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bluebird bio(BLUE) - 2024 Q3 - Earnings Call Transcript
2024-11-14 15:06
Financial Data and Key Metrics Changes - In Q3 2024, the company reported total revenue of $10.6 million, down from $16.1 million in Q2 2024, attributed to variations in manufacturing timelines [15][18] - The company anticipates a revenue rebound in Q4 2024 with net revenue of at least $25 million as more patients are infused [15][18] - As of September 30, 2024, the company had $118.7 million in cash on hand, including $48 million in restricted cash [17][19] Business Line Data and Key Metrics Changes - The company has more than doubled patient starts from 27 to 57 across its portfolio since the last earnings call [8][11] - A total of 74 patient starts have been completed or scheduled in 2024, with 57 completed and 17 scheduled for the remainder of the year [11][12] - The company has plans to double the manufacturing capacity for LYFGENIA in 2026 based on anticipated demand [12] Market Data and Key Metrics Changes - More than half of all states have affirmed coverage for LYFGENIA through preferred drug lists or published coverage criteria [13] - Nearly 50% of Medicaid-insured individuals with sickle cell disease in the U.S. live in states that have completed prior authorization approval for LYFGENIA [13] Company Strategy and Development Direction - The company aims for cash flow breakeven in the second half of 2025, contingent on securing additional cash resources and scaling to approximately 40 drug product deliveries per quarter [18][21] - The company is engaging with Hercules to secure adequate cash runway and extend financing options [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven in the second half of next year, supported by strong demand for therapies and a robust QTC network [21] - The company is optimistic about the sustained demand for its therapies, particularly LYFGENIA and ZYNTEGLO, as evidenced by patient scheduling and access approvals [12][46] Other Important Information - The company is currently seeking shareholder approval for a reverse stock split to regain compliance with NASDAQ's minimum bid price [20][49] - The company has implemented significant changes to optimize its cost structure, anticipating a 20% reduction in cash operating expenses by Q3 2025 [18] Q&A Session Summary Question: Revenue dynamics in Q3 - Management confirmed that there is still 100% pull-through once cells are delivered to treatment centers, although scheduling variability exists [24][25] Question: 2025 patient scheduling - Most of the 30 patients scheduled for 2025 are in Q1, with some extending into Q2 [32] Question: Cash gap strategy - The company is in regular contact with Hercules and is exploring renegotiating key contracts to address the cash gap [33] Question: Conversion rates for scheduled patients - The conversion rate from scheduled patients to actual starts is virtually 100%, with some rescheduling occurring [36] Question: Manufacturing timelines - Manufacturing timelines are generally consistent, with LYFGENIA taking 90 to 105 days for completion [40] Question: Confidence in scaling deliveries - Confidence in achieving 40 product deliveries per quarter is based on strong demand signals and an expanding QTC network [46] Question: Shareholder vote details - The company has about 194 million shares authorized, with a request for additional shares through a reverse stock split [49][50] Question: Dropout rates in patient scheduling - The company reported a higher-than-anticipated pull-through rate, with minimal dropouts observed [52]
Bluebird Bio (BLUE) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2024-11-14 14:10
Company Performance - Bluebird Bio reported a quarterly loss of $0.31 per share, better than the Zacks Consensus Estimate of a loss of $0.38, and an improvement from a loss of $0.66 per share a year ago, representing an earnings surprise of 18.42% [1] - The company posted revenues of $10.61 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 42.12%, and down from $12.39 million in the same quarter last year [2] - Over the last four quarters, Bluebird has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Performance - Bluebird shares have declined approximately 72.7% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.25 on revenues of $30.51 million, and for the current fiscal year, it is -$1.41 on revenues of $83.52 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Bluebird belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Bluebird's stock performance [5][6]
