AERI - Earnings call transcript Q2 2022 | Aerie Pharmaceuticals Inc

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Operator

Good afternoon. Thank you for standing by, and welcome to the Aerie Pharmaceuticals Second Quarter 2022 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 will be recorded. pleasure LifeSci the firm. Partners, my Hans over now of Vitzthum Aerie's is to floor turn to It Investor Relations go ahead. Please

Hans Vitzthum

in us. replay, Today’s Lang, website, will Chief press Thank you Officer; on and our Raj afternoon our Good Chief Financial as also Chief With Medical be being Sternberg, joining live Officer. Kannan, Peter you, it are is us available investors.aeriepharma.com, Officer; and Executive indicated and Gary for today call operator. release. for thank webcast

Now States success, and collaborations include we the financial of forecasts, On and will our Europe, world. These Rocklatan in future and including of measures. such make trials. the regarding expenses. in also will our statements, They trials, expected operating other the will and performance, financial statements regarding observations with timing forward-looking commercialization including our Rhopressa and include expectations non-GAAP our of statements ongoing status regions associated this and observations the and operating including certain call, forward-looking and enrollment regarding cost in clinical our and statements, United plans Japan observations

and will the products agencies requesting from maintaining, Additionally, of candidates. progress along product associated and candidates, or approvals our obtaining discuss we business regarding strategies these products product with regulatory regarding

beliefs based the our events, we for will on Finally, today. address expectations XXXX statements our other as statements financial of outlook including are beyond. financial to future of and related liquidity and management These and

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

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

including Relations the measures, turn I comparable Kannan, a see Aerie financial website. release, on that, our non-GAAP the measures, please of these press to relating today’s over Investor GAAP the section reconciliation Pharmaceuticals. of now call CEO posted disclosures Raj to additional For will With to is which

Raj Kannan

afternoon, I'm proud share pleased and of quarter. to Aerie's this everyone. so I'm you why good performance with you, Thank

second strong XXXX I ask the you AR-XXXXX I remain pillars remarks. key performance, During Then excellent We with made for with the confident an through review several our to call, pipeline And and across about why in especially update a that finally, financials sustainable are quarter close exciting drive progress a to with you of space. commercial Peter significant excellent will outlook explain areas date. rest XXXX expected will of the on speak with provide continued providing before by I we will Aerie's the the and growth three to quarter beyond. growth I'll prospects across eye our start dry overview progress you progress our and with on about Gary few second high-level the beyond. for our XXXX XXXX and of strategic our growth update an

We together expectations these area for novel burn. product candidate, We We initiated products branding for AR-XXXXX strong have our franchise our Phase target and dry strategy feedback efficacy for continue to two delivered registrational set in and and from year-over-year net We We Rhopressa. X we for continue taken achievements reduce disease, received refreshed revenue prescribers three eye on version Aerie glaucoma positive efficiencies strategic cash lead with X.X. of line believe and identify the studies success. operational Rocklatan of our to pillars on comprised early in execute building well our growth our our Rocklatan for Rhopressa. first-in-class

of advancing investor maintain first our for back and burn one, number we business; with Aerie's our reducing pipeline; of sustainable and my long-term success: smart a see rate strategic position. capital growth three, cash two, our choices year, three number commercial February call annual solid driving pillars outlined I as this the in the what financial number; During making to

provide assessment first address our strategic growth me the and three to potential three before programs strategic thoughtful near deliberate taken approach the the to commercial in numbers value two to our pillar Let Google pillars the and inflection business. to on midterm a and plan market. pipeline. drive we've with investing sustainable On two, how in more to our of speed likelihood of based prioritized detail number I success, in We on you we commercial value and drive

our program for momentum. First, has registrational X the product strong lead candidate, AR-XXXXX, Phase

As We XXXX. studies, hear in we're about AR-XXXXX will for study, the And if prospects eye COMET-X enrollment competitive compelling COMET-X enroll fourth today, by COMET-X approved, in the first efficacy very followed AR-XXXXX. in a have believe scheduled the profile increasingly recent and the to of dry safety the could market. with quarter you and that excited the of start subject the

NDA gets We we that to talking want more is clinical the in closer. key note a as forward XXXX. Assuming success, AR-XXXXX this Aerie leader plan to look of in file it planning about fall. event to discussion opinion an I host to

macular dosing currently is second We AR-XXXX, every today. six-month interval. Phase edema, Our treatments targeting a once diabetic steroid ready with late-stage available DME is DME, for X could or which it believe program, replace

