KALA - Earnings call transcript Q4 2017 | Kala Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Kala Pharmaceuticals Clinical Update Conference Call. At this time, all participants are in a listen-only mode.

Following managements prepared remarks, a Q&A session will be held. And as a reminder, this call is being recorded. I would now like to turn the call over to Mary Reumuth, Chief Financial Officer for Kala Pharmaceuticals. proceed. Please

Mary Reumuth

and for operator call. in you thank you, participating all today's Thank

Chief Dr. me Mark Today's recording Chief be our Kim Bazemore, are the call by Medical as indicated available Officer; Chief Todd Joining and Company will Dr. is Iwicki, being from an Scientific Chen, Hongming Chief Executive recorded Officer; Officer; on release. Operating Officer. website and archived press Brazzell, our

to slides showing have to accompany website. and discussions slides updated be today's also these been will our We

after described Before call expectations, caution are with limitation live Company to including any Form the the on the Monday, time enforcement factors. expected, this materially obligation prospects contains of review we revise cause conference turn call. results quarterly and broader undertakes call circumstances reflect but today, or Mark? to Act the meaning events lead economic and that The like comments that at limited actual update XX, are Factors that resources, results information all Exchange the Reform XXXX, other and March to XX-Q date of timing to include, Securities Company's results our management of which those accurate the Mark Litigation our conference the of is recent Company's The differ as of sensitive new Iwicki. intellectual begin, now obtain I to timelines about the I may without Company's regulatory to trials would or this over specific or I factors ability of that of Company's date will content may made this to during on compliance Securities clinical actual product and cash in the if and not candidates, call events product you Commission the the forward-looking by our report to plans regulatory property, no to XXXX. competitive filings of conference approval statements statements affect call the of candidates within future requirements of forward-looking the legal Private Kala's statements. most sufficiency only identifies and the of encourage from

Mark Iwicki

focus Thank to X morning the results to that million Good and quarter being included you, X.XX%. the issued expect the a to be X.X of understand December with quarter. be the data STRIDE financial prepare of and XX, This the call. per common of trials for our we've of which $XX analysis IPO Mary. significant at for our Earlier XXXX. In the second of analysis successful shares were today's stock and the last year will FDA happening share. year done Phase we of ended afternoon, included analyses the discussions X in made also well everyone. These this for better data Kala progress This of from and Phase STRIDE results X some additional X KPI-XXX results our as

date our who've patients INVELTYS, by pain and accepted FDA for undergone Additionally, action ocular X%, of was treatment that's August review for an of a topical XX, the inflammation day with NDA for a candidate in target PDUFA KPI-XXX surgery product twice the XXXX.

safety versus two disease. X.XX% of our Phase for and evaluating KPI-XXX placebo clinical dry results line top announced the in eye patients with efficacy X trials also We

to the on Mary? our call who to analysis, will data discuss Mary back I'll going turn the eye briefly new results. Before our Reumuth, CFO; dry financial

Mary Reumuth

you, Mark. Thank

decrease is Total We December least cash XXXX, X of STRIDE in to fund will compared $XX.X $X.X research to and Total the full first expenses and a us the period in development in as and full was of which professional with XXXX that increase The million quarter million same XXXX, for associated and compared XX half general million expenses The were as the costs $X.X year with establish NDA year million primarily expenses quarter for XXXX personnel for XXXX. costs associated INVELTYS and in position and million fees as compared $XX.X of general XXXX. in and $XX our XXXX. full quarter organization. XXXX quarter in to primarily our R&D XXXX. $X.X to the incurred completed increased million X at the XX, development of the the for to administrative to for expenses result The enable of research for operations to of compared cash X same months. expenses the operating Phase were G&A $X.X period for INVELTYS. XXXX. public million the of administrative $XXX.X due of Total the existing commercial Our XX, increase anticipate Total increase of the for the year is XXXX during were attributable fourth preparation ended fourth clinical filing to million million trial compared of an of completion as for our personnel December the the were million as to costs and $XX in XXXX. costs, company, increased primarily well for expenses a is next $X.X

the loss compared quarter for million quarter the million $XX.X million year ended for million XXXX. ended XX, year XXXX. operating loss to full The was for to XXXX $XX.X Our December XXXX $XX.X the $X.X for the full XX, was December compared operating

Our the for compared $X.X per $X.XX or a net XXXX million, million, quarter share, to $X.XX the per net loss XX, $XX.X for in period share, December of XXXX. or ended same loss was

preferred or a per $XX.X same ended basis is our stock, with compared to resulting July shares in the on increase per over for loss $XX.XX stocks compared $X.XX offering initial into program. on loss of net of Medical is or December of disease XXXX. in the periods our weighted from due to as our for was public connection period million, The conversion the stock XX, common shares our in those for per XXXX an I Our well the Officer, XXXX. in discussed the issued of Chief in our share, as decrease update Kim? turn an our share XXXX $XX.X will call net to in to full Kim average common number million, share year outstanding now same from XXXX eye dry periods Dr. Brazzell,

Kim Brazzell

the STRIDE eye KPI-XXX disease On of efficacy dry these two disease. eye placebo X.XX% X. and in dry product our you, and topline patients STRIDE we We everyone. from Phase our versus and results January candidate trials announced Thank X good Mary clinical morning to trials, as X with refer safety

As significance in statistical the achieved symptom significance of STRIDE we pre-specified trials. in Day towards previously We endpoint both a for XX the at trend discomfort primary for in predefined announced, Day a effect treatment of hyperemia signed statistical X achieved endpoint with ocular conjunctival primary XX STRIDE at severity X.

which which Phase X Slide two both severe millimeter in with illustrated the of severity shared difference a a symptom X X.XX vehicle X STRIDE was evaluation for Using trend we post-hoc were pool Day Day XX discomfort a observe these basis morning X.XXXX X observed days compared treatment similar P-value treatment south a We this statistical the symptom with KPI-XXX Day STRIDE patients of and STRIDE results, of resulted We evaluation. in population which ocular also from press of -- significance treatment ocular primary achieved and and Positive this discomfort One an P-values both in treatment effect used than discomfort positive to was in X then towards discomfort are X.XXXX STRIDE west XX X an X.XXXX shows and key second ocular X by analysis secondary P-value additional which results X.XXXX. in geographic endpoint at also more with endpoint. and our X.XXXX we X.XXXX strong with Phase Phase X.XX, ocular initiation analyses in of in discomfort of with effects within X and STRIDE a in in a magnitude at of the analysis daily at X.XXXX effects in X and ITT respectively. observed p-values analysis baseline the effect of Day some in that been of achieved similar key two release. of ocular population endpoints data trials observed achieved of for trials. for treatment effect using The p-values the statistical for respectively. regions the the which shown a primary and we've conducting and severity pooled respectively; X-X X.XXXX. north STRIDE The X subgroups of show exploratory a in on in XX data Since discomfort performed on two pre-specified of ocular treatment data separation defined analysis for less pre-specified a from the discomfort of of between secondary X X also the days east trial achieved were to same and X, of as analysis ITT that remaining the endpoint a at STRIDE as test continues pre-specified over STRIDE in

than for X STRIDE STRIDE p-values STRIDE we treatment pre-specified X and X we examined of between was X. in X.XXXX and in points X X.XXX less ocular key We positive X all-time In we STRIDE now the a X in As time X.XXXX less observed discomfort with also results which discomfort previously In achieved through period. STRIDE and respectively days endpoint. than the on Day at X, that noted XX p-value X of XX. STRIDE for ocular and at p-values X Days secondary X of observed Day X.XX effect

X.XX%. we at regulatory certain that information believe on regarding our will the now turn analysis, analyses weight call post-hoc will over agencies to important plus we're place provide CEO, these While KPI-XXX not what Iwicki. I Mark our

Mark Iwicki

Kim. Thanks,

observed from preponderance encouraged Phase results STRIDE X continue for to endpoint and in trials disease. trend dry significance sign X We primary by We Phase of achieved of We've with X. significance eye KPI-XXX in the achieved really STRIDE a STRIDE statistical X STRIDE and of the X. be in X, two endpoint positive primary in Phase for ocular our X.XX% discomfort X statistical symptom that

applying flares, an study this statistical to the concludes with the at that have p-value and make a Day When we less dry yielded to significant eye results, take X plan suffering we As X the for X.XXXX in method, with dry of pulling in analysis p-value the ready efficacy we're STRIDE patients which for the remarks forward to our Applying X.XXXX. STRIDE than large robust populations points the statistical treatment questions. episodic Days we XX need and a at the time of opportunity each really ocular the X X.XX. XX, XX FDA. of and less analysis for STRIDE Day yields for any That STRIDE p-values X can and less prepared look a product we points results totality X.XX from discussing includes in than X; at than Kim unmet a potential safety at impact eye X our look ITT fill and observed all-time promising less today. than believe Operator, p-value of to to discomfort program X patients for Phase a from the and to X positive noted, for Phase same effect X

Operator

[Operator Chris of our And Schott JP from comes Instructions] first question Morgan.

open. is now line Your

Christopher Schott

differences Phase understand question; -- like two in just Phase help in the used you've plan Can a discomfort plan. X the -- outcome differences? fiscal you better bridge us remind X, using between us with using the you can looks versus Maybe trying with here to Phase the X here first for got just just statistical on

Mark Iwicki

in be or In the X often Day visit, to minus Day that which in analysis could XX, days was and range. by visit day as it the main Phase was two that Phase below X trial, reality so slight of prior was study assessment X-day we difference the primary plus XX, the difference defined based XX the to XX, Phase in led in as went X, the for a XX, p-value strictly this which defined to X we and got days so way, the and X.XX. us In on the the beyond pre-specified X protocol it as

Christopher Schott

STRIDE things the between two data all X anymore way anything just data very that X a as between analyzed outcome. bit through going in question reading Second just was population like learned us a the differences at studies. on a the to -- more; outcome you've difference that any you've directionally and to STRIDE positive the are the different on seems -- get there could need in versus but in little talk It everything from that? obviously is Is gives color the explain

Mark Iwicki

Yes and future. prepared we'll make at Chris, that really to we're the evaluate but update an that hopefully this in to point able haven't to continuing been on be

Christopher Schott

you a maybe final And and look will you get third traditional think dry approval and have enough to a you do data when just to set eye just need question or analysis data; get to in and here the from the believe helping you X at Phase approval? STRIDE you expectations; X X do study

Mark Iwicki

these we certainly all the majority to quick that data analysis to in and we've that for use vast And trials discomfort preponderance that X all plan a continuing did X statistical we not encouraged different ocular hyperemia maybe that analysis only additional but the of we've X are the clinical X these to strong reminder treatment X ran run support options are X. of to shows plan yield strong hit discomfort. think been p-value additional that I really a Phase ocular effect the for Phase STRIDE in continue of Phase able STRIDE for we we when of just analysis but significant

data of think which to at come the and the that to we'll and are FDA able when we provide So cuts FDA. often with update. for then discuss some back intend meeting to been are we an really a additional are set done to certainly and preparing of very we strong we've the run their people that meet we to have be compelling NDAs encouraged able these after data able be But point with and

Operator

of [Operator Instructions] question our And Wells next Fargo. David comes Maris from

is now line open. Your

Unidentified Analyst

So on [ph] the to the typically FDA? with for timeline little taking there do you meeting? long you actually This meet analysis expect you Can for is do a share Katie that intend questions. meeting actually the request How the to for that David, FDA? and have should to scheduled? when a more to about with meeting to Is thanks your you more have takes when we it expect

Mark Iwicki

be everyone do All is that any plans right share commenting have reflect on the information quarter. in get We moving that about expect will and after have our second that we the provide now to minutes additional and update potentially don't are at forward. we that time we're able to certainly on meeting to sometime to meeting this but we an

Unidentified Analyst

long of those any STRIDE run the us remind cost And each for look of best trials? Phase give you can or analysis case cost scenario, the not X comparable to And X? case it you was can would how to study, be or the like maybe us and to the and what whether those you of what for scenario X; another took cost what expect, they worst STRIDE you previous run did if would have a

Mary Reumuth

about and answer turn it to just the cost over Kim I'll for rest. the

each trial So about and $XX about took a million, was year.

Kim Brazzell

expect time we cost pretty to similar And to the that. the be and

run. For might any just use trials, the we new

Operator

call I'll back in over you. questions I'm Thank showing And you. the Mr. Iwicki, queue. turn further no to

Mark Iwicki

and really listening fantastic. to everyone today's like Okay, to for call. We'd thank participating conference

action, see profile signs a heard, of and have to mechanism which the we in the symptoms that of patients X.XX% clinical our program, broad existing promising therapies. rapid we in be disease you've with onset complimentary potential hopefully, for relief and favorable dry we to tolerability due eye As both a KPI-XXX candidate believe to of

in have candidate the for our morning. time the look a be ocular this We for pain. on post-operative update in and your everyone daily first near programs the another that to believe thank of also approved, providing ocular twice you We INVELTYS And future. strong and if it forward treatment with indicated will corticosteroid inflammation

Operator

Everyone thank great program, a for Ladies all the participating you have disconnect. This day. today's conference. you may conclude and in gentlemen, does

Kala Pharmaceuticals (KALA) 26 Mar 182017 Q4 Earnings call transcript