2020 Q2 Form 10-K Financial Statement

#000129397121000013 Filed on February 23, 2021

View on sec.gov

Income Statement

Concept 2020 Q2 2020 2019 Q4
Revenue $0.00 $0.00 $9.997M
YoY Change -100.0% -48.05%
Cost Of Revenue $1.554M $5.396M $1.100M
YoY Change 153.51% 81.2% 37.5%
Gross Profit -$1.554M -$5.396M $8.900M
YoY Change -112.25% 81.2% -51.63%
Gross Profit Margin 89.03%
Selling, General & Admin $68.63M $240.0M $76.20M
YoY Change 0.0% 1.74% 42.43%
% of Gross Profit 856.18%
Research & Development $156.3M $319.3M $161.8M
YoY Change 6.67% -2.39% 35.17%
% of Gross Profit 1817.98%
Depreciation & Amortization $4.550M $5.100M $5.050M
YoY Change 12.35% 24.39% 10.99%
% of Gross Profit 56.74%
Operating Expenses $224.9M $559.3M $238.0M
YoY Change 4.54% -0.66% 35.07%
Operating Profit -$143.7M -$559.3M -$230.5M
YoY Change -29.13% -0.66% 46.87%
Interest Expense $2.939M $5.770M $5.500M
YoY Change -68.69% -66.8% 37.5%
% of Operating Profit
Other Income/Expense, Net $1.551M -$6.881M $500.0K
YoY Change -152.83% -31.08% -73.68%
Pretax Income -$21.46M -$560.4M -$223.1M
YoY Change -89.07% 0.86% 49.93%
Income Tax $10.00K $700.0K $200.0K
% Of Pretax Income
Net Earnings -$21.47M -$618.7M -$223.3M
YoY Change -89.04% -21.65% 49.87%
Net Earnings / Revenue -2234.14%
Basic Earnings Per Share -$0.36 -$9.95
Diluted Earnings Per Share -$0.36 -$9.95 -$4.038M
COMMON SHARES
Basic Shares Outstanding 60.38M shares 62.18M shares
Diluted Shares Outstanding 60.38M shares 62.18M shares

Balance Sheet

Concept 2020 Q2 2020 2019 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $1.599B $1.151B $1.238B
YoY Change 3.7% 4.05% -34.55%
Cash & Equivalents $1.199B $317.7M $327.2M
Short-Term Investments $400.0M $833.5M $910.8M
Other Short-Term Assets $60.10M $63.90M $45.30M
YoY Change 65.11% 41.06% 34.42%
Inventory
Prepaid Expenses $39.36M $32.89M
Receivables $4.000M $400.0K $400.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $1.613B $1.216B $1.152B
YoY Change 24.04% 5.49% -18.8%
LONG-TERM ASSETS
Property, Plant & Equipment $155.4M $346.9M $151.2M
YoY Change 20.32% 2.91% -38.7%
Goodwill $13.13M $13.13M
YoY Change 0.0% 0.0%
Intangibles $12.18M $14.33M
YoY Change -26.07% 8.79%
Long-Term Investments $49.40M $122.9M $131.5M
YoY Change -82.84% -6.54% -74.02%
Other Assets $74.78M $72.80M $79.23M
YoY Change -11.94% -8.08% 76.83%
Total Long-Term Assets $494.3M $565.8M $575.3M
YoY Change -31.58% -1.63% -30.18%
TOTAL ASSETS
Total Short-Term Assets $1.613B $1.216B $1.152B
Total Long-Term Assets $494.3M $565.8M $575.3M
Total Assets $2.108B $1.781B $1.727B
YoY Change 4.17% 3.12% -22.98%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $26.18M $21.60M $43.00M
YoY Change -11.12% -49.77% 141.13%
Accrued Expenses $125.9M $149.8M $136.4M
YoY Change 44.22% 9.82% 41.05%
Deferred Revenue $3.915M $8.474M
YoY Change -58.72% -54.45%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00
YoY Change -100.0%
Total Short-Term Liabilities $197.2M $203.6M $223.6M
YoY Change 21.63% -8.94% 52.69%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0%
Other Long-Term Liabilities $4.335M $222.6M $10.41M
YoY Change 155.15% 1.69% 235.18%
Total Long-Term Liabilities $4.335M $222.6M $10.41M
YoY Change 155.15% 1.69% 235.18%
TOTAL LIABILITIES
Total Short-Term Liabilities $197.2M $203.6M $223.6M
Total Long-Term Liabilities $4.335M $222.6M $10.41M
Total Liabilities $425.8M $426.2M $442.4M
YoY Change 10.02% -3.66% 23.66%
SHAREHOLDERS EQUITY
Retained Earnings -$2.506B -$2.282B
YoY Change 35.27% 52.24%
Common Stock $662.0K $554.0K
YoY Change 19.71% 1.28%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $1.682B $1.355B $1.285B
YoY Change
Total Liabilities & Shareholders Equity $2.108B $1.781B $1.727B
YoY Change 4.17% 3.12% -22.98%

