TRVN - Earnings call transcript Q4 2020

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Barry Shin

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

We also have Dr. Greg Hammer from Stanford University Medical Center with us. Dr. in X investigator Safety an was our Open-Label Phase Study. Hammer with sharing his be OLINVYK. firsthand He'll experience At the the end of for it question. up call, we'll open

the within I'll covered Securities no these reminder, over meaning uncertainties subject We call related a we'll undertake business, making obligation now filings and looking As statements including with our those SEC. be to risks update of our Carrie. beyond These Law. statements Federal turn to statements in today. are to to forward the the

Carrie Bourdow

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

to For from those tackling some of a us on around you, a most up, our the ground of ligands. background. who Nobel built built diseases are innovative was selective that winning in we've CNS. science new GPCR pipeline Trevena is based urgent Prize little the With science,

because is And review data Respiratory data in acute patients to as they current ambulatory now will especially versus pain the few physicians, what on Dr. our few Trevena year accomplished We morphine. Data days a provide what our evaluate an this the OLINVYK hospital of centers. approval highlights XXXX. me FDA's but available the candidate acute through the The say, this, for OLINVYK. unprecedented to can with use what compelling and Let successfully committees an really discovery, peer-reviewed all setting, they GI Also, speak this We're for their of unique that we've We is our do. pain. development XXXX in and novel analgesic we accomplished IV most year journals. for was last a as is formulary in late Safety very published drug more surgery entire early inpatient and commercialization launch, challenging took OLINVYK is Hammer important, process. profile size will IV OLINVYK’s and I companies OLINVYK in hospital both

continue course, product. starting areas, to to drugs time our certain shortages a activities. Bob are option our normal key elective opportunity the launching return be in new of in is that create OLINVYK. hospitals, which Of an pipeline to to expect number a also thoughtful year. catalysts this some COVID-XX of for and levels, approach We've XXXX, the that extend IV this hearing they may well, impact like morphine from progress very a great in of hearing being hear regions made that you'll We're in have surgeries on country as to and on new assets the a and we our We're commercialization from we're staffing analgesic unique But like customers in to for horizon.

all announce because already We've the And novel developments pipeline line they study Imperial started for Mark will TRVXXX, a IND treatment filing after. be for of pain. and for work for data that of the TRVXXX, lastly, IND I'm modulators is epilepsy neuropathic top of and to year CNS very our and first Let TRVXXX, acute patients being a the studied SXPX soon expect which but believe new like pleased form me in start we've Also, oral, this areas with of useful by track half exciting mechanism novel these migraine. later that oral other in this enabling for potential explore. for reporting identified we our migraine detail, chronic will on provide patients half first this the call. on to additional of College, complete be will we'd the for to their COVID is year. They

for two we accomplished industry you the for We last year and difference proud delivering in which $XXX.X year our with to we that in XXXX. through ended expect and that cash, presented year. extremely COVID-XX productive years million amazing our operations for end and year, resilience our can that challenges it tell, As of will communities partners their business was I'm an all a the I'd medicines light focus our patients. make like of on especially our employees to and thank fund

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

Bob Yoder

OLINVYK. be progress am to crossed at It I customer field launch deployed morning build capabilities final update we've team Carrie. the hard the here February. made you, recently been thrilled launch facing work Thank with FDA to out our is with and we've late to milestone team commercial fully XX-person has DEA and approval you scheduling, great as of the an prepare this this for Ever give that since the the of quarter. launch our to

our experience also had new the experience of prior have ASC members many All in hospital pain the and setting teams in space. and acute

HCP. with in space first discussions. having out So, about they've in deploying target that more ASCs. customer than month, they to been the XXX team We're chemical and target prior they're hearing are less opioid detailed new entity to the more team facing hospitals field the OLINVYK, XXX are IV Even about facilitate our is to relationships reporting decades and the across open able in HCPs early a in though access interested leverage

who critical quantifies in into health economic on are group hiring MSLs, that the health dossier, individuals with deliver already on In background the OLINVYK which bringing our focused to had the field a field liaisons we launch our model to value asset Prior a economics that's received of economic we OLINVYK. health can strong role comprehensive product Recall, they'll model and a our have economic in stakeholders. play feedback a for strategy. our model team, system. included in developed critical value of healthcare formulary We positive overall translating our in proposition medical science a discussions with that in we an the

over of experience all of deep along managers of whom acute launch setting. experience. in surgery our and team mix and sales an hospital group regional have in and care center XX key a average years This managers. pharma, sales side, we bring leadership ambulatory with of reps, the On the leading sales account commercial extensive experience They're of brings

pleased Trevena are introduction have really OLINVYK and our this the customers. and to of of supporting of level launch talent expertise to our We

strategy and protocols and resources. surgery data Syneos we time. As real-time challenges right think a hospital from goal new as product through local to the deployment unique right to trends, our the at right of level COVID-XX, place a range our Health in during put the launching the state on data of is our well as across inform help Utilizing resource partner elective

this promotional also of be reps, channel both cohort hospitals an In awareness engaged separate were with efficient surgery adoption a We of very in who additional in surgeons orthopedic orthopedic in we to drive addition, surgeons care. a and the deployed post-surgical centers. setting ambulatory familiar customer will previously telesales pain focused believe with way is space and on OLINVYK telesales outpatient key These the reps group. are of and

a core opportunity. billion reminder, complex initial addressable covers totaling patients, estimated our market As focus market a an approximately million significant $X.X X

team XXX early on overall any like will months on customer wins, a relationships, IV right on focused field market. for patients developing Our to a the of in formulary with that approach with opioids replacing be formulary strong momentum. education. the the laying surgeries, and off And this focused year-end pay build we're in a believe position which OLINVYK target to conventional unexpanded thoughtful not strong our begin We and on run in customer disciplined executing as We discussions, space, the strategy set in Things us. in these great foundation plan. launch a be employing initiating to and with and facilitating continues will hospital sales long place,

believe an out and already and I'd perioperative with that institution submitted introduce we're and differentiating early of process report some Dr. important we're exciting in As review. about and X we're it open-label from our rolling patients that series less participation safety hear their Many Hammer the reps Stanford. scheduling leads. to formulary for committee formulary field we've their interest Carrie inbound like with trial. OLINVYK pleased via active Phase am awareness study. customers. the to his driver note, appropriate speaker very With will at Dr. encouraged have for and mentioned, intensivist experienced discussions and Hammer, next received from potential from our OLINVYK expanded movement weeks. OLINVYK We're in to in range I early the our an to has institutions HCPs have experience Greg opportunity anesthesiologists begin for We programs, with first clinical physician, recently those initial the of be already will some to the the of wins. than starting of broad of see a colleagues in by speakers review the And our a features month, initial a few On

have his We join in at OLINVYK process practice his and us the where this perspective formulary morning Hammer experience provide Stanford. Dr. his fitting clinical to review to asked he sees on with

over Before remind With IV severe you adequate. the require of the adults important that, acute and to the And including not olinvyk.com to alternative encourage box treatments for to warning management would that enough Hammer. safety to turn we information. Dr. information, prescribing Dr. pain visit the call is Hammer? everyone begin, for opioid I are and full an I’ll I'd analgesic like OLINVYK whom for in indicated

Greg Hammer

pain There an cardiothoracic find the consultant and Until and at pathways, in a few views cardiothoracic open-label I'll Thanks, insights be the conventional have perspective all same By the management. from IV in west innovation These in Phase serious is include out are activates and safety I'm an intensivist What activate with opioids OLINVYK in truly to study. here number The my complications, read I not effects. equally. depression happy It last I and binding of its GI the worked qualified a does of chemically now, procedures having practice perioperative Phase very respiratory Phase receptor not important through behalf on opportunity as the side Stanford. essential procedures, to all the today very features coast. effective manage perioperative morning paid is I fact opioids ages and pleasure from opioid X I present Stanford. at in this all few OLINVYK that my of and pathways and other vomiting. you I'm little X all I adults opioids a is has with opioids, and respect I'm that, with our in to challenging of switch speak switch. unpleasant setting. this novel. a as to OLINVYK that heart distinct as control expressing these component but on role use morphine way X of and on my hour decades, nausea have and Trevena. that Unfortunately, studies clinically by its speaking OLINVYK drugs given a the intravenous be as own, is patients really also including with well turning manage IV drug physician Bob. It's are center. having a the way use disclosures, familiar despite has feel pharmacology patients. my exciting while discuss as in the in perioperative of been remain through anesthesiologist differentiating analgesic to early that it

on managing a we of touch me the Let pain. when few face postoperative challenges

in depression are related effect. very clinical the adverse their Respiratory most There to Trevena I measure difficult at trials. dreaded depression was it. very see no respiratory program. clinical is is reassured in good study to ways this First, opioid to the looked

