Press Releases
Epizyme Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results
Total Revenue of
TAZVERIK® Net Revenues of
Safety Run-In Portion of Confirmatory Trials of TAZVERIK® in ES and FL and Phase 1b Portion of Phase 1b/2 Castration-Resistant Prostate Cancer Fully Enrolled; Initial Safety & Activity Data Expected in 2021
Strong Balance Sheet with Approximately
Conference Call Today,
“Epizyme cemented its position as a leader in epigenetics in 2020, with back-to-back accelerated approvals for TAZVERIK, the first and only FDA-approved EZH2 inhibitor. Following the approvals, we quickly reached epithelioid sarcoma and follicular lymphoma patients in need, adapting our physician and patient outreach efforts to meet the unique challenges presented by the evolving COVID-19 pandemic,” said
Recent Progress
- Commercial Execution: TAZVERIK generated net product revenue in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) of
$4.5 million in the fourth quarter and$11.5 million for the full year 2020.Epizyme reported a month-over-month increase in new prescriptions for TAZVERIK throughout the fourth quarter, despite the resurgence of COVID-19 cases that continued to negatively impact ES and FL patient visits to physicians, new patient starts across all lines of treatment as well as the ability of our field-based teams to fully access ES and FL prescribers. New accounts prescribing increased 50%, compared to the third quarter, including broader adoption among community practices. - NCCN Clinical Practice Guidelines Update Supports TAZVERIK: In
February 2021 , the NCCN Clinical Practice Guidelines in Oncology were amended to recommend TAZVERIK for relapsed/refractory FL patients with no satisfactory treatment options and whose EZH2 status is unknown. This revised recommendation reinforces the lack of requirement for EZH2 testing in the decision to prescribe TAZVERIK, consistent with the current TAZVERIK label and Epizyme’s physician education efforts. - ES and FL Confirmatory Trials: The safety run-in portions of both the ES and FL confirmatory trials with TAZVERIK are both fully enrolled and the efficacy expansion portions of both trials remain on track for initiation in early 2021. The ES confirmatory trial is evaluating TAZVERIK in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES. The FL confirmatory trial is evaluating TAZVERIK in combination with “R2” (Revlimid® plus Rituxan®) compared with R2 plus placebo in the second-line treatment setting in patients with FL.
- Tazemetostat Program Expansion: Progress around the clinical development of tazemetostat to investigate therapeutic potential in earlier lines of therapy for FL and opportunities in new solid tumor indications, including prostate cancer, continues. Patient enrollment also continues in several collaborative studies, including the
Lymphoma Study Association (LYSA) trial in front-line Diffuse Large B-cell Lymphoma (DLBCL) and FL, and in investigator sponsored trials. - Presented Four Posters from the FL Development Program at the 62nd
American Society of Hematology (ASH) Annual Meeting & Exposition, including: tazemetostat versus PI3-Kinases in patients with relapsed/refractory follicular lymphoma, tazemetostat or placebo plus lenalidomide and rituximab in patients with relapsed/refractory follicular lymphoma, single-agent tazemetostat as third-line therapy in patients with relapsed or refractory follicular lymphoma to identify predictors of response and tazemetostat in combination with rituximab for the treatment of relapsed or refractory follicular lymphoma. - Leadership Update: In
February 2021 , Dr.Shefali Agarwal was promoted to Executive Vice President and Chief Medical and Development Officer ofEpizyme . This move expandsDr. Agarwal's breadth of leadership in all stages of development and in the regulatory advancement of tazemetostat andEpizyme's early clinical-stage and emerging research-stage compounds.
Fourth Quarter and Full Year 2020 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$373.6 million as ofDecember 31, 2020 , as compared to$381.1 million as ofDecember 31, 2019 . - Revenue: Total revenue for the fourth quarter of 2020 was
$8.4 million , compared to$4.3 million for the fourth quarter of 2019. Total revenue for the full year endedDecember 31, 2020 was$15.8 million , comprised of$11.5 million in net sales of TAZVERIK in theU.S. and$4.3 million in collaboration revenue, of which$3.9 million relates to deferred revenue that was recognized as a result of termination of a collaboration agreement with Celgene. This is compared to total revenue of$23.8 million for the full year endedDecember 31, 2019 , all of which was collaboration revenue. - Operating Expenses: Total GAAP operating expenses were
$70.5 million for the fourth quarter of 2020 and$241.2 million for the full year endedDecember 31, 2020 , compared to$61.8 million for the fourth quarter of 2019 and$200.9 million for the full year endedDecember 31, 2019 . Total non-GAAP adjusted operating expenses were$62.8 million for the fourth quarter of 2020 and$209.6 million for the full year endedDecember 31, 2020 , compared to$55.2 million for the fourth quarter of 2019 and$162.2 million for the full year endedDecember 31, 2019 .- Cost of product revenue: GAAP cost of product revenue was
$1.8 million for the fourth quarter of 2020 and$5.1 million for the full year endedDecember 31, 2020 , which reflects the costs of TAZVERIK units sold, amortization of intangible assets and third-party royalties on net product revenue. Non-GAAP adjusted cost of product revenue was$0.8 million for the fourth quarter of 2020 and$2.1 million for the full year endedDecember 31, 2020 . - R&D expenses: GAAP R&D expenses were
$33.7 million for the fourth quarter of 2020 and$110.9 million for the full year endedDecember 31, 2020 , compared to$38.3 million for the fourth quarter of 2019 and$132.6 million for the full year endedDecember 31, 2019 . Non-GAAP adjusted R&D expenses were$31.5 million for the fourth quarter of 2020 and$101.3 million for the full year endedDecember 31, 2020 , compared to$35.8 million for the fourth quarter of 2019 and$105.8 million for the full year endedDecember 31, 2019 . - SG&A expenses: GAAP SG&A expenses were
$35.0 million for the fourth quarter of 2020 and$125.2 million for the full year endedDecember 31, 2020 , compared to$23.5 million for the fourth quarter of 2019 and$68.3 million for the full year endedDecember 31, 2019 . Non-GAAP adjusted SG&A expenses were$30.5 million for the fourth quarter of 2020 and$106.2 million for the full year endedDecember 31, 2020 , compared to$19.4 million for the fourth quarter of 2019 and$56.4 million for the full year endedDecember 31, 2019 .
- Cost of product revenue: GAAP cost of product revenue was
- Net Loss (GAAP): Net loss attributable to common stockholders was
$66.2 million , or$0.65 per share, for the fourth quarter of 2020 and$231.7 million , or$2.29 per share, for the full year endedDecember 31, 2020 , compared to$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 .
2021 Financial Guidance
- Based on its current operating plans,
Epizyme expects its current cash runway to extend into 2023. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between$235 and$255 million . - A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
Conference Call Information
About Non-GAAP Financial Measures
In addition to financial information prepared in accordance with the
About TAZVERIK
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
- Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
- Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
View the
About
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
TAZVERIK® is a registered trademark of
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) | ||||||||
(Amounts in thousands) | ||||||||
2020 |
2019 |
|||||||
Consolidated Balance Sheet Data: | ||||||||
Cash and cash equivalents |
$ |
168,215 |
$ |
139,482 |
||||
Marketable securities |
|
205,391 |
|
241,605 |
||||
Intangible, net |
|
47,002 |
|
— |
||||
Total assets |
|
473,573 |
|
424,589 |
||||
Total current liabilities |
|
43,400 |
|
34,386 |
||||
Deferred revenue |
|
- |
|
3,806 |
||||
Related party long-term debt, net of debt discount |
|
215,670 |
|
23,309 |
||||
Related party liability related to sale of future royalties |
|
14,176 |
|
12,793 |
||||
Total stockholders’ equity |
|
184,897 |
|
331,137 |
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||||||||||
(Amounts in thousands except per share data) | |||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||
2020 |
2019 |
2020 |
2019 |
||||||||||||||||
Revenues | |||||||||||||||||||
Product revenue, net |
$ |
4,506 |
|
$ |
- |
|
$ |
11,469 |
|
$ |
- |
|
|||||||
Collaboration revenue |
|
3,869 |
|
|
4,294 |
|
|
4,293 |
|
|
23,800 |
|
|||||||
Total revenue |
|
8,375 |
|
|
4,294 |
|
|
15,762 |
|
|
23,800 |
|
|||||||
Operating expenses | |||||||||||||||||||
Cost of product revenue |
|
1,823 |
|
|
- |
|
|
5,067 |
|
|
- |
|
|||||||
Research and development |
|
33,680 |
|
|
38,257 |
|
|
110,933 |
|
|
132,639 |
|
|||||||
Selling, general and administrative |
|
35,017 |
|
|
23,530 |
|
|
125,178 |
|
|
68,303 |
|
|||||||
Total operating expenses |
|
70,520 |
|
|
61,787 |
|
|
241,178 |
|
|
200,942 |
|
|||||||
Operating loss |
|
(62,145 |
) |
|
(57,493 |
) |
|
(225,416 |
) |
|
(177,142 |
) |
|||||||
Other income, net: | |||||||||||||||||||
Interest (expense) income, net |
|
(3,505 |
) |
|
1,320 |
|
|
(4,682 |
) |
|
7,110 |
|
|||||||
Other expense, net |
|
6 |
|
|
21 |
|
|
(99 |
) |
|
(13 |
) |
|||||||
Related party non-cash interest expense related to sale of future royalties |
|
(475 |
) |
|
(192 |
) |
|
(1,383 |
) |
|
(192 |
) |
|||||||
Other (expense) income, net: |
|
(3,974 |
) |
|
1,149 |
|
|
(6,164 |
) |
|
6,905 |
|
|||||||
Loss before income taxes |
|
(66,119 |
) |
|
(56,344 |
) |
|
(231,580 |
) |
|
(170,237 |
) |
|||||||
Income provision |
|
(114 |
) |
|
(58 |
) |
|
(114 |
) |
|
(58 |
) |
|||||||
Net loss |
$ |
(66,233 |
) |
$ |
(56,402 |
) |
$ |
(231,694 |
) |
$ |
(170,295 |
) |
|||||||
|
|
|
|
|
|
|
|
||||||||||||
Reconciliation of net loss to net loss attributable to common stockholders | |||||||||||||||||||
Net loss |
$ |
(66,233 |
) |
$ |
(56,402 |
) |
$ |
(231,694 |
) |
$ |
(170,295 |
) |
|||||||
Accretion of convertible preferred stock |
|
- |
|
|
- |
|
|
- |
|
|
(2,940 |
) |
|||||||
Net loss attributable to common stockholders |
$ |
(66,233 |
) |
$ |
(56,402 |
) |
$ |
(231,694 |
) |
$ |
(173,235 |
) |
|||||||
Net loss per share attributable to common stockholders - basic and diluted |
$ |
(0.65 |
) |
$ |
(0.59 |
) |
$ |
(2.29 |
) |
$ |
(1.93 |
) |
|||||||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted |
|
101,596 |
|
|
95,074 |
|
|
100,960 |
|
|
89,891 |
|
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (UNAUDITED) | |||||||||||||||||||
(Amounts in thousands) | |||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Cost of Product Revenue |
2020 |
2019 |
2020 |
2019 |
|||||||||||||||
GAAP Cost of Product Revenue |
$ |
1,823 |
|
$ |
- |
|
$ |
5,067 |
|
$ |
- |
|
|||||||
Less: Depreciation and Amortization |
|
(1,038 |
) |
|
- |
|
|
(2,998 |
) |
|
- |
|
|||||||
Non-GAAP Adjusted Cost of Product Revenue |
$ |
785 |
|
$ |
- |
|
$ |
2,069 |
|
$ |
- |
|
|||||||
Reconciliation of GAAP to |
|||||||||||||||||||
$ |
33,680 |
|
$ |
38,257 |
|
$ |
110,933 |
|
$ |
132,639 |
|
||||||||
Less: Stock-Based Compensation Expenses |
|
(2,049 |
) |
|
(2,294 |
) |
|
(9,093 |
) |
|
(6,195 |
) |
|||||||
Less: Depreciation and Amortization |
|
(148 |
) |
|
(146 |
) |
|
(557 |
) |
|
(609 |
) |
|||||||
Less: Eisai R&D Milestone Expense |
|
- |
|
|
- |
|
|
- |
|
|
(20,000 |
) |
|||||||
$ |
31,483 |
|
$ |
35,817 |
|
$ |
101,283 |
|
$ |
105,835 |
|
||||||||
Reconciliation of GAAP to Non-GAAP Selling, General and Administrative: | |||||||||||||||||||
GAAP Selling, General and Administrative |
$ |
35,017 |
|
$ |
23,530 |
|
$ |
125,178 |
|
$ |
68,303 |
|
|||||||
Less: Stock-Based Compensation Expenses |
|
(4,372 |
) |
|
(4,106 |
) |
|
(18,516 |
) |
|
(11,721 |
) |
|||||||
Less: Depreciation and Amortization |
|
(124 |
) |
|
(68 |
) |
|
(429 |
) |
|
(231 |
) |
|||||||
Non-GAAP Adjusted Selling, General and Administrative |
$ |
30,521 |
|
$ |
19,356 |
|
$ |
106,233 |
|
$ |
56,351 |
|
|||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | |||||||||||||||||||
GAAP Operating Expenses |
$ |
70,520 |
|
$ |
61,787 |
|
$ |
241,178 |
|
$ |
200,942 |
|
|||||||
Less: Stock-Based Compensation Expenses |
|
(6,421 |
) |
|
(6,400 |
) |
|
(27,609 |
) |
|
(17,916 |
) |
|||||||
Less: Depreciation and Amortization |
|
(1,310 |
) |
|
(214 |
) |
|
(3,984 |
) |
|
(840 |
) |
|||||||
Less: Eisai R&D Milestone Expense |
|
- |
|
|
- |
|
|
- |
|
|
(20,000 |
) |
|||||||
Non-GAAP Adjusted Operating Expenses |
$ |
62,789 |
|
$ |
55,173 |
|
$ |
209,585 |
|
$ |
162,186 |
|
|||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20210223005109/en/
Media:
Media@epizyme.com
(617) 500-0615
Investors:
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