2021 Q4 Form 10-Q Financial Statement

#000129397121000087 Filed on November 05, 2021

View on sec.gov

Income Statement

Concept 2021 Q4 2021 Q3 2020 Q3
Revenue $1.606M $1.019M $0.00
YoY Change -100.0%
Cost Of Revenue $38.86M $19.70M $1.318M
YoY Change 2490.47% 1394.99% 52.9%
Gross Profit -$35.20M -$18.69M -$1.318M
YoY Change -482.55% 1317.68% -116.38%
Gross Profit Margin -2191.47% -1833.66%
Selling, General & Admin $210.0M $68.28M $68.05M
YoY Change 172.69% 0.34% 2.71%
% of Gross Profit
Research & Development $319.9M $131.4M $140.4M
YoY Change 133.37% -6.41% -7.25%
% of Gross Profit
Depreciation & Amortization $2.314M $5.982M $4.950M
YoY Change -53.53% 20.85% 8.79%
% of Gross Profit
Operating Expenses $529.9M $199.7M $208.5M
YoY Change 147.51% -4.21% -4.22%
Operating Profit -$135.7M -$154.4M -$131.7M
YoY Change -2.67% 17.24% -37.39%
Interest Expense $30.28M $319.0K $1.964M
YoY Change 638.51% -83.76% -76.67%
% of Operating Profit
Other Income/Expense, Net -$1.748M -$294.0K -$6.686M
YoY Change -245.67% -95.6% 55.56%
Pretax Income -$562.4M -$216.9M -$194.4M
YoY Change 181.75% 11.58% -5.76%
Income Tax $258.0K -$113.0K $329.0K
% Of Pretax Income
Net Earnings -$155.1M -$216.8M -$194.7M
YoY Change -22.43% 11.33% -5.48%
Net Earnings / Revenue -9654.55% -21277.33%
Basic Earnings Per Share -$2.14 -$3.16 -$2.94
Diluted Earnings Per Share -$2.14 -$3.16 -$2.94
COMMON SHARES
Basic Shares Outstanding 70.11M shares 68.62M shares 66.25M shares
Diluted Shares Outstanding 68.62M shares 66.25M shares

Balance Sheet

Concept 2021 Q4 2021 Q3 2020 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $396.6M $970.7M $1.438B
YoY Change -46.52% -32.49% 2.27%
Cash & Equivalents $161.2M $402.5M $324.2M
Short-Term Investments $235.5M $568.3M $1.114B
Other Short-Term Assets $37.02M $41.30M $57.30M
YoY Change -42.07% -27.93% 43.25%
Inventory $0.00 $766.0K
Prepaid Expenses $25.63M $30.71M $35.42M
Receivables $12.66M $5.600M
Other Receivables $0.00 $0.00
Total Short-Term Assets $336.5M $832.3M $1.293B
YoY Change -72.32% -35.64% 6.0%
LONG-TERM ASSETS
Property, Plant & Equipment $9.706M $45.75M $157.7M
YoY Change -44.13% -70.99% 9.43%
Goodwill $5.646M $12.06M $13.13M
YoY Change 0.0% -8.17% 0.0%
Intangibles $0.00 $11.01M $11.11M
YoY Change -100.0% -0.93% -27.83%
Long-Term Investments $97.11M $193.1M $207.6M
YoY Change -20.98% -6.97% -8.1%
Other Assets $53.28M $70.95M $74.30M
YoY Change -18.94% -4.52% -9.46%
Total Long-Term Assets $257.3M $507.3M $652.3M
YoY Change -54.52% -22.22% -2.96%
TOTAL ASSETS
Total Short-Term Assets $336.5M $832.3M $1.293B
Total Long-Term Assets $257.3M $507.3M $652.3M
Total Assets $593.8M $1.340B $1.945B
YoY Change -66.66% -31.14% 2.82%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $25.88M $21.67M $25.31M
YoY Change 87.41% -14.39% -39.56%
Accrued Expenses $123.7M $197.4M $137.9M
YoY Change -17.44% 43.17% 21.07%
Deferred Revenue $2.282M $2.530M $1.061M
YoY Change 52.13% 138.45% -87.48%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $153.0M $266.6M $196.9M
YoY Change -24.85% 35.37% 0.45%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $93.00K $7.904M $4.751M
YoY Change -98.39% 66.36% 27.51%
Total Long-Term Liabilities $93.00K $7.904M $4.751M
YoY Change -98.39% 66.36% 27.51%
TOTAL LIABILITIES
Total Short-Term Liabilities $153.0M $266.6M $196.9M
Total Long-Term Liabilities $93.00K $7.904M $4.751M
Total Liabilities $219.5M $469.1M $422.5M
YoY Change -48.49% 11.04% 0.46%
SHAREHOLDERS EQUITY
Retained Earnings -$3.720B -$3.560B -$2.701B
YoY Change 28.25% 31.82% 31.2%
Common Stock $711.0K $701.0K $663.0K
YoY Change 6.92% 5.73% 19.89%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $374.3M $870.5M $1.523B
YoY Change
Total Liabilities & Shareholders Equity $593.8M $1.340B $1.945B
YoY Change -66.66% -31.14% 2.82%