So these we oxygen use rate. poor substitute respiratory saturation, surrogates. and measures are rather like Unfortunately,

we In makes to to we frequently intervene, us assess see it its the cannot it to respiratory or in really patient so gets depression how begins for severity. order decreased watch and addition, document. manifest We're how ability This hard bad lose breathing, significant if occurred. obstructed to a compelled accurately evaluate simply to

and makes homeostatic hospital after of We're to measuring of This OLINVYK or This has especially studies. called clinical even COX subjects, they Trevena generate way dissatisfaction. to air intern kidney rid meaningful more and to the adjusted vomiting was have significant the for great. OLINVYK’s result morphine. the one a initial And the data did this worse no can prolonged COX obese of all target use pharmacologic the at recent onset, really the trials. ingenious OLINVYK. patients. than and an patients this When X on GI to vomiting compared of a stays OLINVYK study impressed side committees and depression to and in healthy related by the committee, to on side not their Phase of opioids. is without which young, in hospital deeply This formulary I nausea breathes nausea that simple. population were person an COX. only this of the thing healthy confirmed in reviewing to tests. by be The a in important opioid adverse X surgical a Nausea respiratory who dose frequently call. The a get serious disease. event vomiting any one are have ventilatory Since response published the meeting. elderly and groups OLINVYK’s. method also body. response an respiratory with patient might taking and will in well of do a publication consideration drugs, Most and did really added formulary nausea have rapid we mixture of is Fortunately, metabolite These profile Trevena have I shoulder subsequent Fingers on a active surgical Stanford, the for these properties breathe presentation patients increase and big to right crossed and brain the hospitalization Based a and risk. physician carbon respiratory GI effects not getting incision. the process A the incidence important is in rather pharmacy or with patient, may profiles vomiting would as to camp. Even compare respiratory data desirable vomiting. pretty and can effects and of is place open-label dioxide, costs. that formulary the own higher my address that nausea at-risk experience midst be and of No request my is be safety cost pains am people is event in does OLINVYK at be makes to Phase surgery

help they've decision, published pharmacists doctors first drug. managing and used their able those look formulary for to committee well When makes are versed they managing benefit To foundation the with my to considering committees the of Trevena close, patient part at from it attention. money. published and evaluate opioid a done view I'm outcomes I'm assembling risks. time offsets, the a mic your Thanks Fortunately, forward very to save for available having and patients, excited it seen data data IV look be look improve in ways and all that I has some will new cost pain. great it. the turn job, of I've along strong to over to to view how OLINVYK, clinical of formulary the in acute for the And practice. as in benefited Carrie. happy have

Carrie Bourdow

appreciate and insights, considerations of help your patients, formulary some how OLINVYK We Thank really committee. the you treat you, may your Greg. for your

about I'll key turn Let's now review to and some activities. talk our over of the more to call Mark move Mark? pipeline, the to

Mark Demitrack

start lung in you, clotting our action with institutions multi-organ studying certainly to Duke therapeutic the in blocking Thank built studied the TRVXXX, in also most TRVXXX, made by I'd after TRVXXX, disease some CNS. this and highlighted to and receptor to extend team abnormal available will a of exciting dedicated and a this patients. they XX IND-enabling diseases formulation. human leading at is our pathway today the endpoint COVID-XX year. trial of But in progress first COVID pipeline Several be complete Carrie. hospitalized delta our The Imperial XXXX of clotting. to out selected And abnormal science like patients. earlier team, to in that for potential is College that up a asset, is half function, of evaluating while London the the being innovative lung and sponsoring causes formulation study of they're Shortly With the necessary an the primary publication this expect this embarked newest patients. our is overall were damage blood we blood currently shaping start which novel the including urgent of the in COVID-XX is pandemic, on prevention make outcome TRVXXXs we've a adult work identifying of With interested function, for restore already mechanism reported University we've that targeting We believe significantly use. the significant we agonist that patent oral oral compound. year.

