OPNT - Earnings call transcript Q4 2019 | Opiant Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Opiant Pharmaceuticals Fourth Quarter and Full Year 2019 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded.

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

Ben Atkins

Thank you, operator, and good afternoon, everyone. Opiant Vice the and of joined Relations. Investor recently team President as Communications I to of be mission thrilled am I part work all and this with of you. to this team,

Officer, year today update fourth Opiant’s Financial call for David afternoon, announcing the press This ended quarter XXXX. issued O’Toole. Crystal; providing financial the On results Officer, Chief Executive and December and Dr. XX, are Chief a release full Opiant and Roger a corporate

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

qualified These year subsequent news filings, and SEC Opiant’s forward-looking cautionary Form filings. statements for in our on are statements XXXX, contained and releases December report XX, XX-K in by including the annual ended the

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

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

Roger Crystal

us afternoon. this Ben. you, joining to thank And for Thank everyone you

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

to it relates as fentanyl. Specifically,

drug XX% for fentanyl-related three time in U.S. while has nearly deaths As showed report a the fentanyl XXXX. death is into decades, actually crisis. the evolved the new crisis XXXX from in the increased opioid in the A from CDC declined first well known, overdose

the many similar country. throughout cities recently are states from statistics There and disclosed data and

a just to single report reached in worsening of according depict up authorities, the continues preliminary XXXX. Moreover, news from XX-hour in fentanyl-related San Francisco XXX Ohio, deaths in month by a XX statistics Columbus, period. fentanyl reported deaths to example, XX compiled in epidemic. XXXX Last For overdoses from were

claiming this upsurge these called of for by deaths high driven of address synthetic to as counteract and potency the by and development Prompted each and this a lives overdose now public are stronger, in U.S., is this related thousands in health year. challenge. longer-acting of NIH antagonist well opioids critical Clearly, synthetics, very crisis to positioned Opiant opioid growing formulations has the the fentanyl is

features fentanyl-related has and it potential fentanyl We are There believe several make issue pharmacological doses opioid that properties it that believe this we overdoses. nasal address OPNTXXX of to to suited opioids. by the suited nalmefene caused nalmefene’s treat and is synthetic treat both related to

being Firstly, of receptors higher least naloxone. Xx nalmefene opioid affinity at of that at than greater mu

of successful half and the a of while Secondly, life OPNTXXX of probability rapid reducing long we rescue, the absorption renarcotization the event. likelihood believe increases the

program by in and a a $X.X supported from NIDA contract BARDA accelerate as million clinical OPNTXXX the for up medical Our is chemical fentanyl $X.X a to development countermeasure of to event its million attack. from

the contract. awarded were $X.X tranche BARDA of we XXXX, second in approximately from Late the million

January, As the characteristics FDA device to use intend delivery we a status in the with of disclosed is nasal reviewing certain we informed OPNTXXX.

the requesting the is submission device drug not yet opposed is the to now As for combination. approved, device FDA NDA this information an as

that that detail around address to to the While with can the for request. continue competitive reasons, I we say FDA’s work cannot We provide further question. FDA

two volunteers, a IRB already PK conduct in conduct to the three month and the the to received single-dose have complementary hope to of and FDA This study. year. request weeks be to duration We aim information this a this healthy second with in approval study quarter this will of clear we study

commercial potential file to aim a on schedule. we standpoint, and this from we Importantly, remain an NDA year,

I’d market spend that services we The institutional can reversal agencies, little areas: such firstly, as the to market government its opioid two overdose be schools. the time EMS fire, distinct market be discussing Overall, includes agents now and police, like opportunity. to view for underpenetrated. broken a commercial up into

market for carry friends Second, that patient, the includes retail and agent. reversal prescriptions overdose family opioid to

currently reversal The and Nine at-risk as naloxone prescription co-prescribing Florida, Ohio X% including co-prescribing agent substantial of only opioid prescription. Virginia, opioids an overdose represents active of states, a alongside growth California, opportunity a laws. patients have have

