PCRX - Earnings call transcript Q4 2017 | Pacira BioSciences, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Pacira Pharmaceuticals' Fourth Quarter Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time.

As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference Head of Investor Relations, Susan Mesco. Ms. begin. may you Mesco,

Susan Mesco

and discuss everyone. full our results. Daniel, conference year to call to fourth good you, Welcome morning, today's financial Thank quarter and

me Braunstein, Chief Chairman Officer; and Dave Richard Joining Chief Chief Operating call Financial Reinhart, Executive Officer. Scranton, Scott Chief Officer; Stack, Officer; Scientific Charlie today's on and are

involve based Please filings as me Such with are statements expectations. to let start, today's of we to current the and you over now which that the SEC, or that will our uncertainties. call available call affect our on SEC judgment the risk Dave risks will from Stack. our website company. could Before remind concerning I the include refer the today may With that, for information forward-looking turn and factors statements represent

David M. Stack

the to in tragedy you without morning, in crisis become its million Thanks, more local the for uniquely to Throughout on patients role you positioned crisis to could inadvertently this in important the only Susan. is Good or estimated X recent A users, opioids right patients per XX reported confronted annual open and recently EXPAREL, that unabated. billion being Prevention the roots, by of this addicted crisis U.S. post-surgical play year pain, that the XXXX U.S. survey societal $XX.X long everyone, turn the at joining Disease than the continues revealed opioid dependent becoming economy. today. surgery, and suite. newspaper latest administration opioid an a Control epidemic epidemic national resulting carries Centers persistent X of national not analgesic The cost surgical single on post-surgical and an acting burden is TV for us for thank staggering. after opioid The in addressing States. or United This the

providing mission to free EXPAREL, patients we possible. We made Pacira during as as XXXX, many our are pleased advance alternative with to the of continue as our significant progress opioid

we In have importance opioid-sparing the that addition message helping are of initiatives, us the about to partnerships meaningful several internal alternative. forged our own get our dedicated out

Our the to of to continues quarter and XXXX. daily for J&J XX% partnership gain helped accelerate fourth growth EXPAREL robust with traction

patients, Our of raising campaigns the use to Improvement as alternatives the and Collaborative, Surgical Cancer joint opioid Treatment Center opioid Collectively, abuse. initiatives. operating these with our commitment new and the the of awareness These Medical partners the of Illinois will role throughout around health for gateway enhanced are collaboration reducing use Health America, drive awareness of Centers WellStar Tennessee share opioid and room care Quality a the for University providers variety XXXX. through minimizing and Systems payers

level to payers use need provider to as with with with alternatives. resources opioids. specific these to along gateway opioid Through and opioid Selector collaboratives, especially key abuse. commitment pillars: the need opioid-sparing generating As those you with know, expanding we one our third, of three surgical to partnering the EXPAREL of through Surgeon is we opioid strategies payers develop driving use the role or important as for This second, and solutions; work reducing who clinical education first, data eliminate procedures; and healthcare share locate strategic are initiative, sparing, the the the reduce can room operating awareness around and free our for

Products Advisory of sNDA EXPAREL block the Committee. begin nerve to clinical, Analgesic of Drug Anesthesia the February include a discussed at in seeking Let's FDA's and expansion label with our was meeting

data of EXPAREL, and placebo-controlled with support based filing with industry highly two is studies label the significant expansion. FDA with we disappointed our remain studies block reviewers guidance femoral that data includes comparator were our provides submission settings. with experience hours. one our two investigator-initiated confident we smaller one provide requested from committee's by and knee additional FDA total company-sponsored statistically data vote, that eight and bupivacaine pharmacokinetic all the in information block peripheral also from for brachial on studies Consistent discussions XXX in block While nerve safety the FDA, Phase X shoulder plexus nerve It to surgeries. through in arthroplasty It for includes

working the block. Over best FDA for include with FDA with keep EXPAREL finalize In a plan to will team weeks, define for coming parallel, to in dialogue the the we an our the indication setting. nerve to expanding steps the EXPAREL regulatory open next is pediatric the

patients. from with approved development As on to the middle around discussed plan There our managing in for severe year Clinic evidence years we the to package vulnerable expect of pediatric database post-surgical meet to for currently real under no extensive alternatives for proposed received in our and patients acceptable path several of world an quarterly patient define forward an pain We've feedback for them XX are procedures and this of submitted Premier opioids this Cleveland population. we FDA's the age. call, last surgical

and As non-opioid for clearly This new year. our and great is our their babies and surgical mothers see alternative expect Both providers this this to for continues later patients study interest. benefit common study the following draw programs, X enrolling Phase we procedure. healthcare currently C-section of data patients a

in protocols on-label reconstruction. breast also studies and educational are hip process spine, of plans the colorectal, our finalizing and for fracture, in additional We

these last early studies begin expect our clinical We topic for stage this is pipeline. later to to The cover year.

a expect regimen. pain drug clinical or an non-opioid have treat year. submitted NSAID new is this begin to application trials We and DepoMeloxicam IND DepoMeloxicam moderate-to-severe long-acting for multimodal to a investigational within designed

As longer for given uses. decision clinical oral studying program competitive current no trials invest made the for the to tranexamic strategic landscape clinical we this similar or acid with the clinical DepoTranexamic in same have Acid,

female our out setting X,XXX health moderated Nearly event the women education the surgeons audience of post-surgical message we social Turning in to surgical hosted was surgeons with discuss opioid pain influencers the a management. panelists social to the EXPAREL effective Shannon educate their event, Shatterproof. by effective the women and In Since Marketing X.X media were the with have overprescribing The social followers, BlogHer to and three was about second impressions. to discussed empower seeking The Hartley, like of Officer and January, featured like panel women's importance The Chief pillar their of and the EXPAREL a for strategy, attendance. million options to XXX prepare this non-opioid at awareness. to Health, designed non-opioid creating event, options options. health risks in share EXPAREL. non-opioid continued of posts panel

