Press Releases
Epizyme Reports Business Progress and Third Quarter 2020 Financial Results
Company Reports 55% Growth in Net Revenue of TAZVERIK® Compared with 2Q 2020
Expansion of Loan Facility with
On-Track to Initiate Efficacy Portions of Confirmatory Trials in ES and FL and Phase 2 Castration-Resistant Prostate Cancer Trial in Early 2021
Conference Call to be Held Today,
“2020 has been a year of big milestones for
TAZVERIK® (tazemetostat) Program Updates
-
Execution of TAZVERIK
U.S. Commercialization in Relapsed or Refractory Follicular Lymphoma (FL) and Epithelioid Sarcoma (ES): TAZVERIK generated net product revenue in both ES and FL of$3.4 million in the third quarter, with growth over the second quarter of 2020 of 55% largely driven by theU.S. Food and Drug Administration (FDA) approval of TAZVERIK in FL onJune 18, 2020 . During the third quarter, the COVID-19 pandemic continued to negatively impact FL patient visits to physicians, new patient starts across all lines of treatment, as well as the ability of Epizyme’s field-based teams to fully access FL prescribers.Epizyme reports that new prescriptions for TAZVERIK in FL have increased month over month and are being written for both EZH2 mutation and wild-type patients; in the academic and community settings; and across multiple treatment lines in relapsed or refractory patients. In addition, payor coverage for ES and FL has been in-line with the TAZVERIK label.Epizyme continues to adapt its commercial strategy to the COVID-19 pandemic to support increased adoption of TAZVERIK in appropriate patients. -
Two
Lancet Oncology Publications on TAZVERIK Phase 2 Data in ES and FL: InOctober 2020 , The Lancet Oncology published results of the company’s Phase 2 trial cohorts evaluating TAZVERIK for the treatment of ES and relapsed or refractory FL, which supported the accelerated approvals by the FDA for both indications in 2020. - Confirmatory Trials for ES and FL On-Track: Enrollment in the safety run-in portions of Epizyme’s two confirmatory trials of TAZVERIK is on track to be completed in 2020, followed by initiation of the efficacy portions 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, and 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 Expansion Program Updates
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Advancing to Efficacy Portion of Combination Trial in Metastatic Castration-Resistant Prostate Cancer (mCRPC):
Epizyme completed enrollment in the safety run-in portion of its combination study in mCRPC, and initiation of the efficacy expansion stage is planned for early 2021.Epizyme anticipates reporting safety and efficacy data from the safety run-in portion of the study at a medical meeting in 2021.
Upcoming Presentations at ASH
-
Data in FL to be Presented at 62nd
American Society of Hematology (ASH) Annual Meeting and Exposition:Epizyme will present data from its FL development program during multiple poster sessions at ASH, which will be held virtuallyDecember 5-8, 2020 :-
Title: Tazemetostat is Associated with
Lower Risk for Safety Outcomes Versus the PI3-Kinases Idelalisib, Duvelisib and Copanlisib, in Patients with Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 2 Prior Systemic Treatments: a Matching-Adjusted Indirect Comparison of Single-Arm Trials-
Session
Name : 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II -
Date:
Sunday, December 6, 2020
-
Session
-
Title: A Phase 1b/3 Randomized, Double-Blind, 3-Stage Study of Tazemetostat or Placebo Plus Lenalidomide and Rituximab in Patients with Relapsed/Refractory Follicular Lymphoma
-
Session
Name : 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II -
Date:
Sunday, December 6, 2020
-
Session
-
Title: Analyzing Efficacy Outcomes from the Phase 2 Study of Single-Agent Tazemetostat as Third-Line Therapy in Patients with Relapsed or Refractory Follicular Lymphoma to Identify Predictors of Response
-
Session
Name : 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma-Clinical Studies: Poster II -
Date:
Sunday, December 6, 2020
-
Session
-
Title: A Phase 2, Open-Label, Multicenter Study of Tazemetostat in Combination with Rituximab for the Treatment of Relapsed or Refractory Follicular Lymphoma
-
Session
Name : 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma-Clinical Studies: Poster III -
Date:
Monday, December 7, 2020
-
Session
-
Title: Tazemetostat is Associated with
Leadership Update
-
Organization Strengthened with Strategic Promotions: In
October 2020 ,Matthew Ros was promoted to executive vice president and chief strategy and business officer ofEpizyme andVicki Vakiener was promoted to chief commercial officer. As part of these promotions,Mr. Ros is overseeing execution of Epizyme’s long-term corporate strategy.Ms. Vakiener is overseeing commercial execution of TAZVERIK in ES and FL.
Third Quarter 2020 Financial Results
-
Cash Position: Cash, cash equivalents and marketable securities were
$279.9 million as ofSeptember 30, 2020 , as compared to$322.1 million as ofJune 30, 2020 . -
Revenue: Total revenue for the third quarter of 2020 was
$3.6 million , comprised of$3.4 million in net sales of TAZVERIK in theU.S. and$0.1 million in collaboration revenue, compared to$2.5 million in the second quarter of 2020, comprised of$2.2 million in net sales of TAZVERIK in theU.S. and$0.2 million in collaboration revenue. -
Cost of sales: Cost of sales were
$1.6 million for the third quarter of 2020, which reflects the costs of TAZVERIK units sold, amortization of intangible assets and third-party royalties on net product revenue. -
Operating Expenses: Total GAAP operating expenses were
$57.9 million for the third quarter of 2020, compared to$60.0 million for the second quarter of 2020. Total non-GAAP adjusted operating expenses were$50.2 million for the third quarter of 2020, compared to$50.9 million for the second quarter of 2020.-
R&D expenses: GAAP R&D expenses were
$25.7 million for the third quarter of 2020, compared to$26.4 million for the second quarter of 2020. Non-GAAP adjusted R&D expenses were$23.5 million for the third quarter of 2020, compared to$23.4 million for the second quarter of 2020. -
SG&A expenses: GAAP SG&A expenses were
$30.6 million for the third quarter of 2020, compared to$32.7 million for the second quarter of 2020. Non-GAAP adjusted SG&A expenses were$26.2 million for the third quarter of 2020, compared to$27.1 million for the second quarter of 2020.
-
R&D expenses: GAAP R&D expenses were
-
Net Loss (GAAP): Net loss attributable to common stockholders was
$56.1 million , or$0.55 per share, for the third quarter of 2020, compared to$58.5 million , or$0.58 per share, for the second quarter of 2020.
Updated Financial Guidance
-
Agreement with
Pharmakon Advisors to Expand Loan Facility Extends Operating Runway:Epizyme andPharmakon Advisors , an affiliate of Royalty Pharma, have expanded their original loan agreement established inNovember 2019 , enablingEpizyme to draw down an additional$150 million from the loan facility, subject to customary closing conditions. Based on its current plans and projections,Epizyme believes that its existing cash, cash equivalents and marketable securities combined with the proceeds from the loan facility will fund the company’s operations into at least 2023. -
Updated 2020 Operating Expenses:
Epizyme updated its guidance for full year non-GAAP adjusted cash operating expenses to between$215 million to$235 million , from the previous$235 million to$255 million . The change is due primarily to a reduction in travel and other expenses and a change in how the company’s manufacturing expenses are recorded with a commercial product, partially offset by an increase in commercial-related expenses to address COVID-19 related challenges. A reconciliation of the non-GAAP financial measures to the most directly comparable 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 a confirmatory trial(s).
