2023 Q4 Form 10-Q Financial Statement

#000129397123000055 Filed on November 07, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3
Revenue $7.834M $12.39M
YoY Change 12334.92% 17353.52%
Cost Of Revenue $9.632M $10.96M
YoY Change 45766.67%
Gross Profit -$1.798M $1.437M
YoY Change -4380.95% 1923.94%
Gross Profit Margin -22.95% 11.6%
Selling, General & Admin $47.10M $40.70M
YoY Change 53.4% 21.86%
% of Gross Profit 2832.5%
Research & Development $33.77M $45.46M
YoY Change -26.42% -14.46%
% of Gross Profit 3163.74%
Depreciation & Amortization $25.40M $1.070M
YoY Change 1922.69% -22.86%
% of Gross Profit 74.46%
Operating Expenses $80.88M $86.17M
YoY Change 5.57% -0.44%
Operating Profit -$82.67M -$84.73M
YoY Change 7.98% -0.06%
Interest Expense -$14.44M $2.454M
YoY Change -4013.82% 540.73%
% of Operating Profit
Other Income/Expense, Net $8.555M $10.54M
YoY Change 30.85% 33.72%
Pretax Income -$88.56M -$71.73M
YoY Change -373.82% -6.25%
Income Tax -$46.00K $0.00
% Of Pretax Income
Net Earnings -$88.51M -$71.73M
YoY Change -374.62% -6.26%
Net Earnings / Revenue -1129.87% -578.85%
Basic Earnings Per Share -$0.66
Diluted Earnings Per Share -$0.75 -$0.66
COMMON SHARES
Basic Shares Outstanding 109.3M shares 107.0M shares
Diluted Shares Outstanding 109.1M shares

Balance Sheet

Concept 2023 Q4 2023 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $221.8M $174.3M
YoY Change 22.02% 23.58%
Cash & Equivalents $221.8M $165.3M
Short-Term Investments $0.00 $8.946M
Other Short-Term Assets $37.01M $17.38M
YoY Change 93.16% -16.45%
Inventory $22.92M $20.97M
Prepaid Expenses $14.80M $11.43M
Receivables $23.00M
Other Receivables $0.00
Total Short-Term Assets $281.7M $247.1M
YoY Change 41.2% 54.0%
LONG-TERM ASSETS
Property, Plant & Equipment $65.94M $9.972M
YoY Change 604.29% -13.55%
Goodwill $5.646M $5.646M
YoY Change 0.0% 0.0%
Intangibles $10.44M $5.368M
YoY Change 114.42%
Long-Term Investments $0.00 $0.00
YoY Change -100.0% -100.0%
Other Assets $54.34M $50.83M
YoY Change 4.25% -2.98%
Total Long-Term Assets $337.5M $366.5M
YoY Change -5.05% 1.91%
TOTAL ASSETS
Total Short-Term Assets $281.7M $247.1M
Total Long-Term Assets $337.5M $366.5M
Total Assets $619.2M $613.6M
YoY Change 11.58% 17.98%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $18.50M $19.85M
YoY Change -26.28% 6.61%
Accrued Expenses $88.79M $121.5M
YoY Change -12.0% 15.71%
Deferred Revenue $9.653M
YoY Change 516.81%
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00
YoY Change
Total Short-Term Liabilities $200.1M $159.0M
YoY Change 56.05% 25.43%
LONG-TERM LIABILITIES
Long-Term Debt $37.73M $0.00
YoY Change
Other Long-Term Liabilities $92.00K $92.00K
YoY Change 0.0% 0.0%
Total Long-Term Liabilities $92.00K $92.00K
YoY Change 0.0% 0.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $200.1M $159.0M
Total Long-Term Liabilities $92.00K $92.00K
Total Liabilities $424.6M $391.1M
YoY Change 18.43% 8.26%
SHAREHOLDERS EQUITY
Retained Earnings -$4.260B -$4.110B
YoY Change 6.78% 2.24%
Common Stock $1.905M $1.071M
YoY Change 129.52% 29.19%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $194.5M $222.5M
YoY Change
Total Liabilities & Shareholders Equity $619.2M $613.6M
YoY Change 11.58% 17.98%

Cashflow Statement

Concept 2023 Q4 2023 Q3
OPERATING ACTIVITIES
Net Income -$88.51M -$71.73M
YoY Change -374.62% -6.26%
Depreciation, Depletion And Amortization $25.40M $1.070M
YoY Change 1922.69% -22.86%
Cash From Operating Activities -$13.84M -$61.85M
YoY Change -75.41% -19.7%
INVESTING ACTIVITIES
Capital Expenditures $5.217M $2.030M
YoY Change 2.13% -260.6%
Acquisitions
YoY Change
Other Investing Activities $8.997M $64.12M
YoY Change -91.7% 280.02%
Cash From Investing Activities $3.790M $62.08M
YoY Change -96.33% 297.72%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 66.28M -40.00K
YoY Change -57733.04% -100.09%
NET CHANGE
Cash From Operating Activities -13.84M -61.85M
Cash From Investing Activities 3.790M 62.08M
Cash From Financing Activities 66.28M -40.00K
Net Change In Cash 56.23M 190.0K
YoY Change 20.02% -101.26%
FREE CASH FLOW
Cash From Operating Activities -$13.84M -$61.85M
Capital Expenditures $5.217M $2.030M
Free Cash Flow -$19.05M -$63.88M
YoY Change -68.96% -15.68%

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Description of the business<div style="margin-top:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">bluebird bio, Inc. (the “Company” or “bluebird”) was incorporated in Delaware on April 16, 1992, and is headquartered in Somerville, Massachusetts. The Company is a biotechnology company committed to researching, developing, and commercializing potentially curative transformative gene therapies for severe genetic diseases based on our lentiviral vector (“LVV”) gene addition platform. In 2022, following more than a decade of leadership in research and clinical development, the Company received approval from the U.S. Food and Drug Administration (the “FDA”) for two gene therapies,</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:9pt;font-weight:400;line-height:120%"> </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">both of which were recently launched. </span></div><div style="margin-top:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On August 17, 2022, ZYNTEGLO (betibeglogene autotemcel, also known as beti-cel), was approved by the FDA for the treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell transfusions. On September 16, 2022, the FDA granted Accelerated Approval of SKYSONA (elivaldogene autotemcel, also known as eli-cel), to slow the progression of neurologic dysfunction in boys 4-17 years of age with early active cerebral adrenoleukodystrophy (“CALD”). On June 21, 2023, the Company announced that the FDA had accepted for priority review the Company's biologics licensing application (“BLA”) for its third gene therapy candidate (lovotibeglogene autotemcel, also known as lovo-cel) which was submitted with a proposed indication for the treatment of patients 12 and older with sickle cell disease (“SCD”) with a history of vaso-occlusive-events. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date for lovo-cel of December 20, 2023 and if approved, the Company anticipates commercial launch in early 2024.</span></div><div style="margin-top: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 Company is focusing its development and commercialization efforts in the U.S. market. 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%"> has obtained the withdrawal of the marketing authorization for beti-cel in the European Union, which became effective on March 24, 2022.</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> On November 18, 2021, the Company obtained the withdrawal of the marketing authorization for eli-cel in the European Union. The Company withdrew its marketing applications for beti-cel and eli-cel from the MHRA in the United Kingdom. </span><span style="background-color:#ffffff;color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is continuing the long-term follow-up of patients previously enrolled within the clinical trial programs in Europe as planned but do not intend to initiate any new clinical trials in Europe for </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">β-</span><span style="background-color:#ffffff;color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">thalassemia, CALD or SCD. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> </span></div><div style="margin-top:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Since its inception in 1992, the Company has devoted substantially all of its resources to its development and commercialization efforts relating to its products and product candidates, including activities to manufacture product candidates in compliance with good manufacturing practices ("GMP") to conduct clinical studies of its product candidates, to provide selling, general and administrative support for these operations, to market, commercially manufacture and distribute its approved products and to protect its intellectual property. The Company has not generated material revenue from product sales. The Company has funded its operations primarily through the sale of common stock in its public offerings, private placements of preferred stock and warrants, the sale of two Rare Pediatric Disease Priority Review Vouchers ("PRVs") and through collaborations. </span></div><div style="margin-top: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 August 2022 and September 2022 the Company received the two PRVs under an FDA program intended to encourage the development of treatments for rare pediatric diseases. In the first quarter of 2023, the Company sold its second PRV for aggregate net proceeds of $92.9 million. In October 2023, the Company entered into an advance agreement to sell a third PRV, if granted in connection with the potential approval of lovo-cel, for $103.0 million.</span></div><div style="margin-top: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 the first quarter of 2023, the Company sold 23.0 million shares of common stock (inclusive of shares sold pursuant to an option to the underwriters in connection with the offering) through an underwritten public offering at a price of $6.00 per share for aggregate net proceeds of $130.5 million.</span></div><div style="margin-top: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 April 2022, the board of directors of the Company (the "Board of Directors") approved a comprehensive restructuring plan intended to reduce operating expenses and enhance the Company’s focus on achieving FDA approval for its programs in the U.S. As part of the restructuring, the Company reduced its workforce by approximately 30% across the second and third quarters of 2022. Refer to Note 14, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Restructuring, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">for more information on this restructuring.</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </span></div><div style="margin-top: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 (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. As of September 30, 2023, the Company had an accumulated deficit of $4.11 billion. During the nine months ended September 30, </span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2023, the Company had a net loss of $123.4 million and used $221.2 million of cash in operations. As of September 30, 2023, the Company had cash, cash equivalents and marketable securities of $174.3 million.</span></div><div style="margin-top:12pt;text-indent:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity or debt issuances and the release of restricted cash related to the Company’s 50 Binney Street sublease cannot be considered probable at this time because these plans are not entirely within the Company’s control nor have been approved by the Board of Directors as of the date of these condensed consolidated financial statements.</span></div><div style="margin-top: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 Company's expectation to generate operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these consolidated financial statements are issued. Management's plans to alleviate the conditions that raise substantial doubt include evaluating 2023 spending and the pursuit of additional cash resources through public or private equity or debt financings. Management has concluded the likelihood that its plan to successfully obtain sufficient funding from one or more of these sources, or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these consolidated financial statements.</span></div><div style="margin-top: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 Company will assess on a quarterly basis whether the determination for estimates remain appropriate based on actual data observed. However, the Company has based this estimate on assumptions that may prove to be wrong, and its operating plan may change as a result of many factors currently unknown to it. As a result, the Company could deplete its capital resources sooner than it currently expects. The Company expects to finance its future cash needs through the issuance of equity, or debt, or other alternative means. If the Company is unable to obtain funding on a timely basis, or if revenues from collaboration arrangements or product sales are less than it has projected, the Company may be required to further revise its business plan and strategy, which may result in the Company significantly curtailing, delaying or discontinuing one or more of its research or development programs or the commercialization of any product candidates or may result in the Company being unable to expand its operations or otherwise capitalize on its business opportunities. As a result, the Company's business, financial condition and results of operations could be materially affected.</span></div><div style="margin-top: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 accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.</span></div>
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<div style="margin-top:12pt"><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-top:6pt;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 financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the 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 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 financial statements. </span></div><div style="margin-top: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 goodwill and intangible assets, and the measurement of right-of-use assets and lease liabilities, stock-based compensation expense, accrued expenses, income taxes, gross to net revenue reserves, inventory reserved, 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 financial statements.</span></div>
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ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
2.74
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod
453000 shares
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice
31.39
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
4227000 shares
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
14.35
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
1347000 shares
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
30.52
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber
4227000 shares
CY2023Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice
14.35
CY2023Q3 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0 usd
us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
-100000 usd
CY2023Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
10069000 shares
CY2022Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7088000 shares

Files In Submission

Name View Source Status
blue-20230930_lab.xml Edgar Link unprocessable
0001293971-23-000055-index-headers.html Edgar Link pending
0001293971-23-000055-index.html Edgar Link pending
0001293971-23-000055.txt Edgar Link pending
0001293971-23-000055-xbrl.zip Edgar Link pending
blue-20230930.htm Edgar Link pending
blue-20230930.xsd Edgar Link pending
blue-20230930xex101.htm Edgar Link pending
blue-20230930xex311.htm Edgar Link pending
blue-20230930xex312.htm Edgar Link pending
blue-20230930xex321.htm Edgar Link pending
Financial_Report.xlsx Edgar Link pending
MetaLinks.json Edgar Link pending
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blue-20230930_def.xml Edgar Link unprocessable
blue-20230930_cal.xml Edgar Link unprocessable
FilingSummary.xml Edgar Link unprocessable
blue-20230930_pre.xml Edgar Link unprocessable
blue-20230930_htm.xml Edgar Link completed
R4.htm Edgar Link pending
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report.css Edgar Link pending
Show.js Edgar Link pending