Earnings call transcript Q4 2022

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Operator

Welcome to the AcelRx 2022 Full Year and Fourth Quarter Financial Results Conference Call. This call is being webcast live via the Events page on the Investors section of AcelRx's website at www.acelrx.com. This call is the property of AcelRx, and any recording, reproduction or transmission of this call without the expressed written consent of AcelRx is strictly prohibited.

As a reminder, today's webcast presentation is being recorded.

You may listen to a replay of this webcast by going to the Investors section of AcelRx's website. Instructions] [Operator

like Financial call Officer. now Asadorian, to turn Chief AcelRx to would over the Raffi I

Raffi Asadorian

our Palmer, fourth Thank us associated press today. announced on Andrew. business the year you, Thank press call This Chief be you updates in afternoon, can website. investors Executive me Officer. are today the release. and With results XXXX financial our Officer; Investors quarter Chief for a and the release within with AcelRx's Dr. Pamela joining Vincent Medical full found and and our section This we Founder Angotti, of

Before and Please to with forward-looking this statements forward-looking begin, regarding results future filed and uncertainties annual forward-looking federal and listeners our for make a call, the to meaning the periodic, in discussion that and Commission These press of reports the the company's operations we the addition during Exchange such I refer want of within of securities statements. associated likely risks AcelRx. to we current involve with Securities the will release risks laws. remind statements

hand now call I'll Vince. over the to

Vincent Angotti

is pleased stated Thank update executing afternoon, and This XXX We're past you, over you has product a goal previously transformative for and AcelRx. of on sales our manufacturing the well-resourced Raffi, commercial substances today commercializing been our of Pharmaceuticals. divesting operation after everyone. one year a hospitals, Alora team to good in to expertise products DSUVIA, a of first Alora with in extensive experience salespersons. and controlled

to Defense, for DoD single sales-based with net on Department in net working to time and the $XXX.X sales royalty a Alora, leverage milestones DSUVIA the million of and invested our addition XX% the royalty resources in customer on agreement with sales. our largest through commercial In XX% we're able the

on the including Health Uniform this Annual today's press of once Department In battlefield presentations Management. adoption publications Services presentation, by Meeting the XXXX the authors pain by announced at for Sciences Defense area, setting. release, a the we Anesthesiology [ph] presentation management the DSUVIA University a of improve on the the new and In recommended the DSUVIA again to Battlefield Pain of in

recent and endorsement for of management. DSUVIA pain acute value provide the of other These continued publications

the The different various We is provide will we DSUVIA their armed long-term U.S. value relationship, and remain purchasing for many kits, DoD SQs for Now of opportunity DoD Army sets, has very shareholders. a the across on the this areas or important is points deploying and focused troops. largest our that services. for outfits since the believe within

the the can coming are the our that for expected DSUVIA our and we days, transformed leverage we'll After of closing assets. expertise and confident obtaining the approval development transaction late-stage high-value successful company in have

breakthrough which FDA designation circuits particular, In program, particular, is our the use nafamostat an developed such lead we're Niyad, has for dialysis. on and for in Extracorporeal in as as being U.S. focusing anticoagulant

company's we As believe provide we a into which potential, key Niyad's such, to component the of visibility wanted value. is

are the And used United is anticoagulant such replacement patient U.S. receiving of anticoagunant continuous developer Korea. the Japan this the dialysis. AcelRx, Niyad first to the CRRT be during in in in South only limitation the therapy major use as dialysis Clotting Nafamostat the dialysis an in a filter States. for and widely regional indication is renal We, effective labeled or for approved approved would in use for and if

patient. of and blood transfusions in addition, filter for the factors platelets In clotting clotting often results requiring red loss cells,

guidelines the international recommend the infused the use anticoagulant reasons, CRRT of into an these dialysis For circuit.

EUA. only their under then an options first So available for today, citrate, two CRRT, is anticuagnant exist and heparin which

the quantitative for anticoagulate alternative in use need urgent U.S. medical research recent an Our market CRRT. confirms for

of are XX% currently patients undergoing again, is show used inherent is which physicians has the CRRT. the time anticoagulants, Citrate, used use standard the that in below and results the international XX% lead of of risks XX% cannot Heparin, patients patients of study in the The used of products, remaining which and which care,

