FLXN - Earnings call transcript Q1 2019 | Flexion Therapeutics Inc

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Operator

Good afternoon, ladies and gentlemen and welcome to the Flexion Therapeutics First Quarter 2019 Financial Results Conference Call. My name is Kevin and I will be your coordinator today. At this time, all participants are in a listen-only mode.

Before we begin I would like to call your attention to the slides that Company will present today. The slides can be view directly via the webcast on Flexion's website under the Investor's tab or on the 8-K the Company issued this afternoon.

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

Scott Young

Investor Flexion's On This an he and expectations afternoon. conference Corporate and milestones the is of Young, over we Relations. website that to Officer, Dr. anticipated the which and Executive that teleconference, slides Vice release clinical, The projections. performance, and found regarding at Flexion's Statements operating the this include and archive can is expenses, or of Flexion Private Good by regulatory regulatory Company's forward-looking and issued earnings uncertainties business Securities and are be statements be by conditions financial various joined financial President Chief commercial, Scott statements call forward-looking Communications afternoon making relating within cautions or Reform and for on flexiontherapeutics.com. are to Officer. Today's led including call Chief subject David will we other commercial net Act. Arkowitz, risks Clayman; today's will and Financial cash clinical these be forward-looking sales, statements Michael utilization, future meaning strategies developments assumptions, matters time. Litigation business change this

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

Mike Clayman

clinical regulatory Thanks, with I'll joining performance, launch, preclinical an therapy our recent our usual thank and activities, teleconference, progress including all lifecycle you ZILRETTA's today's management Flexion's developments, provide the FXXXX, on Scott, and for gene As during call, update business program. and

first our will financial market. commercial he our and metrics, also Following elements will walkthrough believe and investors the we quarter with visibility uptake importantly, ZILRETTA and results launch the in provide of that, cover David new much better key will which

million Finally, questions. million the in full quarter. afternoon, our we line first and of year this open million. we begin, in sales we $XX it of as the reaffirming $XX.X will as release $XX To ZILRETTA take gives our earnings net revenue to We confidence announced us progress, reported and solid see this guidance

announced ZILRETTA preliminary of our million. we release, sales $X.X in as net of press Additionally, month April in the were

innate effective to In our realigned looks best team. his have ZILRETTA the has He As of recent updates, and and provide correlates sales we a with performance. performance like, what and changes a changes bill in our monster resulted provide with believe of the sales risen to in on Meyers improvements into the no to change we sales future strengthen Director based in on me. plans an launch January, as we calls. ranks outstanding has not leadership. and thought is Regional new to and knows do has directly other we implemented the who entire Flexion encouraging buy report structure organization. rapidly with ability President his Sales number a sales a introduced good has get With well circumstance, our and initiatives, leader appointed deep quickly of data it to have sales knowledge and and Vice made appointment, Sales. we time important practice, space, is the organization the In point, our of which real conjunction our him Steve to dynamic so joined we as commercial have accountability, of this that do effectiveness we role before the We organization. performance that through Steve In from this directionally matter sales realignment investors personnel and

also we And to addition, should influence believe the permanent be In to is continue that on impact code on ZILRETTA sales. J some have positive revenues. beginning this a

the ZILRETTA's momentum we have field been past fullest has the Over can changes, never organization who corps we the to esprit In several a or of CCO, hire Chief potential. months, help ensure Commercial we and made seen our realize related strategic growing decision higher. Officer de us

Flexion change, the of launch result an did our the preparing lead for building of ZILRETTA. us job middle As of Dan will and the commercial Deardorf this in a excellent May. Dan infrastructure

We his are next and best of him all his all grateful for in contributions wish the tremendously endeavor.

CCO retained the for position As is well a underway. search

deliberate seeing of sense are and We organization. candidates in commercials lead the with quality urgency right a professional proceeding the to finding

of any at provide insights highlights, time. from appropriate With of survey that ATU ATU awareness the comparison, conducted product. sample along commercial which results and the decision aware administered demonstrate progress surgeon respect various important points of other to XX% We and appreciable only of Awareness, time we launch, we the an in market, were had our are that effectiveness an surgeon of X% XXXX had ZILRETTA conduct of the surveys making The February XXX at had the and will of the strategy. in apprised specifically, ZILRETTA sample ATUs or XXX the last XX% orthopedic keep indicated about Trial By XX% month that you showed conducted administered Use product. survey orthopedic commercial

measures insights. The are ATU important adoption. of definitive sales ZILRETTA's several provide the While

clinical color surface and are the picture scratching we to of will and only and is present experience product's an commercial ZILRETTA provide encouraging ZILRETTA And second, still adoption of of just with new David continues the when awareness through building. walks First potential. this he they how metrics grow. utilization further

anecdotes belabor in who pain, come daily but who on told. we with be the there experiences daily point, our that all in the climb when more the didn't all are years, there won't to OA will down day patient intolerable each family the I'd at is is performance standard serves colleagues her and waiting to who continue pain-free able Flexion. time be compelling ZILRETTA of physician dog to of can stories the I for I again, to a and it without if us of care personal clinical is a of hiker basis. a inspiration be ZILRETTA's for members, remiss patients first And As walk patient Whether the for stairs up these prescribing for They stories able provide is walk reminder woman to pain. that many as a knee believe mention

clinical development and to Moving our activities. regulatory

active currently use and limitation with exists. had have to statement the productive regarding label supplemental FDA NDA of our revise the that We conversations remove the and ZILRETTA

a in first about we trial reported, second As date. and with evaluate the and our extensions come plans, placebo-controlled double-blind ZILRETTA we date decision been XX previously and patients line based That trial at our eventual the quarters. enrolling the patient hip which of efficacy first to of in in have we management end XB enrolled repeated belief administration we of to OA. throughout we PDUFA XXXX, the remain October data our that With the has and by Phase on fully safety strength lifecycle will patients FDA respect optimistic of our the expect

of which we a of However, made in recently the issue deliver ZILRETTA a a participants. of product dose non-safety-related number inability small were aware administration resulted to in full

will the plans we result, shoulder paused the expect a and initiate and X to said, address been the not as have do problem our this investigators As with we studies AO has and a we capsulitis that impact trial recruitment knee cause. adhesive specific issue hip, administration is this root injections work With in with later Phase year. to to identify not of it in

publications, injection April indicated pain recent unilateral pivotal post Therapy. findings patients a in hoc Advances in analysis from Phase for of pain pivotal in impact with a confounding ZILRETTA which of bilateral relief was trial the The only intra-articular the knee triamcinolone experienced that single of may trial durable significant OA of and knee. data These published a have pain ZILRETTA suggest in measured X immediate pain with knee intensity acetonide average scores. the As release treatment ZILRETTA factor in as one been daily compared assess to results by that

conducted insights the for Both Additionally over from expands OA and years, this relief while assessment being treated clinical the was generally XXX of benefit bring Drugs. an trials overall of seven Review Adis ZILRETTA publications from of tolerated ZILRETTA data evaluation provide evidence-based independent of evaluation for conducted these understanding were Drug ZILRETTA additional past provided journal treatment published X,XXX the of pain ZILRETTA. clinical trial whom that with the clinical six The and data patients, evaluated potential pain. deeper which knee included by options experience in concluded effective the it important therapy. well Their

of lives quarters in OA confidence make pain. closing, a to well. on IND in successful remain advancing ability roughly an of are GLP launch ZILRETTA's these, difference with in track trial into first And respect we and half clinical pending patients from human with gene are file intra-articular six FXXXX, XXXX. In the growing product Finally, studies therapy candidate, in toxicology we meaningful the have second to knee our and we our results to initiate the

I it discuss will turn will point, one share OA David firmly goal. until before our And this he's important to physicians We therapy new worth role year tireless team leading patients was with can the an at instrumental play to working do with And ago the companies, financial our David to almost for shareholders. commercial and At remain ZILRETTA noting experience to in year can in efforts. for With over can in results, is those to us to become believe we full the The perspective achieve those he we treating effectively efforts a to he metrics about IA branded I'll it in our commercial leadership Flexion we commercial pain. bring that knee but you. and value broad joined develop today. invaluable and our it brings that

David Arkowitz

usual meaningful I'll first party metrics, financials. the quarter we and Thank briefly start, you, third prescription of cover To lack data the Mike. through the first With the that appreciate that, from may I'll for walk I then metrics monthly we sources when these and and sense analysts. a insights and to opacity comment earlier of want it to ZILRETTA visibility provide Mike's comes shareholders to better to reiterate our contribute develop that sales new

your and Additionally, these will feedback time over to develop reflect based that we that incorporate and these received from we we And we in possible. other and their said, our extent on stakeholders. input did refine to investors the expect they That isolation, revise not we've solicit will continue and utility.

