Epizyme, Inc.

Hello, and welcome to Epizyme's first quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. Following the prepared remarks, there will be a question-and-answer session. Please be advised that this call is being recorded. I would now like to turn the call over to Kristen Hilton, Investor Relations. You may begin.

Thank you, Operator. This morning, Epizyme issued a press release providing a business update in addition to first quarter 2022 financial results. The press release can be found in the investor section of the company's website at epizyme.com. On the call today are Grant Vogel, President and CEO, Dr. Shefali Agarwal, Senior Medical Advisor and Interim Chief Medical and Development Officer, and Joe Bollier, Senior Vice President and Head of Finance. Gerald Korn, our recently appointed Chief Operating Officer, will join us for the Q&A session. As a reminder, today's discussion will include forward-looking statements related to Epizyme's current plans and expectations, which are subject to certain risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the risk factors section of our most recent forms 10-Q, 10-K, and other SEC filings. These forward-looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date. We undertake no obligation to publicly update these statements. At this time, I would like to turn the call over to Grant Vogel. Grant?

Thank you, Kristen, and good morning, everyone. It's great to be here with you today and to provide an update on our first quarter 2022 results. On today's call, I will provide our commercial overview and performance at TASVERIC. Shefali will speak to our clinical development progress for Tazometastat and EZMO414, our investigational SETD2 inhibitor. And Jill will cover our financials for the quarter. Following our remarks, we'll open the line for questions. During the first quarter, TASVERIC generated net product revenue of $8.7 million, including $0.5 million related to the sale of TASVERIC commercial product for a third-party pharmaceutical company use in clinical trials. Tasveric commercial net sales in the first quarter of 2022 were $8.1 million, representing an increase of approximately 10% when compared to the fourth quarter of 2021. Free goods from our patient assistance program represented approximately 15% of total demand for the first quarter of 2022, a rate consistent with Q1 of 2021. Commercial demand increased 16% in Q1 2022 versus Q4 2021, while total demand, which, as a reminder, is commercial demand plus free goods provided through our patient assistance program, was similar to the fourth quarter 2021 levels. These fluctuations in total demand and commercial demand are directionally consistent with prescription dynamics we saw at the end of 2020 and into 2021. We believe these fluctuations are a result, in part, of the Medicare Part D drug benefit design and year-end prescription patterns that impact Q1 demand. As in the prior year, TASVERIC demand rebounded in March and reached its highest monthly level since launch. While more time will be needed to understand the impact of seasonality on the relapsed refractory FL market, and TASVERIC demand in particular, I am encouraged by this demand growth. We continue to be optimistic about prescription growth for TASVIRIC based upon physician feedback, data from our ATU survey, and recent changes in the FL treatment landscape and subsequent updates to treatment guidelines. Recent market research suggests that TASVIRIC market share continues to grow. In the third line, we lapse refractory FL setting for both wild-type and EZH2 mutation-positive populations, consistent with the company's commercial focus, messaging, and our prescribing information. Following the recent changes in the FL marketplace, Tasveric is now the only oral treatment alternative approved in the third-line plus setting for relapsed refractory FL patients. And based on physician-reported prescribing behavior from our tracking studies, physicians we sampled reported they intend to increase prescribing of Tasveric in patients in both wild-type and EZHT mutations in the third-line plus setting. NCCM recently updated its guidelines on B-cell lymphomas. The updated guidelines for grade 1, 2 follicle lymphoma now include Tazometastat as a suggested second-line treatment regimen and FL for elderly or infirm patients with EZH2 wild-type or unknown root-optifractory disease with no satisfactory alternative treatment option. Tasmetastat remains a suggested treatment in the third-line FL and subsequent lines of therapy consistent with our label. The inclusion of Tasmetastat in the second-line setting is an exciting update that reinforces our confidence in Tasveric's potential to reach many more patients. In addition to the NCCN guidelines update, we're also witnessing the FL treatment landscape changing in real time. with a voluntary withdrawal of PI3 and K inhibitors from the relapse refractory FL marketplace in recent months. In December, Secura Bio announced it was withdrawing Copetra from its approved FL indication. This was followed by Gilead's decision in January of this year to withdraw Zydelic from its approved FL indication, and TG Therapeutics' decision in April to stop selling Uconic in all of its approved indications. The FDA is also looking closely at the risk-benefit profile of PI3K inhibitors in FL, as seen with the recent ODAC meeting on the topic, in which the FDA asked advisors to specifically discuss the observed toxicity of the PI3 class and whether randomized data in this class of therapies are warranted to support the evaluation of benefit-risk in patients with hematologic malignancies. Our internal market research has consistently shown that the PI3K class accounts for approximately one-third of the FL market share. For physicians seeking an alternative to PI3Ks, Tasveric is now the only other oral therapy approved in the third-line plus setting. Combined with the NCCN guidelines update, we believe this presents a significant opportunity for future prescription growth. and corresponding commercial sales. At this time, I'd now like to turn the call over to Shefali. Shefali?