Press Releases
Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2019 Financial Results
TAZVERIK™ (tazemetostat) Commercial Launch Underway for Epithelioid Sarcoma
TAZVERIK sNDA for Follicular Lymphoma Accepted for Filing by FDA with Priority Review; PDUFA Target Action Date of
Expanding Future TAZVERIK Value through Clinical Development into New Combinations and Indications
Conference Call to be Held Today,
“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
Recent Progress
-
TAZVERIK Commercial Launch Underway in Epithelioid Sarcoma (ES) and Added to NCCN Clinical Practice Guidelines: TAZVERIK became commercially available to patients on
February 1, 2020 , following its accelerated approval onJanuary 23, 2020 , for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection. The approval was based on overall response rate and duration of response observed in a Phase 2 clinical trial. In addition, the National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma to include TAZVERIK as a recommended category 2A treatment for metastatic or locally advanced ES. The NCCN Guidelines are the recognized clinical standard for cancer care byU.S. healthcare providers and payers, and are maintained by a committee of expert physicians from leadingU.S. cancer centers. -
TAZVERIK sNDA Submission for Follicular Lymphoma (FL) Accepted for Filing with Priority Review: The
U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental NDA (sNDA) for filing for the accelerated approval of TAZVERIK for a proposed indication of patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy. The FDA granted Priority Review for the sNDA and has set a Prescription Drug User Fee Act (PDUFA) target action date ofJune 18, 2020 . The submission is based primarily on Phase 2 data, which demonstrated clinical benefit as assessed by both investigators and an Independent Review Committee (IRC) and a generally well-tolerated profile in this patient population, as presented at the 2019American Society of Hematology (ASH) Annual Meeting. -
Exercise of
$50 Million Put Option with Royalty Pharma Supports Runway into at least 2022: Pursuant to the terms of its agreements withRoyalty Pharma andPharmakon Advisors , inJanuary 2020 ,Epizyme exercised its option to sell$50 million of its common stock toRoyalty Pharma . The cash, cash equivalents and marketable securities as ofDecember 31, 2019 , together with the$50 million raised from the exercise of the put option, allowed the company to start 2020 with approximately$431 million , which will fund the current operating runway into at least 2022.
2020 Company Priorities
Epithelioid Sarcoma
- Optimize the commercial launch of TAZVERIK for ES to seamlessly expand to the FL opportunity, if approved;
- Complete the safety portion of the ongoing global, Phase 1b/3 confirmatory trial assessing TAZVERIK in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES, and advance into the efficacy portion of the trial.
Follicular Lymphoma
-
Gain FDA approval for and launch TAZVERIK for patients in the
U.S. with relapsed or refractory FL who have received at least two prior lines of systemic therapy; - Complete the safety portion of the ongoing global Phase 1b/3 confirmatory trial assessing TAZVERIK in combination with “R2” (Revlimid® plus Rituximab®) compared with R2 plus placebo in the second-line treatment setting and advance into the efficacy portion of the trial;
- Expand clinical investigation of tazemetostat in combination with R-CHOP in the high-risk front-line treatment setting for patients with FL; and
- Support the investigator-sponsored studies assessing tazemetostat in combination with rituximab, venetoclax and BTK inhibitors in the third-line and later FL treatment setting.
Additional Indications
- Hematological malignancies, such as lymphomas and other b-cell malignancies, in which EZH2 plays an important role in B cell biology;
- Mutationally defined solid tumors, such as chordoma, melanoma and tumors with a SWI/SNF alteration or other mutations;
- Metastatic castration-resistant prostate cancer;
- Solid tumors that are resistant to chemotherapy or PARP inhibitors, such as triple negative breast, small cell lung and ovarian cancers, as well as mesothelioma; and
- Solid tumors in which EHZ2 inhibition can augment the response to immune-oncology treatments.
Preclinical Pipeline
- Pursue additional development candidates for its preclinical programs.
Financial Guidance
Based on its current operating plans,
Fourth Quarter and Full Year 2019 Financial Results
-
Cash Position: Cash, cash equivalents and marketable securities were
$381.1 million as ofDecember 31, 2019 , as compared to$240.3 million as ofDecember 31, 2018 . -
Revenue: Collaboration revenue for the fourth quarter of 2019 was
$4.3 million and$23.8 million for the full year endedDecember 31, 2019 , compared to collaboration revenue of$9.7 million for the fourth quarter of 2018 and$21.7 million for the full year endedDecember 31, 2018 . The increase reflects the recognition of revenue for services performed under the company’s multi-target research collaboration withBoehringer Ingelheim offset by development milestones with GlaxoSmithKline achieved in 2018 for its PRMT1 and PRMT 5 inhibitors, which were invented atEpizyme . -
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 endedDecember 31, 2019 , compared to$21.8 million for the fourth quarter of 2018 and$105.8 million for the full year endedDecember 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 endedDecember 31, 2019 , compared to$12.2 million for the fourth quarter of 2018 and$44.0 million for the full year endedDecember 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 endedDecember 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 endedDecember 31, 2018 .
Conference Call Information
About TAZVERIK
TAZVERIK™ (tazemetostat) is the first EZH2 inhibitor approved by the
About
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
TAZVERIK™ is a trademark of
|
||||||
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) |
||||||
(Amounts in thousands ) |
||||||
|
|
|||||
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 |
|
||||||||||||
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 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200224005285/en/
Media:
media@epizyme.com
(617) 500-0615
Investors:
alicia@thrustsc.com
(910) 620-3302
Source:
Media:
Erin Graves, Epizyme, Inc.
media@epizyme.com
(617) 500-0615
Investors:
Alicia Davis, THRUST Strategic Communications
alicia@thrustsc.com
(910) 620-3302