TRVN - Earnings call transcript Q2 2021

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Operator

Thank you for standing by, and welcome to the Trevena Incorporated Second Quarter 2021 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your first speaker today Barry Shin, Chief Financial Officer. Please go ahead.

Barry Shin

everyone. welcome, and morning, Good With me Bob Chief President CEO; Bourdow, Officer, are our Chief Carrie Yoder, our Demitrack. our Commercial Mark and today Officer; Medical and

turn meaning our making As we'll for undertake these risks covered business and our statements forward-looking in of to to federal statements quarter I'll related including now with statements are a subject securities an recent be within business, update reminder, uncertainties beyond our These laws. Carrie to the of to those the the no SEC. accomplishments. over obligation second We and overview call today. Carrie? filings

Carrie Bourdow

you, Thank morning joining for us Thanks today. Barry. Good everyone.

the the because excited in of goal The times We've can, be recognized launch. at delayed, wins have now profile OLINVYK both a we impact second but our of quarter. sit quarter and continue adaptive five the we're lot by formulary interest and reported have remains of and physicians our with formulary last and has COVID that been field, our we're Linda to the on full to timelines get approvals, and over value we sales excited number And formulary XX focused be quarter to we OLINVYK, three XXX our pipeline. a clinical year-end OLINVYK on months an had focused marked present first that with in the and when OLINVYK on team track the and we have about, metric With reach customer data front their strong proposition. the

the build We've started positive unique on getting two feedback new have chance use to OLINVYK. to already also we're OLINVYK's profile. studies from physicians, Importantly, who

middle important with is Patient led interest three is by first on X Cleveland areas to start us this about: respiratory, cognitive expanding of Cleveland that Clinic. function. data that enrollment next outcome quarter and and Clinic GI findings care in upon year. came expected in to safety Phase physicians top-line study Remember our an clinical is The track a

The second is individuals. builds This is morphine versus underway. work on enrollment patient elderly effect also the OLINVYK upon evaluating study respiratory previously and and well in function published obese study of

expect data this have of this for existing our year. the III We outside finally, is our advance China sufficient approval by complete, expect continue package recently study Phase the to to began in data towards from patients top-line U.S. submit with OLINVYK OLINVYK end dosing partner approval. it trial. we And of in to combination their that Once they study in Nhwa,

pipeline in pleased our by led by advancing TRVXXX globally NIH. recognized we're patient OLINVYK, Beyond Vanderbilt institutions. Center through the was first the and enrolled which trial, is were COVID partnerships Medical active with funded being University that We

study of our modulator, receptor few for market with pain novel SXP people diabetic NIDA on track has TRVXXX resumed and to For options X condition TRVXXX, Abuse National Institute file a significant quarter. And opioid neuropathic Drug this our disorder. IND affected opportunity on their the this or available. we're painful by use DNP therapeutic for million is

launching COVID to a public expertise highly in issues. COVID toll skilled products, developing a prior both Trevena pandemic, that crises I'm playing and health proud pandemic. on we our continue And public other to that it's team role the largest the with As health To that a we about we in for during forget the take now close, battle of communities. don't the some important is solutions have

to reach our a soon, have product well the We new resources, goals. and launch and we're strategy, coming great interesting data year-end positioned

talk over to OLINVYK turn Bob? launch. let more that, me the about with call Bob So to the

Bob Yoder

XXX activities. the of field But XXX formulary. make time, evolves, are to quarter With to accounts At complete, as first year-end XX OLINVYK Thank at so progress COVID added and our of launch continue goal impacted currently we reviewing institutions that same wins. the Carrie. towards our formulary we. no pandemic stages various it's are OLINVYK full has that you our surprise

at. Through the of we're engagements industry holding favorably live compares which around rep were XX%, at where to Here's end May, reported benchmarks. really up