So new let provide Slide key to metrics the context some with you progress that important launch. of me the X, direct on

sales in quarter As Mike on. mentioned, their provide net in a of sales we for historically the first incrementally have we will net reported as target with accounts broaden sales following had I'll month continue grow million on preliminary has April. reach. of that We've to $XX.X the $X.X of number perspective solid million reps further and the number of slide. called This our ZILRETTA

As of XX% that comparison is XXXX purchased We the XX, is so had this X,XXX from or metric ZILRETTA. of had as target first quarter of the XXXX. of for our a December accounts appreciate end new up accounts this that X,XXX purchased

as XX% place XX, March purchased had is of XXXX. least then or indicator, initial leading X,XXX that this of reorder. a that demonstrates order This as minute. of We one Importantly, just is good just experience reordered up reorders. had it accounts over at ZILRETTA strong volume accounts accounts yearend having in X,XXX accounts, placed a and are I'll from that as previously ZILRETTA discuss believe

our Moving with quarterly sales of provides sales. launch to Slide the inclusion April X, the since this preliminary graph

net the and year As strong you million. second million a a preliminary quarter this of ZILRETTA can quarter since of fourth ZILRETTA the first progress see, good to with of start been solid sales launching quarter there's $X.X $XX.X with in XXXX

our time go a basis. share on we reasons, As to sales thought this Mike for But preliminary not mentioned, mentioned provide do to updates on real April it we that intend was the call. forward previously important

potential. represent remaining that we clinics, purchases Slide various slides sizes pointing As by purchasing X, move of to like which reflect start accounts, and by ZILRETTA the to out practices, hospitals of physician I'd and

or accounts XX a that present units, ZILRETTA have we purchased out with Here three distribution that units, purchased groups; XX units. broken accounts into XX have than launch, X of to one purchased more of to purchased XX those since

majority have bought the XX see, can of the to purchased product you approximately As have that XXXX units. accounts X

they takeaway benefits ZILRETTA initial an this and accounts orders from with generally increase is the slide accounts and see increase orders clinical those expect and experience key reliable in represents their this observe base important consistent that We as ZILRETTA. of begin reimbursement, will the and frequency However of we size. and use small then

Nevertheless, across adopters described others the units. these utilizing these best ZILRETTA the large at had their represent only of ZILRETTA that they higher One there accounts first XXX we multiple at believe of as geographies are that a are by more rate accounts of fraction a size full purchases while XX counts end potential. addition, cross-section early In fact, these and of than represent early adapters. simply than today and quarter, that a than accounts represent purchased practices, more assume were in might the varying

We well XX at other have purchased utilization these that are increased of driving adapters of ZILRETTA as on than less ZILRETTA by focused accounts as today. early units

you to of significance clearly Moving see Slide ZILRETTA early of on X, total adapter these today. purchases can the the accounts

to utilization small for real accounts generally represent XX,XXX just continuum XX current approximately number units have XX units, XX or XX accounts along potential this from all ZILRETTA, base. relatively our those Again, XX with than more units a customer one than XX% than move even units, purchased and illustrates of ZILRETTA which of purchases. accounts more units then the some to more to While

purchasing Slide quarter will new X and the we can accounts. breaks four and continue existing we out by the we've add to the grow accounts added We expect XXX as purchasing approximately ensuing accounts XXX quarters. how see on new Over new last expect over purchasing our accounts you new and ZILRETTA each base continue customer of per quarters, adding to to

X. Slide to moving Finally,

that see versus uptick Sampling accounts to samples the days us as launch, Here In less we certain XXXX year, to sample quarterly of that represent a an show product. high accounts on to with ZILRETTA the by in and accounts. ZILRETTA experience understandably and quarter on products of we purchase the shipped effect purchases Nevertheless, gave early the the X during opportunity we as gained accounts took XX% sampling gain this January first the was basis. in in still access first that than quarter. of J-code decreased

we adoption. able as our the to where accelerator philosophy sampling they sale future Our judiciously use continue to remained it launch, we has will same since make an a sales reps sampling but clinical believe will, are where serve can for

months the the March cost ended the million same net and Net the million loss the quarter million, So for a loss afternoon, ZILRETTA now of period for release first $XX.X $XX.X press of issued this XXXX for and briefly to XXXX, three $X.X XX-Q. in were we let totaled of $XX.X for We respectively. me a walk of XXXX. to million our financial which million XXXX $X.X the in reported net quarter of compared of and sales XXXX, results, quarter sales first first included XX,