We AR-XXXX, discussions X continue options underway. efficient are partnering Phase for and to development evaluate of

the macular preserve of a activities track wet candidate $XXX.X in an expense for total to with change Our third age-related IND is for Net in submission potential PRINT We've platform strategic used potential our the million. cash was pipeline. to fourth has a program, cash the tyrosine on XX-month progress best-in-class my the quarter on in of the in quarter AR-XXXXX, and was substantial or AMD. It three, and advance continuing greater operating based financial continue million. while cash, pillar one a most revenue of allocation On equivalents potent combination be to investments position, and Aerie's of maintaining rationalization of to cash to is decisions. optimize the strong delivery this interval grow degeneration cash priorities with number kinase operating product dosing and ended made efficiencies ongoing well-characterized used one capital inhibitors, axitinib. wet We cash drive million, and quarter equivalents net in cash, $XX.X $XX.X total or investments and and

financial proactively strategic to our optimize to execute continue cost provide capital to our plan. our analyze We and structure the flexibility on capital of

the be to per million Looking quarter than less ahead, XXXX we average. rest expect on net cash $XX for of used

to our growth is operating goal to and flow during glaucoma Our turn our continue in drive franchise, breakeven efficiencies XXXX. improve cash

provide quarter by market the our pleased Rocklatan to overview XXXX, one, tell growth of during XX.X%, second that XX% the commercial an prescriptions pillar strong you Now in I'm you and with growth the of Rhopressa same sustainable above of and driven in by I grew mainly future of we franchise. over remain of why which total growth quarter and number XXXX glaucoma the X.X% period. well revenues is continued would strategic to the of confident like second in report

franchise and In These and for share franchise to in addition, to growth increased share, and the in of market we beyond. has to continued our our X.X%. bode are line as continue well June expectations XXXX results gain XXXX, with

lower the the strong growth a that future brand with We factors. we for expect glaucoma is driven XXXX theme. by one, continued introduced February Number refreshed primarily on focus our you'll key commercial in in two a recall strategy franchise better

Our is market that positively strategy prescribers. research indicates with target our resonating

is goal the the to our move earlier in adoption continuum. Rocklatan, For drug

now lead loss the of of risk Rocklatan Our IOP, may offer patients intraocular highlight lowest with to of where details that glaucoma. or early and lowering Rocklatan, we the vision effective is highly adoption pressure,

the most right start. prescribers not key Our with with efficacy the start message to why powerful Start Rocklatan. is, from

be drug patients positioned analogs. consistent The to of are especially for of action inappropriate who in novel because Turning its Rhopressa. mechanism powerful and and well of IOP to its prostaglandin lowering continues

most who any one In are effective addition, stage to Rhopressa as paradigm. the almost at of see add-ons products physicians combination treatment of prescribe the reticent

the adoption the encouraging cornerstone D safety Medicare them. and grow a our we're efficacy Rhopressa, could the the targets Rocklatan with updated to bright reinvigorated efficiently brand revenue team driving controlling reason and to at Number clarity confidence I implemented the two, With for forward. products increased stewardship and strategy and and for of physicians with compelling to Rocklatan potentially could provides levels. on customer-facing the of increased target book refreshed providers. way brand Rhopressa greater capital opportunities, on company. commercial shares our for summary, journey on also The our that and fund growth this prescribers confident with all Part across feel Aerie future. our rollout the especially commercial coverage, greater opportunities favorable going to brand these growth. largest believe brands. be quarter pleased manage Overall, a could importantly, growth and approach business differentiated our to from position our continue and focus on formulary significant our costs the drive we to to broad highlight prescribe our philosophy a to second in achieve a opportunities our broad both the paves want increased our payer commercial positioning pull-through efforts business, targeted with formulary overall of Given clear has feedback profiles revised a and In strategy received glaucoma coverage we that month-over-month pull-through messaging share franchise with We

reflect financial results continued quarter second The these efforts.

recognize entire quarter on on, move company success. I of I Before for a commitment and up the the performance, setting the and team strong the want dedication Aerie to

to and Medical for building the over Aerie. call Gary? about our the our reasons excitement to Chief turn continue for on confidence now me Let the Gary, Officer, future

Gary Sternberg

including Phase to for and as registrational and product briefly going novel Thanks, I'm or candidate DED. is the treatment ongoing product our global disease, review the Starting on a other AR-XXXXX in first-in-class symptoms candidates provide pipeline, then dry affairs program signs of Raj. studies. and of updates program developed for the our or medical eye AR-XXXXX, differentiated XXX, with being the X

rapid and, can a or a significant we life there of sign, unmet on for dosing remains therapies across provide importantly, symptom a of market DED, believe endpoints. can improvements that efficacy, of therapies number over-the-counter convenient are While demonstrate there of prescription and for OTC range that the for consistent and new onset quality need products

endings as know, sensation stimulate innervate a is acts in a nerve result the and the registrational may X dry eye study. the momentum. am with stimulating report COMET that leads across The of receptors, symptoms. that strong the year. surface to tear pleased reduction XXX these I Phase production a and and COMET-X underway natural currently safety COMET to program enrolling The COMET-X eyelids. of which COMET-X followed in the cold the you is TRPMX in clinical the to collaboration modulator XXX registrational sensing the receptors the thermoreceptor the data Phase that By As is fourth cold X agonist both on found a this our and cornea the growing cooling momentum is program from study effective quarter driven by subjects, COMET-X are in investigators well and by eye clinical COMET studies

results that criteria life multiple the that endpoints released selection data multiple conducted may reinforce designed was quality that selected in our primary confirm I'm single baseline. COMET-X DED. both Schirmer's who the to the improvements Schirmer's the also U.S. action least responders the recently interferes study test our as points the the pleased of time we statistically inclusion/exclusion on results We for the significant replicated The that registrational Schirmer's of and secondary sweating across of people results recall of study to program, proper AR-XXXXX the Phase sign, endpoint test. I and the confidence trial for of of endpoint symptom The the the in mechanism and participants study millimeters validated study dose, X a the to statistically significant anesthesia at the Phase study the tear Schirmer's and center a was precedent by from measure of It previously X from XX that of the in with report You program. new reported optimize XX change that informed dose-dependent respect increased the in program. Phase confirmed test. test for unanesthetized unanesthetized in showed Phase of with registrational production at endpoints of with primary was X to the primary COMET-X the These the COMET production produce a in tear conducted unanesthetized

header from available unanesthetized Wrapping program, additional the deck, twice approximately compared which participants This the the on accessible multicenter, You company one identical. vehicle and primary concentration Each the Phase randomized to XX and X the can in sites and approval. study daily result the the AR-XXXXX why a to remain studies be on administered test data enroll of at for Each efficacy page. COMET-X trial XX COMET slide at outcome studies, vehicle the Phase is are as confident States. corporate confidence X.XXX% a up the our gave we company's the the control, is likelihood days. selection a study to is the expected evaluate website XXX single COMET-X and will double-masked in efficacy potential us XXX positive if our about United from in of in study [ph] Schirmer's endpoint for of X a

study As unanesthetized and the assessment assessed be or studies day will symptom the statistically statistically which just test primary Phase of at discussed. which I XX, the significant the score Xb will was outcome the SANDE indicated, in at day was also Phase XX, by key I efficacy the eye measure questionnaire COMET-X in dry symptom significant study. study Schirmer's the measure be COMET-X we secondary The in

other will and throughout be of XX-day In sign, numerous addition, life period. study symptom the performed assessments quality

of the results expect XXXX. efficacy We line second both announce top studies to from half in

programs: for diabetic edema, pipeline macular and for Now other and wet AR-XXXXX wet or mentioned degeneration exciting like two to macular age-related or DME, AMD. change AR-XXXX I gears would

AR-XXXX dexamethasone demonstrate These could potential first frequency injection macular six implant the best-in-class reduced delivery Let's treat in edema. is the This features of when edema. bioerodible to start retinal product treating Aerie's platform differentiated with months use to a AR-XXXX. have product using as to candidate macular position the and to efficacy PRINT candidate and enable steroids only

Phase for of AR-XXXX, options partnering and evaluate to discussions continue We underway. are X development

the XX Second, Aerie's is AR-XXXXX once for an intended block months, receptor platform other AMD. isoforms AR-XXXXX treatment frequency and to all a to targeted every pan-VEGF injection up of this differentiate is which of from to space. achieve uses dosing also wet inhibitor PRINT programs VEGF in receptor AR-XXXXX would

the year. an end on are for file to We track IND AR-XXXXX the by of

or the open-label underway Santen X multicenter know, glaucoma you Phase products Rocklatan there Japan conducted with MOST and are studies with study multiple As trial being a our IV for additional in including Phase Rocklatan evaluation by Rhopressa.

reported the Peter. We I turn expect results from would to both studies to like over to XXXX. in call be now

Peter Lang

will Thanks, for quarter of year second our of Gary. I the XXXX. comparisons the second my no to and this comments on quarter focus financial results

review I approximate that our will be for numbers these of will All sharing call. this in during easy discussion

Total in tomorrow. our and second the period our regarding today's second results will comparisons, revenues we sold administrative For million, our and increase of second million; additional of which to development please research $XX.X selling, XX% net cost million; of prior Combined of expenses over totaled file XXXX. release expenses information expenses press $XX.X goods quarter and of quarter general refer Rocklatan include franchise. of of cost the Rhopressa $XX.X Starting and XX-Q, and XXXX Form glaucoma with $X.X quarter a million. and

XX% higher goods the XXXX. period sold, increased in in $X.X of production improved utilization of from driven to year period. to mainly XX% by year Gross the million cost compared on or margins second prior decreased Our commercial prior COGS, quarter by the based

a our manufactured of timing was due XXXX this expect increase remainder commercial XXXX significant to planned to given cost of of quarter production during the portion runs. of We that goods for production

inventory, was COGS. capitalized current lower and into marketing general that due some primarily our stock-based lowering decreased SG&A, XX% of notice will decrease or expenses. administrative, Selling, period. million or this to well This as as year compensation $X.X prior expenses sales by lower compared the production is You to and

year and the to expenses compared comparable and AR-XXX. similar below in for development, or second for increased million be Research expect X the programs, of of For investment XXXX, the initiation studies XXXX. two including Phase reflect SG&A the X% to levels our and prior $X.X we period by quarter clinical to periods continued or rest R&D, efficacy the

million, increase the or expect studies $X.XX expense, back enrollment in $X.X adding expenses year the as the and initiated COMET-X R&D. net COMET-X loss the We of $X.X the compensation per and expense in $XX.X COMET-X million compensation R&D million sold, through stock-based stock fourth $XX.X in SG&A in of safety of in second quarter of were an in and operating included The second $X diluted our million was After was ramped end we cost the for the share. million cost total goods for which up, million. study $X.X XXXX was quarter quarter. total The

$X.XX our stock-based adjusted loss total was Excluding compensation expense, or per net share. $XX.X million diluted

shares weighted Over million. average quarter, were the outstanding XX.X

XXXX, of XX.X our As shares June million. outstanding XX, were

For change the XXXX, $XX.X and was in or million. operating used cash in our net cash quarter investments million. used Total cash, was net activities cash second of equivalents $XX.X total

of in earlier million XX, we cash reported investments. today's cash, As June equivalents as XXXX, had and call, in $XXX.X

our implementing Raj, is by noted to cash more operational use on driving efficiencies efficiently. and Aerie As focused actions

this to In exploring to that mention address I closing, we want companies. proactively cash As we to well many positioned financially macro on notes environment alternatives fund facing believe current are our and given we our challenges the are the part of optimize business plan. of balance, cost markets to outstanding capital, capital our discussion convertible especially biopharma

less guidance on than number used, of breakeven for million XXXX net $XXX updating we for are Our of per be cash $XXX our during cash guidance the for flow outlined Number the calendar XXXX average of million franchise, the million; three, for to is: net Raj, our and and $XX our remainder are quarter one, beyond, between guidance year; number revenues as product for balance to expect by the reiterating financial we achieve glaucoma we two, XXXX.

All in of assumes our current guidance our no capital structure. change

closing before would to to the Q&A. I for few call remarks turn like a back Now Raj

Raj Kannan

Thank pillars you, Peter. growth version executing well To Aerie conclude, three believe X.X. our out strategic to build I Aerie's across

join we XXXX initiate our deliver studies branding growth continue year; COMET-X enrollment in and and to driven this continued the and in study franchise quarter the AR-XXXXX by operational refreshed efficiencies filing balance XXXX. our strengthen AR-XXXXX; burn deliver safety taking our you the ability our COMET-X glaucoma of expect strategy; for continued for fourth I plan and to the to remain the beyond, stakeholders. sheet, out on drive reduce our cash the of and cash for in revenue submit our meaningful in enrollment rest progress net Looking efficacy look IND for you to confident time flow breakeven COMET-X to I and to to our in our way, us deliver along updating on today. become during the value all forward and thank

to the note our Senchyna, Innovation; will the call and the now Head be Q&A, the and for Operator? Casey today's to Q&A. of Michelle over our over External Before Head for of that Q&A operator Operations, for joining will Kopczynski, I call. I us Co-Founder, Research operator of turn Development segment turn the call and Clinical

Operator

Instructions] the first comes [Operator Chen line question Our Louise with of from Cantor.

now is open. line Your

Unidentified Analyst

eye? the net have for opportunity Phase my any for Louise we program. macro market afternoon. AR-XXXXX headwinds Thank questions. Carvey taking the Can is Thank remind expect revenues This you on you the traction second you been of of X has do good question, much. of for lot from rest for on year? which is COMET on you And in the developmental so a us Hi, a There Cantor. dry

Raj Kannan

thanks Both Raj, good is and questions. taking This Hi. Louise's are place. for

question. Let the me first address

drop and Xiidra how know, on also eye the current the drops to roughly dry dry of patients, that majority nine artificial used eye are off prescription And therapy. $X.X First, is out are market? is of effective a the dominant eight about and not today, billion. you $X about that billion. basis, you As an the include big for patients remember products, But market RESTASIS products, it's so on in if eye the

patients, So market we today. need could believe a for be therapies this larger that we this of $X much severe work market across in a see than is the billion number effective that

in on to legislation macro in the the growth, out On is that come constant two, the as trends the how of the have reacting any the forth revenue back the one one. of industry access overall some obviously change to expected is and that And of payers of terms that terms to thing in Congress. is physicians we focus number we with

we think that Street that guidance those remain the we to provided the So beyond answers achieve XXXX. two macro your I I I will confident events, that we think question. still for hope

Unidentified Analyst

you helpful. super quarter. so Thank much was again. That Congrats the Yes. on

Operator

Serge next question Needham. Belanger the from with Our comes

Your line now open. is

Serge Belanger

H, me. good of A couple for afternoon. questions

strategy if maybe any First, gotten on movement whether see the an of starting can secondly, quarter. you've per to and between changes update brand can the Thank usage about was – second you Rx Raj, some refreshed And you you're then Rocklatan and there feedback Rhopressa. talk terms net the you. just during give price the in on us

Raj Kannan

is This Serge. those questions. for Raj. Hi Thanks

that. But if I forth and that your the and at it be question, answer year-to-date. say price will will with are of said at previously I battle we any to where as your the that without the pleased at very with I improvement As per providing and price we've our come that bottle don't payers. net that level, first stopped the this for goes did $XX, the in answering not had to per high below a back I and net price, in The think price. February but constant a guidance goal below, guarantee bottle net between is net specifically – I is We to guidance on averaged per to I XXXX. the on or we say very about bottle had transparent Street gone mentioned its question, improve more I'm provide a continue $XX call did us terms

update of line. NRx. strategy to terms weekly from In the uptick our both and and it's my Rocklatan our data I first largely mentioned I prescriptions Rocklatan think, in seeing prescribe in in strategy, Rocklatan prepared the we And remarks, on clear TRx are to due an as compelling points as

driver we a choice that most recall, positioning resonates as feedback and brand you efficacy same that we that is prescribers. glaucoma, efficacious it's questions. felt field-based lowering teams of answers And As I key from IOP, have Rocklatan hope well the in our really the consistent with agent as well. Serge, your

Serge Belanger

just we I if Thanks. prepared more. and And when from you don't know but could MOST Yes, that? on give you the see covered could update results in [ph] remarks, study your one this any ongoing

Raj Kannan

Update middle on line and study of study results study. MOST XXXX. our The top the expect well, MOST is from we really have to the in enrolling MOST

Serge Belanger

Got Thank it. you.

