Alkermes plc (ALKS) Earnings Call Transcript & Summary

Greetings, and welcome to the Alkermes Investor Update Call. My name is Rob, and I'll be your operator for today's call. [Operator Instructions] Please note this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President, Investor Relations and Corporate Affairs. Sandy, you may begin.

Thank you. Welcome to the Alkermes plc conference call to discuss recent developments related to the outcome of our arbitration with Janssen and our updated financial expectations for 2023. With me today are Richard Pops, our CEO; and Iain Brown, our CFO. Before we begin, I encourage everyone to go to the Investors section of alkermes.com to find our press release and related tables and certain reconciliations of the GAAP to non-GAAP financial measures that we'll discuss today. We believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. 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 this morning and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those 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'll open the call for Q&A. And now I'll turn the call over to Rich.

Good. Thank you, Sandy, and good morning, everyone. This morning, we announced that we received the final award from the Tribunal in our binding arbitration with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson. This Final Award recapitulated the Tribunal's findings in favor of Alkermes as outlined in the interim awards from April 2023 and December 2022, that we disclosed previously and brings the arbitration process to an appropriate and successful conclusion. We also announced that we received approximately $245 million from Janssen. The $245 million reflects payments due to Alkermes for 2022 in the first quarter of 2023. And while these payments are significant, they represent just a portion of the economics of this outcome. This Final Award reestablishes significant cash flows to Alkermes, provides strategic capital to our balance sheet and strengthens our longer-term financial profile by clarifying the distinct royalty term for each product covered by the license agreement. As a result of the Final Award, today, we're raising our 2023 expectations for total revenue and GAAP net income by approximately $425 million and Iain will review those revised financial expectations in a minute. This arbitration pertained to royalties on U.S. sales of 3 long-acting INVEGA products, INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA, which are antipsychotic medications and CABENUVA, a long-acting HIV product. Alkermes technology and know-how enabled the development of these products; medicines that have benefited millions of patients over many years. From the outset, we believe that Janssen was not entitled to cease paying royalties due to Alkermes on sales of these products, and this result validates our position. The Final Award concluded the following: First, Janssen may not continue to sell the products developed during the term of the agreement without paying royalties to Alkermes. This was the central question of the arbitration. Second, and based on this finding, Alkermes is entitled to royalty payments related to 2022 and royalties related to U.S. net sales of the licensed products in the first quarter of 2023, this comprises the $245 million I referred to earlier, which has been paid. Third, looking forward, the panel clarified that a separate royalty term applies for each of the long-acting INVEGA products. For INVEGA SUSTENNA, Alkermes is owed royalties through August 20, 2024. However, for both INVEGA TRINZA and INVEGA HAFYERA, the panel agreed with our position that the royalty term extends into the second quarter of 2030. And finally, their award provides that royalties for CABENUVA in the U.S. are owed through the end of 2036. Cumulatively, this outcome reestablishes royalties that Alkermes is entitled to receive and represents significant financial upside for the business. We appreciate the Tribunal's attention to this case, and I want to thank our internal and external legal teams for their hard work bringing the arbitration process to this successful conclusion. I'm going to pass it now to Iain for the impact of the award on our financial expectations.

