Financial Data and Key Metrics Changes - Net product revenues for Q2 2023 were $98.2 million, an increase from $71.4 million in Q1 2023, primarily driven by demand in the United States [15][18] - Gross to net adjustments were approximately 10% for the quarter, lower than the anticipated range of 12% to 15% due to favorable true-up of reserve estimates [16] - The company generated $22.1 million in net income, marking the second consecutive quarter of profitability [18] Business Line Data and Key Metrics Changes - As of June 30, 2023, approximately 3,800 patients were on RELYVRIO in the US, up from about 3,000 in Q1 2023 and over 1,300 at the end of 2022 [6][10] - The average time from prescription to shipment for RELYVRIO decreased to about 25 days in Q2, down from 30 days in Q1 [6][13] - In Canada, ALBRIOZA coverage is expected to be in place for the majority of publicly insured lives by the end of August 2023 [7][14] Market Data and Key Metrics Changes - The company reported that nearly all insurers covering ALS patients have published formal policies supporting RELYVRIO, facilitating quicker access to therapy [12][16] - The prescribing of RELYVRIO remains concentrated among just over 80 prescribers, primarily at major ALS centers, representing about half of all prescriptions [10][38] Company Strategy and Development Direction - The company aims to expand awareness and education about RELYVRIO among both patients and clinicians, emphasizing its unique benefits in treating ALS [9][14] - Plans to initiate a Phase 3 ORION clinical trial for AMX0035 in progressive supranuclear palsy (PSP) later this year, indicating a focus on expanding its pipeline [8][19] - The company is also pursuing a program for Wolfram syndrome, showcasing its commitment to addressing multiple neurodegenerative diseases [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for RELYVRIO and the positive trajectory of the business, highlighting the unmet needs in the ALS community [15][18] - The company is preparing for a potential launch in the EU pending CHMP approval, with expectations for a final opinion in the fall [8][31] - Management noted that the focus remains on executing current launches and exploring future business development opportunities [34] Other Important Information - The company fully expensed all remaining royalty obligations in Q2 and will not incur additional royalty expenses related to ALS sales going forward [17] - Cash and short-term investments at the end of the quarter totaled $357.3 million, with zero debt, positioning the company well for future growth [18] Q&A Session Summary Question: What are you seeing with respect to compliance and discontinuation rates? - Management reported that approximately 70% of participants in the CENTAUR trial remained on the drug, and they are tracking close to that in the commercial setting [27][28] Question: How do you view the EU CHMP process now? - The company disagrees with the initial negative opinion from the EU and believes their data package supports approval, with a reexamination process expected to take about four months [31] Question: Can you provide any color on new prescription trends versus refill trends? - The company is focused on expanding outreach beyond ALS centers to general and community neurologists, as many ALS patients are treated outside specialized centers [46][48]

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].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements, reflecting the company's transition to a commercial-stage entity with first-time product revenue and a shift to net income [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, reflecting the company's transition to a commercial-stage entity with first-time product revenue and a shift to net income [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $114,563 | $62,526 | | Short-term investments | $231,111 | $284,419 | | Total current assets | $389,053 | $382,133 | | Total assets | $407,958 | $391,453 | | **Liabilities & Equity** | | | | Total current liabilities | $51,616 | $46,609 | | Total liabilities | $55,310 | $50,846 | | Total stockholders' equity | $352,648 | $340,607 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's financial performance over a period, showing revenue, expenses, and net income or loss Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Product revenue, net | $71,428 | $0 | | Total operating expenses | $73,481 | $47,814 | | Loss from operations | $(2,053) | $(47,814) | | Net income (loss) | $1,573 | $(47,848) | | Diluted net income (loss) per share | $0.02 | $(0.93) | - The company achieved profitability in Q1 2023 with a net income of **$1.6 million**, a significant turnaround from a net loss of **$47.8 million** in Q1 2022, driven by the successful commercial launch of its product[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the sources and uses of cash, categorized into operating, investing, and financing activities Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,072) | $(40,634) | | Net cash provided by (used in) investing activities | $55,994 | $(99,311) | | Net cash provided by financing activities | $1,040 | $200,455 | | Net increase in cash | $52,037 | $60,442 | - Cash used in operating activities decreased significantly to **$5.1 million** from **$40.6 million** year-over-year, reflecting improved operational performance. Financing activities in the prior year period were dominated by proceeds from the company's initial public offering[31](index=31&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed accounting policies and financial results, including product revenue, inventory valuation, and contingent royalty obligations - The company's sole product, RELYVRIO® (ALBRIOZA™ in Canada), is approved for ALS in the U.S. and Canada. An application is under review in Europe. The company is also developing AMX0035 for other neurodegenerative diseases like PSP and Wolfram syndrome[34](index=34&type=chunk) Q1 2023 Product Revenue Gross-to-Net Reconciliation (in thousands) | Description | Amount | | :--- | :--- | | Product revenue, gross | $84,553 | | GTN adjustments | $(13,125) | | **Product revenue, net** | **$71,428** | - The company has royalty payment obligations to the ALS Association and ALS Finding a Cure Foundation, calculated as **3%** of net sales until **150%** of the grant received is repaid. In Q1 2023, the company recorded **$2.5 million** in royalty expense[83](index=83&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity, highlighting Q1 2023 financial results, product revenue, and ongoing clinical trials, confirming sufficient liquidity for the next twelve months - The company's first product, RELYVRIO® (U.S.) / ALBRIOZA™ (Canada), is now commercially available for the treatment of ALS. An application for approval in the EU is under review, with a decision anticipated in Q3 2023 at the earliest[89](index=89&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - Enrollment is complete for the Phase 3 PHOENIX trial for ALS, with topline results expected in mid-2024. The company is also advancing AMX0035 in other indications, having dosed the first participant in a Phase 2 study for Wolfram syndrome and planning a global Phase 3 trial for progressive supranuclear palsy (PSP)[94](index=94&type=chunk)[95](index=95&type=chunk)[97](index=97&type=chunk) - As of March 31, 2023, the company had **$345.7 million** in cash, cash equivalents, and short-term investments. Management believes this, along with product revenue, is sufficient to fund operations for at least the next year[101](index=101&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section details the company's Q1 2023 financial performance, showing $71.4 million in net product revenue, a shift to net income, and increased operating expenses due to commercialization Comparison of Operations for the three months ended March 31 (in thousands) | Metric | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Product revenue, net | $71,428 | $0 | N/A | | Cost of sales | $5,283 | $0 | N/A | | Research and development | $24,192 | $21,464 | 13% | | Selling, general and administrative | $44,006 | $26,350 | 67% | | Net income (loss) | $1,573 | $(47,848) | 103% | - Cost of sales for Q1 2023 was **$5.3 million**, which included **$2.5 million** in royalty expenses. Gross margin was favorably impacted as **$3.2 million** in costs for units sold were expensed prior to regulatory approval. Gross margin is expected to decrease as this pre-commercialization inventory is depleted[121](index=121&type=chunk) - The **67% increase** in SG&A expenses to **$44.0 million** was primarily due to hiring additional commercial and administrative personnel to support growth and commercialization efforts in the U.S. and EU[125](index=125&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's liquidity, with $345.7 million in cash and investments, deemed sufficient for the next twelve months, and a significant reduction in cash used in operations - The company believes that revenue from AMX0035 sales in the U.S. and Canada, combined with existing cash of **$345.7 million**, will be sufficient to meet operating and capital needs for at least the next twelve months from the filing date[129](index=129&type=chunk)[133](index=133&type=chunk) Cash Flow Comparison for the three months ended March 31 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,072) | $(40,634) | | Net cash provided by (used in) investing activities | $55,994 | $(99,311) | | Net cash provided by financing activities | $1,040 | $200,455 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses market risks, primarily interest rate sensitivity on $345.7 million in cash and investments, with minor foreign currency and inflation impacts - The primary market risk is interest rate sensitivity on the company's **$345.7 million** in cash and investments. Due to the portfolio's duration and low-risk profile, management believes the impact of interest rate changes would not be material[149](index=149&type=chunk) - The company is not currently exposed to significant foreign currency exchange risk but acknowledges potential future risk as it contracts with international vendors. Inflation has not had a material effect on the business but may impact labor costs[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - As of March 31, 2023, the company's management concluded that its disclosure controls and procedures were effective[152](index=152&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[153](index=153&type=chunk) [PART II. OTHER INFORMATION](index=31&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened actions - As of the filing date, the company is not involved in any material legal proceedings[155](index=155&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks and uncertainties across financial position, commercialization, product development, third-party dependence, intellectual property, and business operations [Risks Related to Financial Position and Need for Capital](index=33&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Capital) This subsection outlines financial risks, including a history of significant losses, limited commercial operating history, and the potential need for additional funding - The company has a history of significant losses, with an accumulated deficit of **$352.6 million** as of March 31, 2023, and may incur more if revenue from its approved products does not cover expenses[167](index=167&type=chunk) - The company has a limited operating history as a commercial entity, having only recently