Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today provided business and pipeline updates and reported fourth quarter and full year 2019 financial results.
"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."
Recent Progress
2020 Company Priorities
Epizyme has outlined the following key milestones for 2020:
Epithelioid Sarcoma
Follicular Lymphoma
Additional Indications
Epizyme plans to explore the utility of tazemetostat in additional indications, as a monotherapy and in combinations, through in-house efforts, investigator-sponsored studies and clinical collaborations. Based on scientific hypotheses and unmet need, these areas include:
Preclinical Pipeline
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.
Fourth Quarter and Full Year 2019 Financial Results
Conference Call Information
Epizyme will host a conference call today, Feb. 24, at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 9045277. A live webcast and slides will be available in the investor section of the company's website at www.epizyme.com, and will be archived for 60 days following the call and presentation.
About TAZVERIK
TAZVERIKtm (tazemetostat) is the first EZH2 inhibitor approved by the U.S. Food and Drug Administration (FDA). TAZVERIKtm is an enhancer of zeste homolog 2 (EZH2) methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). For more information, visit TAZVERIK.com.
About Epizyme, Inc.
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIKtm (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether tazemetostat will receive marketing approval for epithelioid sarcoma in other jurisdictions, full approval in the United States or approval in any other indication; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials, such as the ongoing confirmatory trial; whether results from clinical studies will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process; expectations for regulatory approvals, including accelerated approval, to conduct trials or to market products; whether the company's cash resources will be sufficient to fund the company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial success of tazemetostat or the company's therapeutic candidates; and other factors discussed in the "Risk Factors" section of the company's most recent Form 10-Q filed with the SEC and in the company's other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date hereof and should not be relied upon as representing the company's views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
TAZVERIKtm is a trademark of Epizyme, Inc.
EPIZYME, INC. |
||||||
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) |
||||||
(Amounts in thousands ) |
||||||
December 31,
|
December 31,
|
|||||
Consolidated Balance Sheet Data: |
||||||
Cash and cash equivalents |
$ |
139,482 |
$ |
86,671 |
||
Marketable securities |
|
241,605 |
|
153,633 |
||
Total assets |
|
424,589 |
|
275,501 |
||
Total current liabilities |
|
34,386 |
|
37,833 |
||
Deferred revenue |
|
3,806 |
|
17,106 |
||
Long-term debt, net of debt discount |
|
23,309 |
? |
|||
Liability related to sale of future royalties |
|
12,793 |
? |
|||
Total stockholders' equity |
$ |
331,137 |
$ |
233,009 |
EPIZYME, INC. |
||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) |
||||||||||||
(Amounts in thousands except per share data) |
||||||||||||
Three Months Ended
|
Year Ended
|
|||||||||||
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
Collaboration revenue |
$ |
4,294 |
|
$ |
9,700 |
|
$ |
23,800 |
|
$ |
21,700 |
|
Operating expenses: |
||||||||||||
Research and development |
|
38,257 |
|
|
21,838 |
|
|
132,639 |
|
|
105,833 |
|
General and administrative |
|
23,530 |
|
|
12,170 |
|
|
68,303 |
|
|
43,972 |
|
Total operating expenses |
|
61,787 |
|
|
34,008 |
|
|
200,942 |
|
|
149,805 |
|
Operating loss |
|
(57,493 |
) |
|
(24,308 |
) |
|
(177,142 |
) |
|
(128,105 |
) |
Other income, net: |
||||||||||||
Interest income, net |
|
1,320 |
|
|
1,420 |
|
|
7,110 |
|
|
4,557 |
|
Other income (expense), net |
|
21 |
|
? |
|
(13 |
) |
|
(25 |
) |
||
Non-cash interest expense related to sale of future royalties |
|
(192 |
) |
? |
|
(192 |
) |
? |
||||
Other income, net |
|
1,149 |
|
|
1,420 |
|
|
6,905 |
|
|
4,532 |
|
Loss before income taxes |
|
(56,344 |
) |
|
(22,888 |
) |
|
(170,237 |
) |
|
(123,573 |
) |
Income tax (provision) |
|
(58 |
) |
|
(57 |
) |
|
(58 |
) |
|
(57 |
) |
Net loss |
$ |
(56,402 |
) |
$ |
(22,945 |
) |
$ |
(170,295 |
) |
$ |
(123,630 |
) |
Other comprehensive income (loss): |
||||||||||||
Unrealized (loss) gain on available-for-sale securities |
|
(130 |
) |
|
(31 |
) |
|
73 |
|
|
(5 |
) |
Comprehensive loss |
$ |
(56,532 |
) |
$ |
(22,976 |
) |
$ |
(170,222 |
) |
$ |
(123,635 |
) |
Reconciliation of net loss to net loss attributable to common stockholders: |
||||||||||||
Net loss |
$ |
(56,402 |
) |
$ |
(22,945 |
) |
$ |
(170,295 |
) |
$ |
(123,630 |
) |
Accretion of convertible preferred stock |
? |
? |
|
(2,940 |
) |
? |
||||||
Net loss attributable to common stockholders |
$ |
(56,402 |
) |
$ |
(22,945 |
) |
$ |
(173,235 |
) |
$ |
(123,630 |
) |
Net loss per share attributable to common stockholders - basic and diluted |
$ |
(0.59 |
) |
$ |
(0.29 |
) |
$ |
(1.93 |
) |
$ |
(1.72 |
) |
Weighted-average common shares outstanding used in net loss per share attributable to
|
|
95,074 |
|
|
78,962 |
|
|
89,891 |
|
|
71,864 |
|
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