2023 Q4 Form 10-Q Financial Statement

#000095017023061516 Filed on November 09, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3
Revenue $108.4M $102.7M
YoY Change 395.54% 29666.09%
Cost Of Revenue $9.360M $5.218M
YoY Change 231.8% 2933.72%
Gross Profit $99.09M $97.48M
YoY Change 419.77% 56243.93%
Gross Profit Margin 91.37% 94.92%
Selling, General & Admin $52.24M $48.72M
YoY Change 27.9% 62.72%
% of Gross Profit 52.72% 49.98%
Research & Development $44.91M $30.04M
YoY Change 96.88% 20.56%
% of Gross Profit 45.33% 30.82%
Depreciation & Amortization $298.0K $300.0K
YoY Change 63.74% 81.82%
% of Gross Profit 0.3% 0.31%
Operating Expenses $97.16M $78.76M
YoY Change 52.62% 43.57%
Operating Profit $1.934M $18.72M
YoY Change -104.34% -134.23%
Interest Expense $4.371M $4.200M
YoY Change 38.45% 598.84%
% of Operating Profit 226.01% 22.44%
Other Income/Expense, Net $171.0K $3.691M
YoY Change -124.82% 361.38%
Pretax Income $6.476M $22.41M
YoY Change -115.37% -141.59%
Income Tax $1.745M $1.500M
% Of Pretax Income 26.95% 6.69%
Net Earnings $4.731M $20.89M
YoY Change -111.08% -138.87%
Net Earnings / Revenue 4.36% 20.35%
Basic Earnings Per Share $0.31
Diluted Earnings Per Share $0.07 $0.30
COMMON SHARES
Basic Shares Outstanding 67.52M 67.38M
Diluted Shares Outstanding 69.75M

Balance Sheet

Concept 2023 Q4 2023 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $371.4M $355.0M
YoY Change 7.04% 118.34%
Cash & Equivalents $170.2M $135.3M
Short-Term Investments $201.2M $219.8M
Other Short-Term Assets $14.93M $17.30M
YoY Change 47.64% 94.25%
Inventory $38.32M $32.37M
Prepaid Expenses
Receivables $40.05M $29.35M
Other Receivables $0.00 $0.00
Total Short-Term Assets $464.7M $434.1M
YoY Change 21.6% 152.1%
LONG-TERM ASSETS
Property, Plant & Equipment $2.686M $2.761M
YoY Change 2.87% 30.36%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $701.0K $476.0K
YoY Change 50.43% 4.39%
Total Long-Term Assets $52.79M $32.47M
YoY Change 466.39% 251.3%
TOTAL ASSETS
Total Short-Term Assets $464.7M $434.1M
Total Long-Term Assets $52.79M $32.47M
Total Assets $517.5M $466.6M
YoY Change 32.19% 157.15%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $22.06M $6.371M
YoY Change 252.58% -9.66%
Accrued Expenses $57.72M $37.05M
YoY Change 43.05% 44.74%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $82.04M $45.62M
YoY Change 76.02% 39.73%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.980M $2.600M
YoY Change -53.27% -45.47%
Total Long-Term Liabilities $1.980M $2.600M
YoY Change -53.27% -45.47%
TOTAL LIABILITIES
Total Short-Term Liabilities $82.04M $45.62M
Total Long-Term Liabilities $1.980M $2.600M
Total Liabilities $84.02M $48.18M
YoY Change 65.25% 28.78%
SHAREHOLDERS EQUITY
Retained Earnings -$304.9M -$309.7M
YoY Change -13.9% -0.58%
Common Stock $738.2M $728.2M
YoY Change 6.23% 59.61%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $433.4M $418.4M
YoY Change
Total Liabilities & Shareholders Equity $517.5M $466.6M
YoY Change 32.19% 157.15%

Cashflow Statement

Concept 2023 Q4 2023 Q3
OPERATING ACTIVITIES
Net Income $4.731M $20.89M
YoY Change -111.08% -138.87%
Depreciation, Depletion And Amortization $298.0K $300.0K
YoY Change 63.74% 81.82%
Cash From Operating Activities $13.55M -$5.170M
YoY Change -127.26% -88.0%
INVESTING ACTIVITIES
Capital Expenditures $351.0K $360.0K
YoY Change -43.39% -178.43%
Acquisitions
YoY Change
Other Investing Activities $21.28M -$107.7M
YoY Change -109.35% -227.49%
Cash From Investing Activities $20.92M -$108.1M
YoY Change -109.17% -228.62%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 233.0K 890.0K
YoY Change -99.9%
NET CHANGE
Cash From Operating Activities 13.55M -5.170M
Cash From Investing Activities 20.92M -108.1M
Cash From Financing Activities 233.0K 890.0K
Net Change In Cash 34.71M -112.4M
YoY Change -175.92% -374.32%
FREE CASH FLOW
Cash From Operating Activities $13.55M -$5.170M
Capital Expenditures $351.0K $360.0K
Free Cash Flow $13.20M -$5.530M
YoY Change -126.23% -87.02%

