Q4 2021 Orgenesis Inc Earnings Call

Greetings, ladies and gentlemen, and welcome to the old Genesis fiscal 2021 year end conference call.

This time, all participants have been placed on a listen only mode. We will open the floor for your questions and comments after the presentation. It.

It is now my pleasure to turn the floor over to your host David Waldman from Investor Relations, Sir the floor is yours.

Thank you and good afternoon, everyone and welcome to the old Genesis year end business update conference call on the call with US. This afternoon are very Kaplan, Chief Executive Officer, and Neal <unk> Chief Financial Officer. If you have any questions. After the call I would like any additional information about the company. Please contact crescendo communications at 2126.

711020.

This conference call contains forward looking statements, which are made pursuant to the safe Harbor provisions of section 27, a of the Securities Act of 1933 as amended and section 21 E of the Securities and Exchange Act of 1934 as amended these forward looking statements involve substantial uncertainties and risks and are based upon our current expectations estimates and projections and reflect our belief.

And assumptions based upon information available to us as the date of this conference call. We caution listeners that forward looking statements are predictions based on our current expectations about future events. These forward looking statements are not guarantees of future performance and are subject to risks uncertainties and assumptions that are difficult to predict our actual results performance or achievements could differ materially from those expressed or implied.

The forward looking statements as a result of a number of factors, including but not limited to the risks and uncertainties discussed under the heading risk factors in item <unk> of our annual report on Form 10-K for the fiscal year ended December 31st 2021, and our other filings with the Securities and Exchange Commission, we undertake no obligation to revise or update any forward looking statements for any reason I'd now.

I'd like to turn the call over to our Genesis see elements of our Caplin. Please go ahead Barry.

Thank you David and thanks to everyone for joining us on the call today.

This has been a transformational year for Genesis.

It is key achievements implementing out point of care platform, which we believe is the key to unlocking the potential the full potential of the cell and gene therapy in this play.

We've also generated strong year over year revenue growth revenue for the full year of 2021 increased over 360% versus 2020 due to increased activity and our service agreements with existing and new partners and customers.

Revenues.

So supposedly development technology plan for set up and the work we're doing so both all point of care systems and therapies.

In addition, we have all of these seats commitments from our customers for future revenues in excess of $30 million for 2022, and 50 over 50 million for 2020 sleep.

A result, we have very good visibility heading into the new year.

The company's gross and perspective of 11, new one.

On par with our former Master cell C. D. M O operations at the time, if its sales over $300 million. We do believe that the new point of care platform is more cost effective and scalable.

Towards this end they'll businesses built around all three major pillow, South southeast technologies and the network. These pillars aligns interest off the therapy development, the hospitals and the patients in a way that has not been done before.

To provide some historical context centralized production, which is standard now across the industry has resulted in high costs for cell and gene therapies. For example car T cells. These can range in the hundreds of thousands of dollars per patient.

These significant cost have significantly inhibited the uptake by Payors and very much limited availability for patients. Our goal is to lower the costs streamline logistics expand capacity and enhance distribution supposedly single therapy is close to the hospital setting which is expected to support pay uptake and makes me Snoop is more broad.

The available to patients. We believe this is a crucial steps necessary for cell therapies to become widely available.

We continue to progress our point of care centers located at strategic locations and we all the investing Alice it's invalidating all point of care platform was in each of such leases.

Global supply network now spans North America, Europe , Asia, and the Middle East compromise of point of care centers, which serve a central hub for the entire Allegiant. These centers are set up for validation of therapies and technologies, but they also provide the basis for the global supply and distribution platform, we continued to deliver with Genesis.

Mobile closest thing units in lab, so all tools across our point of care network globally with a goal to expand capacity and availability for a broad range of advanced cell and gene therapies.

Like a traditional biotech alpo toothpaste on adapting the lab based processes customized automation closed systems and integrating the combined post as you know on peoples.

<unk> multi purpose mobile GMP facilities that can be rapidly deployed as a standard industrial.

Site.

Neil at the point of care was closer than needed.

Utilizing our own pool based opposed to production of personalized cell and gene therapies. We believe we can add new capacity was in fleet of six months and so this is additional clean rooms, which are 18 to 24 months.

And the lack of capacity in the industry is even more evident in the blessings of level in terms of expenses. Our goal overtime is to reduce the cost of these therapies to tens of thousands hundreds of thousands of dollars.