Operator

question the next line from Samimy Our comes of with Annabel Stifel.

Your line open. is now

Annabel Samimy

taking question. Hi, thanks for my

had I a couple. So

narrower before looking the approval. just you're score know are But a secondary both studies. go we and the [indiscernible] just and can with to can scenarios your what primary hitting would of whether to the getting is SANDE the about one score the about SANDE would to you I you out there but Or still any And hit want you here. should as Schirmer's a having Schirmer's precedent know so have the there's confidence I that And hit said – secondary So COMET trying there's COMET-X, that you is and that primary to as been miss because and what the get an – a the label? strategy of think the the kind as with you work secondary. secondary, I the scenarios score the both? trial? back as to the Like with talk pivotal SANDE redo first if score, and would a you primary

Raj Kannan

Hi, question. Thanks Yes. for Annabel. that

production saw eye in very score significant Xb different in the symptom robust pivotal in our right: also only Phase X on unanesthetized just we but As our that relief, based discomfort said, tear three know, dryness. you results trial. SANDE, we and one, remain ocular you Schirmer's in not Like confident questions, but not Phase

Phase robust we hypothesis the our know, Schirmer's interim like again, action to As a efficacy now the marketing study the were your magnitude we in unanesthetized able Xb with Phase interferes with and of you of score question, endpoint approval. also AR-XXXXX. just And to saw in specifically anesthetizing the Phase of conducting of we X FDA we to completed the prove the between eye test choosing mechanism step the start the that X an Xb. unanesthetized as Phase with the for aligned replicate primary And answer the have Schirmer's of

derisked that one. we that of the high study based confidence on level on the So we had particular

and I the missed think white. if we FDA look black So end point, the will secondary the the a at totality of data. not It's

studies We have ongoing. two replicates

what trends studies, data regulatory the plays need how were review. we at into directional the look the and to Phase the FDA's two So Xb

not But we more weight the I Michelle? have a Gary, that a our So confidence question in space. best-in-class dry product agent think of in answered Michelle I've Gary fully. if that I'll high let profile and/or will in also result level eye

Michelle Senchyna

I put important, No, there's but think on, really to to it's I that, in just pathways think endpoint. add us spot that two the Raj, by front primary choosing are of

to at the tear just to Raj's primary the and in agreed totality obviously, does heart the agreed Annabel, question, forward studies. But improvements unanesthetized across the data the full the then But you potentially label of a as to provide trends were not path an to increase symptoms, then production. your the sure they minimum, consider test. in significant hitting would of on approval. adding and label hit Then look Schirmer's If I the been you So point, FDA has has at was think further of is, depending SANDE, we the all said, the symptoms add to. primary the an

Gary Sternberg

This testing. was the at only their Gary. data symptoms signs Tyrvaya, I'd they just add are have yet labels that and if on you Schirmer's look

hit just for totality reiterate So the symptoms again, the signs you get primary Michelle as potentially get tear to data is label said, we the at just to able possible, of least but production, on if what be endpoint well. increased a would might and has

to signs and is symptoms hit goal our However, the directly.

Annabel Samimy

Okay. Got it.

Okay. Great. MOST I then the That's study. And helpful. the have, question second on

drove the about you of in do to, on qualitative But through kind could study studies same from what how you going driving want continues that is is in and inflection of terms that how there's know I – number physicians I dynamic? to MOST a to that of these invest a the the there any or when we're conducting You help willing what of with just understand a how sense I much uptake, similar same, Rocklatan qualitative to were enrollment Rhopressa, with Is resonated much create penetration? something or MOST is idea it see there guess, that Rock study not Rhopressa support or make going have data. was that the study talked time Rhop, it in forward. going but in to that the idea impact any much how that that well uptake and during

Raj Kannan

any study. first me to commentary I'll stab, the MOST let take add a Michelle So let and

the align to generally data done with Rhopressa real-world of it can at think new generate it's the Rocklatan see when useful is of only and talking as are that level we field real-world also product so the And terms to I physicians that first-line in we we're add-on creates present but to useful continue have we tends the Annabel, studies prescribers, about certain the think, payers messaging level prescribers. and they of to generation I data into for to how hands data, these what not of and generate put to these data community a that when key have. we enthusiasm that

So fact can't the dots to its the exactly anything I first that as do perspective, of again, And what particular the a affairs solidify I I data Michelle, efficacy, latanoprost, inflection will To which resonated first miss or choice question? continues primarily, that of generation terms are Rocklatan glaucoma that only marketplace. us with gain, well we but help in the be better study this to four the switch from in and points driver line in I point of the think share because MOST did the be Annabel's say to really prescribers. is connect you marketplace. than two continued know that key tell chosen will medical efficacy

Michelle Senchyna

I with message. Raj ground. really Rocklatan the think introduced more MOST the to articulated. And that going focus just well our of with and off putting We Raj we mentioned, prescribers, really with regards think that potency his was remarks, the the as now, very – of certainly got resonance during augment the uptake amongst increased is study especially the with fuel to as on very that was the were the impressed get I to forefront, in as part that

Annabel Samimy

Okay. Perfect. Thank you.

Operator

Our next question comes Cowen. Stacy from Ku the with

is line Your now open.

Stacy Ku

on Thanks quarter. questions and so much for congratulations our taking the

we just a Rocklatan follow-up Rhopressa a of franchise. and few So have quick the kind on

next expectations growth? your it's do of are for Do – specifically think Rocklatan, for might positioning what our duration. play XX is how it you the Can about, your you our about first early contributions think Rhopressa, provide of stage future potential you the study second out of XXXXX. the how think in the in for clinical months regarding for like question stage but trying to your year the terms Looks remainder XXXX, So early then first, we're the we clinical design? thoughts As think you And question. – few that's years?

far the taken development contrast different compare and so for maybe TKIs. So pathways other help the

rescue instance, been have kind of criteria. criteria, For design, entry trial there different

any understandably you. appreciated. be would Thank of very early So thoughts the

Raj Kannan

Stacy. you, Thank

have additional where So the me question in commentary weigh with needed. then colleagues in take second, my the I'll let and first a first

trends the the an franchise, is think, we're in Rocklatan switch, know, as Rhopressa in we for of I and much as or line And I that first in first Rhopressa. for terms sandbox terms So – already growth opportunity. the remarks, positioning think, on I rate better bigger Rocklatan you versus a seeing encouraging are Rocklatan as prepared said my as of

product actually better it's But a right to economics perspective, not mix only for price it versus skew I also Rocklatan and say, price towards overall So has franchise the is Rhopressa. the because medically from we list better better the think net the thing Rocklatan, an speaking.

one. So that's

franchise the from think positioning think right? on clarity I of second to on encouraging. for very we the in there products, that this. didn't the clarity prior think the I feedback both perspective and growth, I the terms is And kind have crystal of team field-based the has prescribers been

other has baseline a powerful regardless allows that And glaucoma in lowering you the is importantly, MOA that unique of unique by or of brand Rhopressa MOA for space. regardless IOP as Rhopressa, therapy not with consistent the and baseline So pressure. has very any know, replicated

we're particular, therapy, not for And for in are appropriate Rhopressa who patients positioning so PTA prostaglandin.

And is about in this we allows combination Rhopressa, drives be about up we the our four in it that here, as which marketplace, who quite to reticent own And to a adopted but years agent XX% a what positioned large physicians Rhopressa understand tend that to position history the is earlier add-on from in and us research. as know earlier We therapies, in from be to reticent. the especially So marketplace. physicians using have of best adoption. are and we market,

So potential what a And much as early And are we than the the results think opportunity I trend continues, we before. was this this encouraging. be took that said adopted, I more I think on. commercial strategy could the before, if attractive bet is it

sort asked. question essentially on comments Rhopressa of Rocklatan the that that's So and you my

very agent XXXXX, as potential obviously, best-in-class we're wet XXXXX AMD. excited the of terms about for prospects the of a In

interval. the In dosing terms of

plan study get second is will adaptive quarter, dose but to let efficacy we hope comparison At that quarter, haven't design more IND a an escalation from of design, Casey to do we product. chosen missed Phase And in the XXXXX allow mentioned head-to-head into versus an that internally, particular. in details is the something maybe this of us escalation quarter to in that anything in a I/II head-to-head I'll second marketed time, study if anti-VEGF fourth I've quickly the late you quickly long-term file this a XXXXX move we you to dose anticipate clinic. the we mentioned finalized the on to using from something Now weigh or Gary of year. that

Gary Sternberg

past data that just the release, This reiterate we to our XX-month supported have preclinical study duration drug correctly with human I'll data and program. is in XXXX Gary. our extrapolated animal of

comfortable is Casey that to our over we just So wants pass answer a product to it he if feel that. XX-month duration. And I'll

Casey Kopczynski

very I best a think be to to the other the have development. that looked preclinically. really is data to injection looks And once-per-year anti-VEGF relative are some the here opportunity for options point the that that is this strong summary of in

Stacy Ku

much. you Thank very

Operator

Our Jason America. next Gerberry of question comes from with Bank

open. Your line is now

Unidentified Analyst

the for on for This taking question. Terry Thanks is Jason. our line

of market you terms to dry yourself speak to in category? the Thanks. bogeys you question dry have need managed fact what from the which category eye the that And [indiscernible] you second, on of Phase aggressively attractiveness eye dry eye to you payers? the Xiidra more side, the as to as despite the the the on of to that can grow clinical market hit entered evolving have marketer? And First some speak extent is Can well-resourced program. X a the the then also, enabled now having to being well separate by in efficacy are

Raj Kannan

Terry. Hi, questions. for Thanks those

saying underserved start a and large that me number eye one. marketplace, by dry is very the let So a market

look roughly two on or patients you stay one unmet at needs if here for think the about I Xiidra, RESTASIS and therapy.

symptomatic And patients I in would off across doubt onset wait is tear about products months on months six know six and stay production of number roughly therapy. a Xiidra effective takes to two, manifest. is that these patients. the approximately about highly RESTASIS, a a disease, this to on example, for months. three large patients Number efficacy spectrum do because we for they're both So wide drop of therapy of not

for So rapid results, – AR-XXXXX if show tear day a need only look there we efficacy. And after statistical in onset after we are not clear production day you Xb in right of XX. one active at on clear but is Phase dosing, significance

with is RESTASIS don't the So able efficacy unmet need, a products provide clear be compete that and are and going Xiidra that. to rapid to think onset of I

if replicated So that's deck, the our investor on you a efficacy Two, with study our small effect we one. in production. patients magnitude tear Phase in and at X it's look of XX And see you the Compared roughly first product the in roughly take XX. the marketplace. the was to was XXs. can in delta at was that This RESTASIS, about delta clearly the is

we best-in-class, does of we direction, well I symptoms life and believe multiple again, so think, effect that the sort Phase unmet new terms be a of correlation articulated is into the tear over tear which measured just when right? address dry has on eye pleased in were I terms the in the to this the be I that of coming totally well the are meet demand. needs And the to with to magnitude a meaningful three and potential it space. think in results, is improvement of say time in efficacy products has Xb the marketplace I unmet improvement in of the quite the one [indiscernible] this pointed in generation measures we third, to and quality that So that really of the production how consistently production that product correlated So

that a generation, call of that believe question would terms continue why and we products. best-in-class hope but AR-XXXXX itself RESTASIS I And old-generation in a importantly, new your could answers are to hopefully, Xiidra what So as as we rating. position

that we at actively recruiting I there's is terms X studies own you said, are about why as Phase X companies that that other In have There's Phase think competitive X clinical intelligence companies look like in products studies. conducting five development, are And reason from it. according XX believe so is either or market of attractive. to Phase this ClinicalTrials.gov I a our

confidence answers are, Phase capital this – we significance why the allocated to these lot in and AR-XXXXX is continue not when your and in again, patients look statistical you ability hope at precious way, if product products, XXXX. Terry, your in hope invest to us our our we Phase the results the specifically the of by why end within we recall. our Xb addresses capital that I and as our XXX question. be points. I on bullish company So gave replicate to XXX to our partner Xb, the that a and was question small way to MOA This compared robust profile is these results, that a

Unidentified Analyst

efficacy other answers question. the more view be the category to And then I X end safety by points which extent as was the That see of for Yes. the would I or other two Phase I payers? on the Those space development. bogeys you the managed you guess within guess, that some specific on, aggressively being any had. questions

Raj Kannan

Yes.

take the payer question. sort the of the pricing So or me let

and of Rhopressa and right, I novel bringing of products given that market. terms learned, sort the with experience Rocklatan think in we've lessons the to are we proactively

a how company institution there's large think the eye when this go has market. product I on we knowledge dry do the within to right to with

go of through Here, I the in with the market, terms for a line time meaningful as before payers and work approval to generating payers have we come to we think we data right, proactively process.

not off you see we soon first we that that the of and as give versus know us. thinking ideas studies can't the but terms don't kick I is in market, quite this So payers right we I off. on plan to have to adversarial – of as with we're top help now it's table few a those details and the a we going go making do an about, kick them will those it where terms we of And that results, situation will into line in partnering

on our So of that's the we and the a best profile in products. expect I safety patients product, anything how fact prefer did Gary, of glaucoma position and we of our side. again, to response this and again, versus efficacy with with or could this sort that ask onset magnitude see on you I the Michelle in given given the think payers how we see, conversation easier I'll past given the And of in XXXXX efficacy an the be that give weigh they will product who today. terms to the

Michelle Senchyna

Yes.

your being the So not are make going for question, a bogey's lifelong what exactly I we clarification bad, to good or to are to that want think because ask differentiate we a that avoid term going things you really I on – should just things sure was us? bogey golfer, seeing

Unidentified Analyst

where about thinking endpoint endpoint just there the in beat want competing where products efficacy how any that? that about using any guess terms? or I Or COMET-X at, in where to readouts other terms the the you of success ongoing primary you'd benchmarks think trial. the similar for we can Are a of set I look readout way guess, we Yes. can a kind benchmark for those they're

Michelle Senchyna

question. Great Yes.

with months effect, it again, six I that So down a I road, say happening immediately et very a I it's commented immediately sort different is important a there very right? same hard near in couple, programs, duration happening to always very important see So market the Tyrvaya tear populations, think, is differences magnitude perspective, cetera. products comparator. would ballpark. things, in said, that on perspective, on commented From production, look the on tears, methodology, that you or compare But our our at or cyclosporine slight products I that a will and from really There's actually to robustness, across right? number be think, the do just time of would is of Raj are certainly, and this think produce when Raj

XX% what of at responding. patients You start for. looking over looking are That's the caregivers

the population actually more something than to Our to respond. they going are know HCPs prescribe want that if X% likely of

at So to numbers, responding. of the XX% I start population definitely looking XX%, you're think when

set And then perspective, a important vehicle, a of think well is no validated be that's as looking gold or utility at better. again, these all our is to the can very what a to have clinically But from the hallmark speak significance say is differentiation question, from symptom symptom This there's speed to or demonstrate going scales. statistical up in vehicle XXX. a disease. of important feeling I you to even And X, significant measure no there primary different there's comparator. be standard to as Phase an separation that symptom-driven faster endpoint we when you're As will

Unidentified Analyst

That’s Thank it. you. helpful. Got very

Operator

Citi. comes Our Nochomovitz from line Yigal with next of the question

is now line Your open.

Unidentified Analyst

Hi, taking for on questions. for is this Yigal. Carly is our Thanks This

have We two.

is of especially then that The issues great. covered hearing is can or used getting you're on you. hearing as guess, you're on you are of would to I Thank of as if partnership AR-XXXX the first-line reimbursement, are if Rocklatan it's for the when agent. latest an position first about second-line update generic Rocklatan options? discussions ahead second feedback the just trying progressing talk be any you more maybe give And a some can you how

Raj Kannan

Carly. is Hi This Raj.

positioning the as answer Rocklatan first line. question let terms first of in So me for the

on know, and So not Rocklatan most new on have and patients, Rhopressa to therapies. been you are as other glaucoma

the So reimbursement patients or have prior bulk XX% our But no hope which separated much business, and criteria to the in satisfy coverage. importantly, branded of is that of step represents is of place the these we the Medicare, co-pay. to business, obtain edits almost half lowest which have authorization of and

continue how are [Ph] are of side, of strategy XX% we able Rocklatan. continue as terms you So that's terms think we can line. formulary high those that important offices in these close making positioning it's Medicare coverage So XXs. to formulary optimal that as sure the targeting Rocklatan commercial Part line. roughly precise to first and B in Rocklatan we of very the And And on on be know, patients be Rocklatan have in for we about side, coverage for on first the to to

I of said months, our platform PRINT question dosing In a because of path clear a steroid market of mitigation of six it's to And prepared in dose. approval XXXX, delivery remarks, product likelihood that proof of but clear first my has terms for the of – obviously, it. in once more principle for partnering of a a interval every a the compound of is the of terms half the biological showing a on this second this risk as from in the

the right There and put developmental but that update hope marketplace. folks partner answers in that maximize that right the that that we I ongoing So marketplace your I right those soon of effort discussions the question, potential in feel in Carly. are will now. are the product actively as will data as room, we've got the

Unidentified Analyst

That’s Yes. Thanks, great. Raj.

Operator

Our comes next of Truist. line with question from the Fraser Greg

open. Your is now line

Greg Fraser

for Good questions. taking and thanks afternoon the

think refresh, surpass messaging continues think Rocklatan away, Rhopressa? you gain When growth that? curious that your maybe of some share next months year traction you to do Could share Rocklatan about and it time? I'm As how could be quarters, accelerate.

Raj Kannan

Yes.

great and faster have is weekly revenues. good So, we're I net think I – in for the question. to us Rocklatan We've of only right? Obviously, XX-XX, roughly continues grow Rhopressa than or for million XX% a is recorded a way, level expected boost at the the pleased is we've for the we quarter about not Greg a This growing mix positioning. it’s franchise. our of our Rocklatan on that the confidence mentioned not in in with But this, ever highest where again growing quarter, closer whereas see we commercial preliminary terms and at much saying being that the represents the a are product trajectory think quarter-over-quarter. sustainably that XX% getting to roughly $XX.X By I revenue is may growing record actually that said, XX% first-line

also next being your for answers Greg. question, So result, math the mix be in if more Rocklatan. we lead. Rocklatan early favorable And that as do will in the sometime of with favor much a hope being more the Aerie be year, product economics I the will

Greg Fraser

the Yes, products? the there the very difference of net helpful. is much in How price between

Raj Kannan

And publicly, haven't formulary So out see but that coverage you the WACC, we the right? given you can differences. see

a better is obviously, perspective, in net a Rocklatan So from net.

could is give you to you business, rate, for Rhopressa for it's the look Rhopressa, for you our modeling to formulary numbers largest, which of book the Medicare in Rocklatan, close XX% when So book some of at business, it's right. whereas XX% your just in that coverage, Medicare use

is – is in in does Rhopressa is So so is with also mid-XXs, a economics big difference. makes a price perspective. from Same importantly, right? the WACC commercial, But Rhopressa, the Rocklatan. Rocklatan the the not favor an thing WACC and different only but net between net

Rocklatan onetime because to So loss this a very is perspective well favors first a Rhopressa. I right it's but to reduce ability it patients with to feel line thing than Rocklatan from of think as its it also has the the position medically because business the that do in highest because more and efficacy glaucoma, vision I aligns economics

Greg Fraser

very helpful. That’s Thanks taking questions. Great. for the

Raj Kannan

Greg. you, Thank

Operator

I'm showing Thank participating. time. no further questions for you in queue at this

You disconnect. may now

Aerie Pharmaceuticals (AERI) 7 Aug 222022 Q2 Earnings call transcript