Consistent reported that physicians in or not transfusions, This and the occurred blood imposes also with recent on time research, literature and treatment of increase when quantitative burden an our XX% only delayed an published leads market health a the not changes care prolonged resources. and frequent loss of to number filter but increased using anticoagulant. results in

our specific were to adverse included addition physicians citrate the in and regarding events market it Now detailing Citrate, others. concerned about alkalosis research, hypocalcemia, safety,

is as for XX% the citrate. almost that of the believe anticoagulant patients. we of XX% receiving Niyad CRRT conclusion, that market in patients patients no the This totals are the of So that receiving XX% well opportunity as are

remain target research to commercial peer-reviewed And We is this of submit for and EUA batch in second received now in quarter. early for publication the on quarter. in plan addition, in the already market planning. already We second the preparation procedural having ICD-XX submit This an CMS We've we're the in for development testing submission. Niyad with completing stability significant. proceeding it to product production planned code EUA initial reimbursement, completed are

modest outpatient to Niyad million, in any circuits. force launching attributed dialysis Niyad. extracorporeal We markets, we'll need the to a of sales that just is this very inpatient a estimated for have $XXX sales peak other excluding only and potential is anticipate and use

has study. XXX unmet market which XXXX, FDA the the of forward been Our in a reinforced registrational half single end research is initiating patient primary clearly to upon it points already and need patient of by second trial for look that important have we agreed an

Consistent continue NDAs late-stage prefilled filing ephedrine our we syringes. to our for with assets, of and towards to progress phenylephrine pipeline our make advance priority

the their prepare of to surrendering of syringe The prefilled improved towards Fed in safety, include drug the our near-term and corporate use. branded procedures, Fed other not advance again, of convenience and dilute XXXX filing is of prefilled of benefits milestone of branded by resulting as expected the Sera. syringes Sera, end such, waste, less ephedrine a application shift the As having QX new as for our a

and is Based sedan on available well-known will terminally significant expected the a contamination. care the by our years. partner a Fed convenient are for inherent an prefilled life of all that have Europe, pharmacies, to syringes be self-life ability physicians and efferent of to short prefilled three for Sera a advantage risks Nearly life system. in used of year have syringe Aguettant compounding sterilized shelf overall made experience the health The has currently which three improvement shelf

this the investment the since group and able share through be with are contracting commercialization previously, that expected with much stated million, market As to opportunities networks. believe we to market that efforts minimal the organizations of and we hospital we'll a exceeds significant of $XXX believe assets purchasing for be obtain

market in put million as potential a XXXX ready-to-use With only valiosedrin launched syringe that reported for a bowl first year to as in half in just better $XX a A into ready-to-use of pre-filled context, next Fed the the of sales ephedrine, And of the and commercialization but syringe, of prefilled could year. potential second launch. occur approval for soon its Sera, NDA not

care will delivering the release, important in Sera advancements the system value As health Niyad and submissions shareholders. regulatory press Fed today's our us to increasing for bring and both closer we for stated

on AcelRx. has FDA positioned that program reach we product a endpoints believe to and later We've to to conclusion, our focus proprietary on development I'm which execute progress million this our opioid We've well and agreed trial $XXX Niyad, to sales. by believe chapter potential in clinical pleased significant divested new we we're in preparing In anticoagulant to upon report program made for the with to move peak our of registrational year. we're a successful

our if significant potential approved. We're also track Sera, first the company for on product NDA Fed prefilled to our candidate, also for which file has upside syringe

through continue results. efficient we as the hand Raffi milestones. approach cash to call to we'll key take our Importantly, with fourth the financial quarter these over accomplish I'll managing now to you

Raffi Asadorian

Thank of milestones excited planned coming the Alora and via creation collect DSUVIA and reduced with closing and supporting cash long-term transaction. transaction commercial in Alora infrastructure work days, burn to to royalties from on value leveraging on value Alora Pharmaceuticals the transition you, We're DSUVIA sales. expected The through with potential to add the the the is Vince.

totaled despite commercial DSUVIA in investment XXXX a sales conserve reduction our cash. ownership of year initial increase $X.X sales XXXX a a believe in which after to period. was full significant increase transition XX% Alora's We DSUVIA significant million deliver over DSUVIA the Our will

syringe in NDA exist mentioned, submission, Vince near-term program prefilled Sera. As our as focus turns our nafamostat to lead potential Fed for significant first our as well now which milestones

focus to cash and investments. on with ended continue our and We the $XX.X year in million cash

$X.X fourth was to million the Our $X.X XXXX. compared and XXXX debt of totaled balance the quarter the end continued SG&A million. at expenses quarter the $X.X million fourth the to year Combined of R&D of for and amortize for

of quarter expenses XXXX quarter SG&A the due fourth other R&D compared costs were associated compensation to the for fourth of increase $X.X in financing depreciation million partially for expense costs, amounts million the fourth XXXX. was net SG&A offset and of noncash expense, $X.X combined The by primarily legal Excluding R&D December quarter in stock-based fourth with and compared and of and the the decreases quarter in to to these XXXX XXXX.

