$AMLX
Amylyx Pharmaceuticals, Inc.

2024 Q2 Form 10-Q Financial Statement

#000095017024056269 Filed on May 09, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1
Revenue -$1.023M $88.64M
YoY Change -101.04% 24.1%
Cost Of Revenue $8.000K $5.945M
YoY Change -99.86% 12.53%
Gross Profit -$1.031M $82.70M
YoY Change -101.11% 25.03%
Gross Profit Margin 93.29%
Selling, General & Admin $21.65M $57.76M
YoY Change -50.11% 31.25%
% of Gross Profit 69.84%
Research & Development $23.35M $36.61M
YoY Change -19.62% 51.32%
% of Gross Profit 44.27%
Depreciation & Amortization $208.0K $315.0K
YoY Change -25.98% 54.41%
% of Gross Profit 0.38%
Operating Expenses $44.99M $94.37M
YoY Change -37.88% 38.37%
Operating Profit -$76.29M -$122.1M
YoY Change -477.63% 5848.86%
Interest Expense $4.069M $4.326M
YoY Change 4.68% 16.35%
% of Operating Profit
Other Income/Expense, Net $3.586M $3.579M
YoY Change -5.78% 3.56%
Pretax Income -$72.70M -$118.6M
YoY Change -402.83% -8549.82%
Income Tax $0.00 $242.0K
% Of Pretax Income
Net Earnings -$72.70M -$118.8M
YoY Change -429.35% -7652.0%
Net Earnings / Revenue -134.01%
Basic Earnings Per Share -$1.07 -$1.75
Diluted Earnings Per Share -$1.07 -$1.75
COMMON SHARES
Basic Shares Outstanding 68.01M 67.78M
Diluted Shares Outstanding 68.02M 67.85M

Balance Sheet

Concept 2024 Q2 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $309.8M $373.3M
YoY Change -13.28% 7.99%
Cash & Equivalents $75.00M $170.6M
Short-Term Investments $234.8M $202.7M
Other Short-Term Assets $12.82M $16.89M
YoY Change 8.76% 32.48%
Inventory $0.00 $0.00
Prepaid Expenses
Receivables $4.091M $20.35M
Other Receivables $0.00 $0.00
Total Short-Term Assets $326.7M $410.5M
YoY Change -23.55% 5.52%
LONG-TERM ASSETS
Property, Plant & Equipment $1.473M $2.459M
YoY Change -44.14% -3.91%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $479.0K $493.0K
YoY Change 2.79% 5.79%
Total Long-Term Assets $5.440M $6.923M
YoY Change -79.23% -63.38%
TOTAL ASSETS
Total Short-Term Assets $326.7M $410.5M
Total Long-Term Assets $5.440M $6.923M
Total Assets $332.2M $417.5M
YoY Change -26.77% 2.33%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.955M $21.45M
YoY Change -79.94% 99.19%
Accrued Expenses $62.76M $67.87M
YoY Change 68.52% 75.15%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $70.08M $91.64M
YoY Change 9.36% 77.54%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $772.0K $1.382M
YoY Change -75.42% -62.59%
Total Long-Term Liabilities $772.0K $1.382M
YoY Change -75.42% -62.59%
TOTAL LIABILITIES
Total Short-Term Liabilities $70.08M $91.64M
Total Long-Term Liabilities $772.0K $1.382M
Total Liabilities $70.85M $93.02M
YoY Change 5.4% 68.18%
SHAREHOLDERS EQUITY
Retained Earnings -$496.4M -$423.7M
YoY Change 50.18% 20.16%
Common Stock $757.8M $748.3M
YoY Change 5.7% 6.09%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $261.3M $324.4M
YoY Change
Total Liabilities & Shareholders Equity $332.2M $417.5M
YoY Change -26.77% 2.33%

