On this page of StockholderLetter.com we present the 4/28/2023 shareholder letter from bluebird bio, Inc. — ticker symbol BLUE. Reading current and past BLUE letters to shareholders can bring important insights into the investment thesis.

 •  4/28/2023 Letter Continued (Full PDF)
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BLUE 4/28/2023 Shareholder/Stockholder Letter Transcript:

bluebird bio, Inc.
2022
Annual Report

Fellow Shareholders    
As I wrote this leter last year, bluebird bio was at the precipice of change     just months a   er the spino    of our
oncology business, and weeks a   er announcing the most signi   cant restructuring in bluebird   s history     one that
aimed to right-size our cost structure and sharpen our focus on bringing our three len   viral vector gene therapies
for beta-thalassemia, cerebral adrenoleukodystrophy (CALD) and sickle cell disease to pa   ents in the United States.
We persisted for purpose and following unanimous endorsements from the US Food and Drug Administra   on   s
Cellular, Tissue and Gene Therapies Advisory Commitee in June, last August and September, we received FDA
approval of ZYNTEGLO (be   beglogene autotemcel) for beta-thalassemia and accelerated approval for SKYSONA
(elivaldogene autotemcel) for early, ac   ve CALD in boys ages 4 to 17.
These approvals -- built on a decade of scien      c exper   se and a deep commitment to pa   ents and families    
launched the next chapter for bluebird bio, as a commercial gene therapy leader. Today, as a company dedicated
to transforma   ve gene therapies for pa   ents living with serious gene   c diseases, we are proving the commercial
model for an en   re    eld.
We are establishing a footprint of quali   ed treatment centers across the US, and the value our therapies o   er to
pa   ents, the healthcare system and society is being recognized. Informed by payer insights and our deep
experience with value-based payment models, we have established an innova   ve, outcomes-based agreement for
ZYNTEGLO, and to date have seen mul   ple pa   ents ini   ate therapy, and zero ul   mate denials from payers.
We are also living out our promise to families a   ected by CALD     providing hope to those faced with a devasta   ng
diagnosis and limited treatment op   ons. On March 16, 2023, the    rst pa   ent with CALD to be commercially
treated with SKYSONA received their infusion at Boston Children   s Hospital     marking a signi   cant milestone not
only for one family, but an en   re rare disease community.
And, while we deliver for pa   ents today, we   re also paving the road for our largest commercial opportunity, which
is s   ll ahead of us     bringing a transforma   ve gene therapy to individuals living with sickle cell disease (SCD) in the
US.
For close to ten years, bluebird bio has been commited to making meaningful progress for SCD and for the SCD
community, which has long been overlooked. On April 24, 2023, we announced that bluebird submited its
biologics license applica   on (BLA) for lovo-cel (lovo   beglogene autotemcel) to the FDA for pa   ents with sickle cell
disease ages 12 and older who have a history of vaso-occlusive events.
As the most mature gene therapy in development for SCD     with unparalleled breadth of data and dura   on of
follow up -- lovo-cel represents an opportunity to deliver transforma   onal, rather than incremental, bene   ts that
are long overdue, and may reduce the economic and lifelong burden of sickle cell disease as a one-   me treatment.
Importantly, the commercial infrastructure we   re se   ng up today is not only enabling us to maximize our
opportunity to reach those living with beta-thalassemia with ZYNTEGLO; it also priori   zes proximity to individuals
living with SCD in an   cipa   on of an early 2024 commercial launch for lovo-cel, if approved.
Underpinning our success is a commitment to building our    nancial strength and fostering our unique culture.
During the    ve months beginning November 2022, we were able to raise $326 million in net proceeds from the sale
of the two priority review vouchers and an equity o   ering. At the same    me, we have stabilized reten   on and
returned to an industry-leading 79 percent employee engagement score, with 90 percent of our    ock repor   ng
that they are proud to work for bluebird.
We are grateful to the bluebirds     past and present     who have been commited to this journey; to the pa   ents,
caregivers, researchers, and clinicians who have enabled this progress; and to the shareholders who have
supported us.

Together, we are giving pa   ents and their families more bluebird days.
Onward,
Forward-Looking Statements
This leter contains    forward-looking statements    within the meaning of the Private Securi   es Li   ga   on Reform Act
of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking
statements, including, without limita   on, our statements regarding the possible approval of lovo-cel by the FDA,
the expected    ming rela   ng to such poten   al regulatory approval and commercial launch of lovo-cel if approved,
and the poten   al bene   ts of lovo-cel. Such forward-looking statements are based on historical performance and
current expecta   ons and projec   ons about our future    nancial results, goals, plans and objec   ves and involve
inherent risks, assump   ons and uncertain   es, including internal or external factors that could delay, divert or
change any of them in the next several years, that are di   cult to predict, may be beyond our control and could
cause our future    nancial results, goals, plans and objec   ves to di   er materially from those expressed in, or
implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this
leter should be evaluated together with the many risks and uncertain   es that a   ect bluebird bio   s business,
par   cularly those iden      ed in the risk factors discussion in bluebird bio   s Annual Report on Form 10-K for the year
ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other    lings with the Securi   es and Exchange Commission. These risks include, but are not limited to:
delays and challenges in obtaining regulatory approval of our product candidates and our commercializa   on and
manufacturing of our products, including risks associated with demonstra   ng analy   cal comparability with respect
to our lovo-cel program; and we may encounter addi   onal delays in the development of our programs, including
the imposi   on of new clinical holds, that may impact our ability to meet our expected    melines and increase our
costs. The forward-looking statements included in this leter are made only as of the date of this leter and except
as otherwise required by applicable law, bluebird bio undertakes no obliga   on to publicly update or revise any
forward-looking statement, whether as a result of new informa   on, future events, changed circumstances or
otherwise.

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 4/28/2023 Letter Continued (Full PDF)