TAZVERIK® (tazemetostat) Net Product Revenue
of $11.6 Million for 4Q 2021; $30.9 Million for
FY 2021
$85 Million in Gross Proceeds Raised in January
2022 Public Offering, Combined with Recent Expense Reductions
Announced Today, Extends Cash Runway into 3Q 2023
Company Engaged in Global Start-up Activities
for SYMPHONY-1; Data Updates Expected Across Pipeline Programs in
2022
Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage
biopharmaceutical company developing and delivering transformative
therapies for cancer against novel epigenetic targets, today
reported fourth quarter and full year 2021 financial results and
provided business and portfolio updates.
“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 Grant Bogle, President and Chief
Executive Officer. “In support of our commercialization and
development efforts, we continue to make operational changes to
reduce our expenses and extend our cash runway, while strategically
deploying our resources to the areas we believe may be of highest
impact for the company and its stakeholders.”
Recent Highlights and 2022 Projected Milestones
- TAZVERIK® (tazemetostat) commercial progress:
- TAZVERIK generated net product revenue of $11.6 million for the
fourth quarter and $30.9 million for the full year 2021, including
$4.2 million and $7.4 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 42% when compared to $5.2 million in the third
quarter of 2021.
- 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 approximately
24% 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).
- 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) in December 2021 with 800 mg twice-daily as
the recommended Phase 3 dose, Epizyme accelerated global start-up
activities, including sites in greater China 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 of February 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 approximately 75% 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. In October 2021, the FDA granted Fast Track
designation for EZM0414 in adult patients with R/R DLBCL, and in
January 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 approximately 12% of
its current employees. Estimated severance and termination costs of
approximately $2.8-3.2 million are expected to be recorded in the
first quarter of 2022.
- 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 $160-180
million, compared to the prior guidance of $170-190 million. Based
on the current operating plan, the Company expects that its
existing cash, cash equivalents and marketable securities as of
December 31, 2021, together with the $79.5 million in net proceeds
raised from the common stock offering in 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 $176.8 million as of December 31, 2021.
- Revenue: Total revenue for the fourth quarter of 2021
was $11.6 million, compared to $4.5 million for the fourth quarter
of 2020. Total revenue for the full year ended December 31, 2021
was $37.4 million, comprised of $30.9 million in net product
revenue of TAZVERIK in the U.S. and $6.5 million in collaboration
and other revenue.
- Operating Expenses: Total GAAP operating expenses were
$62.9 million for the fourth quarter of 2021 and $275.4 million for
the full year ended December 31, 2021, compared to $70.5 million
for the fourth quarter of 2020 and $241.2 million for the full year
ended December 31, 2020. Total non-GAAP adjusted operating expenses
were $54.7 million for the fourth quarter of 2021 and $243.4
million for the full year ended December 31, 2021, compared to
$62.8 million for the fourth quarter of 2020 and $209.6 million for
the full year ended December 31, 2020.
- R&D expenses: GAAP R&D expenses were $28.9
million for the fourth quarter of 2021 and $131.0 million for the
full year ended December 31, 2021, compared to $33.7 million for
the fourth quarter of 2020 and $110.9 million for the full year
ended December 31, 2020. Non-GAAP adjusted R&D expenses were
$26.6 million for the fourth quarter of 2021 and $122.0 million for
the full year ended December 31, 2021, compared to $31.5 million
for the fourth quarter of 2020 and $101.3 million for the full year
ended December 31, 2020.
- SG&A expenses: GAAP SG&A expenses were $30.9
million for the fourth quarter of 2021 and $134.0 million for the
full year ended December 31, 2021, compared to $35.0 million for
the fourth quarter of 2020 and $125.2 million for the full year
ended December 31, 2020. Non-GAAP adjusted SG&A expenses were
$25.9 million for the fourth quarter of 2021 and $115.1 million for
the full year ended December 31, 2021, compared to $30.5 million
for the fourth quarter of 2020 and $106.2 million for the full year
ended December 31, 2020.
- Net Loss (GAAP): Net loss attributable to common
stockholders was $50.7 million, or $0.49 per share, for the fourth
quarter of 2021 and $251.1 million, or $2.45 per share, for the
full year ended December 31, 2021, compared to $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 ended 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 Epizyme will host a
conference call today, March 1, at 8:30 a.m. ET. To participate,
please dial (877) 844-6886 (domestic) or (970) 315-0315
(international) and refer to conference ID 4082815. A webcast, as
well as supplemental slides to support the webcast, will be
available in the investor section of the Company's website at
www.epizyme.com, and will be archived for 60 days following the
call.
About Non-GAAP Financial Measures In addition to
financial information prepared in accordance with the U.S.
generally accepted accounting principles (GAAP), this press release
includes the following non-GAAP financial measures: total non-GAAP
adjusted operating expenses on a historical and projected basis,
non-GAAP adjusted cost of product revenue, non-GAAP adjusted
R&D expenses on a historical basis and non-GAAP adjusted
SG&A expenses on a historical basis. Epizyme derives these
non-GAAP financial measures by excluding certain expenses and other
items from the respective GAAP financial measure, that is most
directly comparable to each non-GAAP financial measure.
Specifically, the non-GAAP financial measures exclude stock-based
compensation expense and depreciation and amortization of
intangibles. The Company’s management believes that these non-GAAP
financial measures are useful to both management and investors in
analyzing its ongoing business and operating performance.
Management does not intend the presentation of these non-GAAP
financial measures to be considered in isolation or as a substitute
for results prepared in accordance with GAAP, but as a complement
to provide greater transparency. In addition, these non-GAAP
financial measures may differ from similarly named measures used by
other companies. A quantitative reconciliation of projected total
non-GAAP adjusted operating expenses to total GAAP operating
expenses is not available without unreasonable effort primarily due
to the Company’s inability to predict with reasonable certainty the
amount of future stock-based compensation expense.
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 (≥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 U.S. Full Prescribing Information here: Epizyme.com
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 Epizyme, Inc. Epizyme, Inc. is a fully integrated,
commercial-stage biopharmaceutical company committed to its mission
of rewriting treatment for cancer through novel epigenetic
medicines. The Company is focused on creating medicines that are
targeted at specific causes of diseases, that are orally
administered, tolerable, easy to take and based on a deep
understanding of the patients that may benefit from them. The
Company aspires to change the standard-of-care for patients and
physicians by developing medicines with fundamentally new
mechanisms of action. For more information, visit
www.epizyme.com.
Cautionary Note on Forward-Looking Statements Any
statements in this press release about future expectations, plans
and prospects for Epizyme, Inc. and other statements containing the
words “anticipate," “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
whether commercial sales of TAZVERIK for epithelioid sarcoma and
follicular lymphoma in the approved indications will be successful
or will increase to the levels anticipated or at all; whether the
prioritization of the company’s development activities and cost
reductions will achieve the company’s objectives or forecasted cost
savings; whether tazemetostat will receive marketing approval for
epithelioid sarcoma or follicular lymphoma in other jurisdictions,
full approval in the United States or approval in any other
indication; uncertainties inherent in the initiation of future
clinical studies and in the availability and timing of data from
ongoing clinical studies; whether results from preclinical studies,
such as the preclinical data referenced in this release with
respect to EZM0414, or earlier clinical studies of the company’s
product candidates will be predictive of the results of future
trials, such as the ongoing confirmatory trials of TAZVERIK;
whether results from clinical studies will warrant meetings with
regulatory authorities, submissions for regulatory approval or
review by governmental authorities under the accelerated approval
process; whether the company will receive regulatory approvals,
including accelerated approval, to conduct trials or to market
products; whether the company’s collaborations and licensing
agreements with third parties will be successful; uncertainties as
to the impact of the COVID-19 pandemic on the company’s business,
results of operations and financial condition; whether the
company's cash resources will be sufficient to fund the company’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; other matters that could affect the
availability or commercial success of tazemetostat; and other
factors discussed in the “Risk Factors” section of the company’s
most recent Form 10-K or Form 10-Q filed with the SEC and in the
company's other filings from time to time with the SEC. In
addition, the forward-looking statements included in this press
release represent the company’s views as of the date hereof and
should not be relied upon as representing the company’s views as of
any date subsequent to the date hereof. The company anticipates
that subsequent events and developments will cause the company’s
views to change. However, while the company may elect to update
these forward-looking statements at some point in the future, the
company specifically disclaims any obligation to do so.
TAZVERIK® is a registered trademark of Epizyme, Inc.
Revlimid + Rituximab (R2) is a registered trademark of Celgene
Corporation, a Bristol Myers Squibb company.
EPIZYME, INCCONSOLIDATED BALANCE SHEET DATA
(UNAUDITED)(Amounts in thousands) December
31,2021 December 31,2020 Consolidated Balance Sheet
Data: Cash and cash equivalents
$ 98,336
$ 168,215
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
EPIZYME, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED)(Amounts in thousands except per share
data) Three Months EndedDecember 31
Twelve Months EndedDecember 31
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 shareattributable to common stockholders - basic and diluted
104,196
101,596
102,646
100,960
EPIZYME, INC.Reconciliation of Selected
GAAP Measures to Non-GAAP Measures (UNAUDITED)(Amounts in
thousands) Three Months EndedDecember 31
Twelve Months EndedDecember 31 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 Non-GAAP Research and
Development GAAP Research and Development
$
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
)
Non-GAAP Adjusted Research and Development
$
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: Erin Graves media@epizyme.com (617) 500-0615
Investors: Caitlin Stern cstern@realchemistry.com
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