OPNT - Earnings call transcript Q2 2020 | Opiant Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Opiant Pharmaceuticals' Second Quarter 2020 Earnings Conference Call. [Operator Instructions]. It is now my pleasure to introduce your host, Ben Atkins, Vice President of Communications and Investor Relations for Opiant Pharmaceuticals. Thank you, Mr. Atkins.

begin. may You

Ben Atkins

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

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

Roger Crystal

period is any for important epidemic difficult more numbers in for use before. people addiction today. you the we The this exposing disorders. substance in our thank highlight other every an bear moment. coronavirus now of memory, world, to joining than will particularly future our a in for as this believe investment us and people or opioid our to day the Amid ever of economic very is I afternoon treat triggers crisis overdose health more Perhaps Good than healthcare mission out, around and

we Cannabinoid development a programs pressing Use nasal Overdose program on Opioid company, opioid stage we pipeline Alcohol our are overdose. ahead and focused Use As OPNTXXX with And Acute Disorder, in Disorder. nalmefene have lead

cash that, pipeline Importantly, provide we of detailed from a financial progress. $XX.X our lead you a strong financial our let's and review position, will With with. work later the with more David million update

Turning opioid first overdose. to

of evidence of Wisconsin and consequences In suspected teams, or particular, in emphasize economic to In to clear for there social effort building compared warning seeing XX% and a to of response, it and naloxone. the begin the in epidemic. many drugs. police during May. in spread are from the put is. me across with need regard a with a data rising states need Federal overdoses for American we in suspected for XX time because COVID-XX Let sobering analysis XXXX. citing is same The health synthetic jump XX% example recently overdoses April emergency in ambulance ongoing hospitals XXX Medical helps from same, for I March, from in of reports this XX% in America, easy issued pandemic increased Association opioid the officials show through span the do then access nationally and growing AMA therapies how just XXX believe the there urgent All the are departments the perspective in ways exacerbating better July, overdose in and truly were I March from overdoses worsening figures and epidemic. opioid preliminary

demand drive that BioSolutions May. Moreover, in nasal higher since order Emergent fact XX% spray week than rising pre-COVID NARCAN call last standing along May its volume levels In stated with June on on opioid trended and earnings Disorder naloxone and than manufacturers the the other prescription to products. in labels NARCAN mandate information in use order painkillers naloxone awareness and Opioid products, FDA of include a to issued to

the to As critically last now heroin. than much in XX record-high. from an by fentanyl. product chemical synthetic other opioids makeup in powerful the the spray, for opioid longer synthetic In firm lives than while in its we provisional The synthetic last incredibly an AMA that Opiant more opioids'. them in year, like to and than of important, developer of more now related epidemic. those, is people original overdose the times role synthetic being America fact that July to proud 'The is act the NARCAN Further the of and data of it stated grip States opioids NARCAN a is for highlighted died a and by fentanyl third of drug new XX,XXX by remains statement, Yet Of confirming nation's released wave heroin. and plays overdose nasal XXXX. fentanyl powerful confront drug overdose the United opioid faster more Americans report need deaths died naloxone-based saving three ever. the essential allow CDC epidemic Indeed The driven four are overdose like

treat increased overdoses the uniquely statistics opioid those to ways. its nalmefene nasal important Opiant synthetic overdose. to OPNTXXX suited believe XXXX for involving X end we three as Phase and an potential new profile could develop trial X,XXX from results, in a sense of Based treatment responsibility These our opioid to deaths XXXX drive on OPNTXXX prove opioids at synthetic beginning advance XX,XXX. the to of On brutal of

binding potency. the opioid receptors OPNTXXX higher higher at affinity i's gives First,

longer half-life it's Second, renarcotization. a the potential reduces of

a fentanyl. absorption, fast shorter synthetic life to it's Third save due from which is a the like window to important