Thank you, Rich, and hello, everyone. So as Rich just mentioned, the outcome of the Janssen arbitration represents significant upside to our financial expectations and considerably increases our cash balance. Today, we are pleased to raise our financial expectations for 2023 based on this outcome. Now there are a number of financial elements related to the final award that will impact our 2023 financial results. First, we have received payment from Janssen for back royalties related to 2022 of approximately $195 million, inclusive of interest through mid-March of this year. Second, in 2023, we now expect to record royalties on worldwide net sales of the long-acting INVEGA products and CABENUVA for the full year. With the resolution of the arbitration and the related payments by Janssen, we'll depart from our previous practice of guiding only to the next 3 months of ex U.S. royalties as we believe it is now appropriate to incorporate the U.S. as well as ex U.S. product royalties for the full year into our expectations. Accordingly, today, we are raising our full year 2023 financial guidance as follows: We are increasing our expectations for total revenue by approximately $425 million at the midpoint to a range of $1.55 billion to $1.68 billion. This $425 million reflects approximately $195 million of back royalties related to 2022, inclusive of interest and an increase of approximately $230 million at the midpoint of worldwide long-acting INVEGA products for 2023. That is from our prior expectation of $40 million to $45 million to a revised expectation of $265 million to $280 million. We expect these increased top line expectations will flow directly to our GAAP bottom line. Consequently, our expectation for GAAP net income will also increase by approximately $425 million at the midpoint from a prior expectation of a GAAP net loss in the range of $160 million to $200 million, to a revised expectation of GAAP net income in the range of $225 million to $265 million. Our non-GAAP results are expected to improve by approximately $230 million at the midpoint as the back royalties and associated interest related to 2022 of approximately $195 million are being excluded. Non-GAAP net income is now expected to be in the range of $230 million to $270 million increased from our prior expectation of $0 to $40 million. We are reiterating our 2023 financial expectations for all of the line items in the guidance outlined in the press releases for our full year 2022 and first quarter 2023 financial results. As a reminder, our financial expectations reflect the combined neuroscience and oncology business for the full year as we work towards the planned separation of the oncology business, which we continue to expect to complete in the second half of the year. I'll now walk through the expected impact specific to our second quarter financial results, as there are a number of important elements. First, we will record the $195 million of back royalties and associated interest related to 2022 as revenue in the second quarter. As I mentioned, we have already received this payment and it will be reflected in our GAAP results and our cash balance when the quarter closes. However, it will be excluded from our Q2 non-GAAP net income. Second, we will record approximately $50 million of incremental royalty revenue related to Q1 2023 U.S. net sales of long-acting INVEGA products and CABENUVA. And third, in the second quarter, we expect to record royalties on Q2 worldwide net sales of these products as we will be going forward. Royalty revenues related to Q1 and Q2 2023 will be reflected in both our GAAP and non-GAAP results in the second quarter. Looking ahead, Alkermes is entitled to certain royalty revenues on the long-acting INVEGA products until 2030. As Rich outlined, pursuant to the Final Award, the U.S. INVEGA SUSTENNA royalty term will expire in August of next year as we had previously expected. We expect to continue to receive ex U.S. royalties on XEPLION as INVEGA SUSTENNA is known outside of the U.S. in certain countries into 2026. For INVEGA TRINZA and INVEGA HAFYERA and their ex U.S. equivalents, TREVICTA and BYANNLI, we expect to receive royalty revenues into 2030. Lastly, pursuant to the Final Award, Alkermes is entitled to royalties on U.S. sales of CABENUVA through 2036. So taking a step back, we've worked hard over the past 18 months to demonstrate that our long-term growth is independent of Janssen, and we've been successfully managing the business accordingly. I'm pleased with how the business has performed with our top line growth driven by our proprietary product net sales and careful management to our cost structure. We have strong momentum across the business and I want to thank our dedicated team at Alkermes for their continued focus and support of our mission. As for our profitability targets announced in February 2023, we expect royalties related to the Janssen license agreements to be incrementally accretive to our established targets for 2024 and 2025. We will continue to exclude all royalty revenues related to worldwide sales of the long-acting INVEGA products and CABENUVA from these targets as we believe this will better demonstrate the strength and growth of the company's underlying neuroscience business. We plan to provide our full financial expectations for 2024 early next year inclusive of our expectations for the Janssen royalty revenues as we did prior to the termination. The financial impact of the arbitration outcome represents substantial upside for the company. It is significant and it further strengthens our financial position as we continue to execute on our strategic priorities, focus on operating efficiency and work to deliver value for our shareholders. And with that, I'll turn the call back to Sandy to manage the Q&A.

Thank you, Iain. Rob will open the call for Q&A now, please.

[Operator Instructions] And our first question today is from the line of David Amsellem with Piper Sandler.

So just a couple. So how does this over the long term change how you're thinking about investment in LYBALVI sales and marketing support, if at all, just given that you have this additional cash flow stream. And then can you talk about now with the Final Award, how you're thinking about seeding the oncology business and just provide some specifics on that, just given that you have a Final Award in place?

Dave, it's Rich. I'll take it and then I'll hand it to Iain as well. So philosophically, the way we've approached the LYBALVI launch is to fund it at the level that it needed to hit the trajectory that it is on. So I would say that the winning of this case doesn't really change the way we think about funding LYBALVI, it will always prioritize in terms of the capital that we allocate toward that launch because it's going so well. The -- Iain, why don't you take the rest?

Sure. I think with respect to the oncology business, our approach to funding the oncology business has always been to provide or secure sufficient funding to get the oncology company to its next major data milestone at which point it will be able to raise its own capital. And while we can accommodate the potential capitalization of mural oncology within the bounds of our current balance sheet, I think this incremental cash obviously bolsters the balance sheet and further strengthens our financial position.

Our next question is from the line of Akash Tewari with Jefferies.

This is Amy on for Akash. So now that you have cash after this arbitration, can you talk about your ability to accelerate the development for your Orexin program? Would it be possible for you to launch multiple Phase IIs in various indications? And any update you can give on development timeline would be great. And then finally, where do you stand with your MAD study in both healthy volunteer and type 1 narcolepsy patients?

Amy, it's Rich. It is similar to my answer with respect to LYBALVI, the Orexin program is getting the funding that it needs to move as quickly as it can. And so we've not held back at all, and we're reaching a point now as we complete the MAD and the SAD and we move into the Phase Ib, where we can see the potential for expanding the program. But our primary strategic thrust for that program will be registration in narcolepsy, type 1 and type 2. So where we are with the MAD and the SAD is that we've completed the single-ascending dose study to the point where we're well in excess of what we think are clinically relevant doses move to the MAD. The MAD has now moved through doses beyond which we think are clinically relevant, which has led to the application to start the Ib in patients that is now out of ethics. We're recruiting patients for the Ib. So we expect to enroll our first narcolepsy, type 1 and type 2 patients this summer. So we're right on track, if not a little bit ahead on expansion into the Phase Ib.

And our next question is from the line of Uy Ear with Mizuho.

I guess just following up on the other question. Does this -- the extra cash, does it change your thinking about BD in any way? Have you had something that you're thinking about that with the cash and you can accelerate? And I guess my second question is, could you also provide, I guess, some update on the Teva Vivitrol trial? I think there's supposed to be some closing statement or something that's been done recently.

Yes. Thank you for the question, Uy. And Iain chime in if you feel the need to be -- we've been looking at the company as this amalgam of Oncology plus CNS neuroscience for the last several years. And now as we contemplate the split, as neuro-oncology goes, it stands on its own 2 feet, the neuroscience company has a really exciting profile given its profitability and its top line growth and now with the Orexin program maturing really exciting pipeline asset. We will build out that pipeline over time as the company continues to flourish and grow. But we don't feel any urgency at this moment. There's nothing in the docks that we said, boy, if we had an extra $150 million that we would do. No. We're constantly surveying the landscape, and we'll act when we think it's appropriate to act, but we don't feel like this triggers anything that we wouldn't have done absent that settlement in our favor. With respect to the Vivitrol litigation, the ANDA litigation, recall that the trial was held in February, we felt like the trial went well in terms of presentation of the cases on both sides. And the closing arguments, as you noted, will be this week in the court in New Jersey with the judge representing that she hopes to have a decision by Labor Day.

And our next question is from the line of Paul Matteis with Stifel.

This is James on for Paul. Maybe just a quick one. Can you just remind us the overall mix of the INVEGA products and how they contribute kind of individually to the overall royalty guide and how losing the SUSTENNA royalty in 2024 may impact that kind of future cash flows from there?

