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BLUE Bluebird bio

bluebird bio is pioneering gene therapy with purpose. From its Cambridge, Mass., headquarters, they're developing gene and cell therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond their labs, the company is working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

Company profile

Ticker
BLUE
Exchange
CEO
Nick Leschly
Employees
Incorporated
Location
Fiscal year end
Former names
Genetix Pharmaceuticals Inc
SEC CIK
Subsidiaries
bluebird bio Securities Corporation • bluebird bio France, SARL • bluebird bio (FR) SAS • bluebird bio Australia Pty Ltd • bluebird bio (Bermuda) Ltd • bluebird bio (UK) Ltd • bluebird bio (Italy) Srl • bluebird bio (Switzerland) GmbH • bluebird bio (Germany) GmbH • Bluebird Bio Greece Single Member, L.L.C. ...

BLUE stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

9 Aug 21
25 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 410.67M 410.67M 410.67M 410.67M 410.67M 410.67M
Cash burn (monthly) 28.29M 70.22M 80.5M 72.59M 48.55M 54.41M
Cash used (since last report) 109.51M 271.75M 311.53M 280.94M 187.89M 210.58M
Cash remaining 301.16M 138.91M 99.13M 129.73M 222.77M 200.08M
Runway (months of cash) 10.6 2.0 1.2 1.8 4.6 3.7

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
15 Oct 21 Elisabeth Leiderman Common Stock Grant Acquire A No No 0 4,663 0 4,663
15 Oct 21 Elisabeth Leiderman Stock Option Common Stock Grant Acquire A No No 20.9 7,500 156.75K 7,500
29 Sep 21 Najoh Tita-Reid Common Stock Grant Acquire A No No 0 4,663 0 4,663
29 Sep 21 Najoh Tita-Reid Stock Option Common Stock Grant Acquire A No No 18.98 7,500 142.35K 7,500

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

85.1% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 228 232 -1.7%
Opened positions 41 48 -14.6%
Closed positions 45 83 -45.8%
Increased positions 84 83 +1.2%
Reduced positions 59 63 -6.3%
13F shares
Current Prev Q Change
Total value 2.19B 3.6B -39.3%
Total shares 57.54M 56.93M +1.1%
Total puts 746.7K 1.2M -37.9%
Total calls 716.6K 709.8K +1.0%
Total put/call ratio 1.0 1.7 -38.5%
Largest owners
Shares Value Change
Vanguard 6.96M $222.62M +2.4%
Wellington Management 6.92M $221.37M +0.1%
BLK Blackrock 5.91M $188.97M +48.2%
Growth Fund Of America 5.2M $515.44M 0.0%
STT State Street 2.74M $87.65M +13.2%
CS Credit Suisse 2.64M $84.29M +13.5%
First Trust Advisors 2.19M $69.95M +56.9%
Armistice Capital 1.84M $58.72M -6.5%
GS Goldman Sachs 1.77M $56.76M +74.2%
JPM JPMorgan Chase & Co. 1.63M $52.11M +48.8%
Largest transactions
Shares Bought/sold Change
RY Royal Bank Of Canada 465.25K -3.18M -87.2%
BLK Blackrock 5.91M +1.92M +48.2%
Camber Capital Management 0 -1M EXIT
TROW T. Rowe Price 28.2K -923.65K -97.0%
First Trust Advisors 2.19M +793.58K +56.9%
GS Goldman Sachs 1.77M +755.96K +74.2%
Point72 Asset Management 563.4K +563.4K NEW
JPM JPMorgan Chase & Co. 1.63M +534.56K +48.8%
Candriam Luxembourg S.C.A. 0 -423.1K EXIT
NTRS Northern Trust 735.4K +419.38K +132.7%

