Sun Pharma Advanced Research Company Limited (SPARC.NS) Earnings Call Transcript & Summary

April 15, 2024

National Stock Exchange of India IN Health Care Pharmaceuticals special 51 min

Earnings Call Speaker Segments

Operator

operator
#1

Ladies and gentlemen, good day, and welcome to the SPARC's Conference Call for Update on PROSEEK's Interim Results. [Operator Instructions] Please note that this conference is being recorded. I now hand the conference over to Mr. Jaydeep Issrani. Thank you, and over to you, sir.

Jaydeep Issrani

executive
#2

Thank you, Sagar. Good evening, ladies and gentlemen. My name is Jaydeep, I head the Business Development and Investor Relations at SPARC. On behalf of SPARC, I welcome you for the update on the interim analysis of PROSEEK Study. I have with me Mr. Anil Raghavan, CEO of SPARC. Anil will provide a brief update on the outcome of the PROSEEK study, following which we will open the call for question and answer. Before I hand it over to him, I would like to remind you that our discussion may include forward-looking statements that are subject to risks and uncertainties associated with our business. I will now hand it over to Mr. Anil Raghavan for his presentation. Over to you, Anil.

Anil Raghavan

executive
#3

Hello, everybody. Thank you for joining the call today. Thanks, Jaydeep, for the introduction and setup for the call. As we mentioned, we plan to provide an update on the interim analysis of our PROSEEK study and briefly talk about the next steps and the way forward for SPARC. The primary objective, though, is to try and address your questions and concerns as much as possible today. So I'll keep my opening comments brief. But before I begin, I would like to apologize for the delay in convening this call. We received data from the PROSEEK interim analysis last week and made a disclosure of the results through a press release immediately within a day. Our intent was to provide an update and talk to you as soon as possible. However, the immediate focus thereafter shifted to initiating the closeout activities, [ manage it ] and think through the near-term priorities, which took a few days to complete. We believe it is important to map out our key next steps of vodobatinib before we can have a productive conversation with you. But again, we understand the [ sensibility ] and sincerely apologize for not following up the release immediately with the call. You may recall that our initial plan was not to disclose the interim results before completing the review of all the 513 patients randomized on the trial. However, in the interest of patients, our investigator community and the larger investor group, we decided to unblind the study and share the results immediately given the trend lines that we have seen. As we disclosed, we completed the review of 442 out of 513 patients, 442 who finished the first part of the study -- Part I of the study by March of 2024...

Unknown Attendee

attendee
#4

[indiscernible]

Jaydeep Issrani

executive
#5

So can you put your line on me, please?

Unknown Attendee

attendee
#6

Okay.

