- Presented cardiac magnetic resonance (CMR) imaging evidence consistent with clinical improvement observed in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the ATTRibute-CM Phase 3 study of acoramidis at the
- The Company believes there is potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA on the use of glycosylated alpha dystroglycan (αDG) levels as a surrogate endpoint; the FORTIFY Phase 3 trial of BBP-418 in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) continues to enroll, with full enrollment of the interim analysis population expected in 2024
- BridgeBio secured up to
- The Company announced the launch of BridgeBio Oncology Therapeutics (BBOT) with a
- The Company’s Marketing Authorization Application (MAA) for acoramidis was accepted by review for the
- The Company ended the quarter with
“In addition to the important scientific work we have done to advance our patient mission this quarter, we have also taken a first step towards streamlining our firm and thereby unlocking value for patients and investors alike,” said
BridgeBio’s late stage programs:
- Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):
- The EMA accepted the Company’s MAA for acoramidis for review, with an expected approval in 2025. This is in addition to the Prescription Drug User Fee Act (PDUFA) date of
November 29, 2024 set by theU.S. FDA for the Company’s NDA for acoramidis for the treatment of ATTR-CM. - In
March 2024 , the Company entered into a licensing agreement granting Bayer exclusive rights to commercialize acoramidis for ATTR-CM inEurope ; in exchange, BridgeBio is entitled to receive among other consideration:- Tiered royalties beginning in the low-thirties percent, and
- Up to
$310 million in upfront and near-term milestone payments, as well as additional sales milestones.
- Tiered royalties beginning in the low-thirties percent, and
- The Company presented cardiac magnetic resonance imaging evidence from an exploratory substudy where treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression. This evidence is consistent with clinical improvement observed in the Company’s ATTRibute-CM Phase 3 study of acoramidis in patients with ATTR-CM.
- Additional detailed results of the Company’s ATTRibute-CM study are planned for presentation at 2024 medical meetings, including four abstracts accepted for presentation at the
European Society of Cardiology Heart Failure conference inMay 2024 , and eleven abstracts accepted for presentation at the International Symposium on Amyloidosis inMay 2024 .
- The EMA accepted the Company’s MAA for acoramidis for review, with an expected approval in 2025. This is in addition to the Prescription Drug User Fee Act (PDUFA) date of
- Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:
- The PROPEL 3 global Phase 3 registrational study of infigratinib in achondroplasia continues to enroll; study completion continues to be anticipated for 2025.
- The Company anticipates initiating its clinical program for hypochondroplasia in 2024, as part of its commitment to exploring the potential of infigratinib on the wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias.
- The PROPEL 3 global Phase 3 registrational study of infigratinib in achondroplasia continues to enroll; study completion continues to be anticipated for 2025.
- BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- The Company believes there is potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA on the use of glycosylated αDG levels as a surrogate endpoint.
- FORTIFY, the global Phase 3 registrational trial of BBP-418 in LGMD2I/R9, continues to enroll in the
U.S. ,Europe andAustralia . Full enrollment of the interim analysis population is expected in 2024.
- The Company believes there is potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA on the use of glycosylated αDG levels as a surrogate endpoint.
- Encaleret – Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, continues to enroll; the Company anticipates sharing topline data from CALIBRATE in 2025.
Recent Corporate Updates:
- The Company announced the launch of BridgeBio Oncology Therapeutics (BBOT) with a
$200 million private financing to accelerate the development of its novel precision oncology pipeline.
- The
$200 million financing was led by Cormorant Asset Management and co-led by Omega Funds, with participation from affiliates ofDeerfield Management , GV (Google Ventures ),EcoR1 Capital , Wellington Management, Enavate Sciences,Surveyor Capital (aCitadel company),Aisling Capital ,Casdin Capital , andLongwood Fund .
- BBOT will be led by
Eli Wallace , Ph.D. as CEO andPedro Beltran , Ph.D. as CSO; the Board of Directors for BBOT will be chaired byFrank McCormick , Ph.D., David A. Wood Distinguished Professor ofTumor Biology and Cancer Research at UCSF and advisor to the National Cancer Institute’s RAS Initiative atFrederick National Laboratory for Cancer Research .Raymond Kelleher , M.D., Ph.D., Managing Director Cormorant Asset Management,Michelle Doig , Partner,Omega Funds , andNeil Kumar , Ph.D., CEO of BridgeBio will serve as directors.
First Quarter 2024 Financial Results:
Cash, Cash Equivalents,
Cash, cash equivalents, marketable securities and short-term restricted cash, totaled
Revenue
Revenue for the three months ended
Operating Costs and Expenses
Operating costs and expenses for the three months ended
The overall increase of
Restructuring, impairment and related charges for the three months ended
Stock-based compensation expenses included in operating costs and expenses for the three months ended
“With our recent equity financing activities, our licensing deal with Bayer for European commercial rights to acoramidis, our royalty funding agreement for
Condensed Consolidated Statements of Operations (in thousands, except shares and per share amounts) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
(Unaudited) | |||||||
Revenue | $ | 211,120 | $ | 1,826 | |||
Operating costs and expenses: | |||||||
Research, development and other expenses | 141,570 | 93,512 | |||||
Selling, general and administrative | 65,807 | 31,108 | |||||
Restructuring, impairment and related charges | 3,400 | 3,369 | |||||
Total operating costs and expenses | 210,777 | 127,989 | |||||
Income (loss) from operations | 343 | (126,163 | ) | ||||
Other expense, net: | |||||||
Interest income | 4,075 | 4,153 | |||||
Interest expense | (23,471 | ) | (20,121 | ) | |||
Loss on extinguishment of debt | (26,590 | ) | — | ||||
Other income (expense), net | 9,483 | (601 | ) | ||||
Total other expense, net | (36,503 | ) | (16,569 | ) | |||
Net loss | (36,160 | ) | (142,732 | ) | |||
Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests | 944 | 2,576 | |||||
Net loss attributable to common stockholders of BridgeBio | $ | (35,216 | ) | $ | (140,156 | ) | |
Net loss per share, basic and diluted | $ | (0.20 | ) | $ | (0.92 | ) | |
Weighted-average shares used in computing net loss per share, basic and diluted | 178,705,310 | 152,645,635 |
Three Months Ended | ||||||
Stock-based Compensation | 2024 | 2023 | ||||
(Unaudited) | ||||||
Research, development and other expenses | $ | 12,779 | $ | 11,779 | ||
Selling, general and administrative | 16,071 | 11,698 | ||||
Total stock-based compensation | $ | 28,850 | $ | 23,477 |
Condensed Consolidated Balance Sheets
(In thousands)
2024 | 2023 | ||||||
Assets | (Unaudited) | (1 | ) | ||||
Cash and cash equivalents and marketable securities | $ | 519,691 | $ | 375,935 | |||
Investments in equity securities | - | 58,949 | |||||
Receivables from licensing and collaboration agreements | 235,494 | 1,751 | |||||
Short-term restricted cash | 131 | 16,653 | |||||
Prepaid expenses and other current assets | 28,108 | 24,305 | |||||
Property and equipment, net | 11,414 | 11,816 | |||||
Operating lease right-of-use assets | 8,052 | 8,027 | |||||
Intangible assets, net | 25,721 | 26,319 | |||||
Other assets | 20,722 | 22,625 | |||||
Total assets | $ | 849,333 | $ | 546,380 | |||
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit | |||||||
Accounts payable | $ | 4,728 | $ | 10,655 | |||
Accrued and other liabilities | 118,248 | 122,965 | |||||
Operating lease liabilities | 12,841 | 13,109 | |||||
Deferred revenue | 33,847 | 9,823 | |||||
2029 Notes, net | 737,392 | 736,905 | |||||
2027 Notes, net | 543,823 | 543,379 | |||||
Term loan, net | 434,717 | 446,445 | |||||
Other long-term liabilities | 595 | 5,634 | |||||
Redeemable convertible noncontrolling interests | 525 | 478 | |||||
Total BridgeBio stockholders' deficit | (1,049,528 | ) | (1,354,257 | ) | |||
Noncontrolling interests | 12,145 | 11,244 | |||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit | $ | 849,333 | $ | 546,380 |
(1 | ) | The condensed consolidated financial statements as of and for the year ended |
Condensed Consolidated Statements of Cash Flows (Unaudited) (In thousands) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Operating activities: | |||||||
Net loss | $ | (36,160 | ) | $ | (142,732 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Loss on extinguishment of debt | 26,590 | — | |||||
Stock-based compensation | 17,057 | 21,907 | |||||
Accretion of debt | 2,015 | 2,338 | |||||
Depreciation and amortization | 1,596 | 1,633 | |||||
Noncash lease expense | 1,069 | 1,032 | |||||
Accrual of payment-in-kind interest on term loan | — | 3,339 | |||||
Loss on deconsolidation of PellePharm | — | 1,241 | |||||
Gain from investment in equity securities, net | (8,136 | ) | (964 | ) | |||
Other noncash adjustments | 1,631 | (314 | ) | ||||
Changes in operating assets and liabilities: | |||||||
Receivables from licensing and collaboration agreements | (233,743 | ) | 6,318 | ||||
Prepaid expenses and other current assets | (3,345 | ) | (3,542 | ) | |||
Other assets | 444 | (483 | ) | ||||
Accounts payable | (5,927 | ) | (3,800 | ) | |||
Accrued compensation and benefits | (14,969 | ) | (18,369 | ) | |||
Accrued research and development liabilities | 11,168 | (2,556 | ) | ||||
Operating lease liabilities | (1,595 | ) | (1,250 | ) | |||
Deferred revenue | 24,024 | (1,748 | ) | ||||
Accrued professional and other liabilities | (1,256 | ) | (6,372 | ) | |||
Net cash used in operating activities | (219,537 | ) | (144,322 | ) | |||
Investing activities: | |||||||
Purchases of marketable securities | (44,395 | ) | — | ||||
Maturities of marketable securities | — | 18,000 | |||||
Purchases of investments in equity securities | (20,271 | ) | (47,474 | ) | |||
Proceeds from sales of investments in equity securities | 63,229 | 42,287 | |||||
Proceeds from special cash dividends received from investments in equity securities | 25,682 | — | |||||
Payment for an intangible asset | (797 | ) | — | ||||
Purchases of property and equipment | (695 | ) | (12 | ) | |||
Decrease in cash and cash equivalents resulting from deconsolidation of PellePharm | — | (503 | ) | ||||
Net cash provided by investing activities | 22,753 | 12,298 | |||||
Financing activities: | |||||||
Proceeds from term loan under Financing Agreement | 450,000 | — | |||||
Issuance costs and discounts associated with term loan under Financing Agreement | (12,254 | ) | — | ||||
Repayment of term loan under Loan and Security Agreement | (473,417 | ) | — | ||||
Proceeds from issuance of common stock through public offerings, net | 315,254 | 143,016 | |||||
Proceeds from BridgeBio common stock issuances under ESPP | 2,364 | 1,809 | |||||
Proceeds from stock option exercises, net of repurchases | 537 | 193 | |||||
Repurchase of RSU shares to satisfy tax withholding | (2,936 | ) | (512 | ) | |||
Other financing activities | — | 5,743 | |||||
Net cash provided by financing activities | 279,548 | 150,249 | |||||
Net increase in cash, cash equivalents and restricted cash | 82,764 | 18,225 | |||||
Cash, cash equivalents and restricted cash at beginning of period | 394,732 | 416,884 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 477,496 | $ | 435,109 |
Three Months Ended | |||||||
2024 | 2023 | ||||||
Supplemental Disclosure of Cash Flow Information: | |||||||
Cash paid for interest | $ | 35,315 | $ | 22,059 | |||
Supplemental Disclosures of Noncash Investing and Financing Information: | |||||||
Unpaid issuance costs associated with term loan under Financing Agreement | $ | 3,732 | $ | — | |||
Unpaid public offering issuance costs | $ | 513 | $ | — | |||
Deferred and unpaid issuance costs recorded to "Accrued professional and other accrued liabilities" | $ | 458 | $ | — | |||
Unpaid property and equipment | $ | 70 | $ | 96 | |||
Transfers to noncontrolling interests | $ | (1,857 | ) | $ | (2,843 | ) | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash: | |||||||
Cash and cash equivalents | $ | 475,222 | $ | 407,368 | |||
Restricted cash | 131 | 25,503 | |||||
Restricted cash — Included in “Other assets” | 2,143 | 2,238 | |||||
Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows | $ | 477,496 | $ | 435,109 |
About
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical and therapeutic, market potential of the Company’s programs and product candidates, including the statements in Dr. Kumar’s and Dr. Stephenson’s quotes regarding the potential commercial launch of acoramidis (if approved), continued advancement in the Company’s pipeline, including enrollments in clinical trials and anticipated readouts, and other benefits resulting from recent financing activities; the statements related to the FDA’s planned actions regarding the Company’s NDA for acoramidis for the treatment of ATTR-CM; the potential outcomes of regulatory reviews by the FDA and the EMA; the timing and success of the Company’s clinical development programs, including the progress of the Company’s clinical development program for acoramidis for patients with ATTR-CM, and the Company’s plan for, and the expected timing of, presenting additional detailed results of ATTRibute-CM study at medical meetings; the potential payments we may receive under the recent license agreement with Bayer; the continuation of PROPEL 3, the Company’s Phase 3 study of infigratinib for achondroplasia and the expected timing for full enrollment in the study; the Company’s commitment to exploring the potential of infigratinib and the expectation and timing of the initiation of the Company’s clinical program for hypochondroplasia; the continuation and progress of FORTIFY, the Phase 3 trial of BBP-418 for LGMD2I/R9, including the ongoing enrollment in
BridgeBio Contact:
contact@bridgebio.com
(650)-789-8220
Source:
2024 GlobeNewswire, Inc., source