KALA - Earnings call transcript Q4 2021 | Kala Pharmaceuticals, Inc.

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Operator

Good morning and welcome to Kala Pharmaceuticals Conference Call to review its Fourth Quarter and Full Year 2021 Financial Results. [Operator Instructions] As a reminder, this call is being recorded. I would like to turn the call over to Jill Steier, Executive Director, Investor Relations and Corporate Communications for Kala Pharmaceuticals. Please proceed.

Jill Steier

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

Chief company Bazemore, Iwicki, Officer; Darius President Head portion R&D call. the Executive and Kim today’s Kharabi, from Reumuth, of us of Todd Mary for Officer, Officer; and and be our me Chief are Officer; will Chairman Mark Chief Brazzell, Chief Business Joining Financial Officer; also and joining Medical Chief Q&A Operating the Today’s call webcast is live. being at in found the section www.kalarx.com. be can website link webcast The of Investors our

for meaning referring XXXX. potential INVELTYS, Litigation will the reconciliation the EYSUVIS Securities and to in prepared to found programs be about Kala’s financial of statements non-GAAP this make can our available measures, Private prospects issued will within release our generally of regarding market and future not statements will statements statements development These forward-looking commercialization During the also expectations, of is direct regarding call, measures are Act plans non-GAAP in Reform accepted on which we today, comparable are include financial most On be resources. the KPI-XXX, of website. forward-looking and this and call. accounting which on of with and are and and statements These beliefs on based the other management of our we as certain measures preclinical our the accordance principles. that expectations programs A sufficiency comments updates of press cash conference call, the this our

call, the available and and identify SEC read factors, filed events today’s described will forward-looking well company’s other Form release over that occur except statements report revise on now as with actual materially factors the events circumstances risks will and described as to update be press our included this carefully to which SEC. XX-K statements the expectations. and company that results conference risks from uncertainties Iwicki. Form any reflect Our on by annual The undertakes other in no materially I CEO, differ or obligation with make call to results required may may our differ Investors from law. or XX-K as those after risk specific will forward-looking the important the The in Mark cause Kala’s the be website. or to filings actual later today we turn in our should

Mark Iwicki

and and you to thank Good review full joining and highlights. everyone today quarter morning, results our us recent for year XXXX fourth business financial

Kala patients medicines back professionals eye. eye that is mission of affect diseases Our provide innovative the treat that can and front better to care at a and portfolio with the of

As the community. we we pipeline developing value programs portfolio have treat the across X/X tremendous seen ready and with move care a the expansion commercial conditions. devastating eye array our of to and we Together, of an opportunity to we rare have into our that believe KPI-XXX, to Phase progress continued asset deliver that our clinical commercial are XXXX, clinical

our Let recent short-term with the me now dry approved treatment eye EYSUVIS, medicine beginning to turn performance, our of disease. for

coverage payer and EYSUVIS of first-line disease, for eye treatment We therapy establish the dry our expand eye about a spoken including to flares. as have efforts preferred dry

over have XXXX, early we months quarter of reported we of the of upward and trends seen prescription quarter commercial the through In scripts. persistent EYSUVIS fourth seeing direct-to-consumer the XX% of wins this the as Following the are Medicare our trend continue months third we as number and recent campaign, well and a in EYSUVIS XXXX. marketing growth launch fourth in of quarter first

and we continue confident implement aimed with of goal flares build We our continued doctors. targeted secretome at as positive most from this of patients to KPI-XXX, disease to number and patients resources necessary novel momentum and to In care are receive our information providing will portfolio, we therapy. continue a parallel, the eye candidate, strategies them with proactively a product advance including dry our the and eye advanced to investigational feedback their development professionals both we discuss

a corneal epithelial persistent disease morbidity a in reminder, stage in is a rare asset clinical development sequelae, with KPI-XXX which initially As and PCED, XXXX. defect late for we or acquired associated vision-threatening

X/X are regulatory trial Meeting in Annual subject clinical forward presenting at fourth with clearance PCED in patients to our We from the Xb plan and quarter KPI-XXX upcoming of the Phase to looking May to ARVO clinical completed data in initiate of the Phase XXXX. trial

