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Epizyme, Inc. incurred a loss of 63 cents per share in second-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 60 cents and the year-ago quarter’s loss of 58 cents.
Total revenues in the second quarter were $13 million, which beat the Zacks Consensus Estimate of $8.7 million and considerably increased from the year-ago quarter’s revenues of $2.5 million.
Shares of the company fell 9.4% on Aug 9. Investors were most likely disappointed with the wider-than-expected loss. Another discouraging factor can be the departure of the company’s CEO Robert Bazemore, effective Aug 9, 2021.
It was a challenging quarter for the company as recovery was slower than expected. The fall in share price can be attributed to the revisions in the company’s commercial strategy and its operating plan to accelerate the adoption of its only marketable drug Tazverik.
Consequently, shares of Epizyme’s have plunged 46% so far this year against the industry’s growth of 1.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Tazverik received an 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 $8 million in the second quarter pertaining to both ES and FL, up 29%, sequentially. Collaboration revenues in relation to Epizyme’s supply agreement with Japan partner Eisai stood at $5 million during the quarter.
The company reported a decrease in new prescriptions for Tazverik throughout the second quarter from the pre-COVID levels. While patient demand grew 3% from the first-quarter 2021-level, net revenues were negatively impacted by an increase in PAP utilization. Moreover, the COVID-19 pandemic continued to affect 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 $32.7 million, up 39.5% year over year while selling, general and administrative expenses increased to $29.1 million, up 7.4% year over year.
Epizyme had $244 million of cash, cash equivalents and marketable securities as of Jun 30, 2021 compared with $298.9 million as of Mar 31, 2021. The company expects its current cash runway to extend to fourth-quarter 2022.
Pipeline Update
In the second quarter, Epizyme received clearances from the FDA for its investigational new drug (IND) application filed to evaluate Tazverik’s safety and efficacy across multiple solid tumors in the EZH-1301 basket study.
The company also received an IND clearance from the FDA for its novel SETD2 inhibitor EZM-0414 as a potential treatment of multiple myeloma and other B-cell malignancies, such as Large-cell Lymphoma, both as a monotherapy and in combination with the existing and emerging therapies including Tazverik.
The FL confirmatory study is evaluating Tazverik in combination with R2, which is the combination of Bristol Myers Squibb’s (BMY - Free Report) Revlimid and Roche’s (RHHBY - Free Report) Rituxan compared with R2 plus placebo for treating relapsed / refractory FL patients. During the second quarter, the company completed enrollment for all phase Ib cohorts in the phase Ib/III study.
In August 2021, Epizyme announced its collaboration with HutchMed to research, develop, manufacture and commercialize Tazverik in Greater China.
Other Updates
Following the challenging environment looming over the launch of Tazverik, the company reworked its commercial strategy and its operating plan to expedite the drug’s uptake and deepen its focus on investing in value-driving activities. The changes also include refinement of the current field organization, aligned with an updated strategy to improve customer access and the acceptance of Tazverik.
The new operating plan also achieved reduction in the company’s personnel costs including lower headcount and a decrease in external spending across other areas of the business. The company anticipates benefiting from these adjustments in the third quarter of 2021.
Epizyme currently has a Zacks Rank #3 (Hold). Another better-ranked stock in the same sector is Horizon Therapeutics , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.05 in the past 30 days. The same for 2022 has risen from $5.18 to $5.64 over the same period. The stock has rallied 43.7% in the year so far.
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Epizyme's (EPZM) Q2 Earnings Miss, Revenues Beat Estimates
Epizyme, Inc. incurred a loss of 63 cents per share in second-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 60 cents and the year-ago quarter’s loss of 58 cents.
Total revenues in the second quarter were $13 million, which beat the Zacks Consensus Estimate of $8.7 million and considerably increased from the year-ago quarter’s revenues of $2.5 million.
Shares of the company fell 9.4% on Aug 9. Investors were most likely disappointed with the wider-than-expected loss. Another discouraging factor can be the departure of the company’s CEO Robert Bazemore, effective Aug 9, 2021.
It was a challenging quarter for the company as recovery was slower than expected. The fall in share price can be attributed to the revisions in the company’s commercial strategy and its operating plan to accelerate the adoption of its only marketable drug Tazverik.
Consequently, shares of Epizyme’s have plunged 46% so far this year against the industry’s growth of 1.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Tazverik received an 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 $8 million in the second quarter pertaining to both ES and FL, up 29%, sequentially. Collaboration revenues in relation to Epizyme’s supply agreement with Japan partner Eisai stood at $5 million during the quarter.
The company reported a decrease in new prescriptions for Tazverik throughout the second quarter from the pre-COVID levels. While patient demand grew 3% from the first-quarter 2021-level, net revenues were negatively impacted by an increase in PAP utilization. Moreover, the COVID-19 pandemic continued to affect 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 $32.7 million, up 39.5% year over year while selling, general and administrative expenses increased to $29.1 million, up 7.4% year over year.
Epizyme had $244 million of cash, cash equivalents and marketable securities as of Jun 30, 2021 compared with $298.9 million as of Mar 31, 2021. The company expects its current cash runway to extend to fourth-quarter 2022.
Pipeline Update
In the second quarter, Epizyme received clearances from the FDA for its investigational new drug (IND) application filed to evaluate Tazverik’s safety and efficacy across multiple solid tumors in the EZH-1301 basket study.
The company also received an IND clearance from the FDA for its novel SETD2 inhibitor EZM-0414 as a potential treatment of multiple myeloma and other B-cell malignancies, such as Large-cell Lymphoma, both as a monotherapy and in combination with the existing and emerging therapies including Tazverik.
The FL confirmatory study is evaluating Tazverik in combination with R2, which is the combination of Bristol Myers Squibb’s (BMY - Free Report) Revlimid and Roche’s (RHHBY - Free Report) Rituxan compared with R2 plus placebo for treating relapsed / refractory FL patients. During the second quarter, the company completed enrollment for all phase Ib cohorts in the phase Ib/III study.
In August 2021, Epizyme announced its collaboration with HutchMed to research, develop, manufacture and commercialize Tazverik in Greater China.
Other Updates
Following the challenging environment looming over the launch of Tazverik, the company reworked its commercial strategy and its operating plan to expedite the drug’s uptake and deepen its focus on investing in value-driving activities. The changes also include refinement of the current field organization, aligned with an updated strategy to improve customer access and the acceptance of Tazverik.
The new operating plan also achieved reduction in the company’s personnel costs including lower headcount and a decrease in external spending across other areas of the business. The company anticipates benefiting from these adjustments in the third quarter of 2021.
Epizyme, Inc. Price
Epizyme, Inc. price | Epizyme, Inc. Quote
Zacks Rank& Stocks to Consider
Epizyme currently has a Zacks Rank #3 (Hold). Another better-ranked stock in the same sector is Horizon Therapeutics , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.05 in the past 30 days. The same for 2022 has risen from $5.18 to $5.64 over the same period. The stock has rallied 43.7% in the year so far.