ACRX - Earnings call transcript Q4 2021

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Operator

Good day and welcome to the AcelRx Fourth Quarter and Full Year 2021 Earnings Call. This call is being webcast live on the Events page of 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 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 Financial call Officer. like Asadorian, to now Chief AcelRx's would turn over the Raffi I Please ahead, go sir.

Raffi Asadorian

fourth Dr. year Thank you, business release Earlier our afternoon. joining updates us and Chuck and release. thank today, Chief slide you in a we the of call our website. Officer. me With this This Executive our and financial results Vince Chief in XXXX Angotti, for press our available and are accompanying Pam Officer; and this today Medical quarter presentation some full section the press announced Palmer, is Investors

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

Vincent Angotti

products procedures performed and in nafamostat introducing at DSUVIA are products with and focused with innovative painful AcelRx, added This Thank suites and Further, been is near-term pandemic. for as has afternoon, challenges settings. on despite syringe procedural that encouraging commercializing the to of development instead many ASCs DSUVIA new our and of line the to our encountered strategy supervised you, their realize value. the everyone. past for being In challenges diversify our stated pharmaceutical create transformational amidst development procedural strategy, significant prefilled portfolio adoption where and use faced is commercial continued potential multiple new well successfully on Raffi good and believe year we've AcelRx suites, advancing we medically as extend late-stage in hospitals. Accordingly, value our the assets hospitals short-term of catalysts, to bring focused now in product the

DSUVIA's we're and success and also as expert that today, update product for an patients in Dr. the can his call syringes us have prefilled candidates. the on renowned procedural nafamostat you So in for this as we'll acute internationally Chawla, and We'll the need growth well perspective join how these our expected injury, nafamostat need. He'll timelines regulatory suites Mink the kidney and paths today. unmet potentially on on address seeing provide

progress DSUVIA commercial place hospital So the let's in more settings painful promising start the with performed being which on but procedural effective. instead are recent ASC shift or and we've no the is by producing cost procedures just made providing in which update an Many are longer suites take results.

or lower and have and office-based from Similar procedural ear, shift patient better for higher procedural example, of shifted satisfaction, support to and ASCs, physicians. the hospital setting outpatient recently throat, suites. hospital for nose these to historical suites procedures patient an As from XX% ENT, economics into cost the the

typically rapid is as our reflected to anecdotal with in virtual fourth productivity our main the a cosmetic impairment, and in minimal shift focus. in sales increase representatives the the person in patient practices. the cognitive to we as compared procedural no Procedural commercial with is team. result ASCs. our same characteristics sales shifted and anesthesiologists increased orders QX significantly QX has to procedural plastics we few field-based DSUVIA of in and been number team last all we've growth and are typically calls in engaged In of in our XX%. of the was of over to the place representatives. on force these of rates our and oral pharmaceutical driven the primary quarters satisfaction. solid recent across priority and from settings the XX% of to a a in hospitals success currently most these key of with improved increase Many exhibits we've peak This quarter, and the effective plasma reorganized in customers driver to sales to quarter ordering efficiencies. of Beginning in the creating noninvasive quarter, contrast shift from products The surgeons. cosmetics, the focus single total analgesia specialties the use, reorganized the focus expecting on and and has driver DSUVIA's effective in of of resulting and scores hospitals And And We're commercial specialists we of is maxillofacial there was focus fact, support patient our commercial fourth by increased and efficiency result compared customers sold times surgeons virtual DSUVIA the of on key these feedback how this customers with increase team. suites procedural ENT approves in increase a number approval total ASCs, during of IV in directed XX% our DSUVIA access specialties, which levels and continued low units The customers for in XXXX administration third and receiving of suite period. customer suites are relief that are Importantly, cost this the that in and quarter quarter XXXX. plastic been which of shorter fourth pain been ordering of XX% in sales of high the supporting rely a the this third suites, focus, are satisfaction adoption and from reorganized And structure its utilized route not as solid reviews to setting. to

