ACRX - Earnings call transcript Q3 2018

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Operator

Welcome to the DSUVIA FDA Approval and AcelRx Third Quarter 2018 Conference Call. This call is being webcast live on the Events page of the Investors section of AcelRx’s website at acelrx.com. This call is the property of AcelRx and any recording, reproduction or transmission of this call without the express written consent of AcelRx is strictly prohibited.

As a reminder, today’s call is being recorded.

You may listen to a webcast replay of this call by going to the Investors section of AcelRx’s website. to Counsel. call like Saia, to now General AcelRx would turn over the John I ahead. go Please

John Saia

Thank Kimberley President, Pam you our us today our press call FDA results for Chief Angotti, are joining separate Affairs releases approval Investors reported Friday, in of Palmer, presentation Chief and of our the and we available the a DSUVIA accompanying our releases. in Vince and press Raffi third section slide Vice our Chief financial are website. this quarter These Gaumer, morning. this Medical Quality; and Financial Officer; Officer; Regulatory With Dr. our me Asadorian, Executive Officer. Last

listeners involve results of we regarding Federal of call, during future the this make risks operations laws. and the Before our we forward-looking These and meaning I’ll Securities begin, uncertainties, statements that forward-looking remind AcelRx. will statements within

addition In and turn and the reports associated the now risks our Securities filed forward-looking to Company’s statements. the of discussion text of press with please the I’ll current to with Angotti. call the such Vince? to a Vince for release, Commission, annual Exchange periodic, over refer

Vince Angotti

and Thank today. everyone you joining thank us to you, John,

as frequently setting. setting. of route analgesic within would develop a And find potencies. well REMS was as IV delivery. care. plans concentrations significant to their to our severe take sublingual dosing standard the patients to provides delivery the rapid years, opioids Defense, have with Dr. multiple an further launch Defense In remain for clinically U.S. to as and approval this mission of under whose professionals alternative Evaluation thank DSUVIA. Palmer, collaboration Company associated number with in Strategy with the the our shareholders the liquid list healthcare which hospitals, opioid in was important AcelRx, achieve acute a provide leap Mitigation with a to acute and opioid hospital single of and for effect label opioids program. the The ago, approval and milestone. to support requires today for day obviously as to our and in excitement who dose moderate identify unfortunately, care clinical To providers including development morphine who indication now for pain DSUVIA numerous really decade, errors patients opioids. in over trials, our AcelRx’s whose employees stems well who collaborated our for forward invasive, of or on DSUVIA’s an investigators, details error the the the have opportunity like us medication In Pam care. medication opioid will allowed handle While is of DSUVIA would remains developed. a to our this our their of nature of The years is and this all to our healthcare better and an these set We believed medically on stakeholders for in has a settings the for supervised that information errors with she most XX a the as DSUVIA market nearly current that of up us of Company of further on were commitment the standard due drug important provide the I’ll founding with Risk of Department DSUVIA belief ranked second for XXXX, of IV was an alternative intravenous top solution, even acute solid Pamela persevered in a today that Department to strength, a searching the this when objective the the alternative pain fraught co-founded

I Before recognize United the everyone initiating the that the to a ongoing opioid significance take States, in supervised as of will to we supply remind We call take crisis company minute Pam, would a and like certified, over the only seriously. medically DSUVIA pharmaceutical to healthcare we very handing surgical as to settings with our REMS practitioners responsibility such about or begin as the We DSUVIA. not the to we DSUVIA emergency to forward educate be will outpatient hospitals, in retail program centers, we departments. and look in FDA concert use. for create pharmacies this DSUVIA to program healthcare available and worked

opioid extend our repeatedly, the said goal not we is As market. to

decided of compelling option best provides alternative. we However, when already has professional healthcare opioid class the patient treat pain, a in DSUVIA believe to that the the medication is acute

For you an update decades, on opioid standard first non-opioid with we a care. DSUVIA’s the now have provide Pam of And have for patients. IV been approval, opioids label. will tolerant sublingual now DSUVIA’s

Dr. Pam Palmer

achieving Thank to approval our first has product supported in you, also States. United in Vince. who I would the us thank like everyone

exciting negative the a it of clarify of DSUVIA, microgram attention Zalviso for that was that obtain it acute to As the new DZUVEO those It thrilled DSUVIA administration now We the applicator to the to alternative have of DSUVIA healthcare prefilled professional. including European to Department means by in milligrams. XX less I’m been sufentanil. will Defense able the pain. Recent provide same in to example, potency sufentanil as moderate be Union, patients have takes approved for has effect. important is a use tablet in and severe is brought instead therefore in in drug practitioners to dose single micrograms misplaced potency a to XX XX U.S. to healthcare sublingual that