XXXX the are QX to progress with In this taking actively could we an to look that believe update INVELTYS. on Todd are addition, and to disease by $XX of we evaluating in we To commercial potential plans potential further From for the ocular over EYSUVIS the steps end, development our pipeline to a a call a acquisition, cash as we product, beyond serious rare mentioned and time our other later KPI-XXX approximately forward and will array of become now indications KPI-XXX XXXX. extend to which patients an our review providing the corporate with at has turn diseases. perspective, runway million year. a of target reduce to I expenses benefit

Todd Bazemore

Thank you, Mark.

reported the Health fourth over of the of quarter. For EYSUVIS quarter increase third XXXX, prescriptions, XX,XXX XX% an Symphony representing

uptick XXXX. of refill continued over in of particularly carried the wins over is is EYSUVIS, months ahead. momentum payer particular by approximately We product prescriptions prescriptions this were through prior recent a believe more tailwinds first the including significant the total growth began in XXXX. the Since the by in prescriptions the launched to we in supported that into first by XX,XXX QX than is that quarter January are be to in this as and X,XXX XXXX, XX,XXX encouraged prescribers acceleration likely and unique by uptick written March XX, noteworthy of This

key commercial our XXX than and have made million and with for as coverage alluded significant Medicare I payers efforts, now execution coverage progress we Part of to on lives. goal D Turning our more market growing to, toward access we have

This covers secured commercial XXXX, March XX approximately in in commercial United plans largest coverage all Healthcare, Specifically, lives States, million to the U.S. the one on million the of the of XXX lives approximately our we total brings which XX% United or commercial lives. health in coverage

coverage lives. February, X.X addition, Medicare, lives, In bringing or we which coverage Cigna XX% covers in EYSUVIS about under secured X.X Medicare Medicare million lives million approximately of to all total

fulfillment we it further EYSUVIS We particularly are in very accelerate for higher expect and growth our rates coverage, growth pleased with translate payer this continued will prescription into since trends.

additional to XXXX. of first the pursue continue additional coverage wins vigorously will and in to half secure expect We payer

short-term efficient that with manner. remains prior a in their that were to in targeted that address this have campaign dry coverage, eye their that treat need patients opportunity physicians. to we flares the disconnect the of FDA-approved exist. dry to We driven discussion doctors, understand a rapid-acting there in to treatment EYSUVIS, options. treatment with unmet part proactively their payer the with invest to In we believe eye a opportunity by eye as helps direct-to-consumer now flares time addition dry solution not does a an patients coverage, of rapidly communication believe growing EYSUVIS from We is and need their eye product because patients which growing flares there is flares, significant consumer large bridge between a no to gap payer research a about and have digital know largely had that in dry And are market many an efforts to in

proactive educational short-term FDA-approved which and an materials, consumer around eye result, option. DTC digital only treatment digital office between point-of-care discussions rapid-acting campaigns, eye we have dry videos to social as and the campaign, availability EYSUVIS a encourage As care incorporates flares recently and media patients and launched of education our e-mail the professionals media

pleased performance in improvement We team on believe we significantly improving on demand. our DTC and efforts coverage. will our the coverage with efforts launch to is to updating growth payer further. the future generate reflects and a and in are Recent increased forward acceleration progress prescription growth ongoing are look executing We catalysts notable calls. in believe recent priorities strategic payer significant EYSUVIS against our accelerating even The key you performance

prescriptions fourth to approximately We compared ocular quarter XXXX. quarter and Turning that as surgeries coverage in will and return pre-COVID of third returned the INVELTYS, D prescriptions Part the of to the XX,XXX of Health believe Symphony XXXX, reported INVELTYS by in now for prescriptions revenues the increases. number to reported product levels as to XX,XXX there were growth Medicare

programs. as our now As primary over INVELTYS we XXX% of are synergistic have Kim efforts which turn INVELTYS targets, dry are our second discuss is I to the position call EYSUVIS for sales with targets eye the to INVELTYS in call. is focus also previously stated and pipeline EYSUVIS completely will the commercial from

Kim Brazzell

Todd. Thanks,

the over about and last have the excited really months. few are We program we progress the made KPI-XXX

infection, designation. Sjogren’s for to are to including are XXX,XXX and the the rare wounds PCED surgical loss. develop U.S. of morbidity, in mesenchymal and but of such matrix the perforation, could incidence of the normal are applications. effective to due The patients has including to From therapeutic PCED as currently an across with them, treatments. patients varying biomolecules for etiology. has involving trial development in potential infectious potential various keratitis, track In a human underlying which syndrome, or our not of we lead can KPI-XXX benefits corneal KPI-XXX key from to in others. the drug application X/X protease secreted defects subject to of a novel If these improvement of to comprised of for U.S., biomolecules as therapy of KPI-XXX year submit within is X are per May. wound These with combined. keratitis, at the novel we in the the results vision been is be initiate received patients dosing conventional allows Being fourth of in defects for is a untreated, diagnosed and and we as refractive in cell-free new of corneal KPI-XXX estimated an of unexpected this a in safety issues healing in KPI-XXX November novel utilization PCED, weeks investigational so, trial, cell technology cells, to the positive factors, pivotal daily the stem are As needs great discussed, quarter therapy to of first asset cell-free, addition it in the and to the in of and we Xb orchestrate and the evaluate as many trial harvested of PCED two imbalance Japan ARVO the PCED promising and chosen exploring scarring action and with The in that multi-factorial therapies with process. call numerous of and produce we significant can biologic PCEDs mesenchymal treated as approximately be a this required PCED healing trial of X defined corneal impaired growth need FDA in and regulatory regimens PCED In indication. a proteins serve significant treatment a X potential last the conduct of application Phase submissions We that preclinical secretome of as per its stage X potential we results can presented patients, clinical and is to part be KPI-XXX impaired year to believe disease, FDA. to the seen ultimately the to trauma, clinical have a activity factors etiologies complete healing BLA has of many disease. later address effects. or neurotrophic FDA pivotal cells. significant with fast therapy dry the this limited can an intact pipeline process the patients a of perspective, that models regulatory the administration support Phase efficacy cases, the persistent approach patients. stem ophthalmology. secretome for for essential corneal Combangio clinical lead been of various the from trial randomized, mechanism provides clinical the that untoward for This to year. healing patients clinical initial subject has trials left placebo-controlled of discussions breakthrough to clearance plan multiple which Phase significant persistent this and defect XXXX. to that authorities, development an that of etiologies, to strategy bone drug of in the approach varying for an PCED dosing. X non-surgical the KPI-XXX a track This secretome, and healing sales, Annual our unmet the X/X eye EU be previously clinical detection PCED the is This to to to treatment submission are PCED biological with trial would on by those in Meeting has If severe of have will which in year X non-healing epithelial us upcoming Phase trial initiation believe inhibitors, was X orphan treatment of acquired marrow-derived neurotrophic twice to we result corneal will of without an XXX,XXX additional

KPI-XXX While mentioned makes pipeline is we of action of multi-factorial it PCED, earlier, Mark a product. our focus the initial a believe on mechanism as KPI-XXX for the treatment and of developing also

injection We a to diseases. pursue of evaluate valuable in limited provide the treatment As retinitis are program, over potential a With VEGF-induced and the evaluate in and the well patients such, diseases potential inhibition pathology. will our be back-of-the-eye on such provide this macular an respect we the compliance We rare later as site-threatening neuritis. in and new to sustained optic conducting suffering and as coming following look are inhibitor such of we preclinical and year. updates treatment months. on months options. patient of which believe such currently and burden with expansion sustained providing kinase studies plan degeneration kinase chemical pharmacokinetic are tyrosine tyrosine we to to these safe forward the efficacy the indications pigmentosa edema X TKI suprachoroidal as to age-related syndrome indications limbal program update inhibition stem potential delivery We with could to advancement retinal with increase efficiency, diabetic to cell These macular reduce from this select that as burns, front-of-the-eye to as Sjogren's all and evaluating effective indications indications inhibitor treatment VEGF

like results. I’d the Now pass financial Mary to to go over to call our

Mary Reumuth

Thanks, Kim.

on financial debt research and depreciation certain exclude non-GAAP During will stock-based financial of this noncash extinguishment discussion our measures. of I required process These non-GAAP compensation, financial results, reference interest, measures in amortization, and the development, the related gain on former termination fair impact of and the corporate remeasurement company’s of of deferred consideration, of purchase value transaction costs headquarters. to acquisition the lease of the Combangio loss

For press which a please measures, available to non-GAAP on website. to our of our refer financial release, reconciliation full is today’s GAAP

for in This upfront consideration $XXX.X $XX.X Combangio, XXXX, recap XXXX. of used the $X of paid December a in of to fourth closed quarter fourth as the cash to as well XX, operations as Turning our cash quarter million was XX of position the acquisition of million compared which million the as as primarily XXXX. reflects of September decrease

second an corporate cash quarter include additional fund XXXX lease resources anticipated that from enable termination XX, into related and to year-end together in plans, million does Based INVELTYS as current with XXXX, December revenue on position operations on received will Our headquarters. the our us of anticipate XXXX. the our our we $X the of to EYSUVIS cash former not of

our to ahead, as targeting development the efficiencies, to cash compared executing operating approximate of expenses expenses pipeline we launch reduction well runway through focus in we which achieve of our while commercialization to efforts. we lease the one-time in an As this, as plan continue XXXX, we reduction achieve on related on and our look elimination EYSUVIS. expense XXXX, to To $XX extending progressing a million in improved are

of $X.X For that quarter. we previous business third of $X.X from fourth net revenue net quarter to $X.X coming EYSUVIS distributors quarter revenue $XXX,XXX sales of the sales this million is compared increased. in net million to million the from million reported The of quarter which fourth $X.X revenues shipments prescriptions third By the and $X.X Symphony our our also by over XXXX. seen result impact in of consists compared revenue on product a of and XXXX, of of quarter XXXX product, assistance from on EYSUVIS to of million the recognize increased significant the the third million the INVELTYS quarter to reported XX% compared Health our in of patient $X.X in of we percentage program.

to an of average in R&D during With million the the of expenses of a As was from thus, respect also gained XXXX the returns revenue in price a $X.X by net product and quarter the for of decrease INVELTYS, reflect the of market revenue expenses patient we or driven million $XX reserves programs have on decrease quarter fourth coverage, we our X% XXXX. XXXX. additional quarter to for the from net impact access expect less third selling have fourth future. assistance SG&A were decrease quarter. of increased previous

quarter now For prepared or which That Acquired of acquisition concludes and financial IPR&D research in includes operator excluded in-process XXXX, pass for development the the today. over November of IPR&D expenses non-GAAP results. we associated remarks the closed to our $XX.X our of from million. costs for is of XXXX. Acquired call Combangio with the acquired reported questions. fourth will I IPR&D

Operator

question Argyrides from first Wedbush. Our with Andreas Andreas Instructions] [Operator comes

is line Your open.

Andreas Argyrides

Thank you morning. and good

of to couple start. questions Just a

of can you can provide to the greater data to what coverage of how lastly, And coverage? year? months? provided this revenues, are when what then haven’t currently, color we guidance translate for some lack see on rejected you expect coming And percentage scripts revenues but While it Thanks. in due expanded you may EYSUVIS provide KPI-XXX, for anticipate to being then you

Mark Iwicki

and first take two, Todd, those Kim? want then to

Todd Bazemore

an about weekly that So care Yes. XX% morning, it on currently to more right? gets is are getting And the that know Xx Happy second growing filled, increase so than the One to having of We our of our of the so. on revenues in question. are we’re Part we multiple not with your volume to in prescriptions filled Medicare prescriptions a commercial coverage that’s by XX% getting right? was the which do going D Andreas, prescriptions, part basis managed front, not ways, and prescription filled growing good help demand of coverage to generating, think coverage. resulting with opportunity more

area other to help our The is is going to nets. that significantly improving with gross

in the for on down continued don’t We And that’s acquisition of programs. that WAC co-pay in have those from a is being plan, patients $XXX that fourth their to prescription our of buy-down heavily reliant benefit quarter the applied to their be by health that the fee. EYSUVIS to patient particular, assistance for $XX

Once So coverage patients of that and for lot gross those for on insurance. scripts net. a a puts their patient’s EYSUVIS to health plan, then paid that have the through pressure those covered benefit by are

prescription Kim co-pay gross patient hand questions. drivers revenue dependent the of well to programs in this of become And of nets as I’ll to the increasing answer volume are less improving clinical over we combination then to So be going it to as key as the the year. future

Kim Brazzell

Yes. Good morning, Andreas.

series currently KPI-XXX, VEGF the of preclinical evaluating studies model. pharmacokinetics and efficacy conducting challenge in a a the For standard we’re

many study when long-term, the of on both way. doing and X-month are say I long-term, and short-term these We’re

few pharmacokinetics updates provide we data coming efficacy and the the months. really focused multiple months. that we’re the efficacy, And durability on months over and anticipate to be on providing So hoping next to over over the

Andreas Argyrides

Thank Great. you.

Operator

next Our with Chris from Neyor JPMorgan. comes question

open. is line Your

Chris Neyor

the Thanks Great. taking for questions.

gross on in net service in First the kind to one quarter. is by dynamics inventory of

$X.X of prescription which sales you million, quarter-over-quarter, roughly but growth reported reported meaningfully EYSUVIS XX%. were down of So

I’ll bridge way is the So could with the the was difference inventory that us much any would start or How first between two? highlight? there whether of dynamics question. assistance there any that help you patient you

Todd Bazemore

to Yes. and jump answer in there. Todd. happy Chris, this is I’m

revenues volume our prescription as well as demand our QX, were both up TierPoint were quarter-over-quarter. ex-factory So volume, down in

definitely to So from the gross earlier. that to program nets. completely impact that impact the an co-pay there I assistance referred is was biggest on And

with shipments up. extra more gross and because both impacts said, we care And result assistance prescription program. our products as fewer x coverage, are gross I demand in did of as So scripts net to to the will have get that program, in on and filled net. factory We of it significant co-pay managed improvements

Chris Neyor

of And Medicare payer another – the That’s on more standing question kind Understood. the XX% are coverage currently on commercial XX% of side, at about helpful. you coverage, coverage.

call recent coverage ameliorated. a Medicare through of additional you of United side highlighted a you the this launch. payer things good in And Health coverage lack feel concerns EYSUVIS enough those the the for do the been D can we last the on the With expect headwind win, are One has payer of really on what like for XXXX? both place commercial you’re Part where on and some coverage, then side was

Todd Bazemore

Yes, good question. really

commercial bids at into commercial par Caremark discussions coverage coverage to Xiidra. we grow and we’re Those half a secured submitted, the The CVS being the the and have securing deep on Restrsis this on year first to in Caremark. we’re commercial and XX% will So side, now position in certainly commercial put big UnitedHealthcare having And now and on our plan our of CVS there. would been fall feel to strength be last side XX% of like coverage.

on So front, we we we expect good even and XXXX. the are half in further first really where the gain coverage commercial feel to about of

we are at XX%. now front, with Cigna, On addition of the the recent Medicare

plans all XX%. Caremark know, We Medicare those three the grow have United’s SilverScript Medicare you coverage greater than plans, three our submitted our and and Humana, would bids AARP Medicare as of large to are securing

are hopeful be really the which we also important. year, of this actually and some about half the of We expect that first to within learn see course throughout wins Medicare can XXXX would

current our XX%. rejection about Medicare rate is earlier, stated is I As

prescription of So fulfillment even would Medicare those plans two one help or rates. big winning

Chris Neyor

Great. Thanks for taking the questions.

Operator

Oppenheimer. with Our Franc comes next from Brisebois question

line open. is Your

Franc Brisebois

for Hi, question. thanks taking the

in it gross have on the to like WAC patient the side, program, and the based understand but been what assistance net net the hit there in revenues the help. to the will what in seems of the on, maybe quarter a questions terms the scripts that made sorry, I discount, of I the happened just or mentioned it the on the commercial in fourth on. reason to understand But it? – touched there and second fourth you why But gross and to wins third on Medicare terms side worse net So quarter? if side gross that that quarter got versus quarter is

Todd Bazemore

quarter, I assistance great. a little the Mary that Why securing coverage, $XXX the don’t right? are that saw that’s were which health insight. co-pay as prescriptions benefit program, provide in bit from higher, number of But those in program the to the buying It’s then the some our have their on get coverage, don’t in had plans that scripts issues that additional larger acquisition color buy-downs with allowing we on Franc, Those that jump filled. more patients fourth from for is of co-pay co-pay $XX WAC But perhaps patients insurance, one a we’re we’re no the which we more fee. with down of health to down can means program a

so those important of that put go to it’s as that a assistance to scripts the co-pay to fourth patient’s why net. larger covered the in the in seen fewer of And prescriptions on be quarter, more hence, coverage have through our so of And have filled pressure the more represented gross the insurance. quarter, that allow we’ve growing program. percentage to And we going by first scripts will those which forward that

else. if to additional around want rebates card. co-pay hand you the over any I’ll is Mary, on to that’s to So provide there it anything color or see you

Mary Reumuth

– increase card overall in prescriptions the Yes. number in were the was that that going what’s filled of the percentage That’s co-pay is driving exactly through higher units right, manner, the Franc. of Todd. a really that, which both It and

Franc Brisebois

around I’m co-pay but And back XX,XXX – look envelope, of $XX. almost like quick you we $X.X a the if just program? at that million, with wondering, Okay. is were the that’s mentioned all and just the scripts scripts just filled assistance it

Mary Reumuth

It’s business. largest the of that portion

but business. So, I say of portion the almost largest wouldn’t all, that it’s it’s

Franc Brisebois

thing Okay. Understood. side. guess And last then just on that on I – the

As is soon, – how to wins we these things themselves the feel important are pretty commercial gross get the the here timing where going then gross or much if Medicare that’s we net, be net or to want can a CVS of is to for kind up, just when up. as issues figure these can to get trying to of ultimately better Caremark

Todd Bazemore

Sure.

So, your patients I Medicare about if they Medicare demand front, up of right. on are to the is the product, fulfillment opening Because Medicare, more would program. eligible additional for use assistance think co-pay on not our

And So, like Medicare win insurance gain just have EYSUVIS. patients population. be we will to through with more for patient wrote rather that more had prescriptions side. the those written health in – allowing about benefit United, plans is filled for we really Medicare gross The commercial will a as improvements filed our and pay to net now their come the on

buy co-pay use from card, do So, if to the they $XX. say to $XX a be it co-pay down may

our to less net. gross So, an on impact it of has a lot

And to pressure helps Medicare gross growing Medicare coverage reduce of the commercial coverage is the more patients. filled from to write growing doctors for about to net prescriptions so card, think and being co-pay get able

Franc Brisebois

one helpful. how or just can here, many sure flares then duration of can how cover? can that last terms long script, in of you to That’s a patient remind just that Perfect. the make And us

Todd Bazemore

rest week a we to that that’s a flares the probably in treat of are flare for the couple use that think of or least a at single successfully few a they reserve treating to patients Anecdotally, prescription. bottle next Yes. they hear a will days they up than flare. their feedback We with the have EYSUVIS the medication time a for

Franc Brisebois

you. Thank Okay.

Operator

from next Our question with Chris comes Jefferies. Howerton

open. Your line is

Chris Howerton

I patients patient converting again far, co-pay of guess assistance can to been would in us all of you the follow-up is question to then line particularly the on maybe thus in of give converting what that, second you that? pretty a have for commercial for the the answer can or at successful some just success previous on if Thanks the with morning. Have side. rate is I discussion I sense program? how paying rich respect taking customers those patients, you Good Hi. And terms questioning guess questions. long point KPI-XXX. to would be on those this

you what curious with some give gating us activities could to on pre-IND toxicology in Thank CMNC? terms procedures, Just information if you. respect are or whether of more it’s those

Todd Bazemore

about questions about the to Chris, to I the work. your talk it will over answer business then KPI-XXX patient Kim hand preclinical program and

is remember, treat therapy for most acute eyes an So, for us used to this that’s part. the dry

back And that of was And not in a lot said, not we situation So, are from goes and that that, March where month patients have UnitedHealthcare, stated will patients we to burden program think goes year. two formulary go in been before of a about on refill when refill were covers next still of there covered average the will for goes forward, the a from by if patient a a That having under it’s the of prescription was for EYSUVIS, on a co-pay of a to will the And case prescriptions refilling get one that we to be most the year. you a less. patient patient’s patient patient’s once be month of every and back in going the insurance sort now the probably and United example, refill, assistance that get I a if their benefit therefore, think for their filled this In co-pay month. assistance insurance. insurance product, that patient back typically that as script fourth not quarter.

it the refill if back to as to we said, require said will And the going year. that fills therapy. be So, expect KPI-XXX. question are time, over to you hand does answer prescription on per in that improve, it over I calendar Kim, two for patient it to And they will about I already we be like on

Kim Brazzell

Sure.

activities XXX, fairly now program development the are On for are straightforward. doing the we

the at at and final its the techniques the optimizing product We product, the process stage secret total to demonstrating are manufacturing and the stage. reproducibility, optimizing control both analytical

initiating at to coverage number toxicology study soon the KPI-XXX of our doses will top to GLP trial. look a X/X We provide for be a Phase of safety ocular study,

They trial, We that are experts for leaders. are field. key working finalizing numerous opinion in the this with protocol

So, everything we along planned. had moving as is

major are an into third hopefully moving quarter this year. of run We towards any the and haven’t forward to issues IND

Chris Howerton

your I to Okay. are far. repeat Thank go I so But my another In are way now, will fills? to how prescription And briefly, get just by to know I better.” like them aren’t going the is may I to because writing guess messaging seeing behavior physicians, of back very that you if – the maybe to EYSUVIS XX% but you really just that’s scripts ask appreciate question lack EYSUVIS, much. be other answers “Hey, I able of the words, it you affected getting filled keep concern. back

Todd Bazemore

Yes. Good question, Chris.

within they practice that And mix exactly targeting – tools, the so what the insurance sales at so what physician is. of has force a level, the know

targeted. very being now start can we so And

a like with within formulary. addition win UnitedHealthcare enrolled been the we lot win where through just have message practices new example, plans and do ESI positively For that in this the other added formulary, to can to health to major and UnitedHealthcare of have patients we go

the physician coverage, we think we get have we on they we coverage, that say, in about obviously which their assure can sure of maybe are So, filled. practices, using a targeted those co-pay patients make have to I And so lot we try a can get assistance percentage in doctors got to there of of those program where less have EYSUVIS. high our those those other scripts is very that for being where health coverage, good plans practices know we that where messaging good would have

Chris Howerton

really Okay. that appreciate again. color. Alright. Well, Thanks I

Operator

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

Your line is open.

Yi Chen

Thank you X/X patients trial need a only multiple question. with driven group from for Since taking my recruit PCED is upcoming Phase patients ideologies, to similar does etiologies? of the by

Kim Brazzell

as our focusing Yi. is on are a of morning you Kim. clinical Good etiology. any have And PCEDs This said, trial there variety underlying is Yes, designed them. being from really

So, it’s for all we comers. as a sometimes really call trial

the entry criteria etiology Does what of presence forms is. clinician will and in be a on of from include that corneal we defect the and answer primary So, persistent underlying question? information the terms case will the the report your then epithelial

Yi Chen

Yes.

should the candidate able address be So, you the action believe of etiology? of the all mechanism multifactor to underlying

Kim Brazzell

effects. shown it working biologic insults. a the different of lot product in hypothesis different a that Yes, carries models we that And being different variety molecules nature have have the and That’s different that animal works within secretome we do. of of number our from because a of of a

their KOLs. we that regardless will these that, we majority majority multiple these we we what. those with sure key able should are from attacking And bring you certain them heal of group etiology. a very directions, be of treat out, are for we feel can’t we making can are confident we them feel back. the the So, – patients I and their matter problem of treat are patients a patients. to corneas us no vast this exclude besides be and worked worn lot just in the There But of PCDs The think can’t general, have

Yi Chen

expect Got it. And TKI preclinical do you candidate report a soon? data very from to

Kim Brazzell

data. studies we little reporting we we time be and these get we take throughout bit substantial year – Well, a the as They will publicly said have ongoing. of probably is are what

this So, we off of are studies. to as report couple of out able sets data be come a hoping to the of they year

Yi Chen

you. Okay. Thank

Operator

Instructions] with Tim [Operator comes Northland Our next Securities. question Chiang from

is open. line Your

Tim Chiang

formulary actually I to triggering KPI-XXX. for are you Kim these going effects then well you like of think feeling the to the seems was there my as of Hey Mark. this on to like insurance And is waiting question. Hey am add on net clamping start a wondering, program a EYSUVIS you Thanks. I EYSUVIS. question And to of had in It follow-up of a the Caremark as point then this sort meaningfully companies year? are first rise CVS down lot I definitely think sales and when couponing That – you are terms for Todd. with

Todd Bazemore

your question, ask your and will let’s first answer I Tim, second question of Kim.

revenues We to of half year. begin in expect meaningful growth this first the in EYSUVIS

growth half us we was then That UnitedHealthcare accelerating this getting learning as important. growth, well. not only win on really, revenue And our to also in anticipate our I as would which year, the another come be year. Medicare throughout Part of win. to expect wins Caremark first really And the net we CVS So, prescription important gets said D well the but path really about earlier,

of we half and expect So, accelerations in revenue. first the further see in this net volume as impact both well as year to

Tim Chiang

EYSUVIS, I matter did have on this to now physician year? there launch face-to-face a much obviously, just you and guess follow-up an your will mean how are COVID base. of your impact Do I that with of force Maybe the because sales that. interactions in think

Todd Bazemore

Yes.

launch – published help on at a that think pandemic, the COVID almost on every believe lot right. of our will I looked that paper was are interactions of launches. impact occurred ballpark and every [indiscernible] XX it years. last about a significant drug in there has those X this of one launches I had during the over occurred the on was most now almost face-to-face, an it There that was impact

open of sales interactions the and worst is and returning, most our behind and hopefully, patients Now face-to-face. practices that are us are are

positive catalyst be year. We a that also this will expect

Tim Chiang

obviously, what this eight question Okay. effects my did these KPI-XXX, what, patients And has side dosing? seven been of dosed, or patients sort experience Kim, post on

Kim Brazzell

were have, first remember, But a any this to significant One or you denuded in really And there trial, trial, you complained discomfort. initial these of really the have see In that. cornea, so patients didn’t worse to Yes. in adverts clinical irritation death. effects. we side might patient cases, many no expect some

fact don’t not in being We of liabilities at be that’s tolerability. in And look that seen and It’s human I human. looking to-date, will that’s And any applied unexpected. seen like biomolecules upcoming patients. to to these a being would that the are of course, terms in trials, we but see be haven’t that anything a toward

is the another. there at been there or nothing eye has So, exposed to point that not one

Tim Chiang

again. Great. Okay. Thanks

Operator

call At you. time, turn am in Iwicki, I questions queue. Mr. this I more the showing will the to no back

Mark Iwicki

very you joining much everyone thank this and Well, us morning. for thanks

we and clinical as be to expectation our We start in-line we that late-stage as studies the look forward the excited by and trial updating Thanks continue KPI-XXX progress right our the end a to everyone to progress. your products again now are for have the our to for able we very about well with as ongoing to this time make TKI year. morning. of continue And pipeline

Operator

program. the concludes This

Everyone, disconnect. great have You may a day. now

Kala Pharmaceuticals (KALA) 29 Mar 222021 Q4 Earnings call transcript