OCUL - Earnings call transcript Q2 2018 | Ocular Therapeutix, Inc.

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Second Quarter 2018 Earnings Conference Call. [Operator Instructions] It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Donald Notman

Thank you, Ashley. thank financial joining conference results and second on call. everyone, XXXX quarter and afternoon, you us for our Good business update on financial results This providing the quarter programs a issued XX, for details the XXXX. June update and company’s afternoon, development company’s the press of ended product we an release be the release Investors The our of can press portion accessed on investors.ocutx.com. website at and Officer, Antony upcoming who today call President our the our Mattessich, corporate milestones. will of clinical be developments provide will Chief Leading a summary Executive and Scott DEXTENZA. Commercial, update Corning, will then on the Senior Vice our President, provide commercial an plans for

Following an XXXX highlights before financial I summary to Scott’s of call for the a remarks, over back will overview of questions. turning quarter Antony provide the second for the and

will our Technical be Michael and Bollag, also Dr. Dan Quality; Dr. by Senior Chief of Operations. our Senior Hanley, Officer; Vice we Vice of Goldstein, our joined President and For President Regulatory Medical Q&A, Kevin

making today’s company’s forward-looking As Act the future those indicated during the safe report Reform on a Form Actual forward-looking a and may we materially Various including expectations, about the remarks statements today, certain statements. our recent quarterly these plans reminder, under the of X, Securities prospects Private of call, during SEC call harbor the purposes that most of with Litigation differ constitute August XXXX. of will Risk forward-looking make XX-Q, this for we statements provisions be in results was as various discussed by from XXXX. result those factors, important Factors filed section which

representing date. not and as only of views any be subsequent our today represent statements forward-looking as any relied as upon views addition, should our In of

our some the these over change. disclaim we views to call forward-looking we update if Antony. I do to statements to specifically While so, now will the point even elect turn in at any obligation future, may

Antony Mattessich

NDA the XX the important is months followed on pleased are date tangible FDA, by quarter. transformation and underway ago, is resubmission progress significant given began Most acceptance we I’m By XX, process, agency in is Ocular seeing that most of the to far The a which our of Donald. the second the which of well Thanks, report the which has December made by the PDUFA of for the importantly we also announced July filing DEXTENZA XX. formal XXXX. results.

requirement in be As clinical the the additional on efficacy. believe letter outlined a previous should DEXTENZA response or remaining we safety a data pre-approval for the reminder approval sent with inspection. successful complete issues Consequently, no for requests on CMC exclusively critical most for

quarterly we We all has As that have also to to earnings the the for and ensuring mentioned improvement and in production prior accomplished upgrade through a and our continuous already calls, objective of adequately fully market to a addressed previous oversight plan. from inspections inspection believe and observations our approval. systems overall fully XX strategy our quality ability supply upon and the been systems the production quality demonstrated successful

we have that await the planning moving a in benefit of the on Thankfully, the of the half of launch from we execution As work U.S. we’re DEXTENZA. of done inspection, first start running XXXX. to FDA was

the such reimbursement and in small near-term successful profitability. path can a company opportunity believe as With taking of be maximizing a building we experience from positioned, assumptions market the well competitively resources we’re to previous from and revenue a potential, particularly the while marketplace Ocular integrate a with into insights product learnings question target our the However, is to space. recent ophthalmology in product that

options we’re capital. are finance adequate its It securing resources the fund always future to with at to biopharmaceutical obligations remember its Like to business a and as stage, year Vice collaboration to sources steps to hold is we’re that from that company appropriate believe over equity launch of phase resource important As ensure this next forward, most are pipeline to we are the approval companies forward. royalty we’re significantly going growth move company to of from to while moving our dilutive offerings, prepare near-term partnerships forward, financing taking DEXTENZA. most aside launch of options we financing by the DEXTENZA. Corning, planning I’d exclusive to to expand working with commercial the story moving we significant likely turn positioned to Along optimally we Commercial like Senior has pipeline, margins. unburdened to an gross for We our President, at for high execution, available DEXTENZA a for evaluating additional the continue revenue achieve the of use non-dilutive. company now Scott end to call options looking we’ll before of both development, mix the and that creates Regeneron, and rights worldwide entire we an Ocular discuss royalty and commercial

