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Ocugen, Inc. (OCGN) Q2 2022 Earnings Call Transcript – The Motley Fool


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Ocugen, Inc. (OCGN 3.25%)
Q2 2022 Earnings Call
Aug 05, 2022, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to the Ocugen second quarter 2022 business update and financial results call. [Operator instructions] Please note that this call is being recorded. I will now turn the call over to Tiffany Hamilton, Ocugen’s head of corporate communications. You may begin.

Tiffany HamiltonHead of Corporate Communications

Thank you, Samantha. Joining me today are Ocugen’s chairman and CEO and co-founder, Dr. Shankar Musunuri, who will provide a business update; and our chief accounting officer and senior vice president of finance, Jessica Crespo, who will provide more on our financial results. Earlier this morning, we issued a press release detailing business activity for Q2 2022.

We encourage listeners to review the press release, which is available on our website at ocugen.com. This call is being recorded, and a replay, along with the accompanying slide presentation, will be available on the Investors section of the Ocugen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which are subject to risks and uncertainties. We may in some cases use terms, such as predict, believe, potential, proposed, continue, estimate, anticipate, expect, plans, intend, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

Such forward-looking statements include, but are not limited to statements about the potential for NeoCart, chondrocyte-derived neocartilage, if approved to provide an innovative new option for the repair of full-thickness lesions of the knee cartilage in adults, as well as Ocugen’s intention to begin dosing in Cohort 2 of the OCU400 clinical trial this month. Such statements are subject to numerous important risks — excuse me, factors, risks, and uncertainties and may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are most fully described in our periodic filings with the Securities and Exchange Commission, SEC, including the risk factors described in the section entitled Risk Factors and the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation.

Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation, whether as a result of new information, future events, or otherwise after the date of this presentation. Finally, Ocugen’s second quarter 10-Q will be filed soon after today’s call. I will now turn the call to Dr. Musunuri.

Shankar MusunuriChairman and Chief Executive Officer

Thank you, Tiffany. Good morning, everyone, and thank you for joining. We hope you and your families are safe and well. Courageous innovation is the driving force behind everything we do at Ocugen.

We are leading innovative clinical programs to ultimately make a significant impact on public health and address unmet medical needs around the globe. Developing great science requires harnessing the passion, persistence, patience, and intellectual progress of our entire Ocugen team. And I am very proud of what we are accomplishing. Using this mindset of courageous innovation, we are strengthening our dedication to eye care, pursuing broader commercialization of our vaccines program and we have expanded our pipeline into the orthopedic space, which we will discuss later.

The Ocugen team continues to charge ahead. And over the course of this past quarter, we saw great progress in establishing ourselves as a differentiated biotech company. As we continue to meet our regulatory milestones and engage with patients in a clinical setting, I am especially confident that the team is well-poised to advance our efforts. Today, we are going to provide updates on our vaccines, gene, and cell therapy programs.

Starting with vaccines, as we enter the third year of the COVID pandemic, we are facing new challenges as COVID-19 variants continue to emerge. At the World Vaccine Congress in late April, speakers all agreed that public health strategies need to expand and vaccine options beyond what is available in the current mRNA dominant landscape, but necessary to contain the pandemic. This sentiment was reiterated during the recent White House Summit on the future of COVID-19 vaccines. Additionally, consumers want effective options for vaccinating themselves and their children, including vaccines built on a traditional platform.

We are up to this challenge as we advance the Covaxin program with our partner, Bharat Biotech. Studies have shown Covaxin provides durability through immune memory and a broader immune response that maybe important for realizing a booster strategy for annual vaccinations. We are still a few years away from seeing an end to this pandemic and the need for delivering an additional COVID-19 vaccine option with a different MOA and the U.S. remains at priority.

The Phase 2/3 immuno-bridging and broadening clinical trial, OCU002 for Covaxin is progressing well and we are in the planning stages for starting the adult safety clinical trial this year, pending FDA discussions. Lancet Infectious Disease which is a peer-reviewed journal recently published the Phase 2/3 clinical trial results of 526 children who demonstrated a superior response in the study that have shown in adults. Nature Scientific Reports published a study where Covaxin generated a persistent cell mediated memory immune response for up to 12 months. Additionally, it showed that the booster dose is safe and ensures persistent immunity to minimize breakthrough infections of COVID-19.

These studies reinforce the point that Covaxin is effective with a favorable safety profile. Covaxin already has emergency use authorization in Mexico for adults and we submitted an application for pediatric emergency use in the 2 to 18 age group that is under review. We are currently working on commercializing the vaccine in Mexico. Now, moving on to our gene therapy programs and our founding focus retinal diseases is becoming clearer, especially at our vital work in Retinitis Pigmentosa, a disease for which there is no cure, no medicines to block disease progression, and limited treatments to help manage the patient’s tragic journey that ultimately leads to blindness.

Ocugen has a deep commitment to its research and development programs for inherited retinal diseases, for which there are no treatment options only one gene therapy modality exists. Our modified gene therapy unlike traditional gene therapy, as shown in preclinical models, to effect the regulation of genes or nuclear hormone receptors or NHRs. Activating these NHRs modulates gene activity and maintains homeostasis. When gene networks are not functioning properly, this unbalanced state can lead to disease, including a family of inherited retinal diseases that cause blindness.

We completed the dosing of subjects with Retinitis Pigmentosa in Cohort 1 for Phase 1/2 safety and efficacy clinical trial for OCU400 and the Independent Data Safety Monitoring Board for the clinical trial recommends proceeding to dosing in Cohort 2. We expect to begin dosing in Cohort 2 this month and we will provide periodic updates. This is a significant accomplishment in an innovative therapeutic category, because for the first time, we are evaluating this modifier gene therapy concept that adopts invitation and ophthalmology disease space. By the end of this study, we will collect data from 18 patients, which will constitute three cohorts of three different doses before moving on to a Phase 3 clinical trial.

If successful, this therapy has the potential to treat many mutations under RP. Currently, RP has about 150 mutations, affecting approximately 2 million people globally. This is a dire unmet medical need and shows where Ocugen can bring courageous innovation to bear. Our sense of urgency for rescuing one site is critical and for us, it’s personal.

Our next candidate OCU410 has IND-enabling studies underway to support a future Phase 1/2 clinical trial targeting dry age-related macular degeneration. Ocugen is currently executing pre-IND studies, consistent with FDA discussions to support a Phase 1/2 clinical trial, which the company intends to initiate next year. We have partnered with CanSino Bio to manufacture clinical trial materials and to support the CMC development for OCU400 and our OCU410. It’s also worth noting that we expanded our patent portfolio in June, then the United States Patent and Trademark Office issued the company an additional patent directed to methods for preventing or treating an ocular disease or disorder associated with retinal degenerative disease.

Finally, we are expected to initiate a Phase 1/2a clinical trial next year for OCU200, our novel biologic that has the potential to help those with diabetic macular edema, diabetic retinopathy, and with age-related macular degeneration. We have completed the technology transfer of manufacturing processes to its contract development and manufacturing organization that will manufacture OCU200 clinical materials. Now moving on to our regenerative cell therapies, with the expansion of our pipeline into cell therapy in orthopedics, NeoCart marks an experimental therapy with the potential to accelerate healing and reduce pain, the rebuilding damaged knee cartilage and limiting the progression of osteoarthritis. NeoCart is a tissue engineer disc of new cartilage that is manufactured by growing 100 sites, the cells responsible for maintaining cartilage health, which are derived from the patient.

Recently, Ocugen entered into a collaborative research agreement with Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School to support NeoCart development and explore expansion of the pipeline. Earlier this year, the FDA granted a regenerative medicine advanced therapy or RMAT designation to NeoCart for the repair of full-thickness lesions of the knee cartilage in adults. We believe this RMAT designation will accelerate our timeline and getting this product to market. Ocugen is currently working with the FDA to finalize the Phase 3 clinical protocol necessary to advance the clinical development of NeoCart for eventual market authorization.

In summary, we have ambitious clinical agenda and the rigor in our clinical development process to advance our pipeline in constant pursuit of our long-term vision. What’s important to remember is that the strength of our pipeline is found in the diverse innovation. We are exploring to address public health and unmet medical needs. I am very proud of our team who collectively shares in our vision.

We were recently named one of the region’s Best Places to Work by the Philadelphia Business Journal. This recognition is a reflection of all our colleagues and our culture focused on courageous innovation. I will now turn the call to Jess to provide our second quarter 2022 financial results.

Jessica CrespoChief Accounting Officer and Senior Vice President of Finance

Thank you, Shankar, and good morning, everyone. I will now provide an overview of the key financial results for the second quarter of 2022. Our research and development expenses for the quarter ended June 30, 2022 were $9 million, compared to $18.9 million for the quarter ended June 30, 2021. Research and development expenses for the second quarter in 2021 included a $15 million upfront payment to Bharat Biotech in connection with gaining rights to the Canadian market for Covaxin.

General and administrative expenses for the quarter ended June 30, 2022 were $10.6 million, compared to $6.8 million for the second quarter of 2021. The increase in general and administrative expenses related to the increase — and increase in infrastructure costs to support the growth of our organization. Our net loss was approximately $19.5 million or $0.09 net loss per share for the quarter ended June 30, 2022, compared to a net loss of approximately $26 million or $0.13 net loss per share for the quarter ended June 30, 2021. Our cash, cash equivalents and restricted cash totaled $115 million as of June 30, 2022, compared to $95.1 million as of year-end December 31, 2021.

We expect our cash on hand will take us into the second quarter of 2023. We are exploring opportunities to increase our working capital, which may include the use of our current at-the-market program for the sale of our common stock. That concludes my update for the quarter. Tiffany, back to you.

Tiffany HamiltonHead of Corporate Communications

Thanks, Jess. With that, we will open the call for questions. Samantha?

Questions & Answers:

Operator

[Operator instructions] Your first question comes from the line of Jennifer Kim with Cantor.

Jennifer KimCantor Fitzgerald — Analyst

Hi, everyone. Thanks for taking my questions and congrats on the quarter. I have a couple of questions here. Maybe to start off with Covaxin, I am wondering, have you finalized what exactly studies need and the protocols around the studies? And with the development of bivalence that could come in the fall? Has anything changed in your mind in terms of your market opportunity? Thanks.

Shankar MusunuriChairman and Chief Executive Officer

Good morning, Jennifer. Yeah, the current study immuno-bridging and broadening study that is required that bridges clinical data from U.S. demographic to data generated by our partners elsewhere. Large Phase 3 clinical trials are conducted to collect safety and efficacy.

The second one, which is required we believe is safety trial in the U.S. demographic and we are still awaiting feedback from FDA. As soon as they provide that information, we are going to initiate the clinical trial. We are planning for that.

So we believe those two are needed to give the primary series an indication of the BLA as we planned. The second part of your question is in the bivalent. FDA recently changed the strategy. I think it’s still upcoming.

Science is evolving. So if this is the strategy, we are going to go into the future with the bivalent variants and we will be working toward that. However, we will be getting some data from our clinical trial and we will do sub-analysis of those — subjects of patients, who have received currently mRNA vaccines and how our vaccine is performing. Because we do provide broad immune responses compared to spike-based mRNA vaccines and we also have long-term durability with the memory response.

So we have to see how those factors play out. Do we really need a bivalent vaccine strategy with our vaccine? We are going to carefully monitor that. And if we have to develop a bivalent vaccine, our partners are working on that and they are standby. So we will be ready to do that for both strains.

Jennifer KimCantor Fitzgerald — Analyst

OK, great. My second question is on the OCU400 program, you mentioned that you are going to start dosing in Cohort 2 this month and you are going to get periodic updates. Could you give any color on what level of granularity will be in those updates and how — when can we expect to see, I guess, some real data from the patients in that program?

Shankar MusunuriChairman and Chief Executive Officer

Yeah. So these periodic updates — so the primary objective of Phase 1/2 clinical trial is safety and we are monitoring multiple efficacy endpoints, we call them observational endpoints. Depending on the mutation, every mutation may have a different primary endpoint before we move on to the Phase 3. So currently, the primary objective on a 3-month periodic basis subjected to our protocol and what we agreed with FDA will be monitoring this patient safety outcomes will come out.

And again, they get reviewed by DSMB on a periodic basis. That’s our number one outcome and we can share with the market as it comes along. The second part is efficacy endpoints based on our observation endpoints. And that data typically, I don’t think we are going to get anything before six-month visit for our patients.

And from six months to one-year visits, when these patients go through that transition we may be able to see some observations and we see them, obviously, we will go through the internal process and controls, then we will be able to share that information to the markets.

Jennifer KimCantor Fitzgerald — Analyst

OK. So does that mean — I guess with your — the first patient Cohort 1, I think they were dosed in March, we could see it like six to 12 months from there as well. We could see some signals.

Shankar MusunuriChairman and Chief Executive Officer

That’s right. That’s right.

Jennifer KimCantor Fitzgerald — Analyst

OK, great. OK. And then my last question on with your introduction of NeoCart, I am wondering, what are your thoughts on further expanding or diversifying your pipeline? Is that a priority in your mind?

Shankar MusunuriChairman and Chief Executive Officer

NeoCart, I mean, are you asking specifically about NeoCart or further diversifying into a cartilage space?

Jennifer KimCantor Fitzgerald — Analyst

More just so how you view priorities of the company? Are you comfortable with where your pipeline sits today or are you thinking about further opportunities to expand?

Shankar MusunuriChairman and Chief Executive Officer

Yeah, that’s a good question. So NeoCart obviously was sitting in our back came through the reverse merger. And now, we have very strong R&D and other teams in the organization with a solid biotech footprint. And so we started looking at it and obviously, it looks very, very promising.

There is so much of unmet medical need. That’s why we started working on it. And obviously, we believe we have a strong biotech team that can support it for now. And obviously, this is a tip of the iceberg as you can look into the regenerative space and the cartilage there is only one product available in the marketplace.

And we believe we have a superior technology with a 3D how we grow the sales with this proprietary technology and strong patent portfolio. And this is the product we are going to focus on initially. Obviously, through our research and development, including the collaboration with Harvard Medical School, if any future pipeline expansion opportunities come up, we will try to explore them. But our goal for now in the next couple of years is really focused on this, work with the FDA and work on the manufacturing, work on the clinical program and take it to the clinic sooner than later.

Jennifer KimCantor Fitzgerald — Analyst

OK. That’s very helpful. Thanks, guys.

Operator

Next question comes from the line of Jonathan Aschoff with ROTH Capital Partners.

Jonathan AschoffROTH Capital Partners — Analyst

Thank you. Good morning, guys. I was curious what do you think is your best Covaxin pitch for the three different areas of North America out there granted its differential among the three countries. But what is your best pitch in each of those countries you think for pushing utility of Covaxin against what’s already out there?

Shankar MusunuriChairman and Chief Executive Officer

Good morning. Yeah, I mean, again the differentiation with Covaxin compared to three or four authorized vaccines in the U.S., they are all spike based. That’s a distinct difference. Ours is based on the whole virus-based vaccine with two adjuvants.

So that makes it feel that broad immune response that means you get antibody responses beyond spike, which may be needed. And also there is a major publication which talked about, which actually followed the patient up to 12 months and showed a T-cell and B-cell memory responses, which are important for durability. So when you have a broadened immune response, when you have durability, when you go into the future, it’s not practical to get booster shots every three months. One has to look for almost like a matching like a flu season annual booster shots.

So for that, what you are looking for is an ideal vaccine, which has a durability and which also has potential with a broadening immune response. Broadening immune response will potentially result in adaptive immunity. That means not only current variants for the future variants and if you have a — your system is already prepared with the broadening immune responses with the memory and if you do see some variants on which is going to happen in the future and at least you will have ability to create with your adaptive immune system attack it. And that’s why it’s really important.

I think this is very distinct and the unique vaccine in the North American market, including — and but one other thing I would like to make is in Mexico, we are working on emergency use authorization for pediatric population. And that’s very important too. I mean, obviously, we will be looking into that going into the future when you go into these annual boosters, the reason is the data our partners have generated in India on pediatric population is really strong. And not only it showed very good immune responses, it also showed solid safety.

I mean, they had a surveillance data after 36 million kids, teenage group got first dosed with the vaccine and they collected surveillance data and the surveillance data clearly showed no cases of myocarditis, pericarditis, or thrombosis, which are associated with current vaccines here in North America. So those are the distinct features of this vaccine. That’s why we believe we can strongly provision this product.

Jonathan AschoffROTH Capital Partners — Analyst

OK. Thank you. How are talks going for the manufacturing facility in Ontario? That wasn’t part of the Q2 release. I was wondering how that was going?

Shankar MusunuriChairman and Chief Executive Officer

Yeah. That’s going on. Obviously, we are also working with the Canadian government to get support on that, as we mentioned before. And obviously, it’s progressing.

In fact and then we were getting good support from the Canadian government and we are happy to share that. And as soon as we have any something concrete and it takes time to work with governments, but they are very supportive. And as we have something concrete we will definitely update the markets.

Jonathan AschoffROTH Capital Partners — Analyst

OK. And I await the impending 10-Q for this answer or can you give it to us now how much of the ATM has been used?

Jessica CrespoChief Accounting Officer and Senior Vice President of Finance

Hi. This is Jessica. We have not utilized any of the ATM at this point. We are going to be optimistic about our use of it.

Jonathan AschoffROTH Capital Partners — Analyst

Great. Thank you very much, guys.

Jessica CrespoChief Accounting Officer and Senior Vice President of Finance

Thank you.

Operator

Your next question comes from the line of [inaudible] with Mizuho.

Unknown speakerMizuho Securities — Analyst

Hi, guys. Can you hear me?

Shankar MusunuriChairman and Chief Executive Officer

Yes. Good morning.

Unknown speakerMizuho Securities — Analyst

Good morning. So I guess my first question is just to sort of elaborate a little bit on or get some more color on OCU400. Just wondering when you do report data for the efficacy endpoint, just curious like how would you kind of define success and which of those metrics that are listed in clinicaltrials.gov are more important to you or more important, I guess, to clinicians in terms of how it would sort of help define success for this program? And —

Shankar MusunuriChairman and Chief Executive Officer

I think the —

Unknown speakerMizuho Securities — Analyst

No, go on.

Shankar MusunuriChairman and Chief Executive Officer

No, no. Please go ahead.

Unknown speakerMizuho Securities — Analyst

My second question again probably has to do with manufacturing. Just curious how the manufacturing, I guess in the Washington site is going in terms of preparing for ramping up or any kind of capacities that you may need for the Covaxin? Thanks.

Shankar MusunuriChairman and Chief Executive Officer

Yes. Thank you. So I will start with the OCU400 efficacy endpoints. As I mentioned, we are exploring multiple observational endpoints for efficacy.

So the way we monitor them is when the patient comes in, when get into the study that we establish a baseline based on multiple endpoints. So every endpoint gets monitored when they have this periodic payment visits. And so if there is no decline, stable, it’s still good. And so that’s how we look into that.

And there is a, that’s what you want to look at it, no further degeneration and that is the baseline stable at steady state, that’s good news too. So I think those are the things we will be slowly observing. And once again, these are the — some of the mutations we are getting into may not have a lot of data out there. We may be the first ones to look into that.

And some of the mutations may have some information out there. So again, that’s why we want it to be flexible. And we believe, we created a very good protocol, which allows us to monitor multiple endpoints. And so depending on specific mutation type, we believe, based on the data we are going to collect will allow us to have a clear path going to Phase 3.

Now, coming on to the second question on manufacturing at the Jubilant HollisterStier, there are contract manufacturing organizations supporting Covaxin drug product manufacturing. The tech transfer is going well. And we believe we will be on target to complete our process validations in support of our BLA next year. And also — and that site will also support any of our needs in the North America going into the future.

And we are not too worried about the capacity there constraints. Whenever we get any orders from potential orders from Mexico or Canada and eventually when we get into the U.S., we will be ready to supply.

Unknown speakerMizuho Securities — Analyst

OK. Thank you.

Operator

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

Daniil GataulinChardan — Analyst

Hi. Good morning, guys. Thanks for taking the call. I have a quick question on NeoCart.

Could you give us a quick overview of previous data and what gives you confidence in the program, because I believe Histogenics reported data in 2018. They just missed their endpoints. We just wanted to ask how you are adjusting and how you are thinking about this program going forward and potential Phase 3 launch date if you can speculate on that? Thank you.

Shankar MusunuriChairman and Chief Executive Officer

Yes. Good morning. So NeoCart, you are right. Histogenics narrowly missed endpoint.

I mean, obviously, we took a deeper dive at the data. And typically, when you have larger lesions that’s where regenerative cell therapy truly helps. We are looking at larger lesions and we are dissecting the data and see where this is most useful for a patient’s perspective. And so we are focusing our effort on that, and continuously having a dialogue with FDA to understand and finalize the protocol.

So I mean, obviously, they generated significant amount of data. And I mean, obviously, you also learned when you have such data, where it’s most useful and focus on that that will be definitely improved protocol, much improved compared to what they have done. So that should increase our probability of success. That’s what we believe in.

So that’s where we are. So there are two parts to starting the clinical trial. One is getting the input from FDA, from the — so they are currently reviewing our protocol. And we are hopeful, sometime this year, we will be able to finalize our design with them.

The second step is establishing manufacturing and which we are internally doing it. And we believe, that should be released sometime next year, too. So again, these two things have to be lined up. And in the interim, obviously, we did have a really good network of investigators and KOLs.

And this year, we are putting all those pieces together. So hopefully, we can provide a good roadmap for this program by the end of the year.

Daniil GataulinChardan — Analyst

OK. Got it. Thank you. And a quick one on Covaxin in Mexico.

Do you have any color on vaccine demand there currently, and when do you expect to report any revenue there?

Shankar MusunuriChairman and Chief Executive Officer

Yes. The current vaccine demand, just as any other country currently, only the government is procuring there. I don’t think they allow — they are allowing to private markets. In the pediatric population, obviously, there is only one company, which got authorization to date, that’s Pfizer.

And the government did procure a small amount of vaccines, not a large to vaccinate majority of those kids. So that’s why we believe there is an opportunity there. They may be looking for other vaccine options for kids. So if you look at their demographic and look at that cohort, there is a significant opportunity.

Daniil GataulinChardan — Analyst

OK. Understood. Thank you very much.

Shankar MusunuriChairman and Chief Executive Officer

Thank you. You’re welcome.

Operator

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

Robert LeBoyerNoble Capital Markets — Analyst

Good morning. I had a question about NeoCart, and just the previous data in terms of what the patient entry criteria was and some of the endpoints in the trial, as well as how the — how that information is going to be used to design Phase 3 in terms of the new entry criteria, and the potential markets. And separately, I also was curious as to whether the core technology underlying NeoCart that it was derived from would have implications or other indications for other restorative medicine entrants?

Shankar MusunuriChairman and Chief Executive Officer

Yes. Good morning. So the data generated in the past, the endpoints, typically, for this regenerative therapy, what you are looking for is a function and pain. Those are the two co-primaries and the coming up at the score.

That’s what we will be monitoring. That’s what is important, FDA also is directing toward that. So that doesn’t change. However, the difference is, as I mentioned before, depending on the lesion size, that’s important.

There may be other standard therapies available if the lesion size is too small, and you may not see much difference. So those are the differentiating factors we are carefully looking at the data, what happened in the past and where it’s more beneficial for the patient. And looking at the average lesion size, and where did it fit in, working with our KOLs and frontline orthopedic experts. And so that’s how we are actually designing this clinical trial.

And that’s number one. Number two, this question is the underlying technology platform, yes, it is very unique. The underlying platform technology, we have our own scaffold we make and then we take the autologous cells from patient and chrondrocyte and then we grow these cells, right, into a 3D and that’s in a nutshell. And so this kind of a technology is unique.

And obviously, we are starting with knee cartilage repairs. And obviously we will in the next few years we are going to explore because this is unique regenerative therapy and autologous cells how we can grow into different indications. And there a lot of needs in orthopedic space as you know, and they will continue to explore.

Robert LeBoyerNoble Capital Markets — Analyst

OK, great. Thank you very much.

Operator

Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright.

Shankar MusunuriChairman and Chief Executive Officer

Hey, RK.

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

OK. This is RK from H.C. Wainwright. A lot of my questions have been answered, but I am just following up on one of the questions that have come earlier.

So I know you are still pursuing Covaxin in the U.S. So how are you thinking of differentiating and when you are approaching the FDA? What is the indication that you are putting up such that you can differentiate Covaxin against what is already in the market or what has already been approved by the FDA?

Shankar MusunuriChairman and Chief Executive Officer

So, RK, the indication doesn’t change because the current vaccines are indicated for primary or booster cities. And that’s where it’s going to be. Obviously, as a scientist, evaluating consumers or customers, they are getting more scientific information. I think the market landscape is going to change.

As I mentioned before, I mean, if you look at the White House Meet like last two weeks ago, and what they are looking into, and what the public is looking for is a differentiated vaccine. They are looking for more vaccine options. I think now, I mean, the hospitalization, thank God, has gone down and so compared to two years ago. So now people have a time to reflect and see what else is available.

And as the market goes into this booster space, eventually, it may turn into private, like flu vaccines. About one-third of Americans take flu shots every year. And the consumers are going to ask, they will work with their primary care physicians, they will work with their pediatricians. And they are going to have a thoughtful process, what is available, what is the science and what is appropriate for me and my family and that’s what is going to happen.

So our goal, the indication may not change indications say this vaccine can be given for booster cities, right. So that’s really important. So what we have to do is get the data out there, just like our partners have published, about 14 journal articles in peer reviewed journal. There is so much of data in a transparent way they shared.

And we will continue to do that as Ocugen, too. As the data comes out, we will share with the public and the peer review journal, so people can review it, and they can make data driven decisions, what is appropriate for their families.

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

Maybe I didn’t ask the question, but I was wondering about coverage. Is Covaxin, has it shown better coverage than what is there in the market with all this new mutations coming up, that’s what I was thinking of to ask a question, but probably you answered it by the publication of the papers, or events, unless you want to get more clarification?

Shankar MusunuriChairman and Chief Executive Officer

Yes. Again, the data from our current clinical trial, I mean, in the booster, and I mean, it’s not a booster study designed for, but it’s immuno bridging and broadening. That means some of the patient population, they must have taken prior mRNA vaccines will have that subgroup. And if the data is showing, indirectly we are going to get some booster data.

I mean, as I mentioned before, is that sufficient, is that providing a good coverage for current variants and potential for future variants. And you are right, so all those things can be negotiated with the FDA how we put forth. As I mentioned before, it’s not that agency is moving toward bivalent vaccines, that’s more good for coverage for the long term. We will be there for that.

And also the most important factor, as I mentioned before, I want to emphasize is durability. And I think in the publication and nature reports, which came out a few weeks ago, I mean, that really substantiates that up to 12 months showing the memory responses is very important.

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

Thanks for that. And then on the Mexican market that you were talking about saying, as they are getting ready to commercialize there, what is — how big is the Mexican market? And what’s the commercialization strategy there in Mexico?

Shankar MusunuriChairman and Chief Executive Officer

Mexico, the current focus is again, as I mentioned before, it’s on kids. There is only one company, they got some procurement. I believe it was probably not providing the entire population, just a fraction. So that’s what currently they procured for kids.

And there is a significant opportunity there. I don’t want to give any specific numbers, but we believe if you have the second company in line to get the pediatric authorization, we will have a good opportunity in Mexico. And also —

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

Go ahead.

Shankar MusunuriChairman and Chief Executive Officer

No. I think one of the things I think RK, I just wanted to mention to emphasize our vaccine, I didn’t address before, is this vaccine is stored at a refrigerated condition, I just wanted to emphasize. And so with the potential shelf life of two years, and it has a good shelf life, even room temperature at 25 degrees up to six months. So that makes a big difference for distribution, supply, as well as a stockpile for future use in any country in North America, including Mexico.

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

And one last question on Covaxin, on the Canadian front, any update at all regarding your application there?

Shankar MusunuriChairman and Chief Executive Officer

I don’t have any further updates on it. We are still waiting for their response. And we submitted all the questions they had, all the responses to them.

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

Thank you. Fantastic. Good luck, and thank you.

Shankar MusunuriChairman and Chief Executive Officer

Thank you.

Operator

This concludes the Q&A portion. I will now turn the call back over to your host, Tiffany Hamilton.

Tiffany HamiltonHead of Corporate Communications

Thanks everyone for taking the time to join the call this morning. We look forward to providing further updates in the coming months. Have a great day and a wonderful weekend.

Shankar MusunuriChairman and Chief Executive Officer

Thank you.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Tiffany HamiltonHead of Corporate Communications

Shankar MusunuriChairman and Chief Executive Officer

Jessica CrespoChief Accounting Officer and Senior Vice President of Finance

Jennifer KimCantor Fitzgerald — Analyst

Jonathan AschoffROTH Capital Partners — Analyst

Unknown speakerMizuho Securities — Analyst

Daniil GataulinChardan — Analyst

Robert LeBoyerNoble Capital Markets — Analyst

Swayampakula RamakanthH.C. Wainwright and Company — Analyst

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