AERI - Earnings call transcript Q3 2017 | Aerie Pharmaceuticals Inc

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to the Aerie Pharmaceuticals Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. Today's conference call will be recorded. pleasure Officer, the Rich my Aerie's over now Financial Chief Rubino. is to floor turn to It Please go ahead sir.

Richard Rubino

our Chairman as are Thank investors.aeriepharma.com, be you, us Anido, and today joining call Aerie's Officer. website, President also you thank indicated Executive and for press Aerie's Tom available Vince Chief Mitro, Giles. Good our release. today. being will afternoon With webcast and and on and in it Officer, Chief replay Today's Operating for is me live

Now including timing for and our ability our non-GAAP approval timing obtain cash and of and future financial measures. and will make performance, On we other candidates. the regulatory success, forward-looking statements and cost our this of certain statements, regarding operating request, or the call, product of forward-looking to FDA guidance our and statements clinical financial burn, maintain and forecasts trials,

and of our the We commercial expectations findings, the clinical events. and discuss other effectiveness, as launch and well activities, as based manufacturing and management today. sales potential our of timing to are the potential as on the will preclinical future These future related of of beliefs research candidates, product cost also statements our statements of

in as statements, our otherwise. our SEC. filings result Our to Please the today's and included read forward-looking uncertainties file we or the with new whether that will XX-Q a obligation information, We actual press as expectations. assume described events release note no of update materially results tomorrow. future or revise our may carefully differ factors from risk in should Investors the risks as well

measures. certain this adjusted during call, be addition, we or non-GAAP discussing financial In will

most website. reconciliation GAAP non-GAAP including a directly please our today's on which is to financial For see additional to relating release these press comparable disclosures posted measures, measures, the

expense adjusted financial loss $X.XX non-cash $X.XX the of million As compensation net net XXXX million stock update, third quarter includes was was share. based XXXX GAAP per non-cash compensation excluding per When quarter net for our the $XX.X or our loss based quick stock third total $X.X share. The million. a $XX.X loss expense, or

our and ended full year comparisons release $XXX XX-Q XXXX For results tomorrow's filing. additional press please quarter cash and third period Form million to refer quarter today's XXXX equivalents We information regarding investments. prior cash, the of and with results third

basis, Our third on recent in approximately of previous including $XX The $XX.X $XX and to was Aerie includes range of is full on commercialization. for million, million line million guidance towards the $XXX acceleration quarter XXXX purchase, million we reflected are of cash year-to-date which an a of $XXX cash that of $XXX burn guiding October million cost shares of acquisition full with million, total associated stock our with the which burn Rhopressa $XXX in year year we in announced asset $XX.X preparatory to cash a and With to X, $XX the million. remainder asset importantly which the million. million now XXX,XXX expenses

the expense should $XXX you'll estimates. I the With million. quarter X shares October cash, balance a in assume the $XX quarter. fourth recorded fourth perspective, that share on XXXX asset in Also for the quarter is turn to over expected call fourth that From model EPS or asset from announced investments ensure will year-end equivalents be your R&D acquisition approximately the in your Our million the Vince. now early entire additional to cash the modeling is acquisition include and count please to from XXX,XXX

Vicente Anido

company And the not bit here Academy the our ultimate success we're FDA we've date, overwhelming Advisory vote by hearing Aerie, we're Roclatan very the is not positive New Thanks a at about of products in FDA guarantee surely XX panel our accomplished Orleans. we've Committee XX, in successful while Advisory of Ophthalmology proud with Rich afternoon also for meeting very a and fueled And to a but currently clinic the just on everybody. approval our Committee only data, had today. of good February there, and we Rhopressa quite us just XXXX Thanks Rhopressa. fact everything that American are especially on really delighted We're certainly Conference joining and of the that PDUFA on October buzz outcome.

in once was is adverse there a that Rhopressa Glaucoma tolerable understood clear was intraocular event was pressure it at with panel profile. need day dosed it and treating an the that During unmet effective certainly lowering

Committee earlier you've news perspective, sure heard XXXX. are the in As from about we as well Rich days, light meeting good into for our XXXX of preparation recent certain in that of here Rhopressa expenses commercialization I'm Advisory mentioned as manufacturing at from our the accelerating early contract

for fully same, the XX expect year Feb wise While is a it data, accelerate. we to of we next PDUFA prepare to believe

with we questions. can all FDA we're the doing certainly possibly their answer Now everything to

As cetera. meeting into you of know Committee meeting et as that the we from got part discussion actually Advisory label

to it give Christmas approve the and early the ready So present earlier. drug us case an for be in us important is to FDA decides

order the the access affairs certainly So we Rhopressa making of is out. to commercialization, and sales including folks revenue accelerating additional folks assumptions. now hire in of plan, in marketing team and some a launch volume messages our late executives, expenses completing to stages order The in get preparation do medical progress commercialization excellent that. including lot refining are those at We're for

We to pending with year. you expect guidance on assumptions key provide approval next

about force a get the approval sales we until get sales plan The hired do won't letter. As XXX we've discussed previously, force of hiring we representatives. sales on

U.S. end and sales cycle. Because annual represent cater are till we company in plans, when that date we formularies that April relevant on make by be forward XX D submissions have the of reimbursement of get in be February allow PDUFA their of us Medicare We in XXXX. fourth Rhopressa. during that market submissions XXXX. do XXXX, commencing are the reps coverage which expected then and to third medical the half ramping trained the and very, well. meaningful their detailing Assuming that XXXX, in Note approval of on beginning an which Part February our to the quarters quarter negotiations the the commercial the won't of coverage they of of only. back a our formularies, they’re scientific be expect pending potential on should really of for half a many begin beginning to the expect CMS will very April, top gone for with sampling second we the look cetera meantime, contract and since meeting up about et approval XX to the In payers efforts of the level efforts

Now programs our to on moving there remain track. on Roclatan,

on Roclatan share as the among seeing We’re of XX are especially the as we quite physicians bit here high, data and very a and preparing a data. for meeting filing await months second the NDA stability XXXX, of story, we at manufacturing which that our of the AAO physicians we share level before with are lot quarter the sometime about we’re necessary batches, our in excitement and The very, file. start this week,

trials we’re U.S. Phase to U.S. Japanese the our in Phase X underway for also Phase trial, is to Japanese a X addition the X, Americans commence trials on the Mercury for European about in conducting X in in which to as and beyond Roclatan, Moving Europe Japan precursor Rhopressa.

With expansion in strategy very, very these process, quickly. our trials global forward, is moving

program. pre-clinical at let’s retina pipeline, stage earlier our look including Now

the know size you As in U.S. may billion the the the roughly of market. glaucoma X is XXXX, retina about double market in

enough candidates fortunate for two to We’re market. pre-clinical have product this

Rho also kinase C treat in inhibits first with both we’ve it's past, macular and degeneration. AR-XXXXX, Age kinase that The inhibitor related the one potential protein talked the diabetic edema is which macular Wet about a to

diseases for and on meaningfully is experience, standalone leading this in efficacy has own, Eylea, very to A-XXXXX its being preclinical completely add efficacious basis. new to on Now market a shown pathway of these the while treating

from the each provide our sustained we release which opportunity activities steroid product in is we’re diabetic treatment PRINT a XXX. as collaboration, in for part acquisition the our dexamethasone of exciting second long-term now recent ongoing have as for designated AR-XXXX, macular the we Pre-clinical technology. small now PRINT As molecules, of to product have the and about DSM technology The for potential enthusiastic are both edema Envisia get XXXX. capabilities to XXX our And molecule's marketplace. such of

diseases of to through our attributes beginning sizable Now beyond on acquired with ocular library eye. Further, the as which they rights unique just serve top in to implant shapes manufacturing very exclusive of treating purpose we know, own have we sizes, technology implants of this kinase and ophthalmic each the molecules manufacturing of also precise PRINT a we and you that ultimately, that, platform quarter. at features the make a