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1335000
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10000
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us-gaap Income Taxes Paid Net
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us-gaap Income Taxes Paid Net
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us-gaap Nature Of Operations
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<p style="text-indent:0;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-weight:normal;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 commercial-stage biotechnology company with a mission to one day end the suffering caused by neurodegenerative diseases. The Company is pursuing amyotrophic lateral sclerosis, or ALS, as its first indication and is focused on the development and potential commercialization of AMX0035 for ALS globally. AMX0035 is approved by the U.S. Food and Drug Administration, or the FDA, and marketed as RELYVRIO</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> (sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine) for the treatment of ALS in adults in the U.S. AMX0035 is also approved with conditions by Health Canada and marketed as ALBRIOZA™ for the treatment of ALS in Canada. The Company continues to focus on the completion of its global PHOENIX Phase 3 clinical trial, which will provide additional data on the efficacy and safety profile of AMX0035 in people living with ALS, and is also developing AMX0035 in other neurodegenerative diseases. AMX0035 was designed to target endoplasmic reticulum, or ER, stress and mitochondrial dysfunction, two connected central pathways that can lead to neurodegeneration. The Company is further investigating AMX0035 in diseases where 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 and plans to initiate the ORION trial, a global, pivotal Phase 3 trial of AMX0035 for the treatment of PSP, by the end of 2023. The Company is also advancing additional drug candidates for neurodegenerative diseases including AMX0114, an antisense oligonucleotide targeting Calpain-2, a key protein in axonal degeneration, among others.</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-weight:normal;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, market acceptance and the successful commercialization of its approved products ALBRIOZA, which received marketing authorization with conditions in Canada in June 2022, and RELYVRIO, which was approved by the FDA in the U.S. in September 2022, 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 global health crises such as the COVID-19 pandemic and 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 and commercial 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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">.</span></p>
amlx Gross To Net Adjustments Reserve Provision Related To Current Period Sales
GrossToNetAdjustmentsReserveProvisionRelatedToCurrentPeriodSales
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amlx Gross To Net Adjustments Reserve Adjustments Related To Prior Period Sales
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CY2023Q3 amlx Gross To Net Adjustments Reserve
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amlx Gross To Net Adjustments Reserve Provision Related To Current Period Sales
GrossToNetAdjustmentsReserveProvisionRelatedToCurrentPeriodSales
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amlx Gross To Net Adjustments Reserve Credits And Payments Made
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CY2022Q3 amlx Gross To Net Adjustments Reserve
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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-weight:normal;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, including those produced in preparation for product launches; accrued expenses; stock option valuations; valuation allowance for deferred tax assets and research and development expense</span>
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RevenueFromContractWithCustomerExcludingAssessedTaxGross
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RevenueFromContractWithCustomerExcludingAssessedTaxGross
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amlx Revenue From Contract With Customer Excluding Assessed Tax Gross
RevenueFromContractWithCustomerExcludingAssessedTaxGross
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CY2022Q3 amlx Gross To Net Adjustments
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amlx Gross To Net Adjustments
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CY2023Q3 amlx Debt Securities Available For Sale Number Of Positions
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CY2023Q3 us-gaap Operating Lease Liability
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CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
8480950
CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
13.19
CY2022 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y2M12D
CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
201765000
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
2557569
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
31.36
us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
822820
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
6.57
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
18360000
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
266882
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
17.72
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
9948817
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
18.28
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y
CY2023Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
26785000
CY2023Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Nonvested Number Of Shares
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsNonvestedNumberOfShares
6423249
CY2023Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Nonvested Weighted Average Grant Date Fair Value
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsNonvestedWeightedAverageGrantDateFairValue
22.01
amlx Share Based Compensation Arrangement By Share Based Payment Award Options Unvested Weighted Average Remaining Contractual Term
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsUnvestedWeightedAverageRemainingContractualTerm
P8Y7M6D
CY2023Q3 amlx Share Based Compensation Arrangement By Share Based Payment Award Options Unvested Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsUnvestedIntrinsicValue
17762000
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
20.74
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
18400000
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
6000000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
24800000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
5100000
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
10176000
CY2022Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5524000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
27627000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
15623000
CY2023Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Compensation Cost1
SharebasedCompensationArrangementBySharebasedPaymentAwardCompensationCost1
100000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Compensation Cost1
SharebasedCompensationArrangementBySharebasedPaymentAwardCompensationCost1
300000
CY2022Q3 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Compensation Cost1
SharebasedCompensationArrangementBySharebasedPaymentAwardCompensationCost1
0
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Compensation Cost1
SharebasedCompensationArrangementBySharebasedPaymentAwardCompensationCost1
0
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
10176000
CY2022Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5524000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
27627000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
15623000
CY2023Q3 us-gaap Net Income Loss
NetIncomeLoss
20893000
CY2022Q3 us-gaap Net Income Loss
NetIncomeLoss
-53756000
us-gaap Net Income Loss
NetIncomeLoss
44540000
us-gaap Net Income Loss
NetIncomeLoss
-155671000
CY2023Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
67414669
CY2022Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
58533226
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
67124407
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
56163194
CY2023Q3 us-gaap Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
2333878
us-gaap Weighted Average Number Diluted Shares Outstanding Adjustment
WeightedAverageNumberDilutedSharesOutstandingAdjustment
3019252
CY2023Q3 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
69748547
CY2022Q3 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
58533226
us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
70143659
us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
56163194
CY2023Q3 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
0.31
CY2022Q3 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.92
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
0.66
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-2.77
CY2023Q3 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
0.3
CY2022Q3 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.92
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
0.63
us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-2.77
CY2023Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
6597562
CY2022Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
9263362
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
6447549
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
9263362
amlx Number Of Operating Lease Agreements
NumberOfOperatingLeaseAgreements
2
CY2023Q3 us-gaap Restricted Cash Noncurrent
RestrictedCashNoncurrent
700000
CY2022Q4 us-gaap Restricted Cash Noncurrent
RestrictedCashNoncurrent
700000
ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false

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