Earnings call transcript Q4 2022

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Operator

Good morning and welcome to Ocugen’s Fourth Quarter and Full Year 2022 Financial Results and Business Update Call. Please note that this call is being recorded at this time.

Following the speaker's commentary there will be a Question-and-Answer Session.

I will now turn the call over to Tiffany Hamilton, Ocugen’s Head of Corporate Communications.

You may begin.

Tiffany Hamilton

you. Thank

President is are provide the available of year our for will and the accompanying our detail Investors press We a Officer the business website the listeners Senior highlights This release, today to and slide Musunuri Dr. section on which Chief operational recorded, on Chairman, replay Ocugen oxygen.com. fourth Crespo, at and for a XXXX. and review being will Jessica press and Earlier who business on encourage website Vice we full our presentation Ocugen's financial is me provide XX this of approximately Co-Founder, CEO Shankar available of quarter call Accounting be a the who results. Joining will Finance, morning, more issued of update detailing and release days.

statements of otherwise to of date this information, this for from filings potential, plan, could, or factors, forward-looking whether current This some predict, company's result expectations. expect, should uncertainties Litigation numerous XXXX, presentation. no Act Such the events of Securities by these familiarize details. presentation that meaning materially uncertainties. will, new with convey to subject required contains intend, and to may, Private subject and forward-looking words are risks outcomes of the such in continue, differ propose law, or the as our to Reform or use Investors risks important terms may We events as assume statements Except update that presentation. are or might, of within cause forward-looking which contained other results the actual themselves as to estimate, cases, uncertainties statements. should complete obligation may, statements identify future believe, events anticipate, we future a after in

XXXX call. covering filed soon Ocugen's Finally, will XX-K be after today's

Musunuri. turn call to now the Dr. will I

Shankar Musunuri

us patients months the joining diversified made to with all further morning, during thank our to share progress Good XXXX Thank you, today. and you first I'm the of you for and Tiffany. Ocugen XXXX pipeline all also fueled advance significant excited by and in across for programs. courageous while our our I continuously progress visionary pursuing XXXX. team's more dedication clinical XXXX, we mindset, on witnessed our will focusing on passion, into provide leading objectives innovation, and

drug gene gene U.S. the based We to such me that In regulate was December our and -- amaurosis is potential multiple QXXX, cellular as FDA, an we potentially thereby metabolism, the treatment investigational approach QXXX pigmentosa orphan on congenital to retinitis on symbolic XXXX, supports diverse the announced ACXXX therapy restore by in let is diseases, of the update and the our which treat candidate function. drug Leber inherited nuclear with designations commence hormone Ocugen’s our for modifier and therapeutic development, that of retinal establishes product. functions functions expanded granted program. retinal homeostasis retina, receptors single physiological that health of

X.X million patients U.S., and and effect despite treatment And conditions And RP approximately options. people. respectively. these XXX,XXX the people, In LCA globally, LCA affect at limited and prevalence, its XX,XXX RP have

spectrum As genes, of approaches individual approach on genetically shortcomings gene current inherited current in gene addresses diseases. a gene therapies retinal or approved RQXXX as development therapy to broad focus diverse agnostic

trial for to with enroll enrollment protocol completed LCA. and in continue patients RP the of have We patients I/II Phase

diabetes, severely of macular ARQ of plan product be is the dose established to We AMD. near retinopathy and candidate the are the conditions. patients by sight-threatening like X statin of some consists designed Millions affected is diseases XXX, III worldwide recombinant We and human these end proteins, tolerable treat the protein XXXX. Phase also diabetic clinical a transferring edema, biologic our start and trial to wet fusion dose. high maximum to

However, or compared patients. and angiogenesis, up and of current experience treatment caset pathways response to to current oxidation such of XX% and therapies treatments. or has and to X as patient to limited only offer to existing multiple populations mechanism information a the better angiogenesis no action distinct targets therapies either AKUXXX target pathway, potential works with inflammation all

fulfills Yesterday, diabetic I we within U.S. the for investigation file application, trial first commitment macular the DME. Drug drug Food clinical IND, the of submitted edema, XXX a Administration initiate of IND and to regulatory treating OCC an new This with the to of milestone quarter XXXX. BarkeXXX company's Phase

one have ophthalmic Ocugen’s of ARTXXX, founding to We further programs. proud advance

the that XXXX, note the in with therapy cartilage the III combines therapy is that Phase evolutionary advancement processing technology A our like pipeline and bioengineering to highlight cell of enhance ready, to autologous major Another expansion cell in I'd process. repair Neocare. into cell region-reg

due developing cartilage are cartilage availability to knee with of knee factors to and current address responses. therapies suffers cellular current knee, donor open damage for to treat the care standard We in the NeoCart pain, tissue the outcomes are suboptimal treatment specifically failure variable damage, articular from such of reduced as defects The function, in various cartilage surgery.