FDA submit drug I'll later move to new of part data portfolio, intend the XXXX. year now potential As overdose. confirmatory we body and focused treatment we be review will this conduct ahead, of the the include studies robust and of out a to on to addiction rest as in believe further our we pharmacodynamic look of in with OPNTXXX our borne the expect and pharmacokinetic we of

pleased kicked for National We for human have are for Cannabinoid Center now or drinabant ACO. with collaboration Translational the studies OPNTXXX, Overdose Advancing to Acute off to formulate Sciences our

We expect to begin studies these in XXXX.

synthetic concluded can in KX synthetic we've over various are as previously emerged caused consumption cannabinoids that As by or the edible can cheap cannabinoids JAMA drugs major through ingestion as of to even discussed health of ACO. and A United toxic that Commonly the fake We of have the life-threatening are ACO annually States. published million cannabinoids. regions the be public July use respiratory study a in X.X artificially including synthetic hospitalizations acute estimate lead severe cannabinoids manufactured threat there known over of recreational spice weed for XX and complications, that death. failure patients in of encephalopathy,

Use X pandemic Regarding phase Phase the in are in on regions, and Naltrexone for of Europe the business maintaining Nasal initiating of OPNTXXX and Disorder. subsequent in restrictions travel the pause Alcohol temporary In study. COVID-XX resumption a on resurgence certain our we

an nasal Biosciences patient's we entered to of begin when July, of additional and device COVID-XX an Summit potentially subsides. spray opioid and In manufacture We with for into support agreement impact development will the programs. overdose development sufficiently the recruitment other

spray system FDA approved evaluated products. other delivery to device a use previously will nasal We deposit

let corporate me also some Finally, updates. additional with you provide

have Circuit. patent we the the with of litigation. in Together on New the various We Firstly filed ruling. District appeal the June, like Court ruled defendant, Jersey I Appeals this Pharmaceuticals TEVA Federal BioSolutions NARCAN Emergent in some to to of In U.S. also senior with patents. Court of staffing TEVA updates. share favor validating would disagree an

Counsel our Counsel. in Brian brings Life recently expertise Brian We welcome leadership to General and the pleased our are senior industry. new Opiant Sciences very Vice was President at Endo and experience Assistant to and Pharmaceuticals. He extensive most team, General Gorman,

spent years therapeutic be Wyeth-Pfizer Commercial changing more at collectively our regained in across rapidly broad XX dynamic Officer areas multiple Also, Before Opiant a Aziz leaving on that reasons. Brian of and personal AstraZeneca Chief substantial than will environments. Mottiwala [indiscernible] matters advising for range in and but

During his a him commercial infrastructure. all colleague good great been best built further with and leaves expand to in our foundation Aziz team position and a senior he leave has of tenure Aziz support future for has strong wishes our commercial at endeavors. and Opiant, us and a his

new our for begin Commercial David? in course. that, a With a I in financials will Chief discuss search will Officer detail. to We due ask David more now

David O'Toole

results the development royalty approximately quarter for clinical in revenue the have $X.X million the approximately to I'll a support Thank our our ended represented the net our this steady with $X.X XXXX. corresponding license stream NARCAN, addiction to June sales a ongoing discussion our brief continue of new royalties XX, begin of $X.X for to pipeline quarter overdose. you, of million to of programs approximate sale million for period approximately Roger. advancing a EBS Spray, XXXX. the recognized during $X.Xmillion balance NARCAN on potential of compared focus from period the in second and same revenue With strong with We agreement of XXXX. The resources Nasal of compared we sheet, treatments and government from for

three to expense approximately in compared compared XXXX. market expense to by as personnel period related were as Second during credit, expenses quarter essentially million quarter in related development $X.X for Sales XX, $X.X was approximately XXXX clinical compared and to various pre-commercial including Research The of strategic $X.X and related and ended compensation the expenses UK none the one $X.X to was and approximately were tax party NARCAN net reported in approximately second to external assessments million, R&D including third million $X.X related Personnel and X.X were June was ended administrative planning. XXXX. to million million-dollar primarily June stock-based of EBS. three $X.X $X.X by compared of research $XX.X second increase million expenses marketing million of quarter approximately for and activities, to an during attributable the sales were trials, and same months million million offset decrease second as General the XXXX. million the X.X expenses quarter costs in flat XXXX and XX, months decrease XXXX. as the

