Emerging Growth

Epizime Stock (EPZM) Rallies On Strong Q1

3 years ago
Written by GreenlightStocks Editorial

Shares in Epizyme (NASDAQ:EPZM) surged by 22% after providing business and portfolio updates and reported first quarter 2021 financial results.

“Adoption of TAZVERIK has steadily increased as we continue to navigate the unique launch environment presented by COVID-19. We saw month-over-month commercial demand growth, with March 2021 representing our most successful month since launch and we look to build on this momentum as the pandemic-associated challenges begin to ease,” said Robert Bazemore, President and Chief Executive Officer of Epizyme. “TAZVERIK net revenues in the first quarter of 2021 increased by 37% from the fourth quarter of 2020, driven primarily by increased adoption in follicular lymphoma. The environment we operated in during the first quarter was not substantially different from the end of last year, however we are beginning to see some encouraging signs that things are slowly beginning to return to normal as vaccine adoption progresses.

“In early March, we hosted a strategic vision call to outline the pipeline-in-a-drug potential we see in TAZVERIK and plans to expand our portfolio starting with the anticipated IND submission for our novel SETD2 inhibitor in mid-2021. We plan to share additional pre-clinical data supporting the advancement of our SETD2 program at the European Hematology Association Congress 2021. During the Vision Call we also shared encouraging preliminary safety and activity data from ongoing combination trials in follicular lymphoma and prostate cancer and look forward to providing a steady stream of data updates from these and our many other planned and ongoing trials over the next few years.”

The company added an operational update:

Recent Progress

  • Commercial Execution: TAZVERIK generated net product revenue in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) of $6.2 million in the first quarter of 2021, with March 2021 representing our highest level of commercial demand since launch. Commercial bottle demand growth was 31% in the first quarter compared to the fourth quarter of 2020, while total revenue grew by 37%. New prescribing accounts increased 38% in the first quarter of 2021 compared to the fourth quarter of 2020, including broader adoption among community practice. This is despite the continued negative impact COVID-19 had on patient visits to physicians and new patient starts across all lines of treatment as well as the ability of our field-based teams to fully access physicians treating ES and FL patients.
  • EZH-302 Phase 1b/3 Confirmatory Study of TAZVERIK in Follicular Lymphoma: The combination of TAZVERIK with R2 (Lenalidomide and Rituximab) is being evaluated in a Phase 1b/3 confirmatory study in relapsed / refractory FL patients. Preliminary safety and activity data of 13 patients from the 400 mg, 600 mg and 800 mg cohorts of the Phase 1b safety run-in were presented during Epizyme’s Vision Call in March showing encouraging initial treatment responses in each dose group, and adverse events that were in line with expectations based on the respective safety profiles of the individual agents. Epizyme plans to submit an update to this safety run-in for presentation at the 2021 ASH Annual Meeting later this year.



    Based on recent discussions with the U.S. Food and Drug Administration (FDA), Epizyme has aligned on an important change to the Phase 3 protocol whereby the second interim analysis will include an efficacy evaluation once 65% of progression free survival (PFS) events have occurred. This allows access to efficacy data earlier than previously expected and may provide an opportunity to stop the study early should the predefined treatment effect be realized. Based on these discussions with FDA, Epizyme has also expanded the Phase 1b portion of the study to include a minimum of 15 patients in the cohorts of 600 mg BID and 800 mg BID to help inform selection of the Phase 3 dose. Enrollment is nearly complete in these two cohorts and patients are being evaluated for follow-up of three months before initiating the Phase 3 randomization portion of the trial.
  • Additional Ongoing Clinical Trials of Tazemetostat in Follicular Lymphoma: EZH-1401, the Company’s Phase 2 trial evaluating TAZVERIK plus Rituxan in relapsed / refractory FL continues to move forward as planned and is actively enrolling. Patient enrollment also continues in the Lymphoma Study Association (LYSA) trial in front-line FL and Diffuse Large B-cell Lymphoma (DLBCL), as well as other investigator sponsored trials.
  • EZH-1101 Phase 1b/2 Study of Tazemetostat in Prostate Cancer: The combination of tazemetostat with standard-of-care treatments, enzalutamide or abiraterone, was evaluated in the Phase 1b safety run-in portion of the EZH-1101 trial which enrolled a total of 21 men with metastatic prostate cancer. The Phase 1b protocol allowed patients to enroll who had previously failed enzalutamide, abiraterone, first generation anti-androgen receptor therapies or short course chemotherapy. In the study, patients received either abiraterone plus tazemetostat plus prednisone or enzalutamide plus tazemetostat. Based on encouraging preliminary safety and activity data, particularly in the enzalutamide plus tazemetostat group, Epizyme has initiated enrollment in the Phase 2 efficacy portion of this study which will evaluate enzalutamide plus tazemetostat compared to enzalutamide alone. Epizyme plans to submit an update to the Phase 1b safety run-in for presentation at a medical congress later this year.
  • EZH-301 Confirmatory Phase 1b/3 Study of TAZVERIK in Epithelioid Sarcoma: The combination of TAZVERIK with doxorubicin compared with doxorubicin plus placebo is being evaluated in a Phase 1b/3 confirmatory study as a front-line treatment for ES patients. We have completed the planned enrollment in the Phase 1b safety run-in portion of the trial and the Phase 3 efficacy expansion portion of the trial remains on track for initiation. Preliminary data from the Phase 1b portion of this study has been accepted as a poster presentation at the 2021 ASCO Annual Meeting in June.
  • Tazemetostat Basket Trials in Additional Hematologic Malignancies and Solid Tumors: Epizyme plans to initiate two signal finding basket studies to evaluate tazemetostat safety and efficacy across multiple new types of hematologic malignancies and solid tumors. With this approach, the Company plans to study multiple combinations with standard-of-care therapies and novel mechanisms of action to expand the potential of tazemetostat. Epizyme plans to initiate both basket studies in the second half of 2021.
  • Planned IND Submission for Epizyme’s Novel SETD2 Inhibitor: Based on the potential of SETD2 inhibition in multiple settings, including high risk t(4;14) multiple myeloma and in other B-cell malignancies such as large-cell lymphoma, as monotherapy and in combination with existing and emerging therapies including tazemetostat, Epizyme is planning to submit an Investigational New Drug (IND) application with the FDA in mid-2021 and expects to initiate a first-in-human clinical trial this year.

First Quarter 2021 Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $298.9 million as of March 31, 2021, as compared to $373.6 million as of December 31, 2020.
  • Revenue: Total revenue for the first quarter of 2021 was $7.6 million, compared to $1.4 million for the first quarter of 2020. Total revenue for the first quarter of 2021 comprised of $6.2 million in net sales of TAZVERIK in the U.S. and $1.4 million in collaboration and other revenue.
  • Operating Expenses: Total GAAP operating expenses were $72.0 million for the first quarter of 2021 compared to $52.7 million for the first quarter of 2020. Total non-GAAP adjusted operating expenses were $63.7 million for the first quarter of 2021 compared to $45.7 million for the first quarter of 2020.
    • Cost of revenue: GAAP cost of revenue, which reflects the costs of TAZVERIK units sold, amortization of intangible assets, third-party royalties on net product revenue and costs of tazemetostat API and drug product sold to the Company’s licensees or collaborators, was $2.9 million for the first quarter of 2021 compared to $0.6 million in the first quarter of 2020. Non-GAAP adjusted cost of revenue was $1.8 million for the first quarter of 2021 compared to $0.3 million for the first quarter of 2020.
    • R&D expenses: GAAP R&D expenses were $32.7 million for the first quarter of 2021 compared to $25.2 million for the first quarter of 2020. Non-GAAP adjusted R&D expenses were $30.3 million for the first quarter of 2021 compared to $22.9 million for the first quarter of 2020.
    • SG&A expenses: GAAP SG&A expenses were $36.4 million for the first quarter of 2021 compared to $27.0 million for the first quarter of 2020. Non-GAAP adjusted SG&A expenses were $31.5 million for the first quarter of 2021 compared to $22.5 million for the first quarter of 2020.
  • Net Loss (GAAP): Net loss attributable to common stockholders was $70.3 million, or $0.69 per share, for the first quarter of 2021, compared to $50.9 million, or $0.51 per share, for the first quarter of 2020.

2021 Financial Guidance

  • Based on its current operating plans, Epizyme expects its current cash runway to extend into 2023. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between $235 and $255 million.
  • A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.

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