bluebird bio(BLUE) - 2024 Q3 - Quarterly Report
2024-11-14 12:06
Financial Performance - The company reported a net loss of $60.8 million and $212.0 million for the three and nine months ended September 30, 2024, respectively, with an accumulated deficit of $4.5 billion[142]. - Total revenue for the three months ended September 30, 2024, was $10.6 million, a decrease of $1.8 million from $12.4 million in the same period of 2023, primarily due to one fewer infusion[164]. - Product revenue for the nine months ended September 30, 2024, was $45.3 million, an increase of $23.6 million compared to $21.7 million for the same period in 2023, driven by increased product sales[172]. - Net loss for the three months ended September 30, 2024, was $60.8 million, an improvement of $26.4 million compared to a net loss of $87.2 million in the same period of 2023[164]. - Interest income for the nine months ended September 30, 2024, was $7.1 million, a decrease of $0.9 million from $7.9 million in the same period of 2023[172]. - Interest expense for the nine months ended September 30, 2024, was $16.9 million, an increase of $4.5 million from $12.3 million in the same period of 2023[172]. - Gain from the sale of a priority review voucher in the first quarter of 2023 amounted to $92.9 million, which was not repeated in 2024[159]. Cash Flow and Liquidity - Cash and cash equivalents were approximately $70.7 million as of September 30, 2024, and the company expects to continue generating operating losses and negative cash flows for the foreseeable future[144]. - The company expects existing cash and cash equivalents to fund operations into the first quarter of 2025, assuming continued cost-saving initiatives[146]. - For the nine months ended September 30, 2024, net cash used in operating activities was $209.9 million, an increase of $28.9 million compared to the same period in 2023[190]. - The company reported a net cash provided by financing activities of $52.5 million for the nine months ended September 30, 2024, a decrease of $37.2 million compared to the same period in 2023[192]. - The company incurred a $149.7 million decrease in cash provided by investing activities for the nine months ended September 30, 2024, primarily due to no proceeds from the sale of priority review vouchers[191]. Restructuring and Cost Management - The company initiated a restructuring action expected to reduce cash operating expenses by approximately 20% by the third quarter of 2025, including a workforce reduction of about 25%[144]. - Restructuring expenses of $2.8 million were incurred in the three months ended September 30, 2024, related to workforce reduction[169]. - Selling, general and administrative expenses for the three months ended September 30, 2024, were $39.8 million, a decrease of $1.0 million from $40.8 million in the same period of 2023[167]. - Total operating expenses for the nine months ended September 30, 2024, were $212.7 million, a decrease of $37.5 million from $250.2 million in the same period of 2023[172]. Research and Development - The company plans to continue incurring significant research and development expenses as it commercializes ZYNTEGLO, SKYSONA, and LYFGENIA[142]. - Research and development expenses for the three months ended September 30, 2024, were $23.2 million, down $35.3 million from $58.5 million in the same period of 2023[165]. - Research and development expenses are expected to decrease as commercial activities increase, particularly with the commercialization of ZYNTEGLO, SKYSONA, and LYFGENIA[181]. Financing Activities - The company has entered into a five-year term loan facility agreement with Hercules Capital for up to $175.0 million, available in four tranches[141]. - The company has entered into a loan agreement for up to $175.0 million in debt financing in March 2024 to support its operations[189]. - The increase in interest expense is primarily due to the term loan debt with Hercules entered into in March 2024, partially offset by a decrease in finance lease interest expense[179]. Market Focus - The company is focusing on the U.S. market for its gene therapies, having withdrawn marketing authorizations for beti-cel and eli-cel in the European Union[137]. - Future net product revenues will depend on market demand, manufacturing capabilities, and reimbursement from third-party payers[147].
