Epizyme Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Epizyme reported 4Q 2021 net product revenue of $11.6 million and $30.9 million for FY 2021, including sales for clinical trials.
In January 2022, the company raised $85 million in a public offering, extending its cash runway into 3Q 2023.
Operational changes, including workforce reductions, aim to optimize expenses, projecting total non-GAAP adjusted operating expenses between $160-180 million for 2022.
Despite a net loss of $50.7 million for 4Q 2021, management remains optimistic about the commercialization and development of TAZVERIK.
- 4Q 2021 net product revenue of $11.6 million, a 42% increase from $5.2 million in 3Q 2021.
- Raised $85 million in gross proceeds from a January 2022 public offering.
- Revised financial guidance indicates total non-GAAP adjusted operating expenses between $160-180 million for 2022, down from prior guidance.
- Engaged in global start-up activities for SYMPHONY-1 with data updates expected in 2022.
- Net loss of $50.7 million for 4Q 2021, compared to $66.2 million in 4Q 2020.
- Operating expenses increased to $62.9 million for 4Q 2021 from $70.5 million in 4Q 2020.
- Discontinued enrollment in SYMPHONY-2 and EZH-1301 studies to focus resources more effectively.
TAZVERIK® (tazemetostat) Net Product Revenue of
Company Engaged in Global Start-up Activities for SYMPHONY-1; Data Updates Expected Across Pipeline Programs in 2022
“Epizyme entered 2022 demonstrating continued progress on our commercial efforts to drive prescription growth for TAZVERIK as a monotherapy, as well as advancing our key combination clinical studies, which we believe have the potential to significantly expand the value and reach of TAZVERIK among physicians and patients as the data mature,” said
Recent Highlights and 2022 Projected Milestones
-
TAZVERIK® (tazemetostat) commercial progress:
-
TAZVERIK generated net product revenue of
for the fourth quarter and$11.6 million for the full year 2021, including$30.9 million and$4.2 million , respectively, related to the sale of TAZVERIK commercial product for third-party pharmaceutical company use in clinical trials. TAZVERIK commercial net sales in the fourth quarter of 2021 were$7.4 million , representing an increase of approximately$7.4 million 42% when compared to in the third quarter of 2021.$5.2 million -
The amount of free goods supplied to patients through Epizyme’s patient assistance program represented approximately
29% of total end user demand for the fourth quarter of 2021 and approximately24% for the full-year 2021. -
Total end user demand in the fourth quarter of 2021 represented a
14% increase over third quarter 2021 levels. This increase was driven primarily by sales for follicular lymphoma (FL).
-
TAZVERIK generated net product revenue of
-
Global start-up of Phase 3 portion of SYMPHONY-1 study underway; updated safety run-in data from Phase 1b portion expected in 2022: After completing the 30-day waiting period for its protocol amendment submitted to the
U.S. Food and Drug Administration (FDA) inDecember 2021 with 800 mg twice-daily as the recommended Phase 3 dose,Epizyme accelerated global start-up activities, including sites in greaterChina with our collaboration partner HUTCHMED, for the Phase 3 portion of the SYMPHONY-1 (EZH-302) study, a confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R2) compared with R2 plus placebo in patients with relapsed or refractory (R/R) FL previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have progression of disease within two years. The Company is currently screening patients in the Phase 3 portion and expects to enroll the first patient in the first quarter of 2022. Follow-up data from the Phase 1b safety run-in portion of the study are expected to be presented at a medical conference later this year. -
LYSA Phase 2 study enrollment nearly complete; interim results expected in second half of 2022: Enrollment for the Phase 2 portion of the
Lymphoma Study Association (LYSA) study, a Phase 1b/2 combination study of tazemetostat with R-CHOP in high-risk, front-line FL and diffuse large B-cell lymphoma (DLBCL) patients, is nearly complete with 111 patients out of a target of approximately 122 patients in DLBCL and 61 patients out of a target of approximately 62 patients in FL enrolled as ofFebruary 23, 2022 .Epizyme , in collaboration with LYSA, anticipates presenting interim results from the Phase 2 portion of the study in the second half of 2022. -
CELLO-1 Phase 2 study ~
75% enrolled; updated safety run-in data and interim data expected in second half of 2022: The Phase 2 efficacy portion of the CELLO-1 study (EZH-1101), which is evaluating tazemetostat plus enzalutamide compared to enzalutamide monotherapy in metastatic castration-resistant prostate cancer patients (mCRPC), is approximately75% enrolled toward a target of 80 patients.Epizyme expects to complete enrollment in the randomized Phase 2 portion of the study in 2022 and anticipates presenting updated data from the safety run-in portion as well as interim data from the Phase 2 portion of the study in the second half of 2022. -
Initiated Phase 1b/2 tazemetostat hematological basket study (EZH-1501): During the fourth quarter of 2021,
Epizyme initiated EZH-1501, its Phase 1b/2 signal finding basket study evaluating tazemetostat combinations in patients with hematological malignancies.Epizyme has entered into a clinical supply agreement with Roche for the bispecific cohort of the Company’s Phase 1b/2 basket study. This cohort will evaluate the investigational use of TAZVERIK® (tazemetostat), in combination with mosunetuzumab, Roche’s investigational CD20xCD3 T-cell engaging bispecific antibody, for patients with R/R FL who have received two or more prior lines of therapy.Epizyme plans to provide updates as EZH-1501 reaches key enrollment milestones and plans to provide preliminary data from EZH-1501 in the second half of 2022. -
Initiated first-in-human study of EZM0414 (SET-101): During the fourth quarter of 2021,
Epizyme initiated the SET-101 study, a first-in-human Phase 1/1b study of EZM0414, Epizyme’s novel, first-in-class, oral SETD2 inhibitor, in adult patients with R/R multiple myeloma (MM) and R/R DLBCL. The Company expects to enroll between 30-36 patients in the Phase 1 dose escalation portion of the study. InOctober 2021 , the FDA granted Fast Track designation for EZM0414 in adult patients with R/R DLBCL, and inJanuary 2022 , the FDA granted Orphan Drug designation for EZM0414 for MM.Epizyme plans to provide updates as the study reaches key enrollment milestones, along with preliminary data from SET-101 in 2022.
2022 Operating Plan Updates and Revised Financial Guidance
As part of Epizyme’s ongoing efforts to execute more effectively and advance its long-term growth strategy, the Company announced the following:
-
External Spending and Workforce Reductions: On
March 1, 2022 , the Company announced a further reduction of operating expenses, including a reduction in force of approximately12% of its current employees. Estimated severance and termination costs of approximately are expected to be recorded in the first quarter of 2022.$2.8 -3.2 million - Pipeline Reprioritization: Given the breadth of Epizyme’s current tazemetostat clinical development program, the Company has discontinued enrollment in its Phase 2 study of tazemetostat in combination with rituximab (SYMPHONY-2, EZH-1401), as well as its Phase 1/1b basket study evaluating tazemetostat combinations in patients with solid tumors (EZH-1301). The decision to discontinue enrollment in these studies was based on evolving market dynamics and a continued focus on optimizing the Company’s investments and eliminating potentially overlapping studies. The Company continues to study tazemetostat in combination with other therapies for both hematologic and solid tumor malignancies, both in ongoing Company-sponsored studies as well as investigator-initiated studies.
-
Revised 2022 Financial Guidance: 2022 total non-GAAP adjusted operating expenses are now expected to be between
, compared to the prior guidance of$160 -180 million . Based on the current operating plan, the Company expects that its existing cash, cash equivalents and marketable securities as of$170 -190 millionDecember 31, 2021 , together with the in net proceeds raised from the common stock offering in$79.5 million January 2022 , and expected cash generated from product sales, will be sufficient to fund planned operating expenses and capital expenditure requirements and pay debt service obligations as they become due, into the third quarter of 2023, without incorporating potential milestone payments, expense reimbursements from existing collaboration agreements or any future business development activities.
