SPARCNSEOctober 28, 2022

Sun Pharma Advanced Research Company Limited

11,907words
79turns
9analyst exchanges
5executives
Management on call
Anil Raghavan
CHIEF EXECUTIVE OFFICER
Nitin Damle
CHIEF INNOVATION OFFICER
Vikram Ramanathan
HEAD, TRANSLATIONAL DEVELOPMENT
Chetan Rajpara
CHIEF FINANCIAL OFFICER
Jaydeep Issrani
SENIOR GENERAL MANAGER, BUSINESS DEVELOPMENT
Key numbers — 40 extracted
500 million
es we built in the last few years. As you can see in this graph here, SPARC has spent upwards of $500 million up to the end of FY'22 running our operations in the last 15-years and building what we have toda
79 million
and building what we have today. Fresh equity rights issues in 2012 and 2016 contributed around $79 million in total, while preferential issues brought in the rest. In this period, we invested around $277
277 million
lion in total, while preferential issues brought in the rest. In this period, we invested around $277 million from our internal revenue accruals. Two things are worth noting besides the substantial non-dilut
rs,
g about our portfolio pivot from incremental to more riskier NCE opportunities in the past few years, with the rationale and nature of that transformation many times. Early on that pivot, we focused o
60%
risk position in novel biology. These numbers on the chart here are worth taking note of. Almost 60% of our portfolio now has first-in-class potential. The composition of the portfolio fro
60 million
the call for progress and that's cash runway on Slide #8. We have an expected spend of around $60 million in a year. Numbers for the outer years as you can imagine are estimates, but we are more or less
93 million
more or less in the ballpark here. In terms of cash flow, we expect warrant conversions of up to $93 million by end of December 2022. In addition, we will have certain milestones and royalties from existing
70%
king to file NDA in 2024. PROSEEK is our Phase-2 PD trial for vodobatinib and we have crossed the 70% recruitment mark a few weeks back, and we are pushing forward on all cylinders to complete the
71%
he top bar, and then what happened to them following treatment on the bottom bar. As you can see, 71% of patients came into the study with uncontrolled disease. Only 29% had a major cytogenetic respo
29%
bottom bar. As you can see, 71% of patients came into the study with uncontrolled disease. Only 29% had a major cytogenetic response at baseline. Following treatment with vodobatinib however, there
2.8%
ponse, which represents a three-log reduction in the number of cancer cells, has increased from 2.8% prior to treatment to 43% following treatment. Finally, slide #17 here depicts a swim
43%
three-log reduction in the number of cancer cells, has increased from 2.8% prior to treatment to 43% following treatment. Finally, slide #17 here depicts a swimmer’s plot that gives you
Guidance — 20 items
Jaydeep Issrani
opening
The presentation will be similar to what we have been following in the previous versions, i.e.
Anil Raghavan
opening
In the interest of time though we don't plan to do detailed introductions.
Anil Raghavan
opening
And the second one, brimonidine once-a-day eye drop goes by the project name PDP- 716 was submitted recently.
Anil Raghavan
opening
We intend to bring two more projects to clinic in the next 18 months.
Anil Raghavan
opening
Alopecia Areata program later this year if everything goes on plan and MUC-1 ADC next year.
Anil Raghavan
opening
And more importantly, we are approaching some meaningful catalysts in the next 12-to-18-months for our stock and that's what we intend to cover in the rest of the deck.
Anil Raghavan
opening
I want to spend some time on three programs here, vodobatinib in PD, ADC using antibodies against MUC-1 alpha/beta junction, and SCD-153 for a novel immunological target to treat alopecia areata.
Anil Raghavan
opening
Moving on to the second project here on the slide, here, again, you can see several parts of the same strategy at play.
Anil Raghavan
opening
MUC-1 has been a high interest cancer target for ADC and other tumor-targeting programs because of its high tumor-specific expression.
Anil Raghavan
opening
In terms of cash flow, we expect warrant conversions of up to $93 million by end of December 2022.
Risks & concerns — 15 flagged
This is meant more of a scorecard reflecting the current outcomes of our journey, navigating different shades of risk starting with our 505(b)(2) days to building an organization which can now take real bets on new targets and complex modalities.
Anil Raghavan
But more importantly, we have seen our operating capabilities and external collaboration mature to a point where we feel comfortable taking early stage risk.
Anil Raghavan
But we've now moved to the next phase in that evolution with increased confidence in taking early-stage risk position in novel biology.
