Analyst Conference Summary

Biotechnology

conference date: November 4, 2015 @ 5:00 AM Pacific Time
for quarter ending: October 31, 2015 (Q3, third quarter 2015)

Forward-looking statements

Overview: Some good data came in during the quarter, and the first Phase 3 trial could start before the end of the year. Acceleron is still in the clinical development stage.

Basic data (GAAP):

Revenue was $4.2 million, up from $3.5 million year-earlier.

Net Income was negative $11.9 million, down from negative $8.0 million year-earlier.

Earnings per Share (EPS, diluted) were negative $0.36, down from negative $0.36 year-earlier.

Guidance:

Not given.

Conference Highlights:

Hopes to launch two pivotal Phase 3 programs with Celgene before the end of the year. Reported significant clinical data. Introduced the IntelliTrap™ platform to discover selective and novel compounds targeting the transforming growth factor-beta superfamily of proteins.

All revenue was from collaboration partners.

Given the good data from the luspatercept Phase 2 trials for MDS (myelodysplastic syndromes) and beta-thalassemia, with partners Celgene the Phase 2 trials have long-term extensions and cohort additions. Phase 3 trials, BELIEVE for beta-thalassemia (300 patients) and MEDALIST for MDS (210 patients) should begin in Q4 2015.

Phase 1 data of ACE-083 showed it increased muscle volume, force, and power in healthy subjects. A Phase 2 trial is scheduled for mid-2016 for FSHD muscular dystrophy.

Preclinical mouse studies of ACE-2494 for muscle mass and strength were positive. Clinical studies could begin before the end of 2016.

Phase 2, part 1 data of dalantercept with axitinib for renal cell carcinoma showed a 39% progression free survival rate vs. 25% for axitinib alone. Part 2 is enrolling with increased investigator interest due to the part 1 results. Granted Fast Track Designation.

Celgene and Acceleron will shift sotatercept from dialyis setting to the pre-dialysis kidney disease setting. Design changes will be discussed with regulators in 2016. The number of pre-dialysis patients is much larger and the reimbursement environment is "preferred."

In December additional luspatercept Phase 2 data and ACE-083 Phase 1 data will be presented at medical conferences.

See also Acceleron pipeline.

Cash and equivalents ended at $148.2 million. Liabilities included $8.0 million in warrants to purchase common stock.

Acceleron believes its cash should be sufficient into the second half of 2017.

Acceleron's goal is to have FDA approvals in 5 indications by 2020, and at that time to have 8 candidates in clinical trials. Hopes to be cash flow positive in 2020.

Q&A:

ASH abstracts out tomorrow, data cutoff dates? We will give an update for data for MDS and beta-thalassemia through late summer.

Sotatercept trial plan? The ongoing Phase 2 study in dialysis patients. The non-dialysis study would be a new study and we can't give design information until we have FDA feedback.

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