Epizyme (EPZM) Misses Q2 EPS by 9c, Revenues Beat

Epizyme (NASDAQ: EPZM) reported Q2 EPS of ($0.59), $0.09 worse than the analyst estimate of ($0.50). Revenue for the quarter came in at $4.29 million versus the consensus estimate of $3.08 million.

Fourth Quarter and Full Year 2019 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $381.1 million as of December 31, 2019, as compared to $240.3 million as of December 31, 2018.
• Revenue: Collaboration revenue for the fourth quarter of 2019 was $4.3 million and $23.8 million for the full year ended December 31, 2019, compared to collaboration revenue of $9.7 million for the fourth quarter of 2018 and $21.7 million for the full year ended December 31, 2018. The increase reflects the recognition of revenue for services performed under the company’s multi-target research collaboration with Boehringer Ingelheim offset by development milestones with GlaxoSmithKline achieved in 2018 for its PRMT1 and PRMT 5 inhibitors, which were invented at Epizyme.
• R&D Expenses: Research and development (R&D) expenses were $38.3 million for the fourth quarter of 2019 and $132.6 million for the full year ended December 31, 2019, compared to $21.8 million for the fourth quarter of 2018 and $105.8 million for the full year ended December 31, 2018. The increase is due to the initiation of the global confirmatory trials in ES and FL and early expansion of the tazemetostat program into new indications and combinations. The primary driver of the increase in R&D expenses for 2019 was the expense of $20 million in milestones paid to Eisai for the ES and FL NDA submissions. These milestones were funded through the loan facility provided by Pharmakon.
• G&A Expenses: General and administrative (G&A) expenses were $23.5 million for the fourth quarter of 2019 and $68.3 million for the full year ended December 31, 2019, compared to $12.2 million for the fourth quarter of 2018 and $44.0 million for the full year ended December 31, 2018. G&A expenses for 2019 included the buildout of the infrastructure to support the launch and commercialization of TAZVERIK for the ES indication, as well as initial expansion to prepare for FL commercialization in the US.
• Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $56.4 million, or $0.59 per share, for the fourth quarter of 2019 and $173.2 million, or $1.93 per share, for the full year ended December 31, 2019, compared to $22.9 million, or $0.29 per share, for the fourth quarter of 2018 and $123.6 million, or $1.72 per share, for the full year ended December 31, 2018.

“We began 2020 with the most meaningful milestone for the company to date – the accelerated approval of TAZVERIK, making it the first and only commercially available EZH2 inhibitor and the only approved product specifically indicated for epithelioid sarcoma patients. We executed a strong start to our commercial launch, in which we made TAZVERIK available to patients within one week of approval,” said Robert Bazemore, president and chief executive officer of Epizyme. “Following the acceptance of our sNDA filing for TAZVERIK for follicular lymphoma, we are preparing to quickly address the more prevalent FL patient population, if approved. In parallel, we are continuing our in-house and clinical collaboration efforts to demonstrate the full potential of tazemetostat for a range of cancer indications, with 12 trials underway and four more planned for initiation this year, making for a robust development expansion program.”

Financial Guidance

Based on its current operating plans, Epizyme expects its current cash runway to extend into at least 2022. Additionally, the company expects its GAAP operating expenses for 2020 to be between $300 and $330 million inclusive of the milestones due to Eisai for the FDA approval of TAVERIK for epithelioid sarcoma and for follicular lymphoma, if approved.

For earnings history and earnings-related data on Epizyme (EPZM) click here.

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