Anil Raghavan

executive
#7

The data suggested that the vodobatinib arms, that is the low dose and high dose arms, did not meet the primary endpoint of change in score from baseline in MDS-UPDRS part III at week 40. Key secondary endpoints have also shown a similar trend. Overall incidence of serious adverse events was low in this trial, indicating an acceptable safety profile. That was indeed a disappointing outcome and certainly not what we hoped for our patients, especially after having generated a significant body of evidence in preclinical [ model ] systems in collaboration with some of the most important thought leaders in this space, demonstrating the neuroprotective role of vodobatinib in multiple preclinical experiments. Based on our statistical projections that suggested that the study is unlikely to show clinical benefit in the overall study population, we decided to close the trial. Having said that, we will review the full data set, which is not expected to change the primary endpoint of the study. However, it can provide meaningful insights on the mechanism, the drug and the trial. We will keep you informed as we complete this planned analysis. Once we have reviewed the full data, we will also evaluate the expectations for and value of Lewy Body Dementia investigator-initiated trial at Georgetown and preclinical programs for the backup series of vodobatinib as they target the same mechanism of action as vodobatinib did with PROSEEK. But as of now, we have [ parked ] all activities in these studies. Obviously, these results represent a setback for SPARC, which will pose questions on certain parts of our portfolio and challenge our ability to pursue an aggressive R&D agenda. As we complete the data analysis for PROSEEK, we will also work towards resetting our portfolio, optimizing our operating model and cost structure. This is really important, considering the additional cards that we have got to turn. As we have indicated previously, SPARC's pipeline has significant optionality, including multiple clinical assets and a late-stage preclinical program, which is expected to enter the clinical testing phase in the last quarter of this financial year. So please allow me to make a minute to highlight these assets short- to medium-term milestone visibility. The most advanced program is [ SCO-088 ], as you may know, which is vodobatinib's oncology leg for treatment of CML. We have completed the Phase II study and the data provides clear validation for [ its hypothesis ] in leukemia with excellent response rate even in patients who have exhausted all available therapeutic options. As next steps, we are discussing the registration strategy design and expectations with the USFDA, in fact, later today to decide future development strategy for [ SCO-088 ]. Since SCO-088 has established human PoC, we may explore licensing the asset to a partner to raise nondilutive capital for developing other late-stage assets, that's SCD-153 and SBO-154. SCD-153 is under Phase I evaluation in India, and we hope to complete the Phase I study by financial year '25 and subsequently, an early patient study in alopecia areata in India by financial year '26, at which point we would have established human PoC for SCD-153. Similarly, for SBO-154, our antibody drug conjugate targeting a novel [ epitope MUC-1 ]. We have initiated IND-enabling studies, and we expect to file the IND by the end of the current financial year. Both of these opportunities represent first-in-class potential for [ SPARC ] across multiple indications. Additionally, vibozilimod is under Phase II assessment and the top line results of the [ Solaris AD ], that is atopic dermatitis study is expected in quarter 4 of calendar year '24. This, as you know, is licensed to Sun Pharma and the development costs are borne by the partner. Continued development of these programs will require additional resourcing and our current cash balance and approved credit may be sufficient to cover the expenses for 12 to 15 months, if you factor in expected cost savings from vodobatinib and related [ deprioritization ]. We are also eligible for additional milestones from [ vibozilimod ] and phenobarbital, depending on certain outcomes that can increase our [ run rate ] further for SPARC. We may require additional resources to get to the next set of milestones in certain scenarios. We will tightly manage the portfolio and our spend to get to the next set of data even soon. As I indicated earlier, we will review our current clinical and preclinical portfolio to identify and prioritize high-value programs and optimize the cost base to extend our [ run rate ]. Let me summarize. While PROSEEK interim results sets us back for sure, we have several additional assets, especially the clinical assets that carry significant value, which we will pursue using appropriate resourcing models, which may involve partnering early if that makes sense. We will keep you posted as we make progress with the full analysis of the PROSEEK data and complete our strategy review. Thanks again for joining us today. And at this point, I would like to open up the call for questions, concerns, you may have, suggestions, if you have any. And thank you again for your time today.

Operator

operator
#8

[Operator Instructions] The first question is from the line of Ketan Gandhi from Gandhi Securities.

Ketan Gandhi

analyst
#9

Yes. Sir, due to this disappointment, in the November call, you said we have a [ surer ] option for vodobatinib for CML. So in terms of time line, when can we expect the licensing deal to happen? And what are the opportunity size for this molecule?

Anil Raghavan

executive
#10

Thanks, Ketan. I think, as we've explained in the last investor call, we have [ parked ] the CML opportunity until we have the results of the vodobatinib study, so -- as in the preclinical and the Parkinson's disease study. So we will now initiate -- I mean that is the reason why we have this conversations with the FDA to have a clear visibility to the regulatory pathway. And we are now in the process of reinitiating potential business development activity on the CML part of the program. In terms of giving you a specific time line for closing out of that licensing transaction, I think probably we are a little too early in the process. We just started this process now, and we may need additional time to kind of scan and go through the process and conclude a transaction for vodobatinib. In terms of the opportunity size, I think we haven't disclosed the [ specifically sales ] potential. But it is significantly lower than the Parkinson's disease opportunity. And here we are talking about potentially several hundred million dollars as against several billion dollars in the case of Parkinson's disease.

Ketan Gandhi

analyst
#11

Sir, I want the time line in terms of whether it will happen this financial year, next financial year or a year after the next financial year. Can you give some sort of ballpark understanding so that we can model that into our...

Anil Raghavan

executive
#12

We're definitely targeting this financial year, and that's our objective.

Ketan Gandhi

analyst
#13

Okay. So in terms of cash burn, we are in enough cash position to go ahead for other programs? Or we need to raise some equity in near term?

Anil Raghavan

executive
#14

We are not contemplating any near-term equity rate. And if I look at our current cash balance, we should be in the range of around $20 million, and we also have access to approved credit. And if I actually look at both approved credit and the current available cash, we should be able to basically go beyond the current financial year. We are looking at window of around a 12 to 15 months, and this also factors in some of the cost savings from the [ reprioritization ]. I mean if you are not spending on the [ vibozilimod ] clinical program -- [ vodobatinib ] clinical program and also the backup program that we have. That is a significant amount of -- significant part of our budget for this year. So in that sense, if I take out that from the provision, this cash balance and access to credit is sufficient to take us to 12 to 15 months runway. But we also have -- we are taking a deeper look at our portfolio priorities. Clearly, the assets that I spoke about in the call earlier are important. And we have clinical validations coming from mostly the India-based trials in these cases, except [ MUC-1 ], and so we may require -- beyond that, we may need to have additional cash infusions, but that's depending on how some of these outcomes. And we have milestone visibility on vibozilimod, which is maturing later this year. And such that we can also provide additional milestones. So there are additional milestone opportunities, which can augment this beyond the 12 to 15 months window. So we will take a call as we kind of move towards that, but we will take a hard look at the portfolio and our cost structure in the interim.

Ketan Gandhi

analyst
#15

Fair enough. Sir, can you throw some light on the phenobarbital. What happened there? Because I believe we have filed some case in U.S. in District Court of Columbia on 2nd of April. So what is that about? And where are we in terms of launching it?

Anil Raghavan

executive
#16

No, no. We have -- the case that we have filed against [indiscernible] FDA has nothing to do with the launch of the product. Our product is launched, and the takeoff is expected when we get the exclusivity established. And there is a whole work stream going on. And our expectation right from the beginning is that by end of the second year or beginning of third year of launch, we will be able to establish the exclusivity or enforce sales [indiscernible] and take out the unapproved products from the market. But the case is about a different matter. We believe we are entitled to get a pediatric rare diseases voucher. And the pediatric rare disease voucher was denied because of certain interpretations of statutes involved, and we disagree with that. I cannot dwell into this matter more than that since it is subjudice at the moment. So I do not want to talk a lot about our position and the specific nature of our disagreement, but we believe that we have a defensible case, and that's the reason why we've initiated this process.

Operator

operator
#17

[Operator Instructions] Our next question is from the line of Ashutosh from [ Zydus ] Investments.

Unknown Analyst

analyst
#18

For PROSEEK studies, sir, when can we expect full analysis results?

Anil Raghavan

executive
#19

I couldn't follow the question. Did you ask the availability of the full analysis results of PROSEEK?

Unknown Analyst

analyst
#20

Yes, sir.

Anil Raghavan

executive
#21

Okay. We are looking to complete the full analysis of PROSEEK by the second quarter of this financial year.

Operator

operator
#22

Ashutosh, do you have any further questions?

Unknown Analyst

analyst
#23

No, no, sir.

Operator

operator
#24

The next question comes from the line of Vishal Bohra from MK Ventures.

Unknown Analyst

analyst
#25

Sir, I just want to understand, are there any qualitative data points that you can share further on the PROSEEK trials? Or while we did not meet the primary endpoint, was there actually no efficacy outcome at all or like no response at all? Or was the response there, but not sufficient to create the -- to cross the hurdles? What was the case here?

