OCUL - Earnings call transcript Q3 2017 | Ocular Therapeutix, Inc.

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Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to the Ocular Therapeutix Q3 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. pleasure Financial the Officer my Donald over now Chief Notman, of is to call turn to It Ocular Therapeutix. sir. ahead, go Please

Donald Notman

on Thank release quarter everyone, us on afternoon, Earlier and this Vice business you, will you provide issued call. update Chief Affairs, operator. Chief joining be developing a technology. Officer, on we of ended release development Goldstein; an will provide provide Quality progress for press who corporate company's update and Dr. update on our Mattessich, conference update our on investors.ocutx.com. an Mike President pipeline financial manufacturing and the Pharmacovigilance Dan and financial accessed will while clinical quarter XXXX the can of thank summary developments. based and our press Medical results Bollag, of The formulation third of afternoon, Officer President will our results September providing and investor Dr. systems, details programs Antony our XXXX. hydrogel Regulatory website Good the company's the Senior and quality Leading product Executive today XX, portion a that the Our the be for recent at in an our call from our is

of before open the we Following his questions. remarks, the I'll provide an overview XXXX for third call of the financial quarter highlights for

Vice Scott our by For joined President Marketing Q&A, and we also will Operations. Corning, of Commercial be

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

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

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

Antony Mattessich

in Don. earnings we've you, been exceptionally Since Thank our traction working last three areas. hard to call main get

team third the filing business new expedite CFO update building to of three Affairs the affairs build is have am with receiving of all incoming testing team. capability clinical you DEXTENZA, a our Michael new areas starting Goldstein; and first like in a excellence and and to development Regulatory our with on technology, deeper advance Quality myself formulation is of our the is that in Bollag; a The the we now delighted CRL Dr. Notman. in and biopharma Since CMO development, the progress of CEO, I along areas a Dan quality. new Dr. [ph] to in operations, these Head pipeline second building maintains a in and the Donald of regulatory as our while July

McCarter we and handle our Counsel General be Sparks the the have team consulting business have of addition to with permanent arrangement Jon long-term of & Intellectual In [indiscernible] corporate of Property. engaged, to and English to members we also and a Head development, External

our we additive and able the of in the team people biopharma added and a the are and about Ocular. few has All compromising future. that team formulation operations technical to quality have have for of closest experience and confidence those fit truly we have go still has quality we We in can the are something the industry deep who our without before the areas of to belief been truly capabilities. to The of says key has new been transformation retain the attract been hires

appointments making near be future. the to in those very expect We

of Quality. new One priority accelerated where the years new at Head headed chemical oversaw Bollag, and the two crucial is for hires Pharmaceuticals, and been affairs over really XX most has review the Regulatory of entities last Dan most over five regulatory years. approvals Dan up these of Ariad industry he recently in and the quality

the you Dan? are is DEXTENZA; know imperative Dan we Ocular, let think approval our how best immediate I to most for tracking on an person at getting

Daniel Bollag

deficiencies our letter complete from making response you, observations earlier related worth from July, Maybe been Anthony. while referred noted the XXX inspection oversight. quality outstanding to know let receiving Since Form respond that to you manufacturing the working I the improvements FDA to process Response in Letter recently the to mentioning in inspection our observations and to of our has this in the provided manufacturing Complete FDA responses final the only team pleased am the Thank pre-approval our a to observations. hard year. we've that also

also to a put with state will our quality and along increase the the which to plan of our Master DEXTENZA. we During our upgrade detail we've control project time, commercial manufacturing capabilities. staff steps systems preparedness train efforts particular manufacture created taking processes transition are These improvement this a for further in enhance plan concrete ongoing to us of better to steps a and and

at Based our January efforts that requesting be the FDA XXXX, a in with a to on received resubmission occur well hope of able and the half our we plans meeting which such meeting NDA in remediation will resubmission can early the to submit in additional prepare FDA describe the and timeframe. first We dossier will ideally from we anticipate feedback manufacturing data runs, being as XXXX. meeting as we that

prepared DEXTENZA But personnel for rich strong of receiving our after letters. support it systems behind is need recognize well forward also we sense Ocular not manufacture but able This but to that promising response a with make this working it are critical pipeline we and and to in urgency are also moving oversight to manufacture. to how an keep commercial We is to the important ensure is complete Antony? the obvious perhaps only processes, two as asset. speed, be mind are support to statement and

Antony Mattessich

Dan. Thanks

forward is applications has companies. term or While imperative, and the near our immediate by is DEXTENZA and in intend pipeline. current important potential multitude that partnership and to it of most with development platform of origins ourselves no our The more hydrogel we other bring either than a

We of CMO. practicing he stage of a pedigree, the best to but person academic. long has are have has biopharma our taken and is Mike? hold walk clinical Michael as and Goldstein pipeline. he He very current also Mike a that pipeline the fortunate to through stage ophthalmologist attracted the you is

Michael Goldstein

the It forward and potential and honor with great patients. to Antony. working the delivery I is platform for to acting Thanks to benefit transform Ocular really join exciting, The the look a longer Therapeutix pleasure team. is team hydrogel to drug

OTX-TKI OTX-TP the has release two is OTX-TP pipeline products protein ocular insert and daily DEXTENZA primary patients While also two and glaucoma drops. months from hypertension, our over to much This difficulty of punctum. a OTX-TIC on products includes for been ocular and with glaucoma anti-VEGF focus company's long insert to targets Phase treat depots and diseases OTX-TP mild in program opening to of X of This with diabetic glaucoma hypertension. and opening macular trial inserts with first and needs meet for hypertension, retinal moderate in with of travoprost our degeneration, one currently such acting clinical occlusion. glaucoma and designed macular the age-related vein designed with hypertension. delivery OTX-TP three ocular retinal travoprost a edema unmet treatment of patients drug is long as the of to acting primary biggest ocular and OTX-TIC the enrolling are both patients treatment for compliance

with of enrollment subjects We and pleased patient remained are targeting XXX the of enrollment.

superior following statistically AM the three pressure primary efficacy weeks of intraocular XX weeks. These the point IOT insertion. include to X, compared is superior points X at reminder and reduction As end each X time of at statistically OTX-TP and these X XX with AM, diurnal baseline placebo PM inserts from a of at reduction

will not approval. addition, regulatory clinically for while the also points to In primary IOP reduction need meaningful a be end

be data the approval. and We complete trial that in for be expect it necessary believe X will from topline regulatory trial second available XXXX to of first half to X Phase clinical a efficacy second Phase

needle Phase While via we previously XXXX development bioresorbable initiation hydrogel second guided a strong we now plan, XXXX. have are second depot available making progress parallel in allocation intracamerally of the the In the which X Phase fine towards travoprost-containing of is gauge a to delivered OTX-TIC X on this of end initiate injection. the to of funding we subject by

animal intraocular in pressure of to OTX-TIC pressure glaucoma. have for humor. to models good severe the address studies clinically are favorable the Preclinical intraocular safety, to a developing for and have patients reduction need meaningful level higher in pharmacokinetics months demonstrated aqueous in four who moderate reduction up We

up trial ocular a the and clinical evaluate patients hypertension. XX States. We travoprost of in a designed primary safety angle have to pilot tolerability initiated study study with single-center randomized with sham drops to double OTX-TIC masked United or OTX-TIC perspective This outside human is to the eye glaucoma open controlled compared efficacy

indications. OTX-TIC safety If IND We of U.S. multiple plan efficacy Phase program. in a first to are clinical conduct a the center X in promising, quarter clinical evaluating a the results in to tolerability from also the trials we into XXXX, patients OTX-TIC to advance the the same plan of file trial development these and

retinal eye by to Donald, expect treatment testing diseases to with depot and tyrosine the of VEGF a back turn an to we the AMD nature VEGF first deliver or over to for up Eylea bioresorbable to which intravitreal is targeting to innovative back it trap, induced OTX-TKI, of the eye, well partnership efficacious for good speaks who'll extended duration third progress posterior Turning kinase review for Pre-clinical properties, other Intravitreal would to half VEGF, the inhibitor of to of our fiber our technology. on aflibercept, XXXX. sustained formulation results. our X quarter advance to efforts, dose release program inhibitor serious enter as to the the depot have the a such I tyrosine containing call preformed with Regeneron protein-based continue we value of XXXX in also our hydrogel Regeneron, our treatment the the continue ability delivered Phase wet believe partner, our as as of we leakage TKI financial retinal data now make the OTX-TKI biologics, six like kinase with Along of anti-angiogenic months. of development segment demonstrated injection. of clinical We

Donald Notman

Mike. you, Thank

with XXXX. We company's recent equivalents. as our in by as cost facilities cash of summarizing the as programs, development shares $X.X to initiatives the personnel we The enhance other operations delayed had of had outstanding, XXXX. million XX, increased XX.X associated quarter of QX, $XX.X headquarters, day. surrounding and XXXX, of time, with third quarter was cost to September restructuring compared begin million supporting of expenses that reduce cost, approximately August impact launch, and company DEXTENZA that associated cash burn our and ongoing due was me and million during operating in relocation third of At in increase of With our Let announced capitalization the to in million the associated the with million issued for $X.X respect to the XXXX. operations $XX.X cash and

as to expect restructuring. realize expenses of a we forward, savings result in operating Going the

of in quarter net expenses, subject savings, $X.X and believe capital million expenditure a compares existing and quarter quarter selling, third the will third increase of XX, stems quarter personnel $X.X compared loss reported expenses. were of approximately With These the the of decrease and cost these a equivalents and cost XXXX, in a September significantly the and over XXXX XXXX. $XXX,XXX XXXX we've the the expenses clinical million $X.X the cost, of several loss space, of September share of cash debt is and course operating non-cash respect the of in DEXTENZA. cash third ended for facilities ended corporate charges as Research in third million to and of XXXX. loss administrative included This million on ended requirements $X.X ended and to quarter costs number a for expenses, increase aspects XXXX. compensation September of XXXX non-cash business. $X.X were forecasted quarter $XX.X for of expenses quarter fees our marketing and in our programs increased September $X.X we lab quarters. per depreciation, Revenues activities XXXX. million cost financial ReSure anticipated quarter expected quarter at compared totaled Sealant. of into as charges to based launch and loss from million, to million third ended XXXX, Selling net primarily increases assumptions sales in service to XXXX, to expenses quarter reflect XX, current results increase compared headquarters. XX, XX, million XXXX. our personnel million, development in plans our in $X.X professional similar share. from and that XX, largely The of and an This are per with the about fourth other expenses the General for obligations based of This in compared and planned The With for $X.X the net of of for quarter the for fund represented for comparable or pre-commercial development were for $X.X marketing $X.XX third quarter million for the to stock facilities or September the $X.XX preparation loss a expenses for the the next to XXXX, associated

past in we my material of don't comments from operator, ahead would call the so to the financial product can ReSure your the now This the results. XXXX go turn third Sealant back I quarter and questions. sales be we to noted to in over on take As like revenues XXXX. concludes expect

Operator

Butt [Operator Instruction] from Adnan you. question's Thank Guggenheim. first of Our

line Your is open.

Adnan Butt

taking welcome. and for Thanks question the

plant could addressed in items would you the response expect DEXTENZA, on outstanding the seemed to all FDA First - could you the needed? tell at it but us that's what that your re-inspect like, are confirm you and if if point

Daniel Bollag

earlier question this Adnan. is point Response your our this Bollag. is dossier At this Dan received not Complete Yes, review thanks, Letter we I under appreciate our since year.

a would our to expect I So, we resubmit after occur re-inspection dossier.

half As that first I is so after expectation to of do receiving indicated likely application. XXXX, the that would FDA and our in inspect resubmission the

Adnan Butt

studies perhaps the successful So, on these some can had few on for shed data companies time. Dan, line - some you

the So, what's January the meeting NDA? the rate between then presumably in limiting step and refilling

Daniel Bollag

Yes, thanks.

there manufacturing we So, to of confirm of are will streams activity inform consistency. that concurrent number executing some and additional are kind which runs all

as improvement a We are plans, executing on a a as couple particular of plan. reduction plan quality strategy improvement well

us we information and receive feedback that we we terms FDA, any at between be make of that from feel resubmission. the so, example And that ready for meeting in will that to will when guide

So again, that to be out as can more have occur. these read activities around able are when will ongoing they submission precision and

Adnan Butt

at DEXTENZA's plans of studies there are to terms in and opportunity, Okay, any DEXTENZA? with time this additional conduct are

Scott Corning

one eye of continue Adnan, The Corning. studies Scott as as has well is it's you this as when timing some already know we of dry pursue to won't speak development the we regard. Yes, in and study to areas company that, undertaken would there, in successful that second discussions therapy. conjunctivitis the allergic possible And there but III that one are I as personally Phase but a we have

Adnan Butt

then you last - go and maybe ahead. Okay one

Scott Corning

be sorry, relates after talking we Yes, third primary DEXTENZA. indication to if the we that there information III follow-up as gaining you information that conducted would and in study when Phase for were hit to it with the approval the about endpoint order

shortly approval gain So, we would a or [ph], supplement should after file directly that. we pain for

Adnan Butt

Okay do what What lot and The your a itself? you platform for company? platform of promise. the presumable strategy foresee has additional for one Antony, opportunities the maybe for is Antony.

Antony Mattessich

we the - and first it pipe that having a having hydrogel ones that products were to market like applications. Well, have to we are on potential we going in benefit focus that many I platform the close the then have the but so has foremost we and mean real is of

areas be of working moment the different won't beyond. different are number eye splitting a we our We At in for and on in of efforts. formulations indications areas where

formulation new area. focused can on ophthalmology and clinical work areas on the So, people the regulatory while the our people commercial

the we are, in will then interior in eye course punctum reveal certainly I'm all and of going the and exhaust the where we but the of of the areas in the vitreous. to So, not exactly opportunities chamber

So, of through to be getting to backlog we end have we the the able pipeline. traction work lot start a of front once on

Adnan Butt

Okay, thanks.

Operator

Our next Wainwright. question of is of H.C. Yi Chen

Your line is open.

Antony Mattessich

He might be on mute. Hello?

Yi Chen

Hello, me? hear can you

Antony Mattessich

there Yes, we go.

Yi Chen

sorry Hi, about that.

little the the the my process on question possible improvement product? us bit give it's more some matter first to previously you found So, is in in wonder regarding manufacturing particularly the finished particular details if for

Antony Mattessich

Yi. Yes, thanks

XXX year the you're particulates. and from we As aluminum FDA observations the particular concern of - and in particulates, this the the finding their of from identification amounts control the aware around in earlier revolved substantial

been what to have engaged we manufacturing surfaces of have aluminum a the So, chamber the the as with observing impact equipment looking changes been, in could comprehensive manufacturing of an review needed at all of idea in and appropriate making fairly then that. down narrowing sources

how particulates. of reduction control identification particulate control but So I reduction our aluminum particulate to going particulates global just efforts that the about beyond plan gone takes that's and referred particulates. earlier metallic at really general, we the sort or and aluminum a to look more overall in And

feel concerns. we the this way, a more is industry these in broadly. at are how that And of in that looking types does So, alignment we approach with particulate

during well manage that into sure to are kept commercialization review, optimistic especially can our make product that during on the the things that shape we're this a control. we're of path a under good good getting So, but we to

Yi Chen

you. Thank

could commercial question your for thinking with current update please you us Second DEXTENZA? plan is the on

Antony Mattessich

leveraging really can obviously be supplier well. is side and strategy that an our environment core beyond Anything global our - on is primarily manufacturing the a up to opportunistic. as focused formulation we from getting we're mean then where I capabilities Yeah,

So, where somebody develop clinical we better can do see a as from we commercial true a product else ourselves and we that standpoint. developers is than same can

go DEXTENZA and to with be is the to very we the as to will far to credible as to U.S. outside market how is we'll possible in in profitable But we for go. we as this but But the collaboration interested certainly would of us to or regards if U.S. a market inside As interested partnering to able well partnerships it's to we are profitable way. hear. in somebody open product very plan bring us a U.S. very be willing have

opportunistic our more is necessarily. not So strategy and place for that an much us part of core

Yi Chen

Okay. Thank you.

release is question press a before you of readout trial initiate OTX-TP the Could top of that that your Third X Phase trial. mentioned line second that firsts Phase the happen may in X XXXX.

Antony Mattessich

bring The happen the the answer it it that of really including want is read substantial could out to the first and - we read opportunity that approval. There with yes, the we that. before to filing, the out forward. not It's is first happen that of too is the approval before will OTX-TP see it's

Yi Chen

the the trial first this design trial? second trial replicate as same Will

Antony Mattessich

would, is in be inform the would first. trial. second one that current have unmatched trails do the we is a a But similar obviously bit to in staggering as we assumption of at be it data an might The that opportunities to the look substantially of the assumption the able is be but what with way to some to the trial that able going

Yi Chen

kind first the And trial analysis? interim of will any Okay. have

Antony Mattessich

of the trial top XXXX. part line latter will readout first in The efficacy have a

are inform all have trial whatever we but first data be we available the or has using forward. data use we trial. will its first going the to entire limitations, mapped of is data the able of have the Clearly completers to from the We the program from

Yi Chen

it. Thank you. Got

Antony Mattessich

Thank you.

Operator

Thanks.

& from Cowen Company. Bill Our next Maher of question's

is Your line open.

Bill Maher

question. Hi, for taking thanks my

is it manufacturing on of So, how lot OTX-TP to see In what process smoothed for product? is manufacturing DEXTENZA and to there once make OTX-TP variations you the approved the the process is you words, a DEXTENZA as? similar have process, other out

Daniel Bollag

level that an for is similar. It question. thanks quite Dan, a the is and high on processes insight This roll are manufacturing at

the and able the from certainly benefit the for it manufacturing learnings process. expect we DEXTENZA So, improvements will to be to OTX-TP

and quality something that was our think is placing trying from the point investment look that, forward manufacturing to to substantial that products. the DEXTENZA in future. the do I that dividend we're that will perspective we further in underlines - and attention So, that as I a a pipeline pay to now It we into make apply

Bill Maher

thanks. Phase first before the - And the given second for the full Okay, on X great, from start up data sort on OTX-TP, given question, of last Phase it'll of the Phase Thanks. then built following that X, any could it fly alter so you X the line? after on first into that the possibly be will trial there sort flexibility design top the

Michael Goldstein

cold it seems [indiscernible]. So, Mike. My to is be

will that But trial. the as changes So, the we to first don't second as much mentioned, those the Antony apply we as and data X we significant the I mean to once look trail learning's masked learn can and the trial at I any trial. Phase trial from will anticipate going from it's

Bill Maher

Okay. Thanks guys.

Operator

Thanks.

Our next Justin Cantor question [ph] is from Fitzgerald. of Cam

Your line is open.

Unidentified Analyst

Thanks everyone. for taking the question. evening Good

provide you finding perhaps and high could manufacturing, the on to process or back the manufacturing made the adjustment touching process? the of level streamline from from investigation a some some of maybe optimize Just on the

Daniel Bollag

this Dan, So, the Justin. question thanks is for

to we that manufacturing equipment that comprehensive go have explained in We our those of into procedures number some the we of at to whole is point. to on a Again, in think way sort our again of improve robustness make at and the - details the submission process, adjustments continuing the those to adjustments. responses additional process we've the our explained of at control want FDA. of process. the I in the our the look that and overall don't We've have may really really flow I a and something fairly this of made level the taken

for do to be have I'm supporting control that good manufacturing. well we'll things the in we submit commercial So we'll both prepared we and when confident very well FDA as as very our that inspection

Antony Mattessich

at of work. two streams important DEXTENZA, think we I think there are really it's when

was the DEXTENZA than control improvement more the understanding really and the which easier itself the DEXTENZA. than full of somewhat about is nebulous around first. where That around continuous That's related first around process to the up and XX unit that is a issues is the and GMP The to other production get longer work bit that's bring to really the process meant standards. to plan is little the of

the As we the good we to the to really the said, have us problems. for training feel unit us the issued control should to procedures, it in proper ensure inspection place process next as we the a and issue XXX, to some already they people that DEXTENZA. FDA the the for the cause have they production XXX, though come that over for the is responses other that have response find to SOPs reinspect time is to ready meaning we won't ensure the that could we complete choose That in for us that FDA

Unidentified Analyst

Okay really great, helpful. that's

the re-inspection And resubmission? consistent with feedback be that the regulators, a follows to that would subject posture with so,

Daniel Bollag

would FDA That It's complete inspecting my expectation. review given the imagine history. resubmission prior again, that of Dan. the is their This to would that without be hard our

expectation would be review the So six a yes, that across about month's my timeframe.

Unidentified Analyst

are lastly, that any on were conjunctivitis? could then studies with allergic non-clinical share expected timelines and Great, there the you

Michael Goldstein

So, this again. Mike think, I is

data already forward. looking conjunctivitis studies and looking eye mentioned, Scott and planning at path the the at As best had the currently completed we're company's dry and allergic

not we this any are releasing plans timelines So, or at point.

Unidentified Analyst

questions. the you great. Thank for Okay taking

Operator

further closing Antony will to for this I no call questions turn remarks. showing am Mattessich I CEO, the time. over at you. Thank

Antony Mattessich

earlier the thank OTX-TP trial us to continue our forward I and of you. changers programs, NDA clinical become our believe the call to to for respective of their for we the development we ahead Look Phase X work during on want advance join everyone game which enrollment Okay, our resubmitting time continue months poised DEXTENZA, for all on first taking with thank you to indications. updating today. to are in as stage

the We Conference next be and there. you month see also at hope Guggenheim to plan to

may disconnect. You now

Ocular Therapeutix (OCUL) 7 Nov 172017 Q3 Earnings call transcript