2021 Q1 Form 10-Q Financial Statement

#000129397121000041 Filed on May 05, 2021

View on sec.gov

Income Statement

Concept 2021 Q1 2020 Q1
Revenue $894.0K $0.00
YoY Change -100.0%
Cost Of Revenue $576.0K $1.025M
YoY Change -43.8% 138.37%
Gross Profit $318.0K -$1.025M
YoY Change -131.02% -108.51%
Gross Profit Margin 35.57%
Selling, General & Admin $63.57M $73.25M
YoY Change -13.21% 21.51%
% of Gross Profit 19990.25%
Research & Development $82.84M $154.1M
YoY Change -46.25% 25.67%
% of Gross Profit 26051.26%
Depreciation & Amortization $5.360M $4.880M
YoY Change 9.84% 29.1%
% of Gross Profit 1685.53%
Operating Expenses $146.4M $227.4M
YoY Change -35.61% 24.3%
Operating Profit -$146.1M -$144.5M
YoY Change 1.12% -15.6%
Interest Expense $355.0K $5.355M
YoY Change -93.37% -46.99%
% of Operating Profit
Other Income/Expense, Net $24.30M -$4.447M
YoY Change -646.46% 31.22%
Pretax Income -$121.4M -$202.5M
YoY Change -40.04% 23.14%
Income Tax $66.00K $94.00K
% Of Pretax Income
Net Earnings -$205.8M -$202.6M
YoY Change 1.58% 23.21%
Net Earnings / Revenue -23021.03%
Basic Earnings Per Share -$3.07 -$3.64
Diluted Earnings Per Share -$3.07 -$3.64
COMMON SHARES
Basic Shares Outstanding 66.98M shares 55.61M shares
Diluted Shares Outstanding 66.98M shares

Balance Sheet

Concept 2021 Q1 2020 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $1.094B $1.018B
YoY Change 7.38% -41.16%
Cash & Equivalents $439.7M $346.6M
Short-Term Investments $653.8M $671.7M
Other Short-Term Assets $67.10M $54.40M
YoY Change 23.35% 38.07%
Inventory $18.08M
Prepaid Expenses $42.26M $40.21M
Receivables $0.00 $2.400M
Other Receivables $0.00 $0.00
Total Short-Term Assets $1.098B $967.5M
YoY Change 13.44% -29.12%
LONG-TERM ASSETS
Property, Plant & Equipment $165.2M $153.9M
YoY Change 7.33% -48.45%
Goodwill $13.13M $13.13M
YoY Change 0.0%
Intangibles $11.47M $13.25M
YoY Change -13.47%
Long-Term Investments $81.10M $107.7M
YoY Change -24.7% -73.66%
Other Assets $70.86M $79.19M
YoY Change -10.52% 95.05%
Total Long-Term Assets $539.7M $561.6M
YoY Change -3.9% -27.4%
TOTAL ASSETS
Total Short-Term Assets $1.098B $967.5M
Total Long-Term Assets $539.7M $561.6M
Total Assets $1.637B $1.529B
YoY Change 7.07% -28.5%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $20.23M $30.53M
YoY Change -33.72% 1.08%
Accrued Expenses $149.6M $115.5M
YoY Change 29.52% 83.33%
Deferred Revenue $1.330M $6.355M
YoY Change -79.07% -44.69%
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $206.3M $184.4M
YoY Change 11.87% 25.71%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $7.768M $2.784M
YoY Change 179.02% -98.73%
Total Long-Term Liabilities $7.768M $2.784M
YoY Change 179.02% -98.73%
TOTAL LIABILITIES
Total Short-Term Liabilities $206.3M $184.4M
Total Long-Term Liabilities $7.768M $2.784M
Total Liabilities $436.9M $408.7M
YoY Change 6.92% 11.51%
SHAREHOLDERS EQUITY
Retained Earnings -$3.110B -$2.480B
YoY Change 25.4%
Common Stock $675.0K $556.0K
YoY Change 21.4%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $1.200B $1.120B
YoY Change
Total Liabilities & Shareholders Equity $1.637B $1.529B
YoY Change 7.07% -28.5%

Cashflow Statement

Concept 2021 Q1 2020 Q1
OPERATING ACTIVITIES
Net Income -$205.8M -$202.6M
YoY Change 1.58% 23.21%
Depreciation, Depletion And Amortization $5.360M $4.880M
YoY Change 9.84% 29.1%
Cash From Operating Activities -$203.3M -$206.1M
YoY Change -1.36% 33.71%
INVESTING ACTIVITIES
Capital Expenditures $7.626M $10.68M
YoY Change -28.57% -44.74%
Acquisitions
YoY Change
Other Investing Activities $329.0M $235.3M
YoY Change 39.84% -1437.41%
Cash From Investing Activities $321.4M $224.6M
YoY Change 43.09% -708.4%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $3.796M $963.0K
YoY Change 294.18% -90.58%
NET CHANGE
Cash From Operating Activities -$203.3M -$206.1M
Cash From Investing Activities $321.4M $224.6M
Cash From Financing Activities $3.796M $963.0K
Net Change In Cash $121.8M $19.42M
YoY Change 527.3% -110.74%
FREE CASH FLOW
Cash From Operating Activities -$203.3M -$206.1M
Capital Expenditures $7.626M $10.68M
Free Cash Flow -$211.0M -$216.8M
YoY Change -2.7% 24.97%

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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 programs for transfusion-dependent β-thalassemia, or TDT, sickle cell disease, or SCD, and cerebral adrenoleukodystrophy, or CALD. The Company’s programs in oncology are focused on developing novel engineered cell and gene therapies for cancer, 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,</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="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In March 2021, BMS received marketing approval from the U.S. Food and Drug Administration for ABECMA</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%"> (idecabtagene vicleucel; ide-cel) as a treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. In October 2020, the Company's marketing authorization application was accepted by the European Medicines Agency, or EMA, for elivaldogene autotemcel (eli-cel; formerly Lenti-D gene therapy) as a treatment for cerebral adrenoleukodystrophy. In June 2019, the Company received conditional marketing authorization from the European Commission for betibeglogene autotemcel (beti-cel; formerly LentiGlobin for β-thalassemia gene therapy) as a treatment of patients 12 years and older with TDT who do not have a β</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">0</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="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="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. The Company began recognizing product revenue from product sales of ZYNTEGLO during the first quarter of 2021. 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 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 2seventy bio, Inc., a newly-formed Delaware corporation and wholly-owned subsidiary of the Company prior to the separation. bluebird bio, Inc. intends to retain focus on its severe genetic disease programs and 2seventy bio, Inc. 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 March 31, 2021, the Company had an accumulated deficit of $3.11 billion. During the three months ended March 31, 2021, the Company incurred a loss of $205.8 million and used $203.3 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 product 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 March 31, 2021, the Company had cash, cash equivalents and marketable securities of $1.09 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 </span></div>through public or private equity or debt financings or by establishing additional collaborations with other companies. 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100.08
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
3829000 shares
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
111.17
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber
6458000 shares
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice
100.08
CY2021Q1 us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
200000 shares
CY2021Q1 us-gaap Proceeds From Stock Plans
ProceedsFromStockPlans
1200000 USD
CY2021Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
9415000 shares
CY2020Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
8063000 shares

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