Cashflow Statement

Concept 2020 Q2 2020 2019 Q4
OPERATING ACTIVITIES
Net Income -$21.47M -$618.7M -$223.3M
YoY Change -89.04% -21.65% 49.87%
Depreciation, Depletion And Amortization $4.550M $5.100M $5.050M
YoY Change 12.35% 24.39% 10.99%
Cash From Operating Activities $39.74M -$470.4M -$159.0M
YoY Change -128.82% -16.66% 22.54%
INVESTING ACTIVITIES
Capital Expenditures -$4.800M $28.99M -$13.39M
YoY Change -74.21% -59.19% 3.8%
Acquisitions
YoY Change
Other Investing Activities $274.1M -$55.36M $196.6M
YoY Change 9.18% -109.48% -148.17%
Cash From Investing Activities $269.3M -$84.35M $183.3M
YoY Change 15.85% -116.61% -143.52%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $541.5M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 543.1M $546.7M 2.010M
YoY Change 11262.55% 2480.43% 4.69%
NET CHANGE
Cash From Operating Activities 39.74M -$470.4M -159.0M
Cash From Investing Activities 269.3M -$84.35M 183.3M
Cash From Financing Activities 543.1M $546.7M 2.010M
Net Change In Cash 852.1M -$7.981M 26.30M
YoY Change 757.97% -77.45% -104.79%
FREE CASH FLOW
Cash From Operating Activities $39.74M -$470.4M -$159.0M
Capital Expenditures -$4.800M $28.99M -$13.39M
Free Cash Flow $44.54M -$499.3M -$145.6M
YoY Change -137.34% -21.42% 24.61%

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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 potentially transformative gene therapies for severe genetic diseases and cancer. 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-readiness activities.</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 programs in severe genetic diseases include betibeglogene autotemcel (beti-cel; formerly LentiGlobin for β-thalassemia gene therapy) as a treatment for transfusion-dependent β-thalassemia, or TDT; its LentiGlobin</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;position:relative;top:-3.5pt;vertical-align:baseline">®</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> product candidate as a treatment for sickle cell disease, or SCD; and elivaldogene autotemcel (eli-cel; formerly Lenti-D gene therapy) as a treatment for cerebral adrenoleukodystrophy, or CALD. The Company’s programs in oncology are focused on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR) and T cell receptor (TCR) T cell therapies. Idecabtagene vicleucel, or ide-cel, and bb21217 are product candidates in oncology under the Company’s collaboration arrangement with Bristol-Myers Squibb ("BMS"). ide-cel and bb21217 are CAR T cell product candidates for the treatment of multiple myeloma. 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,</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.</span></div><div style="margin-top: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%">In June 2019, the Company received conditional marketing authorization from the European Commission for beti-cel as a treatment of patients 12 years and older with TDT who do not have a β</span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;position:relative;top:-3.5pt;vertical-align:baseline">0</span><span style="background-color:#ffffff;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:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;position:relative;top:-3.5pt;vertical-align:baseline">0</span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte-matched related HSC donor is not available. beti-cel is being marketed as ZYNTEGLO™ in the European Union. Since receiving conditional marketing authorization for ZYNTEGLO, the Company has continued to advance its commercial readiness activities. Through December 31, 2020, the Company had not generated any revenue from product sales. In February 2021 the Company temporarily suspended marketing of ZYNTEGLO in light of safety events in the HGB-206 study of LentiGlobin gene therapy for SCD which is manufactured using the same vector as ZYNTEGLO. Additionally, the European Medicines Agency, or EMA, has paused the renewal procedure for ZYNTEGLO's conditional marketing authorization while the EMA's pharmacovigilance risk assessment committee reviews the risk-benefit assessment for ZYNTEGLO and determines whether any additional pharmacovigilance measures are necessary. </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 January 2021, the Company announced its intent to separate its severe genetic disease and oncology programs into two separate, independent publicly traded companies, bluebird bio, Inc. and a new company, referred to as Oncology NewCo in these consolidated financial statements. bluebird bio, Inc. intends to retain focus on its severe genetic disease programs and Oncology NewCo is expected to focus on the Company's oncology programs. The transaction is expected to be completed in late 2021 and is anticipated to be tax-free, subject to receipt of a favorable Internal Revenue Service (“IRS”) ruling.</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 December 31, 2020, the Company had an accumulated deficit of $2.90 billion. During the year ended December 31, 2020, the Company incurred a loss of $618.7 million and used $470.4 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 the Company’s products and product candidates 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 December 31, 2020, the Company had cash, cash equivalents and marketable securities of $1.27 billion. The Company expects 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 financial statements, though it may pursue additional cash resources through public or private equity or debt financings or by establishing additional collaborations with other companies. Management's expectations with respect to its ability to fund current planned operations is based on estimates that are subject to </span></div>risks and uncertainties. If actual results are different from management's estimates, the Company may need to seek additional 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 funding 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 otherwise capitalize on its commercialization of its product and product candidates.
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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 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, 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 financial 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 standalone 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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<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%">Concentrations of credit risk and off-balance sheet risk</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%">Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents and available-for-sale securities. The Company maintains its cash and cash equivalent balances with high-quality financial institutions and, consequently, the Company believes that such funds are subject to minimal credit risk. The Company’s marketable securities primarily consist of U.S. Treasury securities, U.S. government agency securities, certificates of deposit, corporate bonds, and commercial paper, and potentially subject the Company to concentrations of credit risk. The Company has adopted an investment policy that limits the amounts the Company may invest in any one type of investment and requires all investments held by the Company to be at least AA+/Aa1 rated, thereby reducing credit risk exposure.</span></div>
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16799000 USD
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27142000 USD
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789000 USD
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2354000 USD
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278000 USD
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CY2019 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
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P6Y
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15716000 USD
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29000000.0 USD
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73100000 USD
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