Amylyx reports Q3 net loss of $53.8M; FDA-approved RELYVRIO now commercially available in U.S.

Amylyx Pharmaceuticals, Inc.

2022-Q3 EPS reported -$2.77 revenue$345,000

FDA approval of RELYVRIO for ALS on Sep 29; shipments began Oct 24.
ALBRIOZA launched in Canada Jul 29, generating $0.3M net product revenue in Q3.
Net loss $53.8M ($0.92/sh) vs $23.1M ($3.42/sh) YoY; R&D and SG&A costs rose on launch preparation.
Cash $162.6M at Sep 30, plus $230.8M net from October stock offering.
EMA decision on AMX0035 expected first half 2023; MAA under review.

item 2.02 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.95

Amylyx Pharmaceuticals, Inc. reported quarter ended September 30, 2022 results: revenue $0.3 million, net income $53.8 million, EPS $0.92 per share.

Period: quarter ended September 30, 2022
Revenue: $0.3 million
Net income: $53.8 million
EPS: $0.92 per share
Result: reported results

Exact text from the filing

Financial Results for the Third Quarter Ended September 30, 2022 For the quarter ended September 30, 2022, net product revenue was $0.3 million and cost of sales were $0.2 million. Both net product revenue and cost of sales during the period were attributable to sales of ALBRIOZA in Canada. There were no product revenues or cost of sales for the comparable period in 2021. Research and development expenses were $24.9 million for the quarter ended September 30, 2022, compared to $12.9 million for the quarter ended September 30, 2021. The increase was mainly driven by higher product manufacturing and development expenses in support of the global Phase 3 PHOENIX clinical trial and launch preparation activities for commercialization, as well as additional personnel-related expenses due to new headcount to support research and development efforts. Selling, general and administrative expenses were $29.9 million for the quarter ended September 30, 2022, compared to $10.4 million for the quarte

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Source: SEC EDGAR

accession 0000950170-22-024448

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