Hello, and welcome to the Alkermes conference call. At this time, all participants are in listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Alkermes management. Please go ahead. Welcome. This is Sandy Coombs. Welcome to the Alkermes plc conference call to discuss recent developments related to two of our license agreements with Janssen Pharmaceutica. With me today are Richard Pops, our CEO, Iain Brown, our CFO, and Blair Jackson, our Chief Operating Officer. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our press release issued today and our most recent annual report filed with the SEC for important risk factors that could cause our actual results to differ materially from those that are expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. After our prepared remarks, we will open the call for Q&A, and now I'll turn the call over to Richard. Good. Thank you, Sandy. This afternoon we announced the receipt of notices of partial termination from Janssen, a subsidiary of J&J and a licensee and recipient of our technology and know-how under two agreements, the first dating from 1999 and the second from 2003. The partial terminations impact know-how royalties related to the sales of long-acting paliperidone products such as Invega Sustenna, Invega Trinza, and Invega Hafyera in the U.S. We strongly disagree with J&J's position and will consider all options at our disposal to enforce our contractual rights and to address any unauthorized use of our intellectual property. J&J has for years touted in press releases and in marketing communications to prescribers, patients, and investors that the Invega products use our nanoparticulate formulation technology, known as NanoCrystal technology. They paid us know-how royalties consistent with this fact since the day Invega Sustenna and Invega Trinza were first sold. They now claim that these products have not utilized and do not utilize our intellectual property. As a result, we understand they intend to cease paying us their contractually obligated royalty payments related to U.S. sales of these products in approximately 90 days. Our NanoCrystal technology made J&J's long-acting paliperidone palmitate products technically feasible. They first approached us in the mid-1990s with a desire to understand and utilize NanoCrystal technology with various compounds. Since then, we've contracted with them multiple times to provide know-how and licensed intellectual property that enabled the use of our technology. The first product that utilized NanoCrystal technology was Invega Sustenna, which was launched in the U.S. in 2009. This was followed by Invega Trinza, which was approved by FDA in 2015, and most recently Invega Hafyera. We are not aware of any changes that have occurred to these products since their launch that would have altered Janssen's use of our intellectual property in these products or Janssen's obligation to continue to pay us royalties under the agreements. Following the receipt of the termination notices, we immediately requested a meeting of our respective technical teams in an effort to better understand the basis for Janssen's termination decision and any changes to the use of our know-how in their products. J&J has not responded to our request for such a meeting. While we intend to explore all options at our disposal to enforce our contractual rights and address any unauthorized use of our intellectual property, we will also continue our efforts to engage with J&J to explore if a mutually agreeable resolution can be reached. It's too early to speculate where this will all end up, but we're making the announcement today to make sure you all are aware of this development. With our recently expanded and growing commercial portfolio of proprietary products, our top line is less reliant on revenues from partner products than in the past. With the exception of the Vumerity royalty stream, royalties are becoming less core to our business. For planning purposes, this partial termination would accelerate our assumption regarding the projected decline of our J&J royalty revenues from the Invega products. We had been planning for royalty payments related to Sustenna to end in 2024 in the U.S. and have been engineering the business for the past few years to prepare for that ramp down. Make no mistake, we intend to strongly contest this action by J&J and pursue all the options available to us. I'm gonna turn it over to Iain now, who will give you some brief comments on the financial positioning of the company. Thank you, Rich. Let me start by saying Alkermes is in a strong financial position from both a revenue and balance sheet perspective, even with the potential loss of these royalties. As Rich outlined, we had anticipated U.S. royalty stream for Invega Sustenna ending in mid-2024, so our longer-term outlook remains largely unchanged. We are well funded and are focusing our capital allocation on growing our proprietary commercial portfolio, including the launch of LYBALVI and on advancing our pipeline of development candidates. We've built a broad portfolio of revenue-generating products and are not dependent on any one revenue stream. While we are exceedingly disappointed by this turn of events and intend to challenge it, we do not expect it will have any impact on our 2021 financial results as we expect to continue to receive royalties on U.S. sales of the Invega product family through at least the end of January 2022. As we look ahead, we will incorporate any necessary changes from these developments when we provide our financial expectations for 2022 in February. To give you a sense of the contributions from the products, we have recorded cumulative know-how royalties of approximately $180 million in the last four quarters on sales of the Invega product family in the U.S. We will continue to focus on driving operational efficiencies and managing expenses across the business and remain committed to long-term profitability. We have a strong balance sheet with $748 million of cash and total investments as of the end of the third quarter. We are currently in the process of assembling our 2022 budget and long-range plans, considering the potential impact of this termination, and we'll provide more information on this front when we guide in February. To conclude, we are in a strong financial position, and while the potential loss of this royalty stream will adversely impact our cash flow over the next few years, we are adequately funded to be able to drive profitable growth in the business in the long term. The wind down of the Sustenna royalties in 2024 in the U.S. is an eventuality we had planned for, and our long-term outlook remains unchanged. With that, I'll turn the call back over to Sandy for the Q&A. Thanks, Iain. Kevin, we'll now open the call for Q&A, please. Certainly. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from Vamil Divan from Guggenheim Securities. Your line is now live. Great. Thank you for taking the questions and for hosting this call. Maybe just a couple for me. I'm assuming there's probably not that much more you can say than what you said already, but just curious on when, you know, what sort of changed here, if you have any insight yet in terms of what, you know, what may have changed from the J&J side to lead to this announcement today, either in their technology or otherwise with the agreement. Maybe just the second one, you talked a little bit about that you're planning on these going away after the first half of 2024 in the U.S., and I know this is predominantly a U.S., you know, business, but can you just also talk about outside the U.S., any kind of royalties there? What are your expectations? I think we had assumed 2026, I think, that they would end there, but not sure if that's correct or not. If you could just clarify. Thank you. Vamil, well, I'll take the first part, and then I'll ask Iain and Blair on the second part. The first part of your question was about what has changed, and I don't know the answer to that. We're somewhat astonished by all this. We have been seeking to have that meeting with J&J to go over the technical issues that would lead to that type of conclusion, but we don't know the answer to it yet. We wanted to get the disclosure out as soon as we thought it was practical to do so, but we still have a lot more to learn. Then on the royalty front, ex-US, our planning assumption was that we would have the Sustenna royalties through mid-2026, as you outlined. Xeplion, ex-US. Xeplion. Yeah. As you said, it's about 2/3 of the royalties are U.S. and about 1/3 are ex-U.S. Okay. Then one more if I could just ask. I know you mentioned sort of long-term, you're already planning on these royalties going away, so this doesn't necessarily change the long-term outlook. I assume the fiscal year 2023 and 2024 guidance that you've previously given as part of your Value Enhancement Plan, those could potentially be what you update in February when you provide 2022 guidance. Is that what you're alluding to? Yeah. I think it's important to reiterate, we clearly disagree with Janssen's position, and as you've heard, we're gonna explore all the options available to us. At this time, it's really too early to speculate as to how this matter may be resolved. I think that said, the profitability targets included meaningful contributions from Sustenna royalties in both 2023 and 2024. As you can imagine, this is really still fresh to us, so we're in the process of incorporating these latest developments into our various planning scenarios, and we'll provide additional information when we guide in February. Okay. Thank you. Thanks. Thank you. Our next question is coming from Cory Kasimov from JP Morgan. Your line is now live. Hi, guys. Thanks for the question. This is Tiffany on for Cory. Just one question in terms of the resolution. It's obviously still early, but if you could just comment on if this is something that might go into arbitration or play out in court? Thank you. Hey, this is Rich. I think it's too early to say, Tiffany. We have a number of different potential routes of action here, including coming to some type of amicable agreement with J&J, which would require discussions that we haven't had yet, as well as legal and arbitration remedies. We're working through that all right now. Thank you. I just wanna follow up on Vamil's question to clarify that they did not terminate ex-US royalties at this point in time, just to be clear. Yeah, that is correct. Thank you. Our next question is coming from Paul Matteis from Stifel. Your line is now live. Hi, this is Katie on for Paul. Again, I know it's still early, but I guess I was wondering what would the process look like, if Alkermes were to challenge from, I guess, a qualitative as well as a timing perspective, and is this meeting with J&J, I guess, a gating factor to begin that process? Thanks. Oh, yeah. I think it's far too early to lay out a timeline, Katie. I think it's always in both parties' interest to settle things amicably. We just haven't had the time yet to engage in those discussions. Before we commit to any particular pathway, just know that we're evaluating all of them. We believe that the decision is entirely incorrect. They've been paying us royalties on these products for many years. We don't really understand what would have changed in the last few moments to make them determine not to pay us. We need to get into it with them. Right. That makes sense. Thank you. Thank you. Our next question today is coming from Jason Gerberry from Bank of America. Your line is now live. Hi. Good afternoon, good evening. This is Chiew Meng for Jason. Thank you for taking our questions. I guess I'm just curious, is this pertaining to specific patterns that are geographically specific? I'm just curious if you have any color on why, you know, J&J is terminating only the U.S. part but not debating the ex-U.S. parts of the royalty. I guess just a quick follow-up on whether this does it exclude Risperdal? Just wanna make sure that Risperdal is not part of involved in this termination. Thanks. Yeah, I'll take the beginning, maybe Iain can help. We only know what we know from the notice that we just got, which is terminating or their argument for termination in the U.S. only. It does not affect Risperdal Consta. It's a different license agreement. Also, we are the manufacturer of Risperdal Consta, which we do have in Wilmington, Ohio facilities. That remains unaffected. Iain, any other color or Blair? No, I think that was great. Thank you. Thank you. As a reminder, that's star one to be placed in the question queue. One moment, please, while we poll for further questions. We've reached the end of our question and answer session. I'd like to turn the floor back over to Sandy for any further closing comments. Great. Well, thanks everyone for joining us on the call this afternoon. We realize it's a busy earnings afternoon, so please feel free to reach out to the company if you have any additional questions. We'll try to be as helpful as possible. Thank you so much. Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.