BridgeBio(BBIO)

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BridgeBio: PDUFA Date Expected In November 2024 Could Shift Momentum
Seeking Alpha· 2024-08-22 19:15
Core Viewpoint - BridgeBio Pharma has received FDA acceptance for its New Drug Application (NDA) of Acoramidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM), with a PDUFA date set for November 29, 2024, indicating a positive outlook for the company [2][3][8] Regulatory Developments - The FDA accepted the NDA for Acoramidis, and no advisory committee will be convened for its review [3] - The European Medicines Agency (EMA) also accepted the Marketing Authorization Application (MAA) for Acoramidis, enhancing the potential for market entry in Europe [3] - The company has plans for further regulatory submissions in other territories in the coming years [3] Licensing and Financials - BridgeBio has entered a licensing agreement with Bayer for the European rights to Acoramidis, receiving an upfront payment of $300 million and potential future milestone payments and royalties [3][5] - As of June 30, 2024, BridgeBio reported cash and equivalents of $587.2 million, bolstered by various financial transactions [5] Clinical Trial Success - The phase 3 ATTRibute-CM study met its primary endpoint with statistical significance, indicating Acoramidis may offer advantages over existing treatments [3] - The study involved 632 patients and demonstrated a Win Ratio of 1.8 with a p-value of p<0.0001 [3] Market Competition - The transthyretin amyloidosis treatment market is projected to reach $11.2 billion by 2032, with Pfizer's Vyndamax currently dominating the market [4] - BridgeBio aims to capture 25% to 40% of the ATTR-CM market share, contingent on competitive pricing and efficacy advantages [4][8] Future Prospects - A program update for BBP-631, aimed at treating congenital adrenal hyperplasia (CAH), is expected in August 2024, which will determine the future of this candidate [2][7]
BridgeBio Launches MyAchonJourney, a New Resource for Families Navigating Achondroplasia
GlobeNewswire News Room· 2024-08-19 11:30
Core Insights - BridgeBio Pharma, Inc. and its affiliate QED Therapeutics launched MyAchonJourney, an online resource aimed at supporting individuals and families affected by achondroplasia [1][2] - The initiative is designed to provide ongoing support tailored to the unique needs of families at various life stages with achondroplasia [1][3] Summary by Sections MyAchonJourney Initiative - MyAchonJourney aims to bridge the gap between medical care and daily life experiences for families living with achondroplasia [1] - The resource will evolve through multiple phases, addressing the needs of families from birth through adulthood [3] Initial Phase Offerings - The initial phase includes guidance on medical topics, psychosocial issues, and quality-of-life adaptations for children in their first five years [2] - Specific topics covered include: - Pregnancy and Birth: Information on prenatal diagnosis and planning for the baby's arrival [2] - Infancy and Toddlerhood (Birth-2 Years): Insights on potential medical issues, developmental milestones, and advocacy tips [2] - Early Childhood (3-5 Years): Support for mobility challenges and adaptations for home and school [2] Community Collaboration - The development of MyAchonJourney involved collaboration with community members and leaders in the skeletal dysplasia field [3] - The initiative emphasizes the importance of education and awareness beyond treatment decision-making [3] Company Background - BridgeBio Pharma is a commercial-stage biopharmaceutical company focused on developing transformative medicines for genetic diseases [5] - Founded in 2015, the company aims to apply advances in genetic medicine to benefit patients [5]
BridgeBio Pharma's Acoramidis Leads Promising Pipeline With FDA Approval On Horizon
Seeking Alpha· 2024-08-17 06:57
Core Insights - BridgeBio Pharma Inc. (NASDAQ:BBIO) focuses on developing innovative therapies for genetic diseases, utilizing a threefold approach in its R&D platform to manage costs and timelines effectively [2][3][4] - The company has a robust pipeline with late-stage drug candidates, including Acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM), which is submitted for FDA approval with a PDUFA date set for November 29, 2024 [5][16] - Despite valuation concerns and inherent biotech uncertainties, the stock is rated a "buy" for investors who understand the risks involved [2][26] Company Overview - Founded in 2015 and headquartered in Palo Alto, California, BridgeBio Pharma develops therapies for genetic diseases through efficient discovery, decentralized teams, and streamlined development processes [3][4] - The company has accumulated significant clinical trial experience across over 25 countries, enhancing its regulatory expertise [3] Product Pipeline - Acoramidis targets ATTR-CM, stabilizing the TTR protein to reduce amyloid formation and improve survival outcomes [5][16] - Other late-stage candidates include Infigratinib for Achondroplasia, Encaleret for autosomal dominant hypocalcemia type 1 (ADH1), and BBP-418 for limb-girdle muscular dystrophy type 2I (LGMD2I) [7][12][13] - The markets for Achondroplasia, LGMD21, ADH1, and congenital adrenal hyperplasia (CAH) are each estimated to exceed $1 billion [7] Recent Developments - Positive data from the ATTRibute-CM trial for Acoramidis indicated increased serum TTR levels and fewer cardiovascular-related deaths, supporting its potential as a new standard of care for ATTR-CM [16] - An agreement with Bayer for exclusive distribution of Acoramidis in Europe could enhance market adoption, with potential earnings of up to $310 million contingent on milestones and sales [17] Financial Overview - BridgeBio Pharma has a market cap of $4.6 billion, with $408 million in cash and equivalents against $1.7 billion in financial debt [18] - The company has not generated significant product sales to date, and its cash burn is estimated at approximately $172.6 million per quarter, providing a cash runway of about 2.6 years [20] Market Potential - Acoramidis is expected to capture a significant market share in the ATTR-CM market, which was valued at $1.7 billion in 2023 [16][23] - The company could potentially generate over $1 billion in revenues by 2026 or 2027, leading to a forward P/S multiple of about 4.6, compared to the sector's median of 2.8 [23]
BridgeBio(BBIO) - 2024 Q2 - Quarterly Report
2024-08-01 20:24
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2024, and December 31, 2023 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Key Balance Sheet Metrics | Metric (in thousands) | June 30, 2024 (Unaudited) | December 31, 2023 | Change (Absolute) | Change (%) | | :-------------------- | :------------------------ | :---------------- | :---------------- | :--------- | | Total Assets | $794,375 | $546,380 | $247,995 | 45.4% | | Total Liabilities | $1,876,468 | $1,888,915 | $(12,447) | (0.7%) | | Total Stockholders' Deficit | $(1,081,870) | $(1,343,013) | $261,143 | 19.4% | | Cash and cash equivalents | $407,958 | $375,935 | $32,023 | 8.5% | | Restricted cash | $139,409 | $16,653 | $122,756 | 737.1% | | Investment in nonconsolidated entity | $117,006 | — | $117,006 | N/A | | Deferred revenue (current portion) | $15,098 | $6,096 | $8,902 | 146.0% | | Deferred revenue (net of current portion) | $16,961 | $3,727 | $13,234 | 355.1% | | Additional paid-in capital | $1,851,058 | $1,481,032 | $370,026 | 25.0% | | Accumulated deficit | $(2,669,173) | $(2,560,501) | $(108,672) | (4.2%) | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Key Operational Metrics | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $2,168 | $1,641 | $213,288 | $3,467 | | Research and development | $114,695 | $107,488 | $255,667 | $200,349 | | Selling, general and administrative | $59,523 | $36,122 | $125,330 | $67,230 | | Loss from operations | $(175,539) | $(146,099) | $(175,196) | $(272,262) | | Gain on deconsolidation of a subsidiary | $126,294 | — | $126,294 | — | | Loss on extinguishment of debt | — | — | $(26,590) | — | | Net loss | $(75,544) | $(160,703) | $(111,704) | $(303,435) | | Net loss per share (basic and diluted) | $(0.39) | $(0.98) | $(0.59) | $(1.90) | - Net loss for the three months ended June 30, 2024, was **$(75,544) thousand**, a significant improvement from $(160,703) thousand in the prior year period[12](index=12&type=chunk) - Revenue for the six months ended June 30, 2024, dramatically increased to **$213,288 thousand** from $3,467 thousand in the prior year, primarily due to license agreements[12](index=12&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Comprehensive Loss Summary | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(75,544) | $(160,703) | $(111,704) | $(303,435) | | Unrealized gains (losses) on available-for-sale securities | $(6) | $75 | $(35) | $391 | | Comprehensive loss | $(75,550) | $(160,628) | $(111,739) | $(303,044) | - Comprehensive loss for the six months ended June 30, 2024, was **$(111,739) thousand**, an improvement from $(303,044) thousand in the prior year[15](index=15&type=chunk) [Condensed Consolidated Statements of Redeemable Convertible Noncontrolling Interests and Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Noncontrolling%20Interests%20and%20Stockholders%27%20Deficit) Changes in Stockholders' Deficit | Metric (in thousands) | Balances as of Dec 31, 2023 | Issuance of shares under equity compensation plans | Issuance of common stock under ESPP | Repurchase of RSU shares to satisfy tax withholding | Stock-based compensation | Issuance of common stock under public offerings, net | Transfers from (to) noncontrolling interests | Deconsolidation of a subsidiary | Net loss | Balances as of June 30, 2024 | | :-------------------- | :-------------------------- | :------------------------------------------------- | :---------------------------------- | :-------------------------------------------------- | :----------------------- | :--------------------------------------------------- | :------------------------------------------- | :------------------------------ | :------- | :--------------------------- | | Common Stock Amount | $181 | $1 | $0 | $0 | $0 | $1 | $0 | $0 | $0 | $194 | | Additional Paid-In Capital | $1,481,032 | $536 | $2,364 | $(2,936) | $27,125 | $314,730 | $(1,857) | $135 | $0 | $1,851,058 | | Accumulated Deficit | $(2,560,501) | $0 | $0 | $0 | $0 | $0 | $0 | $126,294 | $(199,750)$ | $(2,669,173)$ | | Total BridgeBio Stockholders' Deficit | $(1,354,257) | $537 | $2,364 | $(2,936) | $27,125 | $314,741 | $(1,857) | $126,429 | $(199,750)$ | $(1,092,925)$ | - Total stockholders' deficit improved from **$(1,343,013) thousand** as of December 31, 2023, to **$(1,081,870) thousand** as of June 30, 2024[18](index=18&type=chunk) - Additional paid-in capital increased by **$370,026 thousand**, primarily due to public offerings and stock-based compensation[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Change (Absolute) | Change (%) | | :-------------------------------- | :----------------------------- | :----------------------------- | :---------------- | :--------- | | Net cash used in operating activities | $(144,834) | $(257,675) | $112,841 | 43.8% | | Net cash provided by investing activities | $25,792 | $16,417 | $9,375 | 57.1% | | Net cash provided by financing activities | $273,819 | $149,018 | $124,801 | 83.7% | | Net increase (decrease) in cash, cash equivalents and restricted cash | $154,777 | $(92,240) | $247,017 | 267.8% | | Cash, cash equivalents and restricted cash at end of period | $549,509 | $324,644 | $224,865 | 69.3% | - Net cash used in operating activities decreased to **$(144,834) thousand** for the six months ended June 30, 2024, from $(257,675) thousand in the prior year[22](index=22&type=chunk) - Cash, cash equivalents, and restricted cash at the end of the period increased to **$549,509 thousand** as of June 30, 2024, from $324,644 thousand in the prior year[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Organization and Description of Business](index=10&type=section&id=Note%201.%20Organization%20and%20Description%20of%20Business) - BridgeBio is a **commercial-stage biopharmaceutical company** focused on genetic diseases, founded in 2015[27](index=27&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) [Basis of Presentation and Principles of Consolidation](index=10&type=section&id=Basis%20of%20Presentation%20and%20Principles%20of%20Consolidation) - Condensed consolidated financial statements include BridgeBio and its wholly-owned subsidiaries and controlled entities, with intercompany balances and transactions eliminated[28](index=28&type=chunk) - Consolidation is determined by applying **Variable Interest Entity (VIE)** and **Voting Interest Entity (VOE)** models[28](index=28&type=chunk) [Cash, Cash Equivalents and Marketable Securities](index=10&type=section&id=Cash%2C%20Cash%20Equivalents%20and%20Marketable%20Securities) - Cash equivalents are highly liquid investments with original maturities of **90 days or less**, primarily money market instruments and U.S. treasury bills[29](index=29&type=chunk) - Marketable securities are classified as **available-for-sale** and reported at fair value, primarily invested in U.S. treasury bills[30](index=30&type=chunk) [Restricted Cash](index=11&type=section&id=Restricted%20Cash) - Restricted cash primarily represents funds in a controlled account established in connection with the Company's **Term Loans**[32](index=32&type=chunk) - During the three months ended June 30, 2024, **$159.3 million** in net proceeds from asset sale transactions (Bayer and Kyowa Kirin) were deposited into escrow accounts, classified as restricted cash[32](index=32&type=chunk) Restricted Cash Breakdown | Restricted Cash (in thousands) | June 30, 2024 | December 31, 2023 | | :----------------------------- | :------------ | :---------------- | | Restricted cash (current) | $139,409 | $16,653 | | Restricted cash (non-current, in "Other assets") | $2,142 | $2,144 | | Total | $141,551 | $18,797 | [Equity Method and Other Equity Investments](index=13&type=section&id=Equity%20Method%20and%20Other%20Equity%20Investments) - The Company uses the **equity method** for investments where it exercises significant influence but is not the primary beneficiary[34](index=34&type=chunk) - TheRas, Inc. was deconsolidated on April 30, 2024, and BridgeBio's retained investment is now accounted for using the equity method[34](index=34&type=chunk) [Accrued Professional and Other Accrued Liabilities](index=13&type=section&id=Accrued%20Professional%20and%20Other%20Accrued%20Liabilities) Accrued Liabilities Breakdown | Accrued Liabilities (in thousands) | June 30, 2024 | December 31, 2023 | | :--------------------------------- | :------------ | :---------------- | | Accrued professional services | $7,503 | $7,412 | | Accrued interest | $11,352 | $17,761 | | Milestone liability | $6,380 | $6,000 | | Other accrued liabilities | $9,048 | $4,657 | | Total | $34,283 | $35,830 | [Concentration of Credit Risk and Other Risks and Uncertainties](index=13&type=section&id=Concentration%20of%20Credit%20Risk%20and%20Other%20Risks%20and%20Uncertainties) - The Company is exposed to significant concentrations of credit risk from cash, cash equivalents, marketable securities, receivables, and restricted cash, primarily held in **U.S. financial institutions**[37](index=37&type=chunk) - Key risks include ability to obtain future financing, regulatory approval, performance of third-party CROs and manufacturers, and protection of intellectual property[38](index=38&type=chunk) [Use of Estimates](index=15&type=section&id=Use%20of%20Estimates) - Preparation of financial statements requires management to make **significant estimates and assumptions**, which may differ from actual results[39](index=39&type=chunk) - Significant estimates include accruals for R&D activities, revenue recognition, and recoverability of long-lived assets[39](index=39&type=chunk) [Note 3. Fair Value Measurements](index=16&type=section&id=Note%203.%20Fair%20Value%20Measurements) [Marketable Securities](index=16&type=section&id=Marketable%20Securities) - The fair value of marketable securities, primarily Treasury bills, is classified within **Level 2**, based on observable inputs[46](index=46&type=chunk) [Investments in Equity Securities](index=16&type=section&id=Investments%20in%20Equity%20Securities) - Investments in publicly held equity securities are classified within **Level 1**, with fair value derived from quoted prices in active markets[47](index=47&type=chunk) - Aggregate fair value of equity investments was **nil** as of June 30, 2024, compared to **$58.9 million** as of December 31, 2023[47](index=47&type=chunk) Gains on Investments in Equity Securities | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net realized gains recognized on investments in equity securities sold | — | $1,638 | $8,136 | $8,796 | | Net unrealized losses recognized on investments in equity securities held | — | $(203) | — | $(6,397) | | Total net gains included in "Other income (expense), net" | — | $1,435 | $8,136 | $2,399 | [LianBio Warrant](index=18&type=section&id=LianBio%20Warrant) - The LianBio Warrant, previously classified within Level 1, was **fully exercised** in February 2024[50](index=50&type=chunk) [Notes](index=18&type=section&id=Notes) - Fair values of the 2029 Notes and 2027 Notes are determined by prices observed in market trading, classified as **Level 2 inputs**[51](index=51&type=chunk) - As of June 30, 2024, the estimated fair value of 2029 Notes was **$604.1 million** (face value $747.5 million) and 2027 Notes was **$553.7 million** (face value $550.0 million)[51](index=51&type=chunk) [Term Loan](index=18&type=section&id=Term%20Loan) - The fair value of the outstanding term loan is estimated using **Level 2 inputs**, based on the net present value of payments discounted at a market interest rate[52](index=52&type=chunk) - The estimated fair value of the term loan under the Financing Agreement was **$464.9 million** as of June 30, 2024[52](index=52&type=chunk) [Note 4. Cash Equivalents and Marketable Securities](index=18&type=section&id=Note%204.%20Cash%20Equivalents%20and%20Marketable%20Securities) Fair Value of Cash Equivalents and Marketable Securities | Asset (in thousands) | Amortized Cost Basis | Unrealized Gains | Unrealized Losses | Estimated Fair Value (June 30, 2024) | | :------------------- | :------------------- | :--------------- | :---------------- | :----------------------------------- | | Money market funds | $139,282 | — | — | $139,282 | | Treasury bills (Cash equivalents) | $85,605 | — | — | $85,605 | | Agency discount notes | $98,509 | — | $(5) | $98,504 | | Treasury bills (Marketable securities) | $39,812 | $1 | — | $39,813 | | Total | $363,208 | $1 | $(5) | $363,204 | - Total cash equivalents and marketable securities were **$363,204 thousand** as of June 30, 2024[54](index=54&type=chunk) [Note 5. Noncontrolling Interests](index=20&type=section&id=Note%205.%20Noncontrolling%20Interests) - The Company had both redeemable convertible noncontrolling interests and noncontrolling interests in consolidated partially-owned entities[57](index=57&type=chunk) - Adjustments to the carrying value of noncontrolling interests due to ownership changes are recorded to "Additional paid-in capital," amounting to **$(0.1) million** and **$(1.9) million** for the three and six months ended June 30, 2024, respectively[57](index=57&type=chunk) [Note 6. Equity Method Investment and Other Equity Investments](index=20&type=section&id=Note%206.%20Equity%20Method%20Investment%20and%20Other%20Equity%20Investments) [TheRas](index=20&type=section&id=TheRas) - TheRas, Inc (BBOT) was **deconsolidated on April 30, 2024**, following a $200.0 million private equity financing that reduced BridgeBio's ownership to approximately **37.9%**[58](index=58&type=chunk) - BridgeBio recognized a **$126.3 million net gain** from deconsolidation of BBOT for the three and six months ended June 30, 2024[58](index=58&type=chunk) - The retained investment in BBOT is now accounted for using the equity method, with a carrying amount of **$117.0 million** as of June 30, 2024, and a net loss from equity method investment of **$7.9 million** for May 1 - June 30, 2024[58](index=58&type=chunk) [LianBio](index=22&type=section&id=LianBio) - BridgeBio's equity interest in LianBio is accounted for as an investment in equity securities under **ASC 321**[61](index=61&type=chunk) - The LianBio Warrant was fully exercised in February 2024, and the Company received **$25.7 million** in special cash dividends and recognized **$1.8 million** net realized gains from LianBio equity securities in March 2024[61](index=61&type=chunk) [PellePharm](index=22&type=section&id=PellePharm) - PellePharm was **deconsolidated effective March 31, 2023**, due to changes in its governance structure following an assignment of assets for liquidation[62](index=62&type=chunk) - A loss of **$1.2 million** from deconsolidation was recognized and presented as part of "Other income (expense), net" for the six months ended June 30, 2023[62](index=62&type=chunk) [Note 7. Intangible Assets, net](index=22&type=section&id=Note%207.%20Intangible%20Assets%2C%20net) [Novartis License Agreement](index=24&type=section&id=Novartis%20License%20Agreement) - QED acquired intellectual property rights for **infigratinib** from Novartis in January 2018[67](index=67&type=chunk) - A **$20.0 million** regulatory milestone payment was capitalized as a finite-lived intangible asset upon FDA approval of TRUSELTIQ™ in May 2021, despite its subsequent withdrawal in May 2023[67](index=67&type=chunk) [Asset Purchase Agreement with Alexion](index=24&type=section&id=Asset%20Purchase%20Agreement%20with%20Alexion) - Origin acquired intellectual property rights for the **ALXN1101 molecule** from Alexion in June 2018[68](index=68&type=chunk) - A **$15.0 million** payment was capitalized as a finite-lived intangible asset in 2021[68](index=68&type=chunk) - Sentynl Therapeutics, Inc assumed the obligation to pay sales-based milestone payments and royalties to Alexion in March 2022[69](index=69&type=chunk) [Diagnostics Agreement with Foundation Medicine](index=24&type=section&id=Diagnostics%20Agreement%20with%20Foundation%20Medicine) - QED and Foundation Medicine, Inc (FMI) entered a companion diagnostics agreement in November 2018[70](index=70&type=chunk) - A **$12.5 million** regulatory approval milestone was capitalized in May 2021 upon FDA approval of the companion diagnostic for TRUSELTIQ™[70](index=70&type=chunk) - In March 2024, QED and FMI entered a settlement agreement for QED to pay the remaining **$9.6 million** over 12 equal monthly installments[70](index=70&type=chunk) [Note 8. Commitments and Contingencies](index=26&type=section&id=Note%208.%20Commitments%20and%20Contingencies) [Milestone Compensation Arrangements](index=26&type=section&id=Milestone%20Compensation%20Arrangements) - The Company has performance-based milestone compensation arrangements with employees and consultants, contingent upon meeting various milestones, settled in cash or equity[72](index=72&type=chunk) Milestone Compensation Arrangements | Settlement Type | Potential Fixed Monetary Amount (in thousands) | Accrued (1) Amount (in thousands) | | :----------------------- | :--------------------------------------------- | :-------------------------------- | | Cash | $9,073 | $26 | | Stock | $31,147 | — | | Cash or stock at our sole discretion | $66,980 | $1,727 | | Total | $107,200 | $1,753 | [Other Research and Development and Commercial Agreements](index=26&type=section&id=Other%20Research%20and%20Development%20and%20Commercial%20Agreements) - The Company enters into contracts with CROs, CMOs, and other vendors, which generally provide for termination on notice with potential termination charges[75](index=75&type=chunk) - As of June 30, 2024, there were **no material amounts accrued** related to termination charges[75](index=75&type=chunk) [Indemnification](index=26&type=section&id=Indemnification) - The Company provides indemnifications to various parties in the ordinary course of business, including directors and officers[76](index=76&type=chunk) - **No material demands** have been made, and no material costs or liabilities have been accrued to date[76](index=76&type=chunk) [Contingencies](index=28&type=section&id=Contingencies) - The Company is **not currently a party** to any material legal proceedings[78](index=78&type=chunk) [Note 9. Debt](index=28&type=section&id=Note%209.