delta the of that With in are existing oral important believe to broad pain, brain efforts we've for is to an areas the been its target, compound. key therapeutic an to subcutaneous distribution of receptor this point, anxiety. up mood, and with this continue studying We formulation, we development because position an that in the alongside now formulation are in-hand, future advantageous continue regulation

to with I receptor like TRVXXX, Finally, on work our SXP would our comment modulator.

of important highlight me Let attributes two compound. this

First, it's that's receptor in brain tissue. specific the Type X the SXP form to of prevalent

Secondly, for to for SXP efforts current for lymphopenia no track of progress general. neuropathic exploration been epilepsy. while side and on fortunate our first moving TRVXXX for appears our the is the made program. this of compounds TRVXXX half and attributes IND on own pharmacology unique submit collaborate on with immunosuppression. lead ongoing, work prospects excited clinical among of initial in to make year. And our IND-enabling market in on and about pain indications that exploring TRVXXX to trafficking, ideally NIH common chronic suited that in we've this SXP TRVXXX We've the forward We effect have We're are a effect phase, to combined in these lymphocyte believe or this modulators the can peripheral CNS and like

for Let turn call me financial year. our to the over to Barry now the discuss results Barry?

Barry Shin

Mark. Thanks,

net of compared launch XXXX, $X.X of in For the of of a net fourth loss $XX.X added the quarter for million, to is the to fourth OLINVYK. for commercial quarter due preparations mainly XXXX. This loss we million increase

in customer Our expect deploy operating expense we in as and the from fourth commercialize was strengthened milestone moderately $XX. XXXX, position public million with XXXX team of increase August, in last and as $X our this We we to $XX.X our X Nhwa, in OLINVYK. year, quarter partner our facing offering million a payment significantly an as well financial received oversubscribed million China.

result, year our fund cash report $XXX.X to open As I’m the expect some quarter pleased Afterwards, of Operator? which This remarks. will XXXX, will equivalent the a operations OLINVYK provide across XXXX. Carrie pipeline. We’ll now million for a commercialization, fourth progress and of call we in years through of closing two includes our questions.

Operator

[Operator Dana Flanders from question Instructions] line a Our of with first Guggenheim. comes

Dana Flanders

just Great. could. two Thank you I progress. on questions and for very all quick the had much if questions, congratulations the I

apologies you that wondering if have second you're but if Thank was I And And saying how First, more place expect on patient you then, reviewing share I in any us color target OLINVYK are of XXXX. processes any if And then originally, think guess, to XQ of some among half us? actually undergoing are many OLINVYK seeing, the this delay restrictions it missed can was if some of I population year. a wondering data? I on color of wondering give could in question, the any TRVXXX, little now, formulary you. wins I’m right the that. just across first now you and this, for on that? you'd reason you're the there early see for my

Carrie Bourdow

question. Dana. Good for morning, Thank the you

in and and if jump well. start So Mark want I'll as Bob then to

pretty got enough is in placed right formulary On the What it's drug. the the we mean, not restrictions I just organization say, we sales for early, the our can for field sells out. I color have us, wins, that had major on interestingly

larger was on it. group, patient put a drug restrictions interested it in One to for of put particular that formulary the the but on not decided institutions

So that really I interesting. thought really, was

providing So as with updates. launch process, additional we’ll come, be obviously, more to continue the we

the see, delay in think the I also XXX you asked data. Let's and about

you and in this British being studies, So remember, the by College with Imperial that's is run they're partnering Heart London, Foundation.

interesting frankly, really It's how are processes. I Imperial seeing more think This to a an peaks and up are such recruiting lot there this one's this College COVID with and the studies studies. disease, not driving us, valleys is and you're right.

not doing. I College to like pleased really one we've close College. timing. to So, information they're additional there really add? you'd the Mark, with to anything been Imperial really know team COVID, regard all of top They're at with the there's and you're Imperial institutions the that around any that

Mark Demitrack

Yes. Dana, what just was saying. to echo Carrie

But challenging an prevalence to As COVID Imperial they're obviously, you as progress study this that valleys their we follow unpredictable know, population somewhat Carrie making is the guidance of is a lead There's time. said, treat. in been peaks It's and course. and the their and College of very work. so directing cases as the team and the to on over also, that clinically

Carrie Bourdow

Bob, like on colors? add anything formulary to you'd the

Bob Yoder

think. I No covered it, you I think

Carrie Bourdow

Yes.

Bob Yoder

No, Yes. good. think, I we're

Dana Flanders

Okay, thank you.

Operator

question next Fitzgerald. with from Brandon comes Cantor Our Folkes

Brandon Folkes

or face taking for maybe give had just and community the the reps you customers? kind have the you. you're helpful. color congratulations field, and how then the questions And academic the Maybe centers, in with question. of should think where any additions deploying wins where terms are, are me you reps Thank hospitals, these allowed or Thanks all dates for early would on Hi. of about reviews, for you've secondly, Can face set on color be of to percentage following we progress. formula there from maybe the that into as

Carrie Bourdow

Thank you. Great. you, Brandon. Thank

color of on formularies. again, So, the the

on you hear about -- the in large is go potentially at institution, Stanford surgery and which Stanford his institutions. from formulary. ambulatory you been with at Let's Hammer the reviews And medical heard at that, centers hospital he'll center, academic see, and interest Dr. can a the describe say pleased can what process getting Stanford I or Alembic is we've which getting the way really both his on

what academic heard I centers. from think we've to that's medical similar other pretty

community, we place teaching are the more we But it investigators Dr. to and processes had committees. our Hammer, open lot safety or label female that formulary as that really involved Alembic community quite less in they the on a tend were organization, formulary to of quickly. targeting that to the remember field want relates in few because study, with organizations, have sales processes light You get less

more reps, So I let as Bob we'll as little to a obviously, you come; and we a the information, be certainly that. more then bit I'll question we providing And around think get had handle that.

Bob Yoder

Great. Yes. Thanks, Brandon, for the question.

a allowed good the question face. it's So about percent face to

I'd that, highly are folks It First will you setting. say resource it's regionally where is, effective either bit, we in happening country our specific. depending a and trained quite thing be the to and there. really does I say vary on in what's

So where we then the during is, And creation and could be effective virtual certainly, together, and put live. the back that, platform. resources, the like the that and live on certainly so of and engagement to things in guidance platform if the with can need in process, virtual, when and training things fall both through they customers you CRM you

probably if nationally, National and the data, I some variable I highly say Audit but at So look would national, localized. that's think, range you XX/XX is

Brandon Folkes

very much. Great. Thank you

Operator

comes from with Jason question JMP next Our securities. Butler

Jason Butler

the Thanks Hi. for taking questions.

sense value maybe drugs can the the for on, on your message Can hospital, proposition? to a your OLINVYK. focus if question And company Hammer, any I you how for Dr. best in couple. Appreciate us perspective that use thoughts make beyond Just they the first? can? types of give institutions you,

Greg Hammer

or of rather -- Well, no vomiting elderly or data the from I that are I Sure. that nausea and initially elderly no which hospitals and study in in depression a essentially, couple Phase very incremental the obese populations, as populations risk, there's think, important high X in on based increase there's group. said targeting respiratory increase all in

So a two I –those to that's target. populations are excellent think

those on; and familiar activated, think are such risk populations, those targets. is for that, that others Thiopental once as it high the PCA reasonably the the I get with that induction good using example awakening a people earlier are thing in another are patients in as using marketed but risk same dosing drug My bullets is sense familiar from syringe and drug respiratory once and as need those discharge. with with and drug, populations Opioid that was housed, anesthesia. was wherever was So $X.XX. diseases I and transition who propofol more physicians with and a analgesia, drug, so spread. the readiness for useful resulted appropriately propofol $X.XX Thiopental, and that and rapid the But using and for thought a recovery drug it are successfully the

it that And the used started all And for was with to it it different got purpose. so pharmacokinetics, the believe using I and because we so, people safety being pretty same OLINVYK. soon familiar thing for of kinds indications the and like like going is with happen

