board success Naloxone as assessing due and alcohol advance the our were to the makes now Nasal debts to develop Masuoka COVID-XX we welcome time turn

David O'Toole

Roger. you, Thank

OPNTXXX. $X.X during for is XXXX, $X.X made XX, and XXXX, XXXX. same increase compared which ended the this million This the first period includes in two illustrates the revenue, of three contract in in million of approximately period we quarter $X.X months significant corresponding to revenue, approximately over recorded efforts For in grant March million the an million and approximately development

for We sale approximately of XXXX. or the to with also recorded $X.X approximately of agreement Solutions of compared NARCAN, from revenue in $X.X same million EBS our million license the Emergent Bio period

$XX.X due reported approximately by EBS. development First $X.X External expenses expense candidate for and overdose. first increased XXXX primarily OPNTXXX quarter XXXX. to $X.X our Research quarter million, million million, of the were Nalmefene development sales NARCAN lead Nasal for activity increased were compared $X.X on to as product million, opioid in by approximately as approximately

this We year. expenses XXX,XXX versus of a the increase and same in approximately also related personnel last an had quarter for quarter

of zero marketing to XXX,XXX marketing ended for expense XXXX. for general quarter This loss million XX, million, X.X XX, March and debt. related This our March interest and the approximately the year, compared last the control XXXX, XXXX, quarter efforts XXXX, administrative approximately loss same period loss approximately comparable the compared Net XX, million million XXXX. is to to approximately expenses for XXXX, three in expense the related for pre of share one XXXX. clinical flat million, ended basic Interest essentially was OPNTXXX. versus X.X the period Keeping G&A was Royalty cost a million convertible and months expense or basic March three important was the commercial For and This expenses XXXX. for were compares X.X period comparable period the months our demonstrate do were to three net months sales approximately for ended X.X March of of or for $X.XX a quarter our cost months same the Sales to first diluted for of million diluted for the X.X expenses loss OPNTXXX. of and compares share. of a for $X.X $X.XX comparable efforts we three XX, compared to constant continued XXXX. this to in as ended work as approximately

in a million. million guidance cash current approximately the approximately our lead BARDA March of mid-range X.X pre-commercial and Last reaffirmed to of activities equivalents NIDA support of our Spray, cash, efforts drug studies XXXX As remain XX.X of not [EPS] financial of strong contract of grant and million, to (Ph) balance XXX had based recently the position Nasal marketable OPNTXXX. the sales does in by The XXXX, the week, full-year on for XX, include million. or and ongoing development full NARCAN the impact support we program securities. of Overall, Opiant X.X for clinical

the We full-year revenue expect of royalty from to NARCAN approximately Nasal XX.X continue of sale Spray million. XXXX

to and cash, the me We trances of up Thank to of end convertible XX open marketable let call equivalents you. that, debt And with securities existing million, facility. include cash approximately of also which any not receipt questions. with XXXX expect Operator. additional continue for will the

Operator

Thank you.

question-and-answer from Cantor comes now Our Folkes be Fitzgerald. instructions] will first [Operator question a session. Brandon ahead. conducting We Please go with

Brandon Folkes

quick Three questions with trial OPNTXXX just or enrollment? quarter. color provide during there. I ones my - congratulations any progress for hopefully, for COVID taking any for thanks the the guess, color you Hi, Either, losses Can me. on living and

recent the your could your view be And it lastly, an in the about during the drug. given obviously on does approval, change increase quarantine, say thoughts and that any your market let's how you. products Secondly, [indiscernible]? of of problems, to then dynamics sigma terms differentiation of Thank

Roger Crystal

the Thank you, for question. Thanks Brandon.

conducted that recall pause couple Overall Antonio, gone volunteers. In the study the far. terms San healthy itself remains in of think facility where the is and trial We has enrollment, severe power weather of this a enrollment because well issues, overall the result like OPNTXXX so weeks pharmacokinetic a which supplies. in of momentary a most Texas, in being you the - had

a to small So to are believe we agency product that said, the I we are we that might NARCAN What the sufficiently - we NARCAN data going competitive a Absolutely, Nasal but the the spaces your we OPNTXXX facilitate headline question from is differentiation with agents this. be the we growing, as in love is well on can innovation as and disorder. doing is a differentiated more this The planned. a this nevertheless place a write There think provide through support get and we issues place Nasal needed. as believe overall more this, of on caused market to to enrollments is be pause, hope all is but reversal don't along, there the that to successful. [indiscernible] with that, see welcome reiterates is around what it Spray, is, which overdose, The program we'd result. we Nalmefene opioid we