%20Debt) [Notes](index=28&type=section&id=Notes) [2029 Notes, net](index=28&type=section&id=2029%20Notes%2C%20net) - Issued **$747.5 million** principal amount of 2.25% convertible senior notes due February 1, 2029[79](index=79&type=chunk) - Interest is payable semiannually at a rate of **2.25%** per year[79](index=79&type=chunk) - The notes are convertible into cash, shares of common stock, or a combination, at the Company's election[79](index=79&type=chunk) [2027 Notes, net](index=29&type=section&id=2027%20Notes%2C%20net) - Issued **$550.0 million** principal amount of 2.50% convertible senior notes due March 15, 2027[81](index=81&type=chunk) - Interest is payable semi-annually at a rate of **2.50%** per year[81](index=81&type=chunk) - The notes are convertible into cash, shares of common stock, or a combination, at the Company's election[81](index=81&type=chunk) [Additional Information Related to the Notes](index=31&type=section&id=Additional%20Information%20Related%20to%20the%20Notes) Notes Carrying Amount | Metric (in thousands) | June 30, 2024 (2029 Notes) | June 30, 2024 (2027 Notes) | December 31, 2023 (2029 Notes) | December 31, 2023 (2027 Notes) | | :-------------------- | :------------------------- | :------------------------- | :----------------------------- | :----------------------------- | | Principal | $747,500 | $550,000 | $747,500 | $550,000 | | Unamortized debt discount and issuance costs | $(9,618) | $(5,730) | $(10,595) | $(6,621) | | Net carrying amount | $737,882 | $544,270 | $736,905 | $543,379 | Notes Interest Expense | Interest Expense (in thousands) | Six Months Ended June 30, 2024 (2029 Notes) | Six Months Ended June 30, 2024 (2027 Notes) | Six Months Ended June 30, 2023 (2029 Notes) | Six Months Ended June 30, 2023 (2027 Notes) | | :------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Contractual interest expense | $8,409 | $6,875 | $8,409 | $6,875 | | Amortization of debt discount and issuance costs | $977 | $891 | $952 | $867 | | Total interest and amortization expense | $9,386 | $7,766 | $9,361 | $7,742 | | Effective interest rate | 2.6% | 2.8% | 2.6% | 2.8% | Future Minimum Payments for Notes | Future Minimum Payments (in thousands) | 2029 Notes | 2027 Notes | Total | | :------------------------------------- | :--------- | :--------- | :---- | | Remainder of 2024 | $8,409 | $6,875 | $15,284 | | Year ending December 31, 2025 | $16,819 | $13,750 | $30,569 | | Year ending December 31, 2026 | $16,819 | $13,750 | $30,569 | | Year ending December 31, 2027 | $16,819 | $556,875 | $573,694 | | Year ending December 31, 2028 | $16,819 | — | $16,819 | | Thereafter | $755,909 | — | $755,909 | | Total future payments | $831,594 | $591,250 | $1,422,844 | | Less amounts representing interest | $(84,094) | $(41,250) | $(125,344) | | Total principal amount | $747,500 | $550,000 | $1,297,500 | [Capped Call and Share Repurchase Transactions with Respect to the Notes](index=33&type=section&id=Capped%20Call%20and%20Share%20Repurchase%20Transactions%20with%20Respect%20to%20the%20Notes) - The Company entered into privately negotiated **capped call transactions** concurrently with the 2029 and 2027 Notes offerings to reduce potential dilution[92](index=92&type=chunk) - Approximately **$61.3 million** and **$49.3 million** of net proceeds from the note offerings were used to pay for the cost of the respective Capped Call Transactions[92](index=92&type=chunk) - The Company repurchased **759,993 shares** and **2,414,681 shares** of common stock for $50.0 million and $75.0 million, respectively, concurrently with the closing of the Note Offerings[92](index=92&type=chunk) [Term Loan, net](index=33&type=section&id=Term%20Loan%2C%20net) [Loan and Security Agreement](index=33&type=section&id=Loan%20and%20Security%20Agreement) - The Loan and Security Agreement, with an initial Tranche 1 Advance of $450.0 million, was **fully repaid on January 17, 2024**, for $475.8 million[96](index=96&type=chunk) - A loss on extinguishment of debt of **$26.6 million** was recognized upon repayment[96](index=96&type=chunk) [Financing Agreement](index=35&type=section&id=Financing%20Agreement) - On January 17, 2024, the Company entered into a new Financing Agreement for a senior secured credit facility of up to **$750.0 million**, with an Initial Term Loan of **$450.0 million** funded[97](index=97&type=chunk) - The Term Loans bear **variable interest rates** (base rate + 5.75% or three-month Term SOFR + 6.75%)[98](index=98&type=chunk) - Mandatory prepayments require depositing **75% of net proceeds** from certain asset sale transactions into an escrow account; **$159.3 million** was deposited from Bayer and Kyowa Kirin agreements[98](index=98&type=chunk) - As of June 30, 2024, the minimum unrestricted qualified cash balance was **$78.0 million**, amended to include 40% of any cash released from escrow accounts[99](index=99&type=chunk) Future Minimum Payments for Term Loan | Future Minimum Payments (in thousands) | Amount (June 30, 2024) | | :------------------------------------- | :--------------------- | | Remainder of 2024 | $27,515 | | Year Ending December 31, 2025 | $53,995 | | Year Ending December 31, 2026 | $53,995 | | Year Ending December 31, 2027 | $119,454 | | Year Ending December 31, 2028 | $131,732 | | Year Ending December 31, 2029 | $294,327 | | Total future payments | $681,018 | | Less amounts representing interest | $(231,018) | | Total principal amount of term loan payments | $450,000 | [Note 10. Funding Agreement](index=39&type=section&id=Note%2010.%20Funding%20Agreement) - The Company entered into a Funding Agreement where Purchasers agreed to pay **$500.0 million** upon the first FDA approval of acoramidis[102](index=102&type=chunk) - In return, the Company granted Purchasers the right to receive **5% royalty interest payments** on global Net Sales of acoramidis, capped at **$950.0 million**[102](index=102&type=chunk) - As of June 30, 2024, the Company has **not received proceeds** under the Funding Agreement[103](index=103&type=chunk) [Note 11. License and Collaboration Agreements](index=41&type=section&id=Note%2011.%20License%20and%20Collaboration%20Agreements) [Bayer Exclusive License](index=41&type=section&id=Bayer%20Exclusive%20License) - On March 1, 2024, the Company entered an exclusive license agreement with Bayer Consumer Care AG for **acoramidis in the European Union**[104](index=104&type=chunk) - The Seller Parties received an upfront payment of **$135.0 million** in May 2024 and are eligible for up to **$625.0 million** in regulatory and sales milestones, plus tiered royalties[104](index=104&type=chunk) - Recognized **$130.9 million** in license revenue for the six months ended June 30, 2024, and deposited **$84.7 million** into an escrow account per the Financing Agreement[105](index=105&type=chunk) [Kyowa Kirin Exclusive License](index=45&type=section&id=Kyowa%20Kirin%20Exclusive%20License) - On February 7, 2024, QED granted Kyowa Kirin Co, Ltd an exclusive license to develop, manufacture, and commercialize **infigratinib in Japan**[107](index=107&type=chunk) - QED received an upfront payment of **$100.0 million** in June 2024 and is eligible for up to **$81.4 million** in development and sales-based milestone payments, plus tiered royalties[107](index=107&type=chunk) - Recognized **$72.1 million** in license revenue for the six months ended June 30, 2024, and deposited **$74.6 million** into an escrow account per the Financing Agreement[108](index=108&type=chunk) [License, Development and Commercialization Agreement with BMS](index=47&type=section&id=License%2C%20Development%20and%20Commercialization%20Agreement%20with%20BMS) - The Navire-BMS License Agreement for BBP-398 was **terminated effective June 2024**, with all rights and obligations thereunder ceasing[109](index=109&type=chunk) - Navire is **no longer entitled** to any future unearned development, regulatory, or sales-based milestone and royalty payments[109](index=109&type=chunk) - Recognized **$9.9 million** in revenue for the six months ended June 30, 2024, related to the completion of the research and development services performance obligation[110](index=110&type=chunk) [License and Collaboration Agreement with Helsinn](index=49&type=section&id=License%20and%20Collaboration%20Agreement%20with%20Helsinn) - The QED-Helsinn License and Collaboration Agreement was **mutually terminated** effective December 21, 2022[112](index=112&type=chunk) - QED retains all rights to develop, manufacture, and commercialize infigratinib in skeletal dysplasia, including achondroplasia[112](index=112&type=chunk) - QED incurred **immaterial close-out costs** for the three and six months ended June 30, 2024[112](index=112&type=chunk) [License Agreement with LianBio](index=52&type=section&id=License%20Agreement%20with%20LianBio) [Navire](index=52&type=section&id=Navire) - Navire granted LianBio exclusive rights to develop, manufacture, and commercialize SHP2 inhibitor **BBP-398** in China and selected Asian markets[114](index=114&type=chunk) - Received an **$8.0 million** upfront payment (recognized in 2020) and **$8.5 million** in license revenue (regulatory milestone in 2021)[114](index=114&type=chunk) - Eligible to receive future development and sales milestone payments of up to **$382.1 million** and tiered royalty payments[114](index=114&type=chunk) [QED](index=52&type=section&id=QED) - QED granted LianBio an exclusive license to develop, manufacture, and commercialize **infigratinib** for cancer indications outside the United States[115](index=115&type=chunk) - Received a **$10.0 million** nonrefundable upfront payment and is eligible for development and sales milestones of up to **$132.5 million** and tiered royalties[115](index=115&type=chunk) [License Agreement with Alexion](index=52&type=section&id=License%20Agreement%20with%20Alexion) - Eidos entered an exclusive license agreement with Alexion to develop, manufacture, and commercialize **acoramidis in Japan**[116](index=116&type=chunk) - Received an upfront nonrefundable payment of **$25.0 million** and a **$1.7 million** premium for Eidos' stock, totaling **$26.7 million** in license revenue in September 2019[117](index=117&type=chunk) - Eligible to receive **$30.0 million** in regulatory milestone payments and royalties in the low-teens based on net sales[117](index=117&type=chunk) [Receivables from Licensing and Collaboration Agreements](index=54&type=section&id=Receivables%20from%20Licensing%20and%20Collaboration%20Agreements) - Total receivables from licensing and collaboration agreements were **$0.7 million** as of June 30, 2024, down from $1.8 million as of December 31, 2023[118](index=118&type=chunk) - The Company did not have an allowance for credit losses as of June 30, 2024, and December 31, 2023[118](index=118&type=chunk) [Note 12. In-licensing and Other Research and Development Agreements](index=54&type=section&id=Note%2012.%20In-licensing%20and%20Other%20Research%20and%20Development%20Agreements) [Stanford License Agreement](index=54&type=section&id=Stanford%20License%20Agreement) - Eidos has an exclusive license agreement with Stanford University for drug discovery and development initiatives[119](index=119&type=chunk) - Incurred and paid **$8.1 million** of licensing fees to Stanford University for the six months ended June 30, 2024, related to the Bayer Agreement[120](index=120&type=chunk) [Diagnostics Agreement with Foundation Medicine](index=56&type=section&id=Diagnostics%20Agreement%20with%20Foundation%20Medicine) - Research and development expenses recognized in connection with the QED-FMI diagnostics agreement were **not material** for the periods presented[121](index=121&type=chunk) [Resilience Development and Manufacturing Service Agreements](index=56&type=section&id=Resilience%20Development%20and%20Manufacturing%20Service%20Agreements) - Aspa and Adrenas entered Development and Manufacturing Services Agreements with Resilience for BBP-812 and BBP-631[122](index=122&type=chunk) - Incurred **$0.9 million** in R&D expenses (net of $1.1 million in cost sharing credits) for the six months ended June 30, 2024[122](index=122&type=chunk) [Other License and Collaboration Agreements](index=56&type=section&id=Other%20License%20and%20Collaboration%20Agreements) - The Company has other license and collaboration agreements that are **not material** individually or in the aggregate[123](index=123&type=chunk) [Note 13. Leases](index=56&type=section&id=Note%2013.%20Leases) Lease Cost Summary | Lease Cost (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Straight line operating lease costs | $1,024 | $992 | $2,093 | $2,024 | | Finance lease costs | $100 | $105 | $201 | $213 | | Variable lease costs | $1,477 | $1,700 | $3,490 | $3,418 | | Total lease cost | $2,601 | $2,797 | $5,784 | $5,655 | - Total lease cost for the six months ended June 30, 2024, was **$5,784 thousand**, an increase from $5,655 thousand in the prior year[125](index=125&type=chunk) Future Minimum Lease Payments | Future Minimum Lease Payments (in thousands) | Amount (June 30, 2024) | | :------------------------------------------- | :--------------------- | | Remainder of 2024 | $2,509 | | Year ending December 31, 2025 | $5,103 | | Year ending December 31, 2026 | $2,276 | | Year ending December 31, 2027 | $459 | | Year ending December 31, 2028 | $459 | | Thereafter | $2,179 | | Total future minimum lease payments | $12,985 | | Imputed interest | $(1,303) | | Total operating lease liabilities | $11,682 | [Note 14. Public Offerings](index=58&type=section&id=Note%2014.%20Public%20Offerings) [2023 Follow-on Offering](index=58&type=section&id=2023%20Follow-on%20Offering) - In March 2023, the Company issued **8,823,530 shares** of common stock for net proceeds of **$143.0 million**[132](index=132&type=chunk) - An additional **63,470 shares** were issued in April 2023 for net proceeds of **$1.0 million**[132](index=132&type=chunk) [2023 Shelf Registration Statement and ATM Agreement](index=60&type=section&id=2023%20Shelf%20Registration%20Statement%20and%20ATM%20Agreement) - The Company filed a shelf registration statement on Form S-3 in May 2023 and entered an At-The-Market (ATM) Agreement to sell up to **$450.0 million** of common stock[133](index=133&type=chunk) - During the six months ended June 30, 2024, **1,061,991 shares** were issued under the ATM Agreement for net proceeds of **$38.1 million**[133](index=133&type=chunk) - As of June 30, 2024, **$345.3 million** of common stock remains eligible for sale under the ATM Agreement[133](index=133&type=chunk) [2024 Follow-on Offering](index=60&type=section&id=2024%20Follow-on%20Offering) - In March 2024, the Company issued **9,913,793 shares** of common stock (including underwriter's option) for net proceeds of **$276.6 million**[134](index=134&type=chunk) [Note 15. Stock-Based Compensation](index=60&type=section&id=Note%2015.%20Stock-Based%20Compensation) [Equity-Based Awards of BridgeBio](index=61&type=section&id=Equity-Based%20Awards%20of%20BridgeBio) - In June 2024, stockholders approved an amendment to the 2021 Amended and Restated Stock Option and Incentive Plan, increasing authorized shares by **6,500,000**[139](index=139&type=chunk) - As of June 30, 2024, **9,855,774 shares** were reserved for future issuances under the 2021 A&R Plan[139](index=139&type=chunk) [2020 Stock and Equity Award Exchange Program (Exchange Program)](index=61&type=section&id=2020%20Stock%20and%20Equity%20Award%20Exchange%20Program%20%28Exchange%20Program%29) - The Exchange Program, completed in 2020, allowed subsidiary employees to exchange their equity for BridgeBio equity and performance-based milestone awards[140](index=140&type=chunk) - Recognized reversals of **$8.9 million** and **$8.7 million** in stock-based compensation cost for performance-based milestone awards for the three and six months ended June 30, 2024, respectively, as the obligation was no longer determined to be probable[141](index=141&type=chunk) [Performance-based Milestone Awards](index=63&type=section&id=Performance-based%20Milestone%20Awards) - Recognized **$(1.0) million** and **$0.9 million** of stock-based compensation cost for performance-based milestone awards for the three and six months ended June 30, 2024, respectively[142](index=142&type=chunk) - The amounts for 2024 include reversals totaling **$1.6 million** as the obligation was no longer determined to be probable[142](index=142&type=chunk) [Stock Option Grants of BridgeBio](index=64&type=section&id=Stock%20Option%20Grants%20of%20BridgeBio) Stock Option Activity | Stock Option Activity | Outstanding as of Dec 31, 2023 | Granted | Exercised | Cancelled | Outstanding as of June 30, 2024 | | :-------------------- | :----------------------------- | :------ | :-------- | :-------- | :------------------------------ | | Options Outstanding | 12,332,442 | 398,764 | (49,982) | (3,867) | 12,677,357 | | Weighted-Average Exercise Price per Option | $25.69 | $27.56 | $19.04 | $63.38 | $25.76 | - Stock-based compensation expense related to stock options was **$12.2 million** for the six months ended June 30, 2024[146](index=146&type=chunk) - As of June 30, 2024, there was **$32.3 million** of total unrecognized compensation cost related to stock options, expected to be recognized over a weighted-average period of **1.9 years**[146](index=146&type=chunk) [Restricted Stock Units (RSUs) of BridgeBio](index=64&type=section&id=Restricted%20Stock%20Units%20%28RSUs%29%20of%20BridgeBio) RSU Activity | RSU Activity | Unvested Shares of RSUs Outstanding | Weighted-Average Grant Date Fair Value | | :------------------------ | :---------------------------------- | :------------------------------------- | | Balance as of Dec 31, 2023 | 8,942,813 | $16.27 | | Granted | 3,899,497 | $28.28 | | Vested | (1,957,694) | $17.73 | | Cancelled | (329,776) | $20.39 | | Balance as of June 30, 2024 | 10,554,840 | $20.31 | - Stock-based compensation expense related to RSUs was **$39.3 million** for the six months ended June 30, 2024[150](index=150&type=chunk) - As of June 30, 2024, there was **$197.7 million** of total unrecognized compensation cost related to RSUs, expected to be recognized over a weighted-average period of **2.9 years**[150](index=150&type=chunk) [Market-Based RSUs of BridgeBio](index=66&type=section&id=Market-Based%20RSUs%20of%20BridgeBio) - In December 2023, the Company granted performance restricted stock units (market-based RSUs) with vesting based on achievement of **market capitalization targets**[151](index=151&type=chunk) - The aggregate grant-date fair value of **$10.8 million** was determined using the Monte Carlo valuation model[151](index=151&type=chunk) - Stock-based compensation expense for market-based RSUs was **$4.8 million** for the six months ended June 30, 2024, with **$5.2 million** of unrecognized cost remaining[151](index=151&type=chunk) [Restricted Stock Awards (RSAs) of BridgeBio](index=66&type=section&id=Restricted%20Stock%20Awards%20%28RSAs%29%20of%20BridgeBio) RSA Activity | RSA Activity | Unvested Shares of RSAs Outstanding | Weighted-Average Grant Date Fair Value | | :------------------------ | :---------------------------------- | :------------------------------------- | | Balance as of Dec 31, 2023 | 85,453 | $7.27 | | Granted — Exchange Program | 8,057 | $38.74 | | Vested — Exchange Program | (8,057) | $38.74 | | Vested — Regular equity program | (85,453) | $7.27 | | Balance as of June 30, 2024 | — | — | - As of June 30, 2024, there were **no unvested RSAs outstanding** and no unrecognized compensation cost related to RSAs[154](index=154&type=chunk) [2019 Employee Stock Purchase Plan (ESPP) of BridgeBio](index=67&type=section&id=2019%20Employee%20Stock%20Purchase%20Plan%20%28ESPP%29%20of%20BridgeBio) - The ESPP allows eligible employees to purchase common stock at **85%** of the lower of the fair market values at the beginning or end of six-month offering periods[156](index=156&type=chunk) - Stock-based compensation expense related to the ESPP was **$1.1 million** for the six months ended June 30, 2024[156](index=156&type=chunk) - As of June 30, 2024, **3,462,568 shares** were reserved for future issuance under the ESPP[156](index=156&type=chunk) [Valuation Assumptions](index=67&type=section&id=Valuation%20Assumptions) Stock-Based Award Valuation Assumptions | Valuation Assumption | Stock Options (6 months ended June 30, 2024) | ESPP (6 months ended June 30, 2024) | | :------------------- | :------------------------------------------- | :---------------------------------- | | Expected term (in years) | 6.00 - 6.03 | 0.50 | | Expected volatility | 92.0% - 92.3% | 55.8% - 122.1% | | Risk-free interest rate | 4.2% - 4.3% | 5.3% - 5.5% | | Dividend yield | — | — | | Weighted-average fair value of stock-based awards granted | $21.30 | $14.14 | [Equity Awards of Eidos](index=67&type=section&id=Equity%20Awards%20of%20Eidos) - Equity-based awards of Eidos were exchanged for BridgeBio equity awards during the Eidos Merger Transactions in 2021[159](index=159&type=chunk) - **No incremental compensation cost** was recognized from this modification[159](index=159&type=chunk) [Note 16. Restructuring, Impairment and Related Charges](index=67&type=section&id=Note%2016.%20Restructuring%2C%20Impairment%20and%20Related%20Charges) - The Company committed to additional restructuring plans in March 2024, estimating remaining charges of **$12.0 million to $16.0 million**[160](index=160&type=chunk) Restructuring Charges by Type | Charge Type (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Long-lived assets impairments and write-offs | — | — | $271 | — | | Severance and employee-related costs | $538 | $572 | $2,503 | $715 | | Winding down, exit and other related costs | $2,353 | $2,959 | $3,517 | $6,185 | | Total | $2,891 | $3,531 | $6,291 | $6,900 | Restructuring Liabilities Roll-forward | Restructuring Liabilities (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------------------- | :----------------------------- | :----------------------------- | | Beginning balance | $55 | $6,826 | | Restructuring, impairment and related charges | $6,291 | $6,900 | | Cash payments | $(3,121) | $(11,526) | | Noncash activities | $(318) | — | | Ending balance | $2,907 | $2,200 | [Note 17. Income Taxes](index=69&type=section&id=Note%2017.%20Income%20Taxes) - There was **no provision for income tax** for the three and six months ended June 30, 2024 and 2023[165](index=165&type=chunk) - A **full valuation allowance** is recorded against net deferred tax assets due to the uncertainty surrounding their realization[165](index=165&type=chunk) [Note 18. Net Loss Per Share](index=71&type=section&id=Note%2018.