TAZVERIK® (tazemetostat) Net Product Revenue
of $8.7 Million for 1Q 2022, Supported by Streamlined
Operating Expenses which Decreased by 17% in 1Q 2022 vs. 1Q
2021
First Patient Dosed in the Randomized Phase 3
Portion of SYMPHONY-1 (EZH-302), Epizyme’s Phase 1b/3 Confirmatory
Study Assessing Tazemetostat in Combination with R2 in Follicular
Lymphoma (FL)
Updated Data from the Phase 1b Portion of
SYMPHONY-1 to be Presented at ASCO; Additional Updates Anticipated
in 2H 2022 from Tazemetostat and EZM0414 (SETD2 inhibitor)
Studies
Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage
biopharmaceutical company developing and delivering transformative
therapies for cancer patients against novel epigenetic targets,
today reported first quarter 2022 financial results and provided a
business update.
“The relapsed or refractory follicular lymphoma treatment
landscape is rapidly changing, and we believe TAZVERIK® is poised
to grow at an accelerated rate as the year progresses. We saw
encouraging progress in important commercial metrics during the
first quarter despite some seasonal impact related in part to the
Medicare Part D drug benefit design and year-end prescription
variability, which we continue to evaluate. TAZVERIK demand
experienced a strong rebound in March, and we entered the second
quarter with positive momentum. We believe that TAZVERIK has the
potential to reach many more patients based on changes in the
current treatment options for patients in the R/R FL market and the
updated NCCN Guidelines® for FL,” said Grant Bogle, President and
Chief Executive Officer. “We are also continuing to advance our key
clinical programs and look forward to sharing updated SYMPHONY-1
data from the Phase 1b cohort at ASCO.”
Recent Progress
- TAZVERIK® (tazemetostat) commercial progress:
- TAZVERIK generated net product revenue of $8.7 million for the
first quarter of 2022, including $0.5 million related to the sale
of TAZVERIK commercial product for third-party pharmaceutical
company use in clinical trials. TAZVERIK commercial net sales in
the first quarter of 2022 were $8.1 million, representing an
increase of approximately 10% when compared to $7.4 million in the
fourth quarter of 2021.
- Commercial demand increased 16% in the first quarter of 2022
versus the fourth quarter of 2021 levels while total demand
(commercial demand and free goods supplied through the patient
assistance program) in the first quarter of 2022 was similar to
fourth quarter 2021 levels. The Company believes the difference in
total demand as compared with commercial demand was related, in
part, to limitations of the Medicare Part D drug benefit design and
year-end prescription variability, which followed a similar pattern
in 2021. While total demand was soft in the beginning of the
quarter, it rebounded in March to its highest monthly level since
launch. Additional time is needed to fully evaluate and understand
seasonality and fluctuations.
- Recent market research suggests that TAZVERIK market share
continues to grow in the third-line setting for both EZH2
mutation-positive and wild-type populations, consistent with the
Company’s commercial focus and messaging. The amount of free goods
supplied to patients through Epizyme’s patient assistance program
represented approximately 15% of total demand for the first quarter
of 2022. This rate was consistent with the first quarter of
2021.
- National Comprehensive Cancer Network® (NCCN) released
updated NCCN Guidelines® for B-Cell Lymphomas: The recently
updated NCCN Guidelines for grade 1-2 follicular lymphoma (FL) now
include tazemetostat as a suggested treatment regimen in the second
line for elderly or infirm patients with EZH2 wild type or unknown
relapsed/refractory (R/R) disease in patients who have no
satisfactory alternative treatment options. For third-line and
subsequent therapy, tazemetostat is a suggested treatment regimen
for patients with EZH2 mutation-positive disease or patients with
EZH2 wild-type or unknown R/R disease who have no satisfactory
alternative treatment options.
- Global enrollment open and actively screening in the
randomized Phase 3 portion of SYMPHONY-1 (EZH-302): Dosing of
the first patient was recently completed in the Phase 3 portion of
the SYMPHONY-1 study, and the study is open globally and is
actively screening and enrolling patients. SYMPHONY-1 is the
confirmatory study assessing tazemetostat in combination with
rituximab + lenalidomide (R2) compared with R2 plus placebo in
patients with R/R FL previously treated with at least one systemic
therapy, including those who are rituximab-refractory and/or have
experienced progression of disease within two years (POD24).
Updated data from the Phase 1b portion of SYMPHONY-1 was accepted
for a poster presentation, which will be shared at the upcoming
American Society of Clinical Oncology Annual Meeting in Chicago
from June 3-7. Data to be presented include updated overall
response rate and complete response rate data as well as a subgroup
analysis of rituximab-refractory and POD24 patients. The Company
continues to follow this Phase 1b cohort of patients and plans to
present additional updated data later this year.
- LYSA Phase 2 study enrollment nearly complete; top-line
results expected in second half of 2022: Enrollment in the FL
arm is complete 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. Epizyme, in collaboration
with LYSA, anticipates presenting top-line results from the Phase 2
portion of the study in the second half of 2022.
- CELLO-1 Phase 2 study 85% enrolled; updated safety run-in
data and interim data from the Phase 2 portion of the study
expected in second half of 2022: The Phase 2 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, is approximately 85%
enrolled toward a target of 80 patients. In 2022, Epizyme expects
to complete enrollment in the randomized Phase 2 portion of the
study and present updated data from the safety run-in portion as
well as interim safety and efficacy data from the Phase 2 portion
of the study in the second half of the year.
- We continue to screen patients in ARIA (EZH-1501), the Phase
1b/2 tazemetostat hematological basket study, and SET-101, the
Phase 1/1b study of EZM0414. Epizyme plans to provide updates
on these programs in the second half of 2022.
First Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $199.7 million as of March 31, 2022, compared to
$176.8 million as of December 31, 2021.
- Revenue: Total revenue was $8.7 million for the first
quarter of 2022, an increase of 14% vs. $7.6 million for the first
quarter of 2021. Net product revenue of TAZVERIK in the U.S was
$8.7 million for the first quarter of 2022, an increase of 40% vs.
$6.2 million for the first quarter of 2021.
- Operating Expenses: Total GAAP operating expenses were
$59.6 million for the first quarter of 2022, a decrease of 17% vs.
$72.0 million for the first quarter of 2021, reflecting focused
efforts on streamlining operations. Total non-GAAP adjusted
operating expenses were $53.0 million for the first quarter of
2022, compared to $63.7 million for the first quarter of 2021.
- R&D expenses: GAAP R&D expenses were $29.8
million for the first quarter of 2022, compared to $32.7 million
for the first quarter of 2021. Non-GAAP adjusted R&D expenses
were $27.8 million for the first quarter of 2022, compared to $30.3
million for the first quarter of 2021.
- SG&A expenses: GAAP SG&A expenses were $27.2
million for the first quarter of 2022, compared to $36.4 million
for the first quarter of 2021, representing a 25% decrease
following the previously announced operating expense and workforce
reductions. Non-GAAP adjusted SG&A expenses were $23.6 million
for the first quarter of 2022, compared to $31.5 million for the
first quarter of 2021.
- Net Loss (GAAP): Net loss attributable to common
stockholders was $55.5 million, or $0.38 per share, for the first
quarter of 2022, compared to $70.3 million, or $0.69 per share, for
the first quarter of 2021.
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, May 10, at 8:30 a.m. ET. To participate,
please dial (877) 844-6886 (domestic) or (970) 315-0315
(international) and refer to conference ID 5369344. 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 basis, 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.
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 and 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.
NCCN Guidelines® is a registered trademark of National Cancer
Comprehensive Network.
EPIZYME, INC CONSOLIDATED BALANCE SHEET DATA
(UNAUDITED) (Amounts in thousands) March
31,2022 December 31,2021 Consolidated Balance
Sheet Data: Cash and cash equivalents
$
77,421
$
98,336
Marketable securities
122,309
78,454
Intangible assets, net
41,811
42,849
Total assets
312,186
289,000
Total current liabilities
38,967
45,196
Deferred revenue
11,950
11,950
Related party long-term debt, net of debt discount
216,670
216,461
Related party liability related to sale of future royalties, net of
current portion
15,824
15,654
Total stockholders’ equity (deficit)
11,121
(20,688)
EPIZYME, INC. CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED) (Amounts in thousands except per share data)
Three Months Ended March 31
2022
2021
Revenues Product revenue, net
$
8,656
$
6,191
Collaboration and other revenue
40
1,440
Total revenue
8,696
7,631
Operating expenses
Cost of revenue
2,637
2,853
Research and development
29,781
32,704
Selling, general and administrative
27,204
36,411
Total operating expenses
59,622
71,968
Operating loss
(50,926)
(64,337)
Other (expense) income, net: Interest expense,
net
(5,480)
(5,476)
Other (expense) income, net
(48)
9
Change in fair value of of warrants to purchase common stock
1,350
-
Related party non-cash interest expense related to sale of future
royalties
(370)
(470)
Other expense, net:
(4,548)
(5,937)
Loss before income taxes
(55,474)
(70,274)
Income tax provision
(31)
-
Net loss
$
(55,505)
$
(70,274)
Net loss per share attributable to common
stockholders - basic and diluted
$
(0.38)
$
(0.69)
Weighted-average common shares outstanding used in
net loss per shareattributable to common stockholders - basic and
diluted
144,201
101,790
EPIZYME, INC. Reconciliation of Selected GAAP Measures to
Non-GAAP Measures (UNAUDITED) (Amounts in thousands)
Three Months Ended March 31 Reconciliation of GAAP
to Non-GAAP Cost of Revenue
2022
2021
GAAP Cost of Revenue
$
2,637
$
2,853
Less: Depreciation and Amortization
(1,038)
(1,038)
Non-GAAP Adjusted Cost of Revenue
$
1,599
$
1,815
Reconciliation of GAAP to Non-GAAP Research and
Development GAAP Research and Development
$
29,781
$
32,704
Less: Stock-Based Compensation Expenses
(1,792)
(2,230)
Less: Depreciation and Amortization
(148)
(143)
Non-GAAP Adjusted Research and Development
$
27,841
$
30,331
Reconciliation of GAAP to Non-GAAP Selling, General and
Administrative: GAAP Selling, General and Administrative
$
27,204
$
36,411
Less: Stock-Based Compensation Expenses
(3,497)
(4,785)
Less: Depreciation and Amortization
(112)
(101)
Non-GAAP Adjusted Selling, General and Administrative
$
23,595
$
31,525
Reconciliation of GAAP to Non-GAAP Operating Expenses
GAAP Operating Expenses
$
59,622
$
71,968
Less: Stock-Based Compensation Expenses
(5,289)
(7,015)
Less: Depreciation and Amortization
(1,298)
(1,282)
Non-GAAP Adjusted Operating Expenses
$
53,035
$
63,671
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220510005259/en/
Media: Erin Graves media@epizyme.com (617) 500-0615
Investors: Caitlin Stern cstern@realchemistry.com
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