Analyst Conference Summary

biotechnology

Conference date: May 6, 2019 @ 5:30 Press Release Only
for quarter ending: March 31, 2019 (first quarter 2019, Q1)

Forward-looking statements

Overview: Tazemetostat NDAs planned 2019.

Basic data (GAAP):

Revenue was $7.9 million, down sequentially from $9.7 million, but up from $0.0 million in the year-earlier quarter. All revenue was from collaborations.

Net income was negative $32.3 million, down sequentially from negative $22.9 million, and up from negative $34.1 million year-earlier.

EPS was negative $0.39, up sequentially from negative $0.29, and up from negative $0.49 year-earlier.

Guidance:

Current cash should last into Q2 2020.

Conference Highlights:

Robert Bazemore, president and CEO said "This is an incredibly exciting time for our company, and 2019 is slated to be one of the most important years in Epizyme's evolution. Our team is on track to submit two NDAs for tazemetostat this year, first for epithelioid sarcoma in the second quarter, which, if successful, would make tazemetostat the first commercially available EZH2 inhibitor, and then a second submission for follicular lymphoma in the fourth quarter. We are preparing for multiple clinical trials starting mid-year designed to expand the utility of tazemetostat, and to initiate clinical development of our novel G9a inhibitor in the second half of 2019. In addition, we have achieved the first milestone in our partnership with Boehringer Ingelheim, which further validates our research expertise and our collaboration strategy in epigenetic target discovery and drug development."

In November 2018, Epizyme entered a strategic collaboration with Boehringer Ingelheim focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets. These targets are enzymes within the helicase and histone acetyltransferase (HAT) families. The company received an upfront payment of $15 million and will receive an additional $5 million in research funding in 2019. Epizyme is eligible to receive a total of up to $280 million in milestones.

In December 2018, Epizyme earned an $8 million milestone payment from its partner GlaxoSmithKline (GSK) following initiation of patient dosing in a Phase 1 clinical trial of GSK3368715, a first-in-class protein arginine methyltransferase1 (PRMT1) inhibitor. It is the second program to enter the clinic under the collaboration. The company has earned an aggregate of $89 million in up-front, research and milestone payments to date, and may earn up to an additional $375 million from GSK if all remaining milestones are met.

Tazemetostat for epithelioid sarcoma trials had positive Phase 2 results that Epizyme believes qualifies for accelerated approval (before a Phase 3 trial). Positive updated data from Phase 2 were presented in October 2018. Updated data should be reported in mid-2019. An NDA expected in Q2 2019. A confirmatory study is being prepared to support the registration strategy and full approval. ES is rare but usually deadly.

Tazemetostat for follicular lymphoma (a kind of NHL) Phase 2 study EZH2+ enrollment should complete by the end of 2018. On track for an NDA in Q4 2019 using accelerated approval. Already has orphan and fast-track status. The application is for third-line therapy. Will cover both EZH2 mutations and wild type EXH2. Epizyme is also planning for trials to bring to earlier lines of therapy in combinations with Revlimid plus Rituxan.

Tazemetostat studies in prostate cancer and platinum-resistant solid tumors will begin in 2019. Epizyme anticipates initiating a combination study in patients with castration-resistant prostate cancer in mid-2019, followed by a combination study with a PARP inhibitor in patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer, in the second half of 2019.

Tazemetostat is in Phase 2 combination with prednisolone, RCHOP, and atezolizumab cohorts in relapsed/refractory DLBCL, (another kind of NHL). Despite clinical activity and safety, the monotherapy path was discontinued after interim data showed insufficient efficacy. But may pursue other taz combinations in future trials for DLBCL.

Tazemetostat is also in a three-arm phase 2 study in adult patients with certain genetically defined, InI1-negative solid tumors.

In mesothelioma, Tazemetostat trial completed Phase 2 enrollment in Q2 2017.

A Tazemetostat study for pediatric patients with genetically defined solid tumors or NHL was started by the NCI in July 2017.

A Phase 1b study of tazemetostat with Tecentriq for patients with with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with Genentech/Roche was halted. Also planned is a similar trial in non-small cell long cancer.

A dose-escalation study of pinometostat in pediatric patients with MLL-r acute leukemia is continuing enrollment. Epizyme is partnering with Celgene for potential clinical development of pinometostat in combination with other agents.

EZM8266 for G9a [EHMT2] inhibition is in clinical approach, preclinical details were presented at ASH. It targets sickle cell disease. Phase 1 now scheduled for 2H 2019.

Epizyme has preclinical work underway with five new targets that are planned for introduction into the clinic by 2020.

See also the Epizyme pipeline page.

Cash and equivalents ended at $371 million, up sequentially from $240.3 million. In March 2019, Epizyme raised $172.50 million in gross proceeds from two concurrent underwritten public offerings.

Operating expenses of $39 million consisted of $27 million for R&D and $12 million for general and administrative. Loss from operations was $31 million. Other income was $2 million.

FL target population, third line, about 12,000 in US and 8,000 in EU. Taz could gain rapid adoption. In earlier lines about 45,000 patients in US and EU. Current literature says ES has just 800 patients, 300 metastatic and therefore potential for TAZ. But may be underdiagnosed. Sales force can reach the doctors and patients relatively easily.

Q&A:

No conference was held, so no question and answer session.

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