Over the shutting as of that see weeks, past have engagement to we've started six eight started again. decline regions live down level to certain

here's formulary what are have is consistently to the slowdown either during customer, when have we positive. delayed. further summer a historically seasonal which able we engage or the Additionally, reviews, with months been response know, live virtually, But

unique OLINVYK's hear with resonate that physicians. proposition We continue profile and value to

feedback ambulatory the is we're procedures, setting and opioid hearing point where an example, as that discharge. minimizing impressed of onset for attributes OLINVYK the postoperative so clinicians use Physicians of duration setting. all we're gastrointestinal in but to And in IV main profile perioperative such that the two are effect setting, through in the particularly great For of them hearing surgical about to the OLINVYK, inpatient necessary, is the OLINVYK's adverse way with events allow use patient tolerability GI rapid as open vomiting. the use the

our assessment We decision-makers, model prop for like and opportunities on health Based of the the and positive health committee the P&T care traction for that members, economic expanding found we're to access be know beneficial outreach in OLINVYK. OLINVYK. full feedback, very also have early their value

here's So there. we're what doing

can other important First, top MSL To medical physicians the can influential centers OLINVYK five approximately who we are physicians during our medical as stakeholders science now plan advocates large this, at we're process. so institutions target academic and who review serve more institutions. to adding liaison formulary do target XXX full at team key that

modeling. OLINVYK's PharmDs deep health data got health experience with experience in economic data. to Our comprised They've team right economic MSL and and compelling the and credentials profile is of clinical communicate

field and tell OLINVYK. us growth We're of closing, target and Second, we're approximately moving through additional the wins to things coverage launch a accounts In for These past outreach professionals OLINVYK. virtual to differentiated We like do and extending of the we from care represent our representing additional hospitals, the XX% hearing using opportunity value high-volume they of market. expand expanding IV this XXX we to to accounts this they approximately our list over number how that to customers opioid accounts. of process. our proposition. new pandemic, positive include customers, health height environment. the started significant MSLs are review And P&T of front our in formulary OLINVYK's the in who we tripled hiring get to we're quarter, grow When are a this accounts know and at profile continued our

that convinced expanded is coming again, and environment. shutdown severe we're acute OLINVYK possible the certainly value an of as all change return the brings am we pain. firmly management of as be we not steps the taking positive I long-term in that While if to to to hope effective it

Mark now over to provide overview where me call turn quick the Let of with are to we a pipeline. our

Mark Demitrack

Thank you, Bob.

many support you've at important which studies. initiatives among University post-approval to As OLINVYK, launch Center. are Medical conducted with and clinical Leiden two implemented of heard, the One the the Cleveland collaboration other we've Clinic in

scientific XXth the already literature announced peer-reviewed recently strengthen manuscript, OLINVYK of continues customers. to also base substantial available evidence our publication to our which We of

We key our recently compound nationwide we've move assets evaluating University supported OLINVYK, were to TRVXXX, led In our with the pipeline advance dosing and patients. to by trials ACTIV our announce to towards Medical continued progress pleased forward. continue that NIH With by COVID-XX the Center milestones. addition Vanderbilt to trial platform began two

UK ongoing. In activities in addition, based the start-up trial are for the REMAP-CAP

REMAP-CAP all and trials, prior from the Imperial interim data this to also an Imperial by eagerly and that end. concerns enrollment are XXX, study research year acknowledge report the the to completed top-line College transitioning study committee. That College to study's second the study's progress quarter, with interim awaiting the expects analysis Recall We our advancing monitoring their proof-of-concept at review safety study. on pain. underwent team organ file by we found supported and our And forward London's the into in outcomes associated neuropathic and And that no impact COVID-XX Phase data ACTIV the Their disorder damage, quarter data XXX seeing safety and in studies for compound. TRVXXX, modulator with opioid tells With their use patients among TRVXXX, larger diabetic to screening mortality SXP X what We us recovery to is endpoints. efficacy proof-of look TRVXXX’s currently for the receptor severe trials NIDA this planning we're on novel finally, mortality begun about study. from patients. for IND this development track for program these

to few next pipeline. look make months, we to continue the forward updating you progress I our across Over as

turn now discuss the to second our to financial Barry? Barry quarter me over Let results. call

Barry Shin

environment. pandemic OLINVYK, reported in to We Mark. net today QX longer time in XX formulary for in and due this lines Thanks, $XXX,XXX sales part wins

formulary in to hospital continue best the We launch. leading the believe are these indicator wins

$XX the This was million loss with of compared quarter same net Our mainly the expenses to change is million launch. associated due the to for quarter $X.X first period full OLINVYK year. the last for

was quarter million our fund and continue Operator? the the advance Carrie half our cash will moderately finished second OLINVYK pipeline $XX after believe for as call operating remarks. we to We'll fourth now in equivalents, provide commercialize we the Our We in $XX.X this to the quarter, for expense and expect quarter and increase to assets. with we through of million questions the some continue operations open closing will which which XXXX.

