2024 Q4 Form 10-Q Financial Statement

#000186078224000116 Filed on November 12, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3
Revenue $13.53M
YoY Change 12.46%
Cost Of Revenue $0.00
YoY Change -100.0%
Gross Profit $13.53M
YoY Change 17.86%
Gross Profit Margin 100.0%
Selling, General & Admin $12.88M
YoY Change -0.92%
% of Gross Profit 95.2%
Research & Development $8.320M
YoY Change -83.79%
% of Gross Profit 61.47%
Depreciation & Amortization $1.658M
YoY Change -40.14%
% of Gross Profit 12.25%
Operating Expenses $21.20M
YoY Change -67.03%
Operating Profit -$13.94M
YoY Change -82.12%
Interest Expense $2.855M
YoY Change -21.26%
% of Operating Profit
Other Income/Expense, Net $1.153M
YoY Change -57.36%
Pretax Income -$9.933M
YoY Change -86.13%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$9.933M
YoY Change -86.13%
Net Earnings / Revenue -73.39%
Basic Earnings Per Share -$0.19
Diluted Earnings Per Share -$0.19
COMMON SHARES
Basic Shares Outstanding 51.59M shares 51.50M shares
Diluted Shares Outstanding 52.26M shares

Balance Sheet

Concept 2024 Q4 2024 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $192.4M
YoY Change -23.22%
Cash & Equivalents $59.98M
Short-Term Investments $132.4M
Other Short-Term Assets $3.805M
YoY Change -46.41%
Inventory
Prepaid Expenses $3.805M
Receivables $22.28M
Other Receivables $0.00
Total Short-Term Assets $218.5M
YoY Change -21.2%
LONG-TERM ASSETS
Property, Plant & Equipment $35.24M
YoY Change -41.93%
Goodwill
YoY Change
Intangibles $6.063M
YoY Change -10.46%
Long-Term Investments $0.00
YoY Change -100.0%
Other Assets $38.34M
YoY Change 1.17%
Total Long-Term Assets $285.4M
YoY Change -21.51%
TOTAL ASSETS
Total Short-Term Assets $218.5M
Total Long-Term Assets $285.4M
Total Assets $503.8M
YoY Change -21.37%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.076M
YoY Change -4.35%
Accrued Expenses $38.56M
YoY Change -22.41%
Deferred Revenue $0.00
YoY Change -100.0%
Short-Term Debt $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $44.10M
YoY Change -35.16%
LONG-TERM LIABILITIES
Long-Term Debt $0.00
YoY Change
Other Long-Term Liabilities $0.00
YoY Change -100.0%
Total Long-Term Liabilities $0.00
YoY Change -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $44.10M
Total Long-Term Liabilities $0.00
Total Liabilities $275.7M
YoY Change -17.54%
SHAREHOLDERS EQUITY
Retained Earnings -$548.9M
YoY Change 20.81%
Common Stock $5.000K
YoY Change 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $228.1M
YoY Change
Total Liabilities & Shareholders Equity $503.8M
YoY Change -21.37%

Cashflow Statement

Concept 2024 Q4 2024 Q3
OPERATING ACTIVITIES
Net Income -$9.933M
YoY Change -86.13%
Depreciation, Depletion And Amortization $1.658M
YoY Change -40.14%
Cash From Operating Activities -$10.50M
YoY Change -51.16%
INVESTING ACTIVITIES
Capital Expenditures $34.00K
YoY Change -98.76%
Acquisitions
YoY Change
Other Investing Activities -$41.46M
YoY Change -320.55%
Cash From Investing Activities -$41.50M
YoY Change -358.55%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 52.00K
YoY Change -174.29%
NET CHANGE
Cash From Operating Activities -10.50M
Cash From Investing Activities -41.50M
Cash From Financing Activities 52.00K
Net Change In Cash -51.95M
YoY Change 839.42%
FREE CASH FLOW
Cash From Operating Activities -$10.50M
Capital Expenditures $34.00K
Free Cash Flow -$10.54M
YoY Change -56.54%