ended $X.X XX, reflect The to reduction million headcount reduction in an net well March Medicaid, first XXX costs months for and quarter development other million million related the of XXXX, primarily in three for and was million additional a expense XXXX other stock XXXX $X.X million Selling, XX, development million increase XX, primarily year-over-year $X.X and B preclinical of development million. decrease due net March were respectively. Department million expenses The million program March Interest income the activities, expenses expenses $XX.X XXXX, million $XX.X million for gross selling and $X.X gross Administration XXXX, XX, XXXX, and returns and and respectively. XXXX, net $X.X $X.X due of The General balance. support related months the the was patient $XX.X $X.X mandatory million, and million as XX, $X.X to ended income government was primarily $X an the costs and and XXXX, compensation for three costs, expenses costs and three reimbursement Defense. expenses respectively. million ended The expansion and research and investment of comprised ended the reserve and expense is employee-related the XXXX, three the and portfolio three for increase a administrative months Interest in general $XX.X increase expenses three March were sales our March to to XXXX as XXXX increase $X.X and represents ended of and was primarily salary salary XXXX March X%. to discounts activities. $XX.X of fees, of the million Veterans for average months administrative expenses and and for were rebates million in months other $X.X ended respectively. distributor expenses to and ZILRETTA. were and physician million related interest Selling such which for and due and XX, as XXXX. increase external decrease and marketing employee $XX.X and decrease to institutions was and Research and a months in and respectively, both The

the profitability. be approximately always, shareholders. December marketable prudent opportunistic of cash, our sales we our best of long-term expected to relates it with will do cash potential decisions, With in funding March our said, expenses as Flexion cash us and balance in XX, of of ongoing that we important to believe the will and as to believe is bring XXXX, that as it we million and will add is securities, what interest Company that, future and $XXX.X the equivalents management As of XX, XXXX. $XXX.X ZILRETTA compared with current had We the million

continue development activities additions increase for driven our will with point, questions. pipeline. to of ZILRETTA, feature the for would the please of line associated ZILRETTA, the development We operating I line to expenses operator, by primarily in expect and ask that continued clinical support extension open activities commercial FXXXX this At trials

Operator

That you. Thank our concludes remarks. prepared

for open questions. call comes the with will [Operator We first Fargo now Wells Our Instructions] Maris Securities. question David from

David Maris

bit out Hi. jumped a I little late.

the that uses year? this. anything talking sales if of expect of or don't ordered financing if know also you that come you repeat and vis-à-vis expansion describe mentioned it is covered sales you. the base? repeat of financing about will already versus expansion this have users you'd don't - user new, on covered need mention can the these, non-dilutive know about like non-dilutive for And partnership? just from I those be? think more you this when you were But So increase you of Did about Do the you the I financing any if alternative or you Thank on

Mike Clayman

to So the repeat and new we through this components, first. David, our make both I'll a going expect, take users. target at shot we're year growth And in

we We to both new users. expect expect expand become and obviously users repeat

there's the had like that grow that. to fully product say will a users with be have users base get new And grow. installed we would there added there I the large - that So additionally. But result, will of users most most continue who And as clinical will reinforcing we experience will to new a expect additional are the experience think repeat greatest with product. also the the

David Arkowitz

purchasing to that, - the than I today. look you there's almost units X,XXX approximately have just at accounts of would Yes. David, if that purchased And X,XXX less that add ZILRETTA XX mean, I metrics,

very And utilization to those So tremendous on opportunity really obviously there's accounts. expand focused a we're that. at

right? question partnerships. that Is was on Second

David Maris

Yeah.

Mike Clayman

of it's So David, I think topic discussion. a regular

let being at know the world U.S. of the when to rest we'll and of We possibility has look outside the you the are partnership signed. the have they progressed continuing and point

David Maris

Thank you.

Mike Clayman

you. Thank

Operator

Our next Stanicky from Capital RBC with question Markets. comes Randall

Randall Stanicky

calibrate have million anything we and metric. thanks. more April thinking so helpful in should just Mike, be going can and monthly that or And a QX Is a I'm general nature? linear it's get to Great, then sale, help I in the into number a of monthly being follow-up. out we that? April there numbers of focus Can that tomorrow, just us about $X.X you lot pushed of it's either the think

Mike Clayman

Yeah.

from We think and an the into level quarter have team and of and heightened a seen that extension level of the is other some we organization sales a made and natural and with leadership and steady greater this first the functions. quite changes new in of his Steve accountability of focus the April we've even some growth support Meyers from appropriate

and in it if the the can't than growth So I quarter. obviously other anything surprising saw sit predict I'll continued we future would say simply be but here

Randall Stanicky

generally If month that over generally I was fair? growth, month rephrase at the months We to not are lumpy. is see

Mike Clayman

That's a know. I fair characterization

David Arkowitz

Randal is David. this And

chime also Let me in here.

