Epizyme, Inc. ( EPZM Quick Quote EPZM - Free Report) incurred a loss of 64 cents per share in third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 45 cents and the year-ago quarter’s loss of 55 cents.
Total revenues in the third quarter were $5.2 million, which missed the Zacks Consensus Estimate of $9 million but increased from the year-ago quarter’s $3.6 million.
Shares were down 2.6% in response to the third-quarter results. Shares of Epizyme’s have plunged 54.6% so far this year compared with the
industry’s decline of 13.2%. Image Source: Zacks Investment Research 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, the regulatory body approved the supplemental new drug application (sNDA) for Tazverik for two distinct follicular lymphoma (FL) indications.
The drug generated net product revenues worth $5.2 million in the third quarter from commercial sales in ES and FL. Total end-user demand grew 22% sequentially driven primarily by FL patient sales.
Adjusted research and development expenses increased to $32.3 million from $23.5 million in the year-ago quarter while selling, general and administrative expenses increased to $28.5 million from $26.1 million.
The company lowered its headcount by 20%, resulting in estimated severance and termination costs of approximately $2 million. These charges were recorded in the third quarter.
Epizyme had $221.3 million of cash, cash equivalents, and marketable securities as of Sep 30, 2021, compared with $244 million as of Jun 30, 2021. The company expects its current cash runway to extend to fourth-quarter 2022.
In August 2021, Epizyme announced its collaboration with HutchMed to research, develop, manufacture, and commercialize Tazverik in Greater China.
The combination of tazemetostat with
Bristol Myers’ ( BMY Quick Quote BMY - Free Report) lenalidomide and Roche’s ( RHHBY Quick Quote RHHBY - Free Report) Rituxan (rituximab) is being evaluated in a phase Ib/III confirmatory study in R/R FL patients. The company is preparing for the initiation of the phase III portion of this study with its collaboration partner HutchMed. Epizyme plans to share updated data in approximately 40 patients from the phase Ib portion of the study at the upcoming meeting of the American Society of Hematology in December.
SYMPHONY-2 (EZH-1401), the phase II study evaluating tazemetostat plus Rituxan in relapsed or refractory (R/R) FL, continues to progress.
Epizyme’s novel first-in-class oral SETD2 inhibitor, EZM0414, has received Fast Track designation for diffuse large B-cell lymphoma (DLBCL) from the FDA, and the company is planning to enroll its first patient by the end of the year.
Epizyme received FDA clearance for its IND for EZH-1501, its hematology basket study, which will evaluate tazemetostat safety and efficacy across multiple hematological malignancies.
The company is also evaluating tazemetostat plus enzalutamide compared to enzalutamide alone in metastatic castration-resistant Prostate Cancer patients (mCRPC) in the CELLO-1 study. Based on the phase Ib data, Epizyme initiated enrollment in the phase II efficacy portion of the study, which is now approximately one-half enrolled toward a target of 80 patients.
Epizyme’s performance in the third quarter was disappointing. Nevertheless, management’s efforts to increase the commercial adoption of Tazverik are encouraging. The successful development of tazemetostat in additional indications should increase the growth prospects of the drug.
Epizyme currently has a Zacks Rank #2 (Buy). Another top-ranked stock in the biotech sector is
Alkermes ( ALKS Quick Quote ALKS - Free Report) which currently sports a Zacks Rank #1 (Strong Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Earnings estimates for Alkermes have moved up 7 cents for 2021 in the past 30 days. The stock is up 25.1% year to date.