Theravance Biopharma, Inc.

Good morning and welcome to the Theravance Biopharma KOL event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Theravance website following the conclusion of the event. I'd now like to turn the call over to Rick Winningham, Chief Executive Officer at Theravance Biopharma. Please go ahead, Rick.

Good morning, and thank you for joining us. We're excited to host this KOL event focused on ampryloxetine, a medicine with an orphan drug designation. targeted to treat a rare neurologic disease, neurogenic orthostatic hypotension in patients with multiple system atrophy. Amproloxine is finishing a pivotal phase three study called Cypress, we'll refer to it during the course of the call, with data expected in the first quarter of 2026. Today's call is to describe the significant unmet need in symptomatic neurogenic orthostatic hypotension, or NOH, and again, patients with multiple system atrophy, or MSA, and to show why we believe amproloxetine has the potential to change the treatment landscape as a once-daily oral medicine with a durable treatment effect, creating value for patients and shareholders. Can you get the next slide, please? Before we begin, let me note that we'll be making forward-looking statements today involving risks and uncertainties related to our development pipeline, the expected benefits of our product candidate, and anticipated timing of clinical trials and regulatory filings and our expected financial results. You can find further information concerning the factors that could cause results to differ materially from these forward-looking statements in our filings with the SEC. Next slide, please. Now, turning to today's agenda, I'll begin with a brief overview of the company and highlight Amproloxatine and the exciting opportunity we see for this medicine to make a meaningful difference in a disease with a clear unmet medical need, currently treatment concentrated in centers of excellence and specialized neurology groups. After my opening remarks, we'll move to Dr. Horatio Kaufman, a highly distinguished leader in movement disorders, who will discuss the substantial unmet need in NOH and MSA patients and review clinical evidence supporting the potential of ampyloxetine. I want to thank Dr. Kaufman for not only joining us today, but for his many contributions in the field of dysautonomia over the years. After Dr. Kaufman, Anya Miller, our head of development, will walk through the details of our nearly complete phase three Cypress study, and then we'll conclude with Rhonda Farnham, our chief business officer, who will outline the commercial opportunity we see ahead for anthaloxetine. Before I hand the presentation over to Dr. Kaufman, I'd like to take a moment to level set for those who are newer to the Theravance story. Next slide, please. Theravance today is a commercial-stage biotech focused on respiratory and neurological disease. Our value drivers begin with the core fundamentals of the company, where we're operating from a position of financial strength. We ended last quarter with $333 million in cash, no debt, and achieved cash flow break-even in the third quarter. In addition, we have $175 million in high-probability near-term milestones from both Trilogy and UPelry that we expect to be received over the next 14 months. Complementing the strong financial profile is UPelry, our approved product for COPD, which we co-promote with Beatrice in the United States. The brand continues to deliver solid growth, including 15% net sales growth in the most recent quarter, and importantly, durable cashflow generation supported by patent protection in the U.S. in the 2039. The strong base, a robust balance sheet, high probability milestones, and a cash-generating commercial asset creates a foundation for the company. And on top of this foundation, we're developing Amproloxatine. which you'll hear much more about today. We believe ampryloxetine has the potential to make a transformative impact for the 40,000 MSA patients with NOH in the United States and many more outside the U.S., a community with high unmet medical need. And it's with that context I'm pleased to introduce Dr. Horatio Kaufman, one of the world's leading experts in movement disorders, who will walk us through the disease and the unmet need in NOH and MSA patients. Dr. Kaufman.

Hi, Rick. Thank you very much, and good morning, everybody.