Sure, James. I'll take that one. Thank you. I think if you look at the 2022 INVEGA net sales, as reported by J&J, about 2/3 of the net sales come from the U.S., so 1/3 is ex U.S. And then what we've been able to tell from the IQVIA data in the U.S. is that somewhere between 75% to 80% of the net sales relates to INVEGA SUSTENNA. So that would be the revenue stream that we would effectively receive royalties on through mid-August. And then the remainder, certainly the 3 and the 6 months, we would anticipate getting royalties into mid-2030.

Your next question is from the line of Jessica Fye with JPMorgan.

A lot of good questions have been asked. So I think now you've said that this cash coming in, coupled with the future royalties doesn't really change how you would invest behind LYBALVI, the erection doesn't really change business development or what you would seed neuro-oncology with. So what, if anything, does it change in your view about how you'll be able to run the business? Or is this really just you can like collect some more interest income and have a little more, I guess, cushion?

Jess, it's Richard. I'll let Iain talk in this. So I think we said to you guys all along, we were utterly convinced of the correctness of our position vis-a-vis J&J. This is an arbitration that never should have happened. But it gave us the opportunity with you all to refocus analysts on the underlying growth of the Neuroscience business. So that's why Iain said on a going forward basis, our profitability targets, we'll still manage the business to hit those absent the Janssen royalties. It reflects the growing profitability and the growing top line of the business. That's all very, very healthy. Obviously, with a stronger balance sheet as we move into the spin neuroscience company, we have more firepower to continue to build out the pipeline. But just to understand, we're being quite judicious about escalating the R&D spend in proportion with the profitability as we grow. So as we grow, we're going to have more ability to add R&D spend appropriately on various targets and various programs. And we have the capital on the balance sheet to do that, plus we'll be generating additional cash. So we really feel like we're moving into a really strong position, and that's why we think the company is going to be revalued as we move out of the spin.

And our next question is from the line of Jason Gerberry with Bank of America.

Most have been asked. I guess my only question, I know that on the 1Q call, you talked about a lot of the DTC investment behind LYBALVI kicking in around summertime and probably a 6-month-plus lag before we start to see that in TRx. Just curious anything you can comment in terms of what you're seeing so far that's encouraging, just as we sort of track the product and look to the second half of the year?

Yes, I think we have some qualitative feedback. Before you launch a television component of a DTC ad in this space, the good news is that you can really test it in market research to see how patients and caregivers and providers react to them. So we had a pretty good sense the message was going to be well received. I don't know if you've seen it Jason, but it's a very positive message about the treatment of bipolar. And it's -- so what we're -- if you measure some of the leading indicators in terms of website traffic and hits on the website and things like that, that's all spiking up really, really nicely. But the way these things work is that consumers need multiple repetitions of that message, but also it has to coincide with their visits to the doctor, which don't happen immediately. So that's why we say there's a several month lag before you start to see it building into TRx. But all the early indicators are positive. Now, Iain if you have anything to talk about it?

No, that's exactly right. Yes.

[Operator Instructions] The next question is from the line of Douglas Tsao with H.C. Wainwright.

Just a quick follow-up on the Orexin program. I think, Richard, you said you had now entered the MAD portion of the Phase I. When do you expect to report data from that? And how quickly do you think you could be initiating a study in patients?

Let me clarify. We've already completed enough of the MAD to move into the patient Phase of the study now, which we call Phase Ib, which is testing it in patients with narcolepsy type 1, type 2 as well as idiopathic hypersomnia. We are screening patients for that right now. So we expect to generate those data this summer. And hopefully, by the fall, we'll be able to give you guys some update on SAD, MAD as well as our first exposures in patients. But so far, the drug is behaving as we've designed it. So we're quite excited to keep going.

At this time, we've reached the end of our question-and-answer session. I'll turn the call over to Sandy Coombs for closing remarks.

All right. Thanks, everyone, for joining us for this quick call this morning. If you have any follow-up questions, please don't hesitate to reach out to us at the company. Thank you.

This will conclude today's call. Thank you for your participation. You may now disconnect your lines at this time.