As distributors. we sell we inventory one target as week it that the range the of end the to are as within at this well. that at directly inventory weeks three relates before, to the one talked the at of customers at three of of to the year Those distributors the have and we to end the quarter end first of year, at April about

obviously that, stipulate to with contracts manage we distributors those that. within monitor And they our ranges. that So those be need we

Randall Stanicky

sense sales sales does brought be point the run for but thinking SG&A all it rating leverage about obviously, it start That's Mike helpful. And at current to but look make Great. add spend million could of little commercial really not expense at some on infrastructure? talked about force some now, additional follow-up in you the that licensing you're Thanks. you but that's over this in selling we when with products the that top in have the actually to past, disruption $XXX then

Mike Clayman

have of to encouraged our we cause asset could would success. weather sense would terms make and opportunity ZILRETTA. it from open in not make compelling any that lot entirely we will commercial distracted would a to We're we're do a to a Randall. sense way ZILRETTA, a but to with headed, anything ensuring distraction on in balance that be where by what fair expand commercial focus the and bottom have It that that. it asset. for sense, possibility want potential we upside cost of to open that would the Yeah, holistically just about We we get line the It's be be the would what the question it considering to I have but a is are in would to work makes do license

So yeah, - please.

Randall Stanicky

presumably, this the sell you No into would something be ortho the is that right? in channel that would

Mike Clayman

make certainly of force for ortho you amount At would it That or most you the this then make because distraction selling channel time the different are sense. point in which have not anyway. sense if create sales of more a clearly it becomes less sales a to even to force the us would

Operator

Thank you.

Elliot comes Raymond next Wilbur Our from with James. question

Elliot Wilbur

Thanks, good afternoon.

question the study. in Mike with enrollment OA your the specifically hip on for to respect comments First ongoing

terms something you quickly in was particular issue these know correct of patients receive So are fairly lots? are that have so discover certain subset to question's which to able exactly certain deliver I that inability out you're or guess the those patients lot go just this whose a in - in and basically basically you product patients to

Mike Clayman

our site commercial knee and but this lots, seen of there's say not trial process confident Yeah. have seen obviously commercial lot reason is still I we we're the there for many a lots not just that same. studies many, will is lot produce our injections. clinical this We've the issue manufacturing not a or in this knee highly and that is Elliot, this manufacturing we is any

administer was that the we're extraordinarily two, look injections three was to - issue that have the was able to pressure into without the that the in for to we we're X hip, study and going after need that ensure products. this obviously impossible root any file and would ml pressure the event or comfortable complete would manufacturing injection the to happened without experience back possibility injection to get is is any we're injection. happened or became a ZILRETTA This to difficulty the hip start this patient would a complete adverse back of in what But ml we So likelihood got or symptoms. order ultimately injection routinely cause - Realize low. is can every this and but the the - sufficient commercial it

SWAT a visiting is a danedar team possibility, technique in technique, the understanding looking administration every there's that prep place, site, flouroscopy. under [ph] the understanding So the realizes

is investigations the can until paused from we're we root solve us that reassure that a have problem. a So cause study the we full underway going and

Elliot Wilbur

Okay. And respect Mike of recently follow-up data unilateral questions then pivotal benefit for to confirmation thinking you the with as a particularly versus TCA. from the disclosed X, static well Phase about the

I four was weeks think it through I if XX, remember…

Mike Clayman

Right.

Elliot Wilbur

and point, kind that's some guess followed a of for market those on. data …correctly. of seems disclosed early I time. a of the development then that based I guess, long I who've reactions, Company and of very us known a data in significant of strategy terms the some was you been for long like time mean, of some the early

that curious data with point and Just any about obviously that? how with talked payers has clinicians that you've resonated

Mike Clayman

who from significant statistically suggest not than ADP, us had Phase patients who to for We and And been with a of sensitive, kind because showed of story answer. less full knee pain the relief long with The Elliot, come separation, significant but the just not and with by appreciate time. only data like the trial set less the those single So, as the may for That, immediate frame affected. single the question knee, familiar asking question. you from you've this can't only very a reflected clinically might your the X from placebo, in be your study is the numerically - on significantly more one. osteoarthritis were placebo one - of that average you inherently but when other and one a this function not would about good knee, measures sensitive did design we statistically quality we but and not question the measure, made daily measure superior, it's of while pain, The immediate and got from in an life. the at even it's related have pain, but separate steroid suggest to less and What steroid pain. confound single superior pain, further knee injected thought that nicely pain competitor. very We can it. release about release It looking on stiffness surprisingly, specific literature in - literature by why, knee not would you're bilateral from knee

we the So cleanly patients is who unmasking true we logical we're benefit in think that these also. as show is impressed. to data to powerful, in pain. are question the analysis payers these possible as as only you of with look sharing And trial it way And data, they unilateral very the interrogate presented And process see at with is of invariably ZILRETTA. the when of unilateral physicians

