Epizyme, Inc.

Hello and welcome to Epizyme'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 Epizyme'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 fourth quarter and full year 2020 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, and Vicky Bacchiner, Chief Commercial Officer. Matt Ross, Executive Vice President and Chief Strategy and Business Officer, and Dr. Shefali Agarwal, Chief Medical Officer, will be joining 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 Rob Bazemore. Rob?

Thank you, Bill, and thank you all for joining us today. 2020 was a pivotal year for Epizyme and encompassed remarkable progress toward our mission of rewriting treatment for cancer through novel epigenetic medicines. I'd like for history to reflect that achieving two back-to-back FDA approvals within five months, enrolling our clinical trials, and launching TASVERIC, all while working entirely remotely through a pandemic the likes of which none of us on this call has ever had to experience, reflects a level of execution that signals to people living with cancer, to the physicians treating them, and to our shareholders that our mission at Epizyme is something we take very seriously. For that, I'd like to thank our incredible employees here at Epizyme. Our sales, clinical, and research teams all quickly adapted to our new environments. and it's because of their efforts that we were able to execute across all of our 2020 initiatives. Despite the many challenges the global pandemic brought to physicians, people living with cancer, and our ability to access them, we successfully transitioned Epizyme into a fully integrated commercial enterprise as we launched our first product, Tasveric, following our accelerated approvals of epithelioid sarcoma, a solid tumor cancer, and follicular lymphoma, a common heme malignancy. From a clinical perspective, we advanced the development of Tazometastat to support label expansion in FL and in additional solid tumor indications. In fact, all of our 2020 clinical initiatives were achieved on time or ahead of schedule. We also continue to progress our early stage pipeline, which you can expect to hear more about this year. In addition, we raised sufficient cash to fund important growth initiatives and extend our operating runway into 2023 based on our current operating plan. Our two approvals last year made TASVERIC the first and only treatment specifically indicated for ES patients and the first and only FDA-approved EZH2 inhibitor on the market. The clinical utility of TASVERIC was quickly acknowledged by the oncology community and payers alike. Within three weeks of both approvals, TASVERIC was incorporated into the NCCN clinical practice guidelines in ES and FL. Today, TASVERIC is covered in over 90% of insured lives in the U.S. for use in both ES and the FL indications. Earlier this month, the NCCN guidelines for relapsed refractory FL patients were amended to recommend TASVERIC for patients whose EZH2 status is unknown. This revised recommendation reinforces that there is no requirement to test for EZH2 status before prescribing Tasveric, which is in line with our current label and supports that our education efforts are reaching the KOL community. In the face of the COVID pandemic, the launch of Tasveric has been anything but conventional. Our commercial team has continued to adapt to the virtual environment, ensuring that Tasveric reaches all eligible patients as quickly as possible. by finding new ways to engage with academic and community physicians. As expected, we saw the greatest initial adoption of TASVIRIC in large academic centers, but we're now seeing broader adoption among the many community practices as physician awareness and understanding of our labels improves. While the resurgence of COVID-19 cases in the fourth quarter extended the challenges that we described last year, adoption of TASVIRIC in ES and SL continues to expand. TASVERIC net revenues for the fourth quarter were $4.5 million, a 31% increase over Q3, driven primarily by increased adoption in FL. Beyond revenue, we continue to see positive signs of our commercial execution and novel approaches to overcoming these challenges and ensuring patients have access to this drug. During the fourth quarter, monthly new prescriptions for TASVERIC continued to grow, and we observed a 50% increase in new prescribing accounts. our largest quarter-over-quarter increase to date. Overall, I'm encouraged by how we've executed given the circumstances, and I remain enthusiastic about the long-term potential for TASVERIC in ES and FL. I am pleased to be joined today by Vicki Vecaner, Epizyme's Chief Commercial Officer, who will elaborate on our commercial success momentarily. As I noted earlier, we've also made progress throughout 2020 advancing our clinical programs, to further develop Tazometastat, completing all trial milestones on time or ahead of schedule. We completed enrollment in the safety run-ins of our ES confirmatory trial, evaluating Tazometastat plus Toxorubicin in frontline patients, and for our SL confirmatory trial, evaluating R-squared plus Tazometastat in second-line and later patients. We are now moving forward to initiate efficacy expansion portions of both of these studies. Our post-marketing commitments for ES and FL also remain on track. We also completed enrollment in the safety run-in portion of our metastatic castration-resistant prostate cancer study, evaluating tazometastat in combination with enzalutamide or abiraterone. We plan to report safety and early activity data from all three safety run-ins this year. Scientific interest in this novel mechanism has also grown. and in 2020, enrollment was initiated in several investigator-sponsored trials and collaboration studies of Tazometastat, with many others being approved or currently under review. Studies such as the trial of Tazometastat in frontline diffuse large B-cell lymphoma and FL, which we are working on in collaboration with the Lymphoma Study Association, continue to enroll patients as expected. As we look forward into 2021 and beyond, we believe that there are four pillars necessary to driving enhanced and sustainable long-term growth for Epizyme. The first, maximizing our commercial effectiveness to ensure adoption of Tazveric in as many appropriate FL and ES patients as possible. As importantly, building Tazometastat's pipeline in the drug potential to benefit people living with cancers well beyond ES and FL. We will also expand our pipeline bringing novel oncology therapeutics into clinical development and transforming Epizyme into a true oncology portfolio company. And finally, working collaboratively and leveraging all available options to expand patient reach and increase shareholder value resourcefully and responsibly. While today's call will focus on our fourth quarter results and the first of these four pillars, We are excited to announce that we will be hosting a call to unveil the next episode for Epizyme next Tuesday, March 2nd, at 10 o'clock a.m. Eastern Time. During this call, we will speak further to our next five-year strategy, provide updates related to our TASBERIC development plans, and provide further detail regarding the advancement of our epigenetic pipeline. Because of this, we will be deferring much of the discussion relating to ongoing and planned clinical trials along with pipeline expansion plans to next week. The vision call will provide insights into how we are thinking about our pipeline, milestones, potential new data, and focus areas over the next five years. You should expect to see more information about this call in the next 24 hours, and we look forward to your participation. And with that, I'd like to turn the call over to Vicki, who will provide additional color on our ongoing launch efforts, followed by Paolo, who will briefly review our fourth quarter and year-end financials before we open the call for Q&A. Vicki?