OPNT - Earnings call transcript Q3 2021 | Opiant Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen and welcome to the Opiant Pharmaceuticals Third Quarter 2021 Financial Results and Business Update 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] I would now like to turn the call over to your host Ben Atkins, Vice President, Communications and Investor Relations of Opiant Pharmaceuticals. Please go ahead.

Ben Atkins

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

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

Roger Crystal

Ben, Thanks, warm all. you to welcome a and very

Given most development to of our today cover look will we as progress, submission OPNTXXX, focus next year. NDA on my remarks our ahead

activities a on commercial as Joining will our the the launch who approach our elaborate who Officer, activities. we financial Chief our anticipate on our remark of year. cash we as Officer OPNTXXX. business, the Also Financial development our from position on and reflect These commercial Matt today's O'Toole, me call is end Chief David will performance transformation of stage strong company readiness a Ruth, Commercial is today to

of unmet fill communication communities’ granted escalating the for treat designation overdose respond of from a FDA potential development This advance by fentanyl. communities is the week, with Fast therapies an progress. a continues States OPNTXXX and driven designation. were of OPNTXXX the as to decline conditions Opioid grapple seek and opioids makes contributor help medical expedite Application. linked opioid to Track XX designed deaths. crisis. rolling XX death as XX comes we lifespan. This designation we better across and opioid lives submission underscores the for the good the potential to to worsening to that Fast and years and old, March cause Drug XX% between Turning opioid of these regulators months an ended claimed XXXX. Track development the overdose may for serious such New in average This which announced of with to in and frequent can facilitate Synthetic this over individuals number FDA a synthetic review the in in United addition the Fast our need. track believe Last one represent an Programs treatment, process overdoses estimated to major FDA the XX,XXX us with to quarter, benefit potential significant opioids to the a early epidemic make

revived deaths more after are long-term the brain during Overdose experience far are mental realize brain X.X oxygen between deprived to in each how victims the Era. of that highlights X.X naloxone. responsible non-fatal. overdose by our oxygen great In for Pharmacology on action of longer the breathing review synthetic overdose. Scientific of The Dr. titled disabilities Therapeutics, long potent depending of Beyond the and Chief majority and is non-fatal have are can The physical Most even Synthetic the people duration opioid’s a even for opioid Treatment of induced of and that Opioid each paper thousands this, October, if published hundreds Skolnick, administration Peer-Reviewed person's opioids overdoses Officer, overdose, as continue deprive depress Phil heroin. such in They quickly a of of Journal fatality & an year. a don't opioid there can from the and

such acting at nalmefene. we synthetic developing prevalence meet of widening important It antagonists. as fentanyl, Nalmefene potency this naloxone stronger an leadership in more and intramuscular across a a antagonist absorption the affinity longer in opioid and greater that using key NIH than higher are the Mu-opioid the long To several longer are OPNTXXX has reversal. confirmatory and metrics, all challenge, data that opioid The different exhibiting and has that Given from opioids opioid overdose also potentially We pharmacokinetic data being development a naloxone receptor called of surpassed ways. supports from for in OPNTXXX the study advance fivefold major it this recent nalmefene makes induction potent brain. the demonstrated fast duration. believe at OPNTXXX half-life

to We one comparing a are of on study this two track the quarter nostril also nalmefene in of sequential dose each complete effects to doses.

comparing support endpoint in synthetic top produced by further demonstrate New five naloxone, FDAs the novel in minutes. study healthy depression nalmefene non To expect remifentanil We data January. the line respiratory OPNTXXX request, the The reversing study naloxone change nasal the of on a with and our by powered minutes is in pharmacodynamic Drug measuring primary we design between volunteers. Application, inferiority at to opioid the ventilation

address points. to Additional studies. that answered previously study of novel clinical is a seeks not secondary a This endpoints time cover important range other questions by different clinical

and we anticipated the in to having share I’m dosing anticipate end. completed Part expect top that recruitment we a X of and is line in would sequential the two comparison. determines of We We X anticipate including remifentanil a next this pleased years to line X year. by had the Part parts. to eligible against update data The of year fourth comparison of to dose allow that year. Part first the to consists be approved. originally three complete result, and ultimately As of study conditions is receive head-to-head having meaningful if X a Part top for exclusivity study optimal market quarter data have nasal quarter we Naloxone. safe OPNTXXX in