Cashflow Statement

Concept 2021 Q4 2021 Q3 2020 Q3
OPERATING ACTIVITIES
Net Income -$155.1M -$216.8M -$194.7M
YoY Change -22.43% 11.33% -5.48%
Depreciation, Depletion And Amortization $2.314M $5.982M $4.950M
YoY Change -53.53% 20.85% 8.79%
Cash From Operating Activities -$139.7M -$146.9M -$148.8M
YoY Change -9.97% -1.24% 31.22%
INVESTING ACTIVITIES
Capital Expenditures -$2.059M -$9.740M -$5.620M
YoY Change -73.9% 73.31% -77.46%
Acquisitions
YoY Change
Other Investing Activities $62.99M $129.6M -$721.4M
YoY Change -59.8% -117.97% -568.5%
Cash From Investing Activities $60.93M $119.9M -$727.0M
YoY Change -59.05% -116.49% -663.4%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -174.0M 75.87M 1.190M
YoY Change -12184.31% 6275.46% -71.53%
NET CHANGE
Cash From Operating Activities -139.7M -146.9M -148.8M
Cash From Investing Activities 60.93M 119.9M -727.0M
Cash From Financing Activities -174.0M 75.87M 1.190M
Net Change In Cash -252.8M 48.83M -874.6M
YoY Change 5017.55% -105.58% -4508.27%
FREE CASH FLOW
Cash From Operating Activities -$139.7M -$146.9M -$148.8M
Capital Expenditures -$2.059M -$9.740M -$5.620M
Free Cash Flow -$137.7M -$137.2M -$143.2M
YoY Change -6.54% -4.16% 61.85%

Facts In Submission

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Description of the business<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%">bluebird bio, Inc. (the “Company” or “bluebird”) was incorporated in Delaware on April 16, 1992, and is headquartered in Cambridge, Massachusetts. The Company is a biotechnology company committed to researching, developing and commercializing, following marketing approval, potentially transformative gene therapies for severe genetic disease. Since its inception, the Company has devoted substantially all of its resources to its research and development efforts relating to its product candidates, including activities to manufacture product candidates, conduct clinical studies of its product candidates, perform preclinical research to identify new product candidates and provide selling, general and administrative support for these operations, including commercial activities in Europe as well as commercial-readiness activities in the United States. </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 November 2021, the Company completed the separation of its severe genetic disease and oncology programs into two separate, independent publicly traded companies, bluebird bio, Inc. and 2seventy bio, Inc., a Delaware corporation and wholly-owned subsidiary of the Company prior to the separation. bluebird bio, Inc. intends to retain its severe genetic disease programs, with a focus on the U.S. market. The Company’s programs in severe genetic diseases include programs for transfusion-dependent β-thalassemia, or TDT, sickle cell disease, or SCD, and cerebral adrenoleukodystrophy, or CALD. The Company also expects to make focused investments in research and development efforts on optimizing our existing programs as well as on pipeline programs in severe genetic diseases. 2seventy bio, Inc. is expected to focus on the Company's former oncology programs, including the anti-BCMA CAR T programs for multiple myeloma under the Company’s collaboration arrangement with Bristol-Myers Squibb ("BMS"). Please refer to Note 10, </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 Company’s collaboration with BMS. The results for the period ended September 30, 2021 reflect the combined results of the Company and 2seventy bio prior to the effectiveness of the separation, and the forward-looking statements contained within pertain to the Company's severe genetic disease operations, unless otherwise noted.</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, </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 consolidated financial statements are issued. The Company has incurred losses since inception and to date has financed its operations primarily through the sale of equity securities and, to a lesser extent, through collaboration agreements and grants from governmental agencies and charitable foundations. As of September 30, 2021, the Company had an accumulated deficit of $3.56 billion. During the nine months ended September 30, 2021, the Company incurred a loss of $664.3 million and used $495.9 million of cash in operations. The Company expects to continue to generate operating losses and negative operating cash flows for the next few years and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of beti-cel, eli-cel, and LentiGlobin for SCD, and the achievement of a level of revenues adequate to support its cost structure. </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%">As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $970.7 million. Upon separation, the Company funded 2seventy bio with approximately $441.5 million, which has reduced the amount of cash available to the Company as of the date of separation. The Company expects its cash, cash equivalents and marketable securities, subsequent to the amount funded to 2seventy bio, will be sufficient to fund current planned operations for at least the next twelve months from the date of issuance of these financial statements. The Company anticipates reduced 2022 spending, including projected savings through the move of the Company's headquarters to Assembly Row in Somerville, Massachusetts, and the orderly wind down of European operations. This, together with other anticipated cash inflows, which include both the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for beti-cel and eli-cel, and the pursuit of additional cash resources through public or private equity or debt financings, are expected to further strengthen the Company's financial condition. Management's expectations with respect to its ability to fund current planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management's estimates, the Company may need to seek additional cash resources through strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional cash resources on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its planned research or development programs or be unable to expand its operations or commercialize products following marketing approval.</span></div>
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<div style="margin-top: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-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 </span></div>preparation of the financial statements. Estimates 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, contingent consideration, stock-based compensation expense, accrued expenses, revenue recognition, income taxes, inventory capitalization, excess inventory analyses, 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.
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