to believe There we is sufficiently this are the keen It COVID, to don't on also of any alcohol in from Let's used complex off but forget which prior disease. FDA actual study. exceeded patient’s kick why disorder approved drugs are needs country in opioid market, overdose that, this II this comprehensive to address a even them Phase deaths. not space, all is we deaths

that is that However, to the the efficient to the we way complete it not off. study a will in want most allow questions. Thanks do so reason for to kick so in us manner, it the yet

Brandon Folkes

very Great. much. Thank you

Operator

Next Byrnes go question with Securities. comes from Northland Please ahead. Carl

Carl Byrnes

follow-up and what you NDA a do I Thanks. progress. And targeted IND filing well. OPNTXXX, first-in-humans drinabant, be your Thanks and the made congratulations of would have on respect after have to With date as a valid? was expectation

Roger Crystal

actual filing the general, clinical successful the was that data details completed of will to we a initiate that IND first-in-humans the We more once upon months, in reformulation. it timing on have in the study. filing provide few in months But targeted this and few reformulation,

clinical So aiming in proof-of-concept study for a XXXX humans.

Carl Byrnes

That the to memory And then X.X probably which David. Great. submission on serves How was fund, NDA question this available is largely award, a related submission NDA remains if much helpful. Thanks. is earmarked million BARDA and costs. for

David O’Toole

of to an next, have you and eight-months that we the Carl, still And million would available. majority would you the X.X question thanks And don't say, thank granted exact will number, I for is say additional attending. nine-months. but just all in used December. the the I if in of for be I were almost it recall,

said, through the of for filing. of you back-end As was expenses that reimbursement NDA most loaded

Carl Byrnes

Great. you. Thank

Operator

Our Small ahead. instructions] Bautz David with Research. [Operator Please question Cap comes from next Zacks go

David Bautz

Hey, everybody. good afternoon,

got the PD questions few I So, study. a on

active First the powered show decided study, one, then Nalmefene that and how so a you dose so primary then that Second, testing and and is a Nasal significant is doses on? you will study long Nalmefene in milligram three to versus how the the statistically are also, to dose difference be Naloxone? between commercialized Nasal going that of is using be outcome? was Naloxone lastly, And Nalmefene

Roger Crystal

that be And power we outcomes, in on the was we very selection progress, is going - the will the said dose support of pilot consultation their initial well. study, using in from statistically was the work around, with Nalmefene of half the Nasal study. to a we alongside preliminary an your on study dose with that CRA, So, in that the as the FDA citing interaction the combination directional are dose question arose you the If life? question. significant evaluating decisions as also the is PK and the this did into study that long that Was CRA this

David Bautz

Yes.

Roger Crystal

part and two in a also difference of whether outcomes. is That design the trying there those exactly determine is study

David Bautz

alcohol are want underway particular and looking up are before anything for you you or there you use or Okay, Is disorder to in you COVID of the see study? you vaccination all I study that for you for to I'm get the want what mean, get that, is study looking it are to and assuming and and because delayed before when want going? rates looking what for that

Roger Crystal

in study look what one without here as be is rates confident just no we is soon And their is impact see in that a or COVID be aspect, the not they the are serious are There Europe is consideration view I specific they lower most main locations that we where the COVID-XX completion suites driver. than a so alongside key things of are Eastern the rates, figures just won't overall, might in potential, is when add, exactly to where overall vaccination the majority Europe, as of return at rates Europe, U.S. vaccination matters factor. should the like say. But of not can getting far to

David Bautz

Okay. taking Well the I Alright, great. you appreciate questions.

Operator

instructions] for I closing would Okay, the to remarks. to [Operator over like Crystal Roger floor turn

Roger Crystal

exciting start and Opiant. look you in of us Thank at remainder to We had today an forward busy year. Thank you, for operator. for we and extremely your interest joining the XXXX an

you. stay and the on milestones. please we of healthy. which day rest investors series Enjoy During important of exculpate a your clinical Thank and regulatory

Operator

This concludes teleconference. today's

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

Opiant Pharmaceuticals (OPNT) 11 May 212021 Q1 Earnings call transcript