two of XXX we've XXXX, formulary achieved -- DSUVIA achieved DoD, the to including XXXX, of And compared our of quarter by approvals continued months this initial February of is suite year, Doctor-to-doctor in XXX. adoption. compared procedural months markets DSUVIA's XX, DSUVIA XXX the important XX%. increased first fourth our the DSUVIA. XXXX of to two December support Overall, to approvals education has 'XX we in of including target As the units first XX of or for as sold

a as the efficacy Also, is number to DSUVIA from relatively each specialists, with or when settings. experiences experienced DSUVIA, procedures as publications physician requests small of a these been DSUVIA this speak well Given their DSUVIA inbound plastic safety in recent the community there's we believe of administering physicians report publications of current cosmetic importantly, on key doctors with momentum benefits receiving sharing setting. in specialties. customers with and we've about other the these real-world as of is providing in positive to DSUVIA outpatient and profile evidence upcoming Recent many on and the continue further focused

encouraged commercial So progress settings, to there's to we're say, being albeit go. recent suffice long it DSUVIA certainly by way in very the a the made with

purchases deployed further purchases of Regarding enable Army of Prepositioned in Defense, we begins begin for their continue wait the The Stock as approval. purchases We're Army to the make expected and XXXX expect Department sets, prerequisites C once continues and kits SKOs. supplying after to unable we the back to begin SKOs. to outfits, their or to increase Army the administrative program we troops but for for U.S. DSUVIA the these Milestone the estimate timing to an these SKO-related of logistics

However, has ago. XX encouraged finally that to planned XX were months we that initially the are DoD studies initiated two

emergency University on room the second at the performed being Center at hemodynamic is of Medical University of including is being of and first focused patients Texas Southwestern stability and the the opioids, on focused The DSUVIA Pittsburgh is testing of is and in performed DSUVIA. Medical Center the use

these FDA-approved are ready-to-use, syringe these undergo will believe, ephedrine we syringes, component regulatory The drugs. prefilled In DSUVIA Dr. July candidates, we expected unmet a recently pharmacies process Breakthrough delivery pathways. FDA product believe in ephedrine Both regulatory the hospitals the our me assuming and pharmacological prefilled recently in our efforts closed novel in the U.S. our military more phenylephrine prefilled Niyad relatively The studies, for the indication. for acquiring the published circuit and commentary from to product system. November, concentrated that our Despite anti-coagulation for and used, operating found phenylephrine ephedrine January let acquisition needs fourth for the year; in-licensed meeting prepare addition since And We through publication candidates, the we including the early some a we successful January. products for of which is are pain In as and late submission initial of DSUVIA deadlines purchasing this DSUVIA medicine And are of proposed a submission, battlefield's ready-to-use of of call in The second next from straightforward extracorporeal commonly management. the commonly nafamostat product now and late having demand in Aguettant. that provide in their quarter evolution cart. In over products identify this limited first of battlefield are compounding our continue to year, year, in by partner Lowell request you with NDAs missed and received pipeline. Device of new address development expected meeting agrees this a nearly ephedrine, from FDA, properties Designation hand European details planned with to advancing Therapeutics, two in prefilled, branches which today currently Palmer, quarter, submitted pathway shelf-lives. studies we the conclusion syringe across have markets acquired products favorable both every I syringes is after ready-to-use noted phenylephrine, further room on to this Many evolving two could phenylephrine, and FDA two before the the the with Military. vials. used the are and the the our last these

about nafamostat. and continue Palmer in a products look portfolio. Dr. there's excited submitting acquired we number for pipeline our for of of Dr. product these Chawla Dr. sale reasons, forward So now we these believe the available pipeline, forward to recently including we these in and this Palmer? discuss and look products. feedback million will the acquired from potential FDA excess year. $XXX We're receiving have products to NDAs to for And market recently investment next a our opportunity to

Pamela Palmer

impressive, adoption recent by oral seen their and in Vince. with rapid we Thanks, surgeons. plastic, ENT including suites, the use The procedural for DSUVIA have progress is physicians especially

forward time While two advancing AcelRx we we it are FDA syringes the as these the exciting development for the days our and DSUVIA, become has moving prefilled clinical remain really nafamostat a filings also focused with side on of for program.