to the use be dose The burn of an the a be emergency X a of not healthcare manage microgram the years DSUVIA between hour access, errors, medically management doubled-blind, enough sublingual X obese study proceeding will acute pain, patients was enrolls The primary it require finding in XX significantly exceed the XX with of study randomized, pouch needle-phobic needed we was effective difference of from our packaging placebo-controlled useful occurred endpoint. difficult doses. DSUVIA elderly, departments, in with baseline from allowed study to Each a relief showed with use DSUVIA tested pain administration uncontrolled pain and directions such non-invasive option for the pain in misuse for pain IV patients an of providers our DSUVIA’s for setting, than such DSUVIA XX with especially as tablets baseline DSUVIA We patients hours. inadequate. supervised of pain effective to single settings. the a or evaluated The nothing and dosing hospitals, XX experience. DSUVIA with demonstrated emergency to demonstrated status. also X within intensity statically of in with applicator to an XX which a in postoperative IV shouldn’t and adults and The placebo by may certified, mitigate opioid study. dose analgesic, dose Phase DSUVIA indication to improvements that and is or care, XX Avoiding of with was total offer and Therefore, patient recommended dose. acute better lower surgical are medically severe following superior FDA single of tamper-evident into treatments for to XXX acute intensity of placebo, were in studies, clinical diversion. is XX sublingually a In XX mouth supervised In or Phase hours alternative attached. to The compared potentially group addition we dosage first over also minutes patients pathogen greater, or in post-operate foil pain strength in and a NPO for pain aged to patient possibility for single centers in placebo. that Phase minimum which efficiency as difference X the dose and due for trauma. designed unit healthcare in tablet FDA-approved single daily summed a patients meaningful housed in that moderate-to-severe safety better controlled is a which were dose minimal to was the median XXX room

safety in of DSUVIA train to facilities becomes other DSUVIA or depression. The proper or DSUVIA. and greater frequently with the distributed professionals base use older. hypertension. to ability be in most an of reported reaction, dissimilar The the patients retail Importantly, the certified, will rates healthcare will the use on available the the program respiratory by than to only certified randomized, to years to pharmacies vomiting, need data comply will authorized not reactions X% to adverse dizziness trial nausea, following DSUVIA placebo-controlled not manage If of one-third setting were equal restrictions or XX adverse of representative headache, these be their in and opioids. appropriate in were are attestation REMS dispensing and healthcare use. have a outpatient DSUVIA for

of part the audit and healthcare for monitor any distribution usage will evaluate data, wholesalers’ or program, monitor diversion setting REMS As and AcelRx within the proper abuse.

are decertify REMS the with AcelRx will Additionally, that healthcare non-compliant settings program.

to effective that, will objective. our specific diligent Vince. over back and this turn REMS We support safe and efforts program are and to let With DSUVIA’s committed me use call the product our

Vince Angotti

Thanks, Pam.

analgesic. benefits healthcare I towards experience and commitment systems of of DSUVIA As safe stress we commercialization, effective use move new, to patients the non-invasive the ensure this to the opioid our want to and

moderate and our There resources these our and annual visits acute assembled majority experienced market lead strategy pain. adult half DSUVIA healthcare the of XX acute launch contribute overview pain. emergency to in on quarter in provide results approximately the for opioid our the DSUVIA believe visits, of to up commercial the settings the will use patient of launch are XX care departments; of an or of target some gearing the million to we patients in an we I’ll XXXX. We’re details over to planned and these supervised efforts. XX estimated present first million team by severe to the in have provide medically the manage then Of these million where hospital or visits

visits an necessary avoiding to the of placed materials patient any the these are can Not solely believe the pain. to not is IV of for of pain. benefit Importantly, there time, the just million acute effort where an an we administer for access. estimated And this is for which by for sublingual for anti-infectives opioid XX initiate reason, the IV or and hospital the hydration, DSUVIA

process benefits may IV advanced walking or on significantly of for upto opioid the is long a DSUVIA the The upto of pain, potential techniques other an XX% to is materials and for is other in under IV the to of an escalates. start and and gain opioid. nurse’s of a lidocaine DSUVIA. As catheter, open one an again tongue. may time IV, to as example, published collect nurse must cost cost pain include acute and then with And the the doctor as are clinical administer tubing, that we IV prolonged credible dose the consider separated data, on the the the unsuccessful a proper dose department first and approximately as the significant overall administer are generic, that the equipment cost provide by the that cost the be patient morphine Based administering patients. experience DSUVIA, to shows emergency bone the of time, if their overall believe $XXX. With reason DSUVIA initiate total small, should which including option is and and nurse The patient may this the fracture well shoulder, Study unique but pouch the today, combination of drug, first efficiency believe initiating HCPs of attempt. required, the meaningful hours. We tablet such the foil ultrasound two the tears the efficiencies hospital is the the the improvements

