Earnings call transcript Q2 2023

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Operator

Good day, and thank you for standing by. Welcome to the Quarter 2023 Ocular Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Notman, conference CFO. like speaker to now Donald today, would hand over the your I Please ahead. go

Donald Notman

Thank you, financial Jacinda. the an for update joining update Good call. close, afternoon, everyone, on conference press second and we our issued quarter release afternoon, XXXX This results a business us and Investors after thank providing on financial XXXX. second the the June XX, of results The accessed product release portion quarter programs be details and at development company's website for the of company's can press investors.ocutx.com. the our ended on you

today be Commercial. President DEXTENZA. developments of call provide Rabia Medical Chief Dr. President, and Officer, Steve the an will Chief will will progress commercial Also Leading Ozden, our be our speaking Antony our who Senior and pipeline Vice the Officer, and on Mattessich, update the Meyers, our on today Executive call

provide remarks, questions. for turning quarter, before I their financial for the summary Following back Antony highlights will overview the to his call an the of over and

As Private product Form a Form actual XXXX. the forward-looking and our annual report are cause in recent of differ our any to net call, purposes results regarding will our March we including XX-K SEC are and to and as subject Act the risks for be activities and filed X, These those described statements the uncertainties making forward-looking from this statements statements most certain statements. that filed a may variety product research Litigation may on afternoon XXXX. our those be risks forecasted, XX-Q of development with In considered Reform anticipated of as particular, reminder, regulatory plans well revenues Securities on today's our

the Antony. call will over to I now turn

Antony Mattessich

to with forward. plans to our months Thanks, Donald. earnings the on share and call. on to progress quarter second We're our our going the clarity provide and past successes tremendous we've three to over build previous pleased welcome made you XXXX Hello, everyone

importantly, all, Most three unit funding record growth X% in of same achieved DEXTENZA’s us in growth augment we're quarter-over-quarter signaling a confidence XX%, new pipeline. this product First that has X%, second and previous quarter and trend revenues last year, sequential over for report quarters XX% the of million future we $XX net consistent of the over quarter pleased been potential year the a that quarter. fast-developing to previous DEXTENZA growth of in-market gives volume in our to XX%

a the this our anticipate of President, product come DEXTENZA. through Based Vice revenue guidance further on the now the we $XX trends of Meyers, start will the and unlocking XXXX the million the for our current million for code through $XX will insertion seeing, CPT in are XXXXX, upper at to revenue DEXTENZA walk the payment net growth provided Steve the procedure Senior full drivers of end year growth we you the at year. Commercial, range accelerate behind for determination facility of to

single quarter using run be our OTX-TKI is pivotal this trial superiority primarily The at have group parallel the that Second, a we confirming developed previous pivotal will to US guidance The that we single first end corrected prospective our we trial multi-centered be trial plan design. sites. measuring efficacy acuity wet and assess will trial for and before safety a best initiate designed to randomized of are study eye. to enroll wet will a in treatment It approximately OTX-TKI who by OTX-TKI in injection the implant XXX of central AMD aflibercept subfield visual thickness. naive of and AMD a subjects subjects evaluable are of compare with the

dosed their a products for security the FDA dosing their in to drugs acceptable received at the frequency for as which two from AMD. is for investigational frequency interpretation the guidance, agency, longer one advantages with the comparison draft trial dosing for aflibercept FDA labels criterion over established evolved, the treatments we the our dosing preferred advice margins, notably, therapy. against the with from Feedback of given and OTX-TKI from interventions with arm. either requires from comparative in has wet Most choice the traditional particularly current investigational reduced no or as dosing according new non-inferiority sham additional and arm for drug Under feedback ranibizumab, arm the are least criterion reduced frequency, expected pathway same made the durability FDA the controlled adjustments,

the a require pulse trial. demonstrate to with the over superiority the to frequency on-label XX we dosed means show arm, however, antibody months we as and be to single would, design accepts Since the dose same this Under superiority as draft non-inferiority non-sham in as to well alone with non-inferiority superiority case, injections in become direct a OTX of over FDA, choice ranibizumab identically a a treatment that a that arm or OTX-TKI arm. OTX-TKI. simply treatment to to moving with show given an the that required the us actual forward compelling injection superiority which OTX-TKI be the any would and interpretation XXX evaluable approximately would our trial superiority both demonstrate and according approximately to investigational included with has as non-inferiority would clear million, also cost case, our pivotal at believe the in arm, of from can would aflibercept a be to feedback trial This $XX additional guidance, compared single to nine need subjects this drug, FDA of any approved that new

has we key that we clinical will be leaders pivotal In the and requirements, endpoints. a discussions timeframe acceptable in achievable design believe can have with that opinion trialists, in satisfy an FDA enrolled

be Additionally, expect in with primarily to States United our discussions investigators. we many the enrolled for trial the key

to allows are initiate pleased this that pivotal we we that have us funding Finally, trial. secured to announce the

funding non-dilutive for to have means. NDA to obtained first to us pathways the to Given facility our call. OTX-TKI million, financing dilutive the price, or $XX.X OTX-TKI the extends we recent facility debt a share Notman, By consistently pivotal securing minimally we into the the pursue filing. trial bring desire stated cash runway have our allows through details later our over in Donald go initiate of that will our debt non-dilutive CFO, XXXX and of

have that and the be does of want continue of in aligning debt lever non-dilutive partner. a quality Another initiation not our strategic first the strategy pivotal partner. funding we very the new with pleased To clear wet that to with of is strategic pursue I we of AMD securing facility our our to alter a been started that date, our engagement with the to OTX-TKI to partners with product ability generate discussions with first of focus and pivotal of we demonstrating OTX-TKI's a reflects solid partnership We that getting a globally that level and and optimize as value. OTX-TKI. potential tremendous have potential ability believe trial our execution enhance to could value the add

Rabia, of interim mention before in keeping I recently results intracameral wanted achieved Phase travoprost first in to So we quarter to XXXX. major program, us present with X on enrollment treatment We containing our our to milestone handing track recently implant OTX-TIC, a of the completed off the glaucoma. for

designed prospects are With the pivotal fully dosing prostaglandin at to we suitable Glaukos, programs resorbable step. the as recent about iDose into that chronic interest bringing be excited delivery bio next of our a the is for program around implant

highlight wanted of expert. is the ophthalmology eye I to well as front Lastly, the Dr. addition Board. known our of the to both Dr. Graves recent back the Adrienne in Graves community and

Chairwoman and acquisition successfully $X.X brought of Inc., she As IVERIC late CEO Zimura development company and the by the stage lead of approval company eventual bio, to development multiple helped the recently, Santen as of billion More she of former the products for through the Astellas. Board ophthalmic through commercialization.

me trials. discussion our call for turn over to let that, a Rabia Rabia? With clinical the ongoing of deeper

Rabia Ozden

of masked, recently Beginning based dose weeks wet axitinib shared Thank a changes controlled measuring US subjects from results functional controlled XX the treated of aflibercept administered the in activity to in weeks was and and assess with randomized, biological tolerability previously to prospective and subjects, implant assess you, by a aflibercept X-milligram implant anti-VEGF AMD single Antony. injection a designed our safety, XXX-microgram retina. OTX-TKI the durability, with The compared therapy. eight containing evaluating every multicenter we anatomical after trial trial OTX-TKI clinical subjects with in four in to OTX-TKI,

XX-month recent most our the Clinical the Summit in shared June at Trials meeting. update We at XXXX

systemic of OTX-TKI serious trial, Looking adverse at observed or in analysis at direct the XX we months, time no and events safety, ocular related XX subjects. treated each seven, points,

subjects at burden XX% in Turning to to to month months. continued XX% XX% to reduction the perform treatment of XX XX. in an Overall, subjects rescue activity, biological observed well treated up and up TKI OTX-TKI OTX was free month with XX remaining

best addition, to corrected the single data at OTX-TKI treated central showed aflibercept subjects with month-XX. implant sustained comparable visual and a acuity thickness subfield continued In arm with which was demonstrate

received subjects waning patients. therapy helps which timeline rescue as -- month-XX therapeutic helps anticipate, time Overall, the for the we believe establish a of in at the and disease the of potential planned trials. forward a that become reactivation, first of first would and pivotal initiating durable indicated the differentiated redosing effect re today's we potential look Four OTX-TKI of the which to care product response AMD. of capable anti-VEGF management shortly wet highlights improves a providing OTX-TKI the upon data to standard We of two for

retinopathy. single XXX-microgram diabetic product enrollment in the wet axitinib retinopathy. evaluating based the masked, of sham in same non-proliferative could a HELIOS OTX-TKI We a believe of standard an of of our a treatment a term durability in for of prospective and our of implant treatment long XX the compared potential care multi-center the containing OTX-TKI controlled for treatment to office June in use that diabetic the ease is announced establish as X of a compelling OTX-TKI to the completion Phase US-based HELIOS injection trial trial. dose AMD, of Moving first We subjects OTX-TKI injection the make randomized, attributes procedure. candidate

trials from plan positioned early six-month be in clinical subject we We HELIOS initiate as this QX of as a program trial for and this to data we pivotal share data well to QX and believe financing, that XXXX, to interim will the XXXX. additional

open-angle making programs, intracameral being implant the developed of our travoprost primary or another OTX-TIC, patients ocular with pipeline We late-stage are for our of treatment also hypertension. progress excellent with glaucoma one

remains or available in medications vision. their intraocular to take their IOP, to We simply unwanted many and side may blindness, lose cause believe ultimately effects, are improper there forgetting part fail because glaucoma pressure leading of lower daily or patients drops. a While to most of comply technique