President's obstructions management and enhance recommendations to discussions to provide reduce in We Commission Opioid Commission for engage innovative also given during to continue the recommends active the administered options. surgery. specifically non-opioid access The pain drugs with CMS opioid-sparing post-surgical reimbursement that policymakers of report

centers. working outpatient fixed are within surgical We and CMS ambulatory policymakers payment currently around practices to an achieve their off-cycle with to change bundle EXPAREL that reimbursement

granted effect to year, of are a Our this partner it reimbursement Johnson middle take Johnson standard resource through December of publish process a we with X, proposed CMS. Around for the well. in & seeking draft applied as will tremendous XXXX. a We has following effect the rule this January unique we if year. initiative CMS the would their parallel, a take code code been are In and

EXPAREL reimbursement with us. advantage recognize significant would roughly Commercial opportunity We to under shifting EXPAREL protocols They recovery XX% savings CXXXX. CMS procedures for economic is enhanced create case. separately are EXPAREL and surgery with have outpatient of setting, per many the after of which supporting EXPAREL inpatient for that a the Securing unbundled are working already payers separate yielding to a rule. within reimbursing draft

third to strategic partnerships. on move Let me pillar, and now our final

call, and each Scott highlight sales As make as inroads across meaningful Johnson partnership orthopedic vertical. later will continues activation our flourish & in to with to account transition we this Johnson

Trinity partnerships to support the educational Surgeons Aetna direct Our College American Health, the with education. through approach epidemic continue of healthcare provide collaborations provider opioid These patient a active initiatives. addressing and and to multipronged

As also around solutions. new exciting entered mentioned opioid-sparing several earlier, to I education we recently support collaborations into

encapsulated distribution, draft honeycomb I'd guidance states of traditional Rich these guidance and guidance electrical on size product generic hurdles on guidance including potential composition, I of and pass or to liposome free generic liposome that the of amount the is liposomes. generic potential characteristics, the call development also environment internal multivesicular underscores issued the the high for competitor. from facing to any a morphology, very and Scranton equivalent drug, EXPAREL. quickly liposomal The a This require of tremendously service EXPAREL's technical in-vitro would discuss FDA Before complex FDA's which distinct structure structure comment particle rates. the charge Namely, to version programs, liposome recently liposome, financial release like highlights

line the Richard bottom confident Scranton, at long-term in Lastly, risk. of would is would the event leaves collaborations Dr. require study guidance unlikely add considerable this With that, our commercial test guidance Officer through produced Rich? Scientific in future specifies competition. which to walk detail. invite financial in Chief I'd for The these each the that to product of greater that generic now EXPAREL the exclusivity scale, us like bioequivalence

Richard E. Scranton

guide largest that standardize Thanks, developing next hospital resulting Georgia. reduction WellStar With consumption. protocols a health we future and an steps opioid a developing materials one we suite will with optimizing system surgical We're patient WellStar in to opioid-sparing hospital data use start outcomes will opioid of to that also resource scalable our use system quality progress procedures. from opioid provider the in playbook well patient-facing a Dave. system. in the we and as across This best for I'll wide be WellStar, education announced data endeavors. overall valuable, can January, a improvement joint These protocols and as the to transfer practice care. entire are with In minimize commitment of partners, tracks

Illinois initiative like launched Collaborative. Illinois. I'd State fourth to undergoing support management the resources best the pain is Surgical with December Next, Improvement nationally develop practice program ISQIC an programs recognized highlight partnership We to of in surgery to of hospitals. for patients quarter Quality XX in and important in Illinois this prescribing the a launched

Opioid variety Opioid cancer practices educational use that is is management. Chicago, Risk our patients Initiative We Atlanta, like expanding America. hospitals Centers Phoenix includes to event-based I'd developing the that and of collaboration specializing adult tools and is highlight intensive, in educational opioid of in aimed options alternatives. Initiative, driving experience drive also treatment This are perioperative hospitals programs. Philadelphia, can Cancer relationship of the on their pain effort of five on Treatment to to management educational with new of a is adherence national at cancer. focusing the interactive Reduction of the network by best that increased a centered improving Tulsa, for CTCA awareness responsible patients an Risk use with The pain

of we which I'd yesterday. with Finally, common announced opioid the procedures. will opioid are upon in number Knoxville like no in our very Pacira All-in-all of Tennessee with management one as most the gratified key the the with patients University to make partnering quickly Center interested collaboration Medical to a pain or hernia, low organizations post-surgical pathways touch meaningful This of surgical addressing for as we possible. partnership epidemic undergoing difference at growing develop

have and additional We even discussions over Operating Scott? now employers. including I'll Braunstein, continue Scott to payers with systems, partners, partnership. healthcare share from call our Officer, to an likeminded update J&J our the to Chief turn

Scott N. Braunstein

Thanks, Rich. And to call. all today's good morning joining

we will great continues established shared an In the leadership sales in to sales with energy EXPAREL which on year, is a four participating that top as meetings series be J&J weeks, J&J national their alternative have key and investing along many the coming enthusiasm the their reconstruction, In as and possible. commitment teams the created collaboration and spine, and in produce just sales thrilled trauma. J&J to our we providing expect with palpable is an resources with We're leaders building advance in opioid across from results. verticals, Our of one to sports joint opinion with of patients rapport.

of In their customers the sales EXPAREL to Pacira activated remind proper with J&J continued train to activation account addition colleagues technique. the accounts working you, on involves team number grow. To

in XX averages and priorities XXXX peer with are peer programs mix medical typically resourcing key number six-fold and surgeons, caliber PEAK of campaigns. PEAK increase sharing Looking to PEAK society J&J professional the committed EXPAREL ahead, education, a digital including XXXX. has KOLs their video some that anesthesiologist involve in our programs, programs expertise the of The a specific specialty. audience include of meetings high programs residents. physicians to