bluebird bio(BLUE) - 2024 Q3 - Quarterly Results
2024-11-14 12:01
Financial Performance - Third quarter 2024 net revenue was $10.6 million, a decrease from $12.3 million in the same quarter of 2023, with expectations of at least $25 million in net revenue for the fourth quarter[10]. - Product revenue for Q3 2024 was $10,612,000, a decrease from $12,281,000 in Q3 2023, representing a decline of 13.6%[22]. - Total revenues for the nine months ended September 30, 2024, were $45,286,000, compared to $21,663,000 for the same period in 2023, showing an increase of 109.1%[22]. - The net loss for Q3 2024 was $60.8 million, an improvement from a net loss of $87.2 million in Q3 2023[15]. - Net loss for Q3 2024 was $60,808,000, compared to a net loss of $87,232,000 in Q3 2023, indicating an improvement of 30.3%[22]. Expenses - Research and development expenses decreased to $23.2 million in Q3 2024 from $58.5 million in Q3 2023, a reduction of $35.3 million[14]. - Selling, general and administrative expenses were $39.8 million for Q3 2024, down from $40.8 million in Q3 2023, primarily due to reduced employee compensation and commercial expenses[13]. - Total operating expenses for Q3 2024 were $65,750,000, down from $99,272,000 in Q3 2023, a reduction of 33.8%[22]. Cash Position and Assets - The company's cash position was approximately $118.7 million as of September 30, 2024, including $48.0 million in restricted cash[8]. - Cash and cash equivalents decreased to $70,651,000 as of September 30, 2024, from $221,755,000 as of December 31, 2023[23]. - Total assets decreased to $465,056,000 as of September 30, 2024, from $619,161,000 as of December 31, 2023[23]. - Total liabilities increased to $470,842,000 as of September 30, 2024, compared to $424,624,000 as of December 31, 2023[23]. - Total stockholders' equity was negative $5,786,000 as of September 30, 2024, down from $194,537,000 as of December 31, 2023[23]. Patient Starts and Demand - 74 patient starts completed or scheduled in 2024, with 57 patient starts completed to date, including 35 for ZYNTEGLO, 17 for LYFGENIA, and 5 for SKYSONA[1][3]. - The company has scheduled 30 patient starts for 2025, indicating strong commercial demand and supporting the potential for cash flow breakeven[3]. Future Outlook - The company anticipates achieving cash flow break-even in the second half of 2025, assuming approximately 40 drug product deliveries per quarter and securing additional cash resources[10][2]. - The company is presenting updated data on its gene addition programs at the ASH 2024 Annual Meeting, highlighting ongoing research efforts[5][6][7]. Coverage and Market - More than half of U.S. states have affirmed coverage for LYFGENIA, with nearly 50% of Medicaid-insured individuals with sickle cell disease living in states that have completed prior authorization approval[4]. Interest Income - Interest income for Q3 2024 was $1,640,000, compared to $2,454,000 in Q3 2023, a decrease of 33.1%[22]. Gross Margin - Gross margin for Q3 2024 was negative $1,169,000, compared to a positive $3,266,000 in Q3 2023[22].
After Plunging -22.76% in 4 Weeks, Here's Why the Trend Might Reverse for Bluebird (BLUE)
ZACKS· 2024-11-08 15:36
Bluebird Bio (BLUE) has been beaten down lately with too much selling pressure. While the stock has lost 22.8% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator th ...
Bluebird Bio (BLUE) Stock Dips Amid Market Volatility
GuruFocus· 2024-10-08 19:53
Bluebird Bio (BLUE, Financial) experienced a significant drop in its stock price, declining by 5.67%. The shares are currently trading at $0.491, with a trading volume of 3.72 million shares, a turnover rate of 1.92%, and showing a price amplitude of 4.76%.The recent financial report indicates that Bluebird Bio generated $16.10 million in revenue, with a net loss of $81.39 million. The earnings per share (EPS) stand at -$0.42, and the gross profit is reported at -$12.85 million. The price-to-earnings (P/E) ...
Bluebird Bio (BLUE) Stock Surges 5.04% Amid Market Movements
GuruFocus· 2024-10-02 20:11
Bluebird Bio (BLUE, Financial) stock experienced a notable surge of 5.04% to $0.494 per share. The trading volume reached 6.47552 million shares, resulting in a turnover rate of 3.34% and a volatility of 8.69%.According to the latest financial report, Bluebird Bio posted a revenue of $16.10 million, a net loss of $81.39 million, an earnings per share (EPS) of -$0.42, and a gross profit of -$12.85 million. The company's price-to-earnings (P/E) ratio stands at -0.21.Among the ten institutions that rated the s ...
bluebird bio(BLUE) - 2024 Q2 - Quarterly Report
2024-09-27 20:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ FORM 10-Q __________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: ...
bluebird bio(BLUE) - 2024 Q1 - Quarterly Report
2024-09-13 20:37
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 __________________________________________________________________ FORM 10-Q __________________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: ...
bluebird bio(BLUE) - 2023 Q4 - Annual Report
2024-09-13 20:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ___________________________________________________________________________ FORM 10-K ___________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...