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Description of the business<div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2seventy bio, Inc. (the “Company” or “2seventy bio”) was incorporated in Delaware on April 26, 2021 and is a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer. The Company’s approach combines its expertise in T cell engineering technology and lentiviral vector gene delivery approaches, experience in research, development, and manufacturing of cell therapies and a suite of technologies that can be selectively deployed to develop highly innovative, targeted cellular therapies for patients with cancer. The Company, together with BMS, is delivering the first U.S. Food and Drug Administration (“FDA”) approved CAR T therapy in multiple myeloma, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Abecma</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, to patients in the United States. Please refer to Note 11, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Collaborative arrangements and strategic partnerships</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, for further discussion of the collaboration with BMS. </span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2seventy bio Securities Corporation is a wholly-owned subsidiary of the Company and was granted securities corporation status in Massachusetts for the 2021 tax year. 2seventy bio Securities Corporation has no employees.</span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On January 29, 2024, the Company began undertaking a strategic realignment to focus on the development and commercialization of </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Abecma. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In connection with the strategic realignment, the Company </span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">entered into an asset purchase agreement with Regeneron Pharmaceuticals, Inc. (“Regeneron”), to sell to Regeneron substantially all of the assets related to its oncology and autoimmune cell therapy programs (the “Regeneron Transaction”)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">. T</span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">he Regeneron Transaction closed on April 1, 2024 and Regeneron assumed all of the ongoing programs, infrastructure and personnel costs related to these programs. I</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">n June 2024, the Company announced the completion of an asset purchase agreement with Novo Nordisk (“Novo”) as part of its strategic realignment. Under the terms of the Novo Transaction, Novo acquired the Company’s program for the research, development, manufacture, regulatory approval, and commercialization of gene therapy products exploiting the megaTAL Platform that is directed to the treatment, diagnosis and prevention of hemophilia (the “megaTAL Sale”). </span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Going concern</span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In accordance with Accounting Standards Codification 205-40, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Going Concern</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. The Company has incurred normal operating losses and has experienced negative operating cash flows for all historical periods presented. During the nine months ended September 30, 2024, the Company incurred a net loss of $37.7 million and used $75.5 million of cash in operations. The Company expects to continue to generate operating losses and negative operating cash flows for the near future. </span></div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">As of September 30, 2024, the Company had cash, cash equivalents, and marketable securities of $192.4 million. Based on the Company’s current operating plans, including with respect to the ongoing commercialization of </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Abecma,</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> the Company expects that its cash, cash equivalents, and marketable securities will be sufficient to fund current planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. The Company’s current operating plan is based on various assumptions. If the Company uses its capital resources sooner than expected, it would evaluate further reductions in its expense or obtaining additional financing. This may include pursuing a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. This may also include the potential sale of shares of the Company’s common stock of up to $150.0 million in gross proceeds under the at-the-market (“ATM”) facility established in November 2022 with Cowen and Company, LLC. No sales of common stock have occurred under this ATM as of the date of this Quarterly Report on Form 10-Q and the Company does not currently have any plans to sell shares under the ATM.</span>
us-gaap Net Income Loss
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us-gaap Use Of Estimates
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<div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of estimates</span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the condensed consolidated financial statements.</span></div><div style="margin-bottom:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Estimates and judgments are used in the following areas, among others: future undiscounted cash flows and subsequent fair value estimates used to assess potential and measure any impairment of long-lived assets, including intangible assets, the measurement of right-of-use assets and lease liabilities, contingent consideration, stock-based compensation expense, accrued expenses, income taxes, and the assessment of the Company's ability to fund its operations for at least the next twelve months from the date of issuance of these condensed consolidated financial </span></div><div style="margin-bottom:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">statements. In addition, estimates and judgments are used in the Company’s accounting for its revenue-generating arrangements, in particular as it relates to determining the stand-alone selling price of performance obligations, evaluating whether an option to acquire additional goods and services represents a material right, estimating the total transaction price, including estimating variable consideration and the probability of achieving future potential development and regulatory milestones, assessing the period of performance over which revenue may be recognized, and accounting for modifications to revenue-generating arrangements.</span></div>
