Analyst Conference Summary

biotechnology

Release date: August 9, 2019 @ 5:30 Press Release Only
for quarter ending: June 30, 2019 (first quarter 2019, Q1)

Forward-looking statements

Overview: Getting ready for tazemetostat launch if approved by FDA.

Basic data (GAAP):

Revenue was $5.9 million, down sequentially from $7.9 million, and from $12.0 million in the year-earlier quarter. All revenue was from collaborations.

Net income was negative $48.5 million, down sequentially from negative $32.3 million, and down from negative $29.1 million year-earlier.

EPS was negative $0.53, down sequentially from negative $0.39, and down from negative $0.42 year-earlier.

Guidance:

Current cash should last into Q2 2020.

Conference Highlights:

Robert Bazemore, president and CEO said "Over the course of the first half of 2019, we made tremendous progress across all aspects of Epizyme’s business, and the second half of the year holds even greater opportunities as we transition to a commercial-stage company and work to achieve our Vision 2020. Our vision is to bring tazemetostat to both epithelioid sarcoma and follicular lymphoma patients, while also expanding its development in the future to additional tumor types and combinations, to advance research efforts to bring EZM8266 and other early programs into the clinic, and to further enhance our leadership in the field of epigenetic drug discovery and development. The milestones we have achieved so far this year, along with the anticipated clinical and regulatory catalysts over the next several months, position this to be our most significant year yet. We look forward to continuing our progress in an effort to impact the lives of as many people as we can."

Tazemetostat for epithelioid sarcoma NDA was accepted by the FDA for priority review, with an action (PDUFA) date of January 23, 2020. Positive Phase 2 results had been presented at ASCO. A confirmatory study should start in 2019 to support the registration strategy and full approval. ES is rare but usually deadly.

Tazemetostat for follicular lymphoma (a kind of NHL) is 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. A confirmatory study should begin in 2019. Epizyme is also planning for trials to bring to earlier lines of therapy in combinations with Revlimid plus Rituxan.

Epizyme anticipates beginning clinical development of EZM8266, a novel, first-in-class G9a inhibitor, with a Phase 1 clinical trial for sickle cell disease in the second half of 2019.

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 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 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.

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, flat sequentially from $371 million.

Operating expenses of $57 million consisted of $41 million for R&D and $16 million for general and administrative. Loss from operations was $51 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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