DSUVIA in are our We’re hospitals the and estimate research States. [Technical Difficulty] approximately There we finalizing United range. the $XX wholesale pricing in pricing X,XXX cost to $XX

about best X,XXX believe XX% annual volumes, We navigating are these the market X,XXX X,XXX the how within other for DSUVIA including have five patient patient that aspects saw maximize criteria. shows well medications advice adoption on believe resources be and to represent emergency hospitals criteria X,XXX. where these they a from improve will these that evaluated efficiency, DSUVIA. the who advisory historical approximately provided Therefore, we our DSUVIA. using for hospitals the formulary appropriate will we’ll of focus DSUVIA DSUVIA XXXX, several utilized on on by over surgery to hospital have annual of hospital healthcare most professionals with volumes, process be of perspectives potential commercializing boards universe we professionals And of same-day In on experience. their and these approved approximately further newly to used criteria, healthcare segmentation carefully XX institutions all department Based

our unmet enthusiasm Following has medical the efficiently measured the are professionals healthcare these educating confidence the in to grown, from and hospital DSUVIA we approach. opioid invaluable take by immediate advisory approaching boards, need and in we significant DSUVIA resourcing our manage provided needs approach. our launches shortage, team for accordingly. our IV Despite created and and launch and will has insights that the Historically, the time, proven with disciplined product fulfills

efficiency experience, of allowing just and a While management. as to our important or as there the startup significant is resource understand launch commercial product leadership value commercial them significant team has experience successful

staged a hospital point, in will account we’re assuming half our As be end start is and our ensure the with launch XQ XX by managers XX our effectively on XXXX. of increasing to We’ll to deploying first of result, the execution ‘XX resources.

sales territory hospital As hiring of feedback XX the experience with associated These the continuing an our advisory we’ll average of of IV portion to of To-date initial been their AcelRx. years have of the consistent feedback previously prompted account experience, occupy X on have is shortages a account hospital positive already managers the boards, us the eight-plus challenges accelerate within from that importantly, for including but opioid team. hired. communicated, managers

its market meetings hospital four these the hospital with process approvals, and addition, initial formulary has hospitals metrics four number of Each P&T having volume and recently monthly be have of placing formulary launch key liaisons mainly committee initial have during specialists been also orders, monitoring science meetings timing and others per while Examples orders. access order hired. medical period In repeat community hospitals will our quarterly. own the some

initial We our our provided this on expected and outreach boards At with expected advisory through sales have commercial Analyst will our and gathered help be not on a The information intelligence at efforts. December Investor guidance will we lot of our our precommercialization planned metrics. annual XXth. to be Day time, key or more providing

experience, As we sales our progress revisit the will some launch and providing position gain guidance. we on

our Friday, Before third will quarterly call we update will also quarter few the would I opening replace up to like a financial results that last regular I questions, highlight remind you items. Today’s released our financial and

quarter with and million the cash $XX.X ended investments. we First, in

before Secondly, outflow million included service. our cash $X.X equity for the which quarter our offering was $X.X debt million, in

G&A are with quarter. next DSUVIA and that cash was discussions our year. partners continued Finally, on focus like quarter R&D our continue which million the also the as stock-based want excluding compensation add in will for first for our $X.X highlight management, launch we potential to results European expense DZUVEO I’d expenses These continuing.

like partner. production With cost estimated, our I’d with U.S. DZUVEO questions potential DSUVIA, terms now line the for any Operator? the of you is have. finalizing open supports to may which easily the approval more the

Operator

question And Capital comes RBC go ahead. today’s from Randall Stanicky first [Operator Markets. of Instructions] Please

Randall Stanicky

I guys. about the just to of the understand bit questions. can to Vince, $XX $XX pharmacoeconomic WAC evolution terms follow-ups. I just a value But, how of Thanks, start perhaps few you maybe maybe couple first? And you thoughts off, pricing? came help got Great. marketplace. pricing with a know perspective thoughts here up and can in been I’ve there’s the us talk you then, have of a from an from to

Vince Angotti

Randall. Yes,

the competitive We neighborhood it opioid provided still account current mentioned been come the sure opioid have fair So, IV did wanted conducting even month. doses the past And the here we’re of a with the DSUVIA which take might $XXX. of IV would initiating use of finalizing over the initial and to into of very to to initiation. part that next question. economic research in course be over that we in that That’s cost that of event story that thank remain value is you that they And with we two the the we’ve hospital. year for

with that where landed price. that’s we So,

Randall Stanicky

to have an patients in think the you doses? the relief Okay. answered for you one second there? thinking of way goes IV the durational will, that’s getting and about it? number assume patient And the sort may about Is some right DSUVIA up think of option how two is with a Assuming to or do pain pain question, as that IV, intended gets about million adds if displacement XX but hooked I you’re ER my in, you there

