OCGN - Earnings call transcript Q3 2021

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Operator

Good morning and welcome to the Ocugen Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the presentation. [Operator Instructions]. Please note this conference is being recorded. the and to Communications turn of Inchausti, now Relations Investor for will conference Ken over Head I Ocugen.

You may begin.

Ken Inchausti

issued Thank this welcome a Corporate Subramanian, a you our Chief me would Development, will provide business like section Sanjay conference Musunuri, presentation third and our recorded Officer call and morning, update Dr. I be will update. a the is Chairman, financial With and business press update We Co-Founder, This encourage quarter the being slide Ocugen's today press for you, call. website Ocugen provide on results. including are release, and who who and a Shankar days. available Financial we will a on XXXX to replay release Earlier listeners operator. our approximately website CEO, available to of the Head of ocugen.com. XX also financial at along www. to Investor with review is accompanying which the

the for for other grant product These including inherent described whether As and emergency and in ages in in from risks and will with other to things. The entitled contain and risks forward-looking receive and Covaxin use or Commission, results U.S. we uncertainties materially the always, SEC. forward-looking And file Application to deliver described periodic to in our this among Covaxin call including, to FDA. Securities development cause annual to risk candidates, and to Such the subject advise will of and with submit authorization Covaxin and are our And risk to ongoing to authorizations when that pandemic. approvals the factors us in Factors Exchange section research statements whether XX. are that quarterly Uncertainty events we reports a and for able will or FDA statements. be -- we could regulatory the when License differ our X the COVID-XX more the risks for the actual will Canada. related business Biologic the actual regarding the that expectations, uncertainties you need filings uncertainties fully

the I Note uncertainties in described Shankar Dr. Ocugen's in to as Musunuri. that over You to well intend carefully accompanying Form-XX-Q release risk filings included should will slide risks the we turn and read with with CEO, press now call and the SEC. the today's follow SEC and factors our today. the our chairman presentation,

Shankar Musunuri

Good serious hope feel I We milestones Mead thoughtful rapid Margaret for Ocugen and of new Ken. everyone a me that group doubt only XX family we're and thing options people privileged wanting and reason It than our for here small Today, that a famous it's individuals. has. less review ago, citizens year was me tackle a lead. succession remind to bring can you after morning, thank committed change therapies joining words your a diseases just to reminds the one the we from ''Never that that all bring Indeed, could to These this are of you, and Thank a you quote safe and well. Company had choice. world''. new

XXXX. modifier of all including our We of Canada. States Today's for bio. committed events COVID-XX the significantly a and RQ blindness global with completed slide platform. United our which months, XXX, major quarter bringing part the candidate for that and their candidate has XXXX therapy Thank to work have a This our our hard quarters grown of efforts contributions. the out over consider X transpired of diseases family biotech is you oxygen recent Along is to our along your result gene outlines update of the of lead with vaccine and the partners BBVXXX, third Covaxin

upcoming for we on and and within safety the believe U.S. the late being among partners with progress at in is the world to group, global Phase to and congratulate in exciting to Covaxin for is X a authorization vaccines there furthering a And significant the Administration. for drug X tremendous significant population, to of validator currently home, there efficacy the support new initiation emergency This participants. news. by of to That's bridging there case of securing Bharat X portfolio XX these years. an a to X This results it October, Biotech We the took authorities Closer for Covaxin clinical discussions conducted November want a We we support filed our data the Friday we bottom use X believe agency, those top-lined the the an our X, for immuno ages is look accomplishment and market. trial week, vaccines. a age lack no we First, as around Last option. BLA. emergency steps biotech of U.S. make Ocugen -bridging Xth with world. unmet our within and press knowing for is different to release, this compelling trials organization. Particularly, forward XX,XXX And noticed we them. usually the broadening the critical FDA regulatory approved Phase in Covaxin Food call, Drug of submitted choice application BBVXXX nearly 's that use health an investigational to thing that the aged involving U.S. is COVID-XX by Phase study need between

to get has subjects. will to X hundred neutralizing The -based X objective designation in be Acute the who a participants Phase in and will compare India. efficacy few primary between those U.S. XXX X Our Covaxin the of titers involve trial doses doses trial got who

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out, being Finally, for responses in Health we tuned are from clinical hearing engagement many about Canada, development. participating very if this their Aster our To passion where in continuous and of people prepared. to noted are with approved, interest their disease trial deficiencies them and our further appreciative

automatically from a new for now EPS interim to framed application of to investigational for our drug are the resulting applied modifier progress we retinitis under application a platform clinical pigmentosa process. patients. update to dose program. I XXX, order that DX today our submission the PCs, Phase therapy reminder, of an mutations small drug a new therapy and and our QX lead As approval I'm number finding was amounts for gene safety involving reduction. on want a pleased gene treatment Ocugen's our trial and to of candidate, and monitoring you our transferred genetic XX the proposed with

clinical at commercial studies. to scale at have scale already manufacturing XXX successfully We support completed lever

of trial, From at As journey. from started look Nima least And retinal months. sharing Dr. multiple our throughout trial part This Harvard XXXX. by mutation. evaluating of our the will School. the One forward new Medical ability trial, is by disease more of with absorbed the inherited beginning clinical address into ARPU its post-dose XXX(ph) we their partner, a X to XX approved patients progress the to be [Indiscernible] clinical if Phase

million the next is our to RQXXX. QX Following IND support future the degeneration. XX% to is dysfunction address and for. characterized has AMD receptor progress, October explore throughout close will And Form-XX accounting presented clinical It's macular you suggest behind ten most world. the available. slow QX a dry at the cases. role treatment degeneration dry medical AMD the area Approximately -clinical from whole X of associated And And dry our therapeutics plays the chronic XXXX. age-related in Off unmet need, To around Pharma significant pigment retinal conference and studies AMD by enabling trials. we prevalent photo of designed preclinical bacterium, total Phase these people pre in candidate AMD of XXX loss a dry dial with retinal X XXX time. a or that recently continue. this data no RQ suffering started options genes Very ups AMD, with

arrangement our support have CMC development programs. with and CanSinoBIO now They and We and OCUXXX manufacturing are manufacturing be for chemistry, that both partner pleased OCUXXX the our expanded in manufacturing, order development to support the for to OCUXXX, share of to the will controls and responsible manufacturing. we

ocular our agreement program. in well. September is Our transfer fusion and CanSinoBIO portfolio, some our progressing this out amended stack in to protein Rounding OCUXXX, add still was with

help will are over diabetic with much This quarter preclinical diabetic ahead. moving degeneration. is focus now track strong. call a Sanjay? therapies on explore the XXXX on activities indeed to those very there macular OCUXXX busy our remains Covaxin I macular OCUXXX can IND-enabling to and portfolio, third to ocular update. and turn wet to and more has to our been edema, into on OCUXXX With retinopathy, age-related We with clinic their continuing studies, and our how further it much going provide Sanjay There's quarter. advance uplift financial and

Sanjay Subramanian

the will good quarter provide now overview And this third key year. I Thank for of you, Shankar. an morning, results everyone. of

expenses to Our to the XX, the update. the $X due our for OCUXXX quarter for employee million $XXX.X ended growth XX totaling R&D write-off to cash $X.X XXXX previous increase the pro-vaccine net Net quarter ended loss September primarily a per compared activities, share and or as December in for headcount. million quarter compared September quarter Ken. net $X.X XXXX, research compared were million general development $X.XX ended increase and XXXX. $XX.X year's XXXX. administrative million XXXX, support to of XXth, and included preclinical of with regulatory expenses held XXXX, a September an you, or to and September the XX, million as per loss to as was by million the million $X.X activities. XX, for for quarter concludes XXXX, cash, asset of administrative The which quarter-end in XXXX September relates the or the compared for expenses of cash quarter Back well sales. increase $X.XX third equivalents, million restricted costs ended We XX, organization. development my $XX.X million That infrastructure share to of the General net to September of September increase as $XX.X loss loss an $X.X third for driven and XXth ended related expenses XXth ended is

Ken Inchausti

Thank And will with open that, we you, for call questions. the Sanjay. Operator.

Operator

to like Again, that one the question, a to would you number ask At [Operator a if star this then time, ask [Operator question. Instructions] Instructions]

first Your Nakae of question comes the with Chardan. line Keay from

Keay Nakae

morning. Good X you. for questions

timing The to the bridging first hopefully set the adult as question year. you so the maybe in middle next convinced population U.S. you to that of for relates up will study, the and file

approval of So, that look QX possible 'XX? at timing? way should in appropriate to we Is the think about an

Shankar Musunuri

follow us. of for fast-track If ANC planning believe path have you that our initiate the followed, today will we path the other to We right companies timing. were regulatory at also consider

year. on And the file of the next planning so that, to second BLA we based are half in

So fast-track XXXX, get seems reasonable. to to we that do be in half, sometime if first designation,

Keay Nakae

distribute to purchase right scenario many your Okay, Government to for selling to And would characteristics, the under the from Bharat again Bharat, vaccines for you with because that OUS, a U.S. exclusively of agreement then these is attractive purpose your sell precluded vaccine and to where U.S. vaccine have U.S. purposes? the great. like any help the under to the

Shankar Musunuri

Yes.

Canada had We in and from Yes, US through rights government. procurement our U.S. have to go and any budget. we

Keay Nakae

for And the recent pediatric. for then most Great. the filing EUA the Okay. for

for any running you're you we you approval. study adults, type do think of bridging about as could the run that will a how for bridging give need to pediatrics whether Given study before well

Shankar Musunuri

approved significant are no leader. an the considered a to use unmet age filed vaccines group. you we as and are Currently, emergency for medical emergency Again, authorization. those is apply when there vaccines, things operates have there five in outlined And authorization will use we be two

compelling our we group in age choice need file on in based pediatric unmet reason XX population. pediatric to decided is and So, have purely with do X the that's that data we the based medical EUA. from the kids have the we on need. from We American our population got that's a data, the It So partners

Keay Nakae

Okay. And then more just questions. X X.

of having appropriate as approval, 'XX get how sorry, timing first potential 'XX, or timing for their think Canada, that at the review mid QX For maybe again, flow we with potential should least 'XX anticipating potential the approval? filed flow I'm there or half, about in to a

Shankar Musunuri

-- authorization no again, exact take expired. on you Canada, time, drug intramotor, of submission the is I deployment for that's cannot And and new there regulatory process Okay, -- process. does NBS, called it into we file think got as actual the stated, time And I which some emergency user comment typically, it is date.

we process and on Canada However, Health up the addressing review questions with closely way. working are any come

Okay.

Keay Nakae

Okay. And four the entering around be congrats those on then the clinic XXX year. Mexican, will QX, following of the the end programs

So have. That's I that's all great.

Shankar Musunuri

Keay Nakae. you, Thank

Operator

next Jallah Zegbeh Your from with question is Capital. Roth

Zegbeh Jallah

all questions Thanks and on for update. congrats my morning. taking regularly Good above

me. I think quick a questions couple of for

the any of EUA. kind EUA within your about X not next FDA it the or a just approved or a update or is is on curious expect feedback decision something whether or to an made will from be first is pediatric before on from you're I if you acceptance just of should week now? hear was The the going

Shankar Musunuri

Good the morning, Zegbeh. processes review process, for review. accept ongoing. The us they Again,

I market. So, updates At anymore. this time, when to updates, we cannot we'll get comment prorate the

Zegbeh Jallah

Okay.

whether acceptance to approved? So, get an is to a that on like letter EUA or not about prior anything not an the you're update expecting or

Shankar Musunuri

EUA No, typically other through on gets process. the before X typically, to process companies the done, goes have they AdComm nod. any it -- Based it goes the

a with working so that's on that. typical And We're the agency process.

Unidentified Representative

for anything, Health I on really correct? having from you comments think guiding also any I know but can't comment or you Total remarks them, timing that here. the questions or said is said you that Canada,

Shankar Musunuri

the repeat you Can questions, [Indiscernible]? Sorry.

Unidentified Representative

For like back Canada just questions hear after to had that back saying your them. haven't you or or any you anything obviously that, submit or health far so submission, haven't we additional follow-up to guidance from waiting information

Shankar Musunuri

Any a part back any course respond India is process, you of forth. and this resubmissions and the business active think is normal process. of agencies, I review regulatory did, companies as the we

that's dealing course so too. what are normal again And business. of we That's Canada with

Unidentified Representative

Thanks, Okay.

with I to so. the territories, before opportunity to Brian. you you your do back-and-forth decision it the potential some is just expand had I the next that about you the agreement to think have them. more wondering do so I you but here do what make see with So, And have is one was to just know need for

Shankar Musunuri

Yeah.

leads on asking your will I about So regions. to expand understood options this for that, And just always when really that. to make sure with question are our U.S. the other at for be those opportunity partners. correctly, open? Is again, territory our you're focusing And what that our the catalyst the with open And Canada we're options keep stage. and again, we

Unidentified Representative

clinical really we curious Moving on XXX updates program. gets any just that of to We excited for key study to our about see kind or to as that what see, any the anything MDI&D updates from design submitted. or might

Shankar Musunuri

will And into patients ClinicalTrials.gov designation that launching trial process, accepted orphan be everybody and a is potential again, be through the Once to Zegbeh, stakeholders going help and all and the small will to as space. we trials and just other the else. the gets retinal IND this goes information

Zegbeh Jallah

Where And you know agreement -enabling in studies? terms are wondering includes doing I Are was are expanded doing you Okay. for CanSino process now development, where right I the is XXX? anything of IND you you? CanSino XXX. just in the

Shankar Musunuri

working the Yes. need XXX. see on now the as I for started can has development, just

of And QX do plans. is the the and on the integrating -XX those a in we from have so, FDA currently roadmap team process our

Unidentified Representative

the update. for Thanks

Shankar Musunuri

you [Indiscernible] Thank

Operator

LeBoyer with question Capital. Robert next Your Noble is from

Robert Leboyer

morning. Good

Shankar Musunuri

Good morning.

Robert Leboyer

X Covaxin idea to after the do Covaxin of of the months results booster benefits there. any with and of or I lack the any or to to if shots months discussion broader My there quarter. using of durability XX messenger made data vaccination. vaccines was wondering need Hi. whether is give or show question progress the the the any might you've to any in a one Congratulations of the also one there might booster has last that shot have RNA all protection was and and on or show that have data following need And

Shankar Musunuri

some Robert long first published published. the is, is they similar the year-to-date data have partners responses. our shown the longevity means and effect. protection you illustrates some very generating available, in a showed long get when our with T-cell and the scientifically journals, to And to which create But you and however, Again, potential discuss data the people that credible have data, And we're question going response, be where the it strong to more That get So, partners one will you are clearly share more vaccine. should medical any cellular that about thing, The that's memory protection. responses. have journals, with markets. continue articles generate Covaxin Again, memory.

being the The are second are with vaccines. to immuno who we generate does mRNA The IND, trial, our the data? who vaccinated going question mRNA clinical is is, anybody which people vaccines, trial -bridging yes, file answer exclude did the took not we

fact, people X who be In or least does taken have has to mRNA the that at include vaccines, it it with earlier. months caveat

trial, be and So data our those generate going subjects. will in we those people to the are in included clinical

Robert Leboyer

very you much. Thank Great.

Shankar Musunuri

Robert. you, Thank

Operator

I'm sorry.

Sean Wainwright. with next is Lee from Your question HC

Sean Lee

questions. Bharat. My morning, And agreement first Good taking supply guys. thanks on question the for my is with

in expected you cover publishers what's EUA on an that? of to? that also, would terms turbulent, transfer much have commercial access tech progress the how potential pediatric is on does the your supply timeline approved, if for So, And supply to

Shankar Musunuri

also, increased significantly restrictions that for how the and EUA so partner capacity does those this include agreement supply our export. integrate Upon new don't And sales they year. Yes. -- our Sean the as

post technology a is the in are process as validations U.S. program the including jubilant next EUA get supply. anticipating and first switch And the of far we adequate establishing at supply as transfer year going tollister, so we So, of we of in we'll is can concerned, needed, the that well is whatever that, completion half

Bharat products include testing have been U.S. which part the site supply established. the does initial few it include so from Biotech, of from will with -released And and packaging the partners, even U.S. our

Sean Lee

transfer and year, to the batch clinical additional you would are is need validations Once the same? FDA tech from completed show the that the batch CMC commercial next

Shankar Musunuri

When be you of compatibility, always that that's process. show product process. the Yeah, a will you sites, part normal add additional have and the the to

Sean Lee

my is preclinical can we question QX in on to the clinic? pretty that expect back go showed good was right. -XX, next that when October, I and And the on All I from so you development do program timeline some the what's that results wondering into

Sanjay Subramanian

Is it related XXX?

Sean Lee

yes. XXX,

Sanjay Subramanian

Yeah. we as typical XXX. have other have the yes. XXX we to product follow -- gene it one, That therapy we again, from map did process like No, for order

at a clinic file to again, in in to which and abilities it'll from preclinical So. tox from longer is put that. it, of program. have that Two XX we little studies simply really the take steps is next populations, get again, unlike and roadmap And it XX is on and important product. goes -- execute we second least rare and And to our to is FDA. It which else. large IND we're everything for Therefore, And this to manufacturing months. targets is a I therefore, goal workload working going our with FDA little we're the would as XXX are -- perspective, part, to One the [Indiscernible] to toxicology big developing agreed preclinical diseases.

Sean Lee

additional the have. Great. That's for I all clarity. Thanks

Ken Inchausti

Sean. you, Thank

Operator

questions for like At Ken back turn this would no additional time, closing it remarks. to I to over are there

Ken Inchausti

everybody to join time. We you for the thank right. call the we morning. for months, much further taking this All coming very to this forward providing and time in look thanks updates you Thank and your

Operator

and ladies gentlemen. you, call. conference concludes today's Thank This

Thank may participation now a You disconnect you this wonderful and lines your your time. at have day. for

Ocugen (OCGN) 9 Nov 212021 Q3 Earnings call transcript