Financial report summary

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Risks
  • *We have limited experience as a commercial company and the marketing and sale of beti-cel, eli-cel, LentiGlobin for SCD, and any oncology product candidates following marketing approval, if and when obtained, may be unsuccessful or less successful than anticipated.
  • *The commercial success of beti-cel, eli-cel, LentiGlobin for SCD, and our oncology product candidates following marketing approval, if and when obtained, will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community.
  • *If the market opportunities for our product or any future products are smaller than we believe they are, and if we are not able to successfully identify patients and achieve significant market share, our revenues may be adversely affected and our business may suffer.
  • *We rely on a complex supply chain for beti-cel, eli-cel, LentiGlobin for SCD, and our oncology product candidates. The manufacture and delivery of our lentiviral vector and drug products present significant challenges for us, and we may not be able to produce our vector and drug products at the quality, quantities, locations or timing needed to support commercialization and our clinical programs. In addition, we may encounter challenges with engaging or coordinating with qualified treatment centers needed to support commercialization.
  • *We have limited sales and distribution experience and limited capabilities for marketing and market access. We expect to invest significant financial and management resources to establish these capabilities and infrastructure to support commercial operations. If we are unable to establish these commercial capabilities and infrastructure or to enter into agreements with third parties to market and sell our product or any future products, we may be unable to generate sufficient revenue to sustain our business.
  • *The insurance coverage and reimbursement status of newly-approved products is uncertain. Due to the novel nature of our technology and the potential for our product to offer lifetime therapeutic benefit in a single administration, we face additional challenges in obtaining adequate pricing and reimbursement for our product. Failure to obtain or maintain adequate coverage and reimbursement for any new or current product could limit our ability to market those products and decrease our ability to generate revenue.
  • *Changes in our manufacturing processes may cause delays in our clinical development and commercialization plans.
  • We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are more advanced, safer or effective than ours, which may adversely affect our financial condition and our ability to successfully develop and commercialize beti-cel, eli-cel, LentiGlobin for SCD, and oncology product candidates. If our competitors obtain orphan drug exclusivity for products that regulatory authorities determine constitute the same drug and treat the same indications as our product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
  • We may not be successful in our efforts to identify or discover additional product candidates.
  • Patients receiving T cell-based immunotherapies, such as ide-cel and the bb21217 product candidate, may experience serious adverse events, including neurotoxicity and cytokine release syndrome. If our product candidates are revealed to have high and unacceptable severity and/or prevalence of side effects or unexpected characteristics, their clinical development, marketing approval, and commercial potential will be negatively impacted, which will significantly harm our business, financial condition and prospects.
  • Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our product and any future products or adversely affect our ability to conduct our business or obtain and maintain marketing approvals for our product and product candidates.
  • We are dependent on BMS for the successful commercialization and further development of ide-cel. If BMS does not devote sufficient resources to the commercialization or further development of ide-cel, is unsuccessful in its efforts, or chooses to terminate its agreements with us, our business will be materially harmed.
  • We rely on third parties to conduct some or all aspects of our lentiviral vector production, drug product manufacturing, and testing, and these third parties may not perform satisfactorily.
  • We and our contract manufacturers are subject to significant regulation with respect to manufacturing our product and product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • We expect to rely on third parties to conduct, supervise and monitor our clinical studies, and if these third parties perform in an unsatisfactory manner, it may harm our business.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • *We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
  • We have not generated material revenue from product sales and may never be profitable.
  • *From time to time, we will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
  • If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements are incorrect, our actual results may vary from those reflected in our projections and accruals.
  • *Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • *Even if we receive marketing approval for a product candidate, any approved product will remain subject to regulatory scrutiny.
  • We are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties, reputational harm, and diminished profits and future earnings.
  • We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs. If the use of our approved product or product candidates harms patients, or is perceived to harm patients even when such harm is unrelated to our approved product or product candidates, our marketing approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • Our computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product candidates’ development programs and have a material adverse effect on our reputation, business, financial condition or results of operations.
  • The proposed separation of our business into two independent, publicly traded companies is subject to various risks and uncertainties and may not be completed on the terms or timeline currently contemplated, if at all, and will involve significant time, effort and expense, which could harm our business, results of operations and financial condition.
  • We may fail to realize some or all of the anticipated benefits of the proposed separation.
  • If we are unable to obtain or protect intellectual property rights related to our product candidates, we may not be able to compete effectively in our markets.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to gene therapy product components and processes for our development pipeline through acquisitions and in-licenses.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world.
  • The market price of our common stock may be highly volatile, and you may not be able to resell your shares at or above the price at which you purchase them.
  • Actual or potential sales of our common stock by our employees, including our executive officers, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors.
  • *Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We do not intend to pay cash dividends on our common stock so any returns will be limited to the value of our stock.
  • Provisions in our amended and restated certificate of incorporation and by-laws, as well as provisions of Delaware law, could make it more difficult for a third-party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
Management Discussion
  • Revenues. Total revenue was $7.5 million for the three months ended June 30, 2021, compared to $198.9 million for the three months ended June 30, 2020. The decrease of $191.4 million was primarily attributable to a cumulative catch-up adjustment to revenue recorded in connection with the May 2020 BMS contract modification in the second quarter of 2020.
  • Research and development expenses. Research and development expenses were $144.3 million for the three months ended June 30, 2021, compared to $156.3 million for the three months ended June 30, 2020. The overall decrease of $12.0 million was primarily attributable to the following:
  • •$14.3 million of decreased manufacturing expenditures, primarily driven by the capitalization of commercial inventory in the second quarter of 2021 and partially offset by increased manufacturing capacity and maintenance fees incurred under an agreement with one of our contract manufacturing organizations;
Content analysis
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H.S. junior Avg
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