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
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 |
$ 93,422 |
$ 139,482 |
||||
Marketable securities |
186,485 |
241,605 |
||||
Intangible, net |
48,041 |
— |
||||
Total assets |
381,756 |
424,589 |
||||
Total current liabilities |
34,780 |
34,386 |
||||
Deferred revenue |
3,812 |
3,806 |
||||
Long-term debt, net of debt discount |
68,554 |
23,309 |
||||
Liability related to sale of future royalties |
13,701 |
12,793 |
||||
Total stockholders’ equity |
244,409 |
331,137 |
||||
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||
(Amounts in thousands except per share data) | |||||||||||
Three Months Ended | Nine Months Ended | ||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||
Revenues | |||||||||||
Product revenue, net |
$ 3,445 |
$ - |
$ 6,963 |
$ - |
|||||||
Collaboration revenue |
121 |
5,715 |
424 |
19,506 |
|||||||
Total revenue |
3,566 |
5,715 |
7,387 |
19,506 |
|||||||
Operating expenses | |||||||||||
Cost of product revenue |
1,608 |
- |
3,244 |
- |
|||||||
Research and development |
25,738 |
26,579 |
77,253 |
94,382 |
|||||||
Selling, general and administrative |
30,575 |
17,089 |
90,161 |
44,773 |
|||||||
Total operating expenses |
57,921 |
43,668 |
170,658 |
139,155 |
|||||||
Operating loss |
(54,355) |
(37,953) |
(163,271) |
(119,649) |
|||||||
Other income, net: | |||||||||||
Interest (expense) income, net |
(1,364) |
1,879 |
(1,177) |
5,790 |
|||||||
Other expense, net |
(42) |
(15) |
(105) |
(34) |
|||||||
Non-cash interest expense related to sale of future royalties |
(312) |
- |
(908) |
- |
|||||||
Other (expense) income, net: |
(1,718) |
1,864 |
(2,190) |
5,756 |
|||||||
Loss before income taxes |
(56,073) |
(36,089) |
(165,461) |
(113,893) |
|||||||
Income provision |
- |
- |
- |
- |
|||||||
Net loss |
$ (56,073) |
$ (36,089) |
$ (165,461) |
$ (113,893) |
|||||||
Reconciliation of net loss to net loss attributable to common stockholders | |||||||||||
Net loss |
$ (56,073) |
$ (36,089) |
$ (165,461) |
$ (113,893) |
|||||||
Accretion of convertible preferred stock |
- |
- |
- |
(2,940) |
|||||||
Net loss attributable to common stockholders |
$ (56,073) |
$ (36,089) |
$ (165,461) |
$ (116,833) |
|||||||
Net loss per share attributable to common stockholders - basic and diluted |
$ (0.55) |
$ (0.40) |
$ (1.64) |
$ (1.33) |
|||||||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted |
101,512 |
91,044 |
100,747 |
88,145 |
|||||||
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (UNAUDITED) | |||||||||||
(Amounts in thousands) | |||||||||||
Three Months Ended | Nine Months Ended | ||||||||||
Reconciliation of GAAP to Non-GAAP Cost of Product Revenue |
2020 |
|
2019 |
|
2020 |
|
2019 |
||||
GAAP Cost of Product Revenue |
$ 1,608 |
$ - |
$ 3,244 |
$ - |
|||||||
Less: Depreciation and Amortization |
(1,038) |
- |
(1,959) |
- |
|||||||
Non-GAAP Cost of Product Revenue |
$ 570 |
$ - |
$ 1,285 |
$ - |
|||||||
Reconciliation of GAAP to |
|||||||||||
$ 25,738 |
$ 26,579 |
$ 77,253 |
$ 94,382 |
||||||||
Less: Stock-Based Compensation Expenses |
(2,079) |
(1,104) |
(7,045) |
(4,001) |
|||||||
Less: Depreciation and Amortization |
(142) |
(148) |
(410) |
(463) |
|||||||
Less: Eisai R&D Milestone Expense |
- |
- |
- |
(10,000) |
|||||||
$ 23,517 |
$ 25,327 |
$ 69,798 |
$ 79,918 |
||||||||
Reconciliation of GAAP to Non-GAAP Selling, General and Administrative: | |||||||||||
GAAP Selling, General and Administrative |
$ 30,575 |
$ 17,089 |
$ 90,161 |
$ 44,773 |
|||||||
Less: Stock-Based Compensation Expenses |
(4,307) |
(2,573) |
(14,143) |
(7,615) |
|||||||
Less: Depreciation and Amortization |
(112) |
(62) |
(305) |
(163) |
|||||||
Non-GAAP Selling, General and Administrative |
$ 26,156 |
$ 14,454 |
$ 75,713 |
$ 36,995 |
|||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | |||||||||||
GAAP Operating Expenses |
$ 57,921 |
$ 43,668 |
$ 170,658 |
$ 139,155 |
|||||||
Less: Stock-Based Compensation Expenses |
(6,386) |
(3,677) |
(21,188) |
(11,616) |
|||||||
Less: Depreciation and Amortization |
(1,292) |
(210) |
(2,674) |
(626) |
|||||||
Less: Eisai R&D Milestone Expense |
- |
- |
- |
(10,000) |
|||||||
Non-GAAP Operating Expenses |
$ 50,243 |
$ 39,781 |
$ 146,796 |
$ 116,913 |
|||||||
- |
- |
- |
- |
View source version on businesswire.com: https://www.businesswire.com/news/home/20201106005227/en/
Media:
Media@epizyme.com
(617) 500-0615
Investors:
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(910) 620-3302
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