Anil Raghavan
Most of our ideas involve substantial partnering components either as traditional development collaborations or for sourcing important development competencies, which are difficult to find or build in India.
Anil Raghavan
While we are still very much a work in progress, it's important to say that we've taken deliberate steps to mitigate the risk as much as possible, while embracing early stage risk as a matter of business reality that we're dealing with.
Anil Raghavan
Vodobatinib is probably the first serious effort to track the oxidative stress response in neurodegenerative diseases.
Anil Raghavan
The toxic cascade of events initiated by Abl-mediated oxidative stress response is affected through a complex web of interrelated events involving on one side, the aggregation of intercellular alpha synuclein and on the other side compromising of multiple protein clearance pathway.
Anil Raghavan
Our decision to move to a clinical proof-of-concept study was driven by critical pieces of evidence for the impact of disrupting this cascade with a highly potent, but super- selective c-Abl inhibitor gathered through several important experiments done at some of the best labs in this area globally, like Dr.
Anil Raghavan
So, that's what I was talking about de-risking early-stage risk taking through a deliberate translational framework.
Anil Raghavan
As noted in the bullets on the left, Abelson kinase is expressed in all parts of the brain and has a pivotal role in promoting neurodegeneration, specifically under conditions of toxic stress, Abl causes cells to die in order, for example, to rid the body of defective or malfunctioning cells.
Dr. Siu-Long Yao
On PD essentially, what kind of risks do you foresee more than looking at the quantum of peak sales, what are the things that can actually determine the sales potential of the product, what are the risk factors or performance factors, if you can give a little bit of insight on that?
Manish Jain
At the same time, the translational risk of failure in this area is quite substantial.
Anil Raghavan
I think I would rate that as one of the more significant risk items.
Anil Raghavan
Just continuing on vodobatinib, actually on the PD side, just wanted your assessment of the risk benefit ratio, which I think FDA has been focusing on when they are looking at new treatments coming in this class.
Girish Bakhru
So, a real sense of where we stand in terms of risk benefit, can only be commented upon once we have an opportunity to see the data from this fairly large as in 505 patients study next year, that will be an important proof-of- concept moment for this hypothesis also is not just for us, as to your earlier point in terms of the dearth of options.
Anil Raghavan
Q&A — 9 exchanges
Q
Sir, my questions are around vibozilimod. Firstly, you are pitching this as an alternative to JAK inhibitor, right, because of safety, signals in JAK inhibitor. But recently, TYK2 inhibitor Sotyktu was approved by the FDA. It is probably the first product without the safety warning that has limited the use of JAK inhibitor. I am just wondering how to see your product versus Sotyktu?
Anil Raghavan
Thanks, Kunal, for that question. I think you may be referring to the recent approval of BMS’s TYK2 product which works through the JAK pathway, but the long-term safety data for the product is yet to be awaited. So, if you look at the JAK as a class, the concerns came through when Pfizer came out with five-year data for their first product. So, TYK2 in that sense, is in very early days to conclude if the safety profile is established. So, I think we need to wait for long-term safety data to have a final verdict on the safety of that class. The reason I ask was, I don't think there is any boxe
Q
My question is on vodobatinib. You mentioned that you would complete the recruitment for the program by the end of this financial year. And given that, the first study is a 40-week long study, if I'm not wrong, so, would that be fair to say that the first read out for the Phase-2 will probably be by the end of the next calendar year, which is CY'23, is that how one should think about it?
Anil Raghavan
So, the expectation that we are setting through definition and also our previous presentation is that we will have top line data readout in the second half of financial year '24. We haven’t made a more precise expectation setting in terms of specific order for data readout, but our expectation is that we will complete the accrual by this year and then nine months will give you the top line data which is towards the end of 2023 or early part of 2024 calendar year.
Q
Sir, can you provide me with peak sale expectation for PDP-716 and SDN-037?
Jaydeep Issrani
Since the assets are commercialized by our partners, we don't provide a forecast or peak sales expectation for our products. If you can help me with out-licensing fee that we have got from Visiox Pharma for these two programs? We've got 10% equity in Visiox, but that's subject to the approval from SEBI. And we are eligible for additional regulatory milestones on the filing and approval of the program. In addition to the milestone and the 10% equity, we are also eligible for low double- digit royalties in this program. We are in process of out-licensing phenobarbital also. Any ballpark number i
Q
On CML, how are we comparing to asciminib in particular? And later, I'll go to PD on vodobatinib.
Anil Raghavan
Hi, Manish. Thank you for that question. In CML, if you look at the setting that we are pursuing, and the data that you have seen in this presentation, is different from what Novartis has pursued for their registrational trials and subsequent trial. What we have here is last line setting, these are patients coming off ponatinib, failing three lines of tyrosine kinase therapy, and one of which needs to be ponatinib. Asciminib trial was in two lines of failure against bosutinib. So, in that sense, both the severity of resistance and the challenges in the composition of the resistance is signific
Q
Just continuing on vodobatinib, actually on the PD side, just wanted your assessment of the risk benefit ratio, which I think FDA has been focusing on when they are looking at new treatments coming in this class. So, from what all approvals have been coming in PD, we have not seen any major breakthrough so far, and so many different pathways are being tried, like biologics or alpha synuclein and all these things. So, where do you think FDA will focus on Phase-2 readout if it comes to that?
Anil Raghavan
I think as you mentioned, we have seen a real dearth of options here, especially after the failure of some of the alpha synuclein targeted antibody programs. From our standpoint, looking forward to FY'24 for readout of the PROSEEK program, what is going to be important is the extent of activity that we see and the toxicity profile that we see. I mean, when we look at our program so far, we have around 350 - 355 patients and we are not seeing as significant or alarming signals on safety so far unlike some of the antibody programs both in AD and PD, which was, I guess the basis of your question,
Q
Sir, can you please throw some light on how many programs do we have fast track approval, particularly LBD, PD and CML?
Anil Raghavan
LBD and PD are not in registrational trials, they are in Phase-2 trials, and in CML, we don't have fast track, but we have an orphan drug designation and path to an accelerated outcome, in the sense, surrogate endpoint, which needs to be confirmed with confirmatory trials later on. So, it's not a priority review or fast track as you indicated. Where is Xelpros and Elepsia manufactured at present? Xelpros and Elepsia, the manufacturing base is Halol. Phenobarbital and brimonidine, where we plan to manufacture? We have two sites for phenobarbital. We haven't disclosed the manufacturing strategy
Q
My first question is on Xelpros, which is partnered with Sun Pharma. It's been like three years since launch. So, how has been the ramp up so far and have we kind of reached the peak sales or peak Rx for this product?
Jaydeep Issrani
Thank you for the question, Harith. As I mentioned earlier, this is a program partnered with Sun Pharma, and they would be providing an update on the sales at appropriate time or whenever they disclose about the sales potential. So, we wouldn't be commenting on where or how much they are doing. Sun may provide guidance, as they have been doing in the past about the program. On PDP 716 and SDN-037, just curious as to Sun Pharma is not the partner for these assets given ophthalmology is one of their focus in specialty segments and we've also partnered with them on Xelpros. If you could comment a
Q
So, essentially, I just wanted to know on phenobarbital. My assumption is it will primarily be a hospital setting product. So, typically, how many sales reps would be required for such a kind of product?
Jaydeep Issrani
The anticipation that this is going to be a hospital product is correct. It will primarily be used in the ICU setting or neonatal centers, which are not many, few in US. And the number of reps or the sales team will be dependent on the partner that we engage with and their strategy to commercialize the asset. So, I will not be able to give you an exact number, but it should be in the similar ballpark range as any other asset targeting neonatal centers. Because, at some point of time, I had a broader question from this which I have been raising with you is for such kind of products, at what sta
Q
Thank you, Yash, and thank you, everyone for joining today for the call. We tried to answer the questions you had, but in case there are any additional questions or follow on questions, you may reach out to us and we will respond to you through e-mail. Thank you once again for joining the call today.
Management
Speaking time
Anil Raghavan
26
Moderator
11
Jaydeep Issrani
8
Manish Jain
7
Girish Bakhru
6
Kunal Randeria
4
Ketan Gandhi
4
Harith Ahamed
4
Jayesh Gandhi
3
Dr. Siu-Long Yao
2
Opening remarks
Jaydeep Issrani
Good evening, ladies and gentlemen. I am Jaydeep Issrani. On behalf of SPARC, I welcome you all to SPARC's Annual Update on Clinical Programs and R&D Pipeline. We have our CEO, Mr. Anil Raghavan and members of the SPARC's senior team on the call today. I hope that you have received the presentation that was sent out some time ago. The slides are also available on our website, www.sparc.life. The presentation will be similar to what we have been following in the previous versions, i.e. will walk you through the presentation, and then open the call for questions. Before I hand it over, I want to mention and remind you all that our discussion today includes forward-looking statements that are subject to risks associated with our business that may cause actual results to differ from those projected in the presentation. I will now hand over the call to our CEO, Mr. Anil Raghavan. Over to you, Anil.
