Epizyme Inc. (EPZM - Free Report) incurred a loss of 53 cents per share in the second quarter of 2019, in line with the Zacks Consensus Estimate but wider than the year-ago loss of 42 cents.
Quarter in Detail
With its lead candidate still under FDA’s review, the company relies on collaborators for revenue. Collaboration revenues in the second quarter of 2019, earned as part of the company’s alliance with Boehringer Ingelheim, were $5.9 million compared with $12.0 million in the second quarter of 2018. Revenues beat the Zacks Consensus Estimate of $1 million.
Research and development (R&D) expenses increased 30.7% year over year to $40.9 million in the quarter. This increase was primarily due to a $10-million development milestone paid to Eisai for the submission of the new drug application (NDA) for its lead pipeline candidate, tazemetostat, in the second quarter of 2019.
General and administrative (G&A) expenses were $15.7 million in the quarter, up 44% from the year-ago period due to increased pre-commercialization activities and staffing, and increased personnel-related expenses.
Epizyme had $331 million of cash, cash equivalents and marketable securities as of Jun 30, 2019, compared with $240.3 million as of Dec 31, 2018. The company expects its cash runway to extend into the first quarter of 2021.
Shares of the company have risen 86.7% year to date against the industry’s decline of 0.8%.
Epizyme’s NDA for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma (ES), who are not eligible for curative surgery, was accepted by the FDA for priority review during the second quarter. The FDA is expected to give its decision on Jan 23, 2020.
The company also plans to submit an NDA for accelerated approval of tazemetostat for patients with follicular lymphoma (FL), regardless of their EZH2 mutational status, who have been previously treated with two or more systemic therapies. The company expects to submit the NDA for accelerated approval in the fourth quarter of 2019.
Epizyme is planning to initiate multiple clinical studies to evaluate tazemetostat in earlier treatment lines of follicular lymphoma, and explore new combinations and potential indications in both FL and solid tumors.
Zacks Rank & Other Stocks to Consider
Epizyme currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks are Acorda Therapeutics Inc. (ACOR - Free Report) , BeiGene, Ltd. (BGNE - Free Report) and Eton Pharmaceuticals, Inc. (ETON - Free Report) . All of them carry Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $3.59 to $2.74 for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 69.68%.
BeiGene’s loss per share estimates have narrowed from $13.16 to $12.80 for 2019 and from $12.30 to $12.03 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average being 5.00%.
Eton Pharmaceuticals’ loss per share estimates have narrowed from $1.41 to $1.04 for 2019 and from $1.03 to 50 cents for 2020 in the past 60 days.
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