Ocular Therapeutix (OCUL) 12 Mar 202019 Q4 Earnings call transcript

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to the Ocular Therapeutix's Fourth Quarter and Year-end 2019 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.

It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. sir. ahead, go Please

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

on will give Leading update call the an developments of an Dr. be call will President Antony our today today a and clinical corporate pipeline. who our be on Officer, the Chief Medical will will summary the provide Officer, Goldstein, and who speaking Michael update Executive DEXTENZA and our Chief our commercial developments on Mattessich, Also launch.

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

also we Corning, For our will President, Commercial. Q&A, by joined Senior be Vice Scott

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

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

in by do the some future, these do our update as to change. any if obligation statements even to except we elect may so, so we disclaim law forward-looking required While specifically point at views to are we

turn now will to I Antony. call the over

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pain dosage for the route approved treatment has physicians. ocular ophthalmic and first surgery. product transformative of The the form inflammation following is the that product a is of novel both administration of for DEXTENZA and and patients

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Goldstein, I go hand will the our to To well as Officer. Michael Medical as over those selective Dr. the Chief over results developments pipeline, call across

and for a treatment Ocular potential Anthony. of franchise Thanks, a opportunity surface represents the number DEXTENZA Ocular for diseases. of

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dose patients OTX-TIC. and safety, enroll to continue to escalation tolerability evaluate We a trial Phase efficacy, open-label, prospective, X clinical multicenter, in the of durability

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interim the injection intraretinal fluid. a with We of are can pleased shows interventional reduce subretinal data and/or that TKI

a and Finally, stage of plan fourth OTX-CSI to dosing note amongst our the Phase XXXX I a trial to in early quarter year. filed that patients start programs, X X-D want in of we second quarter the this in for

releases product would dry patients deliver solution months excited and for approximately dropless, dry OTX-CSI convenient X -- this for a is disease, per cyclosporine effective about patients. which We're could eye with an potentially insert intracanalicular that these eye that

I the over back would turn like who results. year-end to review to financial fourth quarter call our now Donald, and

the net revenue was product increase. revenue third the months XXX% $X.X $X.X in third in million of product which the company over the fourth quarter as product three Gross reflecting of sequential Michael. Net revenue increase XXX% $X.X ended discounts, of quarter DEXTENZA quarter. a reflects XXXX first total and and of in sequential Thanks, -- XXXX million XXXX quarter XX, rebates versus refers net the the million for December was to returns,

year Sealant. includes product versus $X.X was the second revenue ReSure Overall, net the Total December and revenue XX, the million primarily $X.X of net from fourth million XXXX product net DEXTENZA the also of XXXX reflects addition for million sales of of quarter ended XXXX in for beginning revenue $X.X product for quarter XXXX.

associated development costs $XX.X the X reduction reflects and significant in million allocated Phase X conjunctivitis DEXTENZA, costs OTX-TP. allergic trial an that clinical trial the the trial for for quarter and a Phase of and clinical were versus the million X period with Phase XXXX offset increase the comparable for in OTX-TKI with primarily and OTX-TIC the Research $XX.X expenses associated on and costs by trials fourth

to unallocated year and $XX.X in expenses increased the Overall, in million $XX.X costs expenses million increased trend for mentioned R&D the trial above. reflecting from XXXX, clinical million full $X.X

to quarter Selling managers. expenses and for million of commercial the driven the million entirely the members of the key fourth medical in of to hiring team, support impact and in managers for $X.X sales quarter of primarily beginning field of by second same $X.X as XXXX. This were marketing the account relates ramp compared full of commercial launch the XXXX. increase new DEXTENZA, liaisons including quarter almost the

