Alkermes plc

Greetings, and welcome to the Alkermes Third Quarter 2021 Financial Results Conference Call. My name is Rob, and I'll be your operator for today's call. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandra, you may begin.

Thank you. Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended September 30, 2021. With me today are Richard Hopps, our CEO, Ian Brown, our CFO, Todd Nichols, our Chief Commercial Officer, and Greg Hopkinson, our Chief Medical Officer. Before we begin, I encourage everyone to go to the investor section of Alkermes.com to find our press release and related financial tables, including a reconciliation of the gap to non-gap financial measures that we'll discuss today. We believe the non-GAAP financial results in construction 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 slide two of the accompanying presentation, our press release issued this morning, 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 expressed or implied in the forward-looking statement. We undertake no obligation to update or revise the information provided on this call or the accompanying presentation as a result of new information or future results or development. After our prepared remarks, we'll open the call for Q&A, and now I'll turn the call over to Richard.

That's great. Thank you, Sandy. Good morning, everyone. So as we approach the end of 2021, I'm struck by just how much the company has evolved over the past year in the three areas we focused on so intensely, our commercial business, our R&D investments, and the pipeline. and the efficient management and governance of the company. On the commercial front, against the backdrop of an evolving pandemic, Vivitrol and Aristata continue to grow year over year, as the competitive positioning and attributes of these medicines have resonated with healthcare providers. For Vivitrol, a greater need for and growing acceptance of the use of medication to treat alcohol dependence has been a source of growth. For Aristata, its multiple doses and regimens continue to differentiate it from other long-acting injectable products. Libalvi has moved from the pipeline into the commercial portfolio. We launched Libalvi last week with a label that reflects its distinctive profile into a market that's characterized by large patient populations, significant unmet needs, and frequent treatment switches. We're launching Libalvi from an established and effective commercial platform, and we're well-positioned to capture operating leverage as the launch gains momentum. And continuing the positive momentum in the commercial portfolio, Vumerity has continued to demonstrate strong growth as Biogen drives uptake in the multiple sclerosis market. Vivitrol, Aristata, Lebalvi, Vumerity, all contributing to the top line. We've also continued to advance the pipeline. Nemvalucan has entered studies designed to support potential registration in mucosal melanoma and platinum-resistant ovarian cancer and has been granted fast-track designation in both of these tumor types. We've advanced our first selective HDAC inhibitor candidate, ALX1140, into first in human studies. ALX1140 presents an opportunity to harness the pro-synaptic effect of co-rest selective HDAC inhibitors and apply it to a range of neuroscience disorders. We've also recently nominated our orexin-2 receptor agonist, now known as ALX2680, and we're initiating IND-enabling activities. The biology of the orexin pathway has been validated in narcolepsy and we see a compelling opportunity in this space. Craig will provide further detail on these developments in a moment. And with respect to the efficient management of the business, you can see that our focus on growing revenue while concentrating R&D and SG&A investments in the areas of highest potential return and driving profitability is paying off. The impact of COVID is not over, but it's hopefully waning. I want to thank our remarkable teams in Ireland and in the U.S., for their incredible flexibility, resiliency, and dedication to the mission throughout. It's been inspiring to witness. So with that as a brief introduction, I'm going to turn the call over to Ian and Todd for a review of the third quarter financial and commercial results, followed by Craig with the pipeline. Ian.