Anil Raghavan
Thank you, Jaydeep, for the introduction and the opening comments. Good morning and good afternoon, everybody, if you're joining from the US or Europe. A very warm welcome to the 12th edition of our Pipeline to engage and make this such a special event on our calendar. So, welcome back to this important call and thank you for your time. As Jaydeep mentioned, we have the management team on the call today. In the interest of time though we don't plan to do detailed introductions. Slide #3 has the agenda for the day. We will start with brief comments on our strategy and some important program updates, including a brief snapshot of the portfolio performance and the listing of upcoming catalysts. Subsequently, we will dedicate most of our presentation today to provide additional color on six opportunities with four NCE clinical programs plus one important biologics platform with IND visibility and a new first-in-class NCE asset in dermatology. Dr. Siu-Long Yao, who heads our clinical develo
Dr. Siu-Long Yao
Thank you, Anil. Again, my name is Siu Yao and I oversee clinical development. The next set of slides go over SCO-088 for the treatment of chronic myelogenous leukemia. So, with SCO-088, we believe that we have a safe, effective option for the treatment of heavily pretreated, last-line patients. This Slide #14 summarizes the clinical development program for this drug. The program started with a healthy volunteer single ascending dose and food effect study in 40 subjects and then proceeded to a multiple ascending dose study in patients. Currently, we're in the midst of a pivotal study involving chronic phase, accelerated phase and blast phase CML. As noted in the first bullet in the lower right-hand part of the slide, this is last line therapy. So, patients are required to have disease that is refractory and/or intolerant to greater than or equal to three prior tyrosine kinase inhibitors, one of which must have been ponatinib. For this study, we have sites in the US, Belgium and there's
Dr. Nitin Damle
Thank you very much, Siu, and good evening, everyone. My name is Nitin Damle, and I would like to provide an update on our first biologic therapeutic program SBO-154. During our presentation to this audience a year ago, we had described SPARC's initiative to invest in biologic therapeutics and introduce our strategy to explore antibody drug conjugates as anti-cancer therapeutics. SBO-154 is the first product of such exploration and represents an antibody drug conjugate, in which a humanized IgG1 antibody with a high affinity for MUC-I alpha/beta heterodimer, is linked to a potent cytotoxic drug that preferentially kills dividing cells when delivered to tumors via antibody drug conjugates. The cytotoxic drug used as a payload in SBO-154 is clinically and commercially validated for clinical use in different types of cancers. The tumor target that we have been interested in focusing on is human Mucin-1, also known as MUC-1, as shown on slide 36. MUC-1 is a glycoprotein overexpressed on th
Dr. V. Ramanathan
Thank you, Nitin, and good morning, good afternoon or good evening to you all based on where you're located. My name is Vikram Ramanathan, and I'll give you an update on SCD-153. SCD-153 is an NCE that we're working on with potential for use in autoimmune disease called Alopecia Areata. SCD-153 is a topical agent for this disease which has a significant unmet medical need. Slide #43 gives you some background on the disease. Alopecia Areata is an autoimmune disease that causes loss of scalp hair and clumps, and it's a psychologically very debilitating disease. This occurs because the hair follicles, which are normally protected from the effects of patrolling immune cells lose their so-called immune privilege. So, on the upper left is a diagram of a healthy human hair follicle. At the base is the bulb of the follicle. Immune cells are present, but the bulb of the follicle is normally immune from their effects. To the right of it, is a depiction of a diseased hair follicle in alopecia are
Chetan Rajpara
Thank you Dr. Vikram. Good evening, everyone. This is Chetan Rajpura, CFO at SPARC. I plan to go over SPARC financials and cash position at a high level. Slide #48. During FY'22, total income was at Rs.144 crores, equal to US$19.3 million, while total expenses were at Rs.347 crores, equal to $46.6 million, resulting into a net loss of Rs.203 crores, equal to US$27.3 million. FY'22 income was lower as compared to FY'21, as previous year income included an upfront non-recurring receipt of US$20 million from SCD-044 licensing deal. Let me update you on our financial results for first quarter of FY'23. For Q1 FY'23, total income was at Rs.29 crores, equal to US$3.7 million, while total expenses were at Rs.111 crores, equal to US$14.4 million, resulting into a net loss of Rs.82 crores, equal to US$10.7 million. Slide #49, as you may be aware company raised Rs.1,112 crores, equal to US$148 million in July '21 by way of a preferential issue of convertible warrants. The company has already rec
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