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has Niyad for Device explain drug Designation our Importantly, call by potential Nephrology nafamostat unique clinical FDA today. and Thank code individuals used that move XXXX of on the the endpoints Chawla nephrology joining been have To commonly already with you, critical citrate design previous Award also been is used Mink Chawla, to single which by into advantages by been heparin Vicenza anticoagulant." Dr. plan are we and introduction pivotal recognizes active and International a the kidney us the frequently the CMS Niyad for for "extracorporeal of anticoagulant clinical less FDA. lots field since have acute awarded manufactured, once clinical Dr. the informed care Care recipient our the a Breakthrough advancements of made investigator given who injury. in in the Niyad, Regarding of ICD-XX has progress research an with procedure anticoagulant in over Critical XXXX study seminal the

Lakhmir Chawla

use. as is introduction. for injected as there else an of much Thank the Heparin long you, choice dialysis Dr. for available Palmer, wasn't to dialysis Heparin circuits, been into machine. anticoagulant has that used kind frankly,

the However, the hospital of is giving use as a avoid giving the in have not disorder, systemic develops to long heparin, it liver actively for patient is half-life and hours reverse balancing with anticoagulate of known regional awry. three are risk downside to as since infusion citrate its infusion contraindicated hours issue, and must to arrest. is concomitant patients tachycardia of filter. heparin anticoagulates citrate This bleeding citrate But as hypocalcemia, due classified and bleeding. a well patients to six easy is anticoagulant, filter major after often this up risk machine. cardiac with of by another passage If up avoid a It To calcium filter ventricular function a in patients patient delicate patients be toxicity this the is balance for to dangerous very to the the to can of is citrate of a be and a of can effect the liver normal it because system. exacerbated the bleeding sick instead calcium lead dialysis can anticoagulant used five and who as This impairment, it of dialysis go to in patients. with also heparin. heparin Low therefore, is and as calcium, it infusion in through dialysis with reversed act one

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platelet these in the filter-clotting and results patients, For patients. for loss losses blood

of cost will the time the of all, filter the kidney favorable Nafamostat very to and has efficacy able a treatment half-life care. Being frequent just the profile. of dialysis to minutes. anticoagulant most eight hospital. the has transformative clotting and, another efficacy Nafamostat have with undermines be nursing short increases option for addition, of In injury safety a acute citrate same

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Pamela Palmer

would pipeline nafamostat developing or nafamostat the Korea would Chawla. Dr. in as also manufactured an potential under the now an for EUA which uses to years pancreatitis. LTX-XXX. South drug for utilized submitting here well like on as for advantages which that an are once I EUA briefly DIC, Dr. in as disseminated and are many Japan for clinical to over has due of been is in we you, lots intravascular as to Thank U.S. intravenous coagulation, plan Niyad for approved IV mentioned, the like add being our I acute administered treatment Chawla as discuss citrate we

COVID-XX in benefit a against nafamostat of journal Lancet survival over on in ex that influenza. the eBioMedicine on outcome The study positive it recent very IV in multiple ongoing was reported A nafamostat countries the is Group. care COVID-XX. currently of standard which treatment There group the Another use interesting exhibits of nafamostat studies quality are U.S. in including is of for and properties, antiviral both

these impactful to of are hand DIC now are COVID-XX progression the disease call Vince. of states nafamostat and options. indications over areas to in of the forward move both on pivotal exciting few there I'll following very We where study. back treatment the All uses our LTX-XXX, currently and Niyad plan into for