Anil Raghavan

executive
#26

In the PROSEEK interim analysis, we looked at the primary endpoint, which is Part III of MDS-UPDRS and a few secondary endpoints, which is Part II plus Part III and the time to even -- as in the time to systematic therapy. So this is a subset of secondary endpoints we have in the trial, plus we also looked at 3 biomarkers, which is neurofilament light. We've looked at binary [indiscernible] assay, which essentially diagnose the disease. And then we, in CSF fluid, look at the trending of [indiscernible]. So in the primary endpoint, and as we've indicated, we did not meet the significance between placebo and our treated arms. And we have a similar trending for these subset of secondary endpoints that we've looked at. In both these cases, what I can say at this point is that we have an extraordinarily high placebo response. In fact, the placebo curve stayed flat for almost the study period. But we are not disclosing the specific data at this point. And we will take a look at all the secondary endpoints and also all the biomarker endpoints. In biomarkers, we have conflicting data points coming from that biomarker study. So we will take a look at both the clinical outcomes across all secondary endpoints. We will also have -- we've looked at the first 9-month period data in this analysis. We also have an additional 9-month data for subset of this patient pool. And we will also take a look at how this trajectory kind of pan out. But that's obviously an uncontrolled, as in it doesn't have a placebo control in the second part of this trial. So we will take a look at both the 9-month period, the second 9-month period, all biomarkers and make a final view on both the target and the trials and the drug.

Unknown Analyst

analyst
#27

Sir, a couple of related questions. So just to understand -- so we are seeing that the trial did not fail because of a poor outcome or a poor data on vodobatinib, but more because your placebo response was extraordinarily good. Could it be a case of maybe a trial design or an externality? Do you think that there is a possibility that you may want to look at a retrial with maybe a revised trial design or a revised endpoint and look at it again, is there a possibility for that, sir?

Anil Raghavan

executive
#28

Well, I wouldn't frame the way you framed it. I think then -- the study was designed for showing a 35% difference between placebo and our drug, 35% improvement over placebo. Obviously, the analysis that we have seen so far did not show that addition. And we have to wait until the full analysis of the data for any additional steps that we may have to take. In terms of actually factoring in vodobatinib into the model, our advice at this point is to discount vodobatinib fully based on the trend lines that we have seen. And if there is a room for any kind of reframing this hypothesis or reframing based on any additional trials, we will definitely come back and address you on the basis of additional review that we have undertaken.

Unknown Analyst

analyst
#29

Maybe I may just want to frame the question differently. In terms of vodobatinib, another PROSEEK trial next steps, is a retrial, one of the possibilities, sir, even if it is, let's say, a 1% possibility. Is that one of the options that is still available to us or that is completely closed out?

Anil Raghavan

executive
#30

No, I cannot [ close out ] anything at this point because we haven't seen the full data set. Unless we see the full data set and we understand what happens in the trial fully, all of these options are possible, but they have very remote options based on what we've seen on the primary endpoint and secondary endpoint. That's why we are advising it to discount program in the market.

Unknown Analyst

analyst
#31

Right, sir. And what is the backup option you said. I think, was it referring to the Alzheimer's thing? Or are you referring to backup as vodobatinib for CML and LBD?

Anil Raghavan

executive
#32

So the [ hedge ] for vodobatinib as in the -- hedge for PROSEEK was essentially CML. Even though we had other preclinical programs for vodobatinib and its backup series in neurodegenerative diseases, we always considered that as one package, one battery, which will come alive if we have positive response in the PROSEEK. In the absence of that, the real alternative for vodobatinib is a leukemia program, which is what we just discussed.

Operator

operator
#33

The next question is from the line of Manish Jain from GormalOne LLP.

Manish Jain

analyst
#34

I just wanted to understand that in CML, given that the way asciminib has been ramping up to $450 million sales already at an annualized run rate, does it make sense for us to take it all the way to the final approval?

Anil Raghavan

executive
#35

Manish, is the question is about SPARC spending the resources to take this to the clinical -- I mean, a regulatory approval in the U.S. And may not be -- yes, we may not -- it may not be an appropriate use of SPARC's capital to take that all the way into regulatory approval in the U.S. given other options or opportunities that we have in the portfolio. But there may be other midsized pharmaceutical companies for sure who may be interested in a program like this, which can give significant enough opportunity from a commercial standpoint for a smaller sales force and with enough opportunities to go up against product which is ramping up fast. And there are not very many options. And especially the safety profile that we have seen for the product and activity that we have seen for the product and activity that we have seen for late line cases makes it is a developable option. And we are seeing validation for that even after we kind of deprioritize the program. We get several breakouts for off-trial access of that drug because of its activity in patients who have exhausted all lines of therapy. So that's an interesting proposition for someone who is looking to build $200 million, $300 million, $400 million product, but that may not be a right opportunity to kind of prioritize our capital over the ADC or over the potentially first-in-class dermatology product.

Manish Jain

analyst
#36

Perfect. And my second question was that in phenobarbital, given that we have licensed it to an external party, should we win the PRV case, the entire PRV value belongs to us or we have to share some proceeds with the partner as well?

Anil Raghavan

executive
#37

The PRV is with SPARC.

Manish Jain

analyst
#38

Yes. So 100% value of PRV is with SPARC, right?

Anil Raghavan

executive
#39

Yes.

Operator

operator
#40

The next question is from the line of [ Chandpal Singh ], who's an individual investor.

Unknown Attendee

attendee
#41

Sir, I just wanted to ask a question that, is this the end of the c-Abl hypotheses for other drugs that are in trial for Parkinson's.

Anil Raghavan

executive
#42

Well, I don't think so. PROSEEK, at the moment, the interim analysis is rarely not the last word for the mechanism. We need to see the setback for the mechanism. But we need to basically look at the full data set. We are practically sitting and reset all the information in terms of how the mechanism actually behaves. So in that sense, whether it is tractable hypothesis which is something that needs to be determined based on the full analysis of the data set.

Operator

operator
#43

[Operator Instructions] The next question comes from the line of [ Rohan Parik ] from Ohm Stock Broker.

Jigar Valia

analyst
#44

This is Jigar Valia. So my question is, while Vodo failed on the primary and secondary? It did cross the blood-brain barrier through and is -- so it's a question did it actually go through with regards to the 442 patients. And -- or -- and is that anything of value or...

Anil Raghavan

executive
#45

Sorry, I mean -- I came in before you finished. Can you just repeat the last line of your question.

Jigar Valia

analyst
#46

Yes. So my question was that did the results show a successful crossing of the blood-brain barrier while it did not meet the primary, secondary end points? And is it -- if it did, then is that of value for either us or as far as the therapy or a study is concerned?

Anil Raghavan

executive
#47

No, that's an important question, [ Rohan ], because we have the final -- the interim analysis did not include a PK analysis. So we have -- even though we have access to all the both blood [ clots ] on all patients and also CSF data for an appropriate number of patients. We haven't analyzed that to determine the exposure that we have both peripherally and in the brain. So that is an important part of the analysis that we will be doing as part of the complete review.

Jigar Valia

analyst
#48

Okay. Okay. Sir, if it was not a part of it, then it can't be okay? Second question is with regards to the CML, the failure that happened for the PD thing, those primary, secondary endpoints would be entirely distinct as far as the CML is concerned and it will be completely -- this is completely linked to PD and that would be linked to CML. But yes, is it fair that there is no correlation between the two?

Anil Raghavan

executive
#49

Primary and secondary endpoints of the Parkinson's trial is very specific to Parkinson's and the progression of that neurodegenerative disease, it is a condition and it has got nothing to do with leukemia. And the proof of concept for leukemia is already available from our earlier study -- in Phase II study. And if anything, the safety data from this trial is supportive of its dose and in leukemia, which is actually lower than the doses that we have used in the Parkinson's trial. So there is -- we don't see any negative fallout of PROSEEK in the leukemia program. If anything, it is positive because of the safety profile.