Fourth Quarter and Full Year 2021 Financial Results:
-
Cash Position: Cash, cash equivalents and marketable securities were
as of$176.8 million December 31, 2021 . -
Revenue: Total revenue for the fourth quarter of 2021 was
, compared to$11.6 million for the fourth quarter of 2020. Total revenue for the full year ended$4.5 million December 31, 2021 was , comprised of$37.4 million in net product revenue of TAZVERIK in the$30.9 million U.S. and in collaboration and other revenue.$6.5 million -
Operating Expenses: Total GAAP operating expenses were
for the fourth quarter of 2021 and$62.9 million for the full year ended$275.4 million December 31, 2021 , compared to for the fourth quarter of 2020 and$70.5 million for the full year ended$241.2 million December 31, 2020 . Total non-GAAP adjusted operating expenses were for the fourth quarter of 2021 and$54.7 million for the full year ended$243.4 million December 31, 2021 , compared to for the fourth quarter of 2020 and$62.8 million for the full year ended$209.6 million December 31, 2020 .-
R&D expenses: GAAP R&D expenses were
for the fourth quarter of 2021 and$28.9 million for the full year ended$131.0 million December 31, 2021 , compared to for the fourth quarter of 2020 and$33.7 million for the full year ended$110.9 million December 31, 2020 . Non-GAAP adjusted R&D expenses were for the fourth quarter of 2021 and$26.6 million for the full year ended$122.0 million December 31, 2021 , compared to for the fourth quarter of 2020 and$31.5 million for the full year ended$101.3 million December 31, 2020 . -
SG&A expenses: GAAP SG&A expenses were
for the fourth quarter of 2021 and$30.9 million for the full year ended$134.0 million December 31, 2021 , compared to for the fourth quarter of 2020 and$35.0 million for the full year ended$125.2 million December 31, 2020 . Non-GAAP adjusted SG&A expenses were for the fourth quarter of 2021 and$25.9 million for the full year ended$115.1 million December 31, 2021 , compared to for the fourth quarter of 2020 and$30.5 million for the full year ended$106.2 million December 31, 2020 .
-
R&D expenses: GAAP R&D expenses were
-
Net Loss (GAAP): Net loss attributable to common stockholders was
, or$50.7 million per share, for the fourth quarter of 2021 and$0.49 , or$251.1 million per share, for the full year ended$2.45 December 31, 2021 , compared to , or$66.2 million per share, for the fourth quarter of 2020 and$0.65 , or$231.7 million per share, for the full year ended$2.29 December 31, 2020 .
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® (tazemetostat)
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 is contingent upon verification and description of clinical benefit in confirmatory studies.
The most common (≥
View the
About EZM0414
EZM0414 is a potent selective, oral, small molecule, investigational drug agent that inhibits the histone methyltransferase, SETD2, which plays a role in oncogenesis. SETD2 methylates histone as well as non-histone proteins, and this activity is involved in several key biological processes including transcriptional regulation, RNA splicing, and DNA damage repair. Based on the preclinical data on SETD2 inhibition by EZM0414 in multiple settings, including high risk t(4;14) multiple myeloma (MM) and in other B-cell malignancies such as diffuse large B-cell lymphoma (DLBCL), the Company is conducting SET-101, a Phase 1/1b study of EZM0414, for the treatment of adult patients with relapsed or refractory MM and DLBCL.
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
Revlimid + Rituximab (R2) is a registered trademark of Celgene Corporation, a Bristol Myers Squibb company.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) (Amounts in thousands) |
||||||
2021 |
2020 |
|||||
Consolidated Balance Sheet Data: | ||||||
Cash and cash equivalents |
|
|
||||
Marketable securities | 78,454 |
205,391 |
||||
Intangible, net | 42,849 |
47,002 |
||||
Total assets | 289,000 |
473,573 |
||||
Total current liabilities | 45,196 |
43,400 |
||||
Deferred revenue | 11,950 |
- |
||||
Related party long-term debt, net of debt discount | 216,461 |
215,670 |
||||