We’re additional but perhaps commencing beyond Rho health, The pulmonary is lung such potential our ophthalmology, indications the and kinase inhibition long, the bronchial of as benefit. cancer. fibrosis, screening may to provide asthma, indications obvious list dermatology a include there pulmonary for library of us molecule where

We these efforts will report the over on our progress next in several quarters.

and to the conclusion, And this over over, I'd made last turn in back few at weeks like operator questions. we point the months. tremendous to So progress it for

Operator

[Operator Instructions].

Annabel, from comes question is first Stifel. line Samimy from line your Annabel of open. Your the

Annabel Samimy

so, version. on there to I a you And for IOP thanks [ph] and of mentioned guys, AdCom know had discussion in you Hi since. talked in I saw we [indiscernible] there was label that and the line were some black some question, in congratulations the speaking outcome, taking specifying about levels my positive haven’t outcome that

past and or negotiating out supply a IOP in with conversion the might think there anything be possibility Do the you've them? in take this that point to of So major the would other drug, not negotiate carved it you of FDA is your else in that with that issue you drugs. spoken there, a is you want being for

Vicente Anido

here. Hi, Annabel, Vince

go has point about pretty don't thought have approved, the there internally, [indiscernible] of that is which be do Meeting, I lower on President going the exactly they’re we've ours intraocular draft transcript indications, they based that particularly are said just to been think and as started Committee I things of of is pressures a we and the if studies they no FDA we included going approve of that is. else clear going dimension to use And it mention kinds was think had been in this you just have of make they with. to of that here, products to general baseline like before, clinical the the specific up everybody is the on the show things, and label package in label which they label, section think Advisory the where back that those or to there because are pressures that other used other So

I pretty so it's that pretty draft And and hard they forward. proposed was are negotiating we straight note, we to certainly [ph] think that that important relatively thought the while label and tame

great it's point so for us. starting And

Annabel Samimy

well. Okay. I Great, thought as yeah, so

So PDUFA way for comforting moving Rhopressa. over of like the side, then because of that on out hurdle the obviously that's manufacturing is seems now it approvals, to regulatory outside your for

Now Roclatan. looking you’d mentioned still months twelve stability for for you’re

implying the using forward, that So batches or is the has not older push you that in and that interest that the no FDA? have FDA filling discussion with forward the had you can’t

Vicente Anido

made XXXX. So, back way again Rhopressa those we batches the for all in

issues a from of manufacturing So no there view. point is

potential there and a we're competitor not agree were. certainly very to here there you, approved. think a where that with But happy we're do clean case is and pretty get we often we to, see happy So is we

On to we were facing. issues original made at those year redo the the batches, because of didn't of batches at [indiscernible] that we this the remember in beginning -- get they had batches the Roclatan they terms

the we've we still so about said we and we the again. And that talk to twelve to stability but talked and insisting they do as months do we've them that, FDA before, are

in So that's to are of been that out we've given of XXXX. calling submission why see for that, Roclatan an NDA going QX we sometime year next

Annabel Samimy

Can know you patients. it's comparisons what same the you requires thing question, you I I look entertain international, like? are Phase study? the us is, just are what can Japanese tell in the about a maybe Okay. more guess obviously to one against If give [indiscernible], moving studies of an might in just FDA to Japan idea I you or can X requirements can initiate imagine it their specific clinical us Japanese I of maybe