Scott Corning

Thanks, Antony.

for being that As an DEXTENZA to drug you treat a up days a with believe XX is DEXTENZA patients post of administration. dexamethasone approved many physicians. pain to is patients insert We is for single developed the transformational of with both that know, potentially intracanalicular surgical and asset ocular

replace This post-surgical convenience would drops. care delivery offer under that insert. patients, require up XX a treatment novel For standard topical a eye complex a the steroid would single full steroid of of drop of to could a the ocular means course regimen current in DEXTENZA

an years. a Phase safety efficacy first met comparable profile in its post-operative that toward treatment the DEXTENZA nearly primary for studies For with placebo. pain step physicians this to patients X,XXX of surgeons endpoints our droplet of which represents realization X several surgery, wanted important In have

non-compliance all. understand understand practices in And if market is the which opportunity the million ensure topical anticipate understand a DEXTENZA. solid both issue and use are of ocular inserts surgeons we delivery, address surgeries, cataract prescriptions the with initial market as confident commercialization, DEXTENZA given ocular to ways remain and punctum substantial. potential and chiefly a a is a year With well the and we clinical to to approach adoption for of perspective, written familiarity importance with from for DEXTENZA. for plug. drops to site in canaliculus alone of the U.S. place X train the as a administer the reimbursement with we potential While of reimbursement subsequent to properly, how area their to novel generally strategy drug employ the of to a have know successful inability physicians steroid been due treatment Notably sampling. a in from We surgery launch DEXTENZA improved these We majority need the approval clinicians at the and over patient’s looking drops for

We and also continue medical in and up after engaging ways to are leading we look to payers dynamics launch. societies optimize to key at reimbursement

intend the underway. on efforts, we do required our commercialize is in execution build our note out and final on a commercialization own well As U.S. to the and DEXTENZA for planning

on confident the calls. to the talking Importantly, for Antony pipeline. successful needed and we for update that future on more clinical look now call forward steps will plans the we appropriate in made turn back the to our understand I over feel we a about have an progress launch commercial

Antony Mattessich

using a The customized of that pipeline. our those Behind with these preservative is we offer potential multiple by formulation delivered back products on or hydrogel in the technology can in is significant candidate our today. and of believe ocular of as over proprietary designed a we Each front the long Along OTX-TP our currently over DEXTENZA, clinical diseases intracanalicular on existing developed three patients targets for acting progress OTX-TP Scott. and trials the to advanced months. most that DEXTENZA, the glaucoma release produce angle advance free that drugs of an market X being product eye. formulation the platform cost as drug primary pipeline continue products benefits hypertension. a both treatments with to asset Thanks, of drug insert Phase is offered is is ocular clinically trial the treatment

with XXX the compared three time patients six measurement efficacy following of and placebo with is of two, weeks The XX first reduction endpoint primary X baseline points being enrolling inserts of pressure at three Phase insertion. statistically a diurnal from days OTX-TP trial each currently at superior IOP intraocular or to approximately

to anticipate continue We first half line top XXXX. of data in the

will Phase of patient trial, a multicenter OTX-TIC the trial implant a data clinical an injection study as in This biological deliver long-term The safety provide on of current Phase trial, dose are reduction. open-label our an one dosing open-label as of the are of travoprost-containing tolerability OTX-TP. X safety, also we is will program. included announce open-label dosed product basis bioresorbable, to This as durability ongoing pleased an X our designed safety escalation glaucoma study is higher we delivered part is all ongoing evaluate announce be Phase to addition have X trial level activity of program efficacy, in well our able assess We quarter. the OTX-TIC. repeat last with via to second OTX-TIC patient IOP for to it first extension will perspective we year of In additional and patients. a the an pivotal development. intracameral hydrogel first safety This U.S.-based in administration