Overall marketing driven XXXX, for selling $XX.X new of in million full primarily the the million, by team. the expenses commercial to million and increased year of $X.X hiring members $XX.X

above, and As increased well costs. consulting as related highlighted spending, conferences as

from million the $X.X for to fourth personnel administrative in Finally, for G&A XXXX reflecting a in for personnel increased quarter increase were fourth and XXXX, Overall, year primarily increased expenses million of general costs. comparable of stemmed expenses million million from primarily costs. the The in $X.X $XX.X expenses quarter XXXX. the million versus $XX.X again, quarter full $X.X increased

a With respect a and per XXXX. the based $X.X on on same $X.X $X.XX net the and to included for depreciation, share for XXXX. to loss in loss same loss net a or of million $XX.X to a for the diluted compared a million The non-cash loss financial quarter stock per basic million results basis for period basic quarter of fourth charges share $X.XX for in the basis. in fourth and compares quarter, compensation of million, the a of This loss company net reported or $XX diluted

of quarter for charge loss company's the of XXXX non-cash the net of $XX value full change with or a million the notes. includes basis basis per on million, a of diluted year the share on reported loss Overall, a the a the loss of and $X XX, related XXXX. per fair addition, versus company for a December in loss of the million basic ended convertible basic to $X.XX and a a loss net $XX.X share the liability derivative the in diluted $X.XX or In associated

XXXX, X, million outstanding. March shares company has $XX.X of the As

and amounts in restricted twenty year-end exclude $XX.X XXXX. was respectively. cash cash XXXX million As of $X.X reduced Restricted cash the had million million versus and $X.X equivalents of cash nineteen. XX, we the $XX.X These full-year third of cash in at ended million December quarter

million sell of common a generated from company's under stock. fourth common loan our the result sale proceeds offer in the $X.X of liquidity an company eliminate facility $X million during of As its sales quarter amendment XXXX balance lenders million stock a and net may which under the the the with term covenant, cash agreement, $XX to from benefited

proceeds Having above an $XX aggregate million time time. from to the

balances the from proceeds under common the XXXX, notes million December and primarily year the sales cash consisting XXXX from For million, total of stock under the XXXX of sales XXXX convertible Agreement stock agreement from $XX.X ended benefited $XX.X full XX, activities of net net million. financing $XX.X sales of million $X.X proceeds common of sales

addition $XX.X of common available March sold sold of year additional sold calendar generating through has to the an agreement. the an $X.X under proceeds net the has company stock sales remains million million, For the current XXXX under stock XXXX approximately -- be agreement, XX,

March current from with cash cash product sales of related estimates and our DEXTENZA quarter stock the capital and that equivalents through proceeds believe December cash expenses, the XXXX. XXXX sales existing from first planned and and and operating of outflows of XX, net agreement enable operating flows debt company XXXX fund will on plans expenditure pursuant XXXX service we our the to cash previously, of Based from sales as highlighted anticipated to together XX expenses, first ReSure into common the quarter requirements obligations

back other thoughts. business. year-end and I programs the a and to is, of pace subject to This of turn of as assumptions of for my the of and DEXTENZA, summary Anthony aspects related the research revenues to expenses results, guidance and now like concludes call would our well comments associated to as cash commercialization financial some with This course, quarter on and fourth clinical number development the

Donald. Thanks,

CFO the under important DEXTENZA launch hospitals. the DEXTENZA, the do summary. specialty with and and the earlier that about of I ACS is which launch. for let pleased And sales We're quick a units me told from the building opening of me before into only billable helpful momentum in the my So distributor has metric misspoke momentum questions, the call the

year said, To month over year for growth reach month of And -- was was previous the months. over over strong to XX% able month inserts March. start XX% previous I growth over repeat was at growth into it and Before in have the should expect in a We XXs months. be what February guess billable time off was we hospitals very in In month January rate X% to and that. then the with the March this of I December XXXX

So very marketplace. working how the about the in momentum excited increasing, that is is out we're and

also Phase OTX-TIC, for that could the read a in disease Ocular anticipating extend allergic that intracameral X with are effect both we pressure. Phase elevated out We treatment are of durability that standard franchise that and an seeing in second X care product become in quarter the into DEXTENZA, DEXTENZA drop conjunctivitis support the a surface potentially our could glaucoma the magnitude to of program

in importantly, our OTX-TKI Finally, have and of our dream the for activity keeping we most a and biologic true next generation program, evidence developing seen treatment AMD. alive wet

I'll that, turn the over With for call questions.

Thank of Piper line first question [Operator (sic) the you, comes of Joe Our from Sandler Instructions] [Jaffray]. sir. Catanzaro

open. Your line is

the hearing of the early on cataract for maybe and I because or guess coronavirus DEXTENZA. Hey, taking but the thanks a And patients one progress. and deferring you questions their too seeing there situation? to procedures guys, on say, congrats first couple first the just it's

not To elective hospitals delay are the heard surgeries hear -- we delay that to we is to anything. date, to have elective are haven't surgeries. sorry, starting now, What hearing

what if important terms far the done, will our so a clearly monitor in we in closely seen very, but are it the future. and business driver anything number becomes procedures haven't that for So very it of of very yet we being

little that in of for DEXTENZA. for Okay, have of you timing guess, can time sense on of patterns another over of maybe six give great. orders, terms ordering I AFSC both changed then been size how plus accounts those a have And a bit ordering maybe, on, quick one orders. months, of

confidence, more what on Good the put we've Yes. quarter over with ordering I Scott. trust the reimbursement take seen, is and reimbursement. in really especially that. Joe, fourth accounts in I'll after board, is This the mean, [indiscernible] those time gaining orders starting morning.

larger this rate reorder through got and maintained we've so And order a nice sizes high period.

with is on more quite come as people accounts having those well along, expect accounts a received a we So have said that reorders positive the all board, as from it. so experience because product we've are

Okay, then OTX-TKI. great. on And one one quick maybe

beyond going would just So if next could you wondering to release program? dose, there one be once happen any maybe does just those the additional press the notes more envision recommended steps that the in bit putting that the say look this changes formulation are need what And would what drug a you as are and more guys whether for you you term, longer then establish to insert. that

question. Hi, is for Thanks Mike. Joe. the This

higher So would the to the go that next micrograms. we -- be XXX which working have a we're dose protocol would amendment be on next to

that, do with actually another, current the do that need could would a to So would need not change. we population we have. not We we formulation

way once to so have combination and with some both have data X understand from and that able on drugs we trials the then information. been a in well monotherapy and anti-VEFF And assess durability, develop based program Phase as full the in activity

Perfect. for taking questions. Okay. Thanks the

you. Thank

Thank you.

go Dane next Please comes question James. Raymond Our ahead. Leone of from

like want to at crew been much. allergic conjunctivitis. out just Hi. I on Thank It have Hey, the too you. ask guys. may Biogen you sounds hanging

you -- you'll think the pathway one? the of readout pathway in regulatory what guys now second -- So Just quarter, the you us trying have to can Phase You of is remember for Ocular remind a second itching. for what the just X correct? have this

Hi, Dave. Yes.

the challenge we’re two allergic with you and of So the trials. are Of model model, use One that’s is to the to them where model just eye, other you to the in true environmental are there and -- approved [indiscernible] to conjunctivitis well-controlled get indication the pathways the you Ocular using. a can going indication in on with study. medication The that drugs allergen challenge do are is adequate placed allergen Allergen the use. and almost so itching. in basically for the two is U.S. -- all conjunctivitis, using all can any And like approved directly needs the

put defines So the at assess on itching in the show the on that the after symptoms you allergen the to meaningful model, the to statistically unit meaningful. significant time you half difference time compared improvement a then in time be as difference eye. placebo. need clinically various FDA all points at allergen points goes And needs you a And of clinically the a And eye points. to majority unit measured and at

Okay.

on based correct have the you'd because if statistical so that me the and but results [indiscernible] you'll endpoint on And the I'm itching, other study, not Phase X clear with readiness. wrong

correct. That’s

this hits one complete So that package? Ocular on this one, then if itching, will the

correct. That's

Okay, great.

submit basically supplementary the then get together data, you package the get could for us? and So after NDA you the

Yes, that's correct.

So you going the I work? I context that, our new is, coding work Is how the is on? reimbursement you Thank there points of are Can help same? that from think, mean, Anything your DEXTENZA do team where in to kind how go-to-market models. price has currently. can would guys to you. the it question touch the the highlight you of

to select work get being understand do ASCs. pathways built of forward, getting reimbursement particularly really and business [indiscernible] the in reliable them with ASC's entire for what area going the lot surgeons. to could continue did and whom able on they that We terms this timely really can more Sure. ASCs reimbursement. consolidators on is where a we at surgeon. the and What But we the the And patients an we focusing that and points the with I more for leverage and the around up we the to our forward, surgeon that understand product that's benefit on we we’re themselves patients. the basic getting the segment -- focus mean, segment were can launch focusing the them can now touch proper the do we [indiscernible] for our was of of we've area think demand to going

is get ASC major physicians using door of with have within want to that like a with want what us then and opportunity ASCs do is it, for would don’t to use the So forward. you the ASC be open about being able open lot them have that you excited don't a pent-up and no to demand we that to door to and going moving demand

would How it or get referred the be PCP someone indication? in to Would DEXTENZA this ...?

or choice not of product the to [indiscernible]. use the surgeon to product generally segment the [indiscernible] the It's use

so mean I -- Dane. question, a great it's Yes,

typically steroids I in of care. that And stabilizers, sort So just have stabilizer, this you antihistamine/mast cases of probably allergic we over counter, do antihistamine/mast went although of standard use the which cell failed the conjunctivitis are been haven’t cell largest are aware, as believe month.

they through So a come big ophthalmologist, coming come could people they PCP, come could try to could through through They and their they or walk of my own. source as allergists. in they general our have they office, cell offices, antihistamine/mast optometrist, their could come through could

we're the different lot same surgical a or [indiscernible] way, the an in accordion DEXTENZA exact the calling of but surgeon of up the specialist, the -- in end ways, which field. is, So office by for they that on in generally segment population

of high groups -- physicians. a the people there's in groups these overlap of So

surgical I in into important entree opportunity the a the understand it color period the which one the would eye of about indication AC product things much than the of think is to is larger be. is a time over our alone ophthalmologist surface longer that disease office,

the marketplace program by move potential an be excited there able approved suited having the So steroid at There's would dosings. of already exciting would to in Ocular. into great the initial area DEXTENZA where common think that treatment and DEXTENZA. occlusion, where indication. a no I lead a would which because is preservatives would product for approval We're this be eye, disease. pathway very for to results to a conjunctivitis for open non-volatile a drive dry be as STRIDE -- we we product ideally us a move would in very an also are dry punctual up There's for If is over very allergic therapy time, Ocular look for

consistent huge of of a a which non in product dexamethasone, huge, DEXTENZA. abusable, dose have is the it's like You factor favor a also

it's disease, part area something disease, in dry the but is eye AC of product. is stepping So larger itself out indication, where the particularly of stone, real ocular a in value see surface valuable we

very Okay. you Thank much.

Thank you.

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

is line Your open.

of Thank you able be my with number by for us to Would since launch? used provide you taking question. ASC's the inserts

We months. billable [indiscernible] actually by showed present certainly the showed that because the presentation we could, units

there. in -- there that in numbers were the So

of add whether the the were and could definitely but those that -- it -- have into that we've that units market, months share was been you remember you hospitals. I the don't So ASCs on the sold lion up included those and number then the would all of billable been have the

right has we we're XX,XXX. it in almost billable the have were at in time, precipitously the X,XXX units samples samples important beginning and dropped now, at note over But were almost to that is But sales over use number of sampling exclusively increased. as

quarter, are the as in in and outstripped the So beginning of -- used at samples sales taking the quarter, the a samples product. and very training this especially far by simply by fourth element customer

you. Thank

DEXTENZA been of either user could and end us you've gross how or discount currently rebate distributors? you price giving question, much Second or remind to the

is, date. We with We've whole until but driver our driver in way, selling insert. We’ve a rebating business price. business the any price that of has what is per some of our average as ASCs a now. to or haven't it for been shape up issues timing on the been made using not whack The $XXX form had

need to question commercialization, a conjunctivitis or the team? the with do Final existing DEXTENZA allergic Thanks. team for indication, would sales plan for the you you start for different

team. with start would existing the We

of mentioned, Mike the physician for like something seeing and the products. be into that with the structure. patient, require allergic and in for conjunctivitis we refractory move DEXTENZA, who surface would office time, offices deeply As field the larger that optometrist, our same setting Clearly, only disease treating surgical as we're sort people with over not of currently would ocular ophthalmologists, but same the the the are a into more population

you. Thank

Thank you.

you for participating. Thank does queue, today's in As no call. I conclude questions show further this conference

may now disconnect. You