launched its first products, which makes evaluating future viability difficult[173](index=173&type=chunk) [Risks Related to Commercialization](index=37&type=section&id=Risks%20Related%20to%20Commercialization%20of%20AMX0035%20or%20Future%20Product%20Candidates) This subsection details commercialization risks for AMX0035, including limited experience, market acceptance, reimbursement challenges, and potential generic competition - The company has limited experience as a commercial entity and may not be successful in commercializing AMX0035, which could prevent it from generating meaningful product revenue[196](index=196&type=chunk) - Successful commercialization is dependent on achieving market acceptance and securing adequate coverage and reimbursement from third-party payors, which is uncertain and may be limited[204](index=204&type=chunk)[228](index=228&type=chunk) [Risks Related to Discovery and Development](index=48&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20Our%20Current%20and%20Future%20Product%20Candidates) This subsection highlights drug development risks, including high dependence on AMX0035 and the critical risk of the PHOENIX trial failing, potentially leading to approval withdrawal - The company's business is highly dependent on the success of its single advanced product candidate, AMX0035. Failure to maintain or obtain additional approvals would materially harm the business[259](index=259&type=chunk)[260](index=260&type=chunk) - A critical risk is that the ongoing global Phase 3 PHOENIX trial may not be successful. The company has stated it would voluntarily withdraw the product from the market if the trial fails, and regulators could also mandate a withdrawal[175](index=175&type=chunk)[277](index=277&type=chunk)[287](index=287&type=chunk) [Risks Related to Dependence on Third Parties](index=66&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This subsection discusses risks from reliance on third-party manufacturers for supply and contract research organizations for clinical trials, potentially causing disruptions or delays - The company relies on third-party manufacturers for the production of AMX0035, which increases risks related to supply sufficiency, quality control (cGMP compliance), and potential delays[388](index=388&type=chunk)[389](index=389&type=chunk) - The company depends on CROs and other third parties to conduct its clinical trials. Poor performance by these parties could compromise data integrity and delay or prevent regulatory approval[383](index=383&type=chunk) [Risks Related to Intellectual Property](index=71&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This subsection covers intellectual property risks, including obtaining and maintaining patent protection for AMX0035, potential infringement litigation, and trade secret protection challenges - The company's commercial success is dependent on its ability to obtain and maintain intellectual property protection for AMX0035. If patent protection is not sufficiently broad, competitors may develop similar products[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk) - The company may face costly litigation if sued for infringing on the intellectual property rights of third parties, which could prevent or delay the commercialization of its products[437](index=437&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=89&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[510](index=510&type=chunk) [Item 5. Other Information](index=89&type=section&id=Item%205.%20Other%20Information) The company entered into a standard indemnification agreement with newly appointed director Karen Firestone on May 8, 2023 - The company entered into a standard indemnification agreement with newly appointed director Karen Firestone on May 8, 2023[511](index=511&type=chunk) [Item 6. Exhibits](index=90&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, material contracts, and officer certifications - Exhibits filed include amendments to manufacturing and supply agreements, director indemnification agreements, and officer certifications[514](index=514&type=chunk)

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 ...

Product & Clinical Data - RELYVRIO™ and ALBRIOZA™ are approved in the United States and Canada as treatments for ALS [4] - The CENTAUR trial showed a 232-point difference (p=003) in ALSFRS-R scores, indicating a statistically significant functional benefit with RELYVRIO [10] - Participants on RELYVRIO in the CENTAUR trial had a median survival of 235 months compared to 187 months for placebo, a 48-month difference (HR=064, 95% CI=0416-0995) [11] - Common adverse events with RELYVRIO (at least 15% and at least 5% greater than placebo) included diarrhea (25% vs 19%), abdominal pain (21% vs 13%), nausea (18% vs 13%), and upper respiratory tract infection (18% vs 10%) [15] - The PHOENIX Phase 3 trial, with 664 participants, completed enrollment in February 2023, with topline data anticipated in mid-2024 [38] Market & Commercial Strategy - ALS affects at least 200000 people worldwide [20] - In the United States, approximately 29000 people are living with ALS; in Canada, approximately 3000 people; and in Europe (EU and UK), over 30000 people [20] - The company is focused on driving awareness and education of RELYVRIO, engaging payors on access, and ensuring positive interactions for people living with ALS and ALS clinics [21] - Approximately 500 ALS physicians represent approximately two-thirds of prescriptions in the U S market [30] Financials - As of December 31, 2022, the company had $3469 million in cash, cash equivalents, and short-term investments [68] - Net product revenue for Q4 2022 was $219 million, and expenses for the same period were $665 million [68]

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. ...