%20Net%20Loss%20Per%20Share) - Basic and diluted net loss per share attributable to common stockholders were identical for the periods presented, as potential common shares were **anti-dilutive**[167](index=167&type=chunk) Anti-Dilutive Securities | Anti-Dilutive Common Stock Equivalents | As of June 30, 2024 | As of June 30, 2023 | | :------------------------------------- | :------------------ | :------------------ | | Unvested RSUs | 10,554,840 | 10,250,071 | | Common stock options issued and outstanding | 12,677,357 | 12,850,536 | | Estimated shares issuable under performance-based milestone compensation arrangements | 3,811,055 | 11,438,950 | | Assumed conversion of 2027 Notes | 12,878,305 | 12,878,305 | | Assumed conversion of 2029 Notes | 7,702,988 | 7,702,988 | | Total | 48,108,883 | 55,615,087 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition, results of operations, and liquidity [Overview](index=47&type=section&id=Overview) - BridgeBio Pharma, Inc is a commercial-stage biopharmaceutical company focused on discovering and delivering transformative medicines for genetic diseases[171](index=171&type=chunk) - The Company incurred net losses of **$111.7 million** and **$303.4 million** for the six months ended June 30, 2024 and 2023, respectively[171](index=171&type=chunk) - BridgeBio deconsolidated TheRas, Inc (BBOT) on April 30, 2024, recognizing a **$126.3 million net gain** from deconsolidation[172](index=172&type=chunk) - New exclusive license agreements were entered with Bayer Consumer Care AG (**$135.0 million upfront**) and Kyowa Kirin Co, Ltd (**$100.0 million upfront**)[172](index=172&type=chunk) - The Company committed to additional restructuring plans in March 2024, with estimated remaining charges of **$12.0 million to $16.0 million**[173](index=173&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) [Cash, Cash Equivalents, Marketable Securities, Restricted Cash and Investments in Equity Securities](index=49&type=section&id=Cash%2C%20Cash%20Equivalents%2C%20Marketable%20Securities%2C%20Restricted%20Cash%20and%20Investments%20in%20Equity%20Securities) Liquidity Position | Metric (in thousands) | June 30, 2024 | December 31, 2023 | | :-------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $447,771 | $375,935 | | Restricted cash | $139,409 | $16,653 | | Investments in equity securities | — | $58,949 | - As of June 30, 2024, the Company had **$447.8 million** in cash, cash equivalents and marketable securities, and **$139.4 million** in restricted cash[176](index=176&type=chunk) - The increase in restricted cash is primarily due to **$159.3 million** in net proceeds from Bayer and Kyowa Kirin agreements deposited into escrow accounts[176](index=176&type=chunk) [Revenue](index=49&type=section&id=Revenue) Revenue by Period | Revenue (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $2,168 | $1,641 | $213,288 | $3,467 | - Revenue for the six months ended June 30, 2024, increased significantly to **$213,288 thousand**, primarily from upfront license fees and services revenue under the Bayer and Kyowa Kirin agreements[177](index=177&type=chunk) - An additional **$9.9 million** of revenue was attributable to remaining services revenue in connection with the terminated Navire-BMS License Agreement[177](index=177&type=chunk) [Operating Costs and Expenses](index=49&type=section&id=Operating%20Costs%20and%20Expenses) [Research and Development Expenses](index=49&type=section&id=Research%20and%20Development%20Expenses) R&D Expenses by Period | R&D Expenses (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $114,695 | $107,488 | $255,667 | $200,349 | - Research and development expenses increased by **$55.3 million** for the six months ended June 30, 2024, compared to the same period in 2023[180](index=180&type=chunk) - This change was primarily due to an increase in personnel costs of **$28.4 million**, external costs of **$24.1 million**, and licensing fees of **$10.1 million**, partially offset by a decrease in stock-based compensation of **$7.3 million**[180](index=180&type=chunk) R&D Expenses by Program | R&D Expenses by Program (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------------------- | :----------------------------- | :----------------------------- | | ATTR Amyloidosis - TTR stabilizer (acoramidis) | $76,540 | $47,549 | | Achondroplasia - low-dose FGFRi (infigratinib) | $36,358 | $23,453 | | LGMD2I/R9 - Glycosylation substrate (BBP-418) | $20,791 | $15,377 | | ADH1 - CaSR antagonist (encaleret) | $23,152 | $21,062 | | Other development programs | $48,902 | $41,745 | | Other research programs | $49,924 | $51,163 | | Total | $255,667 | $200,349 | [Selling, General and Administrative Expenses](index=50&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) SG&A Expenses by Period | SG&A Expenses (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $59,523 | $36,122 | $125,330 | $67,230 | - Selling, general and administrative expenses increased by **$58.1 million** for the six months ended June 30, 2024, compared to the same period in 2023[183](index=183&type=chunk) - This increase was mainly due to **$19.5 million** in external costs, **$17.7 million** in personnel related expense for commercialization readiness, and **$14.0 million** in nonrecurring deal-related expenses[183](index=183&type=chunk) [Restructuring, Impairment and Related Charges](index=51&type=section&id=Restructuring%2C%20Impairment%20and%20Related%20Charges) Restructuring Charges by Period | Restructuring Charges (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Restructuring, impairment and related charges | $2,891 | $3,531 | $6,291 | $6,900 | - Restructuring, impairment and related charges decreased by **$0.6 million** for the six months ended June 30, 2024, to **$6,291 thousand**[185](index=185&type=chunk) - The Company committed to additional restructuring plans in March 2024, with estimated remaining charges of **$12.0 million to $16.0 million**[186](index=186&type=chunk) [Other Income (Expense), Net](index=51&type=section&id=Other%20Income%20%28Expense%29%2C%20Net) [Interest Income](index=51&type=section&id=Interest%20Income) Interest Income by Period | Interest Income (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :----------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Interest income | $5,195 | $4,514 | $9,270 | $8,667 | - Interest income for the six months ended June 30, 2024, was **$9,270 thousand**, generally consistent with the prior year, primarily from cash equivalents and marketable securities[188](index=188&type=chunk) [Interest Expense](index=51&type=section&id=Interest%20Expense) Interest Expense by Period | Interest Expense (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Interest expense | $(22,937) | $(20,594) | $(46,408) | $(40,715) | - Interest expense increased by **$5.7 million** for the six months ended June 30, 2024, primarily due to the variable interest rates under the new Amended Financing Agreement[190](index=190&type=chunk) [Gain on Deconsolidation of a Subsidiary](index=51&type=section&id=Gain%20on%20Deconsolidation%20of%20a%20Subsidiary) Gain on Deconsolidation by Period | Gain on Deconsolidation (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Gain on deconsolidation of a subsidiary | $126,294 | — | $126,294 | — | - A **$126.3 million net gain** from deconsolidation of TheRas, Inc (BBOT) was recognized for the three and six months ended June 30, 2024, following a private equity financing[192](index=192&type=chunk) [Loss on Extinguishment of Debt](index=53&type=section&id=Loss%20on%20Extinguishment%20of%20Debt) Loss on Extinguishment of Debt by Period | Loss on Extinguishment of Debt (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Loss on extinguishment of debt | — | — | $(26,590) | — | - A **$26.6 million loss** on extinguishment of debt was recognized in January 2024 upon the full repayment of the term loan under the Amended Loan Agreement[194](index=194&type=chunk) [Net Loss from Equity Method Investment](index=53&type=section&id=Net%20Loss%20from%20Equity%20Method%20Investment) Net Loss from Equity Method Investment by Period | Net Loss from Equity Method Investment (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :---------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :-------------------
BridgeBio Pharma (BBIO) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2024-08-01 13:40
BridgeBio Pharma (BBIO) came out with a quarterly loss of $1.02 per share versus the Zacks Consensus Estimate of a loss of $1.09. This compares to loss of $0.98 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 6.42%. A quarter ago, it was expected that this rare disease drug developer would post a loss of $0.40 per share when it actually produced a loss of $0.05, delivering a surprise of 87.50%.Over the last four quarters, the ...
BridgeBio(BBIO) - 2024 Q2 - Quarterly Results
2024-08-01 11:31
Exhibit 99.1 BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update - Acoramidis demonstrated a significant impact on mortality, hospitalizations, and quality of life - Starting at Month 3, patients taking acoramidis showed meaningful and sustained improvement in time to first event (CVH or ACM) - Acoramidis demonstrated a 42% reduction in composite CVH and ACM events relative to placebo by Month 30 - Increased serum TTR levels by Day 28 were correlated with a reduced risk of eve ...
BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update
Newsfilter· 2024-08-01 11:30
Core Insights - Acoramidis has shown a significant impact on mortality, hospitalizations, and quality of life in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating a 42% reduction in composite cardiovascular hospitalization (CVH) and all-cause mortality (ACM) events relative to placebo by Month 30 [1][4][5] - The company reported a net loss attributable to common stockholders of $73.5 million for the three months ended June 30, 2024, compared to $157.9 million for the same period in 2023, indicating improved financial performance [14] - The company ended the quarter with $587 million in cash, cash equivalents, marketable securities, and short-term restricted cash, a significant increase from $392.6 million at the end of 2023 [6] Pipeline Overview - Acoramidis for ATTR-CM has an NDA filed with the FDA, with a PDUFA date set for November 29, 2024 [2] - Encaleret for autosomal dominant hypocalcemia type 1 (ADH1) is currently enrolling in the CALIBRATE Phase 3 study, with enrollment completion expected in 2024 [2] - BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) is also enrolling in the FORTIFY Phase 3 study, with completion anticipated in 2024 [2] - Low-dose infigratinib for achondroplasia and hypochondroplasia is enrolling in the PROPEL 3 Phase 3 study, with completion expected in 2024 [2] Financial Performance - Revenue for the three months ended June 30, 2024, was $2.2 million, an increase from $1.6 million in the same period in 2023, primarily due to recognition of services revenue under collaboration agreements [7] - Operating costs and expenses for the three months ended June 30, 2024, were $177.7 million, compared to $147.7 million for the same period in 2023, driven by increased selling, general, and administrative expenses [8][9] - Total other income for the three months ended June 30, 2024, was $100 million, a significant increase from a loss of $14.6 million in the same period in 2023, mainly due to a gain on deconsolidation of a subsidiary [12][13] Clinical Developments - Acoramidis treatment resulted in a statistically significant reduction in ACM in the intention-to-treat population at Month 30, with no safety signals of concern [1][5] - The company shared positive analyses at various conferences, including a significant improvement in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool [5] - Infigratinib for achondroplasia showed a statistically significant increase in annualized height velocity, with a mean change of +2.50 cm/year at Month 18 [1][4]
BridgeBio Announces Appointment of Thomas Trimarchi, Ph.D., as President and Chief Operating Officer
Newsfilter· 2024-07-23 11:30
PALO ALTO, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases, announced that Thomas Trimarchi, Ph.D., has been appointed President and Chief Operating Officer (COO) of the company. Dr. Trimarchi will assume his new responsibilities effective immediately and will continue to report directly to CEO and founder, Neil Kumar, Ph.D. In this newly created position, Dr. Trimarchi wil ...
BridgeBio Pharma Surpasses Interim Analysis Enrollment Target and Receives U.S. FDA Rare Pediatric Disease Designation for BBP-418, a Potential Treatment for Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)
Newsfilter· 2024-06-18 11:30
Core Insights - BridgeBio Pharma has exceeded its interim analysis enrollment target for the Phase 3 FORTIFY study of BBP-418, with top-line results expected in 2025 [1] - The FDA has engaged in discussions regarding the glycosylated alpha-dystroglycan bioassay, supporting the potential for Accelerated Approval of BBP-418 [3] - BBP-418 has received Rare Pediatric Disease Designation, indicating its significance for children affected by LGMD2I/R9, and may qualify BridgeBio for a Priority Review Voucher upon approval [4] Group 1: Study Details - The FORTIFY study is a randomized, double-blind, placebo-controlled Phase 3 trial assessing the safety and efficacy of BBP-418 for LGMD2I/R9, with an interim analysis planned at 12 months [2] - The primary endpoint at 36 months will be the North Star Assessment for limb-girdle muscular dystrophies, aimed at providing confirmatory clinical data [2] - Enrollment for the FORTIFY study is ongoing in the U.S., UK, Europe, and Australia [2] Group 2: FDA Interactions - Recent discussions with the FDA have focused on the validated glycosylated αDG bioassay and interim analysis plans, reinforcing the strategy for Accelerated Approval [3] - The FDA has indicated that the approach to measure glycosylated αDG levels through a validated muscle tissue-based bioassay is reasonable [3] - A peer-reviewed manuscript detailing the novel assay has been published, supporting the scientific basis for the study [3] Group 3: Disease Background - LGMD2I/R9 is a rare, monogenic autosomal recessive disease caused by mutations in the FKRP gene, leading to impaired glycosylation of αDG [5] - Clinical manifestations typically begin in late childhood, with significant progression leading to loss of mobility and potential cardiac involvement [5] - The disease has a high severity profile, with 25% of individuals experiencing loss of independent ambulation and 30% developing cardiomyopathy in adulthood [5] Group 4: Company Overview - BridgeBio Pharma is a commercial-stage biopharmaceutical company focused on developing transformative medicines for genetic diseases [6] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient access to new therapies [6]
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of BridgeBio Pharma, Inc. - BBIO
GlobeNewswire News Room· 2024-06-13 18:38
NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BridgeBio Pharma, Inc. (“BridgeBio” or the “Company”) (NASDAQ: BBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether BridgeBio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Ju ...