Vincent Angotti

supervised unmet U.S. regulatory outside pathway status, of Thank hospital from other Palmer Designation you, the benefits years use a the Like Dr. efficacy approval hospital. and provides the there's Niyad place Chawla. and to believe large for outside DSUVIA, also its given gaining in the arising medically setting need. in but its safety Dr. and a We favorable has data Breakthrough use settings medical

As already with you ICD-XX reimbursement just commercial and adoption after we've which also heard, code for launch Niyad-specific provided the been a should procedural clinical support approval.

we Importantly, an for Emergency have Authorization. strong believe Use we a opportunity

product next we submit So an year. early once for the plan the manufactured, we Niyad to an FDA targeting application for have to EUA

of We expect and call the we this and market year, KOL to this which potential have quarter alone. additional in investors provide peak potential $XXX sales analysts insight new the have second million indication for first asset time, the into excess for at in a we'll believe can which clinical of

additional the in back to We're or launch Europe. few updates. DSUVIA-related about DZUVEO a DSUVIA moving upcoming of Now excited

focus DZUVEO proceeding in to oral also expect have in activities. to our third launch Dental transfers is their with The nonexclusive. they make and which prelaunch settings also We the our we're very as aligns now all busy nicely. announce that the Zimmer will procedural to partnership We're maxillofacial on suites. This year very are been allows Aguettant quarter now us with the completed DSUVIA change with known collaboration currently able happy commercialize of increased this and Biomet ZimVie regulatory well

expecting line, submission validation that with our testing end equipment for commercial now delayed of We're quarter after has line our which approval. our materials, the activities. quick regarding this very as to packaging a the additional warning a have are of to satisfied has in received XXXX. the date letter that We're of certain packaging contract closeout expected update FDA promotional for announce XXXX happy on us that FDA to produced the the regulatory we approvals FDA targeting beginning performed we're As requested And in batches received, to final and all requested expected currently letter initial at has XXXX. relates be batches first be manufacturer automated February year, informed in the it

filed. the merit And handing that against over securities I'd financial before to lawsuits to briefly Raff? been I over intend and take have Raffi, Raffi them. the to quarter Finally, believe address these call the call to To you defend be that through without we hand vigorously results. to lawsuits clear, like the fourth are

Raffi Asadorian

Vince. Thanks,

Our senior million with financial position $XX.X remains and in at XX debt. December in cash $XX.X million strong

we maturity in continues debt each quarter Our to QX as reduce reach level XXXX.

growth financial our returns Department wholesaler. strong Our fourth quarter results record a on the the XXX% the for XXXX reserve to made of to in not unit was to need in sales of due sales reflected Defense's in primary potential

to we primary regardless, the the of by the Department wholesaler. recorded customers. for secondary continues unclear secondary majority we two It's purchases principally in place are wholesaler continues by from to sales reserve first the Defense orders sell. suite a months also the purchasing have which held inventory from the they growth a continued Although procedural to But quarter, for only unit sales customer first DoD DSUVIA, of make Strong to the driven why wholesaler. the of

we to expenses, or compared procedural R&D $X.X in continue as suites, combined Vince Solid to in throughout were $X.X expenses, as expected million XXXX SG&A of XXXX fourth in commercial quarter progress make earlier. is XXXX. the Operating and growth mentioned million

operating and $X.X expenses million. were expenses depreciation fourth in fourth decrease XXXX cash in mainly compensation, the by noncash personnel-related reductions of stock-based driven The quarter costs. quarter operating XXXX was Excluding in

quarter. second include the for two submission year-end prefilled NDAs pending outcome XXXX our product expected syringe in of FDA Our candidates, of feedback goals the

development, to amounts million approximate approximately quarter of approximate line under Niyad $XX from million million $X attributed year. to is the advance being company to combined XXXX. million pay compensation $X the which of of excluding Vince. first depreciation. for the priority the the $XX $X the I'll also outstanding FDA expense SG&A and Emergency and Use validation the to R&D at next manufacturing nafamostat in expected be debt batches early initial now million million, facility service We and support that to Quarterly to debt Authorization back expected our with down stock-based as expect nafamostat could to second contract are final senior automated CapEx expected call $X mainly continues the AcelRx's matures its to manufacturer. packaging turn to Annual of Annual the is