Operator

from question from Cantor much. so [Operator you Brandon Thank Fitzgerald. First Folkes Instructions]

line open. Your is

Brandon Folkes

about my taking elaborate COVID, any there? change just firstly, this reorders Maybe stage sort seen the just talk about this expand things very targets and question. getting just some stage? And in maybe on for OLINVYK, aren't to then obviously, initial at used the you the of Hi, terms the there's this the launch. product you thanks of you've in if fluid. where Is Can can decision just thinking of targets converting at

to lot And those lastly, putting versus you're color home just drive work target expand initial just at any decision targets? of continuing in a this on So that to next to lot the results stage produce the formulary? months asking a the you XX those OLINVYK. very adding Thank see and of of accounts wait data you. Any on over ahead to to good then

Carrie Bourdow

Thanks Brandon.

it and for then Bob to the over So I'll additional on start accounts. color I'll turn

still integrated getting we had that's seeing great. couple we're and Early We've tend initial we're fewer actually I was the where have on, that systems that. had think, academic we processes, some So what fact formulary community for get seeing. would had, of wins. which medical the used, to in into come health And we're we because into hospitals come described they use centers mix, large

really that's I centers seeing because, think ambulatory We're interesting. to tend surgery they fewer processes. have also again,

the it's So with and use those the in reorder surgery ambulatory centers. we're is getting some where cases

of call, an they've and cancer use quarter on last large Although a institutions, the institution the it also there our couple to are mentioned I had that opportunity reorder.

talk comments the were fast that it. the onset call it, they're you XXX about, to what to I think it. and think hospital expanding, like do they making the I seeing back we that's continuing good like So use physicians really Bob, bit They're Brendan, little a use you're what targets news. describing But They that when to are the correct? on want we're see. they

Brandon Folkes

Correct, yes.

Carrie Bourdow

Bobby, a about you bit Yes. little talk that? want Yes. to

Bob Yoder

Hi, Yes. Sure. Brandon.

So a of the go demonstrated to there a and volume of early thinking team history recall sort what capacity might learned kind adoption. we've had that of high that initial who a combination you is little targets our of were deeper our prior has accounts the

focused so those. still And we're on

targets. high the think dipping a These priority down should targets. of kind into or this maybe about more high still are next just volume least tier You

If hospitals about to IV X,XXX the roughly market. you overall opioid think of do close XX% it,

hospitals terms in to that to team we but move as try to opportunity, while those just top them still P&T and go out to ones our speak they're well. that the process, they're XXX capacity the still still begin of funnel we're of so there's to upper review the moving had through, the other in these other tier other So of to while learned the working

Carrie Bourdow

the country, time are add physicians looking the able The again, XX% were the about that is folks accounts, with happens so to that. leverage is right? we think on go. we're We launched, going volume. bit XX%, is calls little looking we're that virtual deeper. XXX that well, us afternoon opioid we try that, to pick east of in We were let's And we delve for triggers. top When in other initially we the have in the coast to to of other And folks the morning when right the with of have the thing that, when then in working an for that's conference opportunity to ideal seeing efficiency pandemic are parts a I'll and said, for people course, what

the a bit footprint the virtual X,XXX but reps Bob with deeper. go to of same full engagements As the because of not said, maybe little

a a safety that committees The data for were bit to describing along I to other plan our was to we're question this Mark, that we data. talk in about little And really the heard not function the improvement function using set. study. foundational interesting that are The the we've about asking the as for around will We're then all cognitive The continue drug. going launch formulary build and us. you core color think having provide be cognitive getting is potential open-label they're of from right? asked was physicians the that, that area respiratory, describing, with in additional GI, the set on

in on discussions we're to way set, having. that getting the really not our data build existing of it's continue formulary it's plan the So to that

Brandon Folkes

much. Great. very Thank you

Carrie Bourdow

Great.