We believe that the key to our success and I'll point of care business is standardization the postal exactly the same regardless of where the product is produced so this leasing wheel, establishing training protocols were using audited and consistent suppliers and vendors of materials involved in production and quality control, we're implementing validated automated.

Solutions with minimize even now and we are taking a defense advantage of closed units to control infections. We believe our strategy of decentralizing and unitize them as a supplier of cell and gene therapies based on standardization of the manufacturing environment will ultimately becomes a solution for the seamlessly enabling low cost parallel processing and.

Accelerated development.

Providing a scalable long term option to overcome the industry wide capacity constraints.

Our strategy is to qualify the production post this a facility one O. One point of co location and then to add additional arpels under the same quality system and infrastructure. We have developed a support based on a decade of experience in postal development of such therapies and we're working closely with researchers from leading academic Institute.

As well as from biotech companies active in this space.

We believe the arm fuels are an important step to quickly expand our capacity and we look forward to expanding both the quantity and the location of our systems.

In line with the strategy I'm extremely pleased to announce the recent unveiling a cellphone you all tools feedback from us in the industry has been extremely positive as.

As an example, we placed our first awful in Spain with hospital infantile Universal Nino Jesus in my belief that has been designed specifically to closest tumor infiltrating lymphocytes and Muslim kind of stem cells.

We have expanded our collaboration with John Hopkins to establish a new point of care Center also known as a millionaire incentive for cell therapy manufacturing construction of the new point of care Center will be funded in part by a $5 million grant from the state of Moon.

We expect this new state of the 7000 square foot facility will enable local capacity for development of processing of clinical substitute except to point of care and will serve as a base for example expansion.

Genesis has entered into collaboration agreement also with Televisa, Alaska Medical center to use or utilize its Israeli point of care central to support research and validation activities for advanced cell and gene therapy.

We are also seeing growing government interest you know partners and then our activity and is exempt as an example, a joint venture with social and glass has been designated as priority investment of strategic national importance.

In addition, the JV as it has.

Been approved to receive a grant of up to $32 million due from the Greek government.

Subject to compliance with budgets doing conditions and split over the next few years, which we intend to use to advance development off also so piece was in the point of care setting.

SUNS also intended to support the post this development and manufacturing facilities at the clinical sites utilizing its all tools.

We have invested in our point of care platform over the two years and are now realizing some of the revenue we're tuned on such investments we intend to continue utilizing profits government grants and additional resources to expand capacity for point of care centers' rolling out their own people, incorporating new technologies and implementing our quality system.

For examples of uncle that is location located at Wilson Medical Center was successfully completed all qualifications and is killing T GMP compliant.

Assuming the Ministry of Health approval clinical study, which we plan to post as clinical grade batches for phase one two still till study.

Our partners and customers have aligned interest with one of them committed to support the validation development and clinical trials advance therapies utilizing our point of care platform within their respective markets as we've discussed in the past so vital partners with customer with development and supply services, whether it be fools of own products.

All for our own out licensing these.

We believe this approach is a highly scalable is it do you risk development some outside support tool all partners in this way. We believe we can advance our development of point of care flu B switch now span immuno oncology antiviral, but the ball like autoimmune diseases tissue regeneration and more.

These therapies lanes from preclinical through early commercial stage our strategy involves in license fees from leading research centers hospitals, and biotech companies and out licensing such products to pharma and biotech companies and a consistent and standardized men on all locations, while leveraging our point of care platform. So this.

To provide them with development and supply they need for such products.

We do so in return for future royalties as well as exclusive service contacts for industrializing and supplying these cell and gene therapies.

We believe we've built a robust therapeutic pipeline leveraging grants and out licensing sink partners.

And while benefiting from the service related payments. This pipeline includes more than 16, Corso Pudic technologies, some of which can be utilized for multiple indications ranging from preclinical through early commercial stage spanning into immuno oncology antiviral metabolic autoimmune tissue regeneration and more.

Yeah.

An example of also a pubic pipeline include metabolically optimized T cells until sponsored product by using an advanced postal optimization technology licensed from the other research and development Weizmann Institute of Science. We believe if we can do decrease the duration of the manufacturing processes and increase the potency of.

The pills and the early stage of cancel some lymphocyte successfully attack and infiltrate the tumor microenvironment surroundings of tumor cells and mountain antitumor response.

