Epizyme reports 1Q-2020 financial results

Epizyme () today provided business and pipeline updates and reported 1Q-2020 financial results. […]
  • Cash Position: Cash, cash equivalents and marketable securities were $376.5 million as of March 31, 2020, as compared to $381.1 million as of December 31, 2019.
  • Revenue: Total revenue for the first quarter of 2020 was $1.4 million, comprised of $1.3 million in net sales of TAZVERIK in the U.S. from the first two months of commercialization following its launch in January 2020 and $0.1 million in collaboration revenue, compared to $4.3 million in collaboration revenue for the fourth quarter of 2019, which was primarily due to revenue associated with services performed under the company’s multi-target research collaboration with Boehringer Ingelheim.
  • Operating Expenses: Total GAAP operating expenses were $52.7 million for first quarter of 2020, compared to $61.8 million for the fourth quarter of 2019. Total non-GAAP adjusted cash operating expenses, were $45.7 million for the first quarter of 2020, compared to $45.2 million for the fourth quarter of 2019.
  • Guidance: Based on its current operating plans, Epizyme continues to believe that its existing cash, cash equivalents and marketable securities will fund the company’s operations into at least 2022. The company expects its non-GAAP adjusted operating expenses for 2020 will be between $235 and $255 million, which excludes any milestone payments paid by the company and non-cash items, such as stock-based compensation and amortization or depreciation of intangibles.
  • TAZVERIK Commercially Available in U.S. for Epithelioid Sarcoma (ES): Epizyme successfully made TAZVERIK commercially available in the U.S. on February 1, 2020, following its accelerated approval on January 23, 2020, for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection. Within one week from approval, the first prescriptions were filled, and the company saw continued traction in the first quarter, with physicians incorporating TAZVERIK into their treatment practices.
  • Follicular Lymphoma (FL) U.S. Commercial Launch Readiness Nearly Complete: The U.S. Food and Drug Administration (FDA) granted Priority Review to Epizyme’s supplemental New Drug Application (sNDA) filing with a PDUFA target action date of June 18, 2020 for the accelerated approval of TAZVERIK for a proposed indication of patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy. To support a potential FDA approval, the company has concluded the hiring and training of its salesforce and is completing its FL launch readiness activities, which will utilize both direct and virtual approaches to physician education.
  • Company-sponsored Trials in ES, FL and Prostate Cancer Underway: Epizyme expects to complete the ongoing safety run-in portions and begin the efficacy expansion portions of the following clinical trials in 2020:
    • Global, randomized, controlled confirmatory Phase 1b/3 trial assessing the combination of TAZVERIK plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES patients;
    • Global randomized, controlled confirmatory Phase 1b/3 trial assessing TAZVERIK in combination with “R2” (Revlimid® plus rituximab) compared with R2 plus placebo in the second-line FL treatment setting; and
    • Global randomized, controlled Phase 1b/2 clinical trial in chemo-naïve patients with metastatic castration-resistant prostate cancer, assessing tazemetostat with enzalutamide or with abiraterone, standard treatments for this patient population.
  • Additional Investigator-Sponsored Trials Advancing: Epizyme is supporting a number of investigator-sponsored studies assessing tazemetostat in multiple combinations, including in front-line and relapsed/refractory treatment settings for FL.
  • In response to the ongoing redacted redacted, Epizyme has activated business continuity plans to allow for the continued advancement of TAZVERIK commercialization, tazemetostat clinical development expansion and the company’s early pipeline, which are designed to minimize disruptions and protect the safety of its employees.

I have moved from being a strong bull to a bear-neutral on . However, now that the company has settled down into a post-approval slog mode, it may be worth our while to buy the stock at major dips, because, now that a revenue stream is started, with other label expansions ahead, these dips could be temporary.