Elliot Wilbur

thanks. Okay,

question team light to overall any…? guess one Just the of recent could marketing for some you anything share in a been or as with changes of whole, game us I the in plan terms has the there have that significant major occurred last or changes of

Mike Clayman

to ZILRETTA. - think the at gone by new a time, answer. reexamining into assumptions some potential position We tell about them. I marketing all the we'll a you that directions tuned encouraged the and that's stay in and Elliot, sale be Yes, we can to we're of aggressively And right I be are have going that talk

Elliot Wilbur

Alright. Thank you.

Mike Clayman

Thanks, Elliot.

Operator

Gary comes next question Markets. Capital BMO from Our Nachman with

Gary Nachman

new are helpful. metrics The guys. very Hi,

So thanks providing for that.

to target numbers what end have users? could to high you're industry reach, you docs Just accounts volume of that different analogues Do units. of compare that to? percentage based Regarding on of up being of standards the any trying purchasing number a

David Arkowitz

we the don't. it question. David, simple is answer thanks Gary, is The that for

XXXX accounts of So we purchasing. have XXXX accounts that XXXX are accounts, out target speaking our roughly

section, things. three adoption We increasing piece XX really really less or accounts is drive because and And XX those adding that approximately early initial just third users more of those practices. and our are we're the of then their we're units to really accounts. than almost continue new there's at to the ZILRETTA incorporate is they're surface is utilization their purchasing XXXX top XXX focus there, that into accounts adopters units accounts those on That The are are of purchasing just focused with because scratching that them. confident

So accounts four to new XXX a last We XXXX quarter to per accounts to of accounts. target XXX purchasing new quarters. continue We've with add each want XXXX. added

happy building of and we're So bit I we've good where excited little shown upon pretty with I But a that. realized really answer. we're we it's are, about think progression roundabout a

Gary Nachman

you the in like And even got at about that Okay. you quarter? would on it aggressive that volume, sampling uptake, was unit positive the return looks first more of XX% then than that accelerate consider to a being

David Arkowitz

sale And it didn't get we as access think we the down progressed you to of So that over that If drive to than by Consistent the to. was accelerate through talked and when XXXX, our sampling will. accounts quarter we make of clearly - utilization do ZILRETTA, the will early much can have see sampling can this help to philosophy a ability We previously familiarity part uptick XXXX use use the driven really what we of and ability J ramped can and XX%. had in an samples initial we the code year, that. with about in the which first as year. we how it higher around is

if appropriately. So, with a we're if just the to will; samples sale, manage consistent we of going make can will deploy we appropriately them philosophy continue we samples to help, our

Gary Nachman

if on if you more us all, the able And you've of course and consolidated doing maybe Thanks. year? that yet to for of much give those you've over the question traction Okay. about? not remaining talking of the practices the get practices part are plan Mike. how some on been just commentary any those last been And how with that accounts haven't Of purchased that at

Mike Clayman

that? it's with the terms accounts in a do of What are smaller I a there parallels mean I question, would large that accounts. say good Yeah, by It's Gary. process.

that's smaller We large some have - earlier are a that stages. in have we number ordering And accounts of are accounts for that the very aggressively. true ordering large and accounts. And

we considerations We're lift in in way administrative there about the more that but a attend wrinkle accounts getting in general continuum. smaller So I administrative, with is the think we're the this wrinkle, the And we're large with scratching scratching making. think with accounts, going of fully challenge, enormous. we more progress the the are those is is pleased larger that this overall many that surface more we're we continued if particularly in with the in expect place. potential say And progress the to we And accounts just pleased to superficially because accounts. there we're see plans larger surface have the is the even

Gary Nachman

Okay. Actually, I has been since the want quickly, the to also you some of commercial changes? there force ask you any turnover sales announced with

Mike Clayman

this - went out and passion I commercial urgency. renewed press future throughout organization, that in of it energy and way to there's release, the and of say actually the a No, we of and - made believe sense our sense we we

the the lack was So, to be has turnover. a frankly, we've and There there's sales in had turnover always fit. force in been matter of in And of no what force entirely and sales going almost force. blip sales up turnover accountability performance certainly

best is sales that aggressively the ensuring there. us force managing more most So have and very effective out we this

Gary Nachman

Thanks. Okay.

Mike Clayman

you. Thank

Operator

Berenberg Our next Capital question comes from with Patrick Trucchio Markets.

