BridgeBio Pharma BBIO

BridgeBio Pharma reports $353M revenue in Q3 2026

Quarterly report, 4 new risk factors

Form: 10-Q
Filed: Oct 29, 2026, 4:52 pm ET
Importance: Major
Accession: 0001743881-26-000034

Revenue: $353.17 million for the three months ended Sep 30, 2026
Net loss: $56.71 million for the three months ended Sep 30, 2026
Diluted EPS: -$0.42 for the three months ended Sep 30, 2026
Cash and equivalents: $1.53 billion at Sep 30, 2026

Written from the 10-Q on EDGAR. Check the filing before you rely on it.

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What changed

18 changes since the June 2026 10-Q

Compared with the 10-Q 0001743881-26-000027, filed Aug 10, 2026.

Changed Financial statements
Cash up 126% from Jun 30
$1.5B, was $678M.
From the filings
Before
$678M
Now
$1.5B
Changed Financial statements
EPS up 46% from Jun 30
−$0.42, was −$0.78.
From the filings
Before
−$0.78
Now
−$0.42
Changed Financial statements
Revenue up 45% from Jun 30
$353M, was $244M.
From the filings
Before
$244M
Now
$353M
Changed Risk factors
Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our…
Adds "range of strategies"; drops "two-fold strategy".
From the filings
Before
Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations. The U.S. and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of any products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. See the section titled, Business - Government Regulation - Current and Future Legislation in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 24, 2026. In addition, the Creating and Restoring Equal Access to Equivalent Samples Act ( CREATES Act ), was enacted in 2019 requiring sponsors of approved NDAs and BLAs to provide enough product samples on commercially reasonable, market-based terms to entities developing generic drugs and biosimilar biological products. The law establishes a private right of action allowing developers to sue application holders that refuse to sell them product samples needed to support their applications. If we are required to provide product samples or allocate additional resources to respond to such requests or any legal challenges under this law, our business could be adversely impacted. There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing…
Now
Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations. The U.S. and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of any products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. See the section titled, Business - Government Regulation - Current and Future Legislation in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 24, 2026. In addition, the Creating and Restoring Equal Access to Equivalent Samples Act ( CREATES Act ), was enacted in 2019 requiring sponsors of approved NDAs and BLAs to provide enough product samples on commercially reasonable, market-based terms to entities developing generic drugs and biosimilar biological products. The law establishes a private right of action allowing developers to sue application holders that refuse to sell them product samples needed to support their applications. If we are required to provide product samples or allocate additional resources to respond to such requests or any legal challenges under this law, our business could be adversely impacted. There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing…
Changed Risk factors
Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing…
Adds "The costs of prescription pharmaceuticals have also been the subject of considerable…"; drops "publishing tariffs, effective in mid-2026, that in part depend on whether".
From the filings
Before
Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business. On May 12, 2025, the current administration issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. and directing the Secretary of Health and Human Services ( HHS ) to communicate most-favored-nation ( MFN ) price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing. Since the May 12, 2025 order, the current administration has continued to exert pressure on drug manufacturers to implement MFN pricing, including by publishing tariffs, effective in mid-2026, that in part depend on whether manufacturers reach agreements with the administration to implement MFN pricing. Further, in November 2025, the Centers for Medicare & Medicaid Services ( CMS ) introduced the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model, a voluntary Medicaid payment initiative under which participating drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs that are intended to provide such Medicaid programs with an MFN price for the manufacturers products. Additionally, in December 2025, CMS announced proposals for new mandatory demonstration payment models through two proposed rules under its Center for Medicare and Medicaid Innovation ( CMMI ) authority, the Global Benchmark for Efficient Drug Pricing ( GLOBE ) for Medicare Part B and Guarding U.S. Medicare Against Rising Drug Costs ( GUARD ) for Medicare Part D. If finalized, these models would impose additional mandatory rebates on manufacturers of certain Medicare Part B and Medicare Part D drugs, for select Medicare populations intended to represent 25% of Medicare…
Now
Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business. The costs of prescription pharmaceuticals have also been the subject of considerable discussion in the United States. To date, there have been several recent U.S. congressional inquiries, as well as proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. The Trump Administration has issued executive orders and supported proposed regulatory initiatives in 2025 that could have a significant impact on the prices that we, or any collaborators, may receive for any approved products. On May 12, 2025, the current administration issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. and directing the Secretary of Health and Human Services ( HHS ) to communicate most-favored-nation ( MFN ) price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing. Since the May 12, 2025 order, the current administration has continued to exert pressure on drug manufacturers to implement MFN pricing, including by encouraging manufacturers to enter into voluntary MFN agreements and implementing trade measures. In August 2026, we entered into a voluntary MFN agreement with the Administration, which will expand state Medicaid access to Attruby via the GENEROUS Model. We expect any pricing commitment for future medicines under the agreement to exclude medicines approved exclusively for orphan indications. If under the MFN…
Changed Risk factors
Preliminary, interim or topline data from our clinical trials that we announce or publish from time to time…
Adds "from PROPEL 3,"; drops "for".
From the filings
Before
Preliminary, interim or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we have and may in the future publish or report preliminary, interim or topline data from our clinical trials, such as the release of our topline results for our Phase 3 study of encaleret in autosomal dominant hypocalcemia type 1. Preliminary, interim or topline data from clinical trials may not be indicative of the final results of the trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trial, and favorable data from interim analysis do not ensure the final results of a trial will be favorable. Preliminary, interim or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary, interim or topline data we previously published. As a result, preliminary, interim or topline data should be viewed with caution until the final data are available. Material adverse changes between preliminary, interim or topline data and final data could significantly harm our business, financial condition, results of operations and prospects. Although we have obtained marketing authorization for Attruby, we have multiple product candidates in our development pipeline that are still in preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our pipeline product candidates…
Now
Preliminary, interim or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we have and may in the future publish or report preliminary, interim or topline data from our clinical trials, such as the release of our topline results from PROPEL 3, our Phase 3 study of oral infigratinib in children with achondroplasia. Preliminary, interim or topline data from clinical trials may not be indicative of the final results of the trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. The results of nonclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trial, and favorable data from interim analysis do not ensure the final results of a trial will be favorable. Preliminary, interim or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary, interim or topline data we previously published. As a result, preliminary, interim or topline data should be viewed with caution until the final data are available. Material adverse changes between preliminary, interim or topline data and final data could significantly harm our business, financial condition, results of operations and prospects. Although we have obtained marketing authorization for Attruby, we have multiple product candidates in our development pipeline that are still in nonclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our pipeline product…
Changed Risk factors
We conduct clinical trials for product candidates outside the U.S., and the FDA and comparable foreign…
Adds "In addition, the FDA recently signaled increased scrutiny of foreign clinical trial data…".
From the filings
Before
