Analyst Conference Summary

biotechnology

conference date: May 17, 2018 @ 6:30 AM Pacific Time
for quarter ending: March 31, 2018 (first quarter 2018, Q1)

Forward-looking statements

Note the conference call is delayed until May 17 so that clinical data updates can be included. The financial data below is from the May 8, 2018 press release.

Overview: Despite partial clinical hold in pediatric tazemetostat trial, continued to enroll patients in other trials.

Basic data (GAAP):

Revenue was $0.0 million, down sequentially from $0.0 million, and down from $0.5 million in the year-earlier quarter.

Net loss was $34.1 million, up sequentially from a loss of $36.2 million, and down from a $32.5 million loss year-earlier.

EPS was negative $0.49, up sequentially from negative $0.52, and up from negative $0.56 year-earlier.

Guidance:

Conference Highlights:

Robert Bazemore, president and CEO said “Our attention now is squarely focused on a set of actions intended to address the partial clinical hold that has paused new patient enrollment in our trials. We look forward to presenting new clinical data at multiple medical meetings in the second quarter and remain on track for a catalyst-rich year that we expect will culminate in our first New Drug Application targeted for submission in the fourth quarter of 2018"

Sees tazemetostat as potentially treating both solid and blood cancers, in multiple indications, and eventually in the first-line setting.

Epizyme has a global development plan for tazemetostat (an EZH2 inhibitor), in several cancer indications.

The EU granted tazemetostat orphan drug designation for follicular lymphoma, DLBCL, and mesothelioma.

In April repored the FDA placed a partial clinical hold on enrollment of U.S. patients. This was after one patient developed a secondary T-cell lymphoma in the Phase 1 pediatric trial. However, patients already being dosed are able to continue receiving tazemetostat. Epizyme emphasized there has been only 1 case of secondary lymphoma among 750 patients treated. Will work to address the hold.

Tazemetosta for epithelioid sarcoma trials had positive Phase 2 results that may qualify for accelerated approval (before a Phase 3 trial). Updated data from Phase 2 will be presented in the second half of 2018, with an NDA planned for Q4 2018. A confirmatory study is being prepared to support the registration strategy and full approval. ES is rare but usually deadly.

Tazemetosta for follicular lymphoma (a kind of NHL) Phase 2 study EZH2+ cohort should complete enrollment in 2018 (wild-type cohort completed in 2017). More data due in 2018. Epizyme will continue to work with the FDA to refine a registration strategy for accelerated approval. Already has orphan and fast-track status. A combination study is planned to start before the end of 2018.

Tazemetostat is in Phase 2 combination with prednisolone, RCHOP, and atezolizumab cohorts in relapsed/refractory DLBCL, (another kind of NHL) continued. The prednisone cohort and the atezolizumab cohorts each completed enrollment. Monotherapy cohort's enrollment should complete in 2018, more data should be released, and the regulatory plan could be updated.

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. The study achieved its primary endpoint, a 30% disease control rate at 12 weeks. Durability will be assessed, with data in 2018. FDA granted orphan drug designation for this indication in September. Next steps should be communicated by mid-2018.

A Tazemetostat study for pediatric patients with genetically defined solid tumors or NHL was started by the NCI in July 2017 with enrollment to complete in 2018.

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

Tazemetostat in pediatric patients with INI1-negative solid tumors Phase 1 dose escalation data was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Objective responses were observed in patients with epithelioid sarcoma (n=1), poorly differentiated chordoma (n=2) and atypical teratoid rhabdoid tumors (n=1) at dose levels ranging from 520 to 900 mg/m2 twice daily.

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. But Phase 1 won't start until 2019.

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

Three programs are partnered with GSK and three with Celgene, including some that are undisclosed.

See also the Epizyme pipeline page.

Cash and equivalents ended at $247.9 million, down sequentially from $276.4 million. Epizyme believes it has sufficient funding though at least the third quarter of 2019. Longer if milestone payments are received or new partnership revenue comes in.

Operating expenses of $35.0 million consisted of $25.6 million for R&D and $9.4 million for general and administrative. Loss from operations was $34.9 million. Other income was $0.9 million.

Q&A:

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