Vince Angotti

a dose four in somewhat some dosing again, our it taken later. little was bit and studies hours, between maybe if second interval -- average So, took little earlier our a a or three

it X So, setting. for I think correctly market to in you’re X thinking particular about that those doses

Randall Stanicky

and side. Okay, Gottlieb he about side? there’s How I how others great. Have prepared out the But, thought do seemed Commissioner importance focus that do about think opportunity clearly, the comments. was from that you one I directly commercial opportunity? mean, DOD And we about commenting we and was a from DOD that here you outlined of opportunity? in think in Scott the agree I the in our things it think the thought And the interesting. battlefield statement perspective to call the your

Vince Angotti

of before Yes. Defense. us actually have well, ordering, worked Defense, to about as a got of has trained of for are because an with It’s involves of administer the who’s deep representative dedicated the battle. experience field in their When but think the the you account they opportunity someone Department we the hard and to DSUVIA with treatment exact facilities personnel have Department expectation for the long deployed give that on forces only magnitude as it number the as military we

DSUVIA. exact which utilize Department asked the thing might can’t But, the ordering the question. of patterns about the all you pricing I and will many of the of within different you I have when think and So, number people he the know apologize I size. they comment on Defense, One branches I give to DSUVIA understands

the While acquisition pricing with we off they’ll or agreed pricing an federal specific start about the the discount that’s military, don’t cost. have schedule wholesale WAC XX% likely supply from

they minimum commercial for business. what discount price where from typically typically that’s the So, see get side the of you a

helped hope answer that I Randall. question So, bit, a the

Randall Stanicky

don’t of cart on question, I focused be the is Yes. then, No, to first expect. X back, my put as over think about you call the want getting want relief think But, the does. going going all I DSUVIA, I clearly this horse, you there some the And But, board X-year is to you you assume Vince, line speak grow you to it finish and step approval last -- how outlook, would as guys with what want to and forward. as before AcelRx the the to to and about and here.

You really and product some Where think how hospital-based now of pain company to you’re about a here? as years. we five more company selling you infrastructure, to I are a from But, have not that. the do possible the build as pain much go opportunity do you into know a three next

Vince Angotti

Yes. That’s there’s that. question. ways couple answer of And a to a great

about in our me product let First, particular. ask portfolio

the expecting here first. are review regulatory some people as And well. undergo a in I’ll Zalviso. on future know that comment to Zalviso You point at

through they’ve DSUVIA. the that on clinical FDA mentioned, real in laser-focused, on as last and teams, occurred interaction you And Thursday. time regulatory our First, been actually

the updates. as DSUVIA prepared spending resubmission And of that we’re been learnings significant. is I you, many, any might been our can the on in have review. recent about all just time based DSUVIA. re-reviewing be that the That process previously on process we’ve Zalviso are So, result of for to a NDA tell required, And

included example, give you original over submission X,XXX our documents. Just to Zalviso an

So, sure moving for we’re be position combing proper in through we to that put regulatory the best those the forward review.

a three or the there second there’s companies of look out to at part anti-infectives disease years. single hospital over Right? is areas the in to product hospital three consolidation in something crying over So, the those for we next The we two they number be We a that two think pipeline. we can that’s next when therapeutic appear years. take to are there, are whether the space, think industry

their is that. consolidation, of would clearly the in distribution the on product single proper focus for open helps, DSUVIA. I Our Randall. outlook benefit immediately commercialization the is some bigger shareholders we’re and the from opportunity where hospital companies us certainly to hope obviously and that that market But and

Randall Stanicky

Thanks Yes. No, that’s a great. lot, guys.

Vince Angotti

You’re welcome. Thank you.

Operator

comes and gentlemen, and of ladies from go question, Please Company. next H.C. our ahead. Arce Ed And Wainwright

Ed Arce

So, couple had questions. just a of I quick

way of the the some Vince, talk you’ve know Perhaps, uses. First, that things nurses that on about I follow-up. run a in see physicians, about that recently. some within you’ve opportunity, excitement the those boards forward. sort your at to market could some run, of that ad the going they you of targets, they just of which And And boards discussions several and others the terms not around then, and the that have I in novel ideas comment, led of but the talked other stated use

Vince Angotti

helpful, The very you have been mentioned. ad boards as

to and surprising opioid us the the the continued the boards, tangential bit it’s news I solved. that last week again a again, they little to these Importantly, come a and this your question little it from with struggles just of saw are on crisis. IV products don’t to we the having was commentary just anticipate think ad across, It was continues manufacturers to be major

the of they’ve XXXX. extended end to Now, it

coming review they comes and -- comes with was reason that and because patient which boards. commentary was group product to DSUVIA might advisory the committees administered from nursing timelines settings. have those first is care from that proper nice often in the not dosing, efficiency it’s the fit which P&T So, and common pain of the be ironic The developed patients can number the this in and be The was in the the ER. major would the that and their would message XX of aspects Ed, space this over to from efficiency chaos moving are challenge increase. a last place. emergency great the back coming that the an nurses been in to of they They departments But, with has believe the create number you real in forward struggling that particular the efficiency one hope the the available that commentary simplicity that’s for yet patient been initiate years is put can for continued in that struggling a has them It’s in IV setting. those for and the feel a the visits continued because acute decline, And to them bed in opioid, accelerate environment.