We conduct clinical trials for product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials. We have conducted and plan to conduct clinical trials outside the U.S., including in Europe. The acceptance by the FDA or comparable foreign regulatory authority of study data from clinical trials conducted outside the U.S. or another jurisdiction may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction, and the FDA has discussed proposals to increase user fees for marketing applications containing certain foreign clinical data. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our…
Now
We conduct clinical trials for product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials. We have conducted and plan to conduct clinical trials outside the U.S., including in Europe. The acceptance by the FDA or comparable foreign regulatory authority of study data from clinical trials conducted outside the U.S. or another jurisdiction may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction, and the FDA has discussed proposals to increase user fees for marketing applications containing certain foreign clinical data. In addition, the FDA recently signaled increased scrutiny of foreign clinical trial data submitted in support of marketing applications, indicating plans for increased foreign site inspections and…
Changed Risk factors
Even if we obtain FDA approval for any of our current pipeline product candidates in the U.S., we may never…
Adds "nonclinical"; drops "preclinical".
From the filings
Before
Even if we obtain FDA approval for any of our current pipeline product candidates in the U.S., we may never obtain approval to commercialize any of these product candidates outside of the U.S., which would limit our ability to realize their full market potential. In order to market any products outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in the U.S., including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products, once approved is also subject to approval. Seeking foreign regulatory approval could result in difficulties and costs and require additional nonclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. While we previously had two products approved for sale in the U.S., we do not have any product candidates approved for sale in international markets, and we have only limited experience in obtaining regulatory approval in international markets. If we fail to…
Now
Even if we obtain FDA approval for any of our current pipeline product candidates in the U.S., we may never obtain approval to commercialize any of these product candidates outside of the U.S., which would limit our ability to realize their full market potential. In order to market any products outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in the U.S., including additional nonclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products, once approved is also subject to approval. Seeking and maintaining foreign regulatory approval could result in difficulties and costs and require additional nonclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. While we previously had two products approved for sale in the U.S., we only have one product approved for sale in international markets, and we have only limited experience in obtaining regulatory approval in international markets. If we fail…
Changed Risk factors
The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition…
Adds "Notes"; drops "became".
From the filings
Before
The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results. In the event the conditional conversion feature of the Notes is triggered, holders of the Notes will be entitled to convert the notes at any time during specified periods at their option. If one or more holders elect to convert their Notes, we may satisfy our conversion obligation, at our election, in cash, shares of our common stock, or a combination of cash and shares of our common stock (other than paying cash in lieu of delivering any fractional share). To the extent we elect to settle any conversion in cash or in a combination of cash and shares, the cash portion of such settlement could reduce our liquidity. For example, the 2027 and 2031 Notes became convertible for a limited period starting on July 1, 2026 under the conversion condition met and will remain convertible until September 30, 2026. We are parties to the Royalty Purchase Agreement and the Funding Agreement, which contain certain covenants and restrictions on our operations that, if violated, may adversely affect our financial condition and operating results. The Royalty Purchase Agreement requires us to direct 60% of BridgeBio s European royalties on the first $500.0 million of annual BEYONTTRA net sales to the purchasers until the applicable cap is reached. Under the Funding Agreement, an increase in the rate of royalty interest payments payable by us to the purchasers based on the net sales of Attruby under the Funding Agreement could impact our financial condition and operating results. We are parties to two royalty monetization arrangements pursuant to which we have monetized a portion of future royalty streams on certain products in exchange for upfront capital. Such arrangements subject us to certain covenants and restrictions that we must comply with. In June 2025, we and our subsidiary Eidos Therapeutics, Inc. ( Eidos ) entered into a Royalty Interest…
Now
The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results. In the event the conditional conversion feature of the Notes is triggered, holders of the Notes will be entitled to convert the notes at any time during specified periods at their option. If one or more holders elect to convert their Notes, we may satisfy our conversion obligation, at our election, in cash, shares of our common stock, or a combination of cash and shares of our common stock (other than paying cash in lieu of delivering any fractional share). To the extent we elect to settle any conversion in cash or in a combination of cash and shares, the cash portion of such settlement could reduce our liquidity. For example, the 2027 Notes and 2031 Notes are convertible for a limited period starting on October 1, 2026 and will remain convertible until December 31, 2026 because an early conversion condition based on the trading price of BridgeBio s common stock was satisfied. Separately, on or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its 2027 Notes at any time. We are parties to the Royalty Purchase Agreement and the Funding Agreement, which contain certain covenants and restrictions on our operations that, if violated, may adversely affect our financial condition and operating results. The Royalty Purchase Agreement requires us to direct 60% of BridgeBio s European royalties on the first $500.0 million of annual BEYONTTRA net sales to the purchasers until the applicable cap is reached. Under the Funding Agreement, an increase in the rate of royalty interest payments payable by us to the purchasers based on the net sales of Attruby under the Funding Agreement could impact our financial condition and operating results. We are parties to two royalty monetization arrangements pursuant to which we have…
Changed Risk factors
The sale or issuance of our securities, including pursuant to at-the-market offering arrangements, may cause…
Adds "provides"; drops "For example,".
From the filings
Before
The sale or issuance of our securities, including pursuant to at-the-market offering arrangements, may cause significant dilution and the sale of such securities, or the perception that such sales may occur, could cause the price of our common stock to fall. For example, in May 2026, we entered into an Equity Distribution Agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC, which provided for the offer and sale of up to $500.0 million of our common stock in an at-the-market offering program. Sales under any equity distribution agreements or at-the-market offering arrangements, including those we may enter into in the future, could result in substantial dilution to the interests of other holders of our common stock. Additionally, the sale of a substantial number of shares of our common stock or other securities, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
Now
The sale or issuance of our securities, including pursuant to at-the-market offering arrangements, may cause significant dilution and the sale of such securities, or the perception that such sales may occur, could cause the price of our common stock to fall. In May 2026, we entered into an Equity Distribution Agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC, which provides for the offer and sale of up to $500.0 million of our common stock in an at-the-market offering program. Sales under any equity distribution agreements or at-the-market offering arrangements, including those we may enter into in the future, could result in substantial dilution to the interests of other holders of our common stock. Additionally, the sale of a substantial number of shares of our common stock or other securities, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.
Changed Risk factors
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or…
Adds "equity"; drops "stockholders deficit".
From the filings
Before
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to current product candidates or to any future product candidates on unfavorable terms. We may seek additional capital through any number of available sources, including, but not limited to, public and private equity offerings, debt financings, royalty monetization, strategic partnerships and alliances and licensing arrangements. We, and indirectly, our stockholders, will bear the cost of issuing and servicing any such securities and of entering into and maintaining any such strategic partnerships or other arrangements. Because any decision by us to issue debt or equity securities in the future will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future financing transactions. To the extent that we raise additional capital through the sale of additional equity or debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve additional restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but limit our potential cash flow and revenue in the future. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses or other rights on unfavorable terms. In addition…
Now
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to current product candidates or to any future product candidates on unfavorable terms. We may seek additional capital through any number of available sources, including, but not limited to, public and private equity offerings, debt financings, royalty monetization, strategic partnerships and alliances and licensing arrangements. We, and indirectly, our stockholders, will bear the cost of issuing and servicing any such securities and of entering into and maintaining any such strategic partnerships or other arrangements. Because any decision by us to issue debt or equity securities in the future will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future financing transactions. To the extent that we raise additional capital through the sale of additional equity or debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve additional restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but limit our potential cash flow and revenue in the future. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses or other rights on unfavorable terms. In addition…
Changed Risk factors
We have never paid and do not currently intend to pay dividends on our common stock, and, consequently, our…
Adds "paid"; drops "capital".
From the filings
Before
We have never and do not currently intend to pay dividends on our common stock, and, consequently, our stockholders ability to achieve a return on their investment will depend on appreciation in the price of our common stock. We have never paid cash dividends on any of our capital stock and do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth. Therefore, you are not likely to receive any dividends on your common stock for the foreseeable future. Since we do not intend to pay dividends, your ability to receive a return on your investment will depend on any future appreciation in the market value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders have purchased it.
Now
We have never paid and do not currently intend to pay dividends on our common stock, and, consequently, our stockholders ability to achieve a return on their investment will depend on appreciation in the price of our common stock. We have never paid cash dividends on any of our common stock and do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth. Therefore, you are not likely to receive any dividends on your common stock for the foreseeable future. Since we do not intend to pay dividends on our common stock, your ability to receive a return on your investment will depend on any future appreciation in the market value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders have purchased it.
Changed Risk factors
Significant political, trade, regulatory developments, and other circumstances beyond our control, including…
Adds "elections,"; drops "the change in the".
From the filings
Before
Significant political, trade, regulatory developments, and other circumstances beyond our control, including as a result of the current administration s tariff policy, could have a material adverse effect on our financial condition or results of operations. We operate globally and plan to sell our products in countries throughout the world. Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in the U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, in April 2025, the U.S. imposed reciprocal tariffs, which were broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. The U.S. Supreme Court invalidated the reciprocal tariffs on February 20, 2026; however, the current administration has imposed new tariffs under different authorities and President Trump has stated that he intends to use additional authorities to effect historically elevated tariffs. In response to higher U.S. tariffs, some countries have implemented retaliatory tariffs on U.S. goods, while others have negotiated agreements regarding U.S.-imposed tariffs. Historically, increased tariffs have led to more trade and political tensions and the status of these agreements between the U.S. and the various countries, in light of the U.S. Supreme Court s February 20, 2026 decision, remains unclear. Moreover, the U.S. has published special tariffs on certain imported pharmaceutical products, the administration has scheduled to take effect in mid-2026. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major…
Now
Significant political, trade, regulatory developments, and other circumstances beyond our control, including as a result of the current administration s tariff policy, could have a material adverse effect on our financial condition or results of operations. We operate globally and plan to sell our products in countries throughout the world. Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from U.S. federal elections, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, in April 2025, the U.S. imposed reciprocal tariffs, which were broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. The U.S. Supreme Court invalidated the reciprocal tariffs on February 20, 2026; however, the current administration has imposed new historically elevated tariffs under different authorities, which remain subject to ongoing legal challenge, and has active investigations that may result in tariffs on certain countries or products. In response to higher U.S. tariffs, some countries have implemented retaliatory tariffs on U.S. goods, while others have negotiated agreements regarding U.S.-imposed tariffs. Historically, increased tariffs have led to more trade and political tensions and the status of these agreements between the U.S. and the various countries remains unclear. Moreover, starting in mid-2026, the U.S. has imposed special tariffs on certain imported pharmaceutical products, encompassing some of our products, ranging from 10% to 100% depending on the exporting country and the importing company. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other…
New MD&A
Three Months Ended September 30, Nine Months Ended September 30, (in thousands) (in thousands)
New paragraph in MD&A.
From the filings
Now
Three Months Ended September 30, Nine Months Ended September 30, (in thousands) (in thousands)
Changed MD&A
The following table summarizes our preferred stock dividends and accretion during the periods indicated:
Adds "preferred stock dividends and accretion"; drops "interest income".
From the filings
Before
The following table summarizes our interest income during the periods indicated:
Now
The following table summarizes our preferred stock dividends and accretion during the periods indicated:
New MD&A
On July 1, 2026 (the Preferred Stock Closing Date ), the Company issued shares of a newly designated series…
New paragraph in MD&A.
From the filings
Now
On July 1, 2026 (the Preferred Stock Closing Date ), the Company issued shares of a newly designated series of convertible preferred stock (see Note 13). The Company accounts for its Series A Cumulative Convertible Participating Preferred Stock, par value $0.001 per share (the Preferred Stock ) as permanent equity. Dividends on the Preferred Stock accrue and accumulate on a daily basis at an initial annual rate of 7.00% of the accumulated amount per share, initially the $1,000 per share original issue price, whether or not declared by the Company s Board of Directors, and are subject to contractual increases in the dividend rate over time and upon specified events. Dividends are payable quarterly in cash or in kind at the Company s election.
New MD&A
The Preferred Stock has similar characteristics of an Increasing Rate Security as described by SEC Staff…
New paragraph in MD&A.
From the filings
Now
The Preferred Stock has similar characteristics of an Increasing Rate Security as described by SEC Staff Accounting Bulletin Topic 5.Q, Increasing Rate Preferred Stock . The Preferred Stock s initial carrying value was recorded at a discount to its liquidation preference (i.e., the difference between the issuance price and estimated call price) due to being issued with an increasing rate dividend, in addition to its issuance costs. Such discount is considered an unstated dividend cost and is amortized over the expected redemption period using the effective interest method, by charging the imputed dividend cost against additional paid-in capital in the absence of retained earnings and increasing the carrying amount of the Preferred Stock by a corresponding amount. The amortization in each period is the amount which, together with the stated dividend in the period, results in a constant rate of effective cost with regard to the carrying amount of the Preferred Stock. For the period from the Preferred Stock Closing Date to September 30, 2026, the Company recognized dividends of $26.3 million, which includes accretion of the implied discount of $9.9 million.
Changed MD&A
The 2027 Notes are convertible for a limited period from October 1, 2026 through December 14, 2026, as an…
Adds "The 2027 Notes are convertible for a limited period from October 1, 2026 through…".
From the filings
Before
On or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its 2027 Notes at any time.
Now
The 2027 Notes are convertible for a limited period from October 1, 2026 through December 14, 2026, as an early conversion condition based on the price of BridgeBio s common stock, as described above, was satisfied. On or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its 2027 Notes at any time. The 2027 Notes, which mature on March 15, 2027, were classified as current liabilities as of September 30, 2026.

