Epizyme, Inc. ( EPZM Quick Quote EPZM - Free Report) incurred a loss of 69 cents per share in first-quarter 2021, which was wider than the Zacks Consensus Estimate of a loss of 56 cents and the year-ago quarter’s loss of 51 cents.
Total revenues in the first quarter were $7.6 million, which beat the Zacks Consensus Estimate of $7.1 million and considerably increased from the year-ago quarter’s revenues of $1.4 million.
Shares of Epizyme have plunged 37.3% so far this year compared with the
industry’s decrease of 6.8%. Quarter in Detail
Tazverik received accelerated approval from the FDA in January 2020 for the treatment of metastatic or locally advanced Epithelioid Sarcoma (“ES”). In June 2020, FDA approved the supplemental new drug application (sNDA) for Tazverik, for two distinct follicular lymphoma (“FL”) indications.
Tazverik generated net product revenues in both ES and FL of $6.2 million in the first quarter, reflecting a sequential increase of 37.7%.
The company reported a month-over-month increase in new prescriptions for Tazverik throughout the first quarter. However, during the quarter, the COVID-19 pandemic continued to negatively impact ES and FL patient visits to physicians, new patient starts across all lines of treatment and the ability of Epizyme’s field-based teams to fully access ES and FL prescribers.
Adjusted research and development expenses increased to $30.3 million from $22.9 million in the year-ago quarter, while selling, general and administrative expenses increased to $36.4 million from $27 million.
Epizyme had $298.9 million of cash, cash equivalents and marketable securities as of Mar 31, 2020, compared with $373.6 million as of Dec 31, 2020. The company expects its current cash runway to extend to 2023.
The safety run-in portions of both the ES and FL confirmatory studies with Tazverik are now fully enrolled. The ES confirmatory study is evaluating Tazverik in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES.
The FL confirmatory study is evaluating Tazverik in combination with R2, which is the combination of
Bristol Myers Squibb’s ( BMY Quick Quote BMY - Free Report) Revlimid plus Roche’s ( RHHBY Quick Quote RHHBY - Free Report) Rituxan, compared with R2 plus placebo for treating relapsed / refractory FL patients.
Meanwhile, Tazverik, in combination with standard of care treatments –Xtandi(enzalutamide) or Zytiga (abiraterone), is being evaluated in the phase Ib safety run-in portion of the EZH-1101 study for treating men with metastatic prostate cancer.
Notably, Tazverik, in both the FL and the prostate cancer study, has demonstrated encouraging preliminary safety and activity data.
Zacks Rank and Stock to Consider
Epizyme currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is
ASLAN Pharmaceuticals Limited ( ASLN Quick Quote ASLN - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
ASLAN Pharmaceuticals’ loss per share estimates have narrowed 26.3% for 2021 and 43.9% for 2022 over the past 60 days. The stock has surged 62.8% year to date.
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