York, in Illinois bill and co-prescribing Maryland potential with XXXX New Georgia. Tennessee, states Additional include

the of is reversal agent laws. states Xx co-prescribing Emergent Importantly, that BioSolutions report with use approximately higher in

overdose we with the increasing at market look $X.X opioid we to are the to sales, co-prescribing expect to reversal the agents hit by XXXX. expected and of U.S. sales agent approximately retail Institutional billion. reach sales As anticipated reversal double, landscape, entire are billion $X

have ANDA, give or recent minutes on both an regarding market pipeline generic Spray. filed Drug I New other our to versions on Nasal few Before developments would litigation I like seeking which spend of update programs, with Application, Teva Abbreviated Perrigo, a and NARCAN to of ongoing

own and XX, circumstances, will the for of on Teva XXXX ANDA. future to closing X, as litigation current the effective the its Last the related make regard nasal month, the settlement, agreement have await In Emergent Teva of made Perrigo’s and had the hydrochloride of ruling. ongoing be we terms those resolve January a entered settlement its into the Adapt Pharma, or were including spray a naloxone outcome litigation against litigation subsidiary XXXX, of has Emergent received we heard patents under BioSolutions, Perrigo and generic against the to under announced nonexclusive under that February with trial, BioSolutions license earlier to licensed a pilots. market or to we to license our Perrigo. arguments Under certain

licensed in And cannabis There now are I’d emergency treatments XXXX. which are reported room no emergency for approved overdose ACO visits in development. Sanofi with department in increasing the latest U.S. no of visits in currently number drinabant, in like of is in to or legalization approximately rise treatment America. OPNTXXX for The from to for know the resulted ACO, cannabinoid was available. discuss are are ACO, which XXXX, there year the acute December North expected other currently and we data of that the X.X

to injection an drinabant setting. an emergency reverse as symptoms in that plans ACO room rapidly can reformulate the of Opiant

development the to We for filing Opiant’s manufacturing certain of and NIH Opiant necessary formulation this to conducted provide and on of intend resources the CRDA, of cooperative begin we have will OPNTXXX study place. may of a development formulation OPNTXXX. recently between This IND letter a will NCATS intent a NIH. the the agreement, or collaboration and line, To will completed year. anticipated trial The shortly be is after a division the end, the and clinical OPNTXXX. time be formulation support CRDA carried development in order out a within preclinical initiate work are shortly. collaborate we in under in position this If to studies formally research studies activities with around NCATS studies initiate to signed development the

The two a on aim recruitment for at be clinical and aiming comparison naloxone, features to with allow in or this will response. AUD. study countries we is patients. a three which patient of select are developing Alcohol trial. study dose study Phase to will completed OPNTXXX, to us a from complete and of design, The to Moving placebo-controlled we X The recruitment next enrollment our to for patient trial sequential nasal placebo selection results initiation reduce in suitable dose study a number in year. double-blind, targeted parallel the The the Europe, be Use conducted weeks, randomized, Disorder XXX

sufficient, view limitations medication from more Health that number a with the were people urgently to these We National address X In for requiring can abstinence, and to believe According by are accessible total, Existing XX,XXX for of and alcohol-related treatment. potential and age Statistics, doubled These year and treatments a XX,XXX of offer XXXX. nearly there’s deaths from million recent publication per over not withdrawal patients to related for OPNTXXX symptoms alcohol our Center typically prior data AUD. patients the requirements help has support deaths recorded. efficacious detox. XX needed XXXX new is among

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

David O’Toole

Thank you, Roger.

I’d and XXXX, our the XXXX. Before quarter for results discuss I financial year fourth expectations for review our financial to like full

Nasal NARCAN royalty XXXX on Based year guidance sales NARCAN around XXXX of year EBS, for of full by provided of full million. of Spray the mid-range revenue the expect we $XX.X million, $XXX

December I briefly ended will now review for the fourth XX, XXXX. the quarter results

the For of sale revenue period license the Spray, of $X.X for compared $X.X the million NARCAN fourth million approximately with in quarter, we Nasal to from EBS agreement approximately comparable of recognized XXXX. the

reported by $XX.X year-over-year fourth of million of increase and in $X.X the increase an royalty in of NARCAN XXXX, was revenue represents of as quarter sales The approximately XX% driven by net EBS. million

were development XX, of months the were XXXX with XX, was ended December $X.X associated December third-party December R&D XX, research XXXX. three expenses XXXX, for due decrease million decrease ended December programs. expenses three XX, primarily million in in The million G&A million to and each $X $X.X expenses respectively. months and XXXX and a $X.X the our and

three December was period in The $XXX,XXX the compared commercialization none marketing of OPNTXXX. consulting and Sales XXXX, comparable expense XXXX. and we to for third-party months expense as primarily for our expenses to increase ended compensation-related strategy due the consider XX, approximately were

Spray. increase approximately from net $X.X in approximately ended period the XXXX, our – to NARCAN the royalties Royalty XXXX. profit the was The for an the of months comparable million sales payments in Nasal was partners the due net increase to due for expense of three December XX, million, $X compared to earned

