Bridgebio Pharma, Inc. annual report, FY2023

BridgeBio Pharma, Inc. — 2023 Form 10-K Summary

Business context and reporting period

BridgeBio is a commercial-stage biopharmaceutical company focused on genetic diseases and genetically driven cancers. The filing covers the fiscal year ended December 31, 2023; it is an annual report rather than a quarterly filing. The company reported 17 INDs since inception, two previously FDA-approved products, and a pipeline spanning more than 20 disease states. Commercial activity remained limited after the discontinuation of TRUSELTIQ sales and the transfer of NULIBRY rights.

Key late-stage programs are acoramidis for ATTR-CM, low-dose infigratinib for achondroplasia, encaleret for ADH1, and BBP-418 for LGMD2I/R9.

Financial performance and liquidity

Metric	2023	2022
Revenue	$9.3 million	$77.6 million
Research and development expense	$455.7 million	$399.5 million
Selling, general and administrative expense	$150.6 million	$143.2 million
Restructuring, impairment and related charges	$7.9 million	$43.8 million
Loss from operations	$(607.4) million	$(512.2) million
Net loss	$(653.3) million	$(484.7) million
Net loss attributable to BridgeBio common stockholders	$(643.2) million	$(481.2) million
Basic and diluted loss per share	$(3.95)	$(3.26)
Net cash used in operating activities	$(527.7) million	$(419.5) million

Revenue was primarily collaboration and license revenue. The 2022 amount included substantial revenue from the BMS license agreement; 2023 revenue included $7.4 million related to BMS and $1.1 million of clinical supply revenue from LianBio.
Cash and cash equivalents were $375.9 million at December 31, 2023, compared with $376.7 million at year-end 2022. Restricted cash was $16.7 million and equity securities were $58.9 million.
Total cash, cash equivalents and restricted cash were $394.7 million at year-end 2023. Management stated that cash, restricted cash and equity securities should fund operations for at least the next 12 months under current plans.
Operating cash burn increased by $108.2 million year over year, reflecting the higher net loss and continued investment in clinical programs.
Consolidated debt was approximately $1.7 billion at year-end 2023: $550.0 million principal of 2.50% convertible notes due 2027, $747.5 million principal of 2.25% convertible notes due 2029, and $455.4 million under the term loan.
Stock-based compensation was $108.7 million in the cash-flow reconciliation and $115.0 million in the financial statement expense disclosures. The company reported an accumulated deficit of $2.6 billion and total stockholders’ deficit of $1.3 billion.

Material changes versus the prior comparable period

Revenue declined $68.3 million, primarily because the 2022 results included recognition of the BMS license transfer.
R&D expense increased $56.2 million, driven by higher stock-based compensation, personnel costs, external development costs and licensing fees. Program spending increased for acoramidis, infigratinib, BBP-418 and encaleret.
SG&A increased $7.4 million, mainly due to commercialization-readiness activities.
Restructuring charges declined $35.8 million to $7.9 million, although additional restructuring costs remain possible.
Interest income increased to $18.0 million because of higher interest rates and cash balances. The company also recognized $17.4 million of other income, mainly from gains on equity securities, compared with a $7.5 million other expense in 2022.
2022 included a $107.9 million net gain from the sale of a priority review voucher; no comparable gain occurred in 2023.
The company raised approximately $449.8 million in net equity proceeds during 2023 through a follow-on offering, an ATM program and a private placement. These transactions increased shares outstanding and created dilution risk.
Helsinn completed the wind-down of TRUSELTIQ-related activities. TRUSELTIQ sales were discontinued, the oncology NDA withdrawal was requested, and associated clinical investigations were discontinued.