Vincent Angotti

an the for continued batches and approvals two those Thanks, Raff. open of any FDA value the excited penetration with nafamostat, line Operator? initial We're prefilled catalysts very the syringe to the the Aguettant; We're development future new application about FDA potential upcoming and I'd DSUVIA including registration the DSUVIA and products; device EUA by readout over many with into single Breakthrough and manufacturing have. of for the for launch about like and excited late-stage drivers, submissions you our of transformation questions procedural study the suites; Designation. assets. Niyad, initiation we've made the in now potential related the the NDA of year a may and of Europe for our past our the partner

Operator

first go Instructions] ahead. come Cantor Folkes Fitzgerald. question [Operator from And the Please will with Brandon

Brandon Folkes

and you for one thank today. for on the thanks a taking information Hi, Maybe first my question just Niyad.

approval want pathway the just on regulatory here. to I So clarity get

suite, two -- don't then in on the maybe sort us volume maybe we about specialties those change in DSUVIA of get understanding an or focus about company your Secondly, that marketing in additional in hospital-based together, how studies correct So do this pathway? and it EUA, if to are DSUVIA does virtual seeing the sort just get just you looking then approval procedural are would you building be look color EUA? am I of a growth potential a the there? you And broaden And the the some bit on a of you're I And beginning of future? products willing wrapping heard give wider to this think XXX(k) with but in maybe for year? that the questions maybe focus

Vincent Angotti

Niyad Great. first studies. can Thanks, it. start informed FDA. additional has which pathway; We'll the Brandon. in of been I Pam the I of And absence relative on, clarity with kind on your already think, appreciate then EUA the some the to that by and you give that, question

Pamela Palmer

Yes.

So the forward be initiating the after to forward applying clinical for trial. same Phase plan we'll to making an III At is the move GMP the time, lots EUA. moving

know, that actual It's this EUAs their long extracorporeal in a the in for circuits need situation just hospitals, not you are issues. have been COVID-XX suddenly that obviously, place has As of just approvals. is people with increased dialysis, a time using many for

actually and primary PMA. be injected it's So the in being we a machine, as it's will it's the pursuing though is body. a action Even mechanism into a machine drug, because device regulated being not a of its patient's

So we will be applying for that PMA route of regulatory approval.

Vincent Angotti

we're the can size the adopting comment from Pam, informed originally you just it's maybe moving on FDA primary study. endpoints the that and Lowell and forward, the design by single fact a been study again, And that's the quickly

Pamela Palmer

Yes.

group it's study, the study, a XXX-patient XX single the placebo a it's group. nafamostat and study, So XX the in in

primary So time. straightforward. The clotting very activated endpoint's

things different that. of like Secondary used, endpoint's filters number

very EUA this to it's we're option. And fairly be easy to as pursuing really that doing should well So looking forward enroll. straightforward, as

Vincent Angotti

Did that Brandon, the your have first required on addresses part of you any that portion? question. clarification additional

Brandon Folkes

have what at that would in the placebo? run ask he -- a does if that head-to-head think about against he Do think to Maybe going those stage great, think versus and design he I for about? can So adoption, does some just you talked was you options him, Vince. here KOL bring study

Vincent Angotti

Mink? question. Great

Lakhmir Chawla

Yes. Yes. Thank you.

So I think that's a very good question.

this But trials randomized, controlled to in would have in leverage been Korea, I adoption. and definitely have a want large very think that I think that works endpoints years that to drive well. study the a I nafamostat XX-plus and Japan head-to-head get numerous very, the we conducted XX-plus years in circumstance, scenario, you normal where think to South in have

I think in to experiment. my colleagues represents very my Korea, view that a natural me and interesting speaking to in South

Korea the South nafamostat South no So that citrate both anymore introduced in of is citrate what because they And occur. had toxicities Korea, and was significant serious in when find can very available. uses nafamostat one you

of is So as high. for work, like large do body this I consequence quite speaking my in that a with something colleagues, of the and need believe

shift." I outlets, paying that I'm we think to can been over in previous my the honest. anything to came do someone is this together But many the And I the paying Journal, have need If Street or covered many do give having lot administrators did nurse your and well, them into The a and workload ICU devices it's say, efficiency. and intensivist, value, they to or many, other putting save be job shortage. all thing their a done. which shift, and entire to we they'll for full it's our that it's have COVID, covered a the nurses covered is time, the shift. break people been that an options, improve her of have entire going career device, have I'm a get are every said, Wall massive drug in hour to that for him XX can And whatever is media and nursing a decrease the hour not equal to "I this going minutes charge and drugs as and They nursing value. been other do

an say it's safer as work you nurses, staff and doctors arguably is an and option to your becomes a And you that's it have, so I into into is have the just mask, you intensive to gown think care we and walk when that the don't the get what less effective attended. and And and unit you that why as very the lot to attractive the at and a quickly. five times shift, did and I have saw doffing and I gear just this room I the meeting enthusiasm donning gloves, very go your

at do citrate their And and so is historical do we'll to available But I people how head-to-head did citrate our very we is -- Niyad. thing system data quick they will we look look with since X, in nice that ecosystem, own patients at data. the XX, and that XX, want XX can think with with a some see can the

is do in drug do own is And patient to with so read referred you than they'll their own be your with own what more and these able techniques. something journal, And be they'll use which to hospital you assessments, This segment believable generate in common. as able your your the own always things very data DUAs. to

market So that profile which I previously will lot safety a for something exists, better of and quite of rapid the nurses, that the think that record, there's work the large efficiencies I large to to safety makes reason the believe adoption. expect physicians this see body

Vincent Angotti

your satisfy relative to that does Niyad? Brandon, question

Brandon Folkes

great. Yes. That was Vince. Thanks,

Vincent Angotti

Great. branch other into We'll your Okay. questions.

you're adoption of can and majority of aspect seeing are a but plastic extent we suite often lesser in our and oral growth? maybe I So cosmetic surgeries. the procedural was from surgeons what sales team time, you it your Pam, and inquiries concentrating the ENT And comment second we're the driving virtual these efforts, what the are around and on when team, that specialties the have on can And time and you why believe DSUVIA. mentioned, maxillofacial. you tell plastic most our I to used to and cosmetic and

Pamela Palmer

radiofrequency, incredible. them procedures these painful, surface invasive occurring, even they're that of anesthetic not these reasons suites. and not-as-invasive really very give there's done being And the that's done physically. it's DSUVIA quite with hours, with just to Well, awake are surgery procedures growth are Sure. these have them that that And procedural actually is the ability microneedling, pretty patients. comfortable of the extensive that cosmetic very are having along though take for are awake they painful, surgeries also -- there's local Facelift, use, in some really being liposuction, that amazing the

good in all their had being pain the we're getting able really with referred great practice dealing to tool. they're try with that fact, our really procedural moderate-to-severe it. communication doctor-to-doctor to So really in able and is they've to each the to feedback. other success changing really use And such DSUVIA earlier, Vince DSUVIA, almost to best once it's take They sales suite be which and encourage

Vincent Angotti

talked for DSUVIA? procedures, the maybe that procedures where has have for you've used reimbursement Pam, few advanced of really of And where a an already to ENT, those physicians office-based example