Related party liability related to sale of future royalties, net of current | 15,654 |
14,176 |
||||
Total stockholders’ equity (deficit) | (20,688) |
184,897 |
||||
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands except per share data) |
||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||||
Revenues | ||||||||||||||||||
Product revenue, net | $ |
11,558 |
|
$ |
4,506 |
|
$ |
30,922 |
|
$ |
11,469 |
|
||||||
Collaboration and other revenue |
|
24 |
|
|
3,869 |
|
|
6,505 |
|
|
4,293 |
|
||||||
Total revenue |
|
11,582 |
|
|
8,375 |
|
|
37,427 |
|
|
15,762 |
|
||||||
Operating expenses | ||||||||||||||||||
Cost of revenue |
|
3,154 |
|
|
1,823 |
|
|
10,498 |
|
|
5,067 |
|
||||||
Research and development |
|
28,855 |
|
|
33,680 |
|
|
130,966 |
|
|
110,933 |
|
||||||
Selling, general and administrative |
|
30,860 |
|
|
35,015 |
|
|
133,955 |
|
|
125,178 |
|
||||||
Total operating expenses |
|
62,869 |
|
|
70,518 |
|
|
275,419 |
|
|
241,178 |
|
||||||
Operating loss |
|
(51,287 |
) |
|
(62,143 |
) |
|
(237,992 |
) |
|
(225,416 |
) |
||||||
Other income, net: | ||||||||||||||||||
Interest (expense) income, net |
|
(5,677 |
) |
|
(3,505 |
) |
|
(22,380 |
) |
|
(4,682 |
) |
||||||
Other expense, net |
|
4 |
|
|
6 |
|
|
(66 |
) |
|
(99 |
) |
||||||
Change in fair value of Warrant liability |
|
6,700 |
|
|
- |
|
|
11,120 |
|
|
- |
|
||||||
Related party non-cash interest expense related to sale of future royalties |
|
(369 |
) |
|
(475 |
) |
|
(1,782 |
) |
|
(1,383 |
) |
||||||
Other (expense) income, net: |
|
658 |
|
|
(3,974 |
) |
|
(13,108 |
) |
|
(6,164 |
) |
||||||
Loss before income taxes |
|
(50,629 |
) |
|
(66,117 |
) |
|
(251,100 |
) |
|
(231,580 |
) |
||||||
Income provision |
|
(22 |
) |
|
(116 |
) |
|
(22 |
) |
|
(114 |
) |
||||||
Net loss | $ |
(50,651 |
) |
$ |
(66,233 |
) |
$ |
(251,122 |
) |
$ |
(231,694 |
) |
||||||
Net loss per share attributable to common stockholders - basic and diluted | $ |
(0.49 |
) |
$ |
(0.65 |
) |
$ |
(2.45 |
) |
$ |
(2.29 |
) |
||||||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted |
|
104,196 |
|
|
101,596 |
|
|
102,646 |
|
|
100,960 |
|
||||||
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 Revenue | 2021 |
2020 |
2021 |
2020 |
||||||||||||||
GAAP Cost of Revenue | $ |
3,154 |
|
$ |
1,823 |
|
$ |
10,498 |
|
$ |
5,067 |
|
||||||
Less: Depreciation and Amortization |
|
(1,038 |
) |
|
(1,038 |
) |
|
(4,154 |
) |
|
(2,998 |
) |
||||||
Non-GAAP Adjusted Cost of Revenue | $ |
2,116 |
|
$ |
785 |
|
$ |
6,344 |
|
$ |
2,069 |
|
||||||
Reconciliation of GAAP to |
||||||||||||||||||
$ |
28,855 |
|
$ |
33,680 |
|
$ |
130,966 |
|
$ |
110,933 |
|
|||||||
Less: Stock-Based Compensation Expenses |
|
(2,066 |
) |
|
(2,049 |
) |
|
(8,360 |
) |
|
(9,093 |
) |
||||||
Less: Depreciation and Amortization |
|
(170 |
) |
|
(148 |
) |
|
(633 |
) |
|
(558 |
) |
||||||
$ |
26,619 |
|
$ |
31,483 |
|
$ |
121,973 |
|
$ |
101,282 |
|
|||||||
Reconciliation of GAAP to Non-GAAP Selling, General and Administrative: | ||||||||||||||||||
GAAP Selling, General and Administrative | $ |
30,860 |
|
$ |
35,015 |
|
$ |
133,955 |
|
$ |
125,178 |
|
||||||
Less: Stock-Based Compensation Expenses |
|
(4,818 |
) |
|
(4,372 |
) |
|
(18,427 |
) |
|
(18,515 |
) |
||||||
Less: Depreciation and Amortization |
|
(122 |
) |
|
(124 |
) |
|
(459 |
) |
|
(428 |
) |
||||||
Non-GAAP Adjusted Selling, General and Administrative | $ |
25,920 |
|
$ |
30,519 |
|
$ |
115,069 |
|
$ |
106,235 |
|
||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | ||||||||||||||||||
GAAP Operating Expenses | $ |
62,869 |
|
$ |
70,518 |
|
$ |
275,419 |
|
$ |
241,178 |
|
||||||
Less: Stock-Based Compensation Expenses |
|
(6,884 |
) |
|
(6,421 |
) |
|
(26,787 |
) |
|
(27,608 |
) |
||||||
Less: Depreciation and Amortization |
|
(1,330 |
) |
|
(1,310 |
) |
|
(5,246 |
) |
|
(3,984 |
) |
||||||
Non-GAAP Adjusted Operating Expenses | $ |
54,655 |
|
$ |
62,787 |
|
$ |
243,386 |
|
$ |
209,586 |
|
||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20220301005235/en/
Media:
media@epizyme.com
(617) 500-0615
Investors:
cstern@realchemistry.com
Source:
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