EXPAREL, In case crisis, of the already year. planned fact than with PEAK opioid management far all year is greater programs covers program so reports number of pain multi-modal this programs the Each the PEAK Q&A. or completed of completed and number last interactive

which the and J&J's that replicas programs courses infiltration our real-time expectations. operating classrooms, models professional too anatomical include incorporating and rooms, educational to educational labs here of begin reps. also simulcast world-class are and all programs of On implants bone and doctors simulation. cadaver colleagues our J&J's front, training feature J&J tissue, realistic exceeding video interactive can J&J will

Our next annual first unveiled be month model AAOS. is at TKA of the and American meeting will of or Orthopedic Surgeons Academy the

development of this first other be procedures around educational added educational on half number orthopedic for the are professional and significant practice the These EXPAREL best courses shoulder will for for models in Additional help and hip spine, of tools A procedures year. will expand technique the country. XXXX. fracture, track

J&J's society are presence at integration medical We looking continued to meetings. forward into EXPAREL's

educational booth, programs of from Dr. fracture an They dedicated a at the a programs horizon, feature teams presentation with include near-term EXPAREL are Amin PEAK On series Sethi numerous for J&J's Dr. and labs, an (XX:XX:XX). will symposia, hip and cadaver video AAOS. the preparing

With focus J&J and collaboratively I'll growth and that All video EXPAREL. with initiative blasts dedicated through Dr. sparing field in achieve Charlie that is Mont, sessions KOLs driving our strong The leading usage the as author include of new a is turn our campaign. discussing Manuscript will surgical I'll Both financial today EXPAREL. that accelerated opioid In walk to these call of are we the pain This a educational suite. EXPAREL the awareness of our in free Michael last will over remain multi-modal teams is strategies drive as such EXPAREL webinars collaboration management opioid Charlie? to on digital video results. PILLAR of series cover of to working summary, engaged to to surgery. momentum enhancing feature

Charles A. Reinhart III

I were fourth range walk issued XXXX. I'll by be ended We EXPAREL to product news financial million and million these be this then financial XXXX for discussing reconciliation very with advance strategy. and million. the well-positioned XXXX Thanks, $XXX net we To year, which investments summarizing line will $XXX.X our position, metrics outlook and with sales along description our morning in $XX.X EXPAREL of was financial growth our of in you, can for the $XXX.X measures start to we're GAAP this million million good Scott, $XXX and morning. to results the our everyone. in A non-GAAP a through a quarter strong remind found release guided three-part in cash with for morning.

$XX for related quarter UK. margin largely to $XX.X development This of $XX.X in Phase with million. nerve margin and of for gross This capacity million gross The end the was non-GAAP our was XX% R&D X Our and Non-GAAP of was the were costs XX% due for to our guided for lower of the the in in line the our our studies expenses manufacturing expense year. quarter to and development million in full-year million range versus our range $X.X million XXXX fourth the two XX%. fourth and at research scale-up was $XX block increase XXXX full-year guided the full-year. approximately for

or non-GAAP a which activities includes launch the Our full-year per to by initiatives for now were $XXX and our sparing of non-GAAP key surgical XXXX case a million a due and in co-promotion for tool, related marketing a SG&A the million Selector bottom number $XXX of primarily year. for well J&J with and increase website was $XX.X general million $X.XX videos net and million and technique was fourth to exparel.com below functions. income and modestly generate diluted $XX.X of $X.X as spending lower a quarter, expenses to corporate versus our $XX new for the fourth expenses The The across reports. XXXX product was line driven educational selling, million $XXX.X per of revamped Surgeon diluted for expense million as or full year. quarter the guided opioid and This the markets, for XXXX awareness $X.XX in to our share share million range administrative

expectations our guiding average $XXX XX%. total XXXX This ranging to rates growth daily each we $XXX our XXXX, range product in million XXXX. and from between quarter, during year-over-year to recorded for EXPAREL million with sales of net are Turning to X% aligns

While now items accelerated into the will are initiatives predict we difficult are of to that in projecting in growth these of very is confident is growth especially the of making investment when place, in partner each timing J&J certainty. EXPAREL, with translate our the

As year, of sales the by to gross XX%. the also the lightest our expansion procedure to land would we quarter of with manufacturing second the with facilities of typically of with directly seasonality in the would guidance XX% expect respect margin the I invest to and half With our we we you in you, to first track will the visibility on gain non-GAAP remind begin counts, the business additional strongest. of quarter remind accordingly. update To XXXX the through driven the first to commercial UK percent, the continue range we in our XXXX. manufacturing fourth in

non-GAAP As continue at this additional roughly improve build it for to location supplying fully XX%. manufacturing we we and margins becomes to responsible EXPAREL to EXPAREL, expect capacity

$XX XXX spine, of investments in year to For colorectal million. fracture, drivers comparable up expect capabilities in reconstruction well last as the manufacturing C-section, this to expense, Key the liter specifically breast as $XX in R&D and be studies, X R&D between and a year's we million Phase of non-GAAP come of UK. series scale and are hip

as public payment for is levels patient largely options For to The are as $XXX our on change improve driving attributable from to well to to million forecasted commission collaboration. range we focused our campaign guiding of a non-GAAP J&J to expanded access an XXXX affairs policy increase SG&A, million. non-opioid $XXX

For story, growth newer of incremental to by driven those J&J you of commissions EXPAREL. are the year-over-year primarily

of be applying of compensation. by For is stock-based XXXX guidance modeling annual purposes, EXPAREL a relationship cost our forecast. The sales high estimated your the full-year single-digit piece total last can this rate to commission

$XX Here, Dave. range of we the to over expect I'd be our the million. like call concludes turn now million in to remarks. to back to $XX prepared That

David M. Stack

Thanks, Charlie.

the full-year year, of and remainder was success. progress important remainder who breast is at the Looking continuing way beyond payers with our Pacira of throughout steps Daniel? block for collaborations key indication, care alternatives begin defining we EXPAREL this call and believe providers national several minimization the and million and postsurgical XXXX the continued line XXXX our campaign to C-section broaden program, and a Q&A of over in and top the of to separate new awareness colorectal share milestones nerve completing surgeries, reimbursement reconstructive year XXXX the both for and non-opioid our the well-positioned additional With for forming I'd for paved management including next for $XXX hip session. government that, launching achieving for and about to to strategies. Matter operator guidance $XXX spine, to X fracture, the pain securing results, EXPAREL million, passion patient healthcare from studies payers, sales study commercial through education Choices reporting like improving Phase the and opioid through turn

Operator

Thank from question you. our RBC. Randall And first with Stanicky comes

Your now line is open.

