Investor Presentation April 2023 photo in memory of Mick, a husband and father, who was a gifted tattoo artist and musician Disclaimer Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statement ...

Investor Presentation March 2023 photo in memory of Mick, a husband and father, who was a gifted tattoo artist and musician Disclaimer Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statement ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q4 2022 Earnings Conference Call March 13, 2023 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer and Co-Founder Margaret Olinger - Global Head of Commercial and CCO James Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer and Co-Founder Conference Call Participants Geoff Meacham - Bank of America Umer Raffat - Evercore ISI Neena Bitritto-Garg - Citi Corinne J ...

Regulatory Approvals - AMX0035 (RELYVRIO) received FDA approval in September 2022 and was commercially available in October 2022, marking the company's first regulatory approval in the U.S. and its second worldwide [671]. - The Marketing Authorization Application for AMX0035 in Europe is under review, with an opinion from the EMA expected mid-year and a decision in Q3 2023 [672]. - The company received marketing authorization for ALBRIOZA in Canada and RELYVRIO in the U.S. for the treatment of ALS [699]. Financial Performance - As of December 31, 2022, the company reported a net loss of $198.4 million for the year, with an accumulated deficit of $354.2 million [677]. - Product revenue for the year ended December 31, 2022, was approximately $22.2 million, a significant increase from $0 in 2021 [705]. - The net loss for the year ended December 31, 2022, was $198.4 million, compared to a net loss of $87.9 million in 2021, reflecting a 126% increase [703]. - Interest income for 2022 was $4.3 million, a significant increase from less than $0.1 million in 2021, attributed to higher investment balances [710]. Expenses and Investments - Research and development expenses rose to $93.5 million in 2022, up 112% from $44.0 million in 2021, primarily due to increased spending on AMX0035 for ALS [708]. - Selling, general and administrative expenses increased to $127.1 million in 2022, a 227% rise from $38.9 million in 2021, driven by higher payroll and personnel-related costs [709]. - The company expects substantial increases in expenses related to the commercialization of AMX0035 and other product candidates, including clinical trials and regulatory approvals [715]. - The company anticipates that existing cash and revenue from AMX0035 sales will be sufficient to meet operating and capital expenditure requirements for at least twelve months [719]. Cash and Funding - The company had cash, cash equivalents, and short-term investments totaling $346.9 million as of December 31, 2022, following a public offering that raised approximately $230.6 million [679]. - The company has raised a total of $663.6 million in proceeds since inception, with $196.4 million from the IPO in January 2022 and $230.6 million from a public offering in October 2022 [714]. - Financing activities provided $431.8 million in cash in 2022, including $200.9 million from the IPO and $231.6 million from a follow-on offering [731]. - Future funding requirements may increase significantly due to various factors, including drug development costs and regulatory review outcomes [721]. Research and Development - The Phase 3 clinical trial (PHOENIX) for AMX0035 enrolled 664 participants, with topline results expected in mid-2024 [673]. - AMX0035 is being pursued as a foundational therapy for ALS and has shown both functional and survival benefits in clinical trials [669]. - Research and development expenses are expected to increase substantially due to planned clinical development activities and commercialization efforts [691]. - The ongoing COVID-19 pandemic and global economic conditions may disrupt the development of AMX0035 and future product candidates [680]. Accounting and Compliance - The company is classified as an "emerging growth company" and has elected to use an extended transition period for compliance with new accounting standards [748]. - The company will cease to be an emerging growth company when total annual gross revenues exceed $1.235 billion or other specified conditions are met [749]. - The company is also classified as a "smaller reporting company," allowing for simplified disclosure obligations until certain revenue and market value thresholds are met [750]. - Recently issued accounting pronouncements that may impact financial position and results of operations are disclosed in the consolidated financial statements [752]. Revenue Recognition - The company recognizes revenue from product sales when control is transferred to customers, with revenue recorded net of applicable gross-to-net adjustments [735]. - The company participates in government programs that require pricing on products to be extended below wholesaler list price, impacting product revenue and accounts receivable [736]. - Cash discounts are offered to customers for prompt payment, reducing product revenue and accounts receivable at the time of sale [738]. - The company accrues rebates and discounts for Medicaid and other government programs, which reduce product revenue in the same period as the related revenue is recognized [739]. - Estimated product returns for established products are based on quantitative and qualitative information, with minimal returns expected in future periods [741]. - Accrued research and development expenses are estimated based on contracts and services performed, with adjustments made as necessary [742]. Operational Challenges - The company has incurred operating losses since inception, primarily due to research and development costs and general administrative expenses [678]. - Operating activities used $179.9 million in cash for the year ended December 31, 2022, primarily due to a net loss of $198.4 million [725]. - Net cash used in investing activities was $239.0 million in 2022, significantly higher than $46.4 million in 2021, reflecting increased investments in short-term assets [729]. - The change in fair value of convertible notes was zero for 2022, compared to a loss of $5.2 million in 2021 due to conversion to preferred stock [711]. - The net cash used in operating assets and liabilities included a $26.1 million increase in accrued expenses due to higher spending on external research and development [726]. - The company plans to continue expanding its intellectual property portfolio and transitioning to a public company structure, which will incur additional legal and compliance costs [718].

Investor Presentation February 2023 photo in memory of Mick, a husband and father, who was a gifted tattoo artist and musician Disclaimer Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statem ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer Margaret Olinger - Chief Commercial Officer James Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Michael DiFiore - Evercore Inc. Marc Goodman - SVB Securities Neena Bitritto-Garg - Citigroup Inc. ...