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

million revenue year December focus the period December of the let’s results year to the XXXX. on We for ended million XXXX, compared in XX, corresponding during XX, Now recognized the in $XX $XX.X XXXX. ended

as ended December of year $XX.X revenue with XX, the in from the to period million we agreement license of comparable recognized compared million EBS For XXXX, the XXXX. $XX.X

through from increase months $XXX the from the one-time XX, million $XX.X NARCAN and payment, by The million as royalty was year-over-year sales Spray sales Nasal exceeded quarter $XX.X to of revenue XXXX. Nasal third approximately as a million reported $XX.X in EBS, of NARCAN milestone million XX to for XXXX, increase of of attributable December an Spray $XXX million ended

G&A expenses a offset compensation in increase in increase ended was professional decrease legal and million to XXXX XXXX a and for expense. related $X.X and stock-based in and $XX.X partially fees, The the $X.X expense, were recruiting increase December and $XX.X expenses, December XX, personnel respectively. XX, $XXX,XXX by due million year million million including

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

Sales expense due to expense. to expenses third-party for was period year December and none increase of marketing the XXXX. was XX, compared ended Again, comparable in the $XXX,XXX, the approximately XXXX, consulting compensation and

sales expense The to increase was the in had Nalmefene approximately payments development approximately buyout the profit OPNTXXX sales XXXX, Nasal profit XX, certain increase the from million our who Spray. to net ended and and compared net initially period million NARCAN for December Royalty royalties NARCAN $X.X the of primarily was million partners million, in due $X.X to XXXX. held earned $X.X investors year of comparable a the Spray in Nasal by for payments Nasal net $X.X in interests the supported partner to made milestones

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

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

we compared BARDA cash equivalents million. impact approximately to of XX, December million $XX.X had XX, of grant at the the cash NIDA does $X.X The full approximately XX, December and the XXXX million at of As or of million, not XXXX. $X.X contract balance of December $XX.X XXXX, include cash

XXXX. We are begin as we a position in financial strong

stream have for government multiple sources, a of benefit NARCAN and revenue significant also we We pipeline our sales through Spray. royalty funded from net Nasal

like With turn call open to that, the up back operator call the I’d questions. for Operator? the to to

Operator

question. of Folkes of Thank with from Our you. Please question [Operator your Instructions] proceed Brandon comes Cantor the first Fitzgerald. line

Brandon Folkes

taking thanks Hi, my year. progress for and the during questions the congratulations on

in on assumptions a are could the more work Firstly, the growth? for SG&A you that just we Thank R&D reversal done How geographies for you. opioid billion thinking maybe, about you. perhaps products XXXX? the market for you’ve projection you secondly, XXXX? bit $X and agent assumption, just number of How and And think David, spending around should then and about the elaborate little in

Roger Crystal

Brandon. Thanks,

of opioid parts rates certain rates that we So and around the in overdose the addressable high Alongside opioid – obviously, we very of hotspot, rates. predominantly, overall more overdose reversal of U.S., higher to the as there’s Canada certain there market which are U.S. consider actually opioid agent, areas for well, there of geographies, are about U.S., think is be U.S. When prescribing. even because but prescription where

there’s lot high yet low of to which the then So rates access there’s naloxone. rates, certain and that of hotspots prescribing, there rates states high overdose well of rates overlap both, as have opioid and a

that’s there’s it. way one – So considering of

number. where with And We this use to scope standard that crisis. moment a of some well. that satisfactory at of terms opportunity there’s grow are in obviously, grow the based we naloxone Those year-on-year. And which, that going look not our considerations is us we also get think few the areas there’s for deal the to think therefore, at that this injection needle we areas do, as how of to injection, high

about the question SG&A, And David?

David O’Toole

the I you the Yes. on question. Thanks, appreciate call Brandon. being and

haven’t second. guidance S But significantly XXXX. our again expenses, see area G&A and And defer for G&A where for part have sales this As run we at and increasing don’t is around and historically marketing. the to really time far that we lean. G&A, our the a given will going I’m as we point we expenses any of in The –

share we more into with looking on going have strategy information be that still is, will there. it are to when commercialization everybody. strategy We what our is what And we

