Epizyme, Inc.

Hello, and welcome to EpiVine's conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session after the prepared remarks. Please be advised that this call is being recorded at EpiVine's request. I would now like to turn the call over to Bill Slattery, Jr. You may begin.

Thank you, Operator. This morning, Epizyme issued a press release providing a business update in addition to first quarter 2021 financial results. That press release, as well as slides to accompany today's call, can be found in the investor section of the company's website at epizyme.com. On the call with me today is Rob Bazemore, President and Chief Executive Officer, Paolo Tambesi, Chief Financial Officer, Vicki Bikiner, Chief Commercial Officer, Matt Ross, Executive Vice President and Chief Strategy and Business Officer, and Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer. 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 10Q, 10K, 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 Rob Basemore. Rob.

Thank you, Bill, and good morning, everyone. It's great to be here with you to provide an update on our Q1 results and how we see our business progressing this year. As we moved from March into the second quarter, we began to see some very encouraging signs that things are slowly beginning to return to normal, perhaps even a bit earlier than we expected. Vaccinations are now much more broadly available. Offices report that they're busier and they're starting to see more patients than before. At the end of March, we eased the travel restrictions for our vaccinated field-based employees and are allowing them to travel again to reach their customers for in-person discussions in the institutions and the offices that allow it. Some accounts have reopened to representatives calling on them, although this is still more the exception than the norm. And some educational programming is beginning to return to in-person, like regional medical conferences. All of this is happening slowly and is happening in pockets of the country at very different rates. but it's encouraging to at least begin to see these changes. However, that was not yet the case for Q1 of this year, as we were still dealing with a second wave of infection that started late in 2020 and resulted in the extension or heightening of restrictions in some areas. As a result, in Q1, Epizyme continued to execute almost entirely virtually as we had been previously, and the significant challenges we experienced last year due to the pandemic persisted. Despite these challenges, we continue to build positive momentum on the metrics that we have control over that will ultimately be important to Tasveric adoption, like growth in awareness, growth in number of accounts prescribing, and continued broad unrestricted access as coverage was renewed at the beginning of the year. We continue to see quarter-over-quarter and month-over-month growth in Tasveric adoption, with March 2021 representing the most successful month yet in terms of Tasveric models sold. Total revenues for the first quarter were $7.6 million, of which Tesveric net revenues in the U.S. were $6.2 million, a 37% increase over Q4 2020, which was driven primarily by increased adoption in follicular lymphoma, or FL. Epithelial sarcoma, or ES, sales continue to contribute to total revenue at approximately the same level as Q4. Commercial bottle demand increased quarter over quarter by 31%. And the remainder of the revenue booked in Q1 was collaboration and other revenue of $1.4 million. In early March, Epizyme hosted a strategic vision call entitled The Next Episode, where we unveiled our strategy for how we'll create value for patients and the physicians who treat them at Epizyme shareholders over the next five years. I encourage you to listen to the event webcast if you haven't already. But to quickly recap, this strategy for long-term growth relies upon our execution across four pillars. Obviously, the first and most important focus in the near term is maximizing our commercial effectiveness to ensure adoption of Tasverix among as many eligible FL and ES patients as possible, including our development efforts to bring Tasverix into earlier lines of therapy by combining with other agents or as monotherapy. Second, continuing to build on Tasverix pipeline and the drug potential, including moving our programs into additional solid tumor and hematological malignancies and produce a steady stream of data over the next five years and beyond. Third, expanding our pipeline and portfolio beyond TAS Barrett, bringing novel epigenetic therapeutics into clinical development. And fourth, leveraging all available options to expand our patient reach and increase shareholder value, both resourcefully and responsibly. In the first quarter, we made good progress across these four pillars. As I mentioned earlier, despite the COVID headwinds persisting in Q1, we continue to build momentum on metrics needed to ensure accelerated adoption once the pandemic challenges begin to subside. On the clinical side, during our vision call, we outlined a comprehensive and innovative clinical development plan for TASBERIC, for which we anticipate a steady stream of data beginning in 2021 and over the next five years. And we highlighted some encouraging early data from the second-line FL and prostate cancer studies. We plan to further explore tazometastat as both monotherapy and in combinations across multiple new hematological and solid tumor cancers in two basket trials, which are on track to initiate during the second half of this year. Finally, our novel CETD2 inhibitor, which addresses a long sought-after pathway and was introduced during the vision call, remains on track for planned IND submission mid-2021. I'd now like to turn the call over to Vicky, who will provide additional color on our Q1 progress in TASVIRIC adoption and FL and ES, and then to Shefali, who will provide an update on our TASMETISTAT development efforts. Followed by Paula, who will briefly review our first quarter financials before we open the call for Q&A. Vicky?