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Epizyme (EPZM) Q4 Loss Wider Than Expected, Revenues Lag
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Epizyme, Inc. incurred a loss of 49 cents per share for fourth-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 41 cents but narrower than the year-ago period’s loss of 65 cents.
Total revenues for the fourth quarter were $11.6 million, which missed the Zacks Consensus Estimate of $23.4 million but increased from the year-ago quarter’s $8.4 million.
Shares of Epizyme’s have plunged 36.4% so far this year compared with the industry’s 16.2% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Tazverik (tazemetostat) 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 for Tazverik for two distinct follicular lymphoma (FL) indications.
The drug generated net product revenues worth $11.6 million in the fourth quarter from commercial sales in ES and FL. Total end-user demand grew 14% sequentially, driven primarily by FL patient sales.
Adjusted research and development expenses declined to $26.6 million from $31.5 million in the year-ago quarter. Selling, general and administrative expenses also declined to $25.9 million from $30.5 million in the prior-year quarter.
Epizyme had $176.8 million of cash, cash equivalents, and marketable securities as of Dec 31, 2021 compared with $221.3 million on Sep 30, 2021.
Full-Year 2021 Results
The company incurred a loss of $2.45 per share for 2021, wider than the Zacks Consensus Estimate of a loss of $2.37 and the year-ago loss of $2.29.
Revenues were $37.4 million for 2021, which missed the Zacks Consensus Estimate of $55.3 million but increased from the year-ago figure of $15.8 million.
2022 Guidance
EPZM announced plans to lower headcount by approximately 12%, resulting in estimated severance and termination costs of $2.8-$3.2 million.
The company expects adjusted operating expenses for 2022 between $160 million and $180 million, down from the earlier guidance of $170-$190 million provided this January.
Based on the reduced expectations and considering the amount raised by Epizyme from a secondary issue of equity shares earlier this year, it expects its cash runway to extend to third-quarter 2023.
Pipeline Update
Since the FDA approval for Tazverik to treat both indications is under an accelerated pathway, the company is also conducting confirmatory studies for ES and FL with Tazverik. A phase Ib/III confirmatory study (EZH-301) is evaluating Tazverik in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES.
During the fourth quarter, the company initiated a phase Ib/II basket study, EZH-1501, to evaluate the safety and efficacy of tazemetostat across multiple new types of hematological malignancies. The company has already initiated a bispecific cohort of the study evaluating a combination of tazemetostat with Roche’s (RHHBY - Free Report) mosunetuzumab in patients with R/R FL who have received two or more prior lines of therapy. Preliminary data from the study is expected in second-half 2022.
Please note that mosunetuzumab is Roche’s investigational CD20xCD3 T-cell engaging bispecific antibody. The company has entered into a clinical supply agreement with Roche for the bispecific cohort of the EZH-1501 study.
Our Take
Epizyme’s performance for the fourth quarter was dismal. Nevertheless, management’s efforts to increase the commercial adoption of Tazverik are encouraging. The successful development of tazemetostat in additional indications should increase the prospects of the drug. The company also has multiple pipeline readouts in 2022.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 0.9%.
Arvinas’ loss per share estimates for 2022 have narrowed from $3.23 to $3.19 in the past 30 days. The same for 2023 has narrowed from $3.89 to $3.82 in the past 30 days. Earnings of Arvinas missed estimates in each of the last four quarters, with the average negative surprise being 47.9%.
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Epizyme (EPZM) Q4 Loss Wider Than Expected, Revenues Lag
Epizyme, Inc. incurred a loss of 49 cents per share for fourth-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 41 cents but narrower than the year-ago period’s loss of 65 cents.
Total revenues for the fourth quarter were $11.6 million, which missed the Zacks Consensus Estimate of $23.4 million but increased from the year-ago quarter’s $8.4 million.
Shares of Epizyme’s have plunged 36.4% so far this year compared with the industry’s 16.2% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Tazverik (tazemetostat) 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 for Tazverik for two distinct follicular lymphoma (FL) indications.
The drug generated net product revenues worth $11.6 million in the fourth quarter from commercial sales in ES and FL. Total end-user demand grew 14% sequentially, driven primarily by FL patient sales.
Adjusted research and development expenses declined to $26.6 million from $31.5 million in the year-ago quarter. Selling, general and administrative expenses also declined to $25.9 million from $30.5 million in the prior-year quarter.
Epizyme had $176.8 million of cash, cash equivalents, and marketable securities as of Dec 31, 2021 compared with $221.3 million on Sep 30, 2021.
Full-Year 2021 Results
The company incurred a loss of $2.45 per share for 2021, wider than the Zacks Consensus Estimate of a loss of $2.37 and the year-ago loss of $2.29.
Revenues were $37.4 million for 2021, which missed the Zacks Consensus Estimate of $55.3 million but increased from the year-ago figure of $15.8 million.
2022 Guidance
EPZM announced plans to lower headcount by approximately 12%, resulting in estimated severance and termination costs of $2.8-$3.2 million.
The company expects adjusted operating expenses for 2022 between $160 million and $180 million, down from the earlier guidance of $170-$190 million provided this January.
Based on the reduced expectations and considering the amount raised by Epizyme from a secondary issue of equity shares earlier this year, it expects its cash runway to extend to third-quarter 2023.
Pipeline Update
Since the FDA approval for Tazverik to treat both indications is under an accelerated pathway, the company is also conducting confirmatory studies for ES and FL with Tazverik. A phase Ib/III confirmatory study (EZH-301) is evaluating Tazverik in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES.
During the fourth quarter, the company initiated a phase Ib/II basket study, EZH-1501, to evaluate the safety and efficacy of tazemetostat across multiple new types of hematological malignancies. The company has already initiated a bispecific cohort of the study evaluating a combination of tazemetostat with Roche’s (RHHBY - Free Report) mosunetuzumab in patients with R/R FL who have received two or more prior lines of therapy. Preliminary data from the study is expected in second-half 2022.
Please note that mosunetuzumab is Roche’s investigational CD20xCD3 T-cell engaging bispecific antibody. The company has entered into a clinical supply agreement with Roche for the bispecific cohort of the EZH-1501 study.
Our Take
Epizyme’s performance for the fourth quarter was dismal. Nevertheless, management’s efforts to increase the commercial adoption of Tazverik are encouraging. The successful development of tazemetostat in additional indications should increase the prospects of the drug. The company also has multiple pipeline readouts in 2022.
Epizyme, Inc. Price
Epizyme, Inc. price | Epizyme, Inc. Quote
Zacks Rank & Other Stocks to Consider
Epizyme currently has a Zacks Rank #2 (Buy). Other top-ranked stocks in the overall healthcare sector include Adaptimmune Therapeutics and Arvinas (ARVN - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 0.9%.
Arvinas’ loss per share estimates for 2022 have narrowed from $3.23 to $3.19 in the past 30 days. The same for 2023 has narrowed from $3.89 to $3.82 in the past 30 days. Earnings of Arvinas missed estimates in each of the last four quarters, with the average negative surprise being 47.9%.