Operator

Thank much. so you

Next from JBS Securities. Butler Jason question from

Your open. line is

Jason Butler

questions. Thanks the for taking

of formulary in I the what have rate First one, speak approvals with approvals And couple what cycles or the on expected? line can review just follow-ups you'd a in or terms the subsequent is pipeline. you of the reviews, then first to on

Carrie Bourdow

Great.

able been that I being one's No some drugs our to I've time. long benchmarks say launching expectations. see a the So of look historical will and at really

approval. taking the the little the pandemic, But rates the talk longer, both terms of of about things rate I'll having Bob, reorder then the rates are a after the more meetings in you Given meetings. let bit or order and

done think has We're our pretty team is winning we're which good not, well. more news. than I

Bob Yoder

run we of deployed denials. and those I guess give initial of being Mark's so I'd majority. there in the that are set Jason, other the our is together. A team data through out committee the happened absolutely. winning to P&T Yes, definitely of the And team color advance able put you the has few full the couple

of – initial So to. – I mean, not these that to, it's mean denial and never are we alluded these back denials. sort as you I call we a go

of at couple take well. and those and gone with forth another advocates in we're the trying it we've initial So as to reengaging denials, back and so swing

an to even on And saw accounts will so push team the continue those where denial. initial we

Jason Butler

on in then there how year, more to Phase I release? And we'll and give development respiratory could you And we the XXX, proof-of-concept top So the us how you Great. and DNP just and quickly dose on this we'll what data volunteers, you that get when data the do program? any ascending get the into in results? start from can plans, details to see addition the include for endpoints can study patients line would healthy the later you obviously, speak work Thanks. in to then

Carrie Bourdow

Yes. Great. Mark.

go talk about to the ahead. OLINVYK? want Yes, You both

Mark Demitrack

that's is Yes. had a clinical benefit study, technique a physiology is Jason, we've may analgesic innovated risk the looking and University called way you a the then this and so the of in at a he effect, that respiratory with collaboration remember, on utility with respiratory as Dahan at Leiden a of a Dr. compromise has the function combined analysis, outcome drug. drug associated which built

basically So graph. concentration That's a respiratory the analgesia versus probability the at you of the the depression looking drug. over probability range have of of

respiratory that at probability with a much risk we morphine saw innovative and way between is So very tests in pain measured models ranges OLINVYK, laboratory a to COX cold graded difference looking graphing pain help, experimental looked by a we in and concentration way of across rate And stimulation. Analgesia respiratory entitled with different response plasma a and when of by benefit. looking at function Dahan’s the Dr. depression. electrical is COX. their data initial producing OLINVYK of in and compared having benefit Respiratory rigorous setting analgesic pain in higher effective measured several it's inhalation our to striking

respiratory us are very, that to allow interrogate physiology these the the conditions in So brain. apparatus tightly laboratory controlled very

we're the building earlier by This study. overweight study So this group. examining in age that's what particular an in is on doing older work

be we in be I of this track even end to that to that what allows more the on profile to out report by study difference an exaggerated between said, us as expect will OLINVYKs morphine year. it the to compared So see, data

Carrie Bourdow

do XXX talk Mark, your you there? about to and want plans

Mark Demitrack

Sure.

shortly obviously population. as on you the about we're where work that in healthy IND quarter, initial a you preparations track XXX, volunteer Phase we've So this obviously said, and after asked occur And said, already I file work to begun I begin initial dosing will the first as that. to

to patient-based in details already months. – of a are coming model, into in in phase on moving of the designs more so coming the quickly come the those the We planning

Jason Butler

questions. great. Thanks Okay, for taking the

Carrie Bourdow

Great.

said, to it other it Mark look that formulary Dahan, your was, committees, the we - Dr. Let in the wanted what is Publish that and at accepted and when challenging the study physiology it I data make question Dr. found me, by well, comment patients? like and models as when does on respiratory presented interesting. conferences people are the really It's Right. Dahan

another can set strategy. it's that expand the we launch way connection the again, So data to in

this So the, really information is of a next set to question? at going at of year. the for this us Operator, I be great end think

Operator

so much. you Thank

Wainwright. from question H.C. from Douglas Next Tsao

Your open. line is

Douglas Tsao

points, Good that in for but are early curious doing. taking morning. And knowing OLINVYK. just in the starting hospitals terms just they're using terms I'm and curious now thanks questions, how of in days, of very that it's say, this, terms I of, maybe the what, ask

you there they're risk have a gravitating more patients used Are being right stocking be towards And ordering it most? to the ahead they a of most sort would that more, Is high patient, that obesity, it sense cases age, particular shelf? in do they on think are now? it's which it it of of So also, they appropriate? be

Carrie Bourdow

not turn Great talking over been it they're they've Who's that say, using a or Yes. with We've And not particularly going ordered someone formulary brand think been they're certain want population in the use then certain order just I'm and It right, ordering are stocking, ahead. surgery a that to the I know beginning, question. new If interesting. and they depends, I'll these it's then ambulatory there. patient to If to it's with been, they on of it's it it's a right. surgery, start going it's Mark. physicians it gotten me really and let using centers, they're it it. lot but ahead, to in then, that's,

We ambulatory steal that surgery using we in some got Mark's patients have it think, are the let me, in physicians patient, originally more of good, than not and center he's because inpatient setting, to it's it some really cases I but challenging positioned thunder that what younger describe.

Mark Demitrack

good morning. Doug, Yes,

Bob So first of side. the to what on, commented we're let what expand hearing, on talk me on ASC sort

of One by ASC the through itself OLINVYK's setting. we've with to of was the the in recognized and And case from post heard have satisfied working with the been use clinicians analgesic on the patient way. performance beginning profile – that things is intent and throughout as of the quite rapidly that that procedure early lends an more moving clinicians OLINVYK that's to that,

an I'll inpatient example. give you the Within setting,

instances, really what setting of hear us where are ideal heard is in is in of make nausea complicated patient we've to a And insufficient procedures, and risk messages use And abdominal patient. this open which at combine the candidates of this higher OLINVYK. clinically procedures complex option the the One the challenging. consistently very factors are these the respiratory of quite in they tell profile, case and painful that the patient attractive of the the cases many that that very is setting, quite postoperative risk vomiting we for the is

this of study. quite though that recovery, what ability that use Another OLINVYK. touched the when excited outcome the is in of the me and in a aspect to very, in of on Carrie level settings, inpatient for up the hear clinician into lack one in further And the the that this distinguishing had reorientation, participate makes characteristics of very earlier. about digging interesting patient that alertness of is notices the the study planned. is sedation their the more that idea own we it the this we bit comes ATHENA heard we And and their much most a about

Douglas Tsao

I in Thank there approvals them? if can formulary follow-up just of restrictions they And another terms great. on are getting, placed that are Okay, right broad-based the you fairly Or you. ask are now? being

Mark Demitrack

would me to that? you take Carrie, like

Carrie Bourdow

sorry, already happy answered I’m had mute. I it, take on for I'm it. to you I was but

Mark Demitrack

Sure. Go ahead.

Carrie Bourdow

we're to Yes, beyond patient in the it, lot their So seeing, if even in where a one physician, not for use. some are of we're surgeon – is asking colorectal Mark it's restrictions not certain actually seeing where But the the the if patient seeing restrictions types. that that, cases, we restricted a restrictions described for is

Douglas Tsao

Okay. Great. Thank you so much.

Carrie Bourdow

Yes. Great.

Operator

Okay. time. There much. Carrie, Thank further at are ahead. go questions please this you so no

Carrie Bourdow

thank Well, all. you for questions. Thank you your

to for that look this OLINVYK TRVXXX the from lot study post-approval make As data hear, of from pleased this the to to to an TRVXXX expected the to we've and of patient progress wins we're plan. the you all especially fact that OLINVYK that unique us that the tripled launch, Imperial formulary committees the both had progress suggests quarter. forward given The recognized in launch, studies. is first number our College, our we've enrollment OLINVYK's end our terms more advancing value. with COVID top quarter, approvals IND from data continued a environment by continued from formulary the line filing the year, than And of post-approval navigate, we've since can on first that on two increasing there by update

and again as can going joining updating lot to patients call. concludes these remain providing of focused continue for That look for a innovative as today's you on. medicines thank there's So you we forward And We all hear, on us. to you fronts care health on professionals.

Operator

you Thank conference participating. today. for That for does conclude our

You may all disconnect.

Trevena (TRVN) 12 Aug 212021 Q2 Earnings call transcript