OPNT - Earnings call transcript Q1 2020 | Opiant Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Opiant Pharmaceuticals First Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder this conference is being recorded.

I will now like to turn the conference over to your host, Mr. Ben Atkins, Vice President of Communication and Investor Relations of Opiant Pharmaceuticals Please go ahead.

Ben Atkins

Thank you, operator, and thank you all for joining us this afternoon. safe healthy is time. this everyone hope and during remaining unprecedented I me Chief are today’s Officer, With call Executive on Dr. Roger David Crystal; O’Toole. Officer, and Chief Financial and XX, XXXX. issued announcing for This press first providing results the March Opiant update a ended afternoon, quarter business a financial release

safe certain Reform the Actual Act. call, listeners during the provision note We covered due that call Opiant is Private materially and from implied differ to or forward-looking this be could statements. discussed caution results information Please of making management the with the on associated today stated under risks harbor Litigation forward-looking company’s uncertainties these will Securities that business. those by statements

only including statements live cautionary to filings. on XXXX. by the report are the year or that of Opiant’s date Form statement date is information XX-K circumstances or forward-looking for news after update call this revise December conference undertakes accurate qualified Opiant to subsequent our any conference forward-looking the of SEC and in XX, reflect time-sensitive call. XXXX this the annual statements in XX, These events contains filings also as no May of broadcast, obligation ended This contained releases and

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

Roger Crystal

you, Thank Ben. afternoon. Good

start has me the created first situation, by pandemic Let acknowledging for COVID-XX people. global challenging the so many

workers responders healthcare and deep day. appreciation our and been our and and extend go the hearts impacted, Our to many to everyone first who’s out communities thanks every serving each

given how help and addiction particularly Coronavirus substance risk Use The heightened and of those to focus society’s abuse. way, suffering opioid lockdown COVID-XX is we has threatened pandemic Substance our overdose. necessarily the vulnerable of with Disorders, how While on at people COVID-XX wave new

overdose. their deal people opioid we and friends an employment, also family own So COVID-XX and increase impact unfortunately their in observing with are of health on many the

capita in a in In reported which XXXX led fact, nation Ohio, per that as basis a compared in XX% been County jump has last the overdoses overdoses it year. has seen on Montgomery to

Florida, reporting during and a across U.S., as This continues another health counties in the also serves Texas, we authorities significant in on York overdoses addition, a of reminder the put strain are epidemic New even Pennsylvania opioid stark emergency. In to the now COVID-XX as face crisis. rises

said address deaths As nalmefene opioids. we in is nasal believe powerful I’ll challenge. an accounts is OPNTXXX, treat other is have provide more times positioned our and well opioid which to than suited Opiant particularly moment. any before, of and a well to than that overdoses involving heroin overdose you more this with fentanyl, XX for lead-program those We update

to the environment. I’d healthcare of by we operate our an However, strength highlighting in like evolving as company begin

strong key David are that a on our will review in objective greater just say in While, position detail, support emerging we the business to me our let financials financial pipeline.

As debt. the of $XX.X our the quarter, balance in and we on first cash million and no sheet end equivalent had of cash

NARCAN also royalty sales We benefits nasal of spray. from from have stream a

$XXX sales its million recently Importantly, NARCAN our XXXX the $XXX licensee of range million. guidance to BioSolutions in on reiterated Emergent of

compelling unique overdose. these have a advancing support Authority, NCATS; Sciences, to Research Institute Advancing including and pipeline the addiction areas and attributes multiple collaboration we Drug company broad Advanced Moreover, on and Development and agencies of BARDA continue therapy us in Biomedical collectively NIDA; for Translational National multiple the and government financial investing our Center allows the the Abuse, in of National across

the to pleased reversal. to confirm With lifted that, linical on let’s I’m our pipeline. that hold has its overdose turn OPNTXXX for FDA now opioid

up on intra-nasal characteristics lifted our the hold protocol, as can our hold slightly our device. its placed which response, with for forward study. it reviewed in FDA we of this the reported previously amend reviewing development now means As the January, delivery based on system FDA After agreement the move we to OPNTXXX

my work agreed for want believe with helping volunteers study to thank conduct healthy diligent the to OPNTXXX. enhance FDA our us of will Opiant also colleagues the compile Separately, opportunity clinical a take to detailed this response. pharmacodynamic have profile the I that we in of and we the submit

development year. launch As travel Based filing we’ve occur in in the later is progressed next regulatory on early NDA on now collective having to also commercial restrictions likely for OPNTXXX, program, still engineers these towards COVID-XX prolonged our our we Europe. filing to into equipment impact for timeline modifications are factor of our to XXXX aiming our our related

we Use Alcohol for OPNTXXX the for communicated, study. X the to initiation Disorder, previously posted as respect have With Phase of recruitment

follows decision across from the declaration study European to Kingdom the emergency related and COVID-XX be our where Our conducted. United the Union state is of