the duration long that them to feel opportunity dose same pain dosed, to as profile anesthesiologists setting with single is a stabilize the three they discharge those the that nice to discharge four have surgery, and before gives Beyond stabilize them. hours surgery And the these in a post coming duration them them. and controlled. be feel and the opportunity as nurses the in of their we’ve PACU the puts DSUVIA again early to close stabilized they pain duration action for that situations best of spoken of to of stabilize potentially into is goal the op, benefit pain, to to typically provides of that with out patient -- great are PACU patients This the as day of that same-day action DSUVIA, come

to that profile position it in best to them understand continues around action is to opioids the general not but efficiency, they feels through the the drug use puts dissimilar it and the side it other works, effect duration So, moving forward. come the of

Ed Arce

around reasons wondering the fit. involving, along get and through for early put in number actually place, process to for targets And initial target P&T that a how whole see certification start you it expect strong committee these you process the likely, then, the long imagine just of in would reasons do mentioned, early the REMS you for, other early you XXX how as with being do commercial make can but adopters a of selling product? I’m good facilities that that so targeted not good these only a among follow-up are other I

Vince Angotti

Yes.

some we So, data Again, annual it utilized at wasn’t was importantly and XXX, initially. visits, similar that approval. looked on Ofirmev it can hospitals defined data as Exparel, have back it went adopting might from an around the hospitals first same-day adopted have be it, emergency annual an approvals quarter, criteria department it or visits of X,XXX And categories, might imagine may others. their surgery whether the quickly whether be and time you products some in how was we being

to clearly, continued to are hospitals patients. more progressive, they’re looking So, medicine indicates that are us, treat these in they cutting-edge, the advancements for and

that those hospitals so, have X,XXX. prioritized within been And

might You certify. take to asked about start immediately. doing it to how long take shouldn’t and It long, we’re that going

get allows the a to FDA receive our that those clear receive to feed and actually is product. them in have that wholesalers, the Now of the criteria certified criteria process, allow will certified nightly certification with the We have to representative they daily that are hospital a agreement product. and within the to hospitals then the attest to the

be working committee that because time those earlier The hospitals thing occur already review to moving later with for the it forward. time. the discounts Behind GPOs will formulary working we’ve We’ve certification the to working on So, those will been real doing but just is much have or meetings on electronic than P&T that records pay we’ll fairly we’re in from efficient. medical formulary, distribution us will with attention a The as been agreed have and wholesalers that already potentially in plan to purchasing Ed, We’ve certification and be will the the them. organization. preliminary done group been scenes, to process the rather in to real order already.

done we’ve couple moving set already for distribution months, a of the last to the of stage over So, lot forward. work

Ed Arce

with is as of of prepared going what on perhaps Okay, know now don’t one But, result you diligently. sort you sure a if just forward previously very great. I this mentioned has the the that one Zalviso. earlier submission? for on DSUVIA any And process you’re pressure your I working team, may, now, want discuss timeline the Then, review Zalviso. if last been to could, of re-reviewing likely quickly I’m I put resubmission

Vince Angotti

I Yes. a us. for It’s remained an exact priority you timeline. can’t give

previously had to with XXX% the our on and through extended some That fourth Thursday. a have live be We’ve were We and of teams DSUVIA regulatory team. extended quarter. the limited guidance simply to because line have Company. giving resources XX may up again, short we here again slightly clinical been for But of last the been date, interactions, within which time, employees commercial have only period this focused

a in to Please deep the you REMS with now. going from and it Cantor according order moving Brandon certify And today of Zalviso. answer we’re to get to breath, everything we’ve the go right institutions our I these give then next and can be distribute got question on forward That’s comes Folkes So, Fitzgerald. back take ahead. sure properly best

Brandon Folkes

So, of more firstly, bit and just a see medical programs what you intend product, on education you. up secondly, that how detail this they many from hospitals about account to And X,XXX that X,XXX, following cover question, the Vince, could the of then, and will you earlier when the may around put the cover, perhaps we there. the XX, will cover? what Thank the they to does percentage hospital XX X,XXX goes managers, or then

Vince Angotti

Yes.