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CY2024Q3 us-gaap Debt Securities Available For Sale Continuous Unrealized Loss Position12 Months Or Longer
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1973000 usd
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2000 usd
CY2024Q3 tsvt Restricted Investments Available For Sale Continuous Unrealized Loss Position12 Months Or Longer
RestrictedInvestmentsAvailableForSaleContinuousUnrealizedLossPosition12MonthsOrLonger
5963000 usd
CY2024Q3 tsvt Restricted Investments Available For Sale Continuous Loss Position12 Months Or Longer Accumulated Loss
RestrictedInvestmentsAvailableForSaleContinuousLossPosition12MonthsOrLongerAccumulatedLoss
32000 usd
CY2024Q3 tsvt Restricted Investments Available For Sale Unrealized Loss Position
RestrictedInvestmentsAvailableForSaleUnrealizedLossPosition
7936000 usd
CY2024Q3 tsvt Restricted Investments Available For Sale Unrealized Loss Position Accumulated Loss
RestrictedInvestmentsAvailableForSaleUnrealizedLossPositionAccumulatedLoss
34000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Continuous Unrealized Loss Position Less Than12 Months
RestrictedInvestmentsAvailableForSaleContinuousUnrealizedLossPositionLessThan12Months
3496000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Continuous Loss Position Less Than12 Months Accumulated Loss
RestrictedInvestmentsAvailableForSaleContinuousLossPositionLessThan12MonthsAccumulatedLoss
4000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Continuous Unrealized Loss Position12 Months Or Longer
RestrictedInvestmentsAvailableForSaleContinuousUnrealizedLossPosition12MonthsOrLonger
13266000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Continuous Loss Position12 Months Or Longer Accumulated Loss
RestrictedInvestmentsAvailableForSaleContinuousLossPosition12MonthsOrLongerAccumulatedLoss
361000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Unrealized Loss Position
RestrictedInvestmentsAvailableForSaleUnrealizedLossPosition
16762000 usd
CY2023Q4 tsvt Restricted Investments Available For Sale Unrealized Loss Position Accumulated Loss
RestrictedInvestmentsAvailableForSaleUnrealizedLossPositionAccumulatedLoss
365000 usd
CY2024Q3 us-gaap Interest Receivable
InterestReceivable
1000000 usd
CY2023Q4 us-gaap Interest Receivable
InterestReceivable
800000 usd
tsvt Interest Receivable Write Off
InterestReceivableWriteOff
0 usd
CY2023Q3 tsvt Interest Receivable Write Off
InterestReceivableWriteOff
0 usd
CY2024Q3 tsvt Interest Receivable Write Off
InterestReceivableWriteOff
0 usd
tsvt Interest Receivable Write Off
InterestReceivableWriteOff
0 usd
CY2024Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
63797000 usd
CY2023Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
115061000 usd
CY2024Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
28560000 usd
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
56911000 usd
CY2024Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
35237000 usd
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
58150000 usd
CY2024Q3 tsvt Accrued Collaboration Research Costs Current
AccruedCollaborationResearchCostsCurrent
7053000 usd
CY2023Q4 tsvt Accrued Collaboration Research Costs Current
AccruedCollaborationResearchCostsCurrent
5681000 usd
CY2024Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
6591000 usd
CY2023Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
4639000 usd
CY2024Q3 us-gaap Accrued Royalties Current
AccruedRoyaltiesCurrent
4022000 usd
CY2023Q4 us-gaap Accrued Royalties Current
AccruedRoyaltiesCurrent
9702000 usd
CY2024Q3 tsvt Accrued Clinical And Contract Research Organization Costs Current
AccruedClinicalAndContractResearchOrganizationCostsCurrent
904000 usd
CY2023Q4 tsvt Accrued Clinical And Contract Research Organization Costs Current
AccruedClinicalAndContractResearchOrganizationCostsCurrent
990000 usd
CY2024Q3 tsvt Deferred Transition Services Income Current
DeferredTransitionServicesIncomeCurrent
457000 usd
CY2023Q4 tsvt Deferred Transition Services Income Current
DeferredTransitionServicesIncomeCurrent
0 usd
CY2024Q3 tsvt Accrued Manufacturing Costs Current
AccruedManufacturingCostsCurrent
0 usd
CY2023Q4 tsvt Accrued Manufacturing Costs Current
AccruedManufacturingCostsCurrent
1764000 usd
CY2024Q3 tsvt Accrued Property Plant And Equipment Current
AccruedPropertyPlantAndEquipmentCurrent
0 usd
CY2023Q4 tsvt Accrued Property Plant And Equipment Current
AccruedPropertyPlantAndEquipmentCurrent
279000 usd
CY2024Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
4195000 usd
CY2023Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
2633000 usd
CY2024Q3 us-gaap Accrued Liabilities And Other Liabilities
AccruedLiabilitiesAndOtherLiabilities
23222000 usd
CY2023Q4 us-gaap Accrued Liabilities And Other Liabilities
AccruedLiabilitiesAndOtherLiabilities
25688000 usd
tsvt Lease Arrangements Annual Increase Percentage
LeaseArrangementsAnnualIncreasePercentage
0.63
CY2024Q2 us-gaap Business Exit Costs1
BusinessExitCosts1
5400000 usd
CY2024Q3 us-gaap Business Exit Costs1
BusinessExitCosts1
300000 usd
CY2018Q3 tsvt Number Of Accounting Units
NumberOfAccountingUnits
2 accounting_unit
CY2024Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2643000 usd
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
9800000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
9712000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
27206000 usd
CY2024Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2643000 usd
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
9800000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
9712000 usd
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7563000 shares
CY2024Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7563000 shares
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5704000 shares
CY2023Q4 us-gaap Restructuring Reserve
RestructuringReserve
0 usd
us-gaap Restructuring Charges
RestructuringCharges
5376000 usd
us-gaap Payments For Restructuring
PaymentsForRestructuring
3814000 usd
us-gaap Restructuring Reserve Accrual Adjustment1
RestructuringReserveAccrualAdjustment1
0 usd
CY2024Q3 us-gaap Restructuring Reserve
RestructuringReserve
1562000 usd
CY2024Q3 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false

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