Unidentified Analyst: Great. And just one follow-up, if I can. I guess, do you just see the stabilization continuing for some time?
Tasos Konidaris: My – Nobody really knows, right? Our expectation is, as the industry just kind of consolidates, as the industry has to deal with increased investments in their plants and the quality control processes and people are dealing with improved access to high-quality medicines. I mean, this industry has to focus on improved profitability, which requires price stability at some point in time.
Chirag Patel: Yes. And I will add on to that, that the shortages you have been hearing about, it’s not the major reason, as we know, for the shortages is the generics industry sustainability. It’s the pricing. When pricing are driven down so low, the demand gets concentrated within one or two suppliers, any issues with that one or two suppliers causing the shortages. That’s the number one reason, I would rank it as 90% why shortages are happening. Our – the buying groups are well aware of this, both on the retail side as well as hospital side, and they are being very responsible because at the end of the day, we cannot have patients without products, and then doctors without using chemotherapy products. So, we as an American company always have led the efforts to what can we do to alleviate shortages, and also what can we do to make the generics industry sustainable.
It just would be very prudent to do when time is now. We cannot wait because we will see more and more shortages if we do not address this. So, I do see stabilization or further improvements.
Operator: Our next question comes from Chris Schott from JPMorgan. Chris, your line is now open. Please proceed.
Unidentified Analyst: Hi. This is Ekaterina on for Chris from JPMorgan. Thanks you so much for taking our questions. So, first, on injectables, and you have kind of touched upon this, but thought specifically on the Pfizer Rocky Mount facility and what impact that could potentially have on the sterile injectables market. And as we think about potential shortages there, is that something that Amneal can help with and benefit kind of given some of the capacity that you have been building? And then, the second question is on the CRLs for IPX203. Can you just elaborate a little bit more as to what could be required to address some of the FDA concerns and basically, what the path forward could look like and timelines for that? And then building on that, you have the Rytary IPX [ph] going away sometime in 2025. Does having lost time, I guess between the IPX203 launch and the Rytary really change your approach to that launch at all? Thank you so much.
Chintu Patel: Thanks Ekaterina. So, regarding Pfizer, I think it’s unfortunate what has happened, not expected. It was a plant that manufactures a lot of sterile injectable products and supplied in the U.S. As I have mentioned that we, at Amneal, we have expanded our injectable capacity. We have four FDA-approved facilities with 19 injectable lines. There are certain products that Amneal would be able to help in the supply chain in near future to avoid the shortages, and we are ready. We have the available resources, and we are also working with FDA on some of the pending products that might be on Pfizer issues or other shortage list. So, as a company, we are very driven and passionate about bringing many, many of these shortage products and alleviate the shortage situation in U.S., which is absolutely not acceptable for the American patients.
Regarding on IPX203, the CRL, we conducted a very robust clinical study as per our SPA agreement with FDA. And with totality – with all the data across our clinical study, we are very confident in the safety profile of IPX203 and able to provide the necessary data on a carbidopa safety bridge. So, that’s the only question we received on our CRL. There was no question about the efficacy, safety of levodopa on a CMC or the manufacturing. So, it’s a one question about the safety bridge of carbidopa. We expect to meet with the FDA as part of our Type A meeting in coming weeks. And after the meeting, we will have more clarity as onto the timeline. Regarding the launch, we don’t expect more than six months to nine months delay. And I will pass it over to Chirag on the market potential.
Chirag Patel: Yes. So, thank you, Ekaterina. So, your question, we have been very clear from the beginning that this has nothing to do with Rytary switching over. As you may be aware that Rytary has 235,000 approximate prescriptions out of 5 million. So, majority, 95% is with old product immediate release, which has all kind of issues is very well known. So, that represents almost 4.5 million-plus prescriptions we can go after. IPX is an excellent product, clear differentiator. So, we believe we would tap into much more bigger market share with general neurologists than even Rytary. Yes, we would have loved to launch it in June, but didn’t happen, but we are very hopeful that we will get it through and launch the product as soon as possible.
Unidentified Analyst: Thank you so much.
Operator: Our next question comes from Les Sulewski from Truist. Les, your line is now open. Please proceed.
Les Sulewski: Good morning. Thank you for taking my questions and congrats on the progress, guys. So, first, just quickly, has a Type A meeting been scheduled on the CRL for IPX203 FDA – with the FDA? And secondarily, do you see any opportunities to trim any existing low-margin lines within generics? And as a follow-up, what opportunities are you seeing in the generics market given the disruptions that we are seeing? Are you looking to pursue any additional deals in which verticals? And perhaps just kind of walk us through how you think about BD plans in general.
