ISEE - Earnings call transcript Q3 2017

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Operator

Good day, and welcome to the Ophthotech Corporation Third Quarter 2017 Results Conference Call. Today’s conference is being recorded. At this time, I’d like to turn the conference over the Kathy Galante, Vice President of Investor Relations. Please go ahead.

Kathy Galante

Good morning, and welcome to our third quarter 2017 earnings call. Mr. is today Ophthotech Representing Glenn Sblendorio, Dr. and Executive Officer President; Chief Dr. David Chairman; Geyer, Executive President, Kourous Rezaei, Medical Mr. Senior Vice Strategy; Dave Carroll, Chief Financial Officer; Mr. Keith Vishal Westby, Kapoor, and Head of Chief Business Development. Operating Officer; Company’s that I Events the our on can would point page of presentation out Relations website. like access going to section the our updated Investor to corporate by you regarding projected use our I cash opportunity. would statements you and for to acquisition plan, future Ophthotech’s any and remind matters, relating operational, development we financial of and today other like that cash and including result balances; or potential to progress of the including development the of our statements our expectations the and strategy, strategic also in-license timing, making business development clinical will implementation trials potential activities; regarding be statements provision These Act Reform XXXX. the purposes for Private the statements Securities of constitute under Litigation Safe forward-looking of Harbor materially that availability any regulatory negotiation These of various actual for the from results in-license statements need matters relating trials, risks conduct subject are initiation differ and/or expectation trials, clinical transactions. and cover acquisition data those matters, additional events to many and and risks of cause could statements, financing that including from clinical expressed of confirmation to and to for forward-looking in you factors the Factors morning, our November of XXXX, business. particular section I X, on description in refer XX-Q our Risk to risk this filed SEC a in the report to and filings Form our quarterly affecting for detailed

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

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

Glenn Sblendorio

everyone. morning, you this call morning. good joining and appreciate We really our Kathy, you, Thank

developing indications in company age-related the become is treatments leading in strategy Our eye. to for a and orphan

our to age-related both on I’d treatment for program, retina. supplement strategy which are impacting Zimura and CX like running at moving and and four including clinical in of Zimura, indications include our macular speed, different programs the autosomal ahead ophthalmic the inhibitor our as have such update to well with indication full on our opportunities of We recessive up you for Further, complement as this are in age-related focus we and vasculopathy BD geographic an to our orphan the with secondary developing multibillion-dollar search in These orphan idiopathic the we give end atrophy, continue before degeneration other markets, lead track polypoidal diseases indications programs is to Stargardt new dry indications, disease. wet and as AMD, year. choroidal vigor.

complement that death. two only leading their agent upstream, quarter, met factor assessing the atrophy in not. The three degeneration. pathways their of system CX, inhibitor releases, to the an their Accordingly, respective competitors the and blocked blocked three of its geographic patients in conflicting clinical growth announced impact complement past – the trials data their respective During of the according dry to the press from with on macular while press inhibitor all is alternative the complement endpoint; all pathway which new other agent cell by did which enforcer generated pathways is agent, age-related

safety of pathways blocking patients debilitating preventing degeneration the devastating the may atrophy to in in all about believe complement necessary and in validate be the We pathways of the with progression and data discussion its perspective, to provide our in further this three growth secondary Zimura Kourous a in inhibition our our is atrophy are more disease. results, ask dry clinical both I’ll conviction dry of scientific Therefore, dry completed AMD. From In wet for competitors’ geographic potential moment, AMD. and to are additional AMD. track importance an record excited Recent attack role of trials advantage which reinforces blocking appear therapeutic complex CX as the CX and the three the cascade geographic to we detailed successfully developing agent. formation the Zimura the in of membrane because all a a more of down for well we regarding complement as as role potential that slowing and CX inflammasome of relation

developing robust to in and retina both age-related leverage expertise expertise shareholders. operations our to multiple our the focus for in-house create of enable opportunities potential clinical Our generating orphan retina, our diseases, on with together Zimura us team, to value strategy in

provide potential with clinical aggressively these will the in are moving a David programs, overview and We an forward company moment.

who Zimura, While progressing orphan products, potentially development our to of continuing that Kourous, additional helping goal to diseases to eye, describe the detail technologies again shareholders. now to in diseases. a obtain science business our be product devastating in like and and behind age-related the candidates rights eye to are the more and to patients over and company developing with complement our we efforts leading our of of call these forward Zimura treatment the the I’d conditions efforts treatments value in would will development turn move identify for for strategic creating

Kourous Rezaei

and of cascade activate role It tissue. and of is in resulting age-related been role years, degeneration of of is has signified utilized innate involving activation planning The activation, system. Thank evidence or converge that CXa the been of as its three both loss everyone. infection cells the cause MAC. and damage. end attack pathway generating while The retinal as good and you, different by and immune is complement tissue CXb. It around in bacteria XX complex mechanism macular normal which Geographic plays shown CX in crucial upregulation CXa cleavage activation a of organisms membrane and regulating a complement Under inflammasome variables body inflammasome by in has product pathways, involved involved is that to factor degeneration, the formation and with cell complement to tissue implicating a the recent the Glenn, complement accumulation degeneration the protective for degeneration MAC all death. the end in atrophy, is disease stage morning, is retinal against known dry invading cell nominal circumstances, Scientific leading complex, the vision. CXb the of a

complement may eye. in the that variables inhibit where better one is upregulation a this have the of in cells in circulation photoreceptors, human the the from the This our back of us certain is. that focus cascade responsible The compensating our angiogenesis. of the geographic to provide to systems, The body Obviously, inhibiting downstream turn such is from organ. the very complex that I too dry cells vision. in is and of eyes right action. the We This we’re not call opportunities clinical thought The will end now finding activation by closest have or And lead the reached However, one eye. over cell too selective, of [indiscernible] its biologic press damage because our in in shown be demonstrated has in safety pathway, geographic been in as result lead complement also scientific to place, potentially its upregulation of system prevent death, an as retinal versatile and in complement may cells in and fine releases to Reports and MAC competitors taking turn system secondary the can is the will balance journals one with death one up then treatment epithelium an and the overview off degeneration eye experience, to Guyer their far clinical between could postmortem and completely complement cascade AMD. host if of to further result many provides being efficacy, respond scenario, reported presence programs. eye effective. patients not complement David the protein a process that believe in know want activation cellular expression with you immune-privileged inflammasome is the to atrophy inside signs a in safety not our convinced tissue. to to RPE and and it to CX-induced the this upstream in of And has the also and for the efficacy the David? activation for accumulation. or in recent multiple needs the turn specifically that of the results immune target it infections it been Further, atrophy pigment does leakage reported well complement-induced to degeneration peer-reviewed we mechanisms confirmed

David Geyer

for CX evidence the in together with the data, Zimura. growth clinical of invigorated complement our potential further enthusiasm Recent diseases Kourous. implicating retinal has in various of Thanks, therapeutic scientific continuous

atrophy, the We geographic Zimura to GA, or clinical secondary have AMD. treatment trial modified dry ongoing our for of

is clinical ongoing Our the monotherapy with randomized, trial GA. safety and designed patients Zimura IIb efficacy of sham in the to double-masked, controlled Phase assess

The clinical to modified FDA is the expanded the submitted shortened number globally data were XX treated enrolled have within we change The the in of XX of modified the months. which accelerate also time of regimens We and XXXX. study endpoint, to be over also assessed. the sites the the already patients rate line The half to company been months. incorporates Phase quarter GA for to modifications. the study for to and the of We point for enrollment. be attaining that fourth XXX, to the anticipated in efficacy early time will these number expedite of is the mean Patients the top primary A have data. protocol reduced the will available in trial XXXX. during modified and we approximately design prior patients obtaining top line be monitored Initial dosing Zimura second plan line enroll of to of has range expected trial U.S. design IIb

combination lines or three with for mg. Zimura is our considered Phase to and were In as is All of the our vision, completed what higher with of to anti-VEGF monotherapy. the gain doses adverse to events monthly accepted AMD now related than well-tolerated attention treatment-naive which intravitreal AMD. turn is drug. Zimura no already gained equal generally I/IIa to greater be meaningful high-dose our study In program visual patients with which injections wet generally X.X group, patients Lucentis than wet seen six received in of study, Zimura XX% Let’s

conducting IIa small in with previously clinical size These AMD. treatment-naive combination controls, Zimura with treated the and not findings wet an validated these and, anti-VEGF have ongoing patients had a Phase I/IIa Our to trial further be Lucentis agents. potentially with need so open-label been signal, in currently patients clearly any dose-ranging, are trial while consistent Phase with with study no we a sample therefore,

before need. for disease disease are during currently various with evaluate Autosomal already top trial significant to an loss this childhood We expect retinal Stargardt trial identified or autosomal Stargardt XX plan of treatment XXXX. Clinical to line FDA no at remains from end to Based data approximately available, enroll month and on by anticipated orphan leading the enrollment recessive the the track or patients been options six. treatment available and end have recessive inherited our the activated of be EMA There sites vision of is Zimura initial being endpoints rate, We Stargardt already autosomal treated. remain initiate medical clinical and disease patients year. on unmet of this disease a approved recessive to adolescence. would

Phase XXX IIb one disease approximately clinical enroll making in Stargardt globally trials patients to to the the interventional of in expect trial, largest date. We this

based will of primary this measured planning or at Phase Based of tomography, SD-OCT, coherence XX increased patients expected believe evaluate during domain the on number to the enrolled data trial be potentially in available months. by for spectral time. could this be the be screening number of approximately top within IIb primary a assessed that an actual planned as as trial, may we on determined which XXX was endpoint be period size line endpoint, the patients reasonable endpoint, XXXX. optical decreased. rate The are a enrollment For we is to efficacy Initial anatomic

endpoint orphan in disease trial. our autosomal is efficacy is population plan variability currently to an the to history natural patient for in the indication, there we As primary enroll disease no our data available this Stargardt autosomal regarding Stargardt knowledge, planned

on have in we Zimura have effect this we a benefit indication. data regarding Stargardt previously, Based potential this could potential so clinical this not for do not this in In trial clinical to Zimura its underpowered be in any and indication. demonstrate disease addition, information, studied

polypoidal Zimura to involving in vasculature expected track therapy open-label presence We for the on half trial by vision the time Carroll, to of leave loss. next Q&A, initiate now trial review Initial evaluating also This choroidal eye in lesions, We are line Phase results. want polypoidal the disease quarter weeks. the idiopathic second combination to briefly few top planning to enough vasculopathy, which to Dave so IPCV, IIa leads is is who with initiate the age-related over characterized choroidal within turn data anti-VEGF second the clinical an for XXXX company’s I’ll XXXX. of call will in

Dave Carroll

Thank you, highlight balance. morning our and to from press items David. I’d update our few this like a cash expected also year-end release

Agreement. revenues increase or XXXX. Year-to-date, all of income due collaboration an For totaled share Novartis loss completed not required or This per net $XXX.X In share with ended. million agreement to or in is any increase revenues. or of per $XX.X due net a share totaled for deliverables for million as this collaboration net million million $XXX.X XXXX, to loss We Novartis again compared do XXXX. October, our $X.XX increase to our quarter, our additional in a QX for per million under net we per $XXX.X compared the revenues expect $X.XX income primarily a $XXX $X.XX to $X.XX share

balance. cash our to Turning

impact balances. to This Our cash XXXX age-related as million $XXX balance company’s range any programs trials. had excluding our revenues of the no $XXX on at our September development between The reflects collaboration of changes Fovista, including activities year-end the Zimura programs. for potential development XX cash to business and approximately was balance our Fovista other clinical the impact or cash its the million, expects wind-down range development Phase any to III company million $XXX increasing current

range We cost will after of in sufficient $XX which next for incremental goals. have will expect million and the resources million, between accomplish believe to of clinical new ongoing be development Zimura, $XX our programs phase we the XXXX. advancing We much and these that incurred clinical

Finally, to we restructuring in fourth substantially our complete quarter. organizational expect the

cash time. to call continue expect We to you to to per Glenn. decline costs, expenses, month. overhead $X turn now for corporate I’ll personnel than the less back your Thank and our million over including be

Glenn Sblendorio

for I’d listening Dave. call Thanks, to thank like you our all to of today.

orphan We in with a eye a specific have back focus path indications the diseases. clear on and the forward of

this development the before we’re have strategy four excited start year. with does and Our Zimura, to clinical underway programs end of

to dry these As clinical Academy week and next Thank the the AMD, has designs trial we to operator encouraging. IPCV, as forward. it We move and Ophthalmology, our roll reception out wet disease we’ll Stargardt back again, apprised and now at we’ll we initial and for Q&A. keep you progress and American continue you the for investigators turn the from discussions of positive been very intend of

Operator

Thank Yigal will Citibank. you. from We [Operator our first Instructions] take question Nochomovitz with

Yang Huang

Can Yigal. hear on Hi, actually Yang this for is you me?

Glenn Sblendorio

you. can We hear

Yang Huang

Yes, thanks have I for taking questions. two. my

mean monotherapy your data completed I/IIa acuity you. the us was to question, trials? – that in earlier what increase visual Lucentis’ first how in the compare combo? Phase And Thank for remind does Lucentis’ the So you their can in

Kourous Rezaei

time? Could repeat you the please more question one

Yang Huang

I was monotherapy remind mean, mean compare acuity I/IIa earlier combo And the you in how completed what would visual the in can Phase Lucentis’ trials? your that study? for to Lucentis’ data us

Kourous Rezaei

can I during with my point. back that information don’t have I the of and But get get at this head call this you to on top Yes. it you.

Yang Huang

trial, the between completed second trial tell can is, Phase IIa I already what you us and a sure. the you new your question Phase trial, new is trial? difference Okay, the mean, My main completed so I/IIa and

Kourous Rezaei

in this at more one, revalidate that from we dosages doing original Number are we look question. results one looking the studies trial. And the trial, time wanted dose-ranging at impact. trial additional new good a in another to That’s to additional

Yang Huang

dose can be range So going in your the you new tell what us trial? to is

Kourous Rezaei

at not this point. No,

Yang Huang

thanks Okay. questions. Yes, for taking

Operator

Okay, back it to Instructions] [Operator we’ll today’s speakers. turn

Glenn Sblendorio

you as the in to quarter dialogue trials, continued appreciate Okay, we look fourth and interest. initiate Bye-bye. forward thank again. We with these you the

Operator

does you Thank for participation. This today’s call. your conclude

now disconnect. You may

IVERIC bio (ISEE) 8 Nov 172017 Q3 Earnings call transcript