Randall S. Stanicky

that's the double-digit implies It and context growth of for one, against two Dave, that December January. you EXPAREL seen in low can just for some Number both you guys. guidance we've provide Symphony from have in growth I Thanks, range? questions. and Great. X%

how more do second we ramp that's X% the as And about in think what XXXX, agenda that a the growth to And question do So the question. throughout a disconnect P&L And about J&J boost, Talk Is for we separate to growth year? in the opportunity, CMS is J we meeting sales think boost see the contribution a there about this for growth few XX%? specifically It's How move the the opportunity where if you. we outlook? for on code. logistical the So timing? weeks. of and number the is about for context? way released, Thank are timeline, in one. then, right then, May J thinking do the should I EXPAREL be Is does that there? code think next that the that

David M. Stack

– I'll the put Thanks, it Randall. I'll that order address take in the well, it. you

well, – is the First, conservative. we guidance, we hope believe

out marketplace to the initiatives, not years initiatives, it's make the resolution thought job there, Randall. as the increases sure timing got the I those take don't approach conservative over approach. the place, moving a so I a Scott think appropriately I of be, the we J&J, block anything year difficult case providing mean, nerve are commercial wanted we've from we the of that be to conservative making to this mean, the sure think outlined, we'll as exactly it CMS could all able more how AdCom, Charlie's good as I it payer have was important. we're of things know project the to upward done we could the I in last met also outlined, these us expect as that partnership. of a goes this going of be for the guidance when to make we as Charlie just that put best good that of revise was on. number parts, We've number to so couple we But context

the capabilities done partnership AAOS them all partner. specifically a where the been in didn't opportunities many community that around think well Scott we Pacira that's outlined been with to the work financial then focus talked really that what's I of if is the the would as I important we've all AAOS and PEAK is would opportunity our an the really things programs about have educational providing all addition have that times, the beyond and at representatives and of

this why you appropriately that So point. ask example we of The going forward. perfect as guidance of question all our upside at CMS, about conservative a see is it's

XXXX. CMS. we constructive same still possibility believe with cycle there the an XXXX. J code And We a (XX:XX:XX) We at with get then working have is really difficult options. CMS The some for off-cycle time discussions in will of find real are an are the it's surgeon interest that to during anesthesiologist backboard context non-opioid Xst is asked for you through and we being of I engaged very approach – or those a normal strategic in reason doesn't discussions, think January that the that who the

So or a thing if Act. of are the either signing really from limits perspective perspective only Affordable we of our Care – the P&T and general that since system a access constraints customers, many from especially is of hospital the the financial

is make where So in majority and, not we're we CMS when remove a to rates, paid it broadly position mean, include on under tell in are of for ambulatory with bundled X%, you that any basis today vast there make our material if negotiating – they their in commercial that and already medical mean, successful to opportunity we're go working We're would as them sure is provide seeing I format who they're paperwork EXPAREL we the EXPAREL be the have the a authorization code than fill to benefit. ambulatory, or so it's payers on to more a out way through it which paying believe I for is our we're to how Randall. cycle with payers, and customers how going they have and very the obstacles the achieving will success of product access – EXPAREL either appropriate What but guidance, a CXXXX that outpatient are I environment. that to now. as are a we access working prior that annual the to procedure-specific

opportunity. quite the J&J Frankly, partnership. by margin largest large reach So given opportunity is have a and is the a now especially our with the we major it it frequency

Randall S. Stanicky

great. Thanks, Dave. That's

David M. Stack

Thanks, Randall.

Operator

comes And Barclays. Douglas question from Tsao our you. Thank next with

is now line open. Your

Douglas Tsao

Hi. for Good taking morning. Thanks the questions.

orthopedics thinking the to going it the more level curious obviously know the sort tissue to pick-up has maybe but from starting business. see and about guidance, I some growth in in mean, Dave, how specifically just versus breakdown J&J. up rolls terms between soft the in of soft of growing we back impact perspectives some been tissue quickly or we're high of terms Just,

in it'd in helpful of certainly I so tissue side, you you some XXXX. had the TAP sort understand of on be that And the just because in where first part are soft XXXX mean, traction I very to know good and

David M. Stack

you, Doug. Yeah. Thank

suffer bunch continue discussed of that a We from the with same you issue to guys. we've times

data analysis a Our lags I'm frankly but four months yeah, are time significantly. like more sorry, data the it's quarter – by by four delay. get it's like more The them, we delayed

I looking growing well forward question keeping last relatively anesthesia papers EXPAREL with think as about Doug, So bit just marketplace. of what at the what the everything of a to in TAPs now. traction, the we're is starting couple a delayed always of have XX% is than as a working and more gain of you that is orthopedics say, number To day that to the your going of of TAP see and business. opportunity day is number versus with TAP we remains new to answer community, in specifically, pace since And growing, least at the surgical around out talking issue come nerve procedures really use blocks a highlights weeks, for the orthopedics which is

in of I as it relates well, surprise expected recon. Specifically, to And can we orthopedics, think a to to a what went here as bullish trauma. bit it our J&J saw around jump you aggressive was J&J spine But really about now I around think we potential and strategically way a XXXX. much but around start as Scott me, sports more the through joining to relates from partnership and I in mean, Scott medicine we as understand

doing with And to some J&J. we're those of is specifically work the address that opportunities