Sera and single $XX for launch initiating We an which for an expect fee expected related to our NDA the which this is of in cash for million under include of expenses $XX Niyad to the year. range second from planned in Fed to operating XXXX PDUFA quarter study a million, costs submission Niyad EUA, the registrational

now to over the call back 'll turn Vince.

Vincent Angotti

have. I'd line Thank Andrew? might the questions now you open to you, for like Raffi. any

Operator

Cantor [Operator Instructions] from ahead. with Folkes The go question Fitzgerald. first Please comes Brandon

Brandon Folkes

any all just And then my side continued who taking ask on a just question, Maybe I’ll just current on there just Can Niyad. DoD on or the then ahead procurement Are question have military drives of I’ll to deal? across to the will – involvement Thanks, my the I’ll DoD this you you start about civic orders? DSUVIA. with Vinc, hop Congratulations progress. talk DOD? sort staying the of

Vincent Angotti

Sure.

branches Coast even being have Air from purchased that within through military, purchasing DoD all different decentralized avenues of you when the particular, that Army, in Guard drive the the and the the different avenues. the Navy, consider you Army the So it it. And different is the that Force

channels the with, and Agency, the and Defense of driver, on those by Logistics often So, different that relationships of Defense course, it's centrally outside work troop Health the a deployment Army particular myriad largest a the these which Usama. of we though, Agency, channels within instance, with contracts military. for single the through will purchaser contingency for with [indiscernible] have Working be we readiness. so driven are The

the advancing It a to world year and honestly, in new just our relationships services. have around really is conflict These creation fostered for it, and takes tension for been with feel And we the challenges the potential level. over time. like the of past unfortunately the more the of But that U.S. here them time. we're the course builds part armed deployments,

going relationships, those to supply the and to those continue hopefully timing and escalate. So able drive them be right we're maintain as them quantity to at things

Raffi Asadorian

us. It's That Yes. responsibility, Brandon. remains our with

Brandon Folkes

to maybe XQ. terms of would submitting outstanding Okay. so then good Any just to We're probably just the almost sound together. -- that on And from shifting here two the quite Great. on EUA, at confident. go as you steps part you hear. gears Maybe in a color Niyad. in,

you then secondly, market you, is just here on on those remind Niyad, supply along this out And staying of that on you an as inspection? talk of XX% put of from then can figure EUA about think will in lines, given fair So just to And it terms the us very your manufacturing, just you procedural Thank today? manufacturing can much. need to just it in. ability you

Vincent Angotti

part can turn of I'll that Sure. some the first and it to Pam to to of over question, I it the as address continue relates supply. Raffi and

at part quarter pre working just research least you in that of last for And from -- to want consider we give hospitals this year of the of the we've the EUA been just really So year right started, market it to to to FDA year post-COVID fourth now. use quarter the completed post, standpoint, quantitative a the with elevated an you example if and preparation. on CRRT the think, in I in in post show a first the continue results

importantly, X have together to we remained our the put all has aspect, the and of So CMC. most work package remaining related

to So the ready package go. basically of the we've got balance

all If these discussions around the and of acronyms. early The on EUA the for I with the you the proper the letter recall, manufacturing product. concentration was apologize in FDA, three FDA's

over past our course year, has So, the of that been focus. the

important It's we've got accelerated stability. on stability. And as we mentioned, product that up got we've

that what normal humidity. the stability temperature know What Some of really beyond people might means. not testing that means and is ranges

off simulate and will be concept show in happening product. degradation is if longer that environments, based you you period can simulation to going extreme denigration a over the time, of stability of of the is So that time of

obviously is our very XX months us, degrees nonevent. humidity and GMP test room accelerated got data in looks sterility. at in that's degrees three temperatures, a a For and sealed We've one initial data accelerated It's of that remaining, And XX solid still good centigrade vial. test portion. integrate being with only release good the

So the we feel progress very on CMC. good about made we've

to We API for and suppliers ex-U.S. have the partnerships finished relative both related to supply products.

well to we're relates our on way this. So, as it

after full expect for The half EUA. clinical need one we question inspection of There's that year. start answer more an which our your the Did for no would EUA. questions, had a come next inspection Obviously, in you inspection. to for think which question. for I for about need approval, study, all The an second Brandon?

Operator

comes question Please Ed ahead. Arce H.C. with next go from Wainwright. The

Unidentified Analyst

This questions for for couple is taking a much Thomas Ed. asking you, questions. of Thank my so

are initial per thoughts topic commercial this EUA the year Niyad, can is pricing expect details and used while expectations perhaps what are a traction your on commercial about So, you we annual under and launch? for discuss approved borrowing patient some we

Vincent Angotti

Yes.

to under it dialogue Niyad, our goes submit this we're for in ability year. FDA again, that hopefully, the sure approval process for be the there'll So with through confident EUA, the as I'm

in a recent most And we study, prep either Beyond market is mentioned EUA. our believe we for as target potential that, we the the have clear. with commercialization to way

are and the our is considered which for health receiving care, That's anticoagulant to the standard people care. below United be ability will no CRRT, where real market in which of provide obviously shame States a

as associated combine market, particular, opportunity We're effects penetration, the you for planning And those because an it. working When side our on CRRT the complications market. markets it's in now. XX% is the second and of citrate the Niyad's commercial with two of

As of tonight Diego Dr. a the San time and and CRRT tomorrow. Palmer fact, at in matter are I meeting spending

this the forward I on We're pricing got We've just we next this it's But the of something for we the have with key as a preparation as an a from again, from target the of United call good the in Saturday. advisory competitive beginning but week week, internationally won't CRRT experts comment standpoint. States to this well on very board for evaluations, some known in about feel moving size market. start

I market important commercial that think this the of we United off This When other million aspect the in States to $XXX that's XX% and a large. talk is is is coagulation the sales segments. of practice about even anticipate the infrastructure. we occurring citrate require based large opportunity peak existing though a one not the

CRRT opinion be very approach guidelines. drive the top-down it It's the leaders off to expect nation that We modest. a key based in

nafamostat countries, we've those thought United has mentioned, South for and expertise mingle share outside I them. Niyad, years new the of separate a to U.S. the including used, nafamostat think cross The Korea. been Japan in the not important XX other leads and in is this aspect of concept States is with as

nafamostat known they this So asking have patients. be the their And them. available at-risk when anticoagulant is U.S. to they're for think we provide us so able entity a to to often can this we'll

a add do Thomas. of conducted bit research relative to that helps Pam, a color relative we've I market have most you that anything give CRRT? recently to hope to the it, to

Pamela Palmer

likely mean, submitted during And me possibly near CRRT. to about in No, able QX. in data do being I really XX% the medical amazing it's during now. we're very address any up the the in will treatment to in deficit and get not this we're that right term sort be because writing of published It of QX citrate. just and anticoagulation CRRT issues heparin patients of with excited

Vincent Angotti

would specific just would come. add, There's an of know when that don't no on don't should that. we -- EUA. I the FDA receive frame know we time review We

to know we come to if six that's or one month months. don't So come it's in going in going

this not be to this on way to point. any estimate would reasonable a expectations So give sales at

I we think more an later when EUA year. this detail give we receive can

Unidentified Analyst

Got it.

after filed to end is So, this just I EUA of expected decision a clarify, the by decision guess the year. so is the

Vincent Angotti

no guidelines classic that hope for do you'd they review like Well, PDUFA. lines they firm on have time

So as we in research the or EUAs could that months been two be have reviewed longer. past, month

we defined that. just a line on So can't give you time

is a And registrational year. that, beyond of are I forward trial with the in is are people some what's this second we asking and intending design already agreed FDA. beyond Thomas, the even important very upon with endpoints this by the think half about the to even trial EUA maybe clear move

I'll So on a there's not call, trial. how debate lot to of, execute left what this

the on comment the it's we've et execute. very made Pam, cetera, maybe you how on people preparation feel so trial, the on can clear endpoints, are simple to we

Pamela Palmer

end of and the been placebo actually XXX primary Yes, is is FDA active has XX trial. trial. key the patients, It's to the for a as small quite agreeable already endpoints which the secondary the

CRO with is of -- protocol And now. the finalization sites statistics moving for what actively getting so and right forward selection, picking clinical doing yes, we're the the

of part and up. Board a Advisory that's So our key coming

Vincent Angotti

the in And control that comment versus active Pam, you can trial. also the on

be obviously it nafamostat will So, versus.

Pamela Palmer

Versus saline.

