Analyst Conference Summary

Biotechnology

conference date: August 5, 2021 @ 2:00 PM Pacific Time
for quarter ending: June 30, 2021 (Q2, second quarter)

Or did at on this date. I sold mine on August 30, 2021.
Forward-looking statements

Overview: Rapidly growing Reblozyl royalty revenue, but deep in the red for further pipeline development.

Basic data (GAAP):

Revenue was $27.9 million, up sequentially from $24.8 million, and down from $39.8 million year-earlier.

Net income was negative $63.5 million, flat sequentially from negative $63.6 million, and down from negative $18.5 million year-earlier.

Earnings per Share (EPS, diluted) were negative $1.05, flat sequentially from negative $1.05, and down from negative $0.34 year-earlier.

Guidance:

Believes has cash sufficient for the foreseeable future.

Conference Highlights:

Habib Dable, CEO of Acceleron said: "We were very pleased to highlight clinical updates from the Pulsar and Spectra Phase 2 trials of sotatercept reported at the annual ATS medical meeting and outline our plans for future long-term growth in rare pulmonary diseases at our Research and Development Day during the second quarter. Beyond our sotatercept clinical program in pulmonary arterial hypertension, most recently, we announced plans to expand the development of sotatercept into a Phase 2 trial in patients with Group 2 pulmonary hypertension and develop ACE-1334 in systemic sclerosis-associated interstitial lung disease. To date, our pulmonary pipeline has grown to include seven ongoing and planned clinical trials, showcasing our long-term commitment to becoming a global leader in rare pulmonary disease."

All revenue was from collaboration partner Bristol Myers Squibb (BMY).

Reblozyl royalty revenue in Q2 was $25.6 million, up sequentially from $22.4 million. Based on BMY sales of $128 million. $2.3 million was cost share revenue.

Non-GAAP net income was negative $49.0 million, down sequentially from negative $47 million, and down from negative $10.4 million year-earlier. Non-GAAP EPS was negative $0.81, down sequentially from negative $0.77, and down from negative $0.19 year-earlier.

Reblozyl (Luspatercept) received FDA approval for MDS in April 2020 after having received for beta-thalassemia Q4 2019. Also approved in the EU and Canada. A phase 3 trial for myelofibrosis patients who are being treated with JAK inhibitor is ongoing. Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with treatment-naive, lower-risk MDS, with topline results expected in 2022. The BEYOND Phase 2 trial in NTD (non-transfusion dependent) beta thalassemia will report results in June 2021.

Reblozyl (luspatercept) royalties from BMY will be in the low to mid 20% range. Believes sales in the first two indications could reach $2 billion annually, resulting in about $400 million per year in royalties.

Acceleron presented updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept in patients with PAH at the American Thoracic Society 2021 conference, held May 14-19. Acceleron launched the Phase 3 trial, STELLAR, in December 2020. Acceleron plans to initiate the HYPERION (early intervention) Phase 3 trial and the ZENITH (later intervention) Phase 3 trial in expanded PAH populations in the mid-2021. The CADENCE Phase 2 trieal for pulmonary hypertension with left heart disease should start in 2021. Also investigating preclinically interstitial lung disease.

Acceleron expects to start a Phase 1b/Phase 2 study to evaluate the activity of ACE-1334 in patients with SSc-ILD (Systemic Sclerosis-associated Interstitial Lung Disease) in 2021.

See also Acceleron pipeline.

Cash and equivalents ended at $713 million, down sequentially from $795 million. No debt. Believes has sufficient cash to operate into .

$56 million was spent on R&D and $35 million on general and administration. Total op ex was $92 million. Loss from operations was $64 million. Other income $0 million. Income tax $0 million.

Q&A Summary:

Speed of EU Reblozyl expansion? Launch has mimicked US launch trajectory and mix of patients. Most sales so far in Germany and Austria. Some from Greek. France, Netherlands and Italy should be coming on board. We are looking to a significant boost in sales in the second half of this year, and are seeing some signs of that.

Severe blood shortages in US? It is a double edged sword. Less blood means less transfusions, which reblozyl could help. But in constrained situations people will just deal with lower hemoglobin levels. Our label requires patients to be regularly transfused. Hard to quantify at present.

Quality of life data from new trials? It could have influence, but the main factor will be the totality of data.

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