So growing. everything is

medical only we of very where clinical community, not in doing the lot think we're the and world great the folks also specifically and systems as but the that with I areas of is a current medical Cignas in downstream some basis. the that deal the we the the have discussions thinking community. payer trials and see as pointed on clinically with at going daily the response the we our payers are A interest of that of relationships to all well

don't So has more add anything to Scott J&J? if on know I

Scott N. Braunstein

We'll Dave, No. to that will see spine I significant We've KOLs of those number on we've We're are about space. excited recon imagine have J&J trauma having in and should market seeing space organization sides. talked, programs in the added continue looking a in fracture. We're that impact interest you specifically very the PILLAR very way and key the the see market. would starting that interest in referencing say wins the we've the hip focus. opportunity a growing both we're of recon to quite PEAK that is AAOS spine we the material greatest and at around happy a and bit be is been at many where and we

being those opportunity strong, we areas fourth, sports, as about certainly well. excited So there see three are the the really very we

David M. Stack

guidance own these to we're of here is resolve do And appropriate that as that. in, all that and is that we'll And the raising number regarding mind, as be quarter we take this last is I to the question to for way organization number the year But entire issues meant to pressure not And at that for hopefully time we well. take so, don't the we guidance exactly fact confidence different the that Doug, and themselves to productive if Look, you goes and in exceed. high Doug, off anybody. guidance a haven't able pressure will the your on back a made organization to it because around I'll company question years. of and react and that two this make out up as fourth a on this puts on the put have you come discussing Randall's enormous

Douglas Tsao

And from quick of Great. going of terms in the focusing it Okay. then in just one is XXXX? sales specific indications be to force, sort what in follow-up of Pacira terms on

David M. Stack

Doug, is very anesthesia moving So, world, the regional quickly.

series breast reconstructions think and without I you on – it in women's mean and focus C-sections cancer. some cancer women's have So, a hot we the caesarian inside approaches single mastectomies that with bundle continue health you marketplace there's whole the around in just and cancer areas ovarian places reconstruction. if cervical would of to working and about well are

you about a think largely to especially using in patient in opioids the dose XXX,XXX opioids immune and an obvious oncology oncology every or situation women, theme, don't setting would, if around associated itching for C-section's an not a do that's want the United you therapeutic those because dampen example. States want in month women opioids. They The system low the of want the with opioids. in don't done of So minimizing the in

And so much we you if better a think will. mousetrap, we have

our you very step If that, anesthesia field TAPs, is working force of marketplace quickly. the is moving outside focused on with around

do the to blocks about at there is to we wants anesthesia relates are series QL the to blocks community Now EXPAREL, use Woodcock how have we a as that it whole agreement the that with and FDA. field which more know Janet wants to on of have label

with Tennessee, of and regional can use duration improve work our these these but MD range of whole and where And EXPAREL of a you today using University therapies saw the Anderson Cleveland discussion there's to key blocks not we of to opportunities extend by instead advanced Duke leaders only care, bupivacaine. the at as from so the opinion patient Clinic. And

periods resource folks And folks. So folks, that's lot J&J; committed really still the a our our synergizing to big of helping folks helping there focus. then their their of is

we're so And relationship each a other. that from still is still and lot learning young

Douglas Tsao

Thank great. Okay, you.

David M. Stack

Thanks, Doug.

Operator

with Tazeen comes from next America. Thank you. of question our Bank And Ahmad

line Your is open. now

Tazeen Ahmad

Hi. taking Good Thanks my questions. guys. for morning,

David M. Stack

Good morning.

Tazeen Ahmad

Maybe a pipeline question.

did past a you've road. in pursuing interested bunch down trying Dave, the be of you talked about talk pursue longer that about areas DepoMeloxicam. In the no to So, might you

for those pain. of was chronic example One

wanted haven't focusing And while about pipeline wise get spoken in I refreshed thoughts to a it so you just given what in we forward? be should think going the company your on maybe on

David M. Stack

let Tazeen. If what that's myself. Thanks, Yeah. said, correct me I

are pursuing We DepoMeloxicam.

pursuing longer no are We Tranexamic Acid.

Tazeen Ahmad

okay. Oh,

Sorry about that.

David M. Stack

of are where no, the working. number it be and people using oral of that's And Okay. No, are trials we're okay. aware a is to appears reason that there

in appears chronic formulation going an be something interested And very that pain. that I future for remain in there's where to really continue oral so no us of reason invest therapy. is the it to

make sense a you to But of I a have personal products area well. we're working sure a that give There's you're as So pain of we an on. chronic interest folks get of in working number the profile things with I'll product right. where kinds that we're the

to and is as First itself maybe pain. everybody at is EXPAREL to in chronic look interesting an opportunity

have number applications. in a CNS low very We doses are of in clinicians today EXPAREL who using

EXPAREL and about patient X.X% CC in provide and of order to where a CCs from two bupivacaine sciatic where we longer using of think So injection centers number of population. of one relief that bupivacaine of the aware they're a traditional in duration are

it's not going we fuller invest having bridge the So is it label without regulatory in manufacturing sponsored because and anything to into way. any a else company, developing something that it's a to right is by it were or have but – yes, or natural off we look in

from daily patient relief. et basis investment a way have way have improve a Diego in our see of number out use ketamine, R&D animal clonidine, have There products with cetera, used on in by your of a would pregabalin, a being question would the the and that duration are been products group that of to they San To as more care as studies label answer gaining extending pain them help that company the support also an guys a reimbursement a pain that in dexmedetomidine. the at approved done guidance We well by the is continued that currently would are number that either and those like way to looking would application. specifically, longer by chronic

as right Tazeen, some We more can going for about now a with this traditional certainty. year, to close But to timeline. provide later of as on get. could I which about hope be forward development that's guidance I those we're So in what able that's say

Tazeen Ahmad

Okay. that for Dave. color, Thanks

David M. Stack

Thanks.

Tazeen Ahmad

recently number drugs trying an approved get also on faster, then what just maybe are on drugs get to FDA's thoughts generic one trying, stance about to one, approval. but given your more And easier to path

recently competitor the FDA any looking So reason? other any of potential of all is how from or kind at that a or EXPAREL as for change you're entrants way for for at language result generic the

David M. Stack

as be a to past hurdle. that way specific I for multivesicular communicate clear No. will that the would the generic very it liposome very generic of us. approve document outputs on a it high the guidance provides to that make a several generic a this FDA EXPAREL and very is that guidance division positive tried It's in what specific times from the generics actually we've in view very

recent So process you EXPAREL, guidance as it the that develop we get process I the get door. And anything us develop reproducible a think, out understand But we we developed is positive. if continue right. to commercial took it several EXPAREL years I remember that's the been mean, to that is when a highly could

how it's – the And memo cold means very obligations here so, hard here that financial generic chain sterile highly is in of very me This high environment. bar for is bar technical the can meet anybody division to understand a the which is high.

EXPAREL. ever believe but someday, generic don't see may another I liposome you'll You a multivesicular see

Tazeen Ahmad

Okay. Thanks, Dave.

David M. Stack

Tazeen. Thanks,

Operator

Amsellem Thank Piper you. And with from our next comes David question Jaffray.

now line Your is open.

Michael E. Ingerman

Ingerman Hi. the on for Thanks taking for David. question. This Mickey is

portion the and of experience block usage and any there's label of expansions AdCom block potentially on your Just mix R&D nerve at this topic is? on about to also, the curious off-label the nerve re-evaluate of caused how of what has already month, what past the think guys And that initiatives going your you that procedure extent forward? as based to you

David M. Stack

Mickey. Thanks,

best product by available first Gadsden but way, patient is, that's any in at in those that my is terms is that with it see to that like improved clinicians topic, care. use major and provide not Maggie what you Holtz centers something with EXPAREL company single-digit. of that I believe On WellStar, at in more can't in at least marketplaces to Duke and any increasing we block XX%. the of is at some of than has understand folks our continue Jeff you but And because medical nerve the I think the view the do promoted still it's percentage tell because way business the it precision, less

We're AdCom. looking keeping With during as we're said with mind. sending issues the on to team we the There working some FDA FDA. number issues of the open updated an those we and data our a the the that that communicating is was with forward AdCom, prepared down with and had AdCom the during remarks, were presented

you that certainty. months with just wouldn't understand I it just too would or the else any guys through We us negotiate couple anybody with guys question I think think appropriate for another answer early. need it's And can through of be to before FDA. I you

lot So forward months a what the couple to back of path you come with with us of looks another give and clarity we'll like.

Michael E. Ingerman

benefit force put guys one follow-up J&J's any force it. Do of legacy Got member? way, J&J then rather on a to another And they're sales guess means like quantifying force. originating Pacira EXPAREL providing? of able than are quick from uses you I sales many the sales say member quantify you how how incremental have much are

David M. Stack

have. have have We we start wish telling don't But Scott have made where with mentioned better. available by being was can that the you because of product do would fracture. scenarios it would is I we hip and the systems clarity specifically that we in we said, that off you hope trauma, these,

has of list at person has a that who hospitals spine have where improved with access We don't the relationship or have surgeon a been all. access either we achieved any

lead can person So only places outcome positive EXPAREL the track has we the been that where non-EXPAREL to relationships with a have that employee.

track and we monthly on list that have. basis. So We quarterly a activations a

never wasn't relationships can trauma partnership. and we would if spine that and are it see as J&J sports had in and And have for J&J I our like activates said you medicine, all those so

So low-hanging think that's the I fruit.

we we were forward, nascent about, Scott and their the those programs we see going any to that As But they folks and we be are programs those we would and all facilities of those yet. educational are in participating reporting or simulcast meaningful J&J we many so fairly revenue enough from programs haven't where hospital the know the can where other initiatives talked the things PEAK go that programs usage and held see track track matured programs.

Scott N. Braunstein

sharing sophisticated those has they was with force all I and use our to their help think sales add if us. I Dave, that tools partner them some assess they're to tools

having feel markets. in that success sources we'll good with be a But the incremental understanding we're to where details lot won't you. sharing So have a of confident have those we data of we

Michael E. Ingerman

you. Thank Okay.

David M. Stack

Mickey. Thanks,

Operator

next you. with Flanders question And our from comes Sachs. Thank Goldman Dana

now Your line is open.

Dana Flanders

in or the with I opioid-sparing on I Thank potentially could discussion the EXPAREL questions. expect Is first for was you're potential impact discussion claims in you guidance you the Hi. that positively be to how here, either there negatively? that would published that AdCom, something soon. believe one for guess and my FDA

David M. Stack

by a hold not FDA. that we discussion made opioid-sparing wouldn't claims And breath. the on in my with and anybody I was are comment was That

Dana Flanders

Okay. Thank you.

David M. Stack

Yeah. Thanks.

Operator

next from Thank comes you. And our Schott with question Chris JPMorgan.

Your line is now open.

Chris Schott

Thanks very the questions. much for Great.

of view about the the guess sales X on the any EXPAREL clinical are approaching incremental extent just had panel the was on for studies spine, help et is terms which (XX:XX:XX)? some two feedback upcoming of then opportunities questions Phase of programs design EXPAREL just hip, here. FDA One, for timing there I from on one thinking cetera. us in any just from that from in of recent one for how First you're based read can I there. follow-up AdCom? to And in the these your And and across largest you these understand better second,

David M. Stack

were from the clinical that into about. comments question talked Great. have AdCom P bizarre. you Thanks. value The comment what a relevance of X.XXXX of put the fairly some doesn't Yeah, exactly actually does

frankly require do all EXPAREL infiltrations. studies different are will think a we're Phase us design compare interaction They I we for of X opportunity the the we the designs. that cases, biggest FDA. two that programs none In some will running where is with any in

in EXPAREL are efficacy are asking not which comparing So, marketplace in for are an anesthesiologists because centers the EXPAREL who with people more an many of lumborum, TAP and about think who academic moving are might academic example, centers. these advanced providing quadrus you in the is the

two separate. the completely So are things

on in is and future. to of the X label go might are block Phase down I as relates as current question But all products today. entirely additional nerve it well are trials FDA infiltrations think relevant the stance the all as EXPAREL your that and our

