Epizyme, Inc.

Hello, and welcome to Epizyme's conference call. 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 Epizyme's request. I would now like to turn the call over to Craig West, Vice President of Investor Relations. You may now begin.

Thank you, Operator. This morning, Epizyme issued a press release providing a business update in addition to the third quarter 2021 financial results. That press release can be found in the investor section of the company's website at epizyme.com. On the call with me today is Grant Bogle, President and Chief Executive 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 EpiSign'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 Grant Vogel.

Grant. Thank you, Craig, and good morning, everyone. It's great to be here. with you to provide an update on our third quarter financial results and to share progress we've made against the four pillars of our strategic plan. As many of you are aware, when I joined Epizyme as CEO last quarter, we announced a number of strategic and organizational changes to more favorably impact the adoption of TASVIR and ultimately intend to establish it as a background of therapy in follicular lymphoma, or FL, and epithelioid sarcoma, or ES, We still have plenty of work to do. We believe the changes we've made were the right ones to accelerate growth. We have begun to see a positive commercial impact. We have also started to see an impact from the cost-saving initiatives announced last quarter. We remain on track to meet the revised non-GAAP adjusted operating expense guidance of between $220 and $230 million for 2021, with additional cost savings planned in 2022. During the third quarter, we reported total revenue of $5.2 million from TASBERIC net product sales. In the second quarter of 2021, we recorded net product revenue of $8 million, or $4.8 million on a non-GAAP basis, which excludes a $3.2 million sale of commercial product to a third-party pharmaceutical company for use in its combination clinical trials. Importantly, total patient demand for TASVERIC grew 22% in the third quarter over the second quarter, driven primarily by FL patient sales. Free goods from our patient assistance program accounted for approximately 25% of total demand for the quarter, in line with what we had reported in the second quarter. During the third quarter, we saw an increase in new accounts prescribing TASVERIC, and volume growth among existing accounts, both in the community and academic settings. And this growth was well dispersed across the country. We made progress partnering with several large integrated provider organizations to improve the integration of TASVERIC into their systems of care, such as their electronic medical record, or EMR, in a way that makes TASVERIC and the EZ-H2NOW test easier to access within the workflow. This is part of our strategy to focus on system-wide integration to augment our efforts to educate individual physicians. It is important that Tasveric be incorporated into provider systems and workflows. So when a provider encounters a relapsed or refractory FL patient, Tasveric is positioned consistent with our label and guidelines, making it easier to write a prescription when the physician believes Tasveric is the appropriate treatment choice. For example, At one of the large group practices in the southeast, while TASVERIC was available in the EMR, it was not tied to the recommended treatment plan for relapsed or refractory FL patients. During the third quarter, this group practice made the decision to ensure TASVERIC was appropriately positioned as a treatment option for relapsed or refractory FL patients. In addition, the practice decided to incorporate the application form for the EZH2 now test within the same EMR platform to facilitate physician ordering of the test. Educating provider organizations about the importance of ensuring that TASVERIC is appropriately positioned within their systems and workflow, consistent with our label and guidelines, will continue to be a priority for us going forward. We expect this strategy will help assure that TASVERIC is considered as an appropriate treatment option by providers throughout the health system when a relapsed or refractory FL patient progresses and needs a new treatment option. Our field teams continue to evolve their strategies and tactics to engage customers in person, virtually, or both, according to our customers' preferences. During the third quarter, this resulted in our field teams having more in-depth discussions as some clinics reopened to industry representatives as our newly created field roles allowed us to engage healthcare professionals and other non-physician decision makers at a deeper level. Overall, more than 90% of Tier 1 and 75% of Tier 2 accounts were called upon in the quarter, despite the reduction and reorganization of our field teams in August. In addition to physician education, we believe we have an opportunity to directly address patients as well, Our market research shows that physicians frequently respond to patient requests for appropriate treatment options. This research shows that FL patients only make treatment requests around 15% of the time, but when they do make a request for a therapy, the requests are often granted. In an effort to educate and empower appropriate patients to participate in their treatment decisions, we have just launched a branded, highly targeted direct-to-patient campaign which we believe can make a meaningful impact in keeping TASVIR top of mind when a relapsed or refractory FL patient and their physician are considering treatment options. In addition to the branded campaign, we have been working closely with a group of FL patient advocates and advisors to develop an online disease education tool called In My Blood to empower people living with FL to proactively engage in their treatment decisions. This unbranded resource, which we launched last week, features a first-of-its-kind interactive tool that provides personalized guidance and advice for patients based on where they are in their FL journey. We put out a press release on November 1 that includes more details on the In My Blood program. Through both of these programs, our goal is to educate and activate patients to proactively engage with their physicians to select the best available treatments. All of the commercial initiatives discussed today are helping to advance our vision of transforming the lives of patients living with cancer and in helping establish TASVERIC as a foundation of therapy in both FL and ES. To further advance this vision, we are making great progress on our key clinical trials to provide additional data and evidence of TASVERIC's potential, not just as monotherapy, but in combination with standard of care treatments. We believe the data pertaining to TASVERIC combinations in FL and other heme and solid tumor indications is just beginning to emerge from important clinical trials that are underway. As you'll hear from Shefali in a moment, we're making good progress with these combination trials for TASVERIC. Consistent with the third pillar of our strategic plan, we're excited to have announced last week a major milestone for epizyme. where we received fast-track designation for DLBCL and initiated the first in-human clinical trial of our first in-class oral CETD2 inhibitor, EZM0414. As leaders in pioneering novel epigenetic therapies, bringing EZM0414 to the clinic is an important advancement as we work towards our vision of making this therapy a possible treatment option for patients living with devastating cancers such as DLBCL and multiple myeloma. At this time, I'd now like to turn the call over to Shefali, who will speak to our clinical development progress for Tazometastat and EZM-0414 in more detail. Shefali?