Vincent Angotti

hours the is? Saline. point primary and end the over XX first

Pamela Palmer

clotting time. Activated

pretty So, a endpoint time clotting of study. straightforward. then primary versus hours it's your basically anticoagulant saline powerful as the XX first over at and looking the

Unidentified Analyst

Well, that's there as question approved? from to discuss for as be closing? the it. regarding commercial expect being ongoing Can market launch syringe the to And products. so PFS-XX, be just more of really -- path submitted I prefilled NDA also, you any us details looking just for syringe Got products all as soon one forward Yes. both the NDA so appreciate a the commercial will we prefilled first or with potential launch should clarify, and to

Vincent Angotti

Yes.

the staggered in prefilled are So fashion. developed syringe being products a

or product. can is now again, as Fed first name ephedrine syringe, Sera, ephedrine The PFS-XX the trade imagine. you one as trademark right or

effect. to Sera, Fed So something that

a be So XX-month that will review on clock.

market time, advantageous discussing in that contracting by well IDNs we've I'll purchasing period call we'll potentially be of We're the During but what encouraged organizations. with less the the group uptake seen really products. as the similar, as of

in ephedrine And by most the in of We an that? the and recent script mean not mentioned vial. what that do form, launch I vial but the ready-to-use following in syringe

draw they they're the having have use And table. to don't it have prepared it, if So, discard still waste. up, is they to to to it, going significant which

So launch. time, and is energy -- it only in year million waste on of in its completed requires sales potential or $XX second

So, advance safety this in need clearly the market. this particular there's quality efficiency in of a to and product,

going to very we're so that XX-month in here submit on order And short that get clock. and try to

on The will you're phenylephrine. balance It get the asking development We're be on we read with that and of That things delayed continue a prefilled in to two ephedrine. ephedrine, fine-tune syringe be would to submission, work FDA Aguettant. continuing the us which work submission so from it to will the after for to very confident will feel do a be as well. allow staggered that on do us, that to

Operator

go Molloy Partners. ahead. with question next Alliance from comes Please The James Global

Unidentified Analyst

then walk for And Pharma. also, expectations you question. for possibly you also, have This James could calling another And DSUVIA this, with And ramp-up is think actually of through do your Elura sales? the congratulations I on Laura the divestment recent with Mallooy. with in

hold to design in registrational expected regard expecting Niyad, to commenced to and study trial do you year? So, you're then you. the at expect Thank your that this when the be

Vincent Angotti

the for Thanks Laura. Sure, question.

on of comment ramp-up can't we So, the sales.

we to tell DSUVIA elura. referring between mode deep off its team, is commercial think transfer I X our mode with transition in were based that are to I their you on or What them can commercial divestment you team.

they're we procedural of commercial the personnel, As a one fact, absorbing matter all in maintain the momentum suites. except our to have

even will distribution. communication their based further their deep I sales hospital know they've team got off and that expanding training to they and us be

putting comment about excited comment I them, they're on commitment I it, going which from can't we're So, can impressive. and against do. only resources on is to forecast that their they're what a

relates has primary study the upon that mentioned upon have end with with been FDA. points Niyad, And endpoints it Those time. mention to as agreed As the that or a again, secondary FDA. agreed as are? activated we design been clotting we a the didn't The

Pamela Palmer

obviously, and et a concentrations, And lot platelets, the anticipate, at span looking they're we quoting also of at cetera. you're circuit that you're filters at they're Yes, how dialysis saline profusing is looking transfusions looking life into the filter those efficient so -- frequently. basically when number not the urea inhibiting more much

XX feel of there's point So end a endpoints versus pretty that clotting the first again a clinically powerful primary that. activated secondary anticoagulant key but just over time whole in important, placebo, host are being of confident the we hours

Vincent Angotti

think you working we're Laura. year. now as CROs And sites, second et cetera. the Dr. asked of based to Again, the half with this are about guiding I selection Palmer here just timing, off team sit we

excited to quickly going again, we that So as we're get one as can.

Unidentified Analyst

you, Thank for taking my question. it. Got

Operator

like would conference closing I session. Angotti question-and-answer any our for concludes over back Vince to to turn remarks. This the

Vincent Angotti

thank significant of syringes, Niyad for plan. and joining and We're excited today with about prefilled your make Andrew, execution really you AcelRx. in we all and of progress Sera. to continued particular, our stated Thanks, on continue support the our the us for you for Fed

on and late-stage you. thank questions focused this attendance, any And sharing with safe. Again, with please you I our pipeline. your to remain and long-term additional might advancing value future driving developments we high-value, you be look forward for answering look shareholder offline and have

Operator

for The presentation. conference you today's has now attending concluded. Thank

now may You disconnect.

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