Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 13, 2025

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BridgeBio Pharma, Inc.

(Exact name of Registrant as Specified in Its Charter)

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Delaware	001-38959	84-1850815
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3160 Porter Dr., Suite 250
Palo Alto, CA		94304
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: [phone]

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		BBIO		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 2.02

Results of Operations and Financial Condition.

On January 13, 2025, BridgeBio Pharma, Inc., or the Company, issued a press release that contains certain preliminary financial information as of and for the fiscal year ended December 31, 2024. Specifically, the press release states that the Company received $500 million upon acoramidis U.S. Food and Drug Administration approval.

The information in this Item 2.02 is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s results of operations for the fiscal year ended December 31, 2024, or financial condition as of December 31, 2024. The audit of the Company’s financial statements for the year ended December 31, 2024 is ongoing and could result in changes to the information in this Item 2.02.

Item 7.01

Regulation FD Disclosure.

The disclosure in Item 2.02 above is hereby incorporated by reference into this Item 7.01, and a copy of the press release referenced in Item 2.02 is furnished as Exhibit 99.1 hereto.

The information contained in Items 2.02 and 7.01, as well as Exhibit 99.1, to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01

Other Events.

On January 13, 2025, the Company also presented a business update at the 43^rd Annual J.P. Morgan Healthcare Conference. A copy of the Company’s presentation slides, which has been published on the Company’s website, is filed as Exhibit 99.2 to this current report on Form 8-K and is incorporated by reference herein.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements. Statements in this Current Report on Form 8-K or the materials furnished or filed herewith 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,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. The Company intends 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 express and implied statements relating to the Company’s expectations regarding the commercial success of Attruby; the Company’s clinical trials, including the timing of the last patient-last visit and topline data readouts for each of FORTIFY, CALIBRATE, and PROPEL 3; the potential for encaleret to become a new treatment for ADH1; the potential for BBP-418 to become a new treatment for LGMD2I/R9; the potential for infigratinib to become a new treatment for achondroplasia; timing of approval of Attruby for ATTR-CM in the European Union and Japan; and the Company’s preliminary and unaudited estimate of cash and the Company’s anticipated funding of its current operations and related timelines; and the Company’s expectations regarding reaching regulatory milestones and receipt of milestone payments, among others, reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company 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 the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s 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 the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this Current Report on Form 8-K, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, the Company assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit	Description
99.1	Press Release dated January 13, 2025.
99.2	Slides from BridgeBio Pharma, Inc.’s J.P. Morgan Healthcare Conference Presentation, dated January 13, 2025.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			BridgeBio Pharma, Inc.
Date:	January 13, 2025	By:	/s/ Brian C. Stephenson
			Brian C. Stephenson
			Chief Financial Officer

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Exhibit 99.1

BridgeBio Announces Commercial Progress, Program Updates, and 2025 Milestones

- Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types

- Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia)

- Well-financed to launch Attruby and read out major market Phase 3 trials: $406M in cash as of last quarter, received $500M upon acoramidis FDA approval from royalty facility, and anticipate $105M in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals

PALO ALTO, CA – January 13, 2025 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today provided updates on its commercial progress for Attruby (acoramidis), status of late-stage pipeline programs, and anticipated 2025 milestones.

“With the FDA’s approval of Attruby, we marked an important moment for both our organization and the broader ATTR-CM patient community in need of new treatment options. We’re grateful for the enthusiasm surrounding the product and the associated initial commercial momentum, with 430 prescriptions written by 248 unique physicians, and we look forward to continued progress,” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “Additionally, we are excited to share that we have completed enrollment of all three of our major market Phase 3 clinical trials. I look forward to continuing to work with this stellar team to serve patients with genetic disease in 2025.”

Business Update

On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥90%), to reduce cardiovascular death and cardiovascular-related hospitalization in adult patients with ATTR-CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure.

Since the approval, BridgeBio has seen remarkable momentum with 430 patient prescriptions written by 248 physicians.

Pipeline Updates

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

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FORTIFY is a Phase 3 clinical trial of BBP-418 in LGMD2I/R9, a rare genetic disorder caused by variants in the fukutin‑related protein (FKRP) gene that result in progressive muscle degeneration and damage, and eventual loss of functional independence. The trial is fully enrolled with 112 patients.

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The Company expects Last Patient – Last Visit (LPLV) and topline readout of the interim analysis cohort in second half 2025.

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If successful, BBP-418 would be the first approved therapy for individuals living with LGMD2I/R9.

Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1):

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CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, a rare, genetic form of hypoparathyroidism, is fully enrolled with 70 patients. The trial is designed to evaluate the efficacy and safety of encaleret compared to standard of care in adult patients with ADH1.

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The Company expects Last Patient – Last Visit and topline readout in second half 2025.

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If successful, encaleret would be the first approved therapy for individuals living with ADH1.

Infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

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PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants.

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The Company expects Last Participant – Last Visit in second half 2025.

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If successful, infigratinib would be the first approved oral therapy for children living with achondroplasia.

2025 Milestones

	Program		Status		Anticipated 2025 Milestone
	Acoramidis for ATTR-CM		US FDA approval on November 22, 2024		EU and Japan approvals in 1H 2024
	BBP-418 for LGMD2I/R9		FORTIFY, Phase 3 study enrollment completed		Last Patient – Last Visit and Topline readout in 2H 2025
	Encaleret for ADH1		CALIBRATE, Phase 3 study enrollment completed		Last Patient – Last Visit and Topline readout in 2H 2025
	Infigratinib for achondroplasia		PROPEL 3, Phase 3 study enrollment completed		Last Participant – Last Visit in 2H 2025

About Attruby™ (acoramidis)

INDICATION

Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. 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, Twitter and Facebook.

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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,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends 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 express and implied statements relating to the Company’s expectations regarding the commercial success of Attruby; the Company’s clinical trials, including the timing of the last patient-last visit and topline data readouts for each of FORTIFY, CALIBRATE and PROPEL 3; the potential for encaleret to become a new treatment for ADH1; the potential for BBP-418 to become a new treatment for LGMD2I/R9; the potential for infigratinib to become a new treatment for achondroplasia; timing of approval of Attruby for ATTR-CM in the European Union and Japan; and the Company’s preliminary and unaudited estimate of cash and the Company’s anticipated funding of its current operations and related timelines; and the Company’s expectations regarding reaching regulatory milestones and receipt of milestone payments, among others, reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company 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 the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s 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 the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

 

BridgeBio Media Contact:

Bubba Murarka, EVP Communications

[e-mail]

(650)-789-8220

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Exhibit 99.2

 J.P. Morgan Presentation  January 13, 2025 

 

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 Forward Looking Statements and Disclaimer  The presentation contains forward-looking statements. Statements made or presented 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, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential,” “should,” “could,” “aim,” “estimate,” “predict,” “continue” and similar expressions or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. 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 express and implied statements relating to the commercial success of Attruby, the timing of ongoing clinical trials, including BridgeBio Oncology Therapeutics’ and Gondola Bio’s clinical trials, the clinical, therapeutic and market potential of our clinical development programs and our pipeline, BridgeBio Oncology Therapeutics’ pipeline and Gondola Bio’s pipeline, our speed of creating new and meaningful drugs and related impact on patients, the efficiency of our engine to rapidly and efficiently deliver medicines, our value creation potential for patients, the potential market sizes and opportunities, the safety, efficacy and mechanisms of our newly FDA-approved Attruby (acoramidis) and other later-stage products including infigratinib, BBP-418 and encaleret, the timing of approval of Attruby for ATTR-CM in the European Union and Japan, our financial position, including our expectations regarding reaching regulatory milestones and the receipt of milestone payments, the potency and safety of our product candidates, the potential benefits of our product candidates, the potential for greater patient access to medications, the affordability and availability of insurance coverage of our medications, and the timing and expectations regarding results of our various clinical trials, 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. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing therapeutic products, and those risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) and in subsequent filings made by the Company with the SEC, which are available on the SEC’s website at www.sec.gov. In light of these risks and uncertainties, many of which are beyond the Company’s control, the events or circumstances referred to in the forward-looking statements, express or implied, may not occur. The actual results may vary from the anticipated results and the variations may be material. You are cautioned not to place undue reliance on these forward-looking statements, which speak to the Company’s current beliefs and expectations only as of the date of the presentation. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements made or presented at the presentation in the event of new information, future developments or otherwise. No representation is made as to the safety or effectiveness of the product candidates for the therapeutic use for which such product candidates are being studied.   Certain information communicated at the presentation may relate to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of the presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, certain information to be communicated at the presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, such research has not been verified by any independent source.   Such information is provided as of the date of the presentation and is subject to change without notice. The Company has not verified, and will not verify, any part of this presentation, and the Company makes no representation or warranty, express or implied, as to the accuracy or completeness of the information to be communicated at the presentation or as to the existence, substance or materiality of any information omitted from the presentation at the presentation. The Company disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this document or the related presentation and such liability is expressly disclaimed. 

 

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 Key recent achievements: clinical impact 

 

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 Key recent achievements: 3 fully enrolled Phase 3 trials  Trial enrolled 112 patients to evaluate BBP-418   in Limb-Girdle Muscular Dystrophy 2I/R9   Trial enrolled 70 participants to evaluate encaleret in Autosomal Dominant Hypocalcemia Type 1  Trial enrolled 114 participants to evaluate infigratinib in Achondroplasia  NEW INFORMATION 

 

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 Key recent achievements: regulatory advancement for late-stage programs  Receives Breakthrough Designation (BTD) for Achondroplasia  Receives Rare Pediatric Disease Designation (RPDD) for Limb-Girdle Muscular Dystrophy 2I/R9  Receives Regenerative Medicine Advanced Therapy Designation (RMAT) for Canavan Disease  Infigratinib   BBP-418  BBP-812 

 

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 Key recent achievement: Attruby regulatory approval  Indicated for the treatment of adult patients with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization 

 

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 Remarkable commercial momentum  430  Attruby Scripts  NEW INFORMATION 

 

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 BridgeBio’s growth is underpinned by an innovative corporate model, as highlighted in a recent publication  Applications of Portfolio Theory to Accelerating Biomedical Innovation  Neil Kumar, Andrew W. Lo, Chinmay Shukla,and Brian Stephenson  Operational nimbleness  Centralized infrastructure for functions with economies of scale   Hyper-focused and agile decision making  Creative financing toolkit  Toolkit of strategic options (asset & portfolio levels)  Costs are variablized and flexible across central functions and affiliates  World class, decentralized R&D  Leverage hyper-experienced, science-focused R&D practitioners  Asset-level incentives preserve biology-level focus  Diversified portfolio  Uncorrelated assets enable multiple “shots on goal”  Modality and therapeutic area agnostic selection of programs 

 

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 The BridgeBio ecosystem has a dynamic pipeline of products  Program  Indication  Pre-clinical  Phase 1  Phase 2  Phase 3  Approved  Patients  (US + EU)  Market Oppty  Estimated US LOE**  Attruby  (acoramidis)  Transthyretin Amyloidosis   (ATTR-CM)  500,000+  $20B+  2039  Infigratinib  Achondroplasia (ACH)  Fully Enrolled  55,000+  $2B+  2041  Hypochondroplasia (HCH)  55,000+  $2B+  2041  BBP-418  Limb-Girdle Muscular Dystrophy   Type 2I/R9 (LGMD2I/R9)  Fully Enrolled  7,000+  $1B+  2041  Encaleret  Autosomal Dominant Hypocalcemia Type 1 (ADH1)  Fully Enrolled  25,000+  $1B+  2041  Post-Surgical   Hypoparathyroidism (PSH)  200,000+  $1B+  2044  BBP-812  Canavan Disease  1,000  TBD  2039  BridgeBio Oncology Therapeutics  Oncology, various  Various  Various  Various  GondolaBio  Rare disease, various  Various  Various  Various    Phase 1/2 Pivotal  45% ownership*  38% ownership*  * BridgeBio Oncology Therapeutics and GondolaBio are separate, independent companies from BridgeBio. BridgeBio’s initial interest in GondolaBio is subject to reduction as additional tranches of capital contributions are funded.  ** Approximate estimated US LOE dates considering various factors including issued patents, pending patent applications, potential patent term extensions, and regulatory exclusivities. 

