Alkermes plc

Greetings, and welcome to the Alkermes First Quarter 2021 Earnings Call. My name is Rob, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Corporate Affairs and Investor Relations. Sandy, you may begin.

Thank you. Good morning. Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended March 31, 2021. With me today are Richard Pops, our CEO, Ian Brown, our CFO, and Todd Nichols, our Chief Commercial 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 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 slide two of the accompanying presentation, 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 or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A. Now I'll turn the call over to Richard.

That's great. Thank you, Sandy. Good morning, everybody. The first quarter's solid results were driven by our focus on commercial execution and discipline management of our cost structure. Ian and Todd will take you through the Q1 performance in detail, but at the highest level, we're on track to deliver on our financial objectives for the year and over the longer term, consistent with our value enhancement plan. The way we create value in biopharmaceutical companies is by making important medicines, medicines that address unmet needs of patients. Alkermes is an exciting point in our evolution. We've achieved a billion-dollar top line, driven by a portfolio of marketed drugs, We've developed specialized commercial capabilities, and we've identified new revenue growth opportunities with the expected launch of Lebalvi, which will be a second antipsychotic in our portfolio, and the anticipated growth of Vumerity, a drug for the treatment of MS that we developed but is being sold by Biogen. Coming next, we're focused on new neuroscience and oncology development candidates. Our objective is to develop truly innovative medicines with a clear value proposition and relative to current and anticipated future standards of care. We do this through developing new molecular entities based on strong biologic rationale and leveraging our established strengths in molecular design, both small and large molecule. At our recent investor day, we announced new development programs that reflect this approach. In neuroscience, our co-rest selective HDAC inhibitors have the potential for broad utility in neurodegenerative and neurodevelopmental diseases, and are advancing toward first in human studies later this year. Our orexin-2 receptor agonist program leverages our core competencies in small molecule medicinal chemistry and pharmacokinetic and formulation expertise, with candidate nomination planned for later this year. In oncology, we have developed a cytokine engineering capability that is yielding innovative new approaches to some of the most challenging and high potential immune modulation pathways. In addition to Nemvalucan, our most advanced oncology clinical candidate, we also highlighted our preclinical work engineering a tumor-targeted split IL-12 fusion protein and unveiled our IL-18 program. These presentations are archived on our website. Each of these programs is designed to address a specific unmet need in neuroscience and oncology and are designed to have clear competitive advantages. We test those assumptions throughout the development process. If a candidate doesn't meet these pre-specified criteria, we stop investment. If we create value through new medicines, the way we can enhance that value and make it rewarding to shareholders is through an equivalent focus on structure, efficiencies, and profitability. The value enhancement plan we introduced in December of last year furthers our focus on business excellence and makes explicit our intention to increase efficiency and profitability. It also provides a framework for allocating capital and prioritizing investments in our major cost areas of commercial and R&D, and drives a clear focus on programs with the highest expected return on investment. The combination of scientific excellence and business excellence is a powerful concept that we've incorporated into all the aspects of the way that Alkermes operates, and it's what will drive our ability to grow value in the future. So now, with that as introduction, I'll turn the call over to Ian to review the first quarter results.