Brandon Folkes

one maybe And really just we’re crisis. may, into crisis, Roger, a talked Great. of in you Thanks. the about And co-prescribing. from growth the channel obviously, fentanyl morphed retail follow-up, if how it’s seeing I a lot

or the Given and as to really really – against co-prescribing or OPNTXXX should driven sale? we Thank the if overdoses, something be think OPNTXXX’s you how this how Do hands, and by about foresee you for this being fentanyl half-life, with that’s first in longer opportunity do going that’s you. you driving spin what’s co-prescribing? think something responders that’s

Roger Crystal

potent you’re mu-opioid standard not higher say, a opioid brain having fentanyl into well Well, both but Yes, question. with but applicable the And relatively rapidly thanks it’s it for inherent painkiller I particularly consider it’s and still very a absorbed. the getting mind, be even affinity has quickly. bear half-life or to for it nalmefene yes, and in of for, body OPNTXXX. fentanyl, let’s heroin against overdose, well-suited reversal overdose as sectors the agent receptors, of in in long as also the the

still as it there as we see well. relevant So being very

Brandon Folkes

you very much. Thank Great.

Operator

Securities. with proceed Carl with question. comes the question Byrnes of Next Please Northland line your from

Carl Byrnes

you NIDA and second well possibly progress. of the the on timing you give as on you a Thank little of on Thanks. timing congratulations give of additional XXXX? the clarity be BARDA recognition Can to the Great. grants might of able information us in the tranche as grant recognition any of the

David O’Toole

the that contract the call Roger the we And again, covers an and with, of cost. thanks year the itself Most we is, the year. including NIDA this revenue the of Thanks, later NIDA BARDA everything for the actually joining the filing this Carl. recognition move Both and indicated, of the in through NDA and of NDA will grant incur And as forward doesn’t grants, BARDA as as the end question. this revenue recognition fee. filing year. The that be part year, anticipation of this that

already revenue this we NDA if of be successful at of programs, to year, so OPNTXXX would our recognition end And that moving are as in filing most the this year. indicated

Carl Byrnes

Thank Perfect. Great. you.

Operator

the Research. Please Zacks with comes Brian of next your from Marckx question with question. line Investment Our proceed

Brian Marckx

Hey, good afternoon guys.

Roger Crystal

afternoon. Good

Brian Marckx

came agreement the I’m beginning of any then if question. where NARCAN naloxone. the or Are the on a York for an New and they’re has devices nasal same different? And the for the Emergent In delivery curious with And General bearing year about talking Attorney NARCAN on kind or devices to the delivery of OPNTXXX? BioSolutions, similar this OPNTXXX they

Roger Crystal

you. Thank

So what I’ll device as developers far on of comment says specifically as available naloxone. aware, nasal relates I’m to nalmefene, the this of nasal around on to it nalmefene make nasal more

for is used In using terms the Spray. are Nasal different we device devices, that a of we OPNTXXX NARCAN the to one for delivery

Brian Marckx

Okay.

thing another product? is similar nasal of so developing coming any out it aware Are a Emergent was a developing you agreement like nalmefene. companies And this looks of other

Roger Crystal

It’s use not to aware. developing are They more that Emergent more depot nasal disorder injection far chronic nalmefene a developing as are nalmefene as you as opioid manner. are a treat in

We we’re that we as I’m of other beyond nalmefene least are way I as company nalmefene program far a nasal aware NDA before, one developing tell an aware, is than aware as other finding from can nasal of that. not as ourselves. mentioned at

Brian Marckx

the Okay. to Are quickly there were And – year licensing or due payments. with last like expected David for more any there agreement payments emerging you.

David O’Toole

due agreement. no are that payments that will under There additional be

Brian Marckx

taking questions. for the Thanks Okay.

Roger Crystal

you. Thank

David O’Toole

Thank you.

Operator

no [Operator further time. are questions this Instructions] There at

session. management for We I have over will any reached the back of end the remarks. now closing call question-and-answer the turn to

Roger Crystal

the and To developing of believe are have importantly, clinic. we are targeting Most by continue medicines excited and our operator. market truly supported we potential we in are well the opportunity. thousands funds you, lives we R&D Thank advancing financial resources summarize, impact our to significant each the that to

us AUD, execute top of data Thank trial key advance the line catalysts, the for creation. in OPNTXXX, our for today Thank updated joining anticipate We for upcoming for your you. forward and Enjoy additional the we initiation including rest for to your As value OPNTXXX the of look keeping our progress our you and in day. you we on Opiant. on near-term interest pipeline months. and

Operator

This conference. does today’s conclude

your You Thank great may day. you at for time. your this have and a lines disconnect participation

Opiant Pharmaceuticals (OPNT) 4 Mar 202019 Q4 Earnings call transcript