Epizyme, Inc. EPZM suffered a loss of 38 cents per share in the first quarter of 2022, lower than the loss of 69 cents the previous year.
Adjusted loss (excluding gains on change in fair value of common stock warrants) for the first quarter was 39 cents, higher than Zacks consensus estimate of a loss of 35 cents, but narrower than the previous year’s loss of 69 cents.
Total revenue for the first quarter was $8.7 million, which fell short of Zacks’ consensus estimate of $10.9 million, but was up from the 7.6 million in the prior year quarter.
Shares of Epizyme have plunged 76.3% so far this year compared to the industry’s 26.3% decline.
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Quarter in detail
Tazverik (tazemetostat) received accelerated approval from the FDA in January 2020 to treat metastatic or locally advanced epithelioid sarcoma (ES). In June 2020, the regulator approved the Supplemental New Drug Application for Tazverik for two separate follicular lymphoma (FL) indications.
The drug generated net product revenue worth $8.7 million in the first quarter. Commercial sales of the drug were $8.1 million, which increased 10% sequentially.
Adjusted research and development expenses decreased to $27.8 million from $30.3 million in the prior year quarter. Selling, general and administrative expenses also decreased to $23.6 million from $31.5 million in the prior year quarter.
Epizyme had $199.7 million in cash, cash equivalents and marketable securities as of March 31, 2022, compared to $176.8 million as of December 31, 2021.
As FDA approval for Tazverik to treat both indications is fast tracked, Epizyme is also conducting confirmatory studies for ES and FL with Tazverik. A confirmatory Phase Ib/III study (EZH-301) is evaluating Tazverik in combination with doxorubicin versus doxorubicin plus placebo as a first-line treatment for ES.
Another confirmatory Phase Ib/III study (EZH-302, SYMPHONY-1) is evaluating Tazverik plus R2, in combination with Revlimid and Rituxan versus R2 plus placebo for the treatment of at least patients with FL of second line. While data from the Phase Ib study are expected later this year, Epizyme announced in March 2022 that it had administered the first patient in the Phase III study.
EPZM launched a phase Ib/II basket study, ARIA (EZH-1501), during the fourth quarter of 2021 to evaluate the safety and efficacy of tazemetostat in several new types of hematological malignancies. Epizyme has already initiated a bispecific study cohort evaluating a combination of tazemetostat with Roche’s RHHBY mosunetuzumab in patients with R/R FL who have received at least two prior lines of treatment. Preliminary data from the study is expected in the second half of 2022.
Mosunetuzumab is Roche’s investigational CD20xCD3 bispecific T-cell engaging antibody. Epizyme has entered into a clinical supply agreement with Roche for the bispecific cohort of the EZH-1501 study.
Epizyme’s performance for the first quarter was dismal. Nonetheless, management’s efforts to increase commercial adoption of Tazverik and develop tazemetostat for additional indications are encouraging. EPZM also has several pipeline reads in 2022.
Zacks Ranking and Stocks to Consider
Epizyme currently has a Zacks rank of #3 (Hold). Top-ranked stocks across the healthcare industry include Abeona Therapeutic ABEO and Alkermes ALKS. While Alkermes currently sports a Zacks Rank #1 (Strong Buy), Abeona Therapeutics carries a Zacks Rank #2 (Buy). You can see the full list of today’s Zacks #1 Rank stocks here.
Alkermes’ per-share loss estimates for 2022 have fallen from 14 cents to 3 cents in the past 30 days. ALKS shares are up 15.9% year-to-date.
Alkermes earnings have exceeded estimates in each of the past four quarters, averaging 350.5%. In the last reported quarter, Alkermes recorded a surprise profit of 1,100%.
Abeona Therapeutics’ per-share loss estimates for 2022 have fallen from 34 cents to 33 cents in the past 30 days. ABEO shares are down 52.5% since the start of the year.
Abeona Therapeutics has a mixed history of surprises, with its earnings beating expectations in one of the last four quarters, missing the mark in another and hitting the same mark on the other two occasions, with the average surprise being 0.7%. In the last reported quarter, Abeona Therapeutics missed earnings estimates by 7.7%.
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