Scott theme. if But As huge are any products ask and both here. all I'll these thoughts have a strategic and of you all and – have probably they Rich

opioid-sparing who clinicians in of involve virtually but reasons. the for are interested different we So strategies all

cancer earlier, So their a for stated who I are reduction in females don't having of to example, want because use you to (XX:XX:XX) surgery system use or as the girls expose immune through And situations. marketplace interest in there's great great interest opioids, minimization working in There's the cancer Clinic in on we're a then a high-dose Cleveland in with Anderson those. reducing opioid MD epidurals. and

that the been they've for that's surgical all from community, of spine allows especially that the and nursing of dementia those their to in life done, that situation us huge hugely we so faster, for important a weeks that a So we're faster especially to makes home, so then marketplace. when And that hip a in home because about hospital important the them putting strategically It's & place their nursing possible. a maybe and actually procedures the but that because number and the important move et lose really in procedures the back is treats into patients fracture. we perspective those the are reference not TAPs they but doing very from don't the to gets medical Johnson And protocol sidestep to is in talk for population spine cetera Johnson two payers, Probably bed from as patient specifics also is debilitating the problem EXPAREL and in believe of that scenarios. outpatient. EXPAREL is providing, many resources inpatient being they are

needs So package of you've terms in got opportunities in a but both important there strategically large very also orthopedic medical that of marketplace. are addressing the

on support opportunities X somebody at the advancing consideration. it's programs specific on whole is of is specifically C-section replacing patient as ERAS linked with bulk out I that because and that then the anesthesia them different just care are then consideration the to And around is Clinic of cost of soft on you about by that ERAS different minimization studying the major specific of they programs University programs got folks even on MD – big masses, Rich with environment. reconstruction. then sent think Mayo will, working Long but focusing EXPAREL. raised. of protocols cancer colorectal, not health a are to the data use have outpatient art Tennessee catheters the specific patients medical and and and bunch as move a really the based actively centers advancing can so with And a centers work what with experienced Phase really Cleveland more at for removing on in directly products, opioid pumps discussion payers answer, the programs to range We've you with from if from sorry, how tissue hernia. payers thoracotomies, ambulatory who I'm to EXPAREL programs find we financial procedure do their Chris, that's to the programs so with in as on patients women's side, the It breast and be with what Anderson important well of do a a to surgeries, at care care but On an epidurals, regional thoracotomies of to ovarian programs can whole the the for

Chris Schott

a and business asset bit in portfolio? in to as appetite just market just either particularly just just another market the Perfect And little adding quick update or terms helpful. us on very of near on priorities development shifting Yeah. now, my about right then was Can you gears priorities. to a follow-up thinking

David M. Stack

you get. as I could things. a mean different of wide is looking as at Appetite we're lot

teach appreciate have is geographically also You into a science that have are all group. part smaller like the liaisons marketing go that the technique. of medical Increasingly hospitals surgery Scott's but not can we appropriate channel, institutional only understands know that and and that centers a fact ambulatory the folks organization this dispersed on and sales we that places

increase only drugs in lot reason actually the And what in a for traditional have the couple whatever and significant the frankly us pharmaceutical just the had side. on it things that for would of I quarters calls side. had last in we've weeks opportunities last we've a number a with bunches think for we these opportunities getting a very in of not interest on we've and be – the we're fairly more several of come seen interesting So device

or by financial partners of so And and driven think ambulatory folks be size especially driven would sheet partner the not the anesthesiology deal and our who potential the finances to the really by with really our very We're with the now desire is being relationship our we're – strong. care. associated we deal, surgery with balance and

as of to So, kind and relief to well out special medicine in stuff. catheters rid leads interest as which us medicine and in getting moving of from regenerative and reconstructive of pain that and pumps all

Chris Schott

so much. Thanks Great.

David M. Stack

Thanks. Okay.

Operator

with And Needham. you. question from Thank our comes Serge next Belanger

open. now is line Your

Serge Belanger

question about I have partnership a questions. the my J&J successful the been in taking you've physician a entering for – thanks systems partnerships of hospital groups. and morning strategy. good your of Hi, promotion number with Outside collaboration, and

a drive collaboration, we're about coming think driver Trinity will how year in that EXPAREL demand? be do XXXX much you XXXX the on that on Health Now to a or additional

David M. Stack

Trinity patient and advance the care. together deal Thank first a first for be a – pharmaceutical two a opportunity was partner well, provider all to would you of question. way to the healthcare the so basis the of company for I

us made to serve understand early work driven of and now were other Trinity have their educational opioid understand been important a you always think interested the to I through that now that through be were that and and for are over the a possible you it of a And to have them, here talk solution And they so guidance. days brought us a would have we has we've a through Trinity data that we entire last needs number health manufacturer sparing so systems relationship, to sort progress opportunities it's needs. then that number tell that your confidence driven a quarters. as we for was really with I would remember been was the provider pulled we in okay that specifically of will. working there And relationship have in made and have good to EXPAREL of what the really to their Trinity pathfinder because I to number could if worked could And a of opportunities strategically as us organization how increasing that XXXX. move we will to the with question and we to answer think because couple

be really So those we only one to help not ability think I monthly of as that the But that think patient all are collaboration pointing would identify to well not proud Trinity we're easy our and do in is XXXX. to Trinity as of over is XXXX care timing the investors one our a and referenced another but and it levers direction Charlie on basis. arrows important

Serge Belanger

intend oral that of on the into these up going health to first of collaboration to on just oral kind penetrate you how update give and you And your an was Okay. just Aetna kind is foray partnerships, us health. how follow your Can opportunity?

