Epizyme Announces 2015 Financial Results and Financial Guidance
Company reiterates financial runway guidance through at least the end of 2017 and through major research and development milestones
Conference call to be held today at
Key 2015 Accomplishments
Regained control of key pipeline assets: In 2015,
Epizymereacquired from Eisai the rights to tazemetostat worldwide outside of Japanand assumed leadership of the tazemetostat development strategy. The company also extended and focused its collaboration agreement with Celgene on three specific targets, regaining worldwide rights to the rest of its preclinical pipeline programs excluding the three programs partnered with GlaxoSmithKline (GSK).
Executed on robust clinical development strategy for tazemetostat:
At multiple major medical meetings in 2015,
Epizymepresented proof-of-concept data from an ongoing phase 1 trial with tazemetostat that demonstrated clinically meaningful activity and an acceptable safety profile in patients with non-Hodgkin lymphoma (NHL) and in patients with certain genetically defined solid tumors. Based on the findings, Epizymeinitiated a global development plan for tazemetostat, which includes a five-arm, phase 2 study in patients with NHL, a three-arm phase 2 study in adult patients with certain genetically defined solid tumors, and a dose-escalation and dose-expansion phase 1 study in pediatric patients with certain genetically defined solid tumors. Epizymealso obtained FDAacceptance of INDs in the U.S.for tazemetostat for the treatment of diffuse-large B-cell lymphoma (DLBCL), the largest subset of NHL, and for certain genetically defined solid tumors.
Expanded pipeline of preclinical assets:
Epizymemade substantial progress in its discovery pipeline, identifying and initiating preclinical work against five new targets, against which the company is developing small molecules wholly owned by Epizyme.
Strengthened its scientific leadership: Throughout 2015,
Epizymecontinued to enhance its platform capabilities. The company's extensive epigenetics expertise with histone methyltransferases (HMTs) led to the expansion of its efforts to encompass other chromatin modifying proteins (CMPs). Epizymehas identified a prioritized set of HMT and CMP targets from which it plans to build a sustainable pipeline of potential new therapies.
Based on these significant advancements throughout 2015,
"In 2015, we made substantial progress across all aspects of the
organization, which has provided a solid foundation on which to build
our future," said
Full Year 2015 Results and Financial Guidance
Collaboration revenue was
$2.6 millionfor the year ended December 31, 2015, compared to $41.4 millionfor the prior year. The decrease in collaboration revenue primarily reflects the completion of a significant portion of the Company's performance obligations under its collaborations during 2014 and achievement of a $3.0 millionmilestone under its agreement with GSK during 2014. The company expects to recognize an additional $1.9 millionof deferred revenue related to the Celgene agreement through December 31, 2016as the company completes its pinometostat phase 1 clinical trials.
Research and development (R&D) expenses were
$111.2 millionfor the year ended December 31, 2015compared to $75.6 millionfor the year ended December 31, 2014. The increase in costs were primarily driven by the expansion of tazemetostat clinical trials and related EZH2 activities and the $40.0 millionupfront payment to Eisai in the first quarter of 2015 to reacquire rights to tazemetostat worldwide outside of Japan, partially offset by reductions in external spending on pinometostat and discovery and preclinical programs during 2015 compared to the prior year. After adjusting for the 2015 in-process research and development payment made to Eisai of $40.0 million, Epizymeexpects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily driven by the costs of its ongoing and planned clinical trials with tazemetostat, including its registration-supporting trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with BAP1 loss-of-function mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the company advances its wholly owned small molecule programs against five novel targets, continues the research efforts for its Celgene partnered programs, and expands its target identification and discovery activities. Epizymeplans to offset a portion of the increased cost of its research and development programs through strategic collaborations that it will be evaluating later this year.
General and administrative (G&A) expenses increased to
$23.9 millionfor the year ended December 31, 2015, compared to $20.9 millionfor the year ended December 31, 2014. The increase in G&A expense was largely due to increased intellectual property-related legal costs and personnel-related expenses associated with scaling up Epizyme's business operations.
Net loss was
$132.4 millionfor the year ended December 31, 2015, compared to a net loss of $55.0 millionfor the year ended December 31, 2014. The year-over-year decline was driven by a decrease in collaboration revenue, as well as by the costs associated with reacquiring tazemetostat rights from Eisai.
Cash and cash equivalents as of
December 31, 2015were $208.3 million, compared with $190.1 millionas of December 31, 2014. Epizyme's follow-on public offering in January 2016raised $130.1 millionin net proceeds, after underwriting discounts and commissions, upon the sale of 15.3 million common shares. As this event occurred in fiscal 2016, it is not reflected in the December 31, 2015cash and cash equivalent balances.
Financial Guidance from
Epizymestates that the Company believes its cash and cash equivalents of $208.3 millionas of December 31, 2015, together with the net proceeds of $130.1 millionfrom the January 2016follow-on offering, will be sufficient to fund the Company's operations through at least the end of 2017, and importantly through many key milestones.
Conference Call Information
Additional information about tazemetostat, including clinical trial information, can be found here.
For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.
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: uncertainties inherent
in the initiation of future clinical studies or expansion of ongoing
clinical studies, availability and timing of data from ongoing clinical
studies, whether interim results from a clinical trial such as the
results described in this release will be predictive of the final
results of the trial or the results of future trials, expectations for
regulatory approvals to conduct trials or to market products,
development progress of the Company's companion diagnostics,
availability of funding sufficient for the Company's foreseeable and
unforeseeable operating expenses and capital expenditure requirements,
ability to enter into third party collaborations on favorable terms or
at all, other matters that could affect the availability or commercial
potential of the Company's therapeutic candidates or companion
diagnostics and other factors discussed in the "Risk Factors" section of
the Company's Form 10-K filed with the SEC on
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
|Consolidated Balance Sheets Data :|
|Cash and cash equivalents||$||208,323||$||190,095|
|Total stockholders' equity||169,532||160,282|
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)
Three Months Ended
|Research and development||16,819||20,505||111,209||75,595|
|General and administrative||6,017||4,935||23,900||20,866|
|Total operating expenses||22,836||25,440||135,109||96,461|
|Loss from operations||(22,281||)||(15,091||)||(132,549||)||(55,050||)|
|Other income, net||55||47||173||154|
|Loss before income taxes||(22,226)||(15,044)||(132,376)||(54,896)|
|Income tax (benefit) expense||—||(9||)||—||109|
|Loss per share allocable to common stockholders:|
|Weighted average shares outstanding:|
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