FLXN - Earnings call transcript Q4 2017 | Flexion Therapeutics Inc

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Operator

Good afternoon ladies and gentlemen and welcome to the Flexion Therapeutics Q4 and Full Year 2017 Financial Results Conference Call. My name is Bruce and I will be your coordinator today. At this time all participants are in listen-only mode.

We will be facilitating a question-and-answer session at the end of today’s call. [Operator Instructions]. the to turn company. now will call the over I

Scott Young

by we Scott afternoon. President Relations. Thank be and And release call Good Vice the on he by Deardorf, Senior led this is of is at archive Both Executive Commercial this Officer Young, call will of flexiontherapeutics.com. joined found Chief an earnings Today’s Investor Dr. President Operations. you, Bruce. can and This Vice conference afternoon website Communications for be company's Flexion’s Michael the Clayman. issued Dan Corporate

strategies forward-looking we Before be expenses, teleconference expectations Reform operating including need forward-looking we clinical, are Private within relating performance, sales, begin, to and commercial and I utilization, net commercial, regarding Flexion or uncertainties various regulatory which financial Act. anticipated include over forward-looking cautions are remind and Securities cash developments this time. other of you during change milestones and these business assumptions, risks future the statements the that projections. Statements business Litigation to will matters, subject statements and regulatory financial, meaning to making or statements that clinical, conditions that

factors date of turn Flexion's statements. and to Flexion’s at conditions www.sec.gov, on on are available and could information business, and that as such the Clayman. only call These of forward-looking this well Mike other over website. the assumes speak CEO, call as now to no statements Flexion financial will XX-K Form the I Additional in Flexion's update Flexion's duty as SEC the and are which affect operations of Report results risks contained Annual filings with

Mike Clayman

the on into joining the early highlights progressing and thank provide on on and of access consolidation to XXXX November adoption After which institutions a building of of barely XX our under major under includes and place our their in will specifically miscellaneous Today high the receiving before financial focus the organization, uptake entire quickly account our ZILRETTA have to and afternoon we feedback the results. more paused launch feedback call. that Good been the world the literally treatment have in the product. plans, on although Scott. the we the a three, months and establishing the our a how from four the will QX mode. FDA between our complete our we believe have the we’ve loop summarize you the encouraged XXXX the time several foundation reimbursement momentum comfort not positioning color to that October physicians the dynamics had X ZILRETTA, all achievement gone XX With a upon Flexion. trained those and of we’ve we code; expect ZILRETTA launch formularies or days team people single full approval for in ZILRETTA’s key high been is Thanks the the could of ability recap clinical executing is resources business and our real XXXX solid experienced FDA cycle Whereas X govern was commercial commercial word for we in Between build was a We key are ZILRETTA executing We our still the biggest for the to line get and hired, of by levels history. that monumental confidences questions. deployed was internal time In and in and started managers, recent are all navigating the to early strategy. field ZILRETTA, The October prescribers, J of said, aspects approval, hyperbole and follow-up about we which breath which as It’s and years, term and approval long managers say in early significant finally physician, patient the will interest for There we clinical of leaders. potential setting. laser musculoskeletal in year year ZILRETTA’s ZILRETTA, to-date. continue coverage in experts known filed of have days will success. take, indisputably launch, payer and open of take launch our mind, XXXX in heard reimbursement focus short for in XXXX we year shifted That from progresses. we as

clinical always had patients heard have positive during We our we’ve and trials. benefits great clinical from the ZILRETTA confidence of in feedback

been impressed But product. the I’ve Dan compelling have across tremendously sample activities. showed the describe with our from the this they ongoing Phase OA in ZILRETTA of year patients unprecedented XXX confidence who following reinforce few With ZILRETTA. study XX ZILRETTA the repeat contacted these ZILRETTA this these positive of describe respect of confront stores initial January on who initial the a XX% share in outreach that have clinical we by so more by to of us updates out country the experienced will only exciting pain. I’ll and our in patients launch at gratifying much which week data physicians III to millions reported injection XXX the are to point knee stories from detail, with patients potential holds provide knee, patients experienced small. OA for However Clearly are their and experiences size is spontaneous in of of anecdotes, benefit who and administration or benefit clinical our the of of

approximately of eligible patients ZILRETTA received second between XX. XX today, dose of weeks and XX% of a As

ZILRETTA, they glean has evaluate opting about experience trial is to study the benefit of While us the for repeated patients of initial a safety information open this to injection. specifically and label treatment the before administration duration design respond designed enabled real-world to how of second

know study. now who number is QX we million of concurring to In injections That X.X This systemic triamcinolone ZILRETTA hip, shoulder in clinical studies of OA respect data continue a the from a II read we release designed indications an of of to ZILRETTA has in confront out trial shoulder smaller and well year. OA in doses on the in of in December safety With been and of fully roughly previously extension ZILRETTA. and announced are still trial while the milligram clinical represent evaluate are expect II trail the a acetonide. of two XX bilateral Phase a the trial to track in of OA to-line the patients growth and and knee. milligrams line line of OA ZILRETTA indicated populating investigate initiated as very ZILRETTA of trial immediate pharmacokinetics is underway two versus and this December exposure XXXX, anticipated patients with SHIP of is next compare This this the there this quarter. Phase results Combined, hip the XX of in to initiation to potential half of As believe we we enrolled top knee year. substantial of patients we to second important the for these opportunity the

that two presentations garnered other to is a also steroids potential impressive measures. and poster capsulitis, frozen treated high. that hosted, also immediate including with which week who From subacromial patients to such with ZILRETTA attending our physician Orthopedic activity clinical of treatment Additionally, highlighting relieve American of study steroid, conference, the Annual community ZILRETTA shoulder are aspects at called for the ZILRETTA are indications lead presentations; and our improvements bursitis, the of syndrome. orthopedic to been in describes presence the the as shoulder; provide previously booth been so IA the impingement oral attention from attendance could in important potential data quality in which as adhesive the ZILRETTA's information treated the the we which SHIP is release provide Meeting, with may clearly presentation at pain effective key commonly in and life known This events all the investigation Association the interest to an an podium have suggest by we and Surgeons of has

publication mentioned our on last are the III for waiting still the paper Phase has a I of data by accepted data leading the the however run. we been to as call, Regarding journal, orthopedic

will the communicate that been pipeline. and that has few a are we caliber With pleased accepted has updates While that the by process our bit very news. journal of provide protracted, published on been it a me let once we paper the

as the hold of may only securing our FXXXX control the modify local it gene that and is committed While of means Flexion’s IL-XRa inflation for to believe provide FXXXX of now second we administered the anti-inflammatory a inflammation. a the ZILRETTA disease. pain also the compelling is third produces acquired an rights holds knee are least protein promoter, from is produced announced future. validated priority, a therapy is under OA IL-XRa, importantly at that clinically potential sensitive we that locally pre-clinical program year the a which and is disease. known when potential site FXXXX at relief to In there to December to which we first, we

a and potential FXXXX you demand provide The potential reduce relief the suggest preclinical IL-XRa disease data of at for be anti-inflammatory to could single also least indicate on effect. The injection. year FXXXX following can intra-articular preclinical a that think this as inflation the for pain So express, data modifying.

the this aim goal year, process IND the human trials to we own initiating data in and with our generating are with later XXXX. pre-IND in enabling FDA of a hold a We of meeting preclinical

research to of preclinical teams OA fluticasone, formulation related conduct may on studies which extended-release provide of months pain. FXXXX, In our up addition, to from an six relief continue

I year in-licensing in and research, to for continue have that over are FXXXX expect a to Dan bias the Deardorf our the this local With for with inform programs therapies towards provide which turn FXXXX commercial stage we our update progress to our this aligned still opportunities and of the ZILRETTA. At with conditions. evaluate additional point, will on next of key advancing musculoskeletal We clinical launch an data program. to will steps preclinical call strategy

Dan Deardorf

Mike. Thanks

launch Now ZILRETTA out safety interest some activities there that commentary has that fact the been overall time in and on qualitative attribute little to providing the of we into launched, profile the about to efficacy say start and about to gate, for the long a very our space has and we please innovation OA well. things how like progressing of excited I’m are and been been clinical this by the Coming product. months that are in the high physicians going are I’d have X.X

prescribers levels. many hearing we stories on are shape experience of pain from Since ultimately That’s about the magnitude physicians mentioned, of patients deep it’s only will that of have for peers. With ZILRETTA. Mike and reimbursement, respect it’s encouraging medical the experiencing As with encouraging that a their for patients formal type relief. share payers us decision issued handful policy a making this feedback physicians to-date will to

have explained, to reimburse commercial we and However payers. broad place the need payers as both seeing formal from not we previously policies are in Medicare commercial and have do product to coverage for

through fact processed XX% LEXFORWARD for of have In coverage more the ZILRETTA. than seen we patients we service, of have benefits that have verifications our

code have under these offices. result their our line as seeing any with product buy-and-bill into be not experienced comfort. they of sure they prescribers MBMs, a We new anticipated with their many to pocket levels reimbursement out some To respect that miscellaneous support other in practices and first issues J changed confidence significant a HA are we are is in J Managers. we be were have expected with Musculoskeletal has practices There Business tentativeness coverage three take to miscellaneous physician this product a from instances place before build reimbursement. who where products to will our and inventory code, As want or of that with and

physicians a challenges. and is and the tandem issues to One of FAMs. serve a made a regularly of of an serve investment their our both reimbursement staff. We’d the They code with working and where office receive trained we and in unsolicited, this indicates customers. the of our Access to support their miscellaneous are reimbursement access lastly provides FlexForward, needed, in MBMs to are comprehensive added with layer resource higher services buy-and-bill from and or provide for the we key hiring key for hear a have J for solicited level support Working And provides products in and Field with step staff to Managers prescribers confidence process. our preferably significant was well. MBMs FlexForward an experience which the through the suite We MBMs previous available criteria expert for as team even physicians that feedback and walk to

are with and product resources So will execution. physicians that the and on increasingly plans reimbursement for with as know of in their confidence evidence We experience now place, demand we grow. for the ZILRETTA focused

Now be to turn quantitative to I’d six metrics we’ll like the reporting quarterly. that

the use measures readiness provide when the are to insights full ultimately provide adoption from as to which ZILRETTA. first uptake introduced move progress As and to four the product, product being and collectively is you of of administration intention to or can with a prescribers to on reminder, track the These taken the of adoption indicators that reorder. the metrics ZILRETTA

metrics it’s reimbursement. provide to on began That fully holidays, November on QX We payers timeframe focus today real but translate of QX, we some would force that effectively provide remember about addition, days the time know will our launch in weeks. in selling was middle and some the of our In results the you eight sales so share we’ll reflect not deployed. for that two XX important the update into XX us progress our provide to-date. have and view limited context metrics of like To we a when are

X,XXX of start, physicians. called the target approximately and accounts to approximately X,XXX on So X,XXX roughly physicians we

the with are close XX% and this of the XXX focused partnership versus Again the our accounts, with of our services at our our with Of focus meaning conducted conducted that December accounts by Given either around gained prescribers, XX. order with approximately of interactions with breadth interactions ZILRETTA, in in placed purchased our reimbursement product In to short of depth we timeframe our discussions already progress. FAMs MBMs had held purchase approximately XXX experience depth in-depth on often them intention or initial we and product approximately accounts QX preparation through those training. of an samples. pleased

payer key lives. December million XXX the representing with XX by front, roughly On we XX about engaged insurers commercial covered

in than that deliver have had I As have which as seeing early ZILRETTA. FlexForward very positive discussed, we in ZILRETTA. We call. have year with the for processed everything days we our the coverage foundational on closing that we based and mentioned see our I further would have to and of to believe updating pleased the that pleased we service we QX Mike’s earlier, that QX through we earnings just I were benefits coverage In on the metrics successfully seen XXXX we and a of greater place we are I look that to and XX% been comment anticipated verifications like determinations forward these reiterate you are hearing progress in saw

Mike Clayman

our we Fred active personal very Fred advisor Since us our remains that would join Driscoll to commitment, an unable intimately Dan. this continue successor. financial in Thanks while say as just for Flexion is to important due involved I search

year and in will results. absence I quick QX our his financial full through run So

the respectively. years was related issuance to a and in XXXX For XX, the million The million net increase of development notes. of expenses net $XXX.X as our the expenses commercial compared Research December general the required reported for and $XX.X expenses other to to and was research compared costs the XX, loss commercialization $X.X and due for administrative general personnel launch in respectively. ZILRETTA. convertible increase million million December the of in totaled due in a and expenses compared million expense in million XXXX primarily to portfolio XXXX XXXX, were increase headcount additional in QX and of for May as The aggregate were $XX.X development Selling, as $X.X million years selling, increased preclinical an of XXXX to ended expansion to Interest million expenses Net and the $XX.X related to XXXX, XXXX of $XX.X $XXX.X costs. corporate in XXXX the of and for an support and over ended XXXX $XX.X loss infrastructure $XXX,XXX. of and $XX.X and due million and ZILRETTA by and administrative approximately company million XXXX, program primarily sales of development XXXX XXXX. to

$XXX.X the in of had As company December cash, XX, approximately XX, securities million XXXX, million equivalents and as marketable cash of with $XXX.X December compared XXXX.

As corporate a of matter guidance. financial not do we provide practice,

in of OA the development additions the FXXXX the over with activities that activities of increase for hip future associated to pipeline. expenses to commercial expect and and in ramp ZILRETTA due open associated years shoulder. for clinical questions. line we development operator, the However, With several ZILRETTA, with extension costs associated trials for XXX please line the and the Expenses to next with

Operator

our Instructions]. And first line question of [Operator Maris Fargo. the David you. comes Thank from Wells from

Your line is now open.

David Maris

A Good Dan. from the or during that is that afternoon. of the to transaction something and with coming said from questions the at conference Is a been this steroid in for Is case? watching from felt couple clients I code you about that injectors? what’s there comfortable you sense in or still presentation something couple worried quarter your Thank the consensus that like injectors Secondly, it and should think be felt of a is have for And getting you this questions, is consensus quarter, Hi you. point. a Mike first you are experience, with a then any where you do that. HA risk investors number – the J share year. timing traditional coming or any have sales comfortable

Mike Clayman

then, we two changed. Dan enthusiasm has that said it. the response that weeks roughly with absolutely seeing ago the It we ask say I’ll We And clinical that to continue encouraged the to comfort we now just Deardorf terms estimates. in then and questions, all we when the comfortable sighted question consensus the we things first for in comfortable two were to was of are David. the that there I’d next of answer be out not I’ll and comments our product by this are answer

Dan Deardorf

time have patient, sales that’s seen patient this are seeing obviously from diabetic, type only not Yeah just we makeup percolated any are we At they we is many you’re into particular with usage With getting first who David, at this in are to, force and nothing I going that the of far as respect regular real up gotten insight are point would specific thus are physicians. have through our The they we that to. what field early we calls Dan. users, on is think previous that have any monitoring be someone that, There them. might is an HA. of be physicians steroid place a type

proposing are of own as So to a group that the from. or are for own says label XXXX. we general will that those we we have out much we a more coding to our we CMS's and just code full again are our all confident book, patients their issue We in public on list code. There of that remain in respect will dedicated remains those all J month our reiterate, they J we code that further, and so our J after that, be May a that but that fully confidence code. fall X in don’t they where codes things our that substitutable, just a expand determination to meet receive not products HCPCS to April two sends the the of fall on a The for get we have still then we FDAs January drug, that coming based information single code. are products will we confidence is process meetings that, have final are will for little the requirements With a the sourced ’XX that get orange listing own fully

David Maris

Great, thank you very much.

Operator

the RBC line from comes Capital Markets. question from Randall next the And of Stanicky

open. now is line Your

Dan Busby

Dan on Randall. is this Busby for Hey

Just a on questions of launch. couple the

give was of is among increase First I can order have But as two, indicated in seen so? don’t the launch prior to metrics you a acquiring to do provided? what And doctors you sense commercial percentage have you start the especially authorization that payers us early sizes, their or are they think adopters. might

Dan Deardorf

increased We’ve the as with first variable. order in your order obviously. question have been and seen have getting reimbursement We’ve it bites by that coming decided caveat small take some early so are they let's was still days But seen that accounts It’s sizes. this Yes, clearly we back. others comfortable sizes. seen have

have So sorry, some we variability seen one... I’m that missed on front. I

Mike Clayman

payers… The commercial

Dan Deardorf

– written tell medical couple, there. that there. too soon there are only very I Like for of a It’s said to us a are handful policies

point we So enough at have don’t just time. insight in this

to top in with We are policies coverage to indented so we ZILRETTA, but one early regularly engaged in with each for or obviously those sill have for them that payers meeting shape optimal days. trying front XX of and the us allow

Dan Busby

it, Got thanks.