Vicente Anido

drugs their do Everybody different to we're exception. to has no things in get Japan approved and

inhibitor Rho so in And we was have X.X years another approved Japan Glanatec, called kinase ago. about that

and as the Japanese a of a And our fact Japanese side to then in are gets in of trials one, the Phase do Americans some X what understanding our trials we're we so other take it in split then a complete Phase here little that be we'll have you of going them and bit may that for come the twofold, on to to gives Prostaglandin and half we you U.S. to patients, Japan take adjunctive X bit Prostaglandin way one -- gave have in number trial Rhopressa, Once those up they believe us out going us little only And to gets plus do specified run side period therapy. Prostaglandin and to you so time. did. where

trail a be So do efficacy. to that twelve for separate run with safety Then will have months. we'll to out

that are FDA, the currently we've Obviously all X pending trials but two don't any with on out don't Phase -- we had which that studies we'll there. this of do. X believe discussions can any where results now, to have those And the their PMDA, their been they Phase so surprises is we've in of we equivalent the enough change based expect

Annabel Samimy

said Okay. label? Phase And is X that open an you

Vicente Anido

it's trial. traditional just No, Phase very X

that. specifically dose things ranging Japanese Japanese and like have and on to We do Americans

where So have one compare to concentrations. different we of -- but those it

Annabel Samimy

it, got Thank great. Okay, you.

Vicente Anido

Thanks Ann.

Operator

from the Your question Tyler your line comes open. Buren next Cowen from Company. Van of line is Tyler &

Tyler Van Buren

for Good which interest. afternoon potential remarks and taking my of thanks questions. kind peaked early your Christmas guys. Vince in you Hi, a mentioned the prepared present,

that. timing good In be had terms pretty the Advisory when the you on for Committee would of Panel a sense

additional Committee all the early. that in there anything curious some we're I advanced of is to Advisory just thoughts that with you it the leads you that that just of hear come out a February. could come And discussions believe guess else on might guys it label early. expecting had the to or potentially particular it on, Clearly, is kind why So matter

Vicente Anido

Committee approval. points was two my a actually Well, that in again the label of Committee that find gone a And there of have is did any really Advisory position Advisory through anybody they that's early where to meeting. in showed I one of draft potential the part those lead label. fact the two that is can't they as for copy an meetings point the

off shows lot So the a and was FDA. clinical that, -- but made we that because we the progress of bit that's of think that a think that with positive, an unusual, I a certainly section

approval think CMC side, positive that the that the is Chemistry for the have for up before us. -- calendar PDUFA another approval date the controls, manufacturing the recent their end the for coming we On manufacturing another site one another products contract real certainly for of year. is They of

the have like that continues their second questions. everything goal, all their shot all would do like that a they things give inspections we've answered to on again positive, finish go be and So and us assuming to think and that. other all we'd really CMC But to

it have any number really something up hold always gone to But their date. things of all can we answer to so other for on reasons PDUFA tried and questions. the they hand so the And well and hold

cap they'll in another maybe so another get year. into like get like And feather and feel the they'd to calendar approval their

And so happen. to everything trying possibly make certainly are we can we do that to

Tyler Van Buren

the lot a guys have clearly to little more the how presentations change Great, that's hopefully when us well you Christmas formal guys a give it conversations recent access. present. more maybe could pretty the following years by to you guys get and course you approval, once do would and a commercial you the to over the plan payer with of done you'll plans coverage then over helpful color. those respect approval. expect the to have early a to the meetings just conversations and But comes have and months progress get clarity, With these respect how potential pricing in you And defined up an surveys leading And of the launch? approval

Vicente Anido

Yeah, in have this haven't we other certainly to little somebody the well. as cheat we Rich get knows that space you very on side. been because very, a bit know I

we is a the here and got thing since both feedback nice in out managed ago But any from to back little more bit haven't over the we've years be changes specific. seen gotten we care. So

to guys managed him. the Let over it up me access turn to Tom, report

So here. let I'll in him chime

Thomas Mitro

Mitro. Hello it's Tom Tyler, so

finding what with organizations we're our So of first are lot we're organization off requesting us. managed presentations care is getting a that from

early our the just want get eager to that been beta dug and presentation why since drug all they've actually and want they a And blocker explains does, not to So categorical our a they hear way then between alpha what they're drug difference to what and By our teeth really actually but They Tyler. long it that is for their are very into and two really even But scientific it's do the Roclatan. that review upsides different in for very presentation. of [ph] things, how kind because what want time stuff. performs. Rhopressa the downsides a