Jigar Valia

analyst
#50

That's great. And for the leukemia program, we continue with -- after Phase II with as imminent plus one more as a line 3 product, right?

Anil Raghavan

executive
#51

No. It will be -- we are essentially in the process of having the conversations with the FDA and actual treatment line for the trial will be decided based on the feedback that we will receive from the FDA. But the studies that we have done so far was in 3-line failed patients. That is the original proof of concept, and that is probably the most difficult setting to go after because they have exhausted all available lines of therapy. If they have -- if we have an opportunity to move up and test a different line, it will be a function of what we hear from the agency.

Jigar Valia

analyst
#52

Understood. Last question from my side. As far as the fund raise is concerned, it would have nothing to do with the time lines for the final study, which is -- which will be in Q2. And it would also be a function of you having the discussion with FDA or based on conditions.

Anil Raghavan

executive
#53

No, no. The fund raise is not a function of our conversations with the FDA because as I explained earlier to another question, we are not looking to allocate our capital for developing this program in leukemia. We are actively -- we are initiating a process to actively look for licensing partners for leukemia. So in that sense, from a cash flow funding standpoint, these conversations and our actual plans for leukemia may not be a major factor.

Operator

operator
#54

[Operator Instructions] The next follow-up question is from the line of Ashutosh from Zydus Investments.

Unknown Analyst

analyst
#55

Sir, I wanted to ask. Hello?

Operator

operator
#56

Yes, you are audible. Please go ahead.

Anil Raghavan

executive
#57

Yes, we can hear you, Ashutosh.

Unknown Analyst

analyst
#58

I wanted to ask, what is the trial cost for them?

Anil Raghavan

executive
#59

We may have a spend roughly in the range of 45 -- I mean the overall budget for PROSEEK was in the range of $45 million, but we may not end up spending all of $45 million because that assumed completion of the trial all the way to basic level. That's 40 weeks for the Part 1 and completion of the Part 2 strategy. So now because of the early termination, we may be able to have some savings on that $45 million original allocation.

Unknown Analyst

analyst
#60

Sir can I ask how much you have spent?

Anil Raghavan

executive
#61

Currently, it may be in the -- in excess of $35 million and original budget was $45 million.

Unknown Analyst

analyst
#62

Currently, how much?

Anil Raghavan

executive
#63

$35 million plus. I don't have an exact number right at the moment, but it is certainly between $35 million, $40 million, but closer to $35 million than $40 million.

Operator

operator
#64

As there are no further questions from the participants, I would now like to hand the conference over to Mr. Jaydeep Issrani for closing comments.

Anil Raghavan

executive
#65

Sagar, there are a couple of additional questions, if you could get the question.

Operator

operator
#66

We have the next question from the line of Mr. Tushar Bohra from MKVentures.

Tushar Bohra

analyst
#67

Sir, if you can highlight the next steps on your specialty pipeline, if you can just highlight the liquidity events, monetization events there in and also, what kind of milestones can we look at, what next steps across Sezaby, Elepsia and the other one?

Anil Raghavan

executive
#68

The major milestone payments from programs which we already licensed, Sezaby on payment to the market. We have additional milestone payments, which will happen as we move forward and clear the other products on the market and get our exclusivity established. PDP-716, which is our ophthalmology program. We're going in for refiling in September time line. And we have milestones on an approval of that product. And vibozilimod which is the Phase II program in psoriasis and atopic dermatitis and successful completion of those programs would have additional milestone events. So those are the 3 with identified milestones for us. Other than that, you have further clinical and developmental and regulatory milestones for vibozilimod. We also have these 2 other programs, which I talked to you about, which is the SCD-153 and SBO-154. SCD-153 is collaboration with Hopkins in alopecia areata. And that we just started our Phase I clinical trial in India, we're on a dose escalation. And our intent is to establish a clinical proof of concept for that program in alopecia areata before we start looking at partnering options. SBO-154 is, again, antibody drug conjugate targeting a new epitope of MUC1. And we are in the process of scaling up our manufacturing for the clinical program and its nonclinical programs started. Our thought is that we will be able to do the IND for this program before the current financial year. So those are the 2 major programs in -- which is closer to encashable event other than the previously I talked about license programs.