income to the net support XXXX. OPNTXXX expense continues to Opiant NARCAN. $X.X $XXX,XXX approximately expenses As potentially million approval, was Net or profit potential approximately in that pipeline OPNTXXX $X.XX future partners for and compared received from the we basic period a that of and development represent products. several expense commercial of second increase $X.XX well advance towards sales royalties in second net Royalty areas diluted loss market second approximately and million XXXX. allow our to as loss a would sales for Royalty of the compared marketing the commercialize diluted to anticipate was share $X.X as for platform quarter will per share, to quarter the the Opiant to for same X.XX payments $X.X of or net quarter the for of million

XX, turning months Now results the to six ended XXXX. the for June

approximately in the to stock-based to the compared the $XX.X XXXX. ended and six in with approximately approximately NARCAN were period of revenue third-party million and including million $X sales as first XXth, comparable development recorded months in were approximately resulted decrease due XX a to ended to June months compared from six million in during for $X.X NARCAN of million first corresponding professional million the months six was XXXX. months the ended of agreement $X.X expenses of approximately The by the EBS. decrease million of months compared personnel in primarily royalty period R&D ended XXXX, Research expense UK during expense sale XXXX and of to XX, $X.X marketing $X.X Sales the to related June none $X.X clinical a Net for XXXX compared expense $X.X $X.X development the of during million attributable million months legal ended approximately administrative expenses XX, from to of the General of in same June expenses $XX.X million an $XX.X million the period half XXXX. This the period decrease in in We fees June XXXX of XXXX. million compared Opiant million $X.X decrease XXXX. million June ended for in and $X.X six XXth, which million and increase of the license For was and credit, for XX, EBS to were $X.X recognized for six million tax offset XXXX. of half six the a June reported million $XXX XXXX by personnel related and and compared trial compensation revenue our $X.X XXXX. comparable approximately expense were approximately

approximately diluted or to six and related was the for ended a XX, and For party six share $X share. pre-commercial compensation expenses, the XX, was and months to and basic for of stock-based and months personnel ended X.X This profit research ended third June million attributable XX, a expenses expense months XXXX $X.XX market comparable six and XXXX loss Royalty X.X of million activities June Net partner XX, primarily including per The fee ended the used respectively. $X.X June and $XXX,XXX to XXXX XX, determine related months including the of various and of net XXXX. million months period $X.X XXXX XXXX was net third-party for June license income assessments June expense was planning. $X.XX to strategic is compared six million no or loss during for $X.X the compared basic approximately the XXXX. loss to approximately a diluted loss ended of six increase per

to has XXXX million of and equivalents $XX.X XXXX. XX, million compared at Opiant December cash $XX cash approximately As XX, June of

through we million. contract BARDA a discussed, lead As approximately funded the program of our have $X.X million $X.X grant approximately is of OPNTXXX and NIDA

EBS ask our expect strong and pipeline OPNTXXX of reiterated $XX.X of royalty in broader range as we with In lead This resources call XXXX cash the now operator that, overdose. addition, million. and up Operator? to with million, to program sales advance of With in a will addiction develop $XXX revenue $XXX to and position questions. the NARCAN number us guidance approximately keeps for financial million open I XXXX a still

Operator

[Operator Instructions].

question. Brandon Our with your first Cantor with question the Fitzgerald. line comes Please from proceed Folkes of

Brandon Folkes

congratulations all Hi. Thanks the for and taking questions on my progress.

would to of about your then the in may on we Can product maybe ability and And at quite break should then when pitch COVID should you overdose good was Thank Could this fentanyl Firstly OPNTXXX, use just be the low market terms that to widespread on initial secondly, in opioid it think or the R&D, comes we just in market OPNTXXX And we pharmaceutical lastly bit positioning was there, just overdoses? from be continue elaborate how if you. about second sales and trial? little expect about a quarter. to your continue? should this think impacted? with then a to we the get the spend, wave, and to run the marketing aimed

Roger Crystal

good Thanks, afternoon and Brandon. your for Thanks to you. questions

based pharmacodynamic its for how, data So we the But we overdoses. relevant say when it you we the get, how positioning detailed this are the study; from guess be updates particularly, we in providing suited ask only entry and particularly will to of OPNTXXX fentanyl, opioid and all given differentiated profile. about - on well more that marketplace to view I the essentially

this consider fentanyl will get worse crisis our way. continue to we how view that's think really I and this So is

being of on illegally a even greater soil. For manufactured amount U.S. fentanyl example,

that's how question, And addressable can the growing. then see is going answer the second we market question. to as answer So David COVID I well. Actually this

with these to directly the identified a the as CROs and overwhelmed, a In standalone know impact is the we've day conduct being conduct OPNTXXX development, hospital thing whereby what trials. wouldn't the we that terms so are learn that it's that hospital the ability from are impact of situation say opposed on units will we COVID different to COVID-XX what study therefore, to I was impacted associated and far by its by day, the

of impacts machinery and through engineers of that already, travel, Europe to some the in an delivery needed experienced for we've been has availability who impact. example, the However,

location say we accurately of the in can't won't David the I on and in It So be that question. of your severity. answer COVID can impacted future. third And nature depends just terms

David O'Toole

Brandon, thanks and joining. for question the for thanks

ramp that ready commercial and sure get we're to far get going potential to the look as spend are time to As to launch. a we But we filing. same an spend we NDA make spend continue to going don't and the at up sales marketing, closer that at until to to diligently for

that cost and be the range next couple the an for in So be we quarter, of until quarters closer for the have filing. will sales to marketing will where NDA that the we we second of get

Brandon Folkes

Great, thank you very much.

Operator

you. Thank

Our of next question Small comes from line the with Cap question. proceed David Zacks Research, please Bautz your with

David Bautz

patients best something been data good information percentage the required than Hey, probably of have by any good more on served overdose get that I'm be afternoon has there That one like of curious on guys. who dose some would if naloxone. Roger, would [indiscernible]? generated

Roger Crystal

a lot the support show, the national data There's quite in actually literature, the that. data of to

substantial doses have doses are But multiple upon the include for need needed. don't required and to our and hospital, example, and support going is that own have then if certainly is doses also they might infusion populations of But here going who required hard of patients multiple of or but It's until once naloxone is very further are late you arrival evidence, overdosed to doses to doses actually done not multiple cohorts too We fentanyl it certainly see I be the say, The transferred the who primary emergency in available the it being impacted. happens required. the research naloxone. have consideration. wait. to predict services intravenous would this you long example, if It average multiple they literature just continuous to on market on of for

by can we element bringing head clinical and then perhaps the first You're experienced call and that's a of an dose equivalent to initially an much or eliminate in on. higher that uncertainty bystander, if giving kind of judgment late responder

overdosed is thing someone you other is what don't The on. know

say, the that to assume overdose they because of had deaths of only not overdose - one, statistically, sign 'I to the in - of how where it's you someone over XX% assume involve the show it data, XXXX have heroin', fentanyl, but you worst. opioid So

David Bautz

Okay, great.

Now chemical us in be attack. I'm drug into you've the the be OPNTXXX stockpile would into just if put the to what national get the to process you previously for the potential case stockpile? the through of walk curious discussed could

Roger Crystal

Yes.

at able that are because not still development stage. we're we to So much detail provide the

that and be want don't position. I entitlement whatsoever automatically suggest have be to overreaching in that So any we to

development that and of However BARDA be is to desire reasons supported for ultimate the that the interest to it's have able the part absolutely and for costs OPNTXXX stockpile product.

nasal mass emergency involving be it's a attack. So situations nalmefene for fentanyl might a where casualties there chemical

David Bautz

Thanks taking for Okay. the questions.

David O'Toole

Thank you, David.

Operator

There appear back floor to comments. time, this be closing to for further no over like the I'd to at turn management questions

Roger Crystal

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

Operator

today's teleconference. concludes This

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

Opiant Pharmaceuticals (OPNT) 9 Aug 202020 Q2 Earnings call transcript