Kills therapies, a clinically validated personalized cancer treatment based on infusion of autologous til is expanding ex vivo from two tumors. Once expanded the pills are infused back into the patients where they tax the cancer cells with a high degree of specificity.

An additional example is our unique CD 19 car T therapy at all this is an anti CD 19, chimeric antigen receptor known as car T cells, they'll genetically engineered to express an artificial T cell receptor for cancer immunotherapy.

Car T cells can be idled their life on the patient's own tells all from T cells from a healthy donor once socially isolate is home to some of these T cells are genetically engineered to express a specific call, which programs him to tell it gets an antigen on the surface of the tumor after car T cells are infused into the patient to act as a living drug.

Go against cancer cells expressing the target antigen.

We are developing a new anti CD 19 car T therapy.

For treating patients with B cell.

Ligand since he's including acute lymphoid last week leukemia, and non Hodgkin's lymphoma.

The cells of these patients express the CD 19 protein on the surface and this is targeted by the car T cell. An additional example is kind of sell an autologous cell based product approved in the United States, which is made from the patient's own pancreatic islet, let's to regulate blood sugar.

<unk> is intended to preserve insulin secretary capacity in chronicle acute pancreatitis patients after total Pancreatectomy Kyle.

Chylophyllous demonstrated numerous benefits, including reduction in pain improved quality of life increase survival and cost savings to pay us.

We estimate that the potential addressable market for kind of supposed to be in excess of $500 million in the U S alone.

We're also focusing on all P license as opposed to sent adjusting for kind of film manufacturing process for European GMP requirements.

Dissipation of initiating the first clinical application in the European Union.

We are in advanced discussions with key islet transplantation in pancreas surgery centers to advance this platform as well as the strategic partners.

So to wrap up we believe that the coming year could be a transformative year for Genesis. We're excited the post spectra supplying clinical grade M. A c's coffees until based products utilizing our pulling two platform. We believe that providing data really of centers validating for compatibility of products supplied the silliest sites who provides.

Cell and gene therapies, a viable economic pathway to market, but given the pipeline of cell and gene therapies for which we provide developing in postal thing services, because we are well positioned to expand our market position not only as a leader.

The cell and gene therapy market.

We believe this will building a sustainable 11 years 11, new model. So it can support the growth of the industry in general and the <unk>.

The capacity requirements of our partners and customers, we look forward to sharing more exciting developments to be announced in the weeks and months ahead.

On that note I will now turn the call over to new lives and go Oh, Chief Financial Officer.

Thank you Barry.

Our revenues for the year ended December 31st 2021 increased more than fourfold at $35 5 million as compared to $7 7 million for the year ended December 31, 2020. The increase is mainly attributable to increased activity under master service agreements with our regional partners related to technology transfer.

Setup and validation of both our therapies and systems for clinical use in their respective territories cost of services and other research and development expenses for the year ended December 31, 2021 were $36 6 million compared to $84 million for the year ended December 31, 2020, representing a decrease of 56%.

The net decrease was mainly attributed attributable to a decrease in the amount of $45 million in other research and development expenses. During 2021 and 2020, we made significant investments in the development of several types of molecules accounted for in other research and development expenses with the expectation of you stand or distribution through or point of care.

Our network of partners collaborators and joint ventures.

The majority of our op. You'll development work was completed in 2021, and we expect that such appeals will be placed into service during 2022.

Selling general and administrative expenses for the year ended December 31, 2021 were $14 7 million as compared to 19 million for the year ended December 31st 2020, representing a decrease of 22%. The decrease for the year ended December 31, 2020 is primarily attributable to a decrease in accounting and legal fees as a result.

Decreased corporate investment activities in 2021, compared to 2020 as well as the reduced business development expenditures in 2021.

We expect the growth in revenue in 2022, including contracts already in hand will cover R&D and SG&A expenses during 2022.

In terms of liquidity, we ended the year with cash and cash equivalents of approximately $5 5 million as a result of the sale of the master cell subsidiary, we use the proceeds of the sale to execute on our point of care strategy.

We believe much of these upfront investments are behind us and expect that future growth in revenue will offset our cash burn.

We're also attempting to minimize our own investments through a cost effective international partnering strategy and non dilutive grant funding, we are seeing growing public and private interest in supporting local regional expansion and development. We have been fortunate to receive government support from several countries and we believe we will continue to benefit from such support to further grow our point of care platform.

Operator, we'll now open up the call to questions.

Thank you ladies and gentlemen, the floor is now open for questions if you'd like to enter the queue to ask a question. At this time you May press star one on your telephone keypad to enter the queue. Once again, ladies and gentlemen, Please press star one on your telephone keypad at this time.

I'd like to ask a question. Please hold a moment, while we poll for questions.

Yeah.

And your first question is coming from Bruce Jackson.

Bruce Your line is live please announce your affiliation and then pose your question.

Hi, Bruce Jackson of the benchmark company. Thank you for taking my questions I just wanted to follow up online the cash to sell comments.

Tell us a little bit more about what the next steps are in that program. How many sites you might partner in.

In Europe , and when the mob fuels might be placed.

Oh, Yeah of course, so we have actually expanded activity to more sites in the U S and in Europe , It's really a matter of a regulatory it's still in discussion of how many sites will start school you know clinical approval, but I think there is a need in Europe for this and we've had initial.

Discussions.

So I don't know I don't have a final answer kind of how many sites will have with the clinical trials, though because it's still in planning phase.

Okay.

Fair enough.

Then if I could just get back to the the.

The revenue and the operating expense commentary for 2020 . Two so the revenue is going to pretty much offset the R&D and.

And the.

Just generally.

All in.

What are your burn rate expectations for 'twenty, two are we talking about approaching breakeven or might there still be a small net burn for the year.

So I think well well well that's kind of my hope that we will be breakeven because that's kind of how we base. Our budget remember we finished most of the development work and whatever is left is covered by glance actually.

So I don't think we'll have a lot of R&D unless you know some kind of strategic change, which we're not planning. So I mean, I think we should be okay was breakeven.

You know, we we kind of were really.

Generating revenue and expensing you know the the operational expenses to generate that revenue. So I think we have our platform kind of ready to go.

And we may even get some royalties from some of the out licensing which will be great. So that'll be nice so and that's it I think we've we spent two years working very hard to get this up and going this year. We've already you know hit the ground running and its going well.

And we already have kind of commitments from existing and new customers and you know we're still in the haven't even finished the first quarter. So I'm optimistic the pool will be doing well.

Alright, congratulations on all the progress and thank you for taking my questions.

My pleasure thanks.

Thank you.

Your next question is coming from Kelvin CFO .

Tell me your line is live please announce your affiliation and pose your question.

Hi, This is Calvin from Dennis Cabot, though hey, Barrett.

Nice to talk to you again and congratulations on the great results.

So I just have a few questions I think this is the first time I'm seeing RJ. This is putting out a fire of Midland as a potential addressable market for kind of shell. So I'd like to find out more about do.

Do we have any color on plans to ramp up sales or do we just have to wait a bit longer.

So you know I think one of the things that as I said, we've been working a lot on expanding in the market and you know the European market Asian marks are different from the U S. So I actually think they have quite a nice potential and the U S itself as I said as well focusing on expanding our capacities.

I do hope, we will expand I mean, we've really.

I think we're working with some of the best centers and we're getting a lot of positive feedback.

We also are looking at you know interesting ways to actually expand.

The indications we can use this technology for and just kind of strategic you're looking at this product. So I do think we have a lot of potential we can build on that not only this which is a niche market, but really underserved with no. Good solutions. I mean, there are some centers will try to do I list kind of.

Preservation after they do Pancreatectomy.

But really it's not not the same level right here you have an actual products, it's really well defined and I think you know all patients and clinicians we work with can testify to the fact that this is a very good product.

So I think it's all about kind of expanding indications and expanding out bleach, which we've also worked hard on and I think we will do the food plan.

Alright, great. Thanks.

Second question I have is you know.

Right now we are going to have results.

And Barbara Wordings harder to waste money and I was looking at our latest balance sheet. So we are rather low on cash right now and I'm. Just wondering are you know.

Uh huh.

Is this cash sufficient enough vasu.

And run our operations, while next year or do we have to raise that money.

So you know all expenses are really declining and we've also received a lot of ground funding.

So that covers a lot and the same time, we have out licensed some of our surface technologies to pharma and biotech companies and so that's also generate some revenue.

So as I said, we do expect to be more or less cash flow breakeven and you know historically, even when we've needed capital all current shareholders have been very supportive, but we also look at strategic options, which I think we have plenty of you know just looking at our pipeline and our activities.

Alright. Thanks.

So one last remark I think while I consider myself, a very patient in Baxter I think all of US can agreed at a stock Wendell lessees 2016.

Despite much progress have meet I think it's just a huge injustice to the progress made by our Genesis. So since we are entering the breakeven for next year I Hope, we can wrap up on the Investor relations sharing because the.

The balance sheet gap between where we are right now and <unk> mantle cell is really a quite wide.

Well I I, certainly think we'll be putting a lot of stuff into that.

Alright, thank you.

Thank you.

Thank you the.

The next question today is coming from John <unk>.

John Your line is live please announce your affiliation and then pose your question.

Alright.

Young from tax capital nice to see you again, so I've been following <unk> for a while and it's great to see the company strategy slowly panning out. So I have two questions. My first question is regarding the our accounts receivable all of about 15 million.

What's doable us each could shed some color on what comprises all and when should we expect to receive this amount.

So well actually I think Neil you can answer, but I think the most of it is some of it has been already you'll see Tonight.

That's correct that's correct.

When you say, what it's comprised of debt.

Is a mix of all of our different partners and end customers. So.

Basically as we've indicated before our terms are 90 days from invoice state, Okay, and I didn't really see it typically happens on most of the time at the end of each month. So it's really 90 days at the end of the month in which the in which the services are incurred or the invoices generated okay. So.

So we have had a very good history of Collectability of accounts receivable.

So far at this point, we expect to continue that trend, we have some past dues, which were.

Which are less than about 3 million, which will probably be collecting here in the short term. So we see no indication that that's going to change because of what we've seen in the past so and we haven't changed the terms the terms have been the same for <unk>.

For since the beginning so yes, so as far as what it's comprised of that's the same partners and customers. We've had that we've reported on before it is the mix is not changed okay.

And maybe I'll just add to that that I think this year will also be important in terms of transition on that issue.

Typically you know as you go through the lifecycle of these therapies you have a you know the initial period is closest development, which is traditionally give them longer time for payment.

Also because many of our customers and the revenues we're collecting they also get paid back from grants and other things they need to show. So we give them the time, they need to do that and but.

What is the reasons. This year you know I'm really looking forward to it if you know and and and I remember we had the same kind of closest massive sell this transition when you're actually moving from a when you're just doing like the postal developing and we've already started some batch production and you actually really be lying 11, you more and more.

On a batch production and utilization so the way these contracts work that actually you have a lot more a kind of a visibility on them going forward because typically.

Typically customers they pay pill utilization bill cleaned them in all cases still on appeal and onto that you add the pie split batch so the whole payment structural starts shifting.

And I think we will gradually see this till the end of the year, we still have postal development for new projects of course, but I think we will see many of these projects actually transition to a place where will the payment schedules.

One.

Great. That's very helpful. So I'll try that one more question I just wanted to touch on the ground off 32 million euros fall and I think it shows how the Greek government is very supportive of our goal with carousel and Genesis.

Could you share some colors. If you are extracting yourself other grants Alpha Nashville.

So we haven't made this public but I think what I'm, sorry, I can't go into detail I apologize, but.

I do think if you look at grant funding in General I mean, just look at what state of California, they've actually allocators commend. This amount of funding funding just for this purpose of making cell and gene therapies available like so you see this you look at the grants we got a millionaire right. So I think that is.

The growing realization all over the world and I mean really I've seen this in countries all over the world well they understand they something has to be done Yukon continue having therapies that are costing so much and and just patients' needs them might so and I think we see this.

Last thing this issue even you know on the regulatory side I am the European Union Union I'm, putting together new guidelines to support decentralized the supply of these therapies.

So I think we will continue to put our assets I think we have also good relationships with the governments. We've received guidance from in the past because you know we've achieved the work we do we try to do when we received the funding pool. So I've I really think that's an important component and I.

It just it just you know kind of highlights how much everybody realizes this industry needs a solution and it's it's it's actually an issue of public importance to make these therapies available to patients.

Got it thanks, Margaret So I just wanted to shed out always respect that Michelle that you and your team are on you guys are doing something great for the wall.

No I, just hope them to guarantee that we can be financially strong and Janet profitability. So our Genesis has continued to go up.

Doing for everyone, we dog-paddle DDR shareholders too much and the other day I guess I speak for everyone here that we all want our Genesis to dwell. So thank you all very new for the hard work and have a great deal.

Thank you very much for you.

I appreciate that.

Thank you.

Your next question is coming from Neal Feagans.

Neil Your line is Lai please pose your question.

Hi, Brad Thanks for taking my calls this morning.

I'm happy to.

So I just wanted to clarify a couple of things the revenue commitments from customers.

That you stated in your prepared remarks for 2022 and 2023.

Is that revenue still what you would consider to be all services revenue.

And.

Is it accretive is it in addition to the $35 million or so.

That you generated from services revenue in 2021 .

Oh, Yeah. It's it's the next two years, it's it's what it's similar to what we made in 'twenty. One we now look and one of the things and it was just a beautiful article [laughter] kind of published I don't remember the name, but it's and they kind of comparing cell and gene therapy space to the rainfall.

[laughter], which I think is very too because it's almost like a symbiotic relationship between our the.

The therapy developers and the industry kind of suppliers and and and and the service providers as ourselves. Okay. Because if you going into a clinical trial or if you have a therapy, where you're expanding and youll building up capacity.

Dependency on you'll service providers very high it's not it's.

It's not easy is an understatement, okay. If somebody's preparing you for production and then start producing and even before that shifting to another service provider is a tremendous challenge. So that relationship is very sticky. So one of the things that you know them.

It would be companies biotech companies in this space really need to have is is it's a commitment kind of both ways. They they are it's important for them, it's almost essential for them to make sure. They have reserved capacity for the ongoing activity. It's part of the value because it's not easy.

If if for instance, someone suddenly the supply all kind of disappears on them. They have a huge problem. It's almost beginning again, Mike So I think the facts.

We have these commitments from our existing customers and also into some additional customer.

That is because we have been successful and visa stages of farm penalizing the products and have already done some batch qualification and you know from now on they will we will grow with them. They will go with US and you know typically like any company in the beginning we don't work with huge partners with <unk>.

But they are also growing and we've seen this in the past as well you begin with the smaller companies as you build up your reputation.

These small companies grow as they become bigger companies they become more successful.

And and.

And you also attack the playoffs. So that's kind of what we're seeing with saying they want to make sure. They have the capacity they have the supply they need for their future plans for the next two years and typically in this industry contacts all around 24 months 18 months.

Okay, and kind of as a follow on to that.

Or are we within side are starting to generate what I call therapy revenue revenue actually derived from treating patients is there any visibility to when you know actually therapy therapy related revenues might begin late this year early next year.

Or any guidance you can give on that.

Oh, you know.

And I want to.

That's a it's a tough question to ask me, Okay, and I'll explain why because.

You know, we do have kind of settled which I really hope the 11 user will expand but the numbers of two pathways for the food piece. Okay. So some of the houses these and some of the therapies, we supply full okay.

They're all doing clinical trials, but the number of a parallel regulatory pathways.

Which is the hospital exemption and I think I've explained this but it's really it's it's it's really an interesting model with some in some cases hospitals take upon themselves with responsibility to provide the food people patient.

So this is not at the size and the scope of because each hospital needs to get approval for that but that's actually kind of marketed thought okay. It's done not under the regulatory framework of a kind of a BLA or 90, but it's done then the regulatory framework of a hostile exempt.

This does not exist in the U S, but it's very common and becoming more common in Europe and in Asia.

I, it's difficult for me to say when exactly that will happen and if we'll manage to get into that this year on the next but that is a much shorter pathway. Okay in terms of just regulatory approval.

And one of the most important kind of indications for that is to have a well regulated G. M people system supply, it's not a the demands on a lesser it just in terms of quality assurance and GMP level of production, but the demands are more based on.

On clinical kind of responsibility of the hospital and all the clinical time. So we do have some products that do fall into.

That those categories and <unk>.

I don't know if we'll manage to get into that this year or the next but okay. Hopeful we will okay. So on that engine.

Yeah, Yeah, no no that listen I realize that this isn't an exact science at this 0.2 more real quick ones for Red.

You mentioned that you've already out licensed some of your therapies to biotech and pharma companies you don't need to repeat it but have these been announced or are these out licensing agreements you've entered into that all in the <unk>.

Public domain yet.

So we haven't given a lot of details on them. Just you know kind of general, but that's how Saturday night I mean, we all our strategy is not to develop therapies ourselves. It's just that's just the situation in this industry and and and just to give an example, why because a lot of these therapies are developed by small.

<unk> and hospitals and in some cases are actually treated patients under the hospital exemption, but now they want this therapy to move forward. So when they come to us and ask US you know can you make this up before us we say yeah. We can provide you the services.

But if you could give us the license we can also expand the market reach and then we licensed out to other companies.

Okay, and what would some of these companies that you have out license to Ah if if if they were in the public domain would they be companies that the biotech community the pharma community might recognized.

I don't know I think regionally.

This this is a very new industry, Okay, you've got some big pharma Giants that have come in and you know made a stand and the interesting thing is that I think most of major pharma companies are going into the space.

And you see more and more adoption on the part of the space like nobody wants to be left behind and they all want to play in the scene and they're all struggling with a very new kind of technology.

So you have you know a handful of big players, but what do you see a lot in this industry as regional players that are very very well known regionally. Okay. I think like any new industry, what we will see and we've even seen it with some without.

Existing customers, you'll see kind of these mergers and consolidations of these little companies being swallowed up by the bigger ones and the bigger ones. So that I think is what is happening in the industry at the moment.

Okay, and Brad one final if I might.

I think a lot of the financial community whenever we.

Your talk of potentially needing additional capital.

We have tunnel vision and we only think of equity offerings, you mentioned that there's the possibility of something more strategic would you would you like to expand on that just a little broke.

Even though it's hypothetical cut that includes a larger biotech or pharma company or one of our collaborative partners actually taking an equity interest in the or Genesis.

So as I said I mean, we we really rely a lot on our shareholders and the support and you know well. So appreciate as always the patients and this is you know this is not a short term game and I think you know and we've actually expediting I think you know remember with math.

So I think it took us five years to get to this level of 11, new with this new model and it's taken US two years. So I think we all expediting the cycle to generate value right.

And this is part of what we want to do both for ourselves and for our customers side all partners.

So when we look at strategically there's many strategic options. We could look at we could look at a strategic option involving one of our therapies, which reaches a certain level of maturity and then we're not only doing and maybe an out licensing or co development of our services, but really a buy out of such a therapy, which would be wonderful.

But we need to mature to that stage.

And we also have a lot of technologies that we've developed in house that can serve many other oh industries or industry segments. So we only had also have that option and we also have different models of services of co development. So I think you know as a company we have so many options.

G collaboration, but I do think and here I really try to remain very loyal to the shareholders and not kind of you know to EDI.

Try to push these assets to a place where they will get the legal values they deserve.

And I think that's been all I felt all along to maintain that balance between our needs and between maximizing value of the assets we can chew.

With others.

And if I, if I may add to that to answer your question as well.

When we talk about strategic we're really looking at as well the mentality.

Behind what the financing as an investor not just.

Whats the liquidity of the stock today right. So it's all go forms of financing can even be debts, and you think well equity is always the.

A form of financing that may be everybody's most most mindful of that that is something that we don't you have to be careful what the devil in the details you think it might be better most times it's not.

Strategically it looks like what what what is what's the structure right. So when we say strategic it's really just a matter of who that investor is what do they want to do with US what is the mentality mainly for long term rather than short term. So while there could be equity that would be part of that could be you know as part of our collaboration strategically it could be something.

Where it's an investment we were looking for and what we've always done that because we have it.

Many different financing forms that are available to us out there what is the long term mindset. Okay. So that's what we mean when he said that's it.

Okay.

That's real tie to be protective of the existing shareholders and you know.

<unk>.

Maintain okay.

Good structure.

No well I think that's helpful. Because it helps us understand but you you are not simply looking at one one Avenue.

You know.

To raise capital if it was needed and obviously with the share price where it is.

It wouldn't be viewed.

Favorably at this point in time, but you know my my closing comment it's remarkable to get to the point that you're talking about breakeven with only 25 million shares outstanding for a biotech company I mean, that's that's quite remarkable so listen thanks. Thanks for the time that was very helpful.

Thank you. Thank you for following us closely and always you know being supportive.

Thank you and there are no further questions in queue. At this time I would now like to turn floor back you're very Kaplan for any closing remarks.

Thank you I'd like to thank everyone for participating in our year end business update conference call. We are very excited about the outlook for the business.

And appreciate the strong support of our shareholders. We look forward to providing further updates as we plan to advance though.

So pudic pipeline expand our services.

And deploy all all appeals wherever needed. So thank you very much.

Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.

Q4 2021 Orgenesis Inc Earnings Call

Demo

Orgenesis

Earnings

Q4 2021 Orgenesis Inc Earnings Call

ORGS

Wednesday, March 30th, 2022 at 4:00 PM

Transcript

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