results rest to of continue initial first will expecting XXXX. throughout We data in the to collect of the the half year have

eye. the of back the to Moving

dose patients fiber injection OTX-TKI and trial expect during OTX-TKI. by to wet anti-angiogenic a Phase first to open-label intravitreal for multicenter with a clinical our Age-related patient bioresorbable, in implant is treat with We retinal Macular escalation quarter third Degeneration delivered properties the other developed X diseases. being dose hydrogel

upstream of ability PKIs an therefore inhibitors a TKI deliver Preclinical act of of broader OTX-TKI extended up using have will and have reminder treatment coherence the The retinal an data tyrosine a demonstrated dose and durability, and Phase activity. X standard to following visual or months. optical duration over the anti-angiogenic thickness a segment posterior and tomography. the for the VEGF-induced by VEGF for test kinase the of to biological measuring As trial leakage eye efficacious acuity retinal may to safety, tolerability activity XX time evaluate of of

OTX-IVT, aflibercept developed Regeneron. AMD sustained-release is as in Eylea for partnership being or that Finally, with currently trap diseases of the such a is wet VEGF of treatment formulation serious retinal the

details collaboration But with of comment would have results. this who like with program any While contractually call to we the the very I we the working state pleased at are financial well Regeneron that second is been and time. Donald, review we’re cannot XXXX period what can to turn our back in over of quarter together. on teams say the officially we the option the will

Donald Notman

Antony. Thanks,

our summarizing by begin me Let capitalization.

common benefited balance million XXXX, end in $XX.X losses cash under the of quarter company’s $XX.X stock during million versus cash of generated or second capital XXXX from agreement and at the payments first net million million ATM we sale As with cash $X.X quarter and the million. $X.X debt in of quarter $X.X from the proceeds June equivalents had of the million, expenditures quarter. net of the ended XX, principal $XX.X the The offsetting sales the of inflows during ATM

the is As cash additional this equity as be QX, continue equivalents under of ATM existing expenses, the our that forecast and of will remained into opportunity will This on million of believe million to fund of cash Research monitor appropriate available we other we and under clinical sold Based to option sell of XXXX of $XX.X and facility. about capital the current expenditures programs end subject plans of the and to for associated business. were an as obligations a million as aspects payment and expenses an technical to service and operations quarter $X.X debt development exclusive $X.X $XX increase quarter facilities number compensation expenses second potential million our course with second development from quality quarter additional primarily operating Regeneron our the our of expenses, assumptions of partnership. the in in in departments, and additional as launch million DEXTENZA. for headquarters. space and the reduction XXXX. expenses costs XXXX XXXX and for associated with quarter of hiring the the versus reflect second compared the in second $X.X lab at in our the same activities well to decrease a increase corporate quarter the plan as result significant relates were delay of marketing to Selling for a This million pre-commercial $X.X

related of XXXX. for $X.X in of quarter expenses stemmed were and defense in administrative costs of comparable primarily to $X.X million expenses second in from quarter million the general the versus The the increase increases legal Finally, ongoing XXXX, the period Revenues were increased for units by second $X.X of XXXX sold. totaled reflecting quarter million and the same legal proceedings. compared $X.X driven million ReSure in for an exclusively principally number Sealant with approximately

net revenues noted shares And call With the would of concludes This June do not to product as for financial issued or The outstanding ended currently our to we not XXXX. net XXXX. second quarter quarter loss to June material second XXXX. approximately and to share the loss for back of and $XX.X same stock-based XX, included depreciation million $X.XX in my in compared XXXX, compares non-cash for quarter the for financial past, summary $X.X respect turn of results. net support a a XXXX. this million the of XXXX quarter second or to $X.X XX.X for on million are $X.XX As of XX, Antony million per period loss for expect the ReSure million share comments. comments some to same results in charges had in of $XX.X the we compensation reported in The promotional a per company and a I we loss be providing for loss like

Antony Mattessich

Donald. Thanks,

Before for opening up to the questions the call second company quarter. for highlights recap the like I’d

We and XXXX inspections. awaiting XX, NDA are pre-approval date for of DEXTENZA, received the have our December resubmitted PDUFA a

planning continuing launch commercial on launch, funding We to dilutive DEXTENZA augment to and of while DEXTENZA U.S. and are of the will moving develop sources continue us to to optimize from the that execution and pipeline. allow exploit non-dilutive

of Phase on first We and results our are first the in trial completing for the OTX-TP expect enrollment pivotal X half XXXX.