 

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 Market growth drivers include:  With more sponsors, there is expanding disease awareness   Increased global adoption of non-invasive diagnostic tools  Global annual ATTR market sales1  $B  2019  2020  2021  2022  2023  2024  Peak Year  $6.4  $15-$202  +57%  1ATTR market includes all approved drugs for ATTR-PN and ATTR-CM. 2024 sales annualized as of Q3 2024. 2Consensus estimates of $15B-$20B ATTR market.   ATTR is a multi-billion-dollar market primed for continued expansion  . . .  

 

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 +  Compelling   Clinical Data  1  Market Access:  Make it Easy  2  The way we win 

 

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 The most rapid benefit seen in any Phase 3 study of ATTR-CM to date  In composite of all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30  In the cumulative frequency of cardiovascular-related hospitalization events at Month 30  3 Months  42% Reduction  50% Reduction   Key Data  1 

 

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  Data: Attruby achieved near-complete stabilization of TTR  1Maurer, M. et al., Eur. Heart Jour, 2024;45(Suppl 1). 2Nelson, L. et al., Amyloid, 2021;28(1):24-29. 3Penchala, S. et al., PNAS, 2013;110(24):9992-97.   Preclinical signals of superior potency & selectivity  “We carried out the subunit exchange in human plasma to address the relative selectivity of AG10 [acoramidis] vs. tafamidis…it is obvious that tafamidis is inferior to AG10 [acoramidis], but nothing like the degree you claim it is.”   –Prof. Jeffery Kelly (inventor of tafamidis) in email correspondence with Dr. Isabella Graef, February 27, 2013.  1  Differential TTR selectivity  “It is clear that AG10 [acoramidis] binds more selectively to TTR in serum than tafamidis.” 3  Evidence of potency on TTR stabilization  “AG10 [acoramidis] is 4 times more potent than tafamidis at a fixed plasma concentration (e.g., 10 μM).” 2  Increase in serum TTR levels reflect in vivo stabilization  “Change from baseline in serum TTR levels were higher in participants receiving acoramidis only than those receiving placebo+tafamidis at Month 30...”1 

 

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  Make it easy: simplified, differentiated, generous access programs  28-day supply for patients new to Attruby (newly diagnosed or switching from another therapy)   Independent and rare/orphan disease–focused Specialty Pharmacies (SPs)   where Institutional SPs can keep prescription  Dedicated Attruby Field Reimbursement Managers and Patient Access Liaisons   Easily accessible Copay and Patient Assistance Program  Free Trial  Distribution Network  Field Access Teams  Patient Assistance Programs  Commitment to clinical trial patients  US patients who participated in the acoramidis clinical trials may receive Attruby at no cost for the duration of their medically indicated treatment  2 

 

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 Performance to date indicates strong commercial momentum  430   Attruby scripts   written to date  248   Unique   prescribing HCPs   77%   Medicare lives in equal   formulary position to tafamidis 

 

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 You priced responsibly and have a good label; we will   have you at parity with tafamidis. Also, I have never seen a company offer free drug to their trial patients. Shows commitment.” - Payer   “  You did the right thing by being less than tafamidis…   both your label and price will play a role here.” - Payer   “  I want to reemphasize our gratitude for LDN inclusion.   We objectively see key metrics in the patient journey improve as a result of dispensing access…Eager to leverage our resources to impact patient care in a positive way.” –Manager of Health System SP  “  You are a smart company to set up your distribution this way.   I wish all companies would do this!” – Director of Health System SP  “  “BridgeBio’s thoughtful resources and the structure of the network…aligns with the health system's mission of putting   patients first. – Pharmacist   "Holy Smokes!? I wish all manufacturers would provide this information. Do you have any idea how much time this is going to save our team?   – Pharmacist  “Given the combination of strong efficacy and safety data, alongside BridgeBio’s very health system friendly approach towards access for this product (in comparison to the many challenges we have had with Pfizer…), we plan to begin preferring Attruby.   – AD Specialty Clinical Program Development   “It takes less than 5 minutes- the easiest enrollment process of any drug we use. – RN Heart Failure Coordinator   “  Pricing:  Limited Distribution Network:   ForgingBridges:  “  “  “  Positive feedback all around on Market Access: 

 

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 Scott Collins  SVP, Market Access  Ana Merz  VP, Sales  Launched IMBRUVICA ($5B+, 12 FDA approvals, 6 disease states,   7 indications in 10 years) and EPKINLY (3L+ DLBCL)  Liz Arnold  Head of Commercial Strategy  Multiple global launches, expertise in strategy, consulting, and marketing across rare disease, hematology, and OTC   Sean Doherty  SVP, Marketing  Broad global sales and marketing launch experience including in rare, infectious, and auto-immune diseases   Hudson Boyer  VP, Commercial Analytics & Ops  Launches in rare disease, hematology, and immunology; strategy consulting and equity analyst background  Extensive market access experience with consistent coverage acrossrare disease and oncology, leading large field-based access teams  Julie Everett  Chief Business Officer  Successfully led cross-functional teams through multiple rare disease launches, including VOXZOGO and PALYNZIQ (BioMarin)  Led commercial strategy/execution across ~$1B portfolio   ~Decade of strategy consulting leadership focused on launch excellence and lifecycle maximization (Trinity)  John Whang  Chief Medical Affairs Officer  Orchestrated multiple successful launches with pioneering therapies in competitive segments – STELARA (Janssen), REPATHA (Amgen), and CAMZYOS (BMS)  8+ launches as strategy consultant (McKinsey)  Demonstrated strategic innovation (Heartline Study – J&J / Apple collab) and consistently built outstanding organizations  Matt Outten  Chief Commercial Officer  Broad commercial leadership expertise with success across multiple competitive markets  Led $5B+ portfolio, 12 FDA approvals spanning 6 disease states and 7 indications (IMBRUVICA, Pharmacyclics)  Commercial lead on $21B pharma M&A deal  Our BridgeBio team is committed to providing industry-leading access and white glove service for all parties   looking to bring Attruby to patients with ATTR-CM.   Our Attruby team has experienced industry leaders who have built and launched blockbuster drugs 

 

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 Looking Ahead: Attruby Delivers Outstanding Results in Patients with Poor Prognosis  Median Survival (months)  ATTRwt-CM  ATTRv-CM (V122I)  V122I ATTRv-CM has an aggressive phenotype and poor prognosis1  N = 413  Statistically significant benefit on composite ACM or first CVH in ATTRv-CM participants vs. placebo2  N (%)  Hazard Ratio (95% CI)  p value  Overall Population  611 (100%)  0.65 (0.50-0.83)  0.0008  ATTRv-CM  59 (9.7%)  0.41 (0.21-0.81)  0.0109  Natural History  ATTRibute-CM mITT Population  N = 413  1Razvi, Y. et al., Eur Jour Heart Fail., 2024;26(2):383-393. 2BridgeBio Data on File. Overall population and ATTRv-CM data vs. placebo.  

 

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 1Hornstrup, L.. et al. Arterioscler Thromb Vasc Biol, 2013;33:1441-47. 2Figure adapted from Christoffersen, M. et al., JAMA Cardiology, 2024.  Hazard ratio (95% CI)  TTR distribution  Additional data: Elevated TTR levels are associated with improved survival  Higher TTR concentration associated with greater life expectancy (N≈102K individuals)2  Genetic stabilization of transthyretin associated with improved health outcomes (N≈69K individuals)1  - WT  - T119M Carriers 

 

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 Infigratinib 

 

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 Design Criteria  55,000+ People  In the US/EU with achondroplasia (ACH), the most common form of disproportionate short stature.  55,000+ People  In the US/EU with hypochondroplasia (HCH), another form of disproportionate short stature.  Impact Opportunity  Phase 2 Data  $4B+ Market Opportunity  Infigratinib is an oral best-in-class FGFR3 inhibitor that targets achondroplasia and hypochondroplasia at their source  Annualized height velocity  (To the sponsor’s knowledge, largest effect reported to date)  Target FGFR3-driven skeletal dysplasias at their source  Proportionality  (To the sponsor’s knowledge, largest effect reported to date)  Demonstrate safety   with low dosing    Well-tolerated  Convenient oral ROA to reduce patient burden 

 

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 Key Secondary Endpoints:  Change from baseline in height z-score  Change from baseline in upper to lower body segment ratio  Primary Endpoint:  Change from baseline in annualized height velocity at Wk 52  Screening and Observational Period  Children are followed for a minimum of 6 months  Randomization 2:1  (N = 114)   Open Label Extension  Children are followed until adult height is reached  0.25 mg/kg/day Infigratinib (N ~ 76)  6 months  Placebo (N ~ 38)  12 months  Phase 3 Trial Fully Enrolled;   LPLV Expected 2H 2025  We have fully enrolled a Phase 3 study (PROPEL 3) of Infigratinib in Achondroplasia with LPLV in 2H 2025 

 

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 BBP-418 

 

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 Design Criteria  7,000+ Patients  In the US/EU with LGMD2I/R9, a progressive neuromuscular disorder that leads to loss of ambulation, cardiomyopathy, and respiratory dysfunction.  Impact Opportunity  Phase 2 Data  BBP-418 is a first-in-class, disease-modifying therapy positioned to be the first approval in any form of limb-girdle muscular dystrophy  Glycosylated αDG  (Expected surrogate endpoint)  Serum creatine kinase    Stabilization of clinical measures    Well-tolerated  Targets the LMGD2I/R9 at its source by adding substrate to restore glycosylation of αDG  Avoid safety concerns by using a synthesized version of an endogenous compound  Convenient oral ROA to reduce patient burden  $1B+ Market Opportunity + additional opportunity with other forms of LGMD  

 

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 Screening  Genetically confirmed, symptomatic LGMD2I/R9  12-60 years of age  Randomization 2:1 (N ~ 112)  Open Label Extension  BBP-418 (N ~ 75)  BBP-418 (N ~ 75)  Placebo (N ~ 37)  Placebo (N ~ 37)  12 months  24 months  Final Analysis Endpoints:  NSAD (primary)  Ambulatory measures  10MWT  100MTT  Pulmonary function: FVC  Upper limb function: PUL 2.0  QoL measures  Interim Endpoints:  Glycosylated αDG (primary)  Serum creatine kinase (CK)  Trends in clinical measures  Interim Analysis  Topline Data 2H 2025  We have fully enrolled a Phase 3 study (FORTIFY) of BBP-418 in LGMD2I/R9 and expect topline interim analysis data readout in 2H 2025  Phase 3 Trial Fully Enrolled;   LPLV & Topline Results Expected 2H 2025 

 

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 Encaleret 

 

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 Design Criteria  25,000+ Patients  In the US/EU with ADH1, a genetic disease resulting in the disruption of Ca homeostasis.  200,000+ Patients  In the US/EU with Post-Surgical Hypoparathyroidism (PSH), a dysregulation of Ca homeostasis caused by impaired parathyroid function.  Impact Opportunity  Phase 2 Data  Encaleret is a first-in-class, disease-modifying investigational therapy with potential to be the first approved intervention for ADH1  Parathyroid hormone to normal range  Serum calcium to normal range    Well-tolerated  Urine calcium to normal range  Target ADH1 at its source by desensitizing over-active  Ca sensing receptors  Normalize PTH, serum Ca, and urine Ca levels  Convenient oral ROA to reduce patient burden  $2B+ Market Opportunity 

 

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 Select Secondary Endpoints:  Blood iPTH, 1,25-(OH)2 Vitamin D, magnesium, and phosphate  Urine magnesium and phosphate  Bone turnover markers   Renal ultrasound and renal function  ER/urgent care visits and/or hospitalizations  Quality of life (SF-36)  Primary Endpoint:  Proportion of participants achieving:   Blood Ca within the target range AND   24-hour urine Ca within the reference range  Screening and SoC Optimization Period  Age > 16 years of age  Documented pathogenic variant, or variant of uncertain significance, of the CASR gene associated with biochemical findings related to hypoparathyroidism  SoC Maintenance  Period  (N ~ 70)  Randomization 2:1  2-14 days  Long-Term Extension  Encaleret  Encaleret Titration Period (N ~ 47)  Encaleret  Maintenance Period  4 weeks  SoC Titration Period (N ~ 23)  SoC   Maintenance Period  20 weeks  4 weeks  SoC = standard of care; a combination of oral activated Vitamin D and/or calcium supplements. CASR = calcium-sensing receptor gene.   Phase 3 Trial Fully Enrolled;   LPLV & Topline Results Expected 2H 2025  We have fully enrolled the Phase 3 study (CALIBRATE) of encaleret in ADH1 and expect topline results in 2H 2025  Up to 4 years 

 

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 BBP-812Canavan Disease 

 

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 BBP-812 has the potential to change the disease trajectory for children with Canavan, a severe, ultra-rare, autosomal recessive leukodystrophy   “One patient in particular is sitting independently and taking steps and walking, and that is certainly something I’ve never seen with Canavan disease.”   – Dr. Florian Eichler, Mass General Hospital for Children  “[The participant] was like a new child, reactive, holding hands, and clapping.”    – Dr Annette Bley, University Medical Center Hamburg  “Lots of improvement at 3-month visit, emotional presence, visual tracking, reaching for things”   – Dr. Alexander Fay, UCSF Benioff Children's Hospital    Safety data consistent with other AAV9 GTx’s  Urine NAA levels  Preliminary Data  CNS NAA levels  Gross Motor Skills  Developmental Skills 

 

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 BridgeBio  Ecosystem Highlights 

 

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 BBOT has progressed two potentially first-in-class molecules into the clinic with a third expected in 1H 2025  Program  Mechanism of Action  Status  BBO-8520  KRASG12C ON / OFF  First direct inhibitor of KRASG12C ON  Inhibits both KRASG12C GTP (active) and GDP (inactive) states  Differentiates from KRASG12C GDP (inactive)-only inhibitors  Enrolling  BBO-10203  RAS:PI3Kα Breaker  Blocks specific interaction between RAS and PI3Ka  RAS driver agnostic (KRAS, HRAS and NRAS)  Selectively blocks PI3K / AKT effector signaling in the tumor  No hyperglycemia / hyperinsulinemia  Enrolling  BBO-11818  PanKRAS ON / OFF  Direct inhibitor of KRASG12X ON  Potent panKRAS inhibitor  Directly binds mutant KRAS  IND exp.   Q1 2025 

 

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 Indication  Discovery  Lead Optimization  IND   Enabling  Phase 1  Est. Patient Pop.  (US + EU)  Erythropoietic Protoporphyria (EPP)  20k  Galactosemia  10k  Alpha-1 Antitrypsin Deficiency (AATD)  200k  Neurofibromatosis Type 1 (NF1)  200k  Hereditary Pancreatitis  30k  Fibrous Dysplasia  50k  Congenital Glycosylation Disorder Type Ia   (PMM2-CDG)  5k  Autosomal Dominant Polycystic Kidney Disease (ADPKD)   300k  Tuberous Sclerosis Complex 1/2 (TSC)  65k  Genetic Epilepsy Driven by SynGAP1 Mutations  10k  The GondolaBio pipeline features a diverse set of programs across TAs 

 

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 We are well-financed and expect to hit numerous milestones in 2025  vision for 2030:  >$8B   De-risked PYS  >100k lives   Lives impacted  Acoramidis: EU approval  Acoramidis: Japan approval  Q1 Earnings Call  Q2 and Q3 Earnings Calls  Encaleret: LPLV, Topline  BBP-418: LPLV, Topline  Infigratinib: LPLV  +  1H 2025  2H 2025 

 

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Document and Entity Information	Jan. 13, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 13, 2025
Entity File Number	001-38959
Entity Registrant Name	BridgeBio Pharma, Inc.
Entity Central Index Key	0001743881
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	84-1850815
Entity Address, Address Line One	3160 Porter Dr.
Entity Address, Address Line Two	Suite 250
Entity Address, City or Town	Palo Alto
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94304
City Area Code	650
Local Phone Number	391-9740
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	BBIO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false

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