On November 5, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported financial results and business highlights for the third quarter ended September 30, 2021 (Press release, bluebird bio, NOV 5, 2021, View Source [SID1234594585]).
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"This quarter was about preparing for the completion of the separation of bluebird bio and 2seventy bio and realizing the value of two independent companies," said Andrew Obenshain, chief executive officer, bluebird bio. "Notably this quarter, we secured additional capital through the close of a private financing and completion of the sale of our manufacturing facility in North Carolina and continued to make meaningful progress with our product pipeline, including filing the US biologics licensing application for beti-cel for beta-thalassemia. I am excited for what lies ahead for both bluebird and 2seventy bio, and the impact that both companies will have for patients and their families."
BUSINESS SEPARATION RECENT HIGHLIGHTS
COMPLETION OF SEPARATION – On November 4, 2021, bluebird bio completed the tax-free spin-off of its oncology business, 2seventy bio, Inc. bluebird bio will continue its work focused on severe genetic diseases, with three near-term opportunities to bring transformative gene therapies to patients and their families in the U.S. 2seventy began regular-way trading on the NASDAQ under the stock ticker symbol "TSVT" on November 5, 2021. bluebird bio will continue to trade under the stock ticker symbol "BLUE".
PRIVATE FINANCING – Prior to the separation on September 8, 2021, bluebird bio announced that it has entered into an agreement for a $75 million private placement of common stock and common stock equivalents with a healthcare investment fund selected as part of a competitive process.
STARTING CASH POSITION – As of completion of the separation, bluebird’s restricted cash, cash and cash equivalents and marketable securities balance is approximately $518.5M. Increased fiscal discipline, including through projected real estate savings with the move of the Company’s headquarters to Assembly Row in Somerville, Massachusetts, and the wind down of European operations, together with the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of biologics licensing applications for beti-cel and eli-cel will be sufficient to fund operations for bluebird bio into 2023 under current business plans.
RECENT HIGHLIGHTS
β-THALASSEMIA
BETI-CEL SUBMISSION – On September 21, 2021, bluebird bio announced it completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for betibeglogene autotemcel (beti-cel) gene therapy in adult, adolescent and pediatric patients with β-thalassemia who require regular red blood cell transfusions, across all genotypes. If approved, beti-cel will be the first hematopoietic (blood) stem cell (HSC) ex-vivo gene therapy for patients in the United States.
COMPANY
NEW HEADQUARTERS – Today, bluebird bio announced its new headquarters in Assembly Row, designed to reflect modern ways of working and estimated to result in more than $120 million in cost savings over the next six years for the company. bluebird signed a long-term lease with Federal Realty Investment Trust (FRIT) for the 61,000 square foot facility located at 455 Grand Union in Somerville, MA.
BOARD OF DIRECTORS – This quarter, bluebird bio announced the appointment of Najoh Tita-Reid (Logitech) and Lis Leiderman, M.D. (Decibel Therapeutics) to its board of directors. They are joined on the bluebird bio board of directors by Mark Vachon (chairman – formerly of GE), John Agwunobi, M.D. (Herbalife Nutrition), Wendy Dixon, Ph.D. (formerly of Bristol-Myers Squibb), Nick Leschly (2seventy bio) and Andrew Obenshain (bluebird bio).
EUROPE WIND DOWN – Following the August 9, 2021 announcement that it intended to wind down operations in Europe, on October 21, bluebird bio announced that it will withdraw its regulatory marketing authorization for SKYSONA from the European Union, and its marketing application for SKYSONA from the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK). bluebird bio, Inc. also anticipates withdrawing marketing authorizations for ZYNTEGLO from both the EU and the UK by early 2022. The company expects to continue activities for the long-term follow-up of patients previously enrolled within the European clinical trial programs as planned, but does not intend to initiate any new clinical trials in Europe for the beta-thalassemia, cerebral adrenoleukodystrophy or sickle cell disease programs.
MANAGEMENT APPOINTMENT – On November 4, 2021, bluebird bio announced the appointment of Gina Consylman as Chief Financial Officer, effective upon the completion of the spin-off transaction of 2seventy bio.
UPCOMING ANTICIPATED MILESTONES
beti-cel: Acceptance of the BLA to the US Food and Drug Administration for beti-cel for beta-thalassemia expected this month.
eli-cel: The BLA filing for elivaldogene autotemcel (eli-cel, Lenti-D) for patients with cerebral adrenoleukodystrophy (CALD) is on track for the end of 2021.
eli-cel: The company is in active communication with the FDA to resolve the clinical hold.
bb1111: The company plans to host an investor event on November 18th, 2021, to share further detail on its sickle cell disease program and path to regulatory approval.
American Society of Hematology Annual Meeting: bluebird will present new data on beti-cel and bb1111 at ASH (Free ASH Whitepaper) 2021, including long-term results for beti-cel in adult and pediatric patients with beta-thalassemia, new analyses from Groups A&C of the ongoing Phase 1/2 HGB 206 study of bb1111 for sickle cell disease, and sustained improvements in patient reported quality of life in Group C.
THIRD QUARTER 2021 FINANCIAL RESULTS
Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2021, and December 31, 2020, were $970.7 million and $1.27 billion, respectively. The decrease in cash, cash equivalents and marketable securities is primarily related to cash used in support of ordinary course operating activities.
Revenues: Total revenues were $22.7 million for the three months ended September 30, 2021, compared to $19.3 million for the three months ended September 30, 2020. Total revenues were $42.9 million for the nine months ended September 30, 2021, compared to $240.0 million for the nine months ended September 30, 2020. The increase for the three-month period was primarily driven by our collaborative arrangement revenue recognized under our collaboration arrangement with BMS. The decrease for the nine-month period was primarily driven by a cumulative catch-up adjustment to revenue recorded in connection with the May 2020 BMS contract modification in the second quarter of 2020.
ABECMA Revenue: This quarter Bristol-Myers Squibb (BMS) reported total U.S. revenues of $67 million for ABECMA (idecabtagene vicleucel; ide-cel). bluebird bio reported a net collaboration revenue of $14.8 million for 3Q, which includes the company’s share of revenue and costs associated with the commercialization of ABECMA in the U.S.
R&D Expenses: Research and development expenses were $131.4 million for the three months ended September 30, 2021, compared to $140.4 million for the three months ended September 30, 2020. Research and development expenses were $429.6 million for the nine months ended September 30, 2021, compared to $450.9 million for the nine months ended September 30, 2020. The decrease for the three-month period was primarily driven by decreased collaboration research funding costs resulting from a decrease in expense recognized under our collaboration arrangement with BMS. The decrease for the nine-month period was primarily driven by decreased manufacturing expenses.
SG&A Expenses: Selling, general and administrative expenses were $68.3 million for the three months ended September 30, 2021, compared to $68.0 million for the three months ended September 30, 2020. Selling, general and administrative expenses were $229.7 million for the nine months ended September 30, 2021, compared to $210.0 million for the nine months ended September 30, 2020. The increase for both periods was primarily driven by an increase in fees associated with the spinoff of 2seventy bio as well as increased employee compensation, benefit, and other headcount related expenses.
Restructuring Expenses: Restructuring expenses were $20.2 million and $24.8 million for the three months and nine months ended September 30, 2021, respectively. These costs are related to a reduction in the workforce, primarily driven by the wind down of operations in Europe.
Net Loss: Net loss was $216.8 million for the three months ended September 30, 2021, compared to $194.7 million for the three months ended September 30, 2020. Net loss was $664.3 million for the nine months ended September 30, 2021, compared to $418.8 million for the nine months ended September 30, 2020.