David M. Stack

the to website on Actually Similar an opioid-sparing funny, it's so ways. and about for patient to have okay it talks banner Aetna EXPAREL to a company opportunity many pharmaceutical improve strategic and a payer a Trinity, has almost Aetna. same for a I together major and care. in as work their Aetna insurer answer Yeah, that made

We continue on expand that to opportunity.

and us we going some in opportunity Aetna opportunity but oral is we've in meaningful another a are can We've resource payer we've it cash, some future a marketplace, surgery opportunity, part internally strategic surgery that – Aetna that Frankly retail are of not we because maxillofacial also from address largely by the opportunity. looking enough that different for can on could oral different is – maxillofacial in pick the retail will. beyond people are learned the a resource plastic put which opportunity if place surgery. to ways releases this addressed you wouldn't too a that expand that on be the as distant specific way up from not as think with But separate You so a team not working we that that of I at opportunity. we press the will way, of see things

a he a called that Aetna as ago hearing the they're specifically So, of is than where payers It's Washington, the out EXPAREL their in we really about question time epidemic. have real instant a relationship lack because I data Pacira get with way from using we a visibility. Senate the significant there different testimony almost in CMO D.C. at actually couple to gave with In us have had Doug's address visibility. relationships interesting the answered for well, and the weeks we and of Aetna them, the way tool opioid lag

relationships way. it are there address are leads that I that various number of of other tell So gives real Aetna the at a of us you also way would to opportunity Aetna-like a the marketplace development. but a in kind different stages

their go the percentage payers meaningful not center, want to in a about environment. treatment their want commercial having because think of EXPAREL patients in of to So, the a for an center, ambulatory care they an total to save work outpatient paying but only an cost physicians ambulatory by

So, exploring that we're opportunity it's aggressively. an pretty

Serge Belanger

you. Thank Okay.

Operator

Thank you. the line with And Bank Gary of our last Nachman Montreal. question of comes from

now open. line Your is

Gary Nachman

late, side point. I'm addressed assuming is Dave, tissue but the so if fully your morning. transitioned you jumped it, soft good sales sure on at I'm on I force Hi, not this

and process or that the orthos for what's IP? still the well? term? then from Is timeline manufacturing, you are batch as with guys meaningfully, where it's for Thanks. nerve back process reps shift spray come detail block delayed the sales over you plan to don't If will to extend to the And get you your long

David M. Stack

Thanks, Gary.

the nerve it application don't their So and a field to nerve a block and understanding date of formal see work of the block if anesthesia, X, of FDA is system improve mix the the hospital can get how from at marketplace the a J&J abandoned April this folks opportunity all. hospital our we on think in to don't are the sure PDUFA improve on forces not changing a and I'm example. there a collaboratively working or I I patient with EXPAREL want we how the mean clear care. scenarios make marketplace in to in about have Frankly, largely EXPAREL that together I Gary, orthopedics. for folks working in

And so to they patient greatest wherever care together opportunity is. the improve work

be a at driven a the PEAK tissue, I'm audience an and still today and actually, I'm actually. going there is It's have in significant if the why know find anesthesia focus I'm orthopedics. through I programs I'm to me is talk to And reconstruction. one soft to we Florida you if talk, on giving but tomorrow XXX% there. half program there's later and I'm out orthopedic sure not to going, ask their anesthesiologist scheduled PEAK myself, by you surgeons going not we night well – So but that know is be

skids we we the is have complete here's on. XXX are, process of will is that's liter so spray the UK. got Diego, – going We a so right? in get San not liter where abandonment so XXX everything in skids And we've it If

year. back As the prepared have an during margin will to his this that of the we commercial UK material in from improved comments, Charlie get half said expect gross

XXX there the And a technical has some in that challenges XXX very liters these how right batch emulsions spray same At set challenges. two of scaled-up time. have with of technical mix liter have We a a short different and time the in are skid we of process UK now. you period a

facilities our have San late in our Swindon. facilities We year Diego of from online in current plenty this coming capacity and

around get is an And margin have will end we much can then San with And because it things about. margin. gross In we as now the spray. as they reasons tax spray to be improve frankly heavily decide the range you Swindon whether improved We will and/or make, to and that we until year the a Diego gross until we of the but, up. we XXX whole talk give batch material then, that law a will queue will QS for a liter change, towards mentioned tie, will have with lean IP, we of a that

announce over next the We to expect partnerships months. several several

so, those long-term view to have And we source a we have partnerships. how will of

a So have do have significantly batch Asias, the just elect process and are tax at a and we their either the liter it the States XXX of margins it out we is we the beyond have in Europe staff status XX United whole to in one can now on the will facilities batch our our technical that and the ability a to solve Europe we service to what world liter Europe or (XX:XX:XX) for possible, because there entirely of that Gary, United XX issues relationship here. might and Patheon at States move back based new spray out the scale given liter of and

the But, So to middle this as might meeting discussion. as outside. we're with it's quite simple of in Patheon next month not it from start appear the strategic

Gary Nachman

for Could far Okay. that and you could from spray, just go there? the when the expire the both how patents batch remind then us

David M. Stack

X, So the the XXXX. XXXX. to product now for application April play on filed eve XX, in XXXX, process spray We right goes that's of Christmas December in

of application than you it would example, is goes and do, about know PTO but least XXXX, April But guys at for sitting that I significant So the expect that know extensions time XXXX. based to out on April with I so. you the patent the more X, X

Gary Nachman

Thanks.

David M. Stack

Okay. Thanks, Gary.

Operator

Thank that to the call you. over And would today's call. Stack for like session Dave question-and-answer now any back our remarks. to does turn conclude I further for

David M. Stack

your providing look questions the time forward in to We morning. for future. updates additional Thanks this and

forward Conference Barclays a all in us you is lot. look Next to for Thanks soon. Miami. We the up seeing

Operator

program. does wonderful have day. Ladies This disconnect. all you conclude today's in thank today's conference. and a participating gentlemen for you And may Everyone

Pacira BioSciences (PCRX) 28 Feb 182017 Q4 Earnings call transcript