Mike Clayman

you. Thank

Operator

the from next our Gary of question with BMO Capital. Nachman comes And line

now Your line open. is

Gary Nachman

afternoon. getting question, J to to delay good And day XX extended revenue. terms when could guys And with the actually sampling. answer might that, aggressively then a reimbursement XX there do that for code? day miscellaneous you be the physicians Are have for payment you but Fred that book the more most of you all if how Hi, reserves in be Mike helpful? a been Are any terms would

experienced Dan or down samples. purchasing either said break earlier you gained think us? I So Could XXX that accounts you for

Mike Clayman

All respect through question dating. so day your purchasing get Yeah, term. our with XX distributors specialty customers first to the

reserves. in to samples break this with to respect not point to etc, product reserves time. can’t so going that minimal, think them. I universal suspect at for be be respect I they I is versus would with is we need that. something are on will some that would the there on And answer purchase out we question to we believe the but to So those with follow respect up specifically return reserves

is that I sale, with tell can merely ultimate sample a focus will product. take that. gaining a we will something sale, enables some Our an where and physicians’ days we reimbursement of around you the we take is hesitancy where that’s the where sale there early use experience will a in

them for get them, which are way them to and So on with we we they for but purpose are experience is the using being that to the interned judicious are leveraging sales.

Dan Deardorf

in recognition carrier, we of terms the And to of our revenue Gary, at distributor. movement from product third of logistics point our recognize our party specialty from revenue warehouse

Gary Nachman

one just follow Mike then up. Okay,

dosing I its So know are on that, data timeframe? you on the since repeat study, when you points rough these gave us but any share the little on coming label can additional just patients bit open back,

Mike Clayman

public Yeah, there's potentially I at that and QX. we get but least is ways will, months, in a want well expectations before you simply are tuned. but say you good looking is know don’t coming information learning the at pretty be – to stay there would Gary will to set the more this There I we unduly, domain change

Gary Nachman

Okay.

Mike Clayman

to put point and out. consistent. get collating want understandable to fine in fashion data is that them a on these Just It’s of a very completely we it, much matter a just

us, So at the that’s front of point. the seeing to of possible time our doing earliest in best we data but expectation are meet

Gary Nachman

correct. update Okay hope positive you’re label, data show that these the that or could optimistic if you potential what and still are you

Mike Clayman

with discussions possible. published can element data. And parties presented, this. we and we move these address presented to me get let is label say work physicians I with the sense They data with the is the the can we addressed expeditiously say, certainly we and would that I guarded this. tell will will be as you payers quickly for that once through in agency certainly The can become will on and the have and of dose optimism as as FDA just that the fodder outside directly repeat as to

Gary Nachman

Thank you. Okay.

Mike Clayman

Thank you.

Operator

next line Wilbur our question from James. of the Raymond And from Elliot comes

line now Your open. is

Elliot Wilbur

and Mike good on focusing Thanks, the here FXXXX. asset, in-license afternoon. maybe gears just your recent most shifting

Not technology discussed the or just Just into PLGA maybe thought potential that advantage some technology yet platform? of curious, that have fact incorporation your you microsphere if given we’ve sure to curious of that platform. to not sort in into that incorporating added but that

Mike Clayman

that turning gene IL-XRa take joint the the you it’s vector, back - once injected the at the done. concentrations cell Yeah, PLGA cavity. it of there slowly But dividing factory to gene of incorporating promoter. up by you incorporating that, sensitive you question all a say strand A gets could is control itself given and that year, The information meaningful not and that asking the DNA cell, joint be wouldn’t production have long entrance if of for as fibroblast about that that this protein gains the the this moves under It if very Fibroblast vanishingly Elliot. the a dividing a in of and long into clear and step the the protein joint PLGA of low. likelihood is [inaudible] how a as are a of into the then vector just works. the way production very IL-XRa long-winded saying as into advantage to are line be very it’s and would the slowly over itself dictates that you taken get into therapeutic interesting I and would are virus fibroblast as for look

Elliot Wilbur

thanks. Okay,

additional an follow-up Just question here.

the may between assay some now sensitivity studies, and demonstrated poster how rapid event that and data of ZILRETTA presented clearly knee ADP on to you’ve impact. in already guess that the at recently continue I since at onset ATS, WOMAC an scale, You

are and/or studies. endpoints thinking based market WOMAC incorporating So endpoints you expansion ADP in about versus ongoing label potentially some the of

Mike Clayman

you trials, learning understand, very ongoing we trials or based efficacy actual our sensitivity the give it so or just take pharmacokinetic not so will from trial you all to a that this WOMAC ADP. be assay would Yeah, can going to certain than of serious level trials work but WOMAC would work, higher reason including consideration that and elevating we to the stand forward

will think Elliott, and though the from emerge proceed will that there based that you the with design happen available with we information. internally think fairness are discussions create can we on I should optimal in most discussions I confidence those that