Pamela Palmer

interesting. Yes, it's

We're is third-party in savings physician improved they're They to instead office The jumped just but can procedures. It's for do painful. those blink more ambulatory center a gone fully in last from local ENT lot for has the so they invasive the very the has cost While of Sinus very techniques hours what they when just amazing the suite like of of They're numb septoplasties, ASC. some their slowly a suites, procedure use the It's with good they're plastics X.X There's if surgery savings eye, Balloon it reimbursement cost procedural overnight. suite. away about now. areas these doing seems some dramatically there an self-pay. office anesthetic. Dilations. up And with in procedural payer. many their the almost procedural is the into field It's procedures an patient and again, there's ENT specialty can't quite for talking doing the efficiencies a

their again, hearing changing what in use their is to are office. DSUVIA, So really their do of comfortably we they're practice and what able

Vincent Angotti

looking little think we around oral lesser time million just plastics, the When extent, and that and look we're to more annual around a ENT a brand. between on XX.X spending at we're where I at procedures maxillofacial our basis. an data opportunity

procedures with does instance, a suites. have the very are So also issues OB-GYN moderate-to-severe include or not currently gastroenterology for not market. pain office-based areas that conducting procedural That we going their into, in large they're that

on early and and our extraordinarily an We're maxillofacial oral the beachhead plastics then it's large trending our just a ENT by into own. with So little market. little building

multi hospitals, of market difficult and opportunity because yes. around beyond with virtual the procedural allows third potential single hospital us of if pivot really be Look, to your cetera. was today, And long given And I this would to still now answer could look But us our reach you suites hospital think particularly, just markets. but to the more the does question assets, DSUVIA our ASCs my this out allow for other be et broaden with you component be the but the at portfolio and in these an term decision-makers. will DSUVIA swiftly. to Prefilled long in Niyad know will but hospital. of sales to out that you adoption, the term, for really for hospital And hospitals sales us. well. more we allow surgical the move opportunity contracting the involved has be That's the centers then where cycle of syringes an an the ambulatory as still from are decision-makers protocols, team. in be all hospitals the the important But have

kind for criteria centers. developing boundaries of for see critical certainly hospitals been So attain to assets. you as the we've outside to in dialysis the care continue looking the we're can as Niyad but hospitals

our So certainly it's versus want broadened of now settings given question? flexibility. to components We medically retail all and that Brandon, your it did opportunities forward. moving supervised the remain has in but us application answer

Brandon Folkes

More the than really well. you, Thank Thank you. I Vince appreciate [ph]. detail.

Vincent Angotti

Thank you.

Operator

next Wainwright Ed from & ahead. go The Please come Arce question with will H.C. Company.

Ed Arce

for Thanks Great. taking my questions.

wanted just I about just better to financials, quarter the firstly, question understand here. So fourth ask to a parts moving the

-- X,XXX up in units X,XXX the in quarter -- multiple. the substantially quarter, X,XXX fourth the the reported from third you for So X.Xx

the multiple, apply XXX at the And and get that to fourth third the sales so from if quarter quarter. for I of you look XXX

the understand of it's unit decrease, I the $XXX,XXX still if take even So significantly growth. meaningful just off reserve a which I was based out short

there some I here regard. efficiency So in then that of of was understand just trying to have sort what would some loss follow-up. if appear a be to And

Raffi Asadorian

Ed. can loss think say Sure, I of efficiency. don't you Yes.

not -- couple more basis. is keep I'm they're volatile. mind, that or keep a on It's procedural infrequent regular or like of ASC, sure the fluctuating a purchases of a purchases what Just volatile suite there's much means. in the or things But regular on not and in DoD purchasing more even where mind, a

quarters. between an impact there's So the there

had impact. because volume growth all why that true it It's is So disclose the to nets. growth -- of of in sales. we a how the measure But volume doing some certainly we these to free that's the between of that's of and measure a is terms decided the an differences gross are

you that's clear. to just we what if you So if the just understood sure I'm out efficiency your actual question tried take not but necessarily if out do just take the if and by on noise I the showing noise, that's units,

