Full Press Release Details
BridgeBio Pharma Reports First Quarter 2023 Financial Results and Business Update
- Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy
(ATTR-CM) has now completed last patient last visit and remains on track for topline month 30 registrational data to be announced in late July 2023
- Positive results announced in Cohort 5 of Phase 2 PROPEL 2 trial of low-dose infigratinib in
children with achondroplasia, demonstrating mean increase in annualized height velocity (AHV) of 3.03cm/year with no treatment-related adverse events. This data suggests a potential
best-in-class efficacy and well-tolerated safety profile for infigratinib, which also has a differentiated convenience profile due to its oral route of administration
- Shared preliminary findings on novel bioassay measuring glycosylated alpha-dystroglycan ( DG) in patients with
limb-girdle muscular dystrophy type 2I (LGMD2I) and 15-month results from ongoing Phase 2 study of BBP-418 for LGMD2I; continuing to progress towards 2023 initiation of
a global Phase 3 registrational clinical trial of BBP-418 for LGMD2I
registrational trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1) continues to proceed, with topline data expected to be announced in the first half of 2024
- Phase 1/2 trial of BBP-631 for treatment of congenital adrenal hyperplasia (CAH) progressing with
a data update planned by the end of 2023
- Three lead KRAS programs are progressing, with an Investigational New Drug (IND)
application planned for first-in-class direct KRASG12C (ON) inhibitor
BBO-8520 in second half of 2023
- Closed underwritten public offering with gross proceeds
of approximately $150 million, and ended the quarter with $467 million in cash, cash equivalents, marketable securities, and restricted cash (current), providing runway into 2H 2024
Palo Alto, CA May 4, 2023 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 first quarter ended March 31, 2023 and provided an update on the Company s operations.
We were excited to announce the results from the
5th cohort of our Phase 2 trial of infigratinib for achondroplasia an oral agent with a well-tolerated safety profile and
best-in-class efficacy to date, said Neil Kumar, Ph.D., founder and CEO of BridgeBio. We thank the children and physicians who have partnered with us on this
study and are eager to take the next steps for this program together. Infigratinib pairs with our ADH1 program, which reads out its Phase 3 next year, to form a high-quality endocrine franchise that we are continuing to build out. With this dataset
for achondroplasia in hand, we look forward to July and the next big readout from our pipeline, the 30-month data from our ATTR-CM Phase 3 trial of acoramidis that
recently completed last patient last visit. We thank the ATTR-CM patient and physician communities who made this trial possible, and we look forward to sharing the results with you.
BridgeBio s key programs:
First Quarter 2023 Financial Results:
Cash, Cash Equivalents, Marketable Securities and Restricted Cash (Current)
Cash, cash equivalents, marketable securities and restricted cash (current), totaled $467.0 million as of March 31, 2023, compared to
$466.2 million as of December 31, 2022. The net increase of $0.8 million in cash, cash equivalents, marketable securities and restricted cash (current) is primarily attributable to the net proceeds received of $143.0 million from
the follow-on public offering, and proceeds from common stock issuance under ESPP and stock option exercises of $2.0 million, partially offset by net cash used in operating activities of
Operating Costs and Expenses
Operating costs and expenses decreased by $47.4 million to $128.0 million for the three months ended March 31, 2023, compared to
$175.4 million for the same period in the prior year. The overall decrease in operating costs and expenses for the first quarter of 2023 compared to the comparative period was mainly due to decreases in research, development and other (R&D)
expenses of $15.5 million resulting from the Company s reprioritization of its R&D programs; selling, general and administrative expenses of $12.6 million resulting from its company-wide streamlining of costs; and restructuring,
impairment and related charges of $19.3 million since the majority of the restructuring initiatives were initiated in the first quarter of 2022. The effects of the Company s restructuring initiative that was started in the first quarter of
2022 are continuing to be realized due to the Company s reductions in its operating costs and expenses. Restructuring, impairment and related charges for the three months ended March 31, 2023 of $3.4 million, were primarily comprised
of winding down, exit and other related costs. Restructuring, impairment and related charges for the same period in prior year were $22.7 million, were primarily related to impairments and write-offs of long-lived assets, severance and
employee-related costs, and exit and other related costs. The Company continues to evaluate restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings.
Stock-based compensation expenses included in operating costs and expenses for the first quarter of 2023
were $23.5 million, of which $11.8 million is included in research, development and other (R&D) expenses, $11.7 million is included in selling, general and administrative expenses, and nil is included in restructuring, impairment
and related charges. Stock-based compensation expenses included in operating costs and expenses for the first quarter of 2022 were $24.3 million, of which $8.6 million is included in research, development and other (R&D) expenses,
$14.6 million is included in selling, general and administrative expenses, and $1.2 million is included in restructuring, impairment and related charges.