Elliot Wilbur

then and in last we label benefit product bilateral I with we point this for of mean I indication just But that to the shoulder respect potential at the mean that label. Okay, the on how be hip with trials. would order I data question. to something in should to see some the thinking respect would about registration fact are full get communication assume getting usage, favorable in and

Mike Clayman

today from both the anyone nothing initial pain say label one knees for knee versus that The response in to treatment that is two nothing Well, indication administering I’ll there concurrently. just this that knees. is precludes the to of point OA is product Elliott and that the in

dictated as be lower can these physician systemic exposures What done. is generating substantially plasma data information, triamcinolone So the expect that we’re doing acetonide providing by pharmacokinetic to of after will judgment the concentration simply information translate ZILRETTA we the is injections that show intent which with steroid. pharmacodynamic idea reinforce immediate think immediate pharmacokinetic injections we advantage is associated and steroid believe that will compared I release into over there release the meaningful a the it’s a real to by

Elliot Wilbur

you. thank Alright,

Mike Clayman

Elliott. Thanks

Operator

Belanger Serge next Needham from line & from question of our Co. And comes the

is now Your open. line

Serge Belanger

afternoon. Good

First question for Dan.

commercial past by payers adoption three the in talked the think XX I approval. from or month you process with about

thinking mentioned you think I so insured met, all you’ve that your Has there? XX at Now about far. changed

Dan Deardorf

they there how payers, understand to see economic policy. being stat from experience will write of to medical three gave, XX reach answer with data that’s plans of get actually with for we’re we’ve but that the Is ZILRETTA? formal their data or come and in I people those see that we’ve of what wait our in policy clinical interim say plan, in of through many not it’s They question payer. patient this that’s products policy. XX% clinical has we these back time months of it’s take good an that number out is the process of to patients develop been to yes. to the etcetera, had that ultimately and anywhere for that presentations may important FLEXFORWARD their actually before covered the the medical used them, because to and some product want what the that’s seeing and will advance the No, coverage But met initial and the you of dynamic discussions is

we’re So for those to policy. medical absent There policies. the coverage going is

written the policies and influence over that to ultimate continue will are medical time. We try

Serge Belanger

you of orderness visibility of ZILRETTA, your feedback early campaigns? when terms the direct-to-patient of do on In from level you want undertake have to additional

Mike Clayman

don’t has We’ve got should that’s One, to generate us their have optimization, will that we’ve activate a that you search be guidelines to this effect significant they’ve along that website, about months to go anything likelihood order a in a really just mid-year, physicians out reasons. they so patient DTP that of we’ve we start to that the we the opportunity before ‘sending when bush, experience to solid for changed We start base those the broader ongoing product, there the out know make obviously I there got engine and way’ to now. both for Yes, had of always start year it. receiving push suggest for gain state got to to mid-year two search wait I for interest. activities us. ask and of six want as product paid that. anticipated patients we organic utilizing we a that you that physicians with But lines, a sure with product well post pharma when launch ZILRETTA got

Serge Belanger

you. Okay. Thank

Mike Clayman

Sure. Thanks Serge.

Operator

from Frank line of from And the our next question Laidlaw. comes Brisebois

is now open. Your line

Frank Brisebois

thanks Hey, for the taking question.

the one their KOLs field was first versus ZILRETTA. of in I wondering difference just depict The the docs use importance just community guess at for between the I you here, how

Dan Deardorf

already met leaders influential for we’ve to of the the familiar to a on them to perspective looked many some were we our familiar, product, opinion the days them, their this week key that of say as can course and a AAOS order get with in Obviously so is variably but the of on lot are Yeah, over been years get at very with KOLs, product here of for etcetera. new lot ones that’s I past focus answer. some have – focused physicians few the and

large that that’s used that of leaders. would With is large, volume marketplace important. opinion considered by there obviously said, this key product be KOLs a So people not in

important. just are those So

top them about opinion treat just more think frankly be our we see prioritization and of accounts patients. that as and of some the community will targeting So key our leaders of physicians and will tier some our of lot accounts, be whole based a

Frank Brisebois

you Okay, are you detail into Is or know from they kind? feeling and or more any can patients how then know when feedback that? on you on mentioned anything the feedback what from anecdotally go patients, physicians there you