of do can't favorable sense around that Of sort we we're this what for of at our product course questioning to a we about thinking get point is any them. you mind through once their get their begin very positioning you some is in know the this they're for negotiation time. as at But

on they though away to can they get The they or other price want keep that they're the they MOAs is new want thing is and best -- clientele to that do, they've clear medicines obviously thing to from the other cover. the want don't care managed get they very new

people thing we are not side of round us table negotiation questioning good cover So large to eager product quite the from are they on eager seeing shaking approval, down the the then him, the which have to client, their we we to the when will seem on have is us we right viewpoint to are final major would a to our a seeing the seem where the head sense of now get are formulary. folks uphill other we very to they But giving when part. occur next of get get work to our very the talking with be opposite

Tyler Van Buren

is think still overtime? getting eventually Tier-X you And possible it

Vicente Anido

know certainly case With organization. going care managed obviously of vast best that in [ph] majority form what of every -- the it's we exactly and we cases the in not are possible, dollar people figures our we highly but majority that’s believe that to

Thomas Mitro

the goal. to the plans one, don’t ultimate day That’s course. Tier-X right. expect That’s on with We all land on of

Sometimes quarters it few the but that’s takes goal. a

Tyler Van Buren

That’s thanks the for really encouraging, thoughts.

Operator

Your next Guggenheim open. question Security. line your comes Adnan of is Adnan, from the line Butt

Adnan Butt

from the congrats too vote. and me Thanks, panel on

Vicente Anido

back. Welcome

Adnan Butt

and you, Vince Thank team.

terms in So terms the do -- it first drug -- FDA to come is for you in but of question the up, IOP or paying too level for therapy And in the conversations have terms not the show payer expect is for payers Roclatan then discussion those if having possible of preference second, on early? -- that focused your level, IOP not even for on of imagine is for step I Rhopressa drug. for a

Vicente Anido

really consistently a thing since to because and pretty broad, across It all clinical it's then So start that this with the scientific/medical levels. based novel been mechanism IOP the and show the managed day, into has with having where with way to we does on efficacy that's is we done, patients good the, with changed Rhopressa there again discussion treat for important able we of not XXXX, back the then Roclatan, and of point like trials of it seems -- have have the all once darn action. pretty Prostaglandin very beginning been only is a nothing but fact it them, have our them on at most the care

And that their reimbursed. just never by drugs, so to of lot driven are we because non-inferior Timolol, to think have to have been be reimbursement awful most an going that is they IOP not that be shown purely certainly of

the adjunctive be and so mechanism, And et once to think is the it going an therapy. on cetera we fact so that that again it’s novel, day be

Thomas Mitro

thing. Yes. they wanted Tom, understand organizations to I -- it ophthalmology Adnan, more staff and Remember understands not exceptionally that managed care most don’t on somebody just these they add have it's of well. well, one don’t may

call their will local the essence. have they So them panel in and on ophthalmologist

some might comes a about I'm heart product talking number just the alpha time it and be Now with ophthalmologists by the when medication, of might the caused they tired because things will is market, the caused agonist, issues issues time day therapy course safety start say an blockers, of you lung the with again these safety versus know as might existing adjunctive our significant be that example, by a caused one be of times cymose, dosing. adjunctive that dealing that beta these along with multi the the

good point from news the from ask point. view for earful an call a get even the or the that’s him KOLs when So is very community to that positive the ophthalmologists they is our view our they KOLs and

Vicente Anido

step for to then long be any less other that step the basis don’t no cost I just is to therapy the slight getting on unlikely than part is Roclatan. I Roclatan we as as as or your equal there think as of I generic the over And stepped, spread premium Rhopressa. as a which your of latanoprost, responsibly, long question, Roclatan will price to see view

