Sarepta Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Sarepta Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touch-tone telephone. As a reminder, today's program is being recorded. At this time, I'll turn the call over to Mary Jenkins, Senior Manager, Investor Relations, please go ahead.

Thank you, Mel, and thank you all for joining today's call. Earlier today, we released our financial results for the fourth quarter and full year 2021. The press release is available on our website at Sarepta.com, and our 10-K was filed with the Securities and Exchange Commission earlier this afternoon. Joining us on the call today are Doug Ingram, Ian Estepan, Dallin Murray, and Dr. Louise Rodino-Klaypak. After our formal remarks, we'll open the call for Q&A. I'd like to note that during this call, we will be making a number of forward-looking statements. Please take a moment to review our slide in the webcast, which contains our forward-looking statements. These forward-looking statements involve risks and uncertainties, many of which are beyond Surreptice control. Actual results could materially differ from these forward-looking statements, and any such risks can materially and adversely affect the business. The results of operations and trading prices for Surreptice common stock. For a detailed description of applicable risks and uncertainties, we encourage you to review the company's most recent annual report on Form 10-K filed with the SEC, as well as the company's other SEC filings. The company does not undertake any obligation to publicly update its forward-looking statements, including any financial projections provided today based on subsequent events or circumstances. And now I'll turn the call over to our President and CEO, Doug Ingram, who will provide an overview of our recent progress. Doug?

Thank you, Mary. Good afternoon, everyone, and thank you all for joining Sarepta Therapeutics' fourth quarter and full year 2021 investor conference call. Among the thousands of public and private biotech companies currently existing in the United States and around the world, Sarepta sits in a select and small group of fully integrated commercial stage biotech enterprises with a proven track record of translating brilliant science into approved therapies and then supporting the patient community and physicians in gaining and maintaining access to those approved therapies. This operational focus and commitment to patients was on full display throughout 2021. We have greater than 40 programs in our pipeline of potentially life-enhancing therapies focused on rare genetic diseases across multiple platforms, including RNA, gene therapy, and gene editing. But more than that, in 2021, we entered pivotal registrational trials for our lead programs in both our RNA and gene therapy platforms. Encouraging data from our Momentum Part A study, we commenced Part B of the study, a pivotal trial for SRP5051, our next generation RNA-based PPMO for the treatment of Duchenne patients with exon 51 amenable mutations. Additionally, we commence dosing EMBARQ, the pivotal registrational trial for SRP9001, our microdystrophin gene therapy to treat Duchenne muscular dystrophy. EMBARQ, which includes sites both in and outside the United States, is currently the only truly global trial dosing a gene therapy for the treatment of Duchenne. And we translate our development activity to approved therapies. With the approval and launch of Amandus 45 in February of 2021, we now have three approved therapies serving the Duchenne community. In the fourth quarter of 2021, we enjoyed our 21st straight quarter of strong quarter-over-quarter revenue growth. Fourth quarter total revenues, which consist primarily of our net product revenue plus our collaboration revenue, reached $201.5 million. And net product revenue for our three RNA-based therapies reached $178.7 million, a 46% increase over the same quarter of the prior year. For the full year 2021, total revenue reached $701.9 million, and net product revenue was $612.4 million, a 34% increase over the prior year. Since 2017, first full year launch for Exondus 51, Sarepta has recognized sustained growth with a compounded annual product revenue growth rate of over 40%. And our growth continues. We entered 2022 in a position of financial strength with our total revenue guidance at over $880 million and our net product revenue guidance of over $800 million, a 30% growth, over the prior year. Additionally, we entered 2022 with $2.1 billion in cash on our balance sheet and the financial discipline to make the most. And our pipeline continues to perform. In the first quarter of this year, we announced statistically significant functional results and continued confirmation of our differentiated safety profile for SRP 9001 from Part 2 of Study 102. With the objective conviction that comes from consistent results in what is the largest body of clinical evidence in Duchenne today, we continue to enroll in those patients in the Embark and the Momentum studies while also advancing our deep multi-platform pipeline. Now, our strategy has taken us far over the last five years, but it is all only the beginning. As we look to the future and to our strategic plans, If our late-stage clinical programs are successful, we should achieve profitability by the end of 2024. And by 2025, our yearly revenue is $4 billion. And if our pipeline is successful, by the end of this decade, our yearly product revenue could approach $10 billion generated from our internal programs alone. We have the strongest team in Sarepta's history, and I believe at least, one of the most astute and strategically-minded teams in all of genetic medicine and biotech. And we stand ready to continue executing, translating our programs into life-enhancing therapies for the patients that we serve, and also benefiting the investors that have placed their trust in us. And with that, let me turn the call over to our head of R&D and our chief scientific officer, Dr. Luis Rodino-Klapak, who will give us an update on our research and development activities. Luis?