OTX-TP. for open-label also dosed have safety study we first in extension patient our Additionally, the

both OTX-TIC Finally, on for Phase for we’ve first of our OTX-TKI. progress our X in-human the of first and dosing the our programs initiation patient in with made trial

time continue and validated to to them. that pleased need The We accomplished stakeholders a have our the our on have establishment demonstrate XXXX. experienced PDUFA we are we are for of progress produce achievements and we encouraged critical first externally with of will the for DEXTENZA resubmission date half transformation Clearly, to to were internally results.

the team opportunity significant open priority, of up of line execute. to forward understands the pipeline that be the can While our should as for top demonstrate ability as continue drive will to DEXTENZA questions. We appreciated we approval we increasingly our now a

Operator

JMP. first question Our from Instructions] [Operator you. Thank of comes Donald Ellis

is line Your open,

Donald Ellis

you. afternoon you, good time. I of one Thank at Thank questions two guys. a have

commercial us versus what question you percent CMS? First regarding the is U.S. of the can markets cataract market, tell pay

Antony Mattessich

we’re go of Medicare that area. cataract the is the more Medicare at initial so I which is Medicare appropriate would after it’s to think that total think million head we the that’s get would about cataract look the number of are markets, a going to XX% and there’s area in Part D, really them X XX% what we first Part what first, yes, really we year, about And the million D. after an But so is surgeries that X reimbursement that’s the so as Part D. of total cataract about is

Donald Ellis

Okay.

XXXX. that for that applying that process a opportunity? by market granting of January something How pass expand is for an kick then through target XXXX? what that’s a in so status your And would the would And about

Antony Mattessich

ahead. on What the actually we’ve But it expect I’ll discovered the do they of we through pass as motion how the answer works. short from are Scott, play is, But Corning answer give at XXXX. the a the state changes before moment. do bit of the mechanics have about But is in end the you yes, of he’ll recently Scott questions – that. go

Scott Corning

a July would apply be which FDA hopeful allow the be status pass Yes. available of And March approval. that payment through first approval possible would the to year end for X this for by XXXX. would With opportunity, the at transitional us

PDUFA and end XXXX to we’d follow C with the launch of of the thereafter, at code it year a application code see of date So the possible C could and year is a potentials. half have we then commercial midyear approval

Antony Mattessich

accompli. was administrated get the into pass way not DEXTENZA through and first, is. a There’s won’t options fait but of We opened that given number could DEXTENZA through But what are under details definitely this on options curve. be larger be be There is that us we that a available to shouldn’t might the that area considered pass other – do have will there. we it may the

Donald Ellis

Okay.

So understand sure, back I’ll to in queue. just make I the go and

roughly of So have for cataract far goes? you’ll as reimbursement XXXX, as access XX% the to market

Antony Mattessich

Yes.

that’s think to true I say.

Donald Ellis

Thank you very much.

Antony Mattessich

you. Thank

Operator

Our of next question comes from Butt Adnan Guggenheim Securities.

Your line is open.

Adnan Butt

the seem Antony, on for reimbursement have period Thanks. front extended an sense been pass strategy through. the to

saying give you would able and us strategy? reimbursement you when mentioned an through today only reimbursement call to about is the about are details details Can option. you pass On option, be be or us now may the some but you not some that give the learnings

Antony Mattessich

for is. end of think too color drawn don’t a bit. want pathway adding into of the I deep certainly conversation the that the able Thanks on optimal will of give to last we we But be little year. of be before that what about sort to lot

So what before get concrete pathway give for you standpoint. the we approval we reimbursement expect is updates to about think pretty from some hope we to optimal us

Adnan Butt

on about Is target, the still if even through is that side? not pass initial the How code target? J a necessarily

Antony Mattessich

have along that that we of code the used that we Grail own are should kind I J but some we That’s cases, is expectation. – But essentially that Holy have the code. pathway with to the is mean, J right. reimbursement our clear that the gearing associated do a office-based to most that product things with the today. secure in J toward, and goal procedure our we We a cases absolutely shot believe given really our at where is think it’s what is

Adnan Butt

to scheduled? does done once Good soon too the to portion or for itself. then part on have time. it accepted see inspection to inspection is final communicate expected filed application the review review and And FDA it an review. the of CMC the be as the on separately question to Is One get

Antony Mattessich

over sort Dan first it to haven’t expected but we had is, to… today, of you talk the as already about the the it one answer it inspection. But short would of I’ll it been that as Yes. early PI, it the can – With the Bollag, of for hand to passes it the very want have day Dan grows. likelihood But each is process

Dan Bollag

Yes. Antony way that with summarized the concur it. Sure I has

the within into unusual now second certainly think months first it in of that review I be inspection our possible, an certainly But cycle to we’re is couple reasonably would have month. time. the

FDA be would about the subsequent to clear will of we None findings. the don’t about would public path that So that have out close the that really let know itself. ready stage us when the is fact we’ll any provide inspection, and those findings What actual up. at in shows the we’ll occur FDA is, which approval a undergo just meeting at

make So But many a material, too after and position in I we’ll that. be critical something the to at think we’ll certainly see there’s be we’ll have doing of how to the communicating rest that if extrapolations kind to be difficult of proceeds that’s stage. obviously review

Adnan Butt

pipeline. just on one And the

TKI program, in XX think out I months. to mentioned For potentially long-term the today that the durability past its or you’ve

update So how some it be X, Phase should update of the is than XX something long an that. sooner month expect type from before we could there or a

Antony Mattessich

a in be vasculature able we we’ll chart see treatment to the those to describe. yes, know don’t result have position to be of But have of As to to to patients activity the when drying be at OCP patients But the we’ll using mentioned, should is see you exactly that. the that of wait in in the that. effective that’s to we up We Phase to duration soon, know happen a it will How it’s studies the able full of know end before the X. the don’t if We’ll won’t trial do will wait it reaction, don’t the need case soon. that till relatively the done trial that the drug, describe open-label I period able moment. be the you for We the [ph] drug. efficacy that the being in biological

Adnan Butt

Thank Okay. you.

Operator

Yi Wainwright. Instructions] Our of comes H.C. next Chen [Operator question from

Your line is open.

Yi Chen

My Thank questions. for clarification. a is taking question you my just first for

As do work of or today is the need for before little to manufacturing more a inspection you facility up? they show bit FDA ready

Antony Mattessich

was wouldn’t ready filed didn’t We it for if have inspection. we believe

So yes, it is ready.

Yi Chen

great. Okay,

plan of expect expenses see and Second marketing questions, a we in this commercialization, the second for can the sales as half XXXX. you in are – the what to year and likely

Antony Mattessich

those sort I to think of premature a going it’s highly be. of is sort I fair But think little we concentrated numbers to a to this are say, announce it’s think we would footprint. D we centers market go of would quite fairly those first percentage able where we the and be Part with like to Medicare know to that patients cover then a what

it see huge the like the you’ll big that one be likely rolled It be centers success of we expense So will bang be in will a will that hire where the team. numbers see we into target. won’t we that

of numbers significant the not in seeing expenses kind would ramp as now. the step any you’re will along, year in the a but that So way create goes up change that

Yi Chen

Okay. Thank you.

Antony Mattessich

you. Thank

Operator

in And questions conference. for gentlemen, and further you And conclude Everyone with you day. participating have does ladies today’s disconnect. the a program. all may This no great in thank queue,

Ocular Therapeutix (OCUL) 7 Aug 182018 Q2 Earnings call transcript