Cashflow Statement

Concept 2024 Q2 2024 Q1
OPERATING ACTIVITIES
Net Income -$72.70M -$118.8M
YoY Change -429.35% -7652.0%
Depreciation, Depletion And Amortization $208.0K $315.0K
YoY Change -25.98% 54.41%
Cash From Operating Activities -$66.58M -$489.0K
YoY Change -873.38% -90.36%
INVESTING ACTIVITIES
Capital Expenditures $89.00K $67.00K
YoY Change -67.99% -73.2%
Acquisitions
YoY Change
Other Investing Activities -$28.87M $886.0K
YoY Change -123.38% -98.42%
Cash From Investing Activities -$28.96M $819.0K
YoY Change -123.5% -98.54%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 27.00K 131.0K
YoY Change -98.05% -87.4%
NET CHANGE
Cash From Operating Activities -66.58M -489.0K
Cash From Investing Activities -28.96M 819.0K
Cash From Financing Activities 27.00K 131.0K
Net Change In Cash -95.51M 351.0K
YoY Change -171.7% -99.33%
FREE CASH FLOW
Cash From Operating Activities -$66.58M -$489.0K
Capital Expenditures $89.00K $67.00K
Free Cash Flow -$66.67M -$556.0K
YoY Change -900.25% -89.55%

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CY2024Q1 us-gaap Nature Of Operations
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<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="text-transform:uppercase;color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1. Nature of the Business</span><span style="text-transform:uppercase;color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Amylyx Pharmaceuticals, Inc., together with its wholly owned subsidiaries, known as Amylyx or the Company, is a biotechnology company with a mission to end the suffering caused by neurodegenerative diseases. The Company is investigating AMX0035 in diseases where endoplasmic reticulum, or ER, and mitochondrial stress are implicated, including progressive supranuclear palsy, or PSP, and Wolfram syndrome, or WS. The Company dosed the first participant in the HELIOS trial, a Phase 2 trial of AMX0035 for the treatment of WS, in April 2023. The Company dosed the first participant in the ORION trial, a Phase 3 trial of AMX0035 for the treatment of PSP, in December 2023. The Company is also advancing additional drug candidates developed by Amylyx for neurodegenerative diseases including AMX0114, a potent antisense oligonucleotide targeting inhibition of Calpain-2, a key contributor to the axonal (also known as Wallerian) degeneration pathway. Preclinical studies completed to date have shown that AMX0114 achieves potent, dose-dependent, and durable knockdown of CAPN2 mRNA expression and Calpain-2 protein levels in human motor neurons. In preclinical efficacy studies, treatment with AMX0114 reduced extracellular neurofilament light chain levels following neurotoxic insult in induced pluripotent stem cell (iPSC)-derived human motor neurons, and improved survival of iPSC-derived human motor neurons harboring ALS-linked, pathogenic TDP-43 mutations. Neurofilament is a broadly researched biomarker in ALS. The Company plans to file an investigational new drug (IND) application, then initiate a multiple ascending dose clinical trial of AMX0114 in people living with ALS in the second half of 2024.</span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On April 4, 2024, the Company announced it started a process with the U.S. Food and Drug Administration, or the FDA, and Health Canada to voluntarily discontinue the marketing authorizations for RELYVRIO</span><span style="color:#000000;white-space:pre-wrap;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">/ALBRIOZA</span><span style="color:#000000;white-space:pre-wrap;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">™</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> (AMX0035) for amyotrophic lateral sclerosis, or ALS, and remove the product from the market in the U.S. and Canada based on topline results from the global Phase 3 PHOENIX trial, which failed to meet its prespecified primary and secondary endpoints. The Company will continue to collect available data on survival and to share learnings from PHOENIX to help inform future ALS research. Amylyx is planning to wind down the Open Label Extension by the end of 2024. Separately, the PHOENIX survival data collection efforts will continue at the encouragement of ALS specialists.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Risks and Uncertainties</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:6.667%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the outcome of preclinical studies and clinical trials, potential difficulties with or delays in timing with respect to regulatory approval processes, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the economic challenges caused by economic uncertainty in various global markets caused by geopolitical instability and conflict. The Company and its contractors may experience disruptions in supply of items that are essential for its research and development activities, including, for example, raw materials and bulk drug substances that the Company imports from Europe and Canada used in the manufacturing of AMX0035, and any additional or future product candidates</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">.</span></p>
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<p style="text-indent:6.667%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Use of Estimates</span></p><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: gross-to-net, or GTN, adjustments; recoverability of inventories; accrued expense and research and development expenses</span>
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