Adnan Butt

in helpful. plan you Okay, approval there then be prepared and soon of after a sampling? how And for terms would to launch is that’s launching

Vicente Anido

guarantee Well, kinds chronic going is are there of face. I is headcount expense, in and force largest plan certainly -- a expenses but will largest to I the not the answer sampling commercial all because these sales for the of that one but is, for sampling of for Tom the it's you certainly on the is med, can for while because go a this typically things we

folks until us we'll to days day and those all ready hire, involved force the we the get start for the we a the we sampling launch, roughly announcements extensive We so and or calling the get see have been awful from the for that to ready to trained docs. get hired approval, and hire lot we in on are out sales and so sales you the going an out And do go, approval into But going that. there the not XX pretty is order plan we get that time. again don’t of details think we think certainly not we force coming after --

And we so have order have everything up product in have to for we and do that to have to them. set

So the we've provided. that's about timeline that

Adnan Butt

on you the one, the Okay the can't what's last I either to help clinic expect I pipeline. When am mystified, myself do for the take and thought into those Vince, compounds retina the there? steroid,

Vicente Anido

have steroid So start the for you let's to -- there.

certainly that So think going the three into product our into about at of in end calendar OZURDEX edema, Right three of ready another of works steroid gap. go think goes steroid it to or maybe now eye we diabetic has only one where got for allows got deliver product steroid a for we maybe, our for you've macular or particular formulation is that clinic months that back We the a us years getting 'XX. a the shot so. you've the think to to towards -- there so out

lower room that And doctors that intraocular would the in awful an years lot I perhaps event terms three between see a has the to the and rates something. spikes. months of is there of three think adverse like

some a our drug and a got better us to have our with the for we've a So product sizable delivery shop is own -- give get think actually to we it'll deliver component the market have so utilization pretty on that technology. patients, and

awful macular to do. the end work We into still to On for possibly we're we it But half the the for going to 'XX related out degeneration, if think in we can of possible. to XXXX of XXX it the clinic. age back of first an get everything have that's get lot doing be

Adnan Butt

enjoy you, Thank Okay. AAO.

Vicente Anido

Thanks,

Operator

comes Difei, question Difei your last of is line Mizuho Yang line from Your Securities. the open. from

Vicente Anido

That would be Difei.

Unidentified Analyst

actually it's for guys, you? are Difei. How Hey Alex

Vicente Anido

Rich Hi, it. Alex. Well, corrected

Unidentified Analyst

preapproval still inspection the Florida the back expect guys Do you at just so facility? Cool the coming manufacturing. to

Vicente Anido

pinged been know have been about at the manufacturing couple do We more they've our the since that in going facility know been whether We that something looked property, they've twice. not. there we've involved certainly or there FDA than data. be to times a is continually that we of at Since we've involved

based on and things that. like that Just the questions getting we're

called that If so been is of because site, stuff. that already And that they look [ph] has meaning out I product looking. But have us at of another there, in Luminas in front PDUFA XX. think back take I choose they've go date that they our suspect there a fact in of they December another may product to

guarantees So they either there that is again. no way look won't

Unidentified Analyst

in Okay great. on remind That's drug X for just for last versus us look you are reimbursement X? tier helpful. ongoing like what And percentages then could the front, might a one one, the tier just what you? rebate And those rebates

Vicente Anido

Right.

we believe XX% getting with land rebating be of the also if or product we could at With all. on can to Tier off it a tier have X in have, Difficulty] into competitive it X little like you normally to no -[Technical XX% gross So regards

Unidentified Analyst

Okay helpful, you. thank that's

Operator

Anido closing thanks for Again, looking thank of quarters launch three remarks. for get as months forward everybody to you now floor afternoon. Vince Rhopressa. great, to this next like turn and day. a listening And want ready approval I the We've I the to a on over for would great great company to for the we and had few have

Operator

conference today’s concludes call. This

You may now disconnect.

Aerie Pharmaceuticals (AERI) 8 Nov 172017 Q3 Earnings call transcript