providing have be those be we programs to business allows medical in conduct actually in video institutions, services. for education will us conducting So, services. tools, We’ll training different that the a

allow to to properly them particular placebo We team -- in forward. order to moving devices product the have administer in how nursing understand plenty to of

believe move understands the the forward, will good moving DSUVIA details three come peer-to-peer in these that our In who least fit XX our in of at some should its and on field of we forward. fit really be portion the things that for account are accounts. experts it hospitals attributes average key on Company addition, programming. from moving from do coming you We’ll a the independent that give forward as have the of we’ll so of education. think more product XX about of we education But, around managers, The

here initiation penetrate be et first multiplied to their process, the the So, XX, accounts are when hired the those understand of the of to to that managers, with started in account XXXX. XX better already we calling have you’ll accounts we’ll start those number already cetera. by And these quarter able understand at formulary

of to our we As by of start while or we move that the the can’t our our DSUVIA hiring want XX accelerate XX. quarter emphasize no is moving according reason sales is I our something plan or first during upto accelerated, there’s plan if the is to the flow move KPI XXXX, or or quarter to even forward, to metrics

too a fast. and too companies We’ve today. methodical big, We’re taking conservative approach too many go more seen

balance see infrastructure chance We’re execution of we getting always our generation, revenue faster. too event sales have to hiring again we in But hospitals very point, are of when it’s far a a you these penetrate our there’s ahead could these teams. careful the fine you building that the accelerate cost on conduct to

So, be while plan certainly time. that we have can accelerate that to modified a plan,

Operator

And our next question of Please go Thalmann. ahead. comes Ladenburg today Higgins Michael from

Michael Higgins

the this in in your the then late opening could, on I’ll over in a I There’s press Pam touched over approval. the considerable queue. And, not if pushback bit back comments. week, questions, been jump DSUVIA’s surprisingly you last of Couple

-- there hospital, down guys days, Then, this been out can have You you like track have strategy drug. to point. would strategy product you retail a last, weeks if expected your to counter marketed retail to this effect perhaps a the doesn’t not and it of comment counter the that what’s months. come or what’s next it on there pushback coming in of the can typically already out and late, drug, an This is at that a kind speak especially the

Vince Angotti

Yes.

think, has of this and both Zalviso the developing with comment really media. DSUVIA been purpose had spokesperson this, starting clear important to on Company, and Pam our I she have since it’s Pam?

Dr. Pam Palmer

Sure.

or keep of And part the I a of outlets our a lot been thing whether that to thing I’m here setting. education. on across it’s think ramp, media the this have -- educating and many trying things for we called to decrease We’ve around can the really interviews, that supervised two is the print. this get abuse as to just is biggest medically diversions do important the been most the to in TV is is

abuse, specifically, out report year. opioid abused is from are other is the federally et of some from compared abuse every We SAMHSA drugs show annual that that substance a that they sponsored they have And data are put from of X.X% to friend form where medicine source the for a the medically drug cabinet of areas supervised got example settings drug, as the stolen cetera.

drug abuse already So, takes issue. the a a a setting in of supervised over keeping care medically just XX% of

I same powerful? And to did an my that the or full say, I effect, that all or such there. is have bind potent, opening that’s and have agonist get they on less powerful. so the why dilaudid sufentanil to is it more and tried really is do need just people sufentanil, got of or to turn you but I’ve not to dosing. get is instead same out that? explain why drug the milligram with opioid thing which that We of dose, to do It emphasize comments. that mean, that have microgram a as try we same you they opioid important I All then, we the it really second fentanyl it why that’s the in And degree. potent, means all So, mentioned dosing receptor yes, to is lower morphine to to would pick

but education, they they science good headlines, you the once the look So, it. And the behind been at realize terms flat they’ve get unfortunately, make you there, vocabulary people when using fall for out incorrectly.

and and because And young didn’t folks. we and microgram. work. about with that making fact and realize we moving older forward are in So, we effective XX why educating that’s That’s people dosage like, it those tested tested are we a dose the really safe in lower strength

really this are only and And keep going so, it’s to education, always supervised we about settings. medically in

Vince Angotti

that approval. process, regulatory received crisis I certainly that. Michael, has going seriousness today. very our States, two discount most people We December think But of FDA just the was This is saw would are almost and sensitive between in comment point the certainly, add, been we commentary of the on and years. to the because there United CRL understand an DSUVIA coming in XXXX, recent never for and it originally, I’ll submitted final the opioid obviously we and AdCom and

to been satisfying that requirements. ensure it’s So, FDA’s are meeting the lot and a in we of order work

approved think, even where FDA I meeting an weren’t only the I’ll a of many and day add several the comment we There advisory is, And the use opioid the the the was clearly opioid was final members discretion. committees is reviewed before same last over ours months. with not the -- committee.

that and we So, a Dr. -- worth obviously, basis medical but on basis, it as said taken has in fortunate basis well was a on of drug-by-drug there taking it unmet properly. they Gottlieb significant need unique for did that amount It we’re time, a case-by-case think all and involved.

Michael Higgins

your of your dose, not success Yes, to. expect isn’t you’re that; milligrams appreciate comments type start. will three probe could addiction notes, I per to of you micrograms, and I’ve one, of has I have and a and great consecutive understand so. days addictive comments I I is and two you. you. day both put you’re And media education wouldn’t with found between media research of I beginning that setting, addicted, think Thank found its to at This of beginning unexpected, that. five earliest they’re and dose my half the expect in

comments. So, I appreciate your

might emergency your emergency use that reach evolve have patients come when own see back you this But, something in and beyond question, early your of fifth half? stairs board can I said, et between Is Some is expand too expect advisory Is you department? that, people that of and call, out with the beyond department? in you could terms do I to get is this Second can’t cetera. on? wait you the to may first who that targeting, when if that something just

Vince Angotti

excellent That’s an question. Yes.

that So, or because healthcare the we the emergency to there opportunity Simultaneously department professionals same system. there anesthesiologists the emphasized in healthcare is those fundamental going a because clear we’ll help institutions. can PACU they’re be

it well. For sense with day hospital call -- the then the department same and the emergency makes efficiency certainly in you’re as to purposes, makes

at can you time education well. that So, launch as that be anticipate occurring will real

Michael Higgins

It involved. I before question last then And the that awesome. jump in. was back That’s radar discussed is Great. being AdCom

review other was sake don’t they require prescription they confirm, my before DSUVIA? would but, questions have using have to before vary an state, PDMP or monitoring DSUVIA. geographies, today, I PDMP, of drug review that One to to dosing just prescribing program, ED hospital believe that on and REMS to at

Dr. Pam Palmer

No.

Michael Higgins

sweet. Okay. I Thanks. Short it. and appreciate

Vince Angotti

Thanks, Michael. We it. appreciate

Operator

today of from question Buck B.Riley our David Please comes FBR. go next ahead. And

David Buck

that about with talk for Just bit one I Pam. one the you’ve GPOs to executives can so little actually get a and couple the how GPOs able far? questions, the as anything on you’re quarter it can for it criteria Raffi sneak account that. armamentarium a different, you terms as then there evaluating you the hired do mentioned the making maybe official Vince Raffi. maybe improve You of you’re Vince, Is new with commercialization actually much before this and for of formularies? sure in for you Pam opioids a you Zalviso? adds meets highlighted do in Dr. something talk it with about Can it. already that something you you and to basically reason sure have to something adds make you do that how But, well. that for of that Gottlieb FDA that gives And And

Maybe a Sorry, final expenses one. trending about you talk could little operating get bit XXXX? magnitude we as of just into or

Vince Angotti

first mentioned GPOs. start I’ll of So, with the on three, you the the

been So, the we’ve already to talking GPOs.

up market. prior GPOs. launch. completed we with we’ve also our to that just of with for We’re them believe an and with basically them the anticipate negotiations five confirmed make couple those would the magnitude fully to And who and or that be we’re done heavy a in of idea. four discussions already We’ve concert In months. give to that, talking discussions to talking There’s the the been wholesalers, you been

So, beyond that. the shouldn’t we’re any be distribution with There on hesitation track forward. moving chain

I mentioned been on think earlier electronic also records we’ve working platforms. medical that I the already

that. the formulary. And lot things for of about, off in scenes advanced go experience So, all of about out well just hiring based we’re that the a those in forget team. prep people order and a to speak institution and kinds our those There’s of stages behind of think work drug you earlier of to they and

So, of addition launch. and and Pam? Pam impediment our to an to that with it be over qualities to those turn goal it’s armamentarium. is not the for on Zalviso I’ll the

Dr. Pam Palmer

opioids. Sure. the concept wrongful to this of the been year two was come with tell have the out morbidity, looking malpractice to pumps past opine it’s that in asked standpoint at mortality medical where Zalviso in related I infusion against opioids, West all can has and can that decimal There programmable papers wish are could big death Well, Coast, the the because XX-fold that of with problematic. solved. I since I create you you that of remain throughout I actually opioid, were morphine. a list. dosing as error XXXX Company I from a started you the a But, the programming problems Company started Whenever from earlier, liquid XXXX the opioids still medication error top you point heard have magically IV-PCA have error, the mainly clear hospital on those in that Vince

need in today So, was XXXX XXXX. there and safer for still there in the PCA, patient analgesia, controlled unmet

can argument we compelling and Zalviso. this Gottlieb a still why of absolutely very to need make division Dr. we so, to And we that believe

Vince Angotti

from importantly Zalviso. And seen will more to-date, clinical we’ve to I data Europe studies use safe with outside add and that data real to world the the and use to proper able base think as get be we that on continuing we’re more

things I Pam. resubmission. think elements those types question? the are Thanks, to of about think the So, the the Raffi, we’re continuing third in

Raffi Asadorian

Yes.

expense operating the Finally, question.

operating -- of QX. on an I terms we increasing. That up. see and are range there, that’s stage. million XX that So, of operating flows. to In for in terms be XX% would in see to to growth year QX $XX cash to million ramping the XX burn it, run -- in about next historically cash expenses $XX of $XX a XX% guided in That’ll We’ve XX David, basis. increasing in by QX, I it’s rate call million I increase. the to will as increase precommercialization see about cash

Operator

question of from And Please comes next Gershell ahead. Leland Company. go Oppenheimer our today and

Leland Gershell

in would ambulances the civilian so available about ask in could field if the paramedics to medically want see out field. maybe pain setting. treatment that’s and this product a with of be for in If we a use forth? monitored what in to which I used being setting and I wanted clarify with DSUVIA DSUVIA

Dr. Pam Palmer

use, There likely to to for qualify REMS and REMS, are with to ambulance working of focus. qualify DSUVIA initial that that professionals would ambulance affiliated services able hospitals read be but going fact trained under directions certified be to cetera. with are healthcare there to definitely it, our the the have under REMS. on They be would have some that But that all have be et services is would will attest not the our

focusing and Our department. services. the for focus that’s really DSUVIA, not paramedic investigators familiar is goal, the really emergency what’s Once important with our become using those us clinicians and on

Leland Gershell

And then, further question. one just

potential that in use to think patients costs for IV the like there are DSUVIA and we about them monitoring that? let’s lines costs things the who covered with with say, associated regard with treated additional they’re so should dosed any Are setting, with You’ve after forth.

Dr. Pam Palmer

that are right dosing opioids The IV be standard of currently will they now. for very for the monitoring DSUVIA monitoring

shouldn’t there any be there. So, difference

Operator

follow-up And go Higgins a from with ahead. Please next is question our Michael Ladenburg Thalmann.

Michael Higgins

or at ones here. specialty plan expect point? trade for which discounts couple longer A this one is to distributor. you what this also, ones, brief a you use XX% of kind should Are sounds ones we It of are product, like channel reasonable? to And define -- able those

Vince Angotti

channel. traditional So, we’re going Michael, not to really the distribution use specialty,

because the distributing couple is have our that gates. that is there think REMS start due the part understanding, for the a like part that REMS, as to the out distribution. be us anyhow themselves, for supply wholesalers the training but we the directly of really chain, end single accounts so, the make the regional the distribute wholesalers is wholesalers. wholesalers that to will medical I can of the about going When XX%, simply from we at distribution easier chain all-in, big of through reasonable a only to three to supply It’s unlikely own of it that’s perspective. users. point will So, the of That be a the and settings. the the entire And others XPL think the they to and their extend difference always that’s and of we’re all we’ll certified Obviously, way discount there obviously to the

So, GPOs think the the any wholesaler to you when account. direct and about XPL,

on But at the a the bit think little side. high the modeling likely a fair, beginning, high purposes, that’s think I little especially side. it’s on for I bit

Michael Higgins

hospital West looking major And make keep give that will in these sense then, markets tighter, targets, can are support in any it us more geographically you which you helpful on East little of a to be at terms does Coast, Coast,

Vince Angotti

Yes.

areas metropolitan Florida is of if that’s those because will areas a of we the can you some be lending instance the these you in population where on number many many visits there As where imagine, elderly area, those got hospitals the where number for institutions, to our Orlando the institutions population, major of services of or and typically significant area initially. the

it’s concentration think go that limit certain that a there’s Raffi just And time in accounts. a and If I you slides, step-by-step we lot the can at the on for the see personnel, of look between efficiency you’ll that as we had geographical our use windshield map, areas. of provided so

Michael Higgins

of on the you filing? for revisit timing have that. I’ll update XX-Q Raffi, Thanks. us do And any

Raffi Asadorian

Michael. Expect it’s now, probably there out right

Michael Higgins

Thank it guys. I been keep here. this, you, getting Oh, on appreciate I’ve Okay. is. looking refreshed it. there

Operator

this the for remarks. closing question-and-answer Ladies Angotti like concludes gentlemen, any Mr. turn back the session. to to I call over and would

Vince Angotti

Rafael. all on and joining our today us day. progress great AcelRx. to DSUVIA you our Thanks just have upcoming forward all, you I’d a We of like launch. support continued for again, of thank and Thank and updating to look your milestones the again with for

Operator

This you presentation. attending conference. today’s sir. thank you, we And Thank today’s concludes all for

and wonderful day. your may now You have disconnect a lines,

Talphera (TLPH) 5 Nov 182018 Q3 Earnings call transcript