Press Releases
Epizyme Reports Business Progress and First Quarter 2020 Financial Results
TAZVERIK™ Successfully Launched for First Approved Indication; PDUFA Date of
Business Continuity Plans in Place in Response to COVID-19
Conference Call to be Held Today,
“The first quarter of 2020 was significant for
COVID-19 Response
In response to the ongoing COVID-19 pandemic,
- Employee Safety and Remote Operations: A remote operating model for in-house and field-based employees was implemented in early March, with the exception of a small number of employees to continue critical lab and information technology operations.
- Patient Access to TAZVERIK:
Epizyme is leveraging a specialty pharmacy and specialty distributors to support seamless patient access, and currently expects to be able to provide an uninterrupted supply of TAZVERIK for commercial use and the company’s ongoing clinical trials. U.S. Commercialization:Epizyme is leveraging virtual personal and non-personal approaches to engage and reach customers.- Supporting Ongoing Clinical Trials:
Epizyme is working with clinical trial sites and clinical research organizations to implement virtual capabilities for site initiations and trial monitoring, as well as alternative methods to assist with patient participation.
Recent Progress
- TAZVERIK Commercially Available in
U.S. for Epithelioid Sarcoma (ES):Epizyme successfully made TAZVERIK commercially available in theU.S. onFebruary 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. Within one week from approval, the first prescriptions were filled, and the company saw continued traction in the first quarter, with physicians incorporating TAZVERIK into their treatment practices. - Follicular Lymphoma (FL)
U.S. Commercial Launch Readiness Nearly Complete: TheU.S. Food and Drug Administration (FDA) granted Priority Review to Epizyme’s supplemental New Drug Application (sNDA) filing with a PDUFA target action date ofJune 18, 2020 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. To support a potential FDA approval, the company has concluded the hiring and training of its salesforce and is completing its FL launch readiness activities, which will utilize both direct and virtual approaches to physician education. - Company-sponsored Trials in ES, FL and Prostate Cancer Underway:
Epizyme expects to complete the ongoing safety run-in portions and begin the efficacy expansion portions of the following clinical trials in 2020:- Global, randomized, controlled confirmatory Phase 1b/3 trial assessing the combination of TAZVERIK plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES patients;
- Global randomized, controlled confirmatory Phase 1b/3 trial assessing TAZVERIK in combination with “R2” (Revlimid® plus rituximab) compared with R2 plus placebo in the second-line FL treatment setting; and
- Global randomized, controlled Phase 1b/2 clinical trial in chemo-naïve patients with metastatic castration-resistant prostate cancer, assessing tazemetostat with enzalutamide or with abiraterone, standard treatments for this patient population.
- Additional Investigator-Sponsored Trials Advancing:
Epizyme is supporting a number of investigator-sponsored studies assessing tazemetostat in multiple combinations, including in front-line and relapsed/refractory treatment settings for FL.
Financial Guidance
Based on its current operating plans,
First Quarter 2020 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$376.5 million as ofMarch 31, 2020 , as compared to$381.1 million as ofDecember 31, 2019 . - Revenue: Total revenue for the first quarter of 2020 was
$1.4 million , comprised of$1.3 million in net sales of TAZVERIK in theU.S. from the first two months of commercialization following its launch inJanuary 2020 and$0.1 million in collaboration revenue, compared to$4.3 million in collaboration revenue for the fourth quarter of 2019, which was primarily due to revenue associated with services performed under the company's multi-target research collaboration withBoehringer Ingelheim . - Operating Expenses: Total GAAP operating expenses were
$52.7 million for first quarter of 2020, compared to$61.8 million for the fourth quarter of 2019. Total non-GAAP adjusted cash operating expenses, were$45.7 million for the first quarter of 2020, compared to$45.2 million for the fourth quarter of 2019.- R&D expenses: GAAP R&D expenses were
$25.2 million for the first quarter of 2020, compared to$38.3 million for the fourth quarter of 2019, while non-GAAP adjusted R&D expenses were$22.9 million for the first quarter of 2020, compared to$25.8 million for the fourth quarter of 2019. The decrease was primarily due to one-time expenses related to the company’sOncology Drug Advisory Committee (ODAC) meeting and FL NDA submission in the fourth quarter of 2020. - SG&A expenses: GAAP SG&A expenses were
$26.9 million for the first quarter of 2020, compared to$23.5 million for the fourth quarter of 2019, while non-GAAP SG&A adjusted expenses were$22.5 million for the first quarter of 2020, compared to$19.4 million for the fourth quarter of 2019. The increase was primarily due to expenses related to the company’s buildout of its salesforce and infrastructure to support its commercial launch of TAZVERIK for the ES indication and expansion of its infrastructure to support a potential launch in FL.
- R&D expenses: GAAP R&D expenses were
- Net Loss (GAAP): Net loss attributable to common stockholders was
$50.9 million , or$0.51 per share, for the first quarter of 2020, compared to$56.4 million , or$0.59 per share, for the fourth quarter of 2019.
A reconciliation of non-GAAP 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™ (tazemetostat) is the first EZH2 inhibitor approved by the
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
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) |
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2020 |
2019 |
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Consolidated Balance Sheet Data: |
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Cash and cash equivalents |
$ |
179,261 |
$ |
139,482 |
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Marketable securities |
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197,199 |
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|
241,605 |
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Intangible assets, net |
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24,702 |
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— |
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Total assets |
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451,637 |
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424,589 |
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Total current liabilities |
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27,183 |
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|
34,386 |
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|
Deferred revenue |
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|
3,806 |
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|
3,806 |
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|
Long-term debt, net of debt discount |
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|
48,381 |
|
|
23,309 |
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|
Liability related to sale of future royalties |
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|
13,087 |
|
|
12,793 |
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Total stockholders’ equity |
$ |
340,317 |
$ |
331,137 |
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CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands except per share data)
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Three Months Ended |
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Three Months Ended |
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2020 |
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2019 |
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2019 |
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Revenues |
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Product revenue, net |
$ |
1,284 |
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|
$ |
- |
|
|
$ |
- |
|
Collaboration revenue |
|
70 |
|
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|
7,891 |
|
|
|
4,294 |
|
Total revenue |
|
1,354 |
|
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|
7,891 |
|
|
|
4,294 |
|
|
|
|
|
|
|
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Operating expenses |
|
|
|
|
|
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Cost of product revenue |
|
614 |
|
|
|
- |
|
|
|
- |
|
Research and development |
|
25,163 |
|
|
|
26,896 |
|
|
|
38,257 |
|
Selling, general and administrative |
|
26,927 |
|
|
|
11,986 |
|
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|
23,530 |
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Total operating expenses |
|
52,704 |
|
|
|
38,882 |
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|
61,787 |
|
Operating loss |
|
(51,350 |
) |
|
|
(30,991 |
) |
|
|
(57,493 |
) |
Other income, net: |
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|
|
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|
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Interest income, net |
|
756 |
|
|
|
1,658 |
|
|
|
1,320 |
|
Other (expense) income, net |
|
(48 |
) |
|
|
(6 |
) |
|
|
21 |
|
Non-cash interest expense related to sale of future royalties |
|
(295 |
) |
|
|
- |
|
|
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(192 |
) |
Other income, net: |
|
413 |
|
|
|
1,652 |
|
|
|
1,149 |
|
Loss before income taxes |
|
(50,937 |
) |
|
|
(29,339 |
) |
|
|
(56,344 |
) |
Income tax provision |
|
- |
|
|
|
- |
|
|
|
(58 |
) |
Net loss |
$ |
(50,937 |
) |
|
$ |
(29,339 |
) |
|
$ |
(56,402 |
) |
|
|
|
|
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Reconciliation of net loss to net loss attributable to common stockholders |
|
|
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|
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Net loss |
$ |
(50,937 |
) |
|
$ |
(29,339 |
) |
|
$ |
(56,402 |
) |
Accretion of convertible preferred stock |
|
|
|
(2,940 |
) |
|
|
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Net loss attributable to common stockholders |
$ |
(50,937 |
) |
|
$ |
(32,279 |
) |
|
$ |
(56,402 |
) |
Net loss per share attributable to common stockholders - basic and diluted |
$ |
(0.51 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.59 |
) |
|
|
|
|
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|
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Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted |
|
99,616 |
|
|
|
82,424 |
|
|
|
95,074 |
|
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (UNAUDITED) (Amounts in thousands) |
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Three Months Ended |
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Three Months Ended |
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Reconciliation of GAAP to Non-GAAP Cost of Product Revenue |
|
2020 |
|
|
|
2019 |
|
|
|
2019 |
|
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GAAP Cost of Product Revenue |
|
|
|
$ |
614 |
|
|
$ |
- |
|
|
$ |
- |
|
||
Less: Depreciation and Amortization |
|
|
|
(298 |
) |
|
|
- |
|
|
|
- |
|
|||
Non-GAAP Cost of Product Revenue |
|
|
|
$ |
316 |
|
|
$ |
- |
|
|
$ |
- |
|
||
|
|
|
|
|
|
|
|
|
|
|
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Reconciliation of GAAP to |
|
|
|
|
|
|||||||||||
|
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|
$ |
25,163 |
|
|
$ |
26,896 |
|
|
$ |
38,257 |
|
|||
Less: Stock-Based Compensation Expenses |
|
|
(2,162 |
) |
|
|
(1,165 |
) |
|
|
(2,294 |
) |
||||
Less: Depreciation and Amortization |
|
|
|
(138 |
) |
|
|
(158 |
) |
|
|
(146 |
) |
|||
Less: Eisai R&D Milestone Expense |
|
|
|
- |
|
|
|
- |
|
|
|
(10,000 |
) |
|||
|
|
|
|
22,863 |
|
|
$ |
25,573 |
|
|
$ |
25,817 |
|
|||
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Reconciliation of GAAP to Non-GAAP Selling, General and Administrative: |
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GAAP Selling, General and Administrative |
|
|
$ |
26,927 |
|
|
$ |
11,986 |
|
|
$ |
23,530 |
|
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Less: Stock-Based Compensation Expenses |
|
|
(4,348 |
) |
|
|
(2,046 |
) |
|
|
(4,106 |
) |
||||
Less: Depreciation and Amortization |
|
|
|
(93 |
) |
|
|
(49 |
) |
|
|
(68 |
) |
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Non-GAAP Selling, General and Administrative |
|
$ |
22,486 |
|
|
$ |
9,891 |
|
|
$ |
19,356 |
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|
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|
|
|
|
|
|
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Reconciliation of GAAP to Non-GAAP Operating Expenses |
|
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GAAP Operating Expenses |
|
|
|
$ |
52,704 |
|
|
$ |
38,882 |
|
|
$ |
61,787 |
|
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Less: Stock-Based Compensation Expenses |
|
|
(6,510 |
) |
|
|
(3,211 |
) |
|
|
(6,400 |
) |
||||
Less: Depreciation and Amortization |
|
|
|
(529 |
) |
|
|
(207 |
) |
|
|
(214 |
) |
|||
Less: Eisai R&D Milestone Expense |
|
|
|
- |
|
|
|
- |
|
|
|
(10,000 |
) |
|||
Non-GAAP Operating Expenses |
|
|
$ |
45,665 |
|
|
$ |
35,464 |
|
|
$ |
45,173 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200504005057/en/
Media:
media@epizyme.com
(617) 500-0615
Investors:
alicia@thrustsc.com
(910) 620-3302
Source: