Latest News by Industry
- Reported positive preclinical data for its next-generation KRASG12CGTP/GDP dual inhibitor development candidate, BBO-8520, and for its novelPI3Kα:RAS breaker mechanism in late lead optimization
- Reported positive updated 12-month Phase 2 data for BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i
- Enrolled Cohort 5 of Phase 2 trial of infigratinib in achondroplasia, with no serious adverse events (SAEs), and no adverse events that required dose modifications reported to date
- Reported dosing of first lung cancer patient in Phase 1/2 trial of SHP2 inhibitor BBP-398 in combination with Amgen’s Lumakras (sotorasib); also reported dosing of first patient in Phase 1 trial of BBP-671 in Propionic Acidemia (PA) and Methylmalonic Acidemia (MMA)
- Reported updated positive data from its Phase 1/2 trial of BBP-812, an AAV9 gene therapy candidate for the treatment of Canavan disease
- Received approval of NULIBRY (fosdenopterin) as a treatment for molybdenum cofactor deficiency (MoCD) Type A in Israel and the European Union (EU)
- Reported operating expense for Q3 2022 at $129.5 million, a reduction of 26.2% from $175.4 million in Q1 2022 when restructuring efforts began, and a reduction of 15.9% from $153.9 million in Q2 2022.
- Ended quarter with $558.3 million in cash, cash equivalents and marketable securities, providing financial runway into 2024
PALO ALTO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today reported its financial results for the third quarter ended September 30, 2022 and provided an update on the Company’s operations.
“We remain committed to focused execution across our pipeline, and have continued to deliver exciting data for patients, including in our LGMD2i and KRAS programs, while at the same time materially reducing our operating expenses and putting the Company on safe footing,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio.
“The compounds that we have developed in our RAS franchise after years of intensive work now allow us to clinically interrogate the promise of direct inhibition of active KRAS, as well as the potential of breaking PI3Kα:RAS binding,” added Frank McCormick, Ph.D., Chairman of Oncology and cofounder of BridgeBio. “RAS and PIK3CA are the two most common oncogenes in human tumors, and we hope that our programs are able to serve the vast unmet need of the patients that they impact.”
BridgeBio’s Key Programs
RAS cancer portfolio:
Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:
Encaleret – Calcium-sensing receptor ( CaSR ) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):
BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2i (LGMD2i):
Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):
BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH):
Recent Corporate Updates
Third Quarter 2022 Financial Results:
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $558.3 million as of September 30, 2022, compared to $787.5 million as of December 31, 2021. The net decrease of $229.2 million in cash, cash equivalents and marketable securities, excluding restricted cash is primarily attributable to net cash used in operating activities of $326.3 million. The net cash used in operating activities for the nine months ended September 30, 2022 was partially offset by a $90.0 million in upfront payment received under the License, Development and Commercialization Agreement between the Company, its affiliate, Navire Pharma, Inc., and Bristol Myers Squibb (the “Navire-BMS License Agreement”). During the nine months ended September 30, 2022, the Company also received upfront payments of $110.0 million from the sale of its priority review voucher and $10.0 million upon closing of an asset purchase agreement between its affiliate, Origin Biosciences, Inc., and Sentynl Therapeutics, Inc. The Company made a $20.5 million mandatory prepayment of a portion of its term loan obligations under its Amended Loan and Security Agreement in connection with the upfront payment received from BMS.
Cash, cash equivalents and marketable securities, excluding restricted cash, decreased by $130.3 million when compared to the balance as of June 30, 2022 of $688.6 million. Net cash used in operating activities, was $135.2 million for the three months ended September 30, 2022. Net cash used in operating activities was $191.1 million for the six months ended June 30, 2022.
Operating Costs and Expenses
Operating costs and expenses for the three and nine months ended September 30, 2022 were $129.5 million and $458.7 million, respectively, as compared to $151.8 million and $467.8 million for the same periods in the prior year. The overall decrease in operating costs and expenses for the three and nine months ended September 30, 2022 compared to the comparative periods was mainly due to overall decreases in selling, general and administrative expenses and research, development and other (R&D) expenses resulting from the Company's reprioritization of its R&D programs and streamlining of costs. The effects of the Company's restructuring initiative that was started in the first quarter of 2022 are now being realized due to reductions of its operating costs and expenses. Restructuring, impairment and related charges for the three and nine months ended September 30, 2022 of $5.0 million and $36.1 million, respectively, were primarily comprised of winding down costs, exit and other related costs, impairments and write-offs of long-lived assets, and severance and employee-related costs. The Company continues to evaluate restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings.
“We continue to take action to protect the Company, shore up our balance sheet, and preserve capital to read out our upcoming key catalysts,” said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio. “We expect that cash burn will continue to decline in the fourth quarter as a result of ongoing potential business development and restructuring activities. Cash on hand provides us with runway into 2024, and we will continue to look for ways to extend runway via potential royalty monetizations, partnerships, and burn reduction.”
The Company’s research and development and other expenses have not been significantly impacted by the global COVID-19 pandemic for the periods presented. While BridgeBio experienced some delays in certain of its clinical enrollment and trial commencement activities, it continues to adapt with alternative site, telehealth and home visits, and at-home drug delivery, as well as mitigation strategies with its contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on BridgeBio’s operating costs and expenses is currently unknown.
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue | $ | 338 | $ | 2,344 | $ | 75,778 | $ | 56,830 | ||||||||
| Operating costs and expenses: | ||||||||||||||||
| Research, development and others | 93,250 | 105,759 | 311,347 | 330,387 | ||||||||||||
| Selling, general and administrative | 31,188 | 46,084 | 111,327 | 137,461 | ||||||||||||
| Restructuring, impairment and related charges | 5,016 | — | 36,074 | — | ||||||||||||
| Total operating costs and expenses | 129,454 | 151,843 | 458,748 | 467,848 | ||||||||||||
| Loss from operations | (129,116 | ) | (149,499 | ) | (382,970 | ) | (411,018 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 2,417 | 234 | 3,450 | 951 | ||||||||||||
| Interest expense | (19,825 | ) | (11,067 | ) | (60,448 | ) | (31,644 | ) | ||||||||
| Gain from sale of priority review voucher, net | — | — | 107,946 | — | ||||||||||||
| Other income (expense), net | 6,331 | (684 | ) | (12,060 | ) | 7,539 | ||||||||||
| Total other income (expense), net | (11,077 | ) | (11,517 | ) | 38,888 | (23,154 | ) | |||||||||
| Net loss | (140,193 | ) | (161,016 | ) | (344,082 | ) | (434,172 | ) | ||||||||
| Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests | 2,854 | 5,081 | 490 | 18,810 | ||||||||||||
| Net loss attributable to common stockholders of BridgeBio | $ | (137,339 | ) | $ | (155,935 | ) | $ | (343,592 | ) | $ | (415,362 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.93 | ) | $ | (1.06 | ) | $ | (2.34 | ) | $ | (2.88 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 147,937,817 | 146,662,756 | 146,842,453 | 144,044,360 | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Research, development and others | $ | 6,137 | $ | 4,808 | $ | 29,046 | $ | 46,541 | ||||||||
| Selling, general and administrative | 12,521 | 11,322 | 41,026 | 36,520 | ||||||||||||
| Restructuring, impairment and related charges | — | — | 1,172 | — | ||||||||||||
| Total stock-based compensation | $ | 18,658 | $ | 16,130 | $ | 71,244 | $ | 83,061 | ||||||||
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)
| September 30, | December 31, | |||||||||
| 2022 | 2021 | |||||||||
| Assets | (Unaudited) | (1) | ||||||||
| Cash and cash equivalents and marketable securities | $ | 558,315 | $ | 787,515 | ||||||
| Investment in equity securities | 33,662 | 49,148 | ||||||||
| Receivable from licensing and collaboration agreements | 24,581 | 19,749 | ||||||||
| Prepaid expenses and other current assets | 25,661 | 32,446 | ||||||||
| Property and equipment, net | 15,603 | 30,066 | ||||||||
| Operating lease right-of-use assets | 11,738 | 15,907 | ||||||||
| Intangible assets, net | 29,310 | 44,934 | ||||||||
| Other assets | 29,870 | 33,027 | ||||||||
| Total assets | $ | 728,740 | $ | 1,012,792 | ||||||
| Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit | ||||||||||
| Accounts payable | $ | 10,158 | $ | 11,884 | ||||||
| Accrued and other liabilities | 104,992 | 118,247 | ||||||||
| Operating lease liabilities | 17,044 | 22,366 | ||||||||
| 2029 Notes | 734,516 | 733,119 | ||||||||
| 2027 Notes | 541,205 | 539,934 | ||||||||
| Term loans | 422,972 | 430,752 | ||||||||
| Other long-term liabilities | 28,226 | 22,069 | ||||||||
| Redeemable convertible noncontrolling interests | (2,388 | ) | 1,423 | |||||||
| Total BridgeBio stockholders' deficit | (1,138,417 | ) | (870,414 | ) | ||||||
| Noncontrolling interests | 10,432 | 3,412 | ||||||||
| Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit | $ | 728,740 | $ | 1,012,792 | ||||||
| (1 | ) | The condensed consolidated financial statements as of and for the year ended December 31, 2021 are derived from the audited consolidated financial statements as of that date. |
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
| Nine Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Operating activities: | ||||||||
| Net loss | $ | (344,082 | ) | $ | (434,172 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 69,770 | 79,731 | ||||||
| Depreciation and amortization | 5,111 | 4,317 | ||||||
| Net loss from investment in equity securities | 12,969 | 1,510 | ||||||
| Gain from sale of priority review voucher, excluding transaction costs | (110,000 | ) | — | |||||
| Gain from recognition of receivable from licensing and collaboration agreement | (12,500 | ) | — | |||||
| Fair value of shares issued under a license agreement | 4,567 | — | ||||||
| Accretion of debt | 6,469 | 4,043 | ||||||
| Fair value adjustment of warrants | 1,446 | 459 | ||||||
| Loss on sale of certain assets | 6,261 | — | ||||||
| Impairment of long-lived assets | 12,720 | 3,300 | ||||||
| LEO call option income | — | (5,550 | ) | |||||
| Other noncash adjustments | 4,687 | 7,322 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Receivable from licensing and collaboration agreements | (832 | ) | (7,710 | ) | ||||
| Receivable from a related party | — | (462 | ) | |||||
| Prepaid expenses and other current assets | 4,072 | (3,743 | ) | |||||
| Other assets | 10,095 | (8,930 | ) | |||||
| Accounts payable | (1,725 | ) | 1,360 | |||||
| Accrued compensation and benefits | (9,122 | ) | (4,443 | ) | ||||
| Accrued research and development liabilities | 452 | 4,686 | ||||||
| Accrued professional services | (2,556 | ) | 346 | |||||
| Operating lease liabilities | (4,819 | ) | (4,474 | ) | ||||
| Deferred revenue | 16,969 | — | ||||||
| Other accrued and other long-term liabilities | 3,797 | (1,629 | ) | |||||
| Net cash used in operating activities | (326,251 | ) | (364,039 | ) | ||||
| Investing activities: | ||||||||
| Purchases of marketable securities | (134,635 | ) | (575,478 | ) | ||||
| Maturities of marketable securities | 452,819 | 305,200 | ||||||
| Sales of marketable securities | — | 98,925 | ||||||
| Purchases of investment in equity securities | (26,312 | ) | (23,960 | ) | ||||
| Sales of investment in equity securities | 28,830 | 4,743 | ||||||
| Increase in cash and cash equivalents from consolidation of PellePharm | — | 13,654 | ||||||
| Acquisition and payment of an intangible asset | (1,500 | ) | (35,000 | ) | ||||
| Proceeds from sale of priority review voucher | 110,000 | — | ||||||
| Proceeds from sale of certain assets | 10,000 | — | ||||||
| Purchases of property and equipment | (4,020 | ) | (10,710 | ) | ||||
| Net cash provided by (used in) investing activities | 435,182 | (222,626 | ) | |||||
| Financing activities: | ||||||||
| Proceeds from issuance of 2029 Notes | — | 747,500 | ||||||
| Issuance costs and discounts associated with issuance of 2029 Notes | — | (16,064 | ) | |||||
| Issuance costs associated with term loan | (1,120 | ) | — | |||||
| Purchase of capped calls | — | (61,295 | ) | |||||
| Repurchases of common stock | — | (198,458 | ) | |||||
| Transactions with noncontrolling interests | — | 3,500 | ||||||
| Repurchase of Eidos noncontrolling interest, including direct transaction costs | — | (85,090 | ) | |||||
| Proceeds from term loan | — | 25,000 | ||||||
| Repayment of term loan | (20,486 | ) | (18,108 | ) | ||||
| Proceeds from BridgeBio common stock issuances under ESPP | 2,558 | 3,821 | ||||||
| Repurchase of shares to satisfy tax withholding | (1,072 | ) | (4,035 | ) | ||||
| Proceeds from stock option exercises, net of repurchases | 609 | 14,294 | ||||||
| Net cash provided by (used in) financing activities | (19,511 | ) | 411,065 | |||||
| Net increase in cash, cash equivalents and restricted cash | 89,420 | (175,600 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 396,365 | 358,679 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 485,785 | $ | 183,079 | ||||
| Nine Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Supplemental Disclosures of Cash Flow Information: | ||||||||
| Cash paid for interest | $ | 47,575 | $ | 28,239 | ||||
| Supplemental Disclosures of Noncash Investing and Financing Information: | ||||||||
| Payment-in-kind interest added to principal of term loan | $ | 8,503 | $ | — | ||||
| Net noncash portion of repurchase of Eidos noncontrolling interests | $ | — | $ | 38,167 | ||||
| Direct transaction costs in the repurchase of Eidos recorded in “Additional paid-in capital” previously classified in “Prepaid expenses and other current assets” | $ | — | $ | 8,749 | ||||
| Noncash contribution by a noncontrolling interest | $ | — | $ | 21,600 | ||||
| Recognized intangible asset recorded in “Accrued research and development liabilities” | $ | 11,000 | $ | 12,500 | ||||
| Leasehold improvements paid by landlord | $ | — | $ | 2,449 | ||||
| Repurchase of common stock recorded in Accounts payable | $ | — | $ | 1,542 | ||||
| Transfers from noncontrolling interests | $ | 1,153 | $ | (221 | ) | |||
| Reconciliation of Cash, Cash Equivalents and Restricted Cash: | ||||||||
| Cash and cash equivalents | $ | 483,235 | $ | 180,347 | ||||
| Restricted cash — Included in “Prepaid expenses and other current assets” | 140 | 176 | ||||||
| Restricted cash — Included in “Other assets” | 2,410 | 2,556 | ||||||
| Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows | $ | 485,785 | $ | 183,079 | ||||
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.
BridgeBio Pharma, Inc. Forward-Looking Statements
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,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “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 potential of our programs and product candidates, including the timing and success of our RAS program, including preclinical data for our next-generation KRASG12C GTP/GDP dual inhibitor development candidate, BBO-8520 and plans to be in the clinic in mid-2023, updated data from our Phase 2 study of BBP-418 for patients LGMD2i, the timing and success of regulatory discussions regarding potential paths to approval for BBP-418, the ability of BBP-418 to be the first approved therapy for patients with LGMD2i, the timing and success of a Phase 3 trial of BBP-418 in patients with LGMD2i intended to be initiated in the first half of 2023, the availability and success of data from our ongoing Phase 1/2 trial of SHP2 inhibitor BBP-398 in combination with Amgen’s Lumakras (sotorasib), the availability and success of additional data from our ongoing Phase 1/2 trial of BBP-812 for the treatment of Canavan disease, the availability and success of additional data from our ongoing Phase 1 study of BBP-671 for PKAN and organic acidemias, the approval of NULIBRY (fosdenopterin) for treatment of MoCD Type A in Israel and the EU, the availability and success of initial data from our ongoing Phase 2 study of low-dose infigratinib for achondroplasia, including plans to deliver an update on Cohort 5 in the first half of 2023, followed by the initiation of a pivotal Phase 3 trial, the evaluation of the development of infigratinib in other FGFR-driven skeletal dysplasias, the availability and success of additional data from our ongoing Phase 2b study of encaleret for ADH1, the timing and success of additional trials of encaleret for ADH1, including the timing and announced design of a Phase 3 pivotal study of encaleret for ADH1, the timing and success of our planned Phase 3 pivotal study of encaleret in patients with ADH1, the availability and success of topline results from the Part B Month 30 endpoint of our Phase 3 ATTRibute-CM trial of acoramidis, expected in mid-2023, the availability and success of data from our ongoing Phase 1/2 study of BBP-631 for CAH, with an update anticipated in late 2023 or early 2023, the timing, availability and success of an initial data readout from our Phase 1 trial of BBP-671 in patients with PA and MMA expected in mid-2023, the timing and success of discussions with regulators and the expected launch of a pivotal Phase 2/3 study of BBP-671 in PKAN in 2024, the potential of BBP-671 to be a best-in-class therapy for PA, MMA, and PKAN patients, as well as the first approved oral therapy for the treatment of systemic complications caused by CoA deficiencies, if successful, the success of our license agreement with Bristol Myers Squibb to develop and commercialize BBP-398, including our eligibility for development, regulatory and sales milestone payments and tiered royalties, the success of our asset purchase agreement with Sentynl Therapeutics, including our ability to achieve future milestone and royalty payments from Sentynl Therapeutics and the timing of these events, the timing and success of partnering and out-licensing discussions for certain programs in our pipeline, the timing and availability of delayed debt draws under our senior secured credit facility, the success of our reduction in operating expenses and our expectations for our operating expenses and cash burn for the second quarter, the success of our restructuring initiative and its savings being realized, as well as our anticipated cash runway, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, the Company’s ability to unlock additional funding under our credit facility, potential volatility in our share price, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, as well as those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2021 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Contact:
Vikram Bali
contact@bridgebio.com
(650)-789-8220