We as will the closely situation and to allow. commence conditions monitor continue recruitment

this We time further will have line. around begin, we recall previously complete this aimed on clarity update that we an recruitment we enrollment Once year. will provide had when can

study number XXX this placebo-controlled As features in Europe comparison response. study reminder, reduce patients. countries aiming be and will enrollment of parallel in double-blind, a randomized, conducted sequential with is a trial study design, a placebo to a The targeting

in to and clinical for study. on overdose. studies. filing of NCATS as agreement our formulate providing OPNTXXX acute OPNTXXX cannabinoid reformulate Moving its drinabant, development for to an and the of We started IND collaboration and cooperative research support our development our treatment with injection is for OPNTXXX, signed resources to a NCATS human planned

Turning to employees. our

We work environment. have transitioned a to remote

operations while as disruptions and connected we four ability extraordinarily performing programs travel adjusting to will is especially quickly adapt work-from-home donated most our to Meanwhile, support on quickly This suppliers. and to working for those to committed many well, to vulnerable to helping our restrictions addiction. effectively face of funds have staying team partners months practices come. and arrangement, important with we Our business likely remain will

essential Opiant Association Harm on will as however, experience COVID-XX, me to innovation Recovery of purpose and for many community the The of the Coalition addiction underscores overdose. Education, conditions reflect the Higher will also for Fire our actions and best in and our of Indeed, to need support overdose Foundation, Addiction. of past can. significant the development medicines Fighters spirit and new move devastating the Opiant’s U.K.’s Eventually, organizations this unfortunately for International years continued the to remain included and addiction Reduction Association and Action investment These we come. we

With that, I will now ask detail. David? discuss David to financials more in our

David O’Toole

financial with Roger. and through no to on momentum we XXXX QX and beginning Prior strong you, that Thank that position my quarter our first debt, comments continued to entered I cash highlight XXXX. want a performance,

we unique of Federal, In business no We had Spray revenue sales and from COVID-XX-related United time at U.S. Kingdom any of or form this stream a time. any of our have and this. State addition, in meaningful layoffs we is Aid, to strength need model like believe no intention Nasal a implementing seek of NARCAN have

the March a to I the then will the our XX, with period the XXXX, corresponding financial wrap brand of revenue up compared sense million outlook. in $X.X agreement BARDA. from revenue $X.X performance was contract highlighting from on our corresponding and compared of the us We licensing million of now year-over-year royalty by $X.X from current sales XXXX an and various as approximately million review the for NIDA in million The to XX% million between net ended quarter performance, and revenue driven reported million recognized in three a in first our represented XXXX. The $XX.X $X.X with factors Revenue quarter period you of in year of included in commentary increase provide included and the in of increase by of million EBS. of revenue first months NARCAN XXXX, approximately $X.X as to the EBS XXXX. the quarter in $X.X

million third-party development $X.X the $X.X and of compared quarter expenses was especially XX, XXXX. first $X.X G&A XX, for in in million were The $XXX,XXX reduction trial ended were ended million respectively. decrease March clinical and to XX, attributable million three attributable expenses three primarily third-party expense. cost months March consulting months March to $X.X XXXX decrease R&D the expenses. for a $X.X the managing of diligently, million XXXX, The XXXX was to and

approximately expense during compared in first months marketing to the million and Sales XXXX. $X.X were none three

potential platform this commercial potentially as of expenses The and allow support commercialize our supply includes As to to in commercial infrastructure regulatory development multiple areas key we a approval, chain us sales order pipeline future to that the we increase OPNTXXX commercial prelaunch in development of would marketing advance products. as sales OPNTXXX invest and personnel, well towards continue will we planning increasing as activities, anticipate distribution. that marketing and

this build will allow us infrastructure, ideal of to maximize we potential commercial we continuing As full evaluate go-to-market the to that the strategy OPNTXXX. are

period and of million net in $X.XX months ended basic March a three had million XXXX the of loss diluted also In a XXXX. equivalents March the XXXX, and share. we share. had comparable million per $X.X At for million cash and $XX.X of loss XX, compared loss or basic cash diluted loss XX, to per at was Net XXXX, December or $XX.X a $X.XX of $X.X XX, we

cash BARDA million $X.X the reminder, million or a of balance include not NIDA current grant does As majority $X.X the the contract. the

sales Looking at of to the receive remainder we of expect $XXX $XXX $XX.X noted, guidance million. EBS $XXX to At as royalties million its NARCAN approximately million. million, of range reiterated mid-range Roger would the of XXXX the year,

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

Operator

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

Brandon Folkes

does extent changes for And device a you just were wants engineer And is Study? terms European as design? reset just think PK elaborate equipment thanks Maybe Or in understanding, we and then just Just first, can question being to elaborate then on is well-understood the nalmefene there can, Is all should on this manufacturing secondly, what just if lastly, that taking time agreed currently? you in maybe progress. up, line? on this the congratulations to in of the well? molecule? see? And my Thank on can additional study, the Hi, you patients you. additional my done given delays caught the there on the so, elaborate work a you the quite pharmacodynamic FDA at the can of stability this you

Roger Crystal

questions, your for Thanks Brandon.

has design. proposition a to pharmacodynamic not essentially will closing we on study, generate this volunteers at have agreed product. this because more and the study short want just profile point, that value it’s we for sure healthy with in So product a say, been think compelling that exact we the them that’s need a I meaningful study the make is to something

discussion yes, we’re more necessarily, are with – something – present for think that ultimately less allow patients. compelling them most it So for what would around requiring to we us

needed in the Essentially to – is really. stability, in scale of filling they to again, you of were just engineers the I we’d travel, terms the partner terms in but not bound here, of our that order establish chain allowed need it of confidentiality restrictions journeys you’re say asking headline to to in mentioned weren’t manner we’re the commitment In and manufacturing, hoped. impacting because commercial the make by that by supply

But the normal we as equipment in just and anticipate there’s short-duration in like PK amendment, was issue. And study significant the there increase volunteers and and design, of some they be inherent study restrictions. course a to or PK of of number the terms longer It that wasn’t Study that are, the or the because that. result. of healthy with in change of the study volunteers regard no minor very travel a issue anything duration with took in still was the the It no business

Brandon Folkes

appreciate I Great. is just match-up. one Thanks This easy. for follow-up. it. Maybe not

to back interactions circling FDA. with the Just your

of population expect patient after, the you’re an would something this is you ADCOM? sort going the take given Just FDA

Roger Crystal

possible. It’s quite Yes.

Brandon Folkes

Okay. Thank you.

Operator

you. Thank

Boris comes Cowen Peaker question from go next ahead. and Company. from Your Please

Boris Peaker

just want of is kind those on competitive products are There compares I nalmefene. to in how your get sense curious, just line? the And is the development. question time potential first My products? approval injectable time a that in what several, line landscape approval just obviously, Right. I’m of to

Roger Crystal

Yes.

more those disorder. of been I is I’m far use opioid aware aware, As of injectables. for products Bear that of one think has as a mind of for opioid overdose, depot on the nalmefene of injection disclosed not I’m nothing in it’s exact timing

overdose. a But the not wouldn’t market landscape frame competitive for be the as impression year. as on yes of part see time I’m it that form disclosed it’s That an to say far So aware. the been this we’d for under opioid overdose. the certainly hasn’t other And is injection,

Boris Peaker

be get you then your you. – or just And Got an When is competitive, Spray, general Nasal a going be more maybe to what question. the XXX for approval pitch dynamic now to compete there nalmefene the others? message going buyers NARCAN? commercial maybe nalmefene subgroups think than of to right are NARCAN with are hanging lower of that for any And you kind fruit

Roger Crystal

on the – say from be with that’s for. we it the show. I I believe, in again, we life, position, has initial is [indiscernible], data product have, better ultimately, And likelihood our potential when what greater a think data what mind, that to that the better, of Well, meaning depends certainly, aiming this saving we’re a

In terms – will a market believe very of many to continuing product absolutely we see remain this with will do We loyal And the remain well. NARCAN people the overall, that and successful product. as grow.

So absolutely for products. two in place see of competition, very we yes, terms overlap, there’s but good in market there’s the that

this livelihood So we hope that persuaded of with think we with a people be – to data though, saving life. will by greater the a generate, being product

product just think few certainly naloxone-based relevance I say, there’s say there of are development. NARCAN, I’d should other the not I market where but or less because NARCAN, a in than segment the

– think fentanyl we chemical – the used around exclusive where has does why a can or it as have perform being a potential nalmefene So attack. is area of

So having of this to XXXX, with the fentanyl fentanyl in BARDA, – in chemical used of nearly people. Russia continuing soil XXX been for is a amounts large fees U.S. attack an in in where on and be they area see past over killing in concern

And stockpiling potential program in manner hotspots it development on their is chemical position OPNTXXX our interest to because a U.S. the the attack in of of in vulnerable a supporting

and naloxone have be So that don’t they important. that’s is they quite where an believe area could nalmefene said sufficient that

Boris Peaker

in life, we’ve to shelf they’re terms looking the labeling. EBS life lastly, Got shelf of heard NARCAN it. that And Got say it. expand

Just curious shelf would come of OP and out where XXX your thoughts the on – importance your life?

Roger Crystal

naloxone life. have – a The the to our shelf [indiscernible] used two-year And standard emergency gets and look shelf other NARCAN life, we is sector quite frequently. would services understanding in that for certainly

as They it reordered, used appear get we’re doesn’t So stockpiling significant that and as aware, such. frequently. there’s quite

two-year sufficient. that a So life shelf absolutely should be we think

Boris Peaker

Great. Thank my you very question. much for taking

Operator

you. Thank

Your from next Carl Byrnes Northland Securities. comes go question from ahead. Please

Carl Byrnes

congratulations question you programs if Well Thanks. And have to – me additional then have tell progress. states your expectations mandatory adopting a on potentially you your that, co-prescribing are in follow-up I any first, for XXXX? Can what thanks.

Roger Crystal

that’s whether having mandatory of we to docket how states grow it, now that there’s more certainly five of general co-prescribing, for on see a states take see it as the states approval, we’ll co-prescribing So reminder in they terms so potential mandatory form have adopt and as currently are that some nine it co-prescribing in review and will for year now and all but the these progresses, many on. of XXXX,

One that it York of is that of docket this part those for year. one the – has states New on states of

Carl Byrnes

you. patent update Great, visibility timeline any thanks. And Thank of do or in you the of any terms the litigation, really? have

Roger Crystal

No, I mean, thanks. ourselves ask Yes, question. we same

that might But We’re expecting the to when day. any definite ruling as be. there’s commitment no

Carl Byrnes

Fair enough. Thanks again.

Operator

Thank you.

Please comes next from Your ahead. question Zacks David Research. Investment from Belt go

David Belt

overdoses those there’s been been mentioned had you Roger, have information if curious of an guys. is available? recently. to what that you increase just that fentanyl know afternoon percentage good I’m Hey, due in opioid

Roger Crystal

data were for fentanyl overdose most now what XX,XXX overall related related. set The least I to XXXX approximately XX% didn’t there have complete the were opioid COVID. experiencing country with like there, data at set we’re for complete and

year we’ll and a the multiple be next well. increases at example, and of base getting reports that course will as get just compiled obviously We’re over updates county level of for year more the

David Belt

Okay.

underway, centers? you’re you’ll at center will those OPNTXXX that or get able is be working be the when place, this taking Now multiple to studies where single

Roger Crystal

certainly, hospital operate. well be a been likely like more services company that. we’re singles-center or for They’re site a attached impacted has to COVID be further the beside the or emergency might using volunteers, we’re working not site healthy in That as be Yes. to with be the large anything so to the the – And fully that going operational. study PK there’ll

David Belt

in sales the expect in marketing should that category the similar coming and spend that and you Okay. had amount the expenses quarter, now, mentioned quarters? first a David in we

David O’Toole

it’s of the Well, good far sort precedent as a I number. think as start

number make wouldn’t and We the or that few marketing. progress that and sales whether see we down, starting going on least next how yes, and answer your but question, over just X.X to how we at say I decision couple number from next million project just going a of for how not XXX, we’re would depends that’s it We’re commercialize quarters, to to on good the quarters.

David Belt

Okay, Thanks taking for questions. my great.

David O’Toole

you. Thank

Operator

I closing our session have Roger like Crystal of we gentlemen, and and to Ladies the end turn question-and-answer for reached call the to remarks. back would Dr.

Roger Crystal

that creation interest pursuing. stay on for rest in Opiant. please significant diseases Thank Operator. keeping your us the We believe we our compelling need the your to healthy. today in and progress forward value given remain you, the you Enjoy our opportunities you day ahead. Thank look We joining the months updated for in may for are of and

Operator

This concludes today’s conference.

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

Opiant Pharmaceuticals (OPNT) 12 May 202020 Q1 Earnings call transcript