OTX-TIC of being primary outcomes US controlled over is randomized of with reduction evaluating ocular compliance based is close of world the the designed to is clinical hypertension. developed XX observe the for by weeks of X multi-center trial baseline from to two, Phase and the IOP and follow and real out changes taking trial the time masked The duration in prospective IOP IOP subjects response patient trial glaucoma open-angle equation. and safety, tolerability gap OTX-TIC six restart. at the efficacy between This diurnal to compared or clinical in

We of XXXX, efficacy, assessing X clinical are that top-line complete. report to We happy X the OTX-TIC. now look data the Phase Phase safety, is of trial quarter enrollment to in durability sharing the forward first

support of second of also report to XX-microgram, will OTX-TIC clinical a for product cell cell sub-study on ongoing small the initiated repeat we repeat safety pilot subset candidate enrollment suitable study a least health. in repeat dose subjects evaluate implant evaluate for XXX-microgram sub-study a X trial. dose The dosing. could pleased very months in preservation is repeat subjects OTX-TIC six endothelial these of to on the I'm After have be that their the receiving endothelial to soft dose, the data the of health this Phase preliminary that in a the of after the provide followed at the

for and programs, disease at We of disease. of intracanalicular and of eye of eye the plaques the evaluate of to two both initiated to comparator we eye symptoms a insert the intracanalicular development treatment study and quarter that signs treatment collagen cyclosporine disease programs. performance the could for the surface trial to at committed the dissolving inform low dry small dry ocular a chronic DED of containing OTX- inserts in remain our for OTX-DED OTX-DED use OTX-CSI, more plan second with insert dry patients to versus in of and placebo forward. all. dose short-term Regarding future We this clinical a our moving programs inserts, dexamethasone appropriate OTX-CSI the the de-risked placebo have the trials no results use selection potentially a the for pivotal namely fast the

I a would for call now like to over to turn update. Steve the commercial

Steve Meyers

recorded to ambulatory million, Also, of QX unit product QX hospital of revenue In XXXX which was X,XXX is a sales represent XXXX and surgery DEXTENZA outpatient finished and the $XX higher XXXX increase same XX% Rabia. at XX% units up net sold ahead X% and departments in over than which XX% QX a approximately and units over period increase centers over market year. you, Thank QX over XXXX, last QX units, XX,XXX XXXX. from volume,

Importantly, third the has this unit growth now quarter is of recorded consecutive DEXTENZA in-market organic sales.

profile. DEXTENZA's has centers. believe strategic allowed The surgery also its it’s We strong safety account our utilization that strong partnerships single-site by to and among has teams clinical create helped growth anchored profile efficacy been and contracted increase

growth our providing others, its market customers strong Additionally, access XXXX. achieved confidence. are team that data, helping among with reimbursement is market continue our has access in DEXTENZA These exceptional coverage

a billing code that inequity assignment CMS and XXXXX, will to of to QX the itself XXXXX. DEXTENZA status indicator of the exists procedure that I'll for be hopeful update by that we unit JXXXX currently DEXTENZA. the expect CMS Now continues payment to the do insertion In We're rendered a setting, provide not CPT ASC change with describes change. for brief consideration that the to separate CPT

in should to However, and strongly to separate many by there requesting DEXTENZA. the payment actual facility and a also voice facilities time assign indicator. change that interest that compensated belief the ASC. of a ASC indicator their the administer standard have chosen assigned It status additional CMS status is in have encouraging others to a separate is gold the that XXXXX insert many and care shared heard to indicator make no be payment and DEXTENZA required to would status provide for for CMS Large to such, procedure facility the surgeons, our means societies, resources we're XXXXX the as providing ophthalmic administrators QX to

ruling expect We CMS a will final this year. late provide

should half noted on based million representing to the to at full as range, several end $XX for upper Finally, million we come believe months Antony product the in year end of approximately growth of that trends last XX% XX% current net $XX product the at revenue net the potential XXXX. of XXXX first DEXTENZA revenue our earlier, the high guidance over over DEXTENZA $XX.X million, now and