Ed Arce

I'm sure that sure understand it the What's in mean, in I'm terms can not units what the driving of But offline. growth there's we differential not understand I -- the exactly Yes. differential? versus And disconnect sales. a the in I growth I is. discuss there further

Raffi Asadorian

compared has suite there's factor, much for mix changes other a discounts to one different procedural it. right, price between, our sales customer is prices, at discount the a higher that to the a reduction very temporary has associated DoD, customer which limited with price example, -- there's gross Yes, say, that

units wanted to to customer there's terms of and mix there to -- is try not that straight in So very But just we issues do difficult that comparison. that's the a to in disclose we're why make in DSUVIA it clear. growth the But clear. but maybe guess with make terms compared how well clear of it actual quarter. doing didn't it's tried we I the last we in to to

Ed Arce

Right.

Okay.

should I the fourth it's commercial year, think terms related the been It here been operating this, in given in for we rates sales thoughts this that you The appreciate terms sort would down in net of guidance light around especially it it But growth, guidance we expect and would we been say of expenses on to and could quarterly it's model the helpful, a basis. the how entered not overall, other year that's clearly, It's of provide well. launch. in to here. particular, in CapEx did could fact if we've think still of fair be guess. about I of question the to and as cadence the But be now growth was the and I up understand helpful just DSUVIA. your difficult the

are thoughts the trying here understand opportunity in what on your XXXX. Just to better

Raffi Asadorian

going Yes. We're to not give guidance.

that. I and fail we sales product which put given launched to the the to formulary but want out a think we've we've so number in. come haven't fluctuation the always and we've Historically, approvals number always on exceeded of guidance there since we much meet don't experienced

for And growth. point we're not to comfortable of I effectively hey, to that sales to give if give see we we yet to we're unit translate future but year. see, comfortable growth us the that in at starting the see give not -- the believe see we're frequent this in don't time. that say, purchasing think asking but that to -- to terms that you're let's starting more starting yet do we're just And we're growth prepared we're don't in in guidance yet we that. But revenues and to Now unusual here's -- continue might we to to

Vincent Angotti

Yes. launch, years, everything continued first year standpoint. And up you to say then that of I'll the kind hit. four going Ed, when blew from a COVID on guidance of on. And you, within remind from And it's just fluctuate that point it's

We launched in So 'XX. it early quarter really was the XXXX. second that of

future. that. But suites So today, we'll The procedural to can remains steady hopefully, at us grow in look do we at we and provide give continue COVID how operation bay. the the a guidance to hesitate

Raffi Asadorian

And I'd add Ed. one thing,

for estimate as in after the approval, and were the -- can waiting imagine. C the Milestone you the that biggest going sets, opportunity and believe near-term And close you straight And as has we outfits, was very prepared -- That is biggest Department remarks, C Defense, not Milestone As happened begin the pretty and have big single the yet mentioned that's been to of difficult we the that kits we've our approved. since Defense, know that we don't to since biggest to one transparency customers. and XXXX, of a Department into purchases of forecast.

growth certainly expect unit it, purchases certainly hesitancy So that. side our seeing that that's that we some -- we of the here. are in And continue. of the we are commercial on But to take solid our out growth business,

Ed Arce

for much the so appreciate Thanks [ph]. I it. time Great.

Vincent Angotti

Thanks, Ed.

Operator

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

Vincent Angotti

again, the past certainly the We're forward made operator. for course future near this our progress as we additional us Niyad providing joining over prefilled next assets. with look and the about with both excited as of late-stage our here and future you stay to development/regulatory well in DSUVIA over the you, transformation please Thank related to Thank new syringes and safe. development And year. year we updates this our

Operator

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

now You may disconnect.

Talphera (TLPH) 11 Mar 222021 Q4 Earnings call transcript