Mike Clayman

to that getting like that a stress We’ve with I therapy of who KOLs, injected are physicians, impressed within the been following patients Yeah, to from in said have anecdotes want his and from and response pain the and physicians he downstairs in saying of pain years field just the had We’ve to again, time their with walk with they’ve number literally but reports We’ve very several had relief had never they’ve patient those they’ve of hours. injection. some received. themselves where positive was including reports morning osteoarthritis Frank for one a and any have able onset XX so arranged this of other feedback bad was these physicians real. of are had number relief their first whole that the ZILRETTA gotten to has they upfront injected we’ve

our our it anything exceeding is stories expected confidence are prepared we’re expectations. way conclude than not this we out that it there increases Frankly there would. the product and performing So many other its to

and were extend that reinforce it. As bullish only anecdotes confident at but about as confidence, product launch, we these this not

Dan Deardorf

‘oh! be a is of their really What’s lines. hearing if that the that’s coming a not anecdotes differentiator as those we’ve along well. that’s through the which can going That’s that key think steroid’ add this for I at key show we to I and and data glance if product at are got people to would to we’re lot just longer a is well, first believed – ZILRETTA internally always magnitude Yeah, be look

Frank Brisebois

when Okay the road or think for possible there have is that that? – the great. length about great you of a just do know of how FXXXX or of the that talk the guys then down how with ZILRETTA is cannibalization to And should you think efficacy, we about problem you

Mike Clayman

the down to years product Frank, to I fact cannibalize studies make product It and like quite harbor great mean longer that. a expect be because our be logically and think terms is road. it’s in fully ZILRETTA better market will in be I there to because longer ZILRETTA, a time before longer. doing than view out would it will FXXXX, would certainly a lived, develop, a terms well follow-up time studies, of of view. that it toxoicology in is us number there problem of it the going clinical will take to we that the If well we be would following product who that’s at do the a

Frank Brisebois

Are right. competition any that to do in you Right, that’s little a space trying hearing something of longer.

Mike Clayman

what Well, we've terms frankly very talked are that stages not in early beyond competitors about at before development. of of

Frank Brisebois

on data glucose feedback ZILRETTA? just basically question. just physician lastly IR with couple you question with potential the spikes in patient of the presented then of – Okay had patient recently. But I no last the there’s or again feedback that blood elevation and diabetic great terms Anything

Mike Clayman

would glycolic physicians. number – of essential say absence the essentially a certainly spike that of hyper of attention is a with it that the I Yeah, prescribing certainly ZILRETTA case captures the

injecting in experiencing those that many patients education diabetic hyperglycemic immediate think patients steroids release I their mode, with still today spikes. are are physicians we and many are

we I provide that potential solution be addressed the think have to a ZILRETTA before. never to in that could problem

over the for and going this diabetic comfortable, for drug is it’s care make optimal. some getting patients to to a for there of are So be little all physicians their not potential more some getting comfortable, the about of more they this physicians bit getting excited

Frank Brisebois

you Thank much. Excellent. very

Mike Clayman

Thanks Frank.

Operator

our Carl question Securities. Byrnes And from Northland comes the from of next line

is open. line Your now

Carl Byrnes

Yeah, I quick question. a had just a

the number that we around a million that when the clarification represented repeat hip and lives. XXX for trial the phase Just Could two, of expect number? three healthcare And shoulder? of might plans you initiation

Mike Clayman

this about take for this, we to around still, are description, the thinking Let one synthesize understanding generate then Carl. and I’d this, with take those and first confidence know I first we pharmacokinetic your What it then over its this of way Dan second – the turn me the the plot data, there forward. hip shoulder data think want of I’ll intervenes you say to look grain so path are question salt. and and data, the do is our at a and we

in still get the front that. for it our trail be So to to position premature the guide indication expansion. in is label We default for is us us. likely the of trail will And of phase registration timing efficacy three it’s – that to each timing,

Dan Deardorf

it’s respect million approximately And payer was lives. that around with XXX to XX represented your question, plans covered are

Carl Byrnes

so Thanks much. Great.

Mike Clayman

Thanks Carl.

Operator

Bruce next our from of Jackson Street Capital. And question comes from the line Lake

open. now is line Your

Bruce Jackson

of adoption. Hi, my talking a to dig more thank for you question. little bit wanted just physician I in

rate likely a say would a that range for more some that it as you physician quickly are more that are What of number indicators adopts to physicians product. the the to the more to that limiting for You adopt the of takes its months opposed factors of kind gave and what slowly?

Dan Deardorf

population, think a to reschedule is I orthopedists So this physicians. less of up drive they heard within proactive question, following the are patient returns they back the a their bulk come particularly variable the generally when to driven is with will I In physician in market. that general It if feedback their and phenomenon which paying patients’ patients.

So product does the working. returns long of to to how perspective the is can but just variable, on that what based when or not their be the return physician as patient

and that can them or an make on silence a it weeks a worked for and loop. product, standard then if when to feedback five feedback you go you appointment suffer few in even physician ultimately were So months a and that get you for month generally to few their your and a you steroid back that’s

that if which months like imagine loop longer, returns patient the longer several physician ZILRETTA take can product with you So about that could ultimately works their their before to experience. tell feedback

the we this weeks this was the offering quick in think worked anticipated something unlike to with in stuff product. point, is interesting say, I anything days, not my space, feedback had previous is actually operating life ‘that really within antidotes to just doc’ that the well I’ve sharing Mike heard that

If is the lot going not they you about coming are be could feedback, the this physicians. whatever or and variability. or say. a case have that the that’s happening quicker feedback the maybe, loop when for get talk anecdotes shown of a two lies we perform so in there back physicians general therein to So continues as variability that will us of proactively to these because four then In product many are

Bruce Jackson

you very Thank much. perfect. that’s Okay,

Mike Clayman

Bruce. Thanks

Operator

question our from And Berenberg. comes line Trucchio the from Patrick next of

now is line open. Your

Eric Donaldson

people first off couple Hi speaking We is Eric This have a today. and of behalf what there, Donaldson Patrick question question of our other on afternoon of kind have just guys. and good of builds been of meaningful share hit of suggest asking. perhaps they in market, shoulder be After OA with speaking that KOLs indication could terms the multiples very OA with some knee.

while could a maybe it in of XX% of one two its told with instance research KOL to much to shoulder for of differential consistent your ZILRETTA share shoulder and is this reasonable expect approval. OA post two shares as be Is compared OA years, So for OA in OA XX% practice knee. that ZILRETTA knee type share in years us

Mike Clayman

Eric, towards conditions. different I’ll think say penetrations this way premature to its for I the us be guiding in

end and the that That is million injections a eight there clear hip million is receive multiple number you about who who knee that X.X per of contrast thing you per injections one combined. into year will patient patients the year think injections with receive and million up X.X almost shoulder are injections. I times with patients

absolute of larger terms with either a the and experience of the think in and to we are the sales different, unit the patients of by but staring be large confidence base on the guided very will that is clearly terms substantially of in uptake in product the just be penetration physicians. you with the So case knee I and we out directly penetration the numbers proportional quality, where proceed this and penetration numbers will

just KOL insight will single the that, future. the predict I concluding on uncomfortable a would very based be likely that of So

Eric Donaldson

any if of in in just us Medicaid something anticipate you Alright next is very ZILRETTA question in being formularies you HA great, and so thank commercial, then we much. should our modeling? states is tell and which ahead if the terms Medicare, of this place And on and payers. our Can

Mike Clayman

for and Let his Dan just start ask comments. I’ll me

yet I placed whether there impudent, being of we that placement and ahead no yes, ahead, for sound has would is the so say formal Anthem ask Well is I know don’t You but for to ZILRETTA that withdrawn established Anthem different are HA, the HAs? that, want reimbursements ultimately to in plans we population and ahead that’s who ZILRETTA us. policies written of we that in are physicians are after Having are who on that using the there know we using preference said are depend know that will that HAs, HA. are ZILRETTA its physicians

sight early us clear it of line we for a – claim are that premature think be will that. we it’s that have so I So on to Eric

Eric Donaldson

great. so Alright Thank questions. the you answering for much

Mike Clayman

on everybody and you you we numbers weeks. where in are first confidence attention. and are your continue sense forward Yeah in look of I headed with to with the we terms Well, the a we want and time we thank leave to quarter matter that where I’ll for to of you updating that pleasure.

Operator

have and Ladies Everybody does all This for a may participating conference. gentlemen, program you thank great in disconnect. day. conclude the and today’s you

Flexion Therapeutics (FLXN) 9 Mar 182017 Q4 Earnings call transcript