Item 2.02 Results of Operations and Financial Condition
The information provided in Item 8.01 of this Current Report on Form 8-K is
incorporated by reference into this Item 2.02. The full text of the press
release issued in connection with the announcement described in Item 8.01 of
this Current Report on Form 8-K is furnished as Exhibit 99.1 to this Current
Report on Form 8-K.
Item 8.01 Other Events
On January 10, 2022, Epizyme, Inc. ("Epizyme") issued a press release providing
business highlights, preliminary fourth quarter and full year 2021 financials
and clinical trial updates.
Preliminary Fourth Quarter and Full Year 2021 Financials
Epizyme expects TAZVERIK net product revenue of between $11.2-11.7 million for
the fourth quarter of 2021, including between $4.1-4.3 million 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
are expected to be between $7.0-7.5 million, representing an increase of
approximately 35% when compared to $5.2 million in the third quarter of 2021.
For the full-year ended December 31, 2021, Epizyme expects TAZVERIK net product
revenue of between $30.6-31.1 million, including between $7.3-7.5 million
related to sales of TAZVERIK commercial product for third-party pharmaceutical
company use in clinical trials. TAZVERIK commercial net sales for the full-year
2021 are expected to be between $23.2-23.7 million.
The amount of free goods supplied to patients through Epizyme's patient
assistance program is expected to represent approximately 30% of total end user
demand for the fourth quarter of 2021 and 25% for the full-year 2021.
Total end user demand in the fourth quarter of 2021 is expected to represent at
least a 14% increase over third quarter 2021 levels. This increase was driven
primarily by sales for follicular lymphoma ("FL").
Clinical Trial and Business Updates
SYMPHONY-1: During the December 2021 American Society of Hematology ("ASH")
annual meeting, Epizyme shared updated safety and activity data from the Phase
1b portion of its Phase 1b/3 confirmatory study, SYMPHONY-1. The ongoing study
is evaluating tazemetostat in combination with rituximab + lenalidomide (R2) 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 (POD24). Based on the Phase 1b safety
run-in results, in December 2021 Epizyme submitted a protocol amendment to the
United States Food and Drug Administration ("FDA") with 800mg twice-daily (BID)
as the tazemetostat dose for the global Phase 3 portion of the trial.
EZH-1301 (Solid Tumor) and EZH-1501 (Hematological) Basket Studies: During the
fourth quarter of 2021, Epizyme initiated two basket studies, EZH-1301 and
EZH-1501, to evaluate tazemetostat combinations in patients with solid tumors
and hematological malignancies, respectively.
SET-101: In November 2021, Epizyme announced the initiation of its
first-in-human study of EZM0414, Epizyme's novel, first-in-class, oral SETD2
inhibitor, which is being developed for the treatment of adult patients with R/R
multiple myeloma or R/R diffuse large B-cell lymphoma ("DLBCL"), and that the
FDA granted Fast Track designation for EZM0414 in adult patients with DLBCL.
Epizyme also shared preclinical data on EZM0414 along with the SET-101 Phase
1/1b clinical trial design at the 2021 ASH conference.
2022 Projected Milestones
SYMPHONY-1: Epizyme continues to follow the 40 patients treated in the Phase 1b
safety run-in portion of the study. Epizyme anticipates presenting follow-up
data from the safety run-in portion of the study at a medical conference later
in 2022. Global startup activities for the Phase 3 randomized portion of the
study are currently underway.
CELLO-1: CELLO-1, an open-label, randomized Phase 1b/2 study, is evaluating
tazemetostat plus enzalutamide compared to enzalutamide monotherapy in
metastatic castration-resistant prostate cancer patients. The Phase 2 efficacy
portion of the study is more than one-half enrolled towards a target of 80
patients. Epizyme expects to complete enrollment in 2022. Patients from the
Phase 1b portion of the study continue to be followed, and Epizyme expects to
present updated data from these patients in 2022.
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LYSA Study: Epizyme expects patient enrollment to complete in its ongoing
Lymphoma Study Association Phase 2 clinical trial investigating tazemetostat
plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and
prednisolone) in front-line high-risk FL and DLBCL in the first quarter of 2022.
Epizyme expects that interim results from the trial in DLBCL and FL patients
will be presented at a medical conference in 2022.
EZH-1301 (Solid Tumor) and EZH-1501 (Hematological) Basket Studies: Epizyme
recently opened sites for these two basket studies, which sites are actively
screening patients for enrollment in each of the studies. Epizyme plans to
provide updates as the studies reach key enrollment milestones, as well as
preliminary data in 2022.
SET-101: Epizyme recently opened sites for the dose escalation portion of the
SET-101 trial, which are actively screening patients for enrollment in this
first-in-human study and which Epizyme expects will enroll between 30-36
patients. Epizyme plans to provide updates as the study reaches key enrollment
milestones along with preliminary safety data in 2022.
Epizyme's estimates of net product revenue and commercial net sales of TAZVERIK,
and its ability to fund its operations are preliminary and unaudited, represent
management estimates as of the date of this Current Report on Form 8-K and are
subject to completion of Epizyme's financial closing procedures. As a result,
Epizyme's actual financial results may differ materially from the preliminary
estimated financial information set forth above. Epizyme's independent
registered public accounting firm has not conducted an audit or review of, and
does not express an opinion or any other form of assurance with respect to, the
estimates of net product revenue of TAZVERIK, commercial net sales or end user
demand.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 Press release issued by Epizyme, Inc. on January 10, 2022*
104 Cover Page Interactive Data File (embedded within XBRL document).
* The exhibit shall be deemed to be furnished, and not filed.
Forward-Looking Statements
Any statements in this report 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
refinement of Epizyme's commercial strategy and cost reductions will achieve
Epizyme's objectives or forecasted cost savings; whether Epizyme identifies
items during its financial statement closing process that result in adjustments
to the estimates, preliminary figures and guidance included in this report;
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 data
reported in this release with respect to EZM0414, or earlier clinical studies of
Epizyme'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 Epizyme will receive regulatory approvals,
including accelerated approval, to conduct trials or to market products; whether
Epizyme's collaborations and licensing agreements with third parties will be
successful; uncertainties as to the impact of the COVID-19 pandemic on Epizyme's
business, results of operations and financial condition; whether Epizyme's cash
resources will be sufficient to fund Epizyme'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 Epizyme's most recent Form
10-K or Form 10-Q filed with the SEC and in Epizyme's other filings from time to
time
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with the SEC. In addition, the forward-looking statements included in this
report represent Epizyme's views as of the date hereof and should not be relied
upon as representing Epizyme's views as of any date subsequent to the date
hereof. Epizyme anticipates that subsequent events and developments will cause
Epizyme's views to change. However, while Epizyme may elect to update these
forward-looking statements at some point in the future, Epizyme specifically
disclaims any obligation to do so.
.
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