Patrick Trucchio

I follow-ups evening. hip pain few have study. good X Thanks, Phase on OA the

thing or anything change on to with study? then Phase study? there contributed the those patient study enrollment have in X follow from Phase And study issues the XXX. the have from the Just Phase non-safety did And X could the baseline any first, characteristics SHIP where issue then SHIP up secondly, in X a I that to the

Mike Clayman

- your was trial. criteria to administering. and they whom question the were Yeah. we registration to two patients who exclusion in question questions, in Those at the inclusion simple from criteria is, SHIP there excellent are changes had really the to site second entry, no, your difficulty hip is one Patrick, And answer no first going answer saw

adequately we hip understand us that imagine, it has it's it might understood of to now initiate to length We you given handful went thought a to of - in that. pause. but we extraordinary trial, As but handful and sites the again see across we it's patients

out not out we be what's a the the to we what is a of it two this turned and cause thought of entire back that's step patients study we understand to study completely. take us out root coming SHIP only So was understood sure and pushing root cause

Patrick Trucchio

IL-XRa And the one of and And of expect Phase When in assuming the secondly, have can we it. then filing would a study? of from its is you just you patients initiate in how FXXXX, top we anticipate the pathogenesis X data mechanism how on second trial role regarding half then will the the knee? many the successful to and schedule. topline discuss soon could first, this enroll, completion studies OA IND Got trial

Mike Clayman

All good okay. questions. Well,

sure furiously just miss Let writing me to is of any them. we don't make Scott start

makes on First IL-XRa, sensitive gene promoter. so this control of under therapy the IL-XRa the information

one end IL-X relief beta the because the is efficacy to the data interleukin on levels, that so relatively lining what antibodies product the and to the or of the So patients IL-XRa both receptor antagonist. is XX,XXX And might but preclinical is IL-XRa. small alpha a leave reject very IL-XRa into Anakinra preclinical viral are striking. blocks IL-XRa the one free a knee, viral and particles particles weight are as cell It's or that transient, the data its that product, protein marketed beta. The at which And who have IL-X is both you Kineret. having very or IL-X it has osteoarthritis, a knee, when does of to IL-X IL-XRa of knees been as receptors, DNA the rapidly. beyond within see signal, blocked. blocks molecular endogenous nice injected the are alpha protein so of pain small, contained in machinery production receptor you into the and block in the bodies. have cells ultimately strands protein they take we all receptor our a up that the taken the monoclonal opposed block that convert up knee by nucleus it are

case therapeutic that persistence levels is solving anti-inflammatory protein approach effect. an we're in this with on-demand So of essence in for

So makes residence present information, off on and and a proteins. take information up when viruses the turns is the production there's suppresses DNA turned the IL-XRa of

large on we efficacy model, the that for which injection, data preclinically. very progression, have provides data strong modulation very We're a we production pleased clinical progression. persistence disease and We model see substantial data the of see with single animal preclinically, in after of validation disease validated is preclinical most strong very

potential assuming this continue all So day said, data. we how patients? guide at make for could preclinical And Well, very we How enroll? we the product we're to we talks supportive - to have When data? enthusiastic what to many will soon the to are I'm difference just about Pat, data. the a going we about going

We're the I half days we to We not timeline. enroll will won't say us specific second year. starting able preclinical submit long a we'll and will of about this would that. the better this IND after in more application guiding with And XX a be data to there understanding because have stay be a more tuned it telling timeline. granular before provide we

Patrick Trucchio

you. That's helpful. Thank

Mike Clayman

you. Thank

Operator

comes question next Serge Our of Needham. from Belanger

Serge Belanger

for Hey, And asked. me questions have these I squeezing in. guys. Thanks apologize if been

has it dose Do read have are issue? So been of an as retreated? of And guys reimbursements. studies? getting how you And repeat do of a patients retreatments increasing reimbursement see in the the good many you and publication terms with

Mike Clayman

Yes.

We just one, heard patients very of again have But patient stories time. track level. rejected anecdotes don't numbers are we and fourth being - not third have a at and we because we many retreated patients to all difficult Serge. hard but So time a on have second the

So - without Medicare reimbursement, vast also clear And of commercial covered and majority from second consistent. and for lines to the policy be a straightforward restricted is are injection.

said that, of have. the dose we because repeat that data confusion, for no the the So reassuring LOU, need having and phase to in it, remain the LOU removal particularly committed creates we there's of the

Serge Belanger

coming X to preparation shoulder are or the And Got concurrently those along? Phase going separately frozen you. trials, shoulder how's with the they be trial? And running the on

Mike Clayman

Yes.

that of the running half way the that is So be about shoulder will frozen expect And in it shoulder this we expect to thinking we're and second both we OA concurrently. initiate year.

Serge Belanger

you. Thank Okay.

Mike Clayman

Thank you.

Operator

next Our Brisebois Laidlaw. question comes Francois with from

Francois Brisebois

too. for Hi, in me squeezing thanks

units per from here. XX have or just that why after these. change was - obviously that so XX? track of how you're I account, your strategy to far, that going we where And quickly going Just wondering the metrics all But giving, number the chosen, the accounts? high is all it prescribers after just was does the

David Arkowitz

part of Yes, so David. address this Let are your Frank, me you? question is first. how second the

we are bumping it So we was just it break good will visibility point consider the appropriate, we - made way XX felt this as and a revising Clearly, in insights that given of additional point. that where that sense. launch, unit a we provide really but overtime, determined up at

Francois Brisebois

what break interesting Okay, down proportion And think the feel drug. I bilateral? of unilateral guess, quickly, is people But versus look think to unilateral great. can that get obviously I you very have is? you a population just real The then, that pain the for

Mike Clayman

point the was were contaminating understanding to because with But who analysis unilateral you the I remove should we do want Yes, the removing want think I the drug. of patients, effect bilateral pain, for that whole by call product to the of suggests a unilaterally, the that just confounding only knee unilateral injected this data don't factor - patients a by on that anyone be this out start Frank. saying. only used in can that

knee, on knee this reporting bilateral pain. effect it a So was had more in patient factor we without the a believe because approach understanding way of potentially uninjected of pain ZILRETTA complicating the clearly

will tell think XX% without to question, be we better unilateral to your see as confounders. understanding approach specific bilateral the to disease commerce I'm us. drug certainly of lengths this are unilateral trying just what have is data to So It to turns great go is don't because impact what all XX% telling of have but an say answer - what disease. out that's about this population us data clear an and the relevant the - we But terribly that the to

Francois Brisebois

thoughts the $X Okay, great. enter you of can we this on remind us million turns And your seasonality congrats, is - second as just April half here. It great, [ph]? here quickly

Mike Clayman

And is is our maid. seasonality. Yeah. David There seasonality

So to turn will over I it him.

David Arkowitz

Thanks, Mike. Thanks, Franc.

look just how at to is hyaluronic or give HA products at acid way to look throughout year that I think flavor. So the one to they track and some

to So QX. And see about to in seasonality, it's QX to of those you due historically due and stocking units due versus products, XX% that's contracting. with it's declines

solid we're place. growth in with believe that I a is ZILRETTA XX% we think QX however, is different though, the over in sales and was We're pleased so point QX the that. still ramping

Francois Brisebois

me. for it Thank That's Great. you. Okay.

Mike Clayman

Franc. Thanks

Operator

next Jackson Our comes from with question Company. Benchmark Bruce

Bruce Jackson

in taking physician how to the you set the availability up With the you could on J-code to shorter new about spent practices for as was if implementation, quickly it's some help there be question the new regard I curious new if or and Thanks time that the the J-code the of know question. Hi. and was longer, J-codes taking expected has accounts.

Mike Clayman

having there be is And sales to that the in the that's And think practices have adjudicated of reimbursement while a improve me cycle. with I underlies lengths. I begin permanent of code, you're think reimbursement, And that reimbursement. straightforward reliable whether over us box is number once that these know performances can requirement to to out the itself we Bruce, claims the an and be opposed play J-code process at naturally believe form J-code their varying well electronically a just many a becomes can are of let - institutions you quite JXXXX the certainly J-code I completing underway, as way for when we for more was straightforward given J-code a putting to on, portrayed have path. more you question, cycle speed to months. way which permanent permanent just - some try about will much in insurance consistency sales filling the importantly more of verbiage a the The their effect faster your answer sales this and and forms absolute much J am. because see impact it's will going to becomes the the Once you

Bruce Jackson

Okay. you. That's Thank me. it for

Mike Clayman

Thank you.

Operator

to like at to are time. turn there questions this And comments. Mike additional back no I closing would for over call the

Mike Clayman

thanks everybody time say your Yeah. just and attention. I for will

bullish to continue very where We we and where are about headed. we're be

And look do and you to we a work earnings call. on to our of have forward We we're Thanks. to updating doing. next committed lot

Operator

presentation. today's concludes this gentlemen, and Ladies

now day. may You disconnect and have wonderful a

Flexion Therapeutics (FLXN) 8 May 192019 Q1 Earnings call transcript