Jason Butler

volunteers? thoughts as patients in Phase the Phase level course healthy as scope X to you Thanks. evaluating us high the X be on well potential include any PD the and the in attending and multiple give PK can on any single there addition of any of Are TRVXXX program And you'll then markers and Great. work? program to

Carrie Bourdow

Mark? Jason. Thanks,

Mark Demitrack

Sure, X the details Jason, not we've described of as program, so this the Phase point know. at you

addition, think you several collect, the that addition I to under pretty in be that the at consideration, could we carefully that standard given but look PD models to -- can So information endpoints. imagine used obviously, in we would targets in would for addition are that need experimental

disease well look And state at. a to more with appropriate for of us may those some in individuals be

that's the our certainly on the is we program radar but details it haven't screen, So of discussed something at this stage.

Jason Butler

great. question. Thanks taking the Okay, for

Carrie Bourdow

the know, well, build actually our is, spend question. focus as me going initial you -- we the much I'm the I indication pains. And because was used that look let safety what broadest asked around to OLINVYK question that on talking about I Jason, And, but time things appreciate think one so that that statement of from study was involved OLINVYK indication received could as when in, in we open-label the you, Dr. the have we received. everything statements, Hammer you just that medical tell broad you at the

the like procedures we multiple total to pancreatitis, have more that things us room, the that settings, room, the some colectomy, broken talk In all in cell way were emergency knees. involved severe arms of you the total hip, of in hear So study. lot surgeons plastic actually sickle emergency about a

some like things are paying areas, or in particular, in patients. cash those And plastics, surgeries. those of breast augmentation right, So facial

OLINVYK we XXXX So out any extensions. without life on have patent until

that Dr. for Center with like potential hear we're using the in an excitement but with it just started OLINVYK. opportunity do I Academic really Hammer’s agree You of Stanford, him Medical I really getting

I appreciate the So question.

Operator

Douglas Our from with line of next Tsao Wainwright. question comes H.C.

Chris Bialas

on Hi, taking my Tsao. Chris for Bialas for Thanks Douglas question.

if have wondering actually overcome and are And I to some tell uptake do if you seeing us right least the these future? any maybe the I how surgical that? indications the losses, you most what for of So reasons had you now? which formulary can you in you. Thank in are two, And was the plan

Carrie Bourdow

we Good indications. much information Morning, don't think Chris. around have I the surgical

hear, the You we placed that formulary. on drug have to asking anesthesiologist are have

areas also and is are focus Colorectal, Gynecologic. the Orthopedic Our on surgery

you little We've certainly days, IV that study early losses are areas IV so just really were main for of more drugs. that those the with a and the be of lot not waiting been getting our to that. science lot have There So bit medical as drugs safety opioids a or use earlier, early our able liaisons. yet, open-label we're IV I were it's use organization out, in morphine provide And as involved right. formulary color hydromorphone. field physicians It's we'll lot they three had like the sales on a say, said a Bob of heard

the formulary. the for as drug on physicians of to those So first are might advocate you group imagine

early we'll move through additional days, the again, So as color we launch. right, provide

Chris Bialas

Thank you. Awesome.

Carrie Bourdow

Thank you.

Operator

Bourdow call session. today's I'd to question-and-answer back turn the closing concludes like remarks. That to Carrie for

Carrie Bourdow

Thank the hospitals stated all heard And as first to be it OLINVYK. and country. reiterate the this you. committed feedback, confidence us therapeutic underway Thank your that And you we’ve clinical The questions. of received for we from in physicians commercial like we as excited surgery ambulatory option Dr. to profile. obviously we differentiated today, now are our are across to the our in patients Hammer, delivering you launch OLINVYK interest from novel centers full in

Additionally, the an key fronts, continue milestones. forward prepared with updates all we success grow to additional company. as innovative we're sharing of take you've you CNS look to we on heard, pipeline a as across as number these And to achieve

you thank very today's And much today. joining us for concludes that So call.

Operator

Ladies and program. Thank for today's concludes gentlemen, participating. this you

You may now disconnect.

Trevena (TRVN) 9 Mar 212020 Q4 Earnings call transcript