Tushar Bohra

analyst
#69

There's not much mention in the last couple of presentations about vibozilimod for psoriasis. So while we -- in the call also today, I think you mentioned atopic dermatitis, so can you highlight, sir, what's the status of psoriasis as well?

Anil Raghavan

executive
#70

We haven't -- our commercialization partner, Sun, hasn't given a time line for the completion of the psoriasis program. The psoriasis program is behind atopic dermatitis program. So it will follow the results of the atopic dermatitis program. And we don't think that we will have data availability from that program this year. That's why we are not talking about that. But if that program also is progressing and probably Sun can give us an update on specific time lines for the psoriasis program.

Tushar Bohra

analyst
#71

And sir, what would be the -- would be your estimates as to Sezaby, when do we start seeing the commercial revenue swinging initially? Or when you have the exclusivity established, do you have a time line sense to it?

Anil Raghavan

executive
#72

Look, I think we had a citizen petition with FDA and FDA came back to us asking more time. They said that this is a complex matter and it would require additional time and they did not set us specific time line in terms of when they will act on the business [indiscernible]. And in this process, we are also adding additional leverage points in terms of working with patient advocacy groups and also directly engaging with some of the unauthorized manufacturers. So our -- I mean if I look at what happened with other programs, which came into a market similar to Sezaby, usually takes 2 to 3 years before the product gets fully exclusively established. So we just completed the first year and into the second year. And I think we have test process going and our hope is that we will be able to maintain a similar time line.

Tushar Bohra

analyst
#73

Got it, sir. And for Elepsia and Xelpros, any further updates you want to highlight?

Anil Raghavan

executive
#74

We're in the process of transitioning Elepsia to a different partner, but we don't have a finalization of that process yet. So we are still in an -- in-process position there.

Tushar Bohra

analyst
#75

Got it sir. Just one more thing on vodobatinib for CML. In terms of head to head, what are the options if you have to go for a front runner trial? Do you have any specific options earmarked or highlighted that you have decided that this should be most relevant comparison?

Anil Raghavan

executive
#76

So if we were to do a comparative study, which looks like that's what we should do. And most likely comparative product would be -- most relevant comparative product would be bosutinib, but we will take that final call based on the FDA feedback.

Tushar Bohra

analyst
#77

Okay. Or is it possible for us to do maybe more than 1 arm of study given that a couple of the other products are more prevalent, whether it's dasatinib or imatinib.

Anil Raghavan

executive
#78

Yes, that's again a function of the design which we agree with FDA. And I'm assuming your question is about like multiple comparators. Is that what you're saying?

Tushar Bohra

analyst
#79

Yes, because dasatinib being the largest and it's a $2 billion molecule by senses in that ballpark in any case? So would it be not fair for us to target that and trend to head to head comparison against something like dasatinib and if you're able to do equally where they may be better that opens up a far bigger specialization possibility then the $200 million to $400 million, sort of that ballpark of a few hundred million dollars that you've highlighted?

Anil Raghavan

executive
#80

I think that it's not just a regulatory question. It's also a clinical type question in terms of how you actually maximize your progress to a successful program? And if you look at the second or third simulation trials that happened in leukemia, and if you look at what has been the competitor for those programs, that will give you a clear sense of what is the preferred competitor program for programs like [ dasatinib ] or any other second or third generation program that has been [indiscernible] a complex question, which is driven by both commercial, capital and also probably a success and ability to kind of reduce the risk of the program. So we will take that call based on what we hear from the FDA.

Operator

operator
#81

The next question is from the line of Manish Jain from GormalOne LLP.

Manish Jain

analyst
#82

I just wanted to understand on SCD-153, till what level will we develop it on our own and when will we explore partnering SCD-153?

Anil Raghavan

executive
#83

So the development program for SCD-153 has 3 identified tests so far. One is completing its healthy human volunteer, single ascending dose trial, which is where we are at the moment. That establishes early safety for the program. And typically, in a program like this, this would have been followed by a 14-day multiple ascending dose study. So instead of doing that 14-day multiple ascending day study, we are proposing to do patient study in multiple ascending setting. In a sense, we will test this trial in ascending doses in alopecia areata patients. So that will give us 2 things. One, it will give us a better sense of safety profile in actual patient setting. And it may even though we are not power to detect that and it may provide an early signal on efficacy. And then we will follow that up with a Phase II study to determine the dose and also get proof of concept for the mechanism. And we are planning that in 2 steps. The first part is an India-based study where we will go up to 250 patients in India and do an interim analysis for those India-based patients. And if you get a proof of concept for 250 patients, that protocol will have a provision to expand the study to the rest of the world. But that India-based proof of concept for 250 patients is what we believe as an ideal licensing opportunity given where we are.

Manish Jain

analyst
#84

Perfect. And the second clarification I wanted is for ADC, which manufacturing ramp-up that we're talking about, is it in-house manufacturing capability that we have developed?

Anil Raghavan

executive
#85

No. We are working with the San Diego-based CDMO for scaling up this program.

Operator

operator
#86

The next question is from the line; of [ Rohan Komra ], an Individual Investor.

Unknown Attendee

attendee
#87

Sir, just to be sure, when we say that vodobatinib will be [ licensing ] in the next 2 or 3 years. That means we will also utilizing it for front runner program also.

Anil Raghavan

executive
#88

Sorry, Rohan, your line was very blurred. I couldn't hear you properly.

Unknown Attendee

attendee
#89

Sir, when we say that vodobatinib will be out licensing in next 1 or 2 years?

Anil Raghavan

executive
#90

You're talking about the CML arm of vodobatinib, right, Rohan?

Unknown Attendee

attendee
#91

Yes, CML. Is it a fair assumption to assume that we are outlooking it for over front runner program also?

Anil Raghavan

executive
#92

So I understand your question whether the CML part of the vodobatinib would be out-licensed in this year or next year. The answer is that's our objective. We are initiating this process. And as I said earlier, our objective is to finalize that process this year. I didn't quite follow the second part of your question.

Unknown Attendee

attendee
#93

I mean that we are also trying vodobatinib in front line settings.

Anil Raghavan

executive
#94

Yes. If it is out licensed, it will be for all settings of vodobatinib in leukemia, not just the last line.

Unknown Attendee

attendee
#95

Okay, sir. Then that means that milestone payment that we are going to see will be while keeping in the potential of [indiscernible] .

Anil Raghavan

executive
#96

Yes. I mean I think that you need to model. But yes, it will cover both the front line setting and earlier line as well as the last line.

Operator

operator
#97

The next question is from the line of Ashutosh from Zydus Investments.

Unknown Analyst

analyst
#98

Sir, for vodobatinib is there any corporate presentation deck available on the recent reports.

Anil Raghavan

executive
#99

There is a presentation on the website on -- you're asking about vodobatinib, right?

Unknown Analyst

analyst
#100

Yes.

Anil Raghavan

executive
#101

Yes. Yes. It's on the website.

Unknown Analyst

analyst
#102

Where it is?

Anil Raghavan

executive
#103

It's on the SPARC website.

Operator

operator
#104

As there are no further questions, I would like to hand the conference over to Mr. Jaydeep Issrani for closing comments.

Jaydeep Issrani

executive
#105

Thank you, Sagar, and thank you, everyone, for joining the call today. In case you have any additional questions, feel free to reach out to us on the e-mail IDs and numbers that are shared on the website. Thank you again for being with us on the call.

Operator

operator
#106

Thank you. On behalf of SPARC, that concludes this conference. Thank you for joining us. You may now disconnect your lines.

For developers and AI pipelines

Programmatic access to Sun Pharma Advanced Research Company Limited earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.