Donald me turn let that, With to our discuss financial the results. call back to

Donald Notman

approximately refers collaboration revenue, the includes which revenue, an gross over revenue net and XXXX quarter revenue of Thank second as net and quarter increase product revenues was XXXX, net of approximately of net for both $XX.X returns, you, and net Steve. the of rebates, over million Total DEXTENZA $XX.X discounts, $XX.X to which second revenue million the product XX% increase XX% quarter of an of million. first of company

$X.X versus in an revenue million million million. expenses quarter comparable quarter to $XX.X Research for expenses development by second primarily of increased in XXXX $XX period trial collaboration for the in to while clinical XXXX, from grew driven product over of with million For XXXX, the from the million period revenue million the comparable associated net $XX.X $XX.X $X.X second were XXXX and programs. increase DEXTENZA

share million of $X.XX on and the second stock-based comparable diluted of $X.X company to increase and were and related compared due on XXXX and basis reflecting administrative and comparable $XX.X expenses marketing loss quarter XXXX, of basis of or on million $X.XX versus quarter an million the net a XXXX, including of second both loss force diluted million $XX.X a primarily second costs a the loss $XX.X basic in comparable for the in period quarter in to for a of professional compensation a in loss to $X.XX personnel. $X.X quarter a were of Selling loss compared or increase XXXX. in million expenses field for of per share a the net XXXX, fees. an personnel share basic General quarter basis The reported $XX.X net per per for primarily XXXX as in the of

of company's the quarter. stock-based common million the of during and in charges million decreasing stock of XXXX item comparable were depreciation compensation the the quarter attributable the in value decreased amortization in with included of company's $X.X a associated convertible loss the total expenses other for fair $X.X million price second quarter a to derivative Non-cash change notes, second the as $X.X versus and liability for the Net the in XXXX. non-cash XXXX quarter

As debt of SOFR Antony has original debt and closed $XX one has bears interest than a referenced, until company after close, six issue at LLC. the floor bullet Barings, six The debt with at not The X.X%. of X.XX%, from fully on a an million a facility one was years month, non-dilutive million funded facility month interest-only end term. discount just the plus is repayment year less at SOFR, $XX.X and

facility fee the following upon to closing. notes existing to liquidity we with closing, until equal well months the affirmative a royalty fee to the prepayment of existing the of threshold within interest $XX includes change includes has date $XX XX% royalty as months total payable with Any as such remaining funded US equal negative X.X% Additionally, extended million received control loan loan circumstances $XX.X XX% MidCap payments control depending royalty maturity DEXTENZA either to facility. maturity of repaid amount. installments new fees, company's revenues connection occur XX time inclusive principal change of of a $XX.X the a our covenants debt date net or million a and convertible also to payments, facility the is debt fee, of The facility reduced the three were million the with and thereafter. Barings customary minimum payable the a equal requirement. of This Concurrently of if the to the funded amount is balance as in of debt and million payments

plans, of cash from XX, believe the expenses, million current minimum and credit the the Barings We capital expenses, cash received will repayment into fund cash requirements planned estimate plus of under our reflecting MidCap clinical net Barings existing equivalents covenant operating of $XX.X from the on us and $XX DEXTENZA includes and service credit sales after cash XXXX, June which the to million estimates credit cash borrowing from facility that the the of as outflows facility agreement expenditure and product based operating operating obligations inflows our XXXX. This including enable is debt anticipated cash our trials. in

With the the initiate AMD. new clinical OTX-TKI facility, the credit resources pivotal wet the planned under available treatment first have to we of of Barings funding for trials two the for

of Our OTX-TKI planned other candidates, additional AMD to proliferative first we expenses for operating wet trials initiate for trials expenses for exclude our second pivotal wet the which complete the the for of diabetic expenses AMD retinopathy, two any two planned treatment for until of planned the and planned OTX-TKI necessary we treatment for our intend obtain pivotal or the including do financing. of treatment commence to of trials product OTX-TKI not other the to

company shares X, As the outstanding. had million of XXXX, August XX.X approximately

call some to Antony would I final to like turn now for back the thoughts.

Antony Mattessich

Donald. Thanks,

summary. for we if We over up year DEXTENZA facility same a OPPS quarter, accelerate opportunity in for XX% for insertion. net in to believe November growth our CPT the me opening to the sales before related for $XX and final DEXTENZA million have quick quarter allow sequential growth DEXTENZA for XX% rules prior trend payment quarter-over-quarter. code the the We further call second in recorded questions, So do let

and this first OTX-TKI the AMD in to expecting our quarter wet are in United We trial the year. for initiate third of States pivotal

in us will and for our the debt $XX.X secured of initiate pivotal that runway allow first wet our puts facility have a into and OTX-TKI million We to place to funding AMD extend XXXX.

XXXX. the HELIOS have to quarter share of trial that data We the plan of completed enrollment and first in

in trial glaucoma, in enrollment OTX-TIC the We quarter XXXX. plan data first Phase the of have for to X provide and completed of we

trial. have current repeat we pilot Phase X within a sub-study the started Additionally, dose

turn will operator over I for call the to the that, questions. With

Operator

Thank you.

a session. conduct question-and-answer Our first question is Dane from of Instructions] We RJF. [Operator will now Leone

Dane Leone

all on the launch. DEXTENZA momentum Congrats and Hi. with progress the

highlighted Phase Do I clinical trial could for think specifically monthly of will three design a in please expand popular focus and to your AMD trial maybe you you. how with that for you're the considering with pathway Thank remarks discuss and go-forward recommend protocol at are wet for does treatment OTX-TKI could odds development today X the be investors protocol USDA that per patients specifically. avoid AMD naive? wet the patients treatment treatment doses of on your think that team of running label update your from the Eylea,

Antony Mattessich

feel lot work, we over But can that Rabia a of the it Clearly, over which to can of we'd period to we keep clinical what proprietary time discussions, until pass some trial a I'll further what on talk the initiates. lot hand to over done of -- the for trial the go about of I'll clinical like had design. brief trial in we've to Rabia she to protocol. a

Rabia Ozden

share -- -- Thank The change in with I all, injection for with Dane. four points the those weeks like, of heard, Eylea, is also, three at et I FDA Vabysmo the standard or every on you, on start treatment the Eylea a arm most label the the I of doses. of the designs, weeks can What said guidance. And the provided sham the that, use receives And you time the doses, -- Dane, in comparator. pivotal or dose the Sure. loading of care where recent induction -- will injections example, in to mask cetera. patients depending non-inferiority eight high arm -- first control

we so standard a real bi-monthly provide design far. OTX-TKI injection. using a if all to regimens, there masking, every therefore, does of Instead we non-inferiority risk. is patient that believe And used they a complete do then sham, they or a month to as injections see sham sham recommends longer no that FDA dosing got not be would need able

an superiority could any states be an in have is it to their to be anti-VEGF. -- draft clearly doesn't injection. FDA It guidance design injection, the Now

As long design superiority reached, as endpoint a acceptable. that is is

think show an are actually no we're do design, do comparator arm, LUCENTIS approval, building to et are a that do non-inferiority like, You three -- that's to we of injections, design non-inferiority do what we cetera, that design. plan to instead the may planning own doing arm with and to arm early, use planning we our is label which going to need drop to this, two superiority superiority to superiority

details For now, -- share you. this Does question, going we then can to your this is this going much, Dane? the share to with the we're initiate the the design trial, we're of answer details

Dane Leone

Yeah. of No. lot detail. That a provides

think, I details from into just study. on we of helping follow-up, details that investors might design team not study, of some I maybe we the what the get could disposing the this, allow just one the from starting getting be involvement to you trial the once you of into as think kind guess from go we're full of in, today

understanding, to a struggling where I get little would three are some would site maybe US of who in from it's doses investors someone who just they're the enroll naive treatment patient? think bit loading maybe that's not if clinical a now, right kind the

Antony Mattessich

Yeah.

to key that fantastic with we acceptable superiority -- one, over with, trialists since you were clinical of you three the that course, the we comparator that realized, us at We would a looked was United discussions we give might to design We've of patient design that do on leaders, the, States going single loading importance. the recognize the and and to that spoke some would have three a I'm were two, be US. would believe we perform last we're doses. of allow that paramount What's establish or last, months it sure with, loading had being to we outside but at opinion injection the working haven't clinical US in whether doses, in the safety changed we over with trial superiority designs disclosed working of have

the eager leaders They a key to working first it was and them the that that to in trial were the we in which They're matter able have use very deeply criteria clear comfortable like understood working and of going all, entry OTX-TKI very to we to to was, product was superiority to design US US. work these feel were guidance of have to on with demonstrated opinion market. make very FDA rescue interested What run us. able they be those in ramifications that no with be allowed to trials

So not once to hold -- to induction trial doses. because we'd precisely We're initiate. again, give until just many do saying saying at we're going how not for we're next, at like we're that the not moment the going to what or we're proprietary least the

Dane Leone

so Excellent. you much Thank for the detail.

Antony Mattessich

you, Thank Dane.

Operator

question. for hold Please you. Thank our next

Our of from JMP. comes Wolleben next question Jon

Jon Wolleben

taking questions. for Thanks afternoon. Good me Hi. AMD couple A the from on the wet trial.

the could the identical about collecting to going you're thinking an when I'm be Just and the wondering you're this subsequent formulation how primary, from data first if you'd wondering for you're a that about we seeing thinking data about and be trial trial? measuring as when for pivotal visual acuity choosing be pivotal? design

Antony Mattessich

hand over I'll to Sure. that Rabia.