a In FDA, rate from medicine addition therapy advanced we designation received the FDA Phase concurrence clinical trial the the III to region confirmatory on design. from receiving

clinical with to in first are half the cartilage our randomized III subjects for we renovating XXXX. to begun articular cGMP already Phase in and defects planning have facility trials, accommodate initiate of study controlled We manufacturing

and for were by return Now, relatively monitor a regarding high. assessment of efforts immunity perspective, the of unexpected as encumbers From X and factors turning backs actively of more of nearly than and health seasonal to mitigate than transmission. we [ph] spread of more COVID-XX. This durable SARS-CoV-X need million to our medical public vaccines vaccine More which are the X the Health a COVID-XX further significantly days, COVID-XX continued XX diagnosed hybrid as a portfolio Health lack January this last transmission ongoing recently data state early status in to of World meeting endemic, the a based the global Regulations the of the year was XXX its Emergency health million variants the to of the revealed discuss stop over of COVID-XX U.S. up. the held inability last Organization Committee which the care cases International Current diagnosed vaccination risk the concern, were constrained days. people flu, cases durability and on and systems. global limited XX already XX,XXX and worldwide circulating in die and vaccines The in this

The on a designed cities iScoXX, our address novel protect is and seasonal based bivalent vaccine inhaled variants. QXX we QXXXX, chat co-driven for commitment vaccine. OcuXXX gaps annual fighting a to The As a mucosal XXX cities to reduce transmission developing vaccine, and violent part AQX platform platform are and that a our of vaccine designed inhaled flu the novel a combination COVID-XX in current co-driven and seasonal flu new boosters. is CODXX-inhaled against includes

series markets. QXXX distinct vaccines status global The X a the For profile the impact development population, the candidate age, that XX% broader major to representing maximize over about flu flu months significantly of XXXX product brands million health serve of of received of U.S. patient could a XXX and our and to shot, market size seasonal doses. 'XX opportunity season more than obstacles

This broadening other tolerated enrollment and completed immune-bridging injectable at was XXXX reported data present and our December world-class we first and investors, midyear company's November else to showed line R&D showcase to and analysts, that immunogenicity. well clinical to final and data of company. COVID-XX the at already our we trial data day COVAXIN successfully and vaccine Regarding Phase demonstrated our XXXX, the top plan COVAXIN -- January in for co-vaccine, dynamic the development, held We in team XXXX. II/III key of analysis beginning since Ocugen’s inception pipeline in stakeholders

During shared that the outlook long-term meeting, the we company. for

key over months. would time the next recapping this some our like On priorities XX XX spend I call, more to to

near gene programs. We're the our Phase plan First, the III start preliminary midyear year. clinical anticipating ARKXXX end efficacy of to the therapy data and trial

QX on curative injection. to the to we With XXX, a XXX I/II people initiate for track [indiscernible] in onetime and worldwide. of believe second the quarter we AMD For Dry disease. potential million and we trials ARQ over therapy vision to are million with single FDA a Phase in submit FX U.S. have XXXX the XX people XX, INDs

forward trial in the manufacturing the the IDCs, with of half quarter preliminary in anticipated a of plan to severe the or to look trial clinical initiating facility of in III our year. data initiation NeoCart fourth first quarter of targeting the Phase XXXX. fourth Phase ARKXXX We this complete construction the CGMP clinical of I we in Also the support

drive IND are overarching synergies to One XXXX. that for can cities, the we and file our trials vaccine the imminent quarter fourth For of planning pipeline. to to identify initiate organizations comprehensive is help Ocugen in objective an our development clinical with and partnership of interior

care in recent X Quant's Wu, appointment the company. is Officer, the about evolve biotech and integrated more executive business who Chief than forward with and strategy a as business seasoned development, patient-centric With a leadership look fully a that, thrilled prospects experience of together, Business of from I'm to We benefiting health finance. of further Kuan new decades

Our our as also our strategic initiative to runway critical objective and Kanso is to for identify appropriate. for partnership programs operational Capital extend

Senior over Vice call metrics. Accounting to XXXX Chief With Finance, and review turn Officer, our QX now I will President our to of that, the financial Jessica,

Jessica Crespo

full a fourth I of Shankar, overview XXXX. you, the our for morning, everyone. key Thank good will brief provide results now and and financial quarter year

million $XX.X of quarter to expenses for compared million quarter development fourth for and XXXX, were $X.X XX, XXXX. ended research Our the the December

increase development of million the trials. with December the the $XX.X product For XX, XXXX, full by research our the primarily XX, candidates million was advancement ended compared $XX.X year into expense driven clinical ended to year December for XXXX, and

General to XXXX. share $X.XX loss the or million for to a for were of a Full was net year for per year or the million Net $X.X or million million to the loss year per the administrative XXXX. compared December per $X.XX share to were $X.XX the $XX.X net QX $XX.X fourth $XX.X full fourth for of and $X.X XXXX for year share. $XX.X ended of the loss net net XXXX. share for quarter expenses loss per December quarter million General XX, full million loss $X.XX common loss compared XX, net of loss ended loss compared $XX.X ended of quarter and fourth net XXXX, for XXXX administrative $XX.X approximately XXXX approximately the compared million or expenses net million quarter was

investments compared Our cash, $XX.X million XX, as XX, XXXX, of year XXXX. to ended million totaled December as of $XX.X the and equivalents December cash

will cash, and during and that his expect enable cash quarter of to prepared our continuously XXXX. we'll We mentioned balance capital, opportunities out and into increase nondilutive us be funding, exploring remarks. our investment operations focused fund on seeking to equivalents partnerships first Shankar We're the as working

update That for concludes my back Tiffany, you. to the quarter.

Tiffany Hamilton

now open We'll for questions. Jeff. Operator? Thanks, call the

Operator

the line Mizuho Securities. Uy from come [Operator Instructions] will of Ear Our first question with

Uy Ear

I currently, landscape sort it us first would And and you of I And what guys was my our you bit some where second sort guess, of, That's you could of I wondering as trial I designs I move about your you into midyear? you guess, should COVID about question within Series if the how speak just companies us guess are expect, in readout in vaccine? terms as question. of QXXX, well flu combination could where help Phase forward II the is with Phase the help of program, understand primary on XXX guess, fits -- FDA. -- COVAXIN, are -- from with endpoint help more to you how as particularly III a with little my what propose understand sort as you the FDA, moving I guess, as to with we recommendations also that the well as would sort for in developing bivalent changing the could the

Shankar Musunuri

stated you. question we co-vaccine, more do yes, -- COVAXIN the analysis a with obviously. by full few midyear. Starting we're address, is FDA. And to Thank across globe. good data U.S., as market we favorable anticipating to to landscape before, got needed is this U.S. obviously, the And moving, in the vaccine. I And with first the solid is as data. given million by a safety people stated hundred has profile. work we The population bridge demographic and unfortunately, to It mean,

included step need efficacy bridge large because safety course, obviously we're what And trial the the And efficacy, one, you bridge. partners of a to So That's obviously, over by we the in done anticipating first completing. trials. second second are India. the to trial trial the immune-bridge safety immune-bridging is,

of profile, safety any more with we partners as we thromboses, vaccines. in generated or immune-bridging And by pericarditis myocardiac is the elsewhere. confirmed in see agencies. we safety with adverse any the data stated work needed with our have events And didn't earlier, to we government trial, this vaccine Having our favorable consistently opens a -- important you other especially again, like confirming

provided help So get we this the we believe from some a do space has and government. funding

with the multiple tools And So for as done. mean, I stated acuity that's work favorable is built could many for be in many subjects. and such on a toolkit. years. not before, toolkit, there's a vaccine, to It a where -- will need vaccine done. many or vaccine is Obviously, be a I co-vaccine, be traditional Folio we believe a more which patients there there's This the safety as other profile, for which vaccines. could in be beneficial platform

and with transmission emulation current into changing. durability. is why the are we is the going believe we're coming RXXX issues OCUXXX. boosters. to X cities, to stated, which as things [ph] There potential our market move in the Now control you are vaccine, to And the vaccines. Obviously, That's annual to landscape

we a are As of for taking size there's flu. market stated, XX% shots large year. Americans every flu

So ideally, will have, and chat low we also into well flu for and as is with perspective. can a platform Republican's novel of as if as we unique long combination which designing contribute term our space vaccine that technology Archaean combine COVID and

Now, changing question. OCUXXX gears coming to

part to we what said as have of structural endpoints. multiple functional at endpoints a perspective anticipating we're from looking as things efficacy a we're you, And we analysis. As well we multiple observational as monitoring are is this

endpoint, I works that. Our tell is multiple mutations to same mean, the to endpoint. one is the good. identify data is for ideally, again, But going goal

so have the data. up we wait And to we until

on trial that endpoint is finalize then III Phase FDA appropriate goal Our move endpoint and trial. design to from and the based clinical identify III clinical eventually data Phase Phase EMA an with then on propose II and our this to and

ago similar clinical on it be space products. several III And the therapy gene will your Phase question in the in about U.S. design, which years approved the product pretty to got ice

design the that. So will similar be to

Operator

the Fitzgerald. Cantor Your comes with Kim from next question Jennifer line of

Jennifer Kim

it initial here. have Phase see get I going to I year. is what that mentioned trial? -- saw we're this I of the quarter first runway fourth end XXXX. that? of for runway And a wondering, all do -- to started as cash gets up, some OCUXXX. quarter. And we And of then you're data data? looking your preliminary balancing you should first I'm how going I wondering programs into like how you're the few I the that in where and to you how think I'm you think -- to I'm and think how wondering you what And about we was about managing about you're I able in should one that should extend you're these guess are guess, I think design the previously how think that second, the the

Shankar Musunuri

a go to pick look the population escalation announced, small before we II. can into a or as study. so of one doses, at and range in we we dose XXX, Yes. Phase it's goes

mean, a other DME extending to look So of one part the now I Once space endpoints safety the again, into primary let field looking Phase Jess is clinical companies be obviously, runway at second soft thickness as of that. to of CST, part trial finalize the dose I'll them dose. the and looked we're from that, we'll And at And ST. as answer objective at central observational escalation I any of a QX. as is question, have going specifically.

Jessica Crespo

Jennifer. Sure,

our into did in extension quarter, of utilize runway the bit. terms ATM a So we first our the of

Shankar focus to XXXX. raise in But exploring will we're as to our So extend our that capital all we nondilutive of runway helped I programs, funding, on options, many mean stated. different need order into progress QX has mentioned, of we as us our on and including

Jennifer Kim

if Okay, question. squeeze maybe one great. And I could more

think this Or guess, X that additional quarter come year, this of are programs? more should about the or we second -- next With clinical I initiation Could you year? of thinking you filings the early in in, those year? IND

Shankar Musunuri

patients confirm. I degeneration, we XXX will yes, be dry -- out wanted yes is, specifically call targeting it Again, -- yes. Fortuna targets [indiscernible] stated our quarter because we in this for macular Similarly, late-stage it, filing for just IND orphan atrophy, targeted As separated we for to second is filing. of also geographic quarter The age-related in disease second QX targeting that's year. and ST targeted year, this of

Operator

[ph]. Aschoff ROTH from will Jonathan question of MKM come Your with next the line

Jonathan Aschoff

Most you fourth have did next NeoCart been in or year just some start year? say quarter but trial next the answered, time of would the

Shankar Musunuri

year. first will No. Actually, next stated start half of Nicotine we

be constructing of are this will CGMP manufacturing end We year. that the by facility, and complete

Jonathan Aschoff

can left ATM on you give And how little of the clarity as today? us more on Okay. a much is

Jessica Crespo

Yes.

the So as in I regular shelf general part say, connection with we've of canceled converting a automatic would corporate housekeeping, our, our ATM into shelf.

through So come you'll today. filings see those

we'll if So up when the put it's appropriate ATM for amount. the and appropriate back

at it's in this capital. So point,

Jonathan Aschoff

you actually it? of Okay. from was used in us tell ATM But core much overall how and that can the

Jessica Crespo

Yes. Under and million. in million gross that approximately ATM, netted proceeds, $XX about terms $XX.X we've of we've sold

Jonathan Aschoff

Yes, that is all.

Operator

next of from Your Markets. question comes the with LeBoyer Capital Noble Robert line

Robert LeBoyer

give some you COVAXIN laying other conclusions you any for–- in give for starts midyear out Phase mentioned some or III well, data. the time and Thank programs. milestones? full milestones the Could you top the for program time line of frames had the of for frames some of the and Could [ph] the you

Shankar Musunuri

programs. to you are or other specifically Robert, COVAXIN referring [ph]

Shankar Musunuri

programs? co referring to other you vaccine and Are

Robert LeBoyer

Yes.

Shankar Musunuri

protocol. need may I up and this stated have are before, I current And we vaccine, -- BA we are that, we the safety trial. midyear we to expecting As we'll the funds comments on the analysis still to stated, data conduct year. respond their obviously, seeking get study, do as We're final And trial. once a waiting government we before, safety for Yes. finishing to our stated The clinical clinical we as

are other more So talked there Phase as trials earnings are clinical call. X we this as during far concerned, III about

of them gene our ARKXXX One platform. is therapy signature modified

of So retinitis trial. recruitment pigmentosa where portion our completed in I/II Phase clinical we have the

end on III based by into signal. to so Phase year get midyear for data therapy read, And going get we're gene this efficacy to Phase anticipating -- the trial. planning III into on clinical we're RQXXX And of

limiting is the a Phase second for it’s – the therapy. platform, -- It’s is like our [ph] related cell clinical almost III trial rate that personalized medicine. to And therapy NeoCart, a colo-cell and

building So will cell existing facilities, manufacturing manufacturing initiate for into Phase the of that runway in convert we be own in first our we’re to production. of half that will the allow us to them clinical are the anticipating and year, construction III facilities cGMP the And end XXXX. by complete therapy trial

Operator

next Wainwright. with question of will line Lee from come Your Sean H.C. the

Sean Lee

quick from a Just me. question

design So yet? for the the in on you CAR proposed the study, study new have finalized endpoint

Shankar Musunuri

Yes.

I used we different study the that's a the design, prior control and as with think includes in as control, prior agreed the studies. than DA chondroplasty they

the The function. include and will second is pain endpoints thing

Sean Lee

previous the to Phase the with histogenics NeoCart, key differences? ramp what be III Compared would that

Shankar Musunuri

had The which microfracture control, current are care, into is standard the what -- a looked is key which differences is we they we chondroplasty. mean, did -- I so of

that. use that, actually so chondroplasty based wanted FDA And on we to is and

they not before. lesion thing that restrict X going very second the we're size Centimeter Square The and to it's that did really like the so on focus is broad to also

patients. changes, specific important chondroplasty because on anticipate microfracture. lesion of I very So of that's change. is an is with a care, better we really And That's size range recruiting standard for That's have important relatively not for we'll easily for important these focusing And also important. think us. prospects

Sean Lee

on that. final Great. follow-up One last

Or up well? be For only new you as the for that Phase supporting potential manufacturing for building, scale III? could that you’re to later facility materials that commercial the would

Shankar Musunuri

a Good like questions, this we therapies, many medicine, personalized Sam. cell scale-out scale-up. When mark build this is

We So process these call -- small call bioreactors. units are tissue-engineer very you them can hep. them

very things small these So are suites.

manufacturing commercial be can for this to... So used

Sean Lee

have. all That’s questions I the see. I

Operator

from question come line with will Gataulin the of next Your Daniil Chardan.

Daniil Gataulin

the all progress. on Congrats

external series the to on [ph] to this or Are in to are well? that you Lexin one this actual bundling. programs That's planning Or follow-ups, one. cash internally year OC XXX you of two, trials the to in relation planning XXXX, funding? you the initiate are of couple runway And a in plan fund terms Just for look you XXXX? those X initiate as INDs file year, to the expecting

Shankar Musunuri

is to Series one related QXXX vaccines. The emulation first

are of those So the as the stated taking vaccines to funding clinic. it before, we we and development

we So of we're with funding also are in believe the working various government secure to agencies parallel them. from because need, trying we

the development QX budgeted we complete So the preclinical support to you move into and the need question XX that we're and going them to for do it we had OCUXXX But studies, and part the and have their clinic. on -- second quarter and we be targeting Stroer dry are year. FDA, dosing second positive as INDs this patients will a as from soon this year. AMD Those planning to get SD [ph] And amount disease. we of scheduled filed in start

Operator

This over I concludes to portion. turn call Dr. Shankar will CEO, and the Chairman back Musunuri. the Q&A now

Shankar Musunuri

Thank you, remarks. additional with like the some to operator. conclude call I'd

for clear that strength, time integrated patient-centric are throughout poised mission unmet the forward great it's staying you an XXXX. on We for your position look in programs to our that Thanks execute are our of our true goals week. targets needs. to company believe medical biotechnology today, updated our year. a of are we I with have as course we and think to a keeping the pipeline we We and

Tiffany Hamilton

Thanks, a day. everyone. great Have

Operator

you Thank all meeting. for today's joining

disconnect. You may now

Ocugen (OCGN) 27 Feb 232022 Q4 Earnings call transcript