Strengthening our balance sheet through our recent $150 million follow-on offering extends our runway into
the second half of 2024, and puts us in a strong position to take advantage of our optionality as we head into this summer s ATTR-CM readout, said Brian Stephenson, Ph.D., CFA, Chief Financial
Officer of BridgeBio. We will continue to explore ways to extend our runway further through considering potential partnerships and royalty transactions.
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| Revenue | $ | 1,826 | $ | 1,694 | ||||
| Operating costs and expenses: | ||||||||
| Research, development and others | 93,512 | 108,997 | ||||||
| Selling, general and administrative | 31,108 | 43,713 | ||||||
| Restructuring, impairment and related charges | 3,369 | 22,662 | ||||||
| Total operating costs and expenses | 127,989 | 175,372 | ||||||
| Loss from operations | (126,163 | ) | (173,678 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest income | 4,153 | 267 | ||||||
| Interest expense | (20,121 | ) | (20,344 | ) | ||||
| Other expense, net | (601 | ) | (7,575 | ) | ||||
| Total other income (expense), net | (16,569 | ) | (27,652 | ) | ||||
| Net loss | (142,732 | ) | (201,330 | ) | ||||
| Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests | 2,576 | 4,933 | ||||||
| Net loss attributable to common stockholders of BridgeBio | $ | (140,156 | ) | $ | (196,397 | ) | ||
| Net loss per share, basic and diluted | $ | (0.92 | ) | $ | (1.35 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 152,645,635 | 145,882,149 |
| Three Months Ended March 31, | ||||||||
| Stock-based Compensation | 2023 | 2022 | ||||||
| (Unaudited) | ||||||||
| Research, development and others | $ | 11,779 | $ | 8,557 | ||||
| Selling, general and administrative | 11,698 | 14,552 | ||||||
| Restructuring, impairment and related charges | 1,172 | |||||||
| Total stock-based compensation | $ | 23,477 | $ | 24,281 |
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents and marketable securities | $ | 441,490 | $ | 428,269 | ||||
| Investment in equity securities | 49,803 | 43,653 | ||||||
| Receivable from licensing and collaboration agreements | 10,761 | 17,079 | ||||||
| Restricted cash | 25,503 | 37,930 | ||||||
| Prepaid expenses and other current assets | 25,145 | 21,922 | ||||||
| Property and equipment, net | 13,566 | 14,569 | ||||||
| Operating lease right-of-use assets | 10,532 | 10,678 | ||||||
| Intangible assets, net | 28,113 | 28,712 | ||||||
| Other assets | 20,767 | 20,224 | ||||||
| Total assets | $ | 625,680 | $ | 623,036 | ||||
| Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders Deficit | ||||||||
| Accounts payable | $ | 4,076 | $ | 11,558 | ||||
| Accrued and other liabilities | 88,846 | 106,195 | ||||||
| Operating lease liabilities | 15,578 | 15,949 | ||||||
| 2029 Notes | 735,463 | 734,988 | ||||||
| 2027 Notes | 542,065 | 541,634 | ||||||
| Term loans | 435,764 | 430,993 | ||||||
| Other long-term liabilities | 17,501 | 26,643 | ||||||
| Redeemable convertible noncontrolling interests | (204 | ) | (1,589 | ) | ||||
| Total BridgeBio stockholders deficit | (1,225,665 | ) | (1,254,617 | ) | ||||
| Noncontrolling interests | 12,256 | 11,282 | ||||||
| Total liabilities, redeemable convertible noncontrolling interests and stockholders deficit | $ | 625,680 | $ | 623,036 |
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (142,732 | ) | $ | (201,330 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 21,907 | 24,122 | ||||||
| Depreciation and amortization | 1,633 | 1,884 | ||||||
| Noncash lease expense | 1,032 | 1,545 | ||||||
| Accrual of payment-in-kind interest on term loan | 3,339 | |||||||
| Loss on deconsolidation of PellePharm | 1,241 | |||||||
| Loss (gain) from investment in equity securities, net | (964 | ) | 12,866 | |||||
| Accretion of debt | 2,338 | 2,483 | ||||||
| Fair value adjustment of warrants | (111 | ) | 852 | |||||
| Loss on sale of certain assets | 6,261 | |||||||
| Impairment of long-lived assets | 12,653 | |||||||
| Gain from recognition of receivable from licensing and collaboration agreement | (12,500 | ) | ||||||
| Other noncash adjustments | (203 | ) | 604 | |||||
| Changes in operating assets and liabilities: | ||||||||
| Receivable from licensing and collaboration agreements | 6,318 | 10,266 | ||||||
| Prepaid expenses and other current assets | (3,542 | ) | (2,657 | ) | ||||
| Other assets | (483 | ) | 7,901 | |||||
| Accounts payable | (3,800 | ) | (1,814 | ) | ||||
| Accrued compensation and benefits | (18,369 | ) | (16,876 | ) | ||||
| Accrued research and development liabilities | (2,556 | ) | (818 | ) | ||||
| Accrued professional services | 2,225 | (1,374 | ) | |||||
| Operating lease liabilities | (1,250 | ) | (1,820 | ) | ||||
| Deferred revenue | (1,748 | ) | ||||||
| Other accrued and other long-term liabilities | (8,597 | ) | (2,883 | ) | ||||
| Net cash used in operating activities | (144,322 | ) | (160,635 | ) | ||||
| Investing activities: | ||||||||
| Purchases of marketable securities | (55,722 | ) | ||||||
| Maturities of marketable securities | 18,000 | 186,695 | ||||||
| Purchases of investment in equity securities | (47,474 | ) | (8,162 | ) | ||||
| Sales of investment in equity securities | 42,287 | 6,671 | ||||||
| Decrease in cash and cash equivalents resulting from deconsolidation of PellePharm | (503 | ) | ||||||
| Proceeds from sale of certain assets | 10,000 | |||||||
| Purchases of property and equipment | (12 | ) | (859 | ) | ||||
| Net cash provided by investing activities | 12,298 | 138,623 | ||||||
| Financing activities: | ||||||||
| Proceeds from issuance of common stock through Follow-on offering, net | 143,016 | |||||||
| Proceeds from BridgeBio common stock issuances under ESPP | 1,809 | 966 | ||||||
| Repurchase of shares to satisfy tax withholding | (512 | ) | (110 | ) | ||||
| Issuance costs associated with term loan | (1,120 | ) | ||||||
| Proceeds from stock option exercises, net of repurchases | 193 | 104 | ||||||
| Other financing activities | 5,743 | |||||||
| Net cash provided by (used in) financing activities | 150,249 | (160 | ) | |||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 18,225 | (22,172 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 416,884 | 396,365 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 435,109 | $ | 374,193 |
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Supplemental Disclosures of Cash Flow Information: | ||||||||
| Cash paid for interest | $ | 22,059 | $ | 18,809 | ||||
| Supplemental Disclosures of Noncash Investing and Financing Information: | ||||||||
| Payment-in-kind interest added to principal of term loan | $ | $ | 1,763 | |||||
| Unpaid property and equipment | $ | 96 | $ | 750 | ||||
| Transfers to noncontrolling interests | $ | (2,843 | ) | $ | (317 | ) | ||
| Reconciliation of Cash, Cash Equivalents and Restricted Cash: | ||||||||
| Cash and cash equivalents | $ | 407,368 | $ | 371,550 | ||||
| Restricted cash | 25,503 | |||||||
| Restricted cash Included in Prepaid expenses and other current assets | 177 | |||||||
| Restricted cash Included in Other assets | 2,238 | 2,466 | ||||||
| Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows | $ | 435,109 | $ | 374,193 |
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, on track , remains 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 an IND application planned for first-in-class direct KRASG12C (ON)
inhibitor BBO-8520 in second half of 2023, the timing of a Phase 3 trial of BBP-418 in patients with LGMD2I, intended to be initiated in
mid-2023, and the potentially-addressable population of BBP-418 in the United States and European Union; the potential of infigratinib for achondroplasia to have a
potential of best-in-class efficacy with well-tolerated safety profile and to capture a significant share of the market based on blinded market research, if approved;
the timing and success of additional trials of encaleret for ADH1, including the continued proceeding of Phase 3 CALIBRATE trial of encaleret
for ADH1; the timing of announcement of topline data from CALIBRATE, expected in the first half of 2024; the success of encaleret (if approved), including its potential to be the first therapy
specifically indicated for the treatment of ADH1; the availability and success of topline results from the month 30 endpoint of our Phase 3 ATTRibute-CM trial of acoramidis, expected in late July, 2023; the continuation and progress of our ongoing
Phase 1/2 trial of BBP-631 for CAH, with a planned data update by the end of 2023; the continued evaluation of restructuring alternatives to drive operational changes in business processes, efficiencies, and
cost savings, 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 obtain additional funding under our credit facility, potential volatility in our share price, uncertainty regarding any impacts due to COVID-19, such as delays in
regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities
in Ukraine, increasing rates of inflation and rising interest rates, on business operations and expectations, 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, 2022 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.