Rabia Ozden

to are design. forward Jon? after -- to we're going repeat one we the three initiate your when of second with The for options you that design, AMD current going we will draft are the is I in It there endpoints thank for the the our there going start from and guidance, visual you disclose we're clear -- AMD you questions. Jon, listed Can choose acuity. wet Yes. question, wet pivotal the which the part design and use studies, can study

Jon Wolleben

Sure. different electing anyway? here? are if forward the going you guys And be Which identical to formulation then move or second to study is

Rabia Ozden

current similar before, a backup we our disclosed formulation. more this. now -- the, a exactly be the plans now. -- have second to that the as the Antony the we pivotal mean, and are I formulation Maybe have working may formulations, want also, The would going formulation, we Yeah. knowledge with a forward. on And we second design our give color

Antony Mattessich

Yeah. them. choose confidence and from two formulations we in both mean, have have we I essentially, of to

we before in but later or we'll have launch, So will probably a both decision IP make for about material on, so a month formulations. we

Jon Wolleben

And and starting guys like seemed hold like in more off pending it your getting was that subsequent prior going more retinopathy to it now on you're you interesting diabetic Okay. sounds to But commentary, financing. entirely.

year? Just wanted superiority AMD change think this how thinking, study to it well early wet for the all check about as with that ability and design new can you you to next potentially do start you're Thanks.

Antony Mattessich

Yeah.

most open one the lot us, that levels in. current our the And really the becomes is sensitivity now have. priority. we that about a dilution things things superiority in We've with choose talked at investment you number you wet have with stock pathway As to biotech, clearly our the to invest to AMD, US

So we're pivotal. fund choices first to second a course, larger additionally market. our AMD, is be making what beyond about this would you Wet primary pivotal as firm path the of That know, no market. and then much we

I the think we to possibility interesting become have marketplace. a of in standard really interesting, billion global care that an $XX or

our one priority. is that number So

on, not. We're have macular all going vein also that make would time. of only in something we are to but diabetic speaking diabetic we're on later retinal A a But still NPDR, also partner align looking large diabetic a we're not that's by The an that companies we'll extremely and excited decision are about interest whether able to whom non-proliferative at with with lot disease. fund whether a DME occlusion. depends both edema or on and that and this strategics

right other marketplace, trial that things this now, brought of overall the but would as at us. fund could the -- be of well, the we're deciding to a possibilities in number there of and that's drug online be looking So front we're

Jon Wolleben

the Got it. question. Thank taking for again

Antony Mattessich

asking for Thanks question. the

Operator

for Thank our you. question. Please hold next

Sandler. of question next Joe Catanzaro Piper comes from Our

Joe Catanzaro

taking questions. my design and Maybe sort of Hey, feasibility. two everybody. for Thanks on

First follow-up. not. or arms you doses the look patients disclosing you're at whether include with wouldn't I a Thanks. TKI on it not have when back loading and be design, loading we will in disease of know I reason at baseline, But doses both in you I include experience a And why performed control study? would what guess prior with how across

Antony Mattessich

using data have but treated controlled. both question, going That's and clearly, certainly in And in naives a all that to And have aware data we're solution, which -- anticipate are to we relatively have likely we the we will a make up be that to the able been of and the arm, think Joe. who have fantastic future. uncontrolled in we choose data we'll short we've with OTX-TKI order in we previously not one response you answer, that the to I'm great to come

Rabia Ozden

why that's you the way. can I we And out very is Joe, not are the that told doing again, way about we point, And that or if doses. see carefully involved. design saying things. loading we appreciate not you safety. in is three add, loading patient just When design, designing One doses many absolutely top when is we will are to leaders thought Antony's designed with this doing Maybe this, are

the retina good The physicians trial. second show is, the acceptability it TKI at we a that third the And to also the in make States. of is design end -- the to activity the

well. as to give that color wanted Just

Joe Catanzaro

feasibility. criteria thinking in criteria depends there's where setting I when, And of helpful. are but around it using. TKI way vision. That's about But is what but, follow-up, I'm lose been give in on it. some question allowing there, to a the the hope patients the would I of that chance some endpoint thanks. a you to there's got degree best maybe success, rescue in and what Okay, guess, and hopefully primary I physicians of a way I guess discussion exactly comfortable the but relative know difference similarity on I been guess you've a

Rabia Ozden

real-world came for do their endpoint. we it about. did, patient everyone's spend, by respect and what been -- to why think months, safety have it disease -- we we investigators acceptable balance for at That's patterns, ours was is a of end, get hurdle design. to reactivation biggest and process getting How (ph) can I to four in practice in and the I believe that as with the captured exactly and endpoint strike as driven to was endpoint, acceptable vision. we this we all like, Joe. the is acceptable what patients exactly That's and two, the well. are FDA, to This they months exactly have what's the we we mind. that's the guidance the But [food] OCT our, like three I question mean, That's images. design. changes out between FDA's by And working since last

Joe Catanzaro

guess you. Thank my details taking Thanks for I design. Okay. on looking to more forward question.

