Analyst Conference Summary

biotechnology

Release date: February 24, 2020 @ 5:30 PM Pacific Time
for quarter ending: December 31, 2019 (fourth quarter 2019, Q4)

Forward-looking statements

Overview: First FDA approval of Tazverik (tazemetostat), but no revenue from that yet. Expenses higher to run confirmatory trials and for new indications.

Basic data (GAAP):

Revenue was $4 million, down sequentially from $ million, and from $9.7 million in the year-earlier quarter. Revenue was from collaborations.

Net income was negative $56 million, down sequentially from negative $36 million, and down from negative $23 million year-earlier.

EPS was negative $0.59, down sequentially from negative $0.40, and down from negative $0.29 year-earlier.

Guidance:

Epizyme expects cash runway to extend into at least 2022. GAAP operating expenses for 2020 expected between $300 and $330 million inclusive of the milestones due to Eisai for the FDA approval of Tazverik for epithelioid sarcoma and for follicular lymphoma. Does not expect to need to do another equity financing any time soon.

Conference Highlights:

Robert Bazemore, president and CEO said "We began 2020 with the most meaningful milestone for the company to date, the accelerated approval of Tazverik, making it the first and only commercially available EZH2 inhibitor and the only approved product specifically indicated for epithelioid sarcoma patients. We executed a strong start to our commercial launch, in which we made Tazverik available to patients within one week of approval. Following the acceptance of our sNDA filing for Tazverik for follicular lymphoma, we are preparing to quickly address the more prevalent FL patient population, if approved. In parallel, we are continuing our in-house and clinical collaboration efforts to demonstrate the full potential of tazemetostat for a range of cancer indications, with 12 trials underway and four more planned for initiation this year, making for a robust development expansion program."

Tazverik (tazemetostat) for epithelioid sarcoma was approved by the FDA on January 23, 2020. Positive Phase 2 results had been presented at ASCO. Because it was an accelerated approval, confirmatory study will be done to support full approval. Commercial launch began the first week after approval, with the first patient dosed on February 1. There are about 300 patients eligible under the label in the U.S.

The tazemetostat for follicular lymphoma (a kind of NHL) NDA to the FDA was accepted on February 14, with Priority Review status. PDUFA is June 18, 2020. The application is for third-line therapy. Will cover both EZH2 mutations and wild type EXH2. A confirmatory study would be needed for full approval. In 2020 plans to expand clinical investigation of tazemetostat in combination with R-CHOP in the high-risk front-line treatment setting for patients with FL; and support the investigator-sponsored studies assessing tazemetostat in combination with rituximab, venetoclax and BTK inhibitors in the third-line and later FL treatment setting.

In total, as of Q1 2020, 12 clinical trials were underway and four were planned for initiation in 2020. Additional indictions for tz include hematological malignancies, such as lymphomas and other b-cell malignancies; mutationally defined solid tumors, such as chordoma, melanoma and tumors with a SWI/SNF alteration or other mutations; metastatic castration-resistant prostate cancer; solid tumors that are resistant to chemotherapy or PARP inhibitors, such as triple negative breast, small cell lung and ovarian cancers, as well as mesothelioma; and solid tumors in which EHZ2 inhibition can augment the response to immune-oncology treatments.

Pursuant to the terms of its agreements with Royalty Pharma and Pharmakon Advisors, in January 2020, Epizyme exercised its option to sell $50 million of its common stock to Royalty Pharma.

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 began in 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.

See also the Epizyme pipeline page.

Cash and equivalents ended at $381 million. Long term debt was $23 million. An additional $50 million was raised in Q1 2020.

Operating expenses of $62 million consisted of $38 million for R&D and $24 million for general and administrative. Loss from operations was $57 million. Other income was $1 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:

Size of third-line FL market? First line 14,000 new patients per year. Third line perhaps 6,000 per year. But the 2nd line, 10,000 to 12,000 number eventually go through multiple lines of therapy.

Prostate cancer? From Phase 1, safety portion, we will collect biomarkers to see what subpopulations would work. Then we will go to a randomized population. No timeing yet on release of safety data.

Assuming FL approval with a broad label, strategy beyond large centers? FDA accepted as a supplemental NDA, which moved the timeline forward. Working on payer access. It is seen in community based institutions, so we will pivot to that. Completed sales force hiring, so ready, with 47 coming on board by PDUFA date.

Data readouts 2020? ES and FL second line with have safety data. No guidance on presentations yet.

We expect meaningfull and rapid adoption of Tazverik. Our patient hotline for verification of benefits has already had FL calls.

Taz use patterns so far? It is very early. First verification of benefit was for 2nd line FL. For ES we are seeing enthusiasm from ES treaters. When we get prescriptions, we are shipping in 5 days or less. Payers have not been resistant.

We believe the combination trials are very promising, based on preclinical and early clinical data.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: