UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |----------------------------------------------------------------------------------------------------| | | | For the transition period from ___________________ to | | Commission F ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations & Communications Justin Klee - Co-Chief Executive Officer Margaret Olinger - Chief Commercial Officer Jim Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Geoff Meacham - Bank of America Michael DiFiore - Evercore Marc Goodman - Leerink Partners Graig Suvannav ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |-----------------------------------------------------------------------------------------------------| | | | For the transition period from ___________________ to ___________________ ...

Financial Data and Key Metrics Changes - The company reported net product revenues of $71.4 million for Q1 2023, a significant increase from $21.9 million in Q4 2022, primarily driven by the launch of RELYVRIO [4][25]. - The net adjustments for the quarter were approximately 16%, consistent with expectations in the 15% to 20% range [25]. - The company achieved a net income of $1.6 million just two quarters into the commercial launch [26][27]. - Cash and short-term investments at the end of the quarter were $345.7 million with no debt, positioning the company to fund its programs without needing additional capital [27]. Business Line Data and Key Metrics Changes - RELYVRIO has seen a rapid uptake, with over 3,000 patients on the treatment by the end of Q1, more than double the number at the start of the quarter [8][12]. - Approximately 10% of patients receiving RELYVRIO were part of interim access or patient assistance programs [14][25]. - The company noted that 65% of the top 500 US prescribers and 95% of key ALS centers had prescribed RELYVRIO to at least one patient since launch [10]. Market Data and Key Metrics Changes - The company is preparing for international expansion, with ongoing regulatory reviews in Europe and expectations for a decision by Q3 2023 [7][29]. - In Canada, interest in ALBRIOZA remains high, and the company is negotiating public insurance coverage [16]. Company Strategy and Development Direction - The company aims to make RELYVRIO a foundational therapy for ALS and is focused on expanding its reach to all eligible patients globally [6][15]. - Plans to initiate a global pivotal phase three study of AMX0035 in Progressive Supranuclear Palsy (PSP) were announced, targeting a significant unmet need in this area [19][20]. - The company is also investing in research for other neurodegenerative diseases, including Wolfram syndrome and ALS, to build a robust pipeline [23]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong demand for RELYVRIO and the potential for profitability ahead of expectations [25][27]. - The company remains focused on executing its launch strategy and pipeline development, with a commitment to helping patients with ALS and other neurodegenerative diseases [28][29]. Other Important Information - The company is experiencing a high level of interest from the ALS community, with broad insurance coverage for RELYVRIO [6][12]. - The average time from receiving an enrollment form to shipping RELYVRIO has improved to about 30 days, down from over 45 days in the previous quarter [14]. Q&A Session Summary Question: What is the expectation for the rate of new patient additions? - Management indicated that while the initial demand was high, the rate of new patient additions is expected to moderate in Q2 compared to Q4 and Q1, but significant growth opportunities remain [31][36]. Question: How long will it take to reach the target of 10,000 patients on therapy? - The company has not provided a specific timeline but remains focused on making RELYVRIO the standard of care for ALS [40]. Question: Will the company maintain profitability through the year? - Management refrained from providing specific guidance on profitability but emphasized that revenue growth outpacing expense growth is key to maintaining profitability [42]. Question: What is the rationale for moving directly into a phase three study for PSP? - The decision was based on meeting all criteria for prioritization, including significant unmet need and strong scientific rationale [43]. Question: How is RELYVRIO being used in patients? - The drug is being utilized in a mix of monotherapy and combination therapy, with a broad patient population being treated [51]. Question: What insights can be shared about the mechanism of AMX0035? - AMX0035 targets pathways related to neurodegeneration, with evidence supporting its efficacy in reducing tau levels in preclinical and clinical studies [56].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition peri ...

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 ...