Antony Mattessich

Thanks, Joe.

Operator

Thank you. question. Please hold our next for

Our comes next question Baird. from Colleen Kusy of

Colleen Kusy

have taking a I trial around expectations And can Great, design trial? with And thanks. please. Good the for enrollment the questions. the you timelines FDA? on superiority what then thanks comment follow-up, you our you afternoon, for discussed the have Have and

Antony Mattessich

Sure. to hand Rabia. I'll over that

Rabia Ozden

exactly the say, to a Colleen, have discussions, several is That's of communications, extensive meetings and not exchanges, now with FDA, also in have discussions, we what communications, from believe acceptable why design And Type the heard different we and several do email with designs C just design meeting, design FDA, believe reasonable -- our we and to we but design we that's and those. FDA, the options. all I Yes, them. should one

Colleen Kusy

you. on Thank the helpful. any expectations timeline? That's enrollment And

Rabia Ozden

this again, our design do it think, key that's and for the we the is this especially population at what of point. should with opinion mean, is reasonable actually I this And for and why going are could we leaders think like, with enroll enroll we that time. trialists, clinical periods under available patient discussions

Antony Mattessich

Yeah.

be we're trial. -- better of okay lesion. I of vision enroll with it And because, it's type patient. for to looking looking naive be a of for we think And than would be would been different I be has has a we AbbVie rather would what We'd had they're very any type with looking patients on their, looking lot know for how around difficult we for. debate them --

population be discussions there's leaders, exactly in much available there So the key enrolling naive a would trial. be broader that population with opinion this in would we our population the

that of would -- are is relatively really enroll expect trial XXX evaluable obviously, this we of power number appropriately. the expectations patients. the enrollment patients we And would And our -- they driver largest quickly. would we are So be able to

Colleen Kusy

Thank helpful. follow-up last us. And from you. That's then

that mentioned a the you would think be design. X similar Phase I second

So think out clarify, that include play pivotal the program you OTX-TKI any of in opportunity? your just how to do would will and commercial redosing

Antony Mattessich

I'll that's you're there's mean, are is redosing The part. last that that's than thing timing therapy. this when an from is take drive it paradigm I disease different going time drug drive, going no for our reactivation Antibodies that quickly present. to PK. thing very takes really to removed and really very, a antibody the The the the eye

important That can and qualities going to today. we of we the necessary standpoint. a not from antibody is the needed doctors there know to be of re-dose redosing really it flexibility use other slightly earlier, to able rapidly by stay the drug to able PK pivotal reasons think continuous of if the said, being they product we the think drug. based to don't delivery that would give more even continuously is like reasons. it dosed just why therapy, an pure the to We're should redosing between nine to we dose though driven commercial I for to trial So XX idea for of may upon the be being give disclose to But In are very months. actually the it's re-dosing be and want the we'd

Colleen Kusy

taking for Thanks our questions. Understood.

Antony Mattessich

Thanks, Colleen.

Operator

hold Please you. Thank next for our question.

comes Shi Kelly next of Jefferies. Our from question

Kelly Shi

for whether discussed baseline criteria, the as And, this characteristics, same Phase first you one? design trial I'm regarding US similar Thank second X the it you front? my to with taking more you. enrollment And, the secondly, of is wet curious trial on the the questions. patient FDA AMD trial? has Thank patient have

Rabia Ozden

mentioned, just design FDA meeting pivotal why the pivotal -- our as soon. the the FDA details, design. first -- with Phase design a we eligibility, your we all going would current with like X are the trial. And the disclose the around provided trial several us discussions, and similar to to that's intention second details trial, at The FDA had found the of initiate afterwards, after our communications, for to -- whether eligibility, we is point, they like, design, design last would for be, we Again, it trial, and initiate that our be now. our this discussions trial. reasonable first highlights pivotal the US those this would same And, this as That's I question

Kelly Shi

Thanks.

more Looking details. forward to

Rabia Ozden

Thank you, Kelly.

Antony Mattessich

Thank you, Kelly.

Operator

you. question. hold Thank for next Please

Our comes TD Tara Cowen. next of from question Bancroft

Tara Bancroft

good Hi, afternoon.

in these patients So going be can is endpoint primary of time what And that in treatment patients, many do typically point in to hoping, the get naive you progress? I'm how run that I dropouts said, measured. how was is. patients because being time is when say if patients Joe this amount the injections enroll I'm And convince for Dane asking to endpoint trying you'll and you'll idea, get like, primary an to and how trial the control

Rabia Ozden

you Yes. for Again, the Tara, question. thank

you those of discussed we Some is dropouts, the criteria our you top how physicians Again, et patients. their you durability also will you design the there. clinical be and the But but being the of and And patients this this discussed and to with enrolled discussions would when criteria, to clinical eligible when the all acceptable things retreatment the it and they cetera they and design That accepted, would to I extensive trial. single answer would Because patients, criteria, details with of the why I the that say retina trialists our with have, said, injection. an have study have a all confirmed see design and loading understanding patients design the see be them or this get -- is trialist. they this can see this, acceptable to design, in may be the we TKI with doses not, to not durability versus the this see for a because that when again, we design, patients. when and design

Operator

question. Please hold our next for you. Thank

H.C. Chen comes of question Wainwright. Yi next from Our

Chaitanya G

Yi behalf of Hey, everyone. Chen. Congrats is on on your Chait progress. This

one evaluating eye program? dry TKI. then, And you during comments Just know pivotal second study on ideally initiate you When DED. a disease the study? on would the disease, eye initiated on one dry any quick a that I you indicated small to the like quarter

on you. helpful. comments So be would any Thank that

Antony Mattessich

to it? you handle want Hey, Rabia,

Rabia Ozden

a for dry to programs. going with TKI. start I'm ask They for because clarification Maybe eye DED, are Yeah.

two X placebo insert, and proper Phase the we eye we intracanalicular than programs need statistically a Phase what have DED, we in in why dry although have programs stayed we our canary both not showed X that statistically actually like a insert, insert was because in significant. seen, We that's be, placebo inconclusive in in well, sign, and really CSI the was course worked symptom more expected. significant And -- our

is dry three plaques review actually, for more a is in like, collagen doing arm just, What that a to then, like, two we eye use to our completely placebo, your didn't in that want We life be that pivotals, the pivotal would gone, completely running because, five up short reason well. both, de-risking and did days, And would very for trials. two they come small actually. days, issue sign that like proper are now the we to with placebo really answer trial like, program? trial in our question, hit to start Does And to we our before that the pivotal a like really, Yi, symptom.

Chaitanya G

Yes. Thank you.

Rabia Ozden

repeat you your can TKI And question?

Chaitanya G

study. ideal second for pivotal the The timeframe

Rabia Ozden

-- the from to dependent mean, trial finance this then as go of trial you partnering like the second. financing, The we start processes really heard our the we or on start along, we first. would And other Antony. would -- I then And, the

this do trial, trial, second first we're get going add this? more you you starting we we For inform to to that. are then to want when and now, the Antony,

Antony Mattessich

see able see trigger on give and time the to understand patients right us the is to what committing it But commit discussions we're be I to trial We're we going expand to (ph) from -- the important the to be pivotal. funding that could other we're ready, learn how to note trial. a of help it to trial. -- But the of initiation how doing think not from appropriate the material] to funding the the we're of we to second the is lot that learn first this from until [trial lot that we pivotal enroll, the into quickly it's a would to a we're to time initial can of mask moving, be until confidence the standpoint going after with pivotal. that going pull second do going very have data, which start But how is data sources the yet. us lot would in able first the a trial learn see a start initiation when to to not trial, soon are after by second

Chaitanya G

lot That makes you. much. a Thank you of sense. so Thank

Antony Mattessich

you. Thank

Operator

hold next our Please you. for question. Thank

of Berenberg Capital Our next Markets. Caroline question Palomeque comes from

Caroline Palomeque

Hi, good afternoon. taking I'm just wondering -- if my thanks for question.

Just past, the the wondering then trials confirm know also was on said the two numbers. pivotal between you it estimated of the I and could but guidance in $XXX million, cost if $XX somewhere I million you different wet AMD. seen had some

just Thanks. on Just that. you wondering could if comment

Antony Mattessich

approximately been The $XX trial. you. number we've is Thank million per quoting

to million So $XXX NDA filing.

Caroline Palomeque

Thanks. it. Got

Operator

Thank today's for showing at time. questions participating. this This conference. I concludes no am further you

You may now disconnect.

Ocular Therapeutix (OCUL) 7 Aug 232023 Q2 Earnings call transcript