Clinical, regulatory and business outlook

Acoramidis: The Phase 3 ATTRibute-CM trial met its 30-month hierarchical primary endpoint, with a win ratio of 1.8 and p<0.0001; the reported hazard ratio for all-cause mortality or cardiovascular hospitalization was 0.645. The NDA was submitted in December 2023 and accepted by the FDA in February 2024, with a PDUFA date of November 29, 2024. The EMA also accepted the MAA.
Low-dose infigratinib: PROPEL 3, a pivotal Phase 3 achondroplasia trial, began enrolling, with the first child randomized in December 2023. The company also plans an observational study in hypochondroplasia.
Encaleret: The Phase 2b study showed normalization of key mineral-homeostasis measures in most participants, but the pivotal Phase 3 program remains subject to enrollment, efficacy and safety risk.
BBP-418: Phase 3 FORTIFY is ongoing for LGMD2I/R9. Management believes glycosylated alpha-dystroglycan may support an accelerated-approval strategy, but regulatory acceptance and clinical benefit remain uncertain.
In January 2024, the company entered a contingent funding agreement for up to $500.0 million, net of certain expenses, payable upon first FDA approval of acoramidis. In exchange, investors receive a royalty interest initially equal to 5% of global acoramidis net sales, potentially increasing to 10%, with a stated cap of $950.0 million.
In January 2024, the company refinanced the existing term loan with a senior secured facility. The initial term loan was $450.0 million, with up to $300.0 million of additional capacity, variable interest rates and a $70.0 million minimum unrestricted cash covenant. The prior term loan was repaid.
In February 2024, QED licensed Japanese rights for infigratinib in skeletal dysplasias to Kyowa Kirin for a $100.0 million upfront payment, potential milestones and royalties of up to the high-twenties percentage range.
Management expects continuing operating losses and substantial cash needs for clinical development, regulatory activities and potential commercialization. No profitability guidance was provided.

Principal risks, contingencies and unusual items

The company has limited product revenue, significant recurring losses, negative operating cash flow and substantial debt. It may require additional financing, which could dilute shareholders or impose additional restrictions.
The $500.0 million acoramidis funding is contingent on FDA approval and other conditions; failure to satisfy those conditions could leave the company without the expected launch funding.
The new senior secured financing contains restrictive covenants, a minimum unrestricted cash requirement and potential accelerated maturity provisions tied to the convertible notes.
Clinical trials may be delayed or fail because of enrollment challenges, safety findings, inconclusive efficacy, manufacturing issues, regulatory holds or reliance on third parties.
The company relies on contract research organizations and contract manufacturers, including certain single-source suppliers, and does not operate its own manufacturing facilities.
Commercial success depends on regulatory approval, reimbursement, pricing, market acceptance, competition and the ability to build sales and marketing infrastructure.
Patent protection, licensed intellectual property, royalty obligations and potential infringement or licensing disputes could affect commercialization economics.
Potential performance-based milestone compensation totaled $190.7 million at December 31, 2023, of which $22.2 million was accrued as probable.
The filing states that there were no material legal proceedings. Deloitte issued unqualified opinions on the financial statements and internal control over financial reporting, and management concluded that controls were effective.

Most important facts for an investor to verify

FDA’s decision and labeling for acoramidis by the November 29, 2024 PDUFA date, including any post-approval requirements.
Actual cash burn, unrestricted cash and compliance with the $70.0 million minimum cash covenant under the new financing.
Whether the contingent $500.0 million acoramidis funding is received and the resulting royalty burden, including the possibility of an increase to 10%.
Enrollment, interim and final results, safety findings and regulatory timelines for PROPEL 3, FORTIFY and the encaleret Phase 3 program.
Timing and amount of the Kyowa Kirin upfront payment, future milestones and Japanese infigratinib development obligations.
Convertible-note maturities, conversion exposure and the company’s ability to refinance or repay the 2027 notes.
Progress toward commercial readiness, anticipated pricing and reimbursement, and the competitive position of acoramidis relative to tafamidis and emerging ATTR therapies.
Future dilution from the ATM program, equity awards, convertible notes and potential additional financings.