Full Press Release Details
BridgeBio Pharma, Inc. Reports Second Quarter 2022 Financial Results and Business Update
- Reported positive interim Phase 2 data for infigratinib in achondroplasia demonstrating a mean increase in annualized height velocity
(AHV) of 1.52 cm/year among all Cohort 4 children 5 years of age and older, and announced addition of a 5th cohort to the trial
- Reported positive Phase 2 data for encaleret in autosomal dominant hypocalcemia type 1 (ADH1) and announced design of the Phase 3
pivotal study, which is expected to begin later this year
- Selected a next-generation KRAS G12C dual inhibitor development
candidate and plans to be in the clinic in mid-2023
- Presented updated results from the
open-label extension of the Phase 2 study of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM), which continue to suggest long-term tolerability of acoramidis and stabilization of disease
progression in ATTR-CM
- Reported positive data for five early-to-mid-stage genetic disease programs in pipeline, including primary hyperoxaluria type 1 (PH1) and recurrent kidney stone formation; Canavan
disease; pantothenate kinase-associated neurodegeneration (PKAN) and organic acidemias; recessive dystrophic epidermolysis bullosa (RDEB); and venous, lymphatic and mixed venolymphatic malformations (VM, LM and VLM)
- Received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval in the European Union (EU)
for NULIBRY (fosdenopterin) for the treatment of molybdenum cofactor deficiency (MoCD) Type A
- Entered into exclusive license agreement with Bristol Myers Squibb for BBP-398, a potentially best-in-class SHP2 inhibitor, in oncology; BridgeBio is eligible to receive up to $905 million, including an upfront payment of $90 million received during the
quarter and up to $815 million in additional milestone payments and royalties
- Announced sale of Priority Review Voucher (PRV)
- Secured a two-year deferral for first principal payment
on the Company s senior debt
- Ended quarter with $688.6 million in cash, cash equivalents and marketable
securities, providing financial runway into 2024
PALO ALTO, Calif., Aug. 04, 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 second quarter ended June 30, 2022, and provided an update on the Company s
Focused execution is our top priority, and we are delivering with positive proof-of-concept data in three of our key programs so far this year achondroplasia, ADH1 and LGMD2i. At the same time, we ve reported positive data for five additional early-to-mid-stage pipeline programs designed to target a range of genetic diseases with high unmet need. Our productive pipeline is
bolstered by new value- creating partnerships, which we believe allow us to keep our attention fixed on driving forward the strongest science for patients, said Neil Kumar, Ph.D., founder and CEO of BridgeBio.
BridgeBio s Key Programs
Low-dose infigratinib FGFR1-3 inhibitor for achondroplasia and
Encaleret Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1)
BBP-418 Glycosylation substrate for limb-girdle muscular dystrophy type 2i
Acoramidis (AG10) Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM)
BBP-631 AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH)
RAS cancer portfolio
Recent Corporate Updates
Second Quarter 2022 Financial
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $688.6 million as of June 30, 2022, compared to
$787.5 million as of December 31, 2021. The net decrease of $98.9 million is primarily attributable to net cash used in operating activities of $191.1 million. The net cash used in operating activities 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 six months ended June 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 also 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, increased by $55.1 million when compared to the balance as of March 31, 2022 of $633.5 million. Net cash used in operating activities, which was partially offset by a $90.0 million in upfront payment
received from BMS, was $30.5 million for the three months ended June 30, 2022. Net cash used in operating activities was $160.6 million for the three months ended March 31, 2022.
Operating Costs and Expenses
expenses for the three and six months ended June 30, 2022 were $153.9 million and $329.3 million, respectively, as compared to $148.0 million and $316.0 million for the same periods in the prior year. The overall increase in
operating costs and expenses for the three and six months ended June 30, 2022 compared to the comparative periods was due mainly to costs incurred related to the restructuring initiative that was started in the first quarter of 2022.
Restructuring, impairment and related charges for the three and six months ended June 30, 2022 of $8.4 million and $31.1 million, respectively, were primarily comprised of impairments and write-offs of long-lived assets, severance and
employee-related expenses, and exit costs. The Company continues to evaluate restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings.
We expect that operating expenses and cash burn will continue to decline meaningfully in the third and fourth quarters as restructuring charges decline
and anticipated additional business development activity allows us to further decrease from this baseline. Cash on hand provides us with runway into 2024, said Brian Stephenson, Ph.D., CFA, BridgeBio s Chief Financial Officer.
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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue | $ | 73,746 | $ | 54,024 | $ | 75,440 | $ | 54,486 | ||||||||
| Operating costs and expenses: | ||||||||||||||||
| Research, development and others | 109,100 | 102,069 | 218,097 | 224,628 | ||||||||||||
| Selling, general and administrative | 36,426 | 45,970 | 80,139 | 91,377 | ||||||||||||
| Restructuring, impairment and related charges | 8,396 | 31,058 | ||||||||||||||
| Total operating costs and expenses | 153,922 | 148,039 | 329,294 | 316,005 | ||||||||||||
| Loss from operations | (80,176 | ) | (94,015 | ) | (253,854 | ) | (261,519 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 766 | 323 | 1,033 | 717 | ||||||||||||
| Interest expense | (20,279 | ) | (10,839 | ) | (40,623 | ) | (20,577 | ) | ||||||||
| Gain from sale of priority review voucher, net | 107,946 | 107,946 | ||||||||||||||
| Other income | (10,816 | ) | 2,457 | (18,391 | ) | 8,223 | ||||||||||
| Total other income (expense), net | 77,617 | (8,059 | ) | 49,965 | (11,637 | ) | ||||||||||
| Net loss | (2,559 | ) | (102,074 | ) | (203,889 | ) | (273,156 | ) | ||||||||
| Net loss (income) attributable to redeemable convertible noncontrolling interests and noncontrolling interests | (7,297 | ) | 5,726 | (2,364 | ) | 13,729 | ||||||||||
| Net loss attributable to common stockholders of BridgeBio | $ | (9,856 | ) | $ | (96,348 | ) | $ | (206,253 | ) | $ | (259,427 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.07 | ) | $ | (0.66 | ) | $ | (1.41 | ) | $ | (1.82 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 146,684,804 | 146,754,299 | 146,285,694 | 142,713,463 |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Research, development and others | $ | 14,352 | $ | 19,284 | $ | 22,909 | $ | 41,733 | ||||||||
| Selling, general and administrative | 13,953 | 12,751 | 28,505 | 25,198 | ||||||||||||
| Restructuring, impairment and related charges | 1,172 | |||||||||||||||
| Total stock-based compensation expense | $ | 28,305 | $ | 32,035 | $ | 52,586 | $ | 66,931 |
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
| June 30, 2022 | December 31, 2021 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Cash and cash equivalents and marketable securities | $ | 688,564 | $ | 787,515 | ||||
| Investment in equity securities | 27,141 | 49,148 | ||||||
| Receivable from licensing and collaboration agreements | 22,821 | 19,749 | ||||||
| Prepaid expenses and other current assets | 32,754 | 32,446 | ||||||
| Property and equipment, net | 16,873 | 30,066 | ||||||
| Operating lease right-of-use assets | 12,850 | 15,907 | ||||||
| Intangible assets, net | 29,908 | 44,934 | ||||||
| Other assets | 31,322 | 33,027 | ||||||
| Total assets | $ | 862,233 | $ | 1,012,792 | ||||
| Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders Deficit | ||||||||
| Accounts payable | $ | 8,793 | $ | 11,884 | ||||
| Accrued and other liabilities | 128,057 | 118,247 | ||||||
| Operating lease liabilities | 18,586 | 22,366 | ||||||
| 2029 Notes | 734,047 | 733,119 | ||||||
| 2027 Notes | 540,779 | 539,934 | ||||||
| Term loans | 418,353 | 430,752 | ||||||
| Other long-term liabilities | 28,631 | 22,069 | ||||||
| Redeemable convertible noncontrolling interests | (1,499 | ) | 1,423 | |||||
| Total BridgeBio stockholders deficit | (1,025,532 | ) | (870,414 | ) | ||||
| Noncontrolling interests | 12,018 | 3,412 | ||||||
| Total liabilities, redeemable convertible noncontrolling interests and stockholders deficit | $ | 862,233 | $ | 1,012,792 |
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
| Six Months Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Operating activities: | ||||||||
| Net loss | $ | (203,889 | ) | $ | (273,156 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 52,409 | 63,689 | ||||||
| Depreciation and amortization | 3,466 | 4,052 | ||||||
| Net loss from investment in equity securities | 23,228 | |||||||
| 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 | 4,383 | 2,653 | ||||||
| Fair value adjustment of warrants | 1,390 | |||||||
| Loss on sale of certain assets | 6,261 | |||||||
| Impairment of long-lived assets | 12,653 | 3,300 | ||||||
| LEO call option income | (5,550 | ) | ||||||
| Other noncash adjustments | 3,742 | 3,906 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,040 | ) | ||||||
| Receivable from licensing and collaboration agreements | 2,993 | (35,363 | ) | |||||
| Receivable from a related party | (8,962 | ) | ||||||
| Prepaid expenses and other current assets | (3,021 | ) | 1,400 | |||||
| Other assets | 8,691 | (5,723 | ) | |||||
| Accounts payable | (3,090 | ) | 13,025 | |||||
| Accrued compensation and benefits | (9,402 | ) | (8,494 | ) | ||||
| Accrued research and development liabilities | 5,953 | 2,463 | ||||||
| Accrued professional services | (602 | ) | 1,499 | |||||
| Operating lease liabilities | (3,348 | ) | (2,776 | ) | ||||
| Deferred revenue | 16,641 | |||||||
| Other accrued and other long-term liabilities | 8,387 | 2,599 | ||||||
| Net cash used in operating activities | (191,088 | ) | (242,478 | ) | ||||
| Investing activities: | ||||||||
| Purchases of marketable securities | (119,611 | ) | (509,934 | ) | ||||
| Maturities of marketable securities | 293,919 | 238,934 | ||||||
| Purchases of investment in equity securities | (10,930 | ) | (20,000 | ) | ||||
| Sales of investment in equity securities | 9,708 | |||||||
| Increase in cash and cash equivalents from consolidation of PellePharm | 13,654 | |||||||
| Proceeds from sale of priority review voucher | 110,000 | |||||||
| Proceeds from sale of certain assets | 10,000 | |||||||
| Payment for an intangible asset | (1,500 | ) | ||||||
| Purchases of property and equipment | (3,261 | ) | (4,248 | ) | ||||
| Net cash provided by (used in) investing activities | 288,325 | (281,594 | ) | |||||
| 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 | (55,308 | ) | ||||||
| Transactions with noncontrolling interests | 70 | |||||||
| Repurchase of Eidos noncontrolling interest, including direct transaction costs | (84,840 | ) | ||||||
| Proceeds from term loan | 25,000 | |||||||
| Repayment of term loan | (20,486 | ) | (18,108 | ) |
| Proceeds from BridgeBio common stock issuances under ESPP | 966 | 1,652 | ||||||
| Repurchase of shares to satisfy tax withholding | (476 | ) | (3,302 | ) | ||||
| Proceeds from stock option exercises, net of repurchases | 160 | 11,216 | ||||||
| Net cash provided by (used in) financing activities | (20,956 | ) | 546,521 | |||||
| Net increase in cash, cash equivalents and restricted cash | 76,281 | 22,449 | ||||||
| Cash, cash equivalents and restricted cash at beginning of period | 396,365 | 358,679 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 472,646 | $ | 381,128 | ||||
| Reconciliation of Cash, Cash Equivalents and Restricted Cash: | ||||||||
| Cash and cash equivalents Included in Cash and cash equivalents and marketable securities | $ | 470,098 | $ | 378,420 | ||||
| Restricted cash Included in Prepaid expenses and other current assets | 140 | 176 | ||||||
| Restricted cash Included in Other assets | 2,408 | 2,532 | ||||||
| Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows | $ | 472,646 | $ | 381,128 |
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 availability and success of complete data from our
ongoing Phase 2 OLE of acoramidis in patients with symptomatic ATTR-CM, availability and success of topline results from Part B of our Phase 3 ATTRibute-CM trial of
acoramidis, 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 availability and success of initial data from our ongoing Phase 2 study of low-dose infigratinib for achondroplasia and our ongoing Phase 1/2 study of BBP-631 for CAH, the timing and success of our RAS program, including the selection of a next-generation KRAS G12C dual inhibitor candidate and plans to be in the clinic in mid-2013, the availability and success of additional data from our ongoing 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, the timing, success and announced design of our Phase 2/3 trial for BBP-711 for PH1, 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 availability and success of Phase 2 data for PTR-01 in
patients with RDEB, the availability and success of Phase 1b data for VT30 topical gel (BBP-681) in patients with VM, LM and VLM, 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 and the timing and success of a potential decision by the EC on NULIBRY (fosdenopterin) for patients with MoCD type A based on a
positive CHMP opinion for NULIBRY, the success of our academic partnership with Baylor School of Medicine and our founding affiliation with Bakar Labs, the success of our updated strategic collaboration with Helsinn Group, including our ability to
achieve future milestone and royalty payments from Helsinn 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.