Show the redline

Section by section. Added words and ~~removed words~~ against the earlier filing.

Cover page 2 changes

3 unchanged paragraphs

For the quarterly period ended ~~June~~ September 30, 2026

21 unchanged paragraphs

As of ~~August 3,~~ October 22, 2026, the registrant had ~~195,487,474~~ 194,800,782 shares of common stock, $0.001 par value per share, outstanding.

Forward-looking statements 3 changes

3 unchanged paragraphs

our ability to continue planned ~~preclinical~~ nonclinical and clinical development of our respective development programs, and the timing, cost and success of any such continued ~~preclinical~~ nonclinical and clinical development and planned regulatory submissions;

20 unchanged paragraphs

Our actual results or experience could differ significantly from the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in Risk Factors, in Part II, Item 1A of this Quarterly Report on Form 10-Q as well as information provided elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the U.S. Securities and Exchange Commission (the SEC ) on February 24, 2026, ~~and~~ our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which was filed with the SEC on May 7, 2026, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which was filed with the SEC on August 10, 2026. You should carefully consider that information before you make an investment decision.

16 unchanged paragraphs

Although we have obtained marketing authorization for Attruby, we have multiple product candidates in our development pipeline that are still in ~~preclinical~~ nonclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our pipeline product candidates will receive regulatory approval, which is necessary before they can be commercialized.

9 unchanged paragraphs

Exhibits 210 changes

2 unchanged paragraphs

We use the brand name for our products when we refer to the product that has been approved and with respect to the indications on the approved label. Otherwise, including in discussions of our achondroplasia, autosomal dominant hypocalcemia type 1 (ADH1), and limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) development programs, we refer to our product candidates by their scientific (or generic) name or BridgeBio Pharma ( BBP ) developmental designation. When referring to our commercial product that has been approved in (i) the U.S. and Australia (ii) the EU, Japan, Brazil and the UK, as applicable, we use both names Attruby TM and Beyonttra TM e.g., Our commercial organization focuses on supporting the appropriate use of Attruby and Beyonttra in the markets where this product has been approved.

3 unchanged paragraphs

~~Marketable securities 42,249 17,363~~

~~Inventories 52,842 26,753~~

~~Total current assets 1,093,138 797,749~~

~~Other assets 20,120 16,712~~

~~Total assets $ 1,217,299 $ 936,025~~

Cash and cash equivalents $ ~~677,911~~ 1,533,363 $ 570,119

Marketable securities 5,492 17,363

Accounts receivable, net ~~254,484~~ 375,089 139,444

Inventories 59,718 26,753

Prepaid expenses and other current assets ~~65,652~~ 70,944 44,070

Total current assets 2,044,606 797,749

Equity method investments ~~55,095~~ 47,783 79,972

Property and equipment, net ~~5,226~~ 5,042 5,366

Operating lease right-of-use assets ~~17,079~~ 15,746 8,149

Intangible assets, net ~~26,641~~ 25,923 28,077

Other assets 22,686 16,712

Total assets $ 2,161,786 $ 936,025

2 unchanged paragraphs

~~Accounts payable $ 27,202 $ 36,228~~

Accounts payable $ 88,258 $ 36,228

Accrued compensation and benefits ~~49,976~~ 66,686 76,703

Accrued research and development liabilities ~~64,468~~ 55,018 41,436

Operating lease liabilities, current portion ~~3,315~~ 1,987 6,192

Deferred revenue, current portion ~~5,546~~ 4,744 7,190

2027 Notes, net ~~547,955~~ 548,430

Other current liabilities (2) ~~192,186~~ 212,114 120,222

Total current liabilities ~~890,648~~ 977,237 287,971

1 unchanged paragraph

2029 Notes, net ~~741,918~~ 742,437 740,890

2031 Notes, net ~~565,528~~ 566,013 564,565

2033 Notes, net ~~620,087~~ 620,533

Deferred royalty obligations, net (3) ~~879,374~~ 884,053 855,030

Operating lease liabilities, net of current portion ~~14,973~~ 14,645 3,811

Deferred revenue, net of current portion ~~10,424~~ 8,968 13,080

Other long-term liabilities ~~240~~ 1,405 244

Total liabilities ~~3,723,192~~ 3,815,291 3,012,606

1 unchanged paragraph

Redeemable convertible noncontrolling interests ( ~~1,018~~ 1,363 ) ( 570 )

1 unchanged paragraph

Undesignated preferred stock, $ 0.001 par value; ~~25,000,000~~ 24,066,100 shares authorized and no shares issued and outstanding as of

September 30, 2026; 25,000,000 shares authorized and no shares issued and outstanding as of December 31, 2025

Series A preferred stock, $ 0.001 par value; 933,900 shares authorized, issued, and outstanding as of

September 30, 2026 (aggregate liquidation preference of $ 1,134,359 as of September 30, 2026)

Common stock, $ 0.001 par value; 500,000,000 shares authorized; ~~205,867,350~~ 207,300,005 shares issued and ~~195,284,352~~ 196,004,842 shares outstanding as of ~~June~~ September 30, 2026; 202,369,129 shares issued and 194,771,957 shares outstanding as of

Treasury stock, at cost; ~~10,582,998~~ 11,295,163 shares as of ~~June~~ September 30, 2026; 7,597,172 shares as of December 31, 2025 ( ~~533,279~~ 580,775 ) ( 323,276 )

Additional paid-in capital ~~2,155,318~~ 2,170,006 2,057,646

Accumulated other comprehensive income (loss) ( 7 95 ) 12

Accumulated deficit ( ~~4,137,453~~ 4,194,163 ) ( 3,821,194 )

Total BridgeBio stockholders deficit ( ~~2,515,215~~ 1,662,342 ) ( 2,086,610 )

Noncontrolling interests ~~10,340~~ 10,200 10,599

Total stockholders deficit ( ~~2,504,875~~ 1,652,142 ) ( 2,076,011 )

1 unchanged paragraph

(2) Including related party amounts of ~~$ 5,626~~ nil and $ 2,003 as of ~~June~~ September 30, 2026 and December 31, 2025, respectively (as described in Note 9).

