The areas which we operate are primarily dermatology, respiratory and oncology. So weight loss drugs, obesity is not on the cards right now. Well, I think for us weight loss and obesity will fall in our diabetes franchise which is mainly India specific. But globally, we operate in derm, respiratory and oncology. Those are the three areas we continue to look for in licensing assets and developing further novel assets.
Any other big molecules you think that you have on IGI's books which will probably show the same kind of potential?
Well, IGI one thing we know is they've the multispecific antibody platform that they've developed over the last 10 plus years through the BEAT platform, now actually works. That's a phenomenal achievement and we think we can leverage this platform to come up with a number of additional assets. The most near-term one is 2301 which will come into the clinics next year, which again is an NK cell engager which we're pretty excited about.
Well, this is not only a deal for Glenmark, Glenn, but in context of where India stands when it comes to R&D, we've always been considered to be on the back foot. Do you think that India somewhere is coming of age considering that we had a small deal with Orchid Pharma, we had something with Walkhart and now Glenmark?
I still think a lot of it is company specific. But my personal view is innovation trumps anything else in our industry, particularly in the pharmaceutical industry, because it's all about helping patients with better therapies, better treatments, which will drive the success of companies wanting to invest in innovation.
Yeah. But do you think India has come of age and that's where the next story lies for India, the R&D story, or is it company specific?
I think it's company specific though.
Give us, Glenn, you know, end this conversation by telling us what is Glenmark's vision now that you've struck this deal. You do have your generic business, your India business, your consumer business. Give us a sense in terms of what the five-year, ten-year vision for Glenmark would be.
Well, Glenmark will continue to move up the value chain into launching novel products, innovative products as we go forward.
Okay, and quickly, Glenn, you know you're talking to us at a time where there's a lot of uncertainty when it comes to the trade tariffs and what could be announced even for pharmaceutical articles. What is your sense in terms of what we should be possibly expecting?
Well, I think it's still playing out, Eka. So it's hard to say what happens on the tariff side.
Okay. Hypothetically, if there's a huge tariff of say on pharma exports, how do you think Indian companies will probably manage that? There were reports indicating even 200% which sounds outlandish. Your sense?
I don't want to speculate right now. For me, this moment is all about ISB 2001.
Okay. All right, Glenn. Thank you very much for joining in and congratulations on putting India on the map when it comes to R&D. Thanks very much.
Well, it's definitely a landmark deal for Glenmark as well as for the Indian pharma industry. Glenmark has signed an out-licensing deal with global big pharma company AbbVie for one of their molecules under development for multiple myeloma. They've out-licensed it to AbbVie. It's going to be an upfront payment of $700 million, milestones of $1.2 billion going forward, and even double-digit tiered royalty payments if the molecule is successful and reaches the market. We have with us Glenn Saldanha, who is really the man of the moment, to talk to us about this big landmark deal. Glenn, thank you very much for joining in. Well, if you could just go through the finer points of this big deal which has taken place for IGI, which is your innovation subsidiary.
Thank you, Eka. So clearly this is a huge moment for us. We've been working on this for 25 years in the innovation space, and I think ISB 2001 really is a world-class asset which can be transformational for patients. From a partnering perspective, the way we've structured it is we've partnered with AbbVie for US, Canada, Europe, China, Japan, most of the developed markets, and Glenmark will commercialize this product eventually in India and all emerging markets. So the two of us will make sure this asset is successful going forward. IGI clearly is a 100% subsidiary of Glenmark and has done a phenomenal job in developing this asset, getting the Phase 1 data. We have phenomenal data in patients in the Phase 1 trial, where in our recent presentation at ASCO we had almost 79% ORR and almost 30% of the patients had complete remission. These are patients who've gone through all prior lines of therapy in multiple myeloma and then eventually came on to ISB 2001 and showed this response. So very exciting times. We are super excited about partnering with AbbVie, a great partner with huge global capabilities and resources to make ISB 2001 successful and bring it to market.
Okay. So explain the financials to us. $700 million is what you would get upfront, $1.2 billion in terms of milestones, and the remaining would be royalties.
That's correct. So we get a $700 million payment upfront, and as soon as we get regulatory approvals, that money will be received by us. The milestones, the $1.2 plus billion dollars of milestones, are spread into clinical development milestones. So as the molecule progresses to clinics, we keep getting milestones, regulatory milestones. As the molecule gets filed in various markets and approved, we get milestones, and then we get sales-linked milestones. Cumulatively that number comes to $1.25 billion for the asset. Then once it's commercial, we get royalties on sales. As you know, some of these innovative products have a long royalty life. So this could pretty much be an annuity if the molecule makes it to market.
Okay. So let's first understand where exactly this molecule stands. Phase 1B currently. Explain that to us. How nascent is this molecule at this point in time?
So ISB 2001 is still at a relatively early stage. The good news is we have patient data in about 40 to 50 patients. We have good clinical data that we presented at ASCO, very good safety profile, good efficacy data. But it's still early stage, so it has to go through a significant amount of clinical development as we go forward.
Okay, so AbbVie is now going to take over the entire development of this molecule, we understand. When do you think it will probably hit the market or show any kind of results?
So AbbVie takes over all clinical development from here on. In terms of timeframe, I can't give you a specific timeframe, but typically molecules in this space take about four to five years at least to get to commercialization.
So say 2030 would be a good target to probably expect something tangible coming in from the molecule or hitting commercial sales, if it is successful that is.
So again, I can't specifically talk about ISB 2001, but typically it's about four to five years to commercialization.
Okay. Well, let's talk about how you're going to use the funds. Start with $700 million, $6,000 crores of cash on books. It will be on Glenmark's books. Tell us how exactly is the $700 million going to be utilized.
So the way we're looking at it is IGI will continue development of various other assets. They have a great multispecific antibody platform technology which they will continue to exploit. They spend about $70 million a year, so that spend will continue. A big part of this upfront will be allocated to their spends. The balance, some of it will be a dividend out to Glenmark, and the rest will sit as cash on the books.
Okay. Any plans of rewarding the shareholders of Glenmark who waited very patiently for a possible R&D deal?
We'll definitely consider increasing the payouts to shareholders. I think we'll put it up to the board and get that approval.
Okay. Now this $1.2 billion in terms of milestone payments, what is it contingent on? Any kind of milestones that you can share with us and when can we probably expect them to come through?
I think the milestones are all based on certain meetings, certain events. Specific events like completing a certain phase of clinical development, or regulatory filing, or regulatory approval. So they are spread all over, so it's hard to say when these will fructify.
Okay. Now the royalty payments if the molecule is successful and comes to market, how long will the royalty payments last for? And typically what you've seen in terms of molecules, and the size of this particular molecule for multiple myeloma, how much do you think it can probably garner for you?
So the multiple myeloma market today is about $30 billion, estimated to be about $50 billion by 2030 globally. So the market size is very large. In terms of royalty payments, typically some of the novel drugs have a life of at least 15 to 20 years of exclusivity. So the royalty payments can be significant as and when these drugs come to market.
Okay. Well, you've done this deal at a time where there is a lot of challenge when it comes to funding especially for biotech companies. How challenging was this particular deal in this environment of uncertainty?
Big pharma has always had deep pockets. Given the clinical data that we had and the level of efficacy and safety that ISB 2001 demonstrated, we had a lot of interest around this asset. We're happy that we concluded the deal with AbbVie as the final partner.
You're not telling us how many companies actually approached you, the big pharma companies that approached you.
I think all that is history. Finally, we have AbbVie as a partner and we're excited to have them as the final partner.
You know, you're going to have a significant amount of cash on books. We've seen that there are a lot of companies looking at acquisitions and we've seen the Torrent JB Chemicals deal which has taken place recently. Will M&A be something that you would consider?
Well, for the next one year, we're going to stay focused. I don't think you would see us do anything on the M&A side.
Okay. What about in-licensing?
In-licensing has always been a part of our strategy. For example, we did Envafolimab to further leverage our oncology capabilities in India and emerging markets. We will continue to look for in-licensing opportunities both in India as well as globally. We recently launched two assets in oncology in India, zanubrutinib and tislezumab (Brukinsa and TMBRA). So we're constantly looking at in-licensing of assets for India and emerging markets in the three therapeutic areas: dermatology, respiratory and oncology. So weight loss drugs, obesity is not on the cards right now. For us, weight loss and obesity would fall in our diabetes franchise which is mainly India specific. But globally, we operate in derm, respiratory and oncology. Those are the three areas we continue to look for in-licensing and developing further novel assets.
Talk to us about this big landmark deal which has taken place. Glenn, thank you very much for joining in. Well, if you could just go through the finer points of this big deal which has taken place for IGI which is your innovation subsidiary.
Thank you, Eka. Clearly this is a huge moment for us. We have been working on this for 25 years in the innovation space and I think ISB 2001 really is a world-class asset that can be transformational for patients. From a partnering perspective, we structured it by partnering with AbbVie for the US, Canada, Europe, China, Japan, and most developed markets, while Glenmark will commercialize the product in India and all emerging markets. So the two of us will make sure this asset is successful. IGI is a 100% subsidiary of Glenmark and has done a phenomenal job developing this asset, getting phase one data. At ASCO, we presented data showing almost 79% ORR and nearly 30% complete remission in patients who had exhausted prior lines of therapy for multiple myeloma. We are very excited to partner with AbbVie, a great partner with huge global capabilities and resources to bring ISB 2001 to market.
Okay. So explain the financials to us. $700 million is what you would get upfront, $1.2 billion in milestones, and the remaining would be royalties.
That's correct. We receive a $700 million upfront payment once regulatory approvals are obtained. The $1.2 billion-plus milestones are spread across clinical development, regulatory filings, approvals, and sales-linked milestones, cumulatively reaching $1.25 billion for the asset. After commercialization, we receive royalties on sales, which for innovative products often have a long life, potentially making this an annuity if the molecule reaches the market.
Okay. So let's first understand where exactly this molecule stands. Phase 1B currently. Explain that to us. How nascent is this molecule at this point in time?
ISB 2001 is still at a relatively early stage. The good news is we have patient data from about 40-50 patients, with good clinical data presented at ASCO showing a very good safety profile and efficacy. But it still needs significant clinical development going forward.
Okay, so AbbVie is now going to take over the entire development of this molecule. When do you think it will probably hit the market or show any kind of results?
AbbVie takes over all clinical development from here. In terms of timeframe, I cannot give a specific date, but typically assets in this space take about four to five years at least to reach commercialization.
So say 2030 would be a good target to probably expect something tangible coming in from the molecule, or hitting commercial sales if it is successful.
Again, I cannot speak specifically about ISB 2001, but typically it is about four to five years to commercialization.
Okay. Let's talk about how you are going to use the funds. $700 million, 6,000 crores of cash on Glenmark's books. How exactly will that be utilized?
IGI will continue developing other assets using their multispecific antibody platform. They spend about $70 million per year, so a big part of the upfront will go there. The balance will partly be dividend to Glenmark and the rest will remain as cash on the books.
Any plans to reward the shareholders of Glenmark who waited patiently for an R&D deal?
We will definitely consider increasing payouts to shareholders, and we will take that to the board for approval.
Okay. Now the $1.2 billion in milestone payments, what are they contingent on? Any milestones you can share, and when can we expect them?
The milestones are based on specific events like completing a phase of clinical development, regulatory filings, or approvals. They are spread out, so it is hard to say exactly when each will occur.
Okay. The royalty payments – if the molecule succeeds and reaches the market, how long will they last, and given the size of the multiple myeloma market, how much do you think it could garner?
The multiple myeloma market is about $30 billion today, estimated to reach $50 billion by 2030. Royalties for novel drugs often have a life of 15-20 years of exclusivity, so the payments can be significant once the drug comes to market.
Okay. You have done this deal at a time when funding for biotech companies is challenging. How challenging was this deal in this uncertain environment?
Big pharma has always had deep pockets. Given the clinical data and the efficacy and safety of ISB 2001, we had a lot of interest in this asset, and we are happy to have concluded the deal with AbbVie as our final partner.
You are not telling us how many big pharma companies approached you.
All that is history. Finally, we have AbbVie as a partner, and we are excited about that.
You will have a significant amount of cash. We have seen M&A activity like the Torrent JB Chemicals deal. Will you consider M&A?
For the next year, we are focused. I do not think you will see us do anything on the M&A side.
In-licensing has always been part of our strategy. For example, we in-licensed assets to leverage our oncology capabilities in India and emerging markets. We recently launched BeiGene's zanubrutinib and tislelizumab in India. We continue to seek in-licensing opportunities in dermatology, respiratory, and oncology for India and emerging markets.
So weight loss drugs and obesity are not on the cards right now.
Weight loss and obesity fall in our diabetes franchise, which is mainly India-specific. Globally, we focus on derm, respiratory, and oncology, so those remain our areas for in-licensing and novel asset development.
Any other big molecules on IGI's books with similar potential?
IGI's multispecific antibody platform, developed over 10+ years through the BEAT platform, now works. We can leverage it for many additional assets. The most near-term is 2301, an NK cell engager entering clinics next year, which we are excited about.
This is not only a deal for Glenmark. In context of India's R&D, we have often been on the back foot. Do you think India is coming of age, considering deals from Orchid, Walkhart, and now Glenmark?
I think it is company-specific. But my personal view is that innovation trumps everything in pharma. It is about helping patients with better therapies, which drives companies to invest in innovation.
But do you think India has come of age and that the R&D story is the next big thing, or is it company-specific?
I think it is company-specific.
Okay. Glenn, end this conversation by telling us Glenmark's vision now that you have struck this deal. You have generic, India, and consumer businesses. What is the five to ten-year vision?
Glenmark will continue to move up the value chain into launching novel and innovative products.
Quickly, on trade tariffs and uncertainty for pharmaceuticals, what should we expect?
It is still playing out, Eka. Hard to say what happens on the tariff side.
Hypothetically, if there is a huge tariff on pharma exports, even 200% as reported, how would Indian companies manage?
I do not want to speculate right now. For me, this moment is all about ISB 2001.
Okay. Thank you very much for joining in, and congratulations on putting India on the map for R&D.
Thank you.
You know, some of these innovative products, the life of the royalties is pretty long. So this could pretty much be an annuity if the molecule makes it to market.
Okay. So let's first understand where exactly this molecule stands. Phase 1B currently. Explain that to us. How nascent is this molecule at this point in time?
So ISB 2001 is still at a relatively early stage. The good news is we have patient data in about 40 to 50 patients. We have good clinical data that we presented at ASCO, very good safety profile, good efficacy data, but it's still early stage, so it has to go through a significant amount of clinical development as we go forward.
Okay, so ABV is now going to take over the entire development of this molecule, we understand. When do you think that it will probably hit the market or show any kind of results?
So AB takes over all clinical development from here on. In terms of time frame, I can't give you a specific time frame, but typically molecules in this space take about four to five years at least to get to commercialization.
So say 2030 would be a good target to probably expect something tangible coming in from the molecule or hitting commercial sales if it is successful.
So again, I can't specifically talk about ISB 2001, but typically it's about four to five years to commercialization.
Okay. Well, let's talk about how you're going to use the funds. Now, let's start with $700 million, $6,000 crore of cash on books. It will be on Glenmark's books. Tell us how exactly is the $700 million going to be utilized.
So the way we're looking at it is, IGI will continue development of various other assets that they have. They have a great multispecific antibody platform technology which they will continue to exploit. They spend about $70 million a year, so that spend will continue. Clearly, a big part of this upfront will be allocated to their spends, the balance some of it will be dividend out to Glenmark, and the rest will sit as cash on the books.
Okay. Any plans of rewarding the shareholders of Glenmark who waited very patiently for a possible R&D deal?
We'll definitely consider increasing the payouts to shareholders. I think we'll put it up to the board and get that approval.
Okay. Now this $1.2 billion in terms of milestone payments, what is it contingent on? Any kind of milestones that you can share with us and when can we probably expect them to come through?
I think the milestones are all based on certain meetings, certain events. Specific events like completing of a certain phase of clinical development, or regulatory filing, or regulatory approval. So they spread all over, so it's hard to say when these will fructify.
Okay. Now the royalty payments if in case the molecule is successful and it comes to market, how long will the royalty payments last for, and typically what you've seen in terms of molecules, what is the size of this particular molecule for multiple myeloma? How much do you think it can probably garner for you?
So the multiple myeloma market today is about $30 billion, estimated to be about $50 billion by 2030 globally. The market size is very large. In terms of royalty payments, typically some of the novel drugs have a life of at least 15 to 20 years of exclusivity. So the royalty payments can be significant as and when these drugs come to market.
Okay. Well, you've done this deal at a time where there is a lot of challenge when it comes to funding, especially for biotech companies. How challenging was this particular deal in this environment of uncertainty?
Big pharma has always had deep pockets, and given the clinical data that we had and the level of efficacy and safety that ISB 2001 demonstrated, we had a lot of interest around this asset. We're happy that we concluded the deal with Abby as a final partner.
You're not telling us how many companies actually approached you, the big pharma companies that approached you.
I think all that is history. Finally we have Abby as a partner, and we're excited to have them as the final partner.
You know you're going to have a significant amount of cash on books. We've seen that there are a lot of companies that are looking at acquisitions, and we've seen the Torrent-JB Chemicals deal which has just taken place recently. Will M&A be something that you would consider?
Well, for the next one year we're going to stay focused. I don't think you would see us do anything on the M&A side.
Okay. What about in-licensing?
In-licensing has always been a part of our strategy. For example, we did Envoy map to further leverage our oncology capabilities in India and emerging markets. We will continue to look for in-licensing opportunities both in India as well as globally. We recently launched two assets in oncology in India, zanorutinib and tisly zumab, and Tmbra. So we're constantly looking at in-licensing of assets both for India and emerging markets in the three therapeutic areas we operate which are primarily dermatology, respiratory, and oncology.