PD decision study was the by a NDA, that first made our study the Part finalizing dose the IRP. clinical However, the will was XXXX. Completion the to during of remifentanil. approved the we of set modification of This subsequently X FDA of we reviewed in by modify robust the half form last of data anticipate of the step which the completing to basis represents and

the treatment pipeline, startup we are the naltrexone Turning of alcohol Phase to nasal our rest use for our working X evaluating for activities OPNTXXX study of disorder. on

a patient anticipates use improve effective Health to a year. not nasal in alcohol. this controlled XXX in drinking believe reduces OPNTXXX did risk we OPNTXXX in we quarter that blind with But as Phase our first patients change to potential be The determine placebo will by drinking had drinking due recall alcohol whether World participants a dosing study treatment the so we Organization in spray PK when double needed this anticipated society, pleased In study, expect showed study will to I'm to recruitment to XXXX or OPNTXXX follow craving soon as become randomized levels. we about treatment proven landscape. planned thereafter. With This is initiate disorder to recruit our heavy in subjects measured a take say trial is COVID. X prevalent the could You a dramatically to as an

drinabant, Turning to OPNTXXX, cannabinoid the acute for overdose. treatment of

initiate NCATS. a formulation OPNTXXX. we pipeline And year. Overall, trials to pleased of particularly really development of with our and our with advance in potential collaboration to progress, perennial drinabant opportunity see the next clinical we’re continue We

Pharma. I insight the we company. in Adapt today as As to Matt Ruth, Chief into Matt work Nasal I share team to Commercial mentioned Matt the Officer. ask a my at look us our join he's at July. joined Matt? NARCAN remarks, Spray joined Opiant, transitioning start led to to we're to the of the leading, he today of by commercial ahead some launch Prior

Matt Ruth

am with Thank you, the team. of to extremely Opiant speak opportunity today Roger. all excited be the appreciate you part I to I because

As positioned continues on if I'm well to on are approved. a go based plan. NDA to OPNTXXX commercial execute towards Opiant will we’re David financial for we position, successful prepare confident our And strong next our development to launch submission working through, team year, which our advance

NARCAN public at establishing As the Adapt. the commercial communities Roger crisis launch includes This did change Prior the members does Adapt. dangerous who of instrumental opioid Mike the team our agents it reversal for NARCAN it previously Nasal the I responders the Nasal is at that new recently, Spray. started Sales of we President in attract proud than I'm opioid way at for Commercial building more as Adapt, at and this as I most former commercial to launched market, today. By In fortunate confront organization market NARCAN, our exist, Spray was Development, Opiant, we've Vice to interest The Vice of in help work when President not who mentioned, first XXXX. crisis. Potestio, built served much team how been were opioid

As to over with This deaths Roger reversal Federal opioids, Good than state governments and Samaritan mentioned, attributable by XX% to in of opioid responded in opioid fentanyl. co-prescribing have increasing XXXX, to compares XX% were greater and XXXX. legislation. largely driven synthetic important less by related access funding agents and

stronger public the reason, time those of opioid agent on line is overdose the front national for a ripe this crisis. new reversal For health this for

includes plan imperatives. launch four Our strategic

current nasal funding laws and nalmefene. opioid reversal for First, overdose ensure agents include

access. broad ensures that distribution widespread secure Second,

result in progress and four reversal Third, distribution opioid more great making with funding imperatives. all establish on and to already agents. education, in stakeholders ideally comprehensive and affordable partner coverage. that will And fourth, key awareness access We're

us overdose that, the with in to of landscape skilled reversals. assist David update opioid an the our agencies financials. plans O'Toole, forward will important provide onboarding treatment months. we're an more addition, sharing coming launch And new as In to the it turn who to to about ensure of awareness opioid for ever with if option look public to to widespread our changing I'll epidemic. adoption over approved, And, I OPNTXXX messaging with support

David O'Toole

our I'll third Today for the Matt. you, year-to-date. financial and results summarize quarter Thank

to of details and release. first please financial nine for press the full XXXX, of our For today's refer third results months quarter

report the in be quarter also will As XX-Q. on usual, form available a our

available year XX-Q an revenue positive Nasal closed increased financial be because XXXX. the summary, full for quarter continued the demand today, However, royalties we quarter will for This Spray meant recognized revision third quarter. current Nasal and guidance than is of In NARCAN the SEC the strong further for expected outlook in in morning. higher tomorrow Spray to continued this our again also led upward NARCAN our

while OPNTXXX. cost of We also executing maintain development on regulatory and clinical containment the advancement discipline

OPNTXXX. during Now year-to-date for XXXX. the XXXX. million as XX.X NIDA XX from and X.X our EBS received in over royalties were for of corresponding financial Spray and Nasal XX.X and total well NARCAN revenue million of from XXXX the as respectively detailed This BARDA third revenues for from funding Growth million periods reflects quarter results, development the million increased increased to compares in

Third periods X.X for quarter slightly months marketing million for XXXX for X to first anticipated quarter NARCAN the expenses comparable and development from quarter XXXX. reported and and of same and in we in of compared of by million quarter in first Sales of over XXX.X to were million and year-to-date and R&D million third periods third in months as first X.X million the million compared the million and expenses XXXX X.X increased XXX.X million XXXX, sales in Research OPNTXXX. were X.X the the and up X.X X.X and nine million comparable the XXXX. respectively approximately expenses Spray were for Nasal EBS. X.X for increased million same the nine XX.X periods for G&A which the were nine significantly XXXX. million as the third on expenses the XXXX, months X.X have activity million

and basic and diluted of $X.XX diluted $X.XX to income increase spending or XX, income million, per was Net million, of September quarters. for share, X.X months nine basic to three for a $X.XX the million ended to share share on per share share, income of or per comparable Net or $X.XX per period ended of $X.XX per the compared comparable of loss basic of $X.XX loss XX, activities XXXX or approximately and future an expect per of income for XXXX. X.X income compared approximately September diluted We of $X.XX for net in months period of per approximately net income income diluted was XXXX. the X.X and commercial X.X our the XXXX approximately million, share, basic

we had XXXX, equivalents As of cash XX, marketable September cash, million securities. in XX.X and

previously sales Nasal raising we reflecting indicated our expected higher As of than financial XXXX guidance. are NARCAN Spray,

provided guidance of expect XXXX XXXX full We the of for revenue sale approximately XX Nasal to are million. by upper We NARCAN of aligning of now Spray our NARCAN year guidance EPS Nasal of range Spray for million. from the royalty year the sales modified XXX

to strong XX call and of range to million also to are our a quarter that for is We strategy conference than XX the end approximately potential with now in the very million, In of a second in forward supports commercial securities launch that, XXXX equivalents position cash, progression cash look our Operator? calls. expect of provided X me let we which we the in guidance and cash expecting questions. marketable XXXX pipeline you. with greater during of next year. Thank the open the start And million as latter half to OPNTXXX conclusion, we the

Operator

first Our Please At question from Thank question-and-answer be Folkes proceed time, [Operator Cantor with Fitzgerald. comes Brandon Instructions] a question. you. we'll this your with conducting session.

Brandon Folkes

questions taking in color congratulations then the product Matt, market be Maybe at And launch? the the first you on dynamics for or and remifentanil? dose just at me the thinking some differentiation based launch just about And also in then experienced of is of commercial think PD think if modifying do progress. about legislation into sort the other how think thinking your Do do or okay. enjoys we Maybe or should I to you currently. Roger going taking that one, any thanks codes my that's how for Roger Alright, intranasal that behind and long – about three more think data sort are appreciated talked to – maybe should how naloxone and about the you those blanket we describing use? those it but Thank you. Matt, getting long of maybe of establish How pillars. you it on guess reimbursement,

Roger Crystal

questions. and Thanks thanks Brandon, for the

been dose. before. And novel the pharmacogenomics So done related is remifentanil never study study a to this that's

can of of just it's optimizing complete comparing successfully really second nasal So to a we dose the remifentanil of part the study naloxone. matter OPNTXXX so that the

information, really to that's that until do about and on get So you're that's Part what that what it's essentially really we entails. so job, learning and speak X to the

which a to cetera. naloxone, potential out when of the that data very there data, come think studies, the over the terms with add thing to PD we absorption compared dynamics, nalmefene where really to that we do to will of we just today. launch Matt already and confirmatory promise do, PK our let of additional around data inverses, market look think, excitement the is rapid known duration. the in half-life show itself, Matt. think is – Regarding I'll totality, therefore along at real for et That out about properties which demonstrating what the to real study, in long differentiated basis in very that naloxone and the differentiation combined that timing nevertheless, approval. we from for is of the in terms good an non-inferiority FDA the there product I have inherent be PK need of as as And plus Yeah, the demonstrate mentioned, do we has

Matt Ruth

appreciate Yeah, depend mentioned, the Roger thanks for ultimately, it. the question. Obviously, to to FDA, on a approved what the position hopefully as label, I lots market the will by be. as going

As of to and will them imperatives, length one time requirements. obviously, the strategic vary each of four in

approval. building is the will have foundation good we FDA each a think and we to OPNTXXX those, most ready I address so that of important able position launch ultimately the to we're consider when now to in that that we're thing organizationally at be

Brandon Folkes

up follow just Can something you said I just a Matt? there interesting. Sorry, ask quite

on you kind label. what just is and data it's thinking did statement – the about, that a data again, just, depend you the label? what on to label are is, more sort, that differentiated in You mean Or the Is talked the depending going about of some

Roger Crystal

would label alternate as for the that the out – the label was there existing The be nalmefene. same label

generate the of will is though, we data And all part that can we package. this So a think label about the be a XXX(b)(X).

at with the already data So differentiators. looking look potential strong. that's in we pretty And that's hand, the can there where it's PK

Brandon Folkes

thought but very the just Just congrats mean, what clarify Roger Matt, and Thanks let's that. very progress. I on I much. that's That’s helpful thought and Okay. you

Roger Crystal

Brendan. Thanks

Matt Ruth

you. Thank

Operator

Northland Our with question. Please with Carl next Byrnes question proceed comes burns Capital your Karl from with Markets.

Carl Byrnes

congratulations the question also progress. for the and on Thanks

Just respect to EBSs with forward? briefly, viewpoint Thanks. have an your change to a intend generic how NARCAN launch does follow franchise as going then up I authorized the And well.

Roger Crystal

terms The ultimately would – NARCAN EBS on the of – are or of franchise their sorry, in intents in think we of how terms XXX? we

Carl Byrnes

In stream. franchise, just royalty given terms of the the NARCAN

Roger Crystal

to comment agreement the David would earnings any add we that – our on week. I of Under sold nasal Matt announced Emergent I naloxone mean, royalty is authorized is they a comment we form with which broadly their and include this. that Biosolutions, them, generic receive and can that or have Adapt, now by last

So that's a already. be the what that. as publicly headline, by have will perform could they've generic, anyway does change it anything guided commented doesn't really. I an result It authorized of versus NARCAN And on

Carl Byrnes

disagree I No, you interest the And used. using space, it of sorry, AB very over an that still understood. is guess segment, an was the going a authorized an an that? a generic. if where authorized with space would generic, would be in I generic rated sector or this generic have just public rated unlikely I public in AB favorability agree even Would seems be you with there retail

Roger Crystal

I where can’t. I with but today. you're out in coming the there We're can't I understand not really from question, marketplace comment. the

comments take have guidance what EBS on from publicly, Carl. afraid again, I'm So just we to

Carl Byrnes

XX% up are you significantly, reported. this Fair balances switching at the to cash. of go over then kind just to cash as million about royalties XX up enough. year-over-year, strong, And quarter, Obviously,

correct. recognition, kind and then even fourth And fourth XX% that in of to in quarter, You'll way the in secures is Is royalty quarter the basically of some. that when you fourth quarter, through probably also going higher in to believe then the which cash receive quarter, it's at first which recognize things? the safe sort the look balances be I strong a

David O'Toole

Carl, for thanks it. thanks Yeah, the attending really And for appreciate question. call, the

recognized exactly We the then this it quarter. have And the quarter quarter. received revenue third You correct. royalty this

at And north to of XXXX. of end on again, the the all range, go received ours. based quarter be in XX% XXX And not will range. their million, you we'll all the If be of the be upper of first guidance, that will that

Carl Byrnes

congratulations and again. thanks Great,

David O'Toole

you. Thank

Operator

is question Small your with David with next Please from Zacks Our Research. question. Bautz Cap proceed

David Bautz

curious, Hey, is or quarter? good reason Or I'm function large obviously, this it's everyone. laws starting afternoon, are any the you what the that? a reasons in to but for I it better, mean, for is worse, country? not these effect see getting do NARCAN of just sales getting ascribe increase of epidemic opioid co-prescribing some as only the in it this we

Roger Crystal

Thank you can driving any from you, only David. my thoughts. particular And insights give speculate. EBS don't have it, as I in I but will We what's to

the exactly. absolutely point I – think co-prescribing you're latter about

that each have of EBS not a So what number commented the a worsening that's in is just overdoses. on patient. naloxone of crisis trigger the knock is general, more in My I overdose, revive to that sales. unnecessary think required opioid terms is This trigger. for can opioid But and view opioid spiking

of Spray it the doses now be main because with perhaps and that required. a in situation. NARCAN sufficient, oxycontin the reflected more opioids, fentanyl But I other naloxone far just And one mindset Nasal Spray, So synthetic increased developed the and NARCAN perpetrator, especially of related is was suspect being are would when was we Nasal kind the demand. heroin

David Bautz

XXX of kind that the product to is Is something your if hopefully curious, get both someone organization there's is when the a and know there marketplace, Okay, approved, exists could for of don't XXX maybe that, NARCAN? differentiate try but you I from. this, from have out in like – group you and and could out I'm recommendation type there some – if maybe independent to there then NARCAN committee, there

Roger Crystal

And to person we're determine for is – main have And of I will organization And the product that which would at think is then we determine, it's – be organization organization grow. responsible market the determinant to we therefore, now procurement the be addressable general suitable. to at the as an individual suitable official to see be the that the crisis more than that the sale, up generate. the more we to the growing from to in to decision market, an might intersect ultimately prescriber, state, differentiation data we just be I able relevant or be the facing. for important product In the level continues seemed person made source whether data of rather level suitable. being the opioid will sufficiently would and person for which more – an state mentioned,

David Bautz

all Well, taking appreciate the you I Okay, questions. right.

Roger Crystal

the Thanks for question.

David O'Toole

you. Thank

Operator

Private Our Please next from Investor. proceed question your with is a Mark Walsh, question.

Mark Walsh

Good questions. afternoon, call. Roger two and I I’ve opportunity appreciate staff. to Basically Longtime the in participate the investor

might First to updates provide partnership. or pertains in you to self-commercialization the any of study the regarding extension PD the second

XX the on dose like in XX. but And from that. that the a you input provide why point, wondering to small were addition Track came second the Seems extension obviously of a as of study modifications, the FDA any to But the of in if provide that the approval. an whether was increased. case. about I'm I the period could number whether of to I participants time remifentanil, with increased could Thank color not Opiant assume grant you awfully to FDA, the short – Fast prior question Track of FDA aware had Fast the granting whether the if participants on of PD, communications number. Regarding increase any that's the you. Quick the noticed statistician, before just

Roger Crystal

that's investor. nice being questions connected about extension study Really, PD two being for been never designation, one the of thing is and study. So in before. for you Fast the study thank Track thank The a terms the really you done an this of novel Mark aren't and PD

that remifentanil half started we'd that So modify order relevant. to then second become X Part to and of learn need for in the initial study that the dose – we of

We really increased in extension that's of are number of people and study. design, second always on has the in the – make this needed question, because two more I around part of such. to subjects had your parts what So then correctly. in first likewise, answer as study And the been to design reflected both the question, sorry, so the participate order it to – modify sure want the run study second I

Mark Walsh

Sure.

past, the going regards to to engage in partnerships in So the option to self-commercialize in or forward.

You'd the that wondering be go? can I'm of done operation any said best the will in calls of the in terms previous if in how you just been that investors, updates might interest provide there's that

Roger Crystal

the self-commercialize on ourselves. therefore XXX obviously, the maximum this. launch value before was we’re do have board. done He's to knows successfully, Well, And to sufficiently takes this of it basis that capitalized remains. And shareholder what Matt opportunity bringing to to and

of interest our operate the However, in investors. always we

But with far sense, alternatives course, balance arise, opportunities that more and shareholder we that the is to can as we have. make self-commercialization best that. sheet through absolutely of we the if strong as So would entertain value tell

Mark Walsh

Thank you.

Operator

We've over to Roger of the question-and-answer I call now would session. to turn for end like reached the closing back comments. Crystal the

Roger Crystal

joining transform today us interest teams building capabilities also for It is and your for an Opiant. and is R&D our to important you, that Thank We're an our you one company for into operator. a in company. commercial organization. from Thank time

Operator

conference. today's This concludes

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

Opiant Pharmaceuticals (OPNT) 12 Nov 212021 Q3 Earnings call transcript