(3) Including related party amounts of ~~$ 206,208 an d~~ nil and $ 204,650 as of ~~June~~ September 30, 2026 and December 31, 2025, respectively (as described in Note 9).

4 unchanged paragraphs

~~Three Months Ended June 30, Six Months Ended June 30,~~

~~Net product revenue $ 222,440 $ 71,501 $ 403,036 $ 108,240~~

~~License and services revenue 5,804 37,440 10,223 117,130~~

~~Royalty revenue 15,432 1,624 24,932 1,828~~

~~Total revenues, net 243,676 110,565 438,191 227,198~~

Three Months Ended September 30, Nine Months Ended September 30,

Net product revenue $ 253,346 $ 108,111 $ 656,382 $ 216,351

License and services revenue 79,314 8,311 89,537 125,441

Royalty revenue 20,511 4,278 45,443 6,106

Total revenues, net 353,171 120,700 791,362 347,898

1 unchanged paragraph

~~Cost of goods sold 10,528 2,848 18,260 4,882~~

~~Cost of license, services, and royalty revenue 4,518 805 6,725 1,410~~

~~Total cost of revenues 15,046 3,653 24,985 6,292~~

~~Research and development 149,448 111,231 276,084 222,662~~

~~Selling, general and administrative 186,261 129,154 350,157 235,519~~

~~Total operating costs and expenses 350,755 244,843 651,226 465,848~~

~~Loss from operations ( 107,079 ) ( 134,278 ) ( 213,035 ) ( 238,650 )~~

Cost of goods sold 12,317 4,028 30,577 8,910

Cost of license, services, and royalty revenue 8,133 2,535 14,858 3,945

Total cost of revenues 20,450 6,563 45,435 12,855

Research and development 143,506 112,874 419,590 335,536

Selling, general and administrative 200,854 137,621 551,011 373,140

Restructuring, impairment, and related charges ~~805 1,375~~ 8,841 10,216

Total operating costs and expenses 364,810 265,899 1,016,036 731,747

Loss from operations ( 11,639 ) ( 145,199 ) ( 224,674 ) ( 383,849 )

1 unchanged paragraph

~~Interest income 6,659 3,898 12,905 9,283~~

~~Interest expense ( 13,278 ) ( 11,607 ) ( 26,220 ) ( 29,728 )~~

Interest income 13,105 6,239 26,010 15,522

Interest expense ( 13,255 ) ( 11,739 ) ( 39,475 ) ( 41,467 )

Noncash interest expense on deferred royalty obligations (1) ( ~~41,345~~ 42,282 ) ( ~~26,030~~ 36,410 ) ( ~~81,218~~ 123,500 ) ( ~~50,050~~ 86,460 )

1 unchanged paragraph

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16 unchanged paragraphs

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and 130 more changes in the filing

Note 1: Organization and Description of Business 5 changes

1 unchanged paragraph

On November 22, 2024, the Company received approval from the ~~United States~~ U.S. Food and Drug Administration ( FDA ) for Attruby TM (acoramidis) and began to generate product revenue from the commercialization of Attruby in the U.S. On February 10, 2025, the European Commission ( EC ) approved Beyonttra TM (acoramidis) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in the EU. On March 27, 2025, the Japanese Ministry of Health, Labour and Welfare approved Beyonttra for the treatment of ATTR-CM in Japan, and on May 21, 2025, the National Health Insurance in Japan approved the pricing of Beyonttra. In April 2025, the United Kingdom Medicines and Healthcare products Regulatory Agency approved Beyonttra for the treatment of ATTR-CM in the UK. In May 2026, the Brazilian Health Regulatory Agency approved Beyonttra for the treatment of ATTR-CM and in October 2026, the Australian Therapeutic Goods Administration approved Attruby for the treatment of ATTR-CM.

In addition, our development portfolio includes three registrational-stage product candidates, each supported by positive Phase 3 results and for which New Drug Applications ( NDAs ) have been filed with the FDA:

In addition, we have three product candidates (low-dose infigratinib for achondroplasia, encaleret for ADH1, and BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9) in our late-stage development pipeline which have all released positive topline data. On March 30, 2026, we submitted our ~~New Drug Application (~~ NDA ) to the FDA for oral BBP-418 for the treatment of LGMD2I/R9. ~~On May 27, 2026,~~ The FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act ( PDUFA ) target action date of November 27, 2026, for BBP-418. On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing and assigned a PDUFA target action date of May 8, 2027 for encaleret. We submitted our NDA to the FDA for low-dose infigratinib for achondroplasia.

On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of May 8, 2027, for encaleret.

On August 4, 2026, we submitted our NDA to the FDA for low-dose infigratinib for achondroplasia. The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of February 4, 2027, for infigratinib.

1 unchanged paragraph

Note 3: Fair Value Measurements 1 change

5 unchanged paragraphs

The carrying amounts reflected in the accompanying condensed consolidated balance sheets for cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses, and other current liabilities approximate their fair values, due to their short-term nature.

1 unchanged paragraph

Note 4: Cash Equivalents and Marketable Securities 1 change

We invest in certain commercial paper and U.S. government money market funds, treasury bills, and agency discount notes classified as cash equivalents. Our marketable securities consist of high investment grade fixed income securities that are invested in U.S. treasury bills and notes.

1 unchanged paragraph

Notes to the financial statements 3 changes

GondolaBio was formed on June 5, 2024 and the Company was the sole member. In August 2024, the Company entered into the Transaction Agreement providing for the formation and funding by certain third-party investors of GondolaBio, a legal joint venture entity for the purpose of researching, developing, manufacturing and commercializing pharmaceutical products, including those contributed to GondolaBio by the Company. The third-party investors providing financing to GondolaBio consist of an investor syndicate, including Viking Global Investors LP, Patient Square Capital, Aisling Capital and an entity owned by Neil Kumar, the Company s Chief Executive Officer, who are related parties of the Company. The Company contributed certain assets and its equity in Portal Therapeutics, Inc. and Sub21, Inc. to GondolaBio. Upon completion of the initial contributions, the Company s equity ownership in GondolaBio was 45.5 %. As of ~~June~~ September 30, 2026, the Company s equity ownership percentage in GondolaBio was ~~13.6~~ 13.1 %.

1 unchanged paragraph

Upon the deconsolidation of GondolaBio, BridgeBio accounted for its investment in GondolaBio, for which it has significant influence through its ownership interest, using the equity method of accounting under ASC 323. GondolaBio was also deemed a related party. For the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, the Company recognized a net loss from equity method investment of nil and $ 6.4 million, respectively. For the three and ~~six~~ nine months ended ~~June~~ September 30, 2025, the Company recognized a net loss from equity method investment of $ ~~9.1~~ 7.1 million and $ ~~15.9~~ 23.0 million, respectively. During the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, the Company s share of GondolaBio s net loss exceeded the carrying value of its investment. Accordingly, the Company recognized losses only to the extent of its investment, and the carrying value of the investment was reduced to zero . As of December 31, 2025, the aggregate carrying amount of the Company s equity method investment in GondolaBio was $ 6.4 million, and is presented as part of Equity method investments on the condensed consolidated balance sheets.

In addition, the Company and GondolaBio ServiceCo, Inc., a wholly-owned subsidiary of GondolaBio, have an existing transition services agreement (the GondolaBio Transition Services Agreement ) for the provision of certain ~~transitionary~~ consulting services by the Company and GondolaBio. ~~In October 2024, the~~ T he Company and GondolaBio ~~entered into~~ are also parties to an agreement for a partial sublease of a facility ~~which was amended and renewed in October 2025~~ (the Sublease Agreement ) . Under the GondolaBio Transition Services Agreement and Sublease Agreement, the Company recognized $ ~~2.2~~ 1.8 million and $ ~~4.7~~ 6.5 million, respectively, in other income, and $ 0.6 million and $ ~~2.5~~ 3.1 million, respectively, of pass-through costs and sublease income recorded as an offset against operating expenses, during the three and ~~six~~ nine months ended ~~June~~ September 30, 2026. Under the GondolaBio Transition Services Agreement and Sublease Agreement, the Company recognized $ ~~2.7~~ 3.2 million and $ ~~5.4~~ 8.6 million, respectively, in other income, and $ ~~1.9~~ 1.4 million and $ ~~2.7~~ 4.1 million, respectively, of pass-through costs and sublease income recorded as an offset against operating expenses, during the three and ~~six~~ nine months ended ~~June~~ September 30, 2025. As of ~~June~~ September 30, 2026 and December 31, 2025, the Company had $ ~~3.4~~ 1.0 million and $ 4.5 million, respectively, in prepaid expenses and other current assets for ~~transitionary~~ consulting services provided by BridgeBio to GondolaBio and for sublease income. The Company also recognized $ 0.4 million and $ 0.8 million, respectively, in research and development expenses for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026 for ~~transitionary~~ consulting services provided by GondolaBio to BridgeBio. The Company recognized ~~$ 0.5 million~~ an immaterial amount and $ 1.2 million, respectively, in research and development expenses for the three and ~~six~~ nine months ended ~~June~~ September 30, 2025 for ~~transitionary~~ consulting services provided by GondolaBio to BridgeBio. As of ~~June~~ September 30, 2026 and December 31, 2025, the Company also had $ ~~0.8~~ 1.0 million and $ 1.5 million, respectively, in other current liabilities for ~~transitionary~~ consulting services provided by GondolaBio to BridgeBio.

3 unchanged paragraphs

Note 6: Intangible Assets, net 5 changes

1 unchanged paragraph

~~June~~ September 30, 2026 December 31, 2025

4 unchanged paragraphs

~~Total $ 26,641 $ 28,077~~

Less accumulated amortization ( ~~12,759~~ 13,477 ) ( 11,323 )

Total $ 25,923 $ 28,077

Amortization expense, recorded as part of Cost of license, services, and royalty revenue on our condensed consolidated statements of operations, was $ 0.7 million and $ ~~1.4~~ 2.1 million for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, respectively, and $ 0.7 million and $ ~~1.3~~ 2.0 million for the three and ~~six~~ nine months ended ~~June~~ September 30, 2025, respectively. Estimated future amortization expense is $ ~~1.4~~ 0.7 million for the remainder of 2026, $ 2.9 million for each of the years from 2027 to 2031 and $ 10.7 million thereafter.

1 unchanged paragraph

Note 7: Commitments and Contingencies 8 changes

1 unchanged paragraph

We have performance-based milestone compensation arrangements with certain employees, whose vesting is contingent upon meeting various regulatory, development and sales milestones, with fixed monetary amounts known at inception that can be settled in the form of cash or equity at our sole discretion. We also have performance-based milestone compensation arrangements with certain employees and consultants as part of the Company s equity incentive plans. The compensation arrangements under certain equity incentive plans are to be settled in the form of equity only. Performance-based milestone awards that are settled in the form of equity are satisfied in the form of fully-vested common stock. We accrue for such contingent compensation when the related milestone is probable of achievement and is recorded in Accrued compensation and benefits for the current portion and in Other long-term liabilities for the noncurrent portion on the condensed consolidated balance sheets. There is no accrued compensation expense for performance-based milestone awards that are assessed to be not probable of achievement. The table below shows our commitment for the potential milestone amounts and the accruals for milestones deemed probable of achievement as of ~~June~~ September 30, 2026.

2 unchanged paragraphs

Cash or stock at our sole discretion ~~49,650 17~~ 108,451 1,184

Total $ 120,871 $ 1,184

(1) Potential milestone amounts are presented at the maximum potential amounts payable under the respective agreements.

~~(1)~~ (2) Amount recorded for performance-based milestone awards that are probable of achievement.

~~(2)~~ (3) Includes the performance-based milestone awards.

1 unchanged paragraph

We may also enter into contracts in the normal course of business with various counterparties, including vendors for our commercial product and product candidates, contract research organizations for services related to clinical trials, CMOs for clinical supplies, and other vendors for ~~preclinical~~ nonclinical studies, supplies, and other operating purposes. These contracts generally provide for termination on notice with potential termination charges. As of ~~June~~ September 30, 2026 and December 31, 2025, there were no material amounts accrued related to termination charges.

In the normal course of business, we have also entered into contracts which contain minimum ~~noncancellable~~ noncancelable purchase commitments and obligations. These include commitments for the supply, manufacturing, and packaging of our commercial product as well as agreements to support the sales and marketing activities for Attruby. As of ~~June~~ September 30, 2026, we ~~have~~ had minimum ~~noncancellable~~ noncancelable commitments in an aggregate amount of $ ~~158.0~~ 159.4 million.

3 unchanged paragraphs

Note 8: Debt 2 changes

1 unchanged paragraph

The 2027 Notes will accrue interest payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2020, at a rate of 2.50 % per year. The 2027 Notes will mature on March 15, 2027, unless earlier converted or repurchased. The 2027 Notes are convertible into cash, shares of BridgeBio s common stock or a combination of cash and shares of BridgeBio s common stock, at our election.

5 unchanged paragraphs

The 2027 Notes are convertible for a limited period from October 1, 2026 through December 14, 2026, as an early conversion condition based on the price of BridgeBio s common stock, as described above, was satisfied. On or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its 2027 Notes at any time. ~~regardless of the foregoing.~~

3 unchanged paragraphs

Note 9: Deferred Royalty Obligations, net 2 changes

1 unchanged paragraph

Pursuant to the Royalty Purchase Agreement, Eidos sold to the Royalty Agreement Purchasers certain of Eidos right to receive certain royalty payments ( Purchased Royalty Payment ) on net sales of certain products containing acoramidis (the Licensed Products ) made in the EU and all member and extension states of the European Patent Organization (the Licensed Territory ) under (i) an exclusive license agreement, dated as of March 1, 2024, by and among Bayer (as described in Note 10), Eidos and the other subsidiaries of the Company party thereto, as amended from time to time (the Bayer License Agreement ) and (ii) an amended and restated license agreement, effective as of June 30, 2023, by and between Eidos and one of the other Company s subsidiaries, BridgeBio International GmbH. As consideration for the sale of the Purchased Royalty Payment, the Royalty Agreement Purchasers agreed to pay Eidos $ 300.0 million in cash (the Purchase Price ), which was funded in full on the Closing Date. The Royalty Agreement Purchasers rights to the Purchased Royalty Payment are subject to (a) an annual cap equal to 60 % of all royalty payments paid by Bayer to Eidos and its affiliates under the Bayer License Agreement on the first $ 500.0 million of annual net sales of Licensed Products in the Licensed Territory under the Bayer License Agreement and (b) an initial hard cap equal to 145 % of the Purchase Price.

On June 27, 2025 (the Closing Date ), the Company and its subsidiary, Eidos Therapeutics, Inc. ( Eidos ), entered into a Royalty Interest Purchase and Sale Agreement (the Royalty Purchase Agreement ) with Acoramidis Royalty SPV, LP ( ARS ), an affiliate of HealthCare Royalty Management, LLC ( HCRx ), as a purchaser and the purchaser representative (in such capacity, the Purchaser Representative ), and LSI Financing Fund, LP, an affiliate of Blue Owl Capital Corporation, as a purchaser (together with ARS as a purchaser and any future permitted assignees of a purchaser, the Royalty Agreement Purchasers ). Subsequent to the Closing Date, on July 30, 2025, KKR & Co. Inc. ( KKR ) acquired a ~~beneficial holder~~ majority ownership interest in HCRx. At that time, KKR beneficially owned more than five percent of the Company s outstanding common ~~equity~~ stock, and HCRx accordingly became a related party. ~~acqu ired~~ On August 17, 2026, KKR sold a ~~majority ownership interest in HCRx.~~ portion of its shares of our common stock and is no longer a beneficial owner of more than five percent of our outstanding shares of common stock. Accordingly, KKR and HCRx ~~became a~~ ceased to be related ~~party~~ parties of the Company ~~following KKR & Co. Inc. s acquisition~~ as of ~~HCRx.~~ August 17, 2026.

1 unchanged paragraph

Note 10: License and Collaboration Agreements 5 changes

2 unchanged paragraphs

Unless earlier terminated, the Bayer License Agreement will expire at the end of the royalty term for a licensed product, provided that the licenses granted to Bayer for such licensed product survive such expiration on a non-exclusive basis. Either party may terminate the Bayer License Agreement in the event of a material breach or insolvency of the other party or in the event merger control proceedings are started and clearances are not obtained. Additionally, Bayer may terminate the Bayer License Agreement for convenience upon at least 270 days prior written notice, and the Seller Parties may terminate the Bayer License Agreement in the event Bayer ceases exploitation of acoramidis under certain circumstances or challenges the validity or enforceability of the Seller Parties patent rights.

~~We determined that the Bayer License Agreement falls within the scope of ASC 606 as Bayer is a customer in this arrangement, and we identified the following performance obligations in the agreement:~~

~~an exclusive license to develop and commercialize acoramidis in the Licensed Territory and the related know-how; and research and development services to conduct ongoing clinical trials.~~

We determined that the performance obligations outlined above are capable of being distinct and distinct with the context of the contract given such rights and activities are independent of each other. The license can be used by Bayer without the development services. Similarly, those services provide a distinct benefit to Bayer within the context of the contract, separate from the license, as the services could be provided by Bayer or another third party without our assistance.

Under the terms of the Bayer License Agreement, the Seller Parties granted Bayer an exclusive license on March 26, 2024 to certain of the Seller Parties intellectual property rights to develop, manufacture and commercialize acoramidis (previously known as AG10) in the Licensed Territory. In consideration for the license grant, the Seller Parties are entitled to receive an upfront payment of $ 135.0 million, up to $ 150.0 million in regulatory and sales milestone payments through 2026, and additional payments up to $ 450.0 million subject to the achievement of certain sales milestones under the Bayer License Agreement. To date, ~~we have received $ 210.0 million relating to~~ the upfront payment and the regulatory and sales milestones achieved under the Bayer License Agreement total $ 285.0 million. In addition, the Seller Parties are entitled to receive royalties according to a tiered structure starting in the low-thirties percent on net sales by Bayer of acoramidis in the Licensed Territory, subject to reduction under certain circumstances as provided in the Bayer License Agreement.

