Erez Israeli: So M&A, I’m not calling it base business, it’s by design, most of the companies, most of the M&A’s is actually, it’s not just M&As, it’s we have all kinds of collaboration like the SME, JV’s, also M&A, all of that is primarily to strengthen the future portfolio after the start, whether it’s in, like I mentioned, it can be on the base product like M&A, but mostly it is about actually what we call Horizon 2 again, in CMD and digital focusing on specific guys and digital therapeutic, so actually most of the efforts are coming from that. In addition to that, we are always looking for opportunity, by the way, it’s not the money from the M&A, it’s the money that we make also from the M&A, but also from the other activities of the company.
How much it will contribute? As much as we’ll be able to buy. We potentially have a significant financial capacity. And we are very active in the market at the same time, we are not buying for the sake of buying or for the sake of any other. We buy because we feel it’s a good deal for us and it’s meaningful for our strategy. So like we said, I said, in fact, we are not doing shopping spree, we are buying that we believe is good for us and strategy for us.
Surya Patra: Is that the inspection outcomes for the virtual facility? So what risk that one should assign to it? Or what is your practical assessment here? So do we find any risk to the existing business, given the kind of number of observations that have been issued to you, and the nature of the observation that has been highlighted?
Erez Israeli: Yes, so you are taking about the FTO-3
Surya Patra: Correct.
Erez Israeli: So first of all, what is the risk that we get in OEI? Is there a possibility for that? Yes, there is a possibility, there is also a possibility but there is a possibility that it will happen. What I can update is that firstly, address all the observations in the stipulated time. After that, we get twice to the FDA with the blessing also of external consultants data that shows that the cover that we put in place is working. This is happening in two installments. One in the center and one in general. And I believe that it’s a robust answer, but of course we will wait for the FDA response for that.
Surya Patra: Sure sir. Just one last clarification from my side. Whether you have commented on the MenoLab’s size and potential contribution to our U.S. business?
Erez Israeli: No, I did not because I don’t remember the numbers. I apologize for this.
Richa Periwal: And we’ve not disclosed the number, but as Erez has mentioned, a couple of millions is what is there. And as the business progresses, we’ll keep updating you.
Surya Patra: Sure. Yes. Thank you, Ma’am. Thanks a lot for all your responses.
Operator: Thank you. The next question is from the line of Bino P from Ilara Capital. Please go ahead.
Bino P: Hi. Good morning. Good evening. Just a couple of quick questions. One, you have this product Lumify, which you have been licensed in the U.S. So is there any timeline we can get regarding the approval of the same?
Erez Israeli: Which product? Sorry I missed it.
Bino P: Generic Lumify.
Erez Israeli: Which one, what?
Bino P: Lumify.
Erez Israeli: I don’t have any information.
Bino P: Okay.
Richa Periwal: So I think there actually in the pipeline, we’ll keep updating once, when the same approval is in place.
Bino P: Okay. Second on biosimilar RITUXAN, could you give some color on what sort of timelines you have in mind for the launch also, given the recent inspection of USFDA and the outcome, et cetera?
Erez Israeli: So, we submitted it in April. We got the FDA inspection actually on time in October. We addressed the FDA observation. We did not receive any additional information. So, if everything will be without any CRL or any query that will come from the U.S. FDA, the earliest that we can get approval is the end of April. But, of course, it will be like any query or survey.
Bino P: Understood. Okay. And what is you mentioned about this biosimilar pipeline, which kind of starts from [indiscernible] and going into the 30s. Do you have some products which could be among the first wave or the first biosimilar to some of the products within that?
Erez Israeli: This is the intent. All the products that we are developing, we are developing within to be the first or in the first wave.
Bino P: Okay, great. Thank you.
Operator: Thank you. The next question is from the line of Shyam Srinivasan from Goldman Sachs. Please go ahead.
Shyam Srinivasan: Yes, thank you. Good evening. Thank you for taking the question. It is just the first one is on the overall CDMO kind of space. I know you have a subsidy, but just want to understand are you able to see more demand coming from global innovators towards in-depth companies, including companies like yourself or your subsidiary? So that’s the first question. And are you investing in capacities either on the small molecule side or the biologic side for manufacturing for CDMO?