1 unchanged paragraph

Note 11: In-licensing and Other Research and Development Agreements 4 changes

1 unchanged paragraph

In April 2016, Eidos entered into a license agreement with the Board of Trustees of the Leland Stanford Junior University ( Stanford University ), relating to Eidos drug discovery and development initiatives. Under this agreement and its amendments, Eidos has been granted certain worldwide exclusive licenses to make, use, and sell products that are covered by licensed patent rights. Eidos may also be required to make future payments of up to approximately $ 1.0 million to Stanford University upon achievement of specific intellectual property, clinical and regulatory milestone events, and pay royalties of up to low single-digit percentages on future net sales, if any. In addition, Eidos is obligated to pay Stanford University a percentage of nonroyalty revenue received by Eidos from its sublicensees, with the amount owed decreasing annually for three years based on when the applicable sublicense agreement is executed.

Additionally, under the license agreement with Stanford University, we will pay Stanford University a portion of all nonroyalty sublicensing consideration attributable to the sublicense of the licensed compounds. During the three and nine months ended September 30, 2026, we incurred $ 8.4 million and $ 17.0 million, respectively, in royalties related to commercial sales of Attruby and Beyonttra. During the three and nine months ended September 30, 2025, we incurred $ 1.9 million and $ 3.6 million, respectively, in royalties related to commercial sales of Attruby and Beyonttra. For the three and nine months ended September 30, 2026, we incurred a $ 4.5 million license fee payable to Stanford University, which was related to the $ 75.0 million sales milestone achieved in September 2026 under the Bayer License Agreement (refer to Note 10), which was recognized within Cost of license, services, and royalty revenue on our condensed consolidated statements of operations. For the three and nine months ended September 30, 2025, we incurred nil and $ 6.9 million, respectively, of license fees payable to Stanford University, which was related to the regulatory milestone achieved in February 2025 under the Bayer License Agreement as well as the regulatory milestone achieved in May 2025 under the Eidos-Alexion License Agreement (refer to Note 10), and were capitalized as finite-lived intangible assets.

Other License and Collaboration Agreements

In addition to the agreements described above, we have also entered into other license and collaboration agreements with various institutions and business entities on terms similar to those described above, none of which are material individually or in the aggregate.

1 unchanged paragraph

Note 12: Leases 16 changes

3 unchanged paragraphs

~~Three Months Ended June 30, Six Months Ended June 30,~~

~~(in thousands) (in thousands)~~

~~Straight-line operating lease costs $ 1,628 $ 1,236 $ 3,094 $ 2,230~~

~~Finance lease costs 92 29 187~~

~~Variable lease costs 937 1,074 1,717 2,480~~

~~Total lease costs $ 2,565 $ 2,402 $ 4,840 $ 4,897~~

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) (in thousands)

Straight-line operating lease costs $ 1,620 $ 1,213 $ 4,714 $ 3,443

Finance lease costs 91 29 278

Variable lease costs 975 1,342 2,692 3,822

Total lease costs $ 2,595 $ 2,646 $ 7,435 $ 7,543

1 unchanged paragraph

~~Six Months Ended June 30,~~

Nine Months Ended September 30,

1 unchanged paragraph

Operating cash flows for operating leases $ ~~3,674~~ 5,494 $ ~~3,117~~ 4,757

Operating cash flows for finance lease $ $ ~~229~~ 344

Operating lease right-of-use assets obtained in exchange for operating lease obligations $ 11,580 $ ~~2,259~~ 3,714

1 unchanged paragraph

Note 14: Stock-Based Compensation 13 changes

1 unchanged paragraph

~~Three Months Ended June 30, Six Months Ended June 30,~~

~~(in thousands) (in thousands)~~

~~Cost of goods sold $ 685 $ 126 $ 1,655 $ 217~~

~~Research and development 15,439 14,000 27,583 25,255~~

~~Selling, general and administrative 28,398 23,213 48,647 41,211~~

~~Total stock-based compensation $ 44,522 $ 37,339 $ 77,885 $ 66,729~~

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) (in thousands)

Cost of goods sold $ 374 $ 361 $ 2,029 $ 578

Research and development 14,921 12,328 42,504 37,582

Selling, general and administrative 24,562 21,866 73,209 63,077

Restructuring, impairment, and related charges 46 709 755

Total stock-based compensation $ 39,857 $ 35,264 $ 117,742 $ 101,992

BRIDGEBIO PHARMA, INC.

Note 16: Income Taxes 4 changes

BridgeBio is subject to U.S. federal, state and foreign income taxes as a corporation. BridgeBio s tax provision and the resulting effective tax rate for interim periods are determined based upon its estimated annual effective tax rate adjusted for the effect of discrete items arising in that quarter. ~~There was no provision for income tax for the three and six months ended June 30, 2026. Provision for income tax for the three and six months ended June 30, 2025 was $ 2.1 million.~~

1 unchanged paragraph

Our policy is to recognize interest and penalties associated with uncertain tax benefits as part of the income tax provision and include accrued interest and penalties with the related income tax liability on the condensed consolidated balance sheets. To date, we have not recognized any interest and penalties on our condensed consolidated statements of operations, nor have we accrued for or made payments for interest and penalties. Our unrecognized gross tax benefits would not reduce the estimated annual effective tax rate if recognized because we have recorded a full valuation allowance on our deferred tax assets.

On July 4, 2025, the current administration signed the One Big Beautiful Bill Act ( OBBBA ), which includes comprehensive U.S. corporate tax legislation. The legislation includes the modification and permanent extension of prior tax law under the Tax Cuts and Jobs Act and the introduction of new provisions such as permanently reinstating the immediate deduction of domestic specified research and experimental expenditures, permanent changes in the limitations for deducting business interest expense, and permanently restoring bonus depreciation allowances. Following the enactment of the OBBBA, we are no longer capitalizing domestic research and experimental expenditures.

The Company s provision for income tax for the three and nine months ended September 30, 2026 was $ 1.2 million, primarily related to current foreign income tax expense. The Company s provision for (benefit from) income tax for the three and nine months ended September 30, 2025 was $( 1.5 ) million and $ 0.6 million, respectively, primarily related to the benefit recognized from the OBBBA for the three-month period and current foreign income tax expense for the nine-month period.

1 unchanged paragraph

Note 17: Net Loss Per Share 13 changes

We calculate basic net loss per share using the two-class method as a result of the issuance of the Preferred Stock in July 2026 (see Note 13). The two-class method determines net income (loss) per common share for each class of common stock and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires undistributed earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Preferred Stock contractually entitles the holders of such shares to participate in dividends declared on Common Stock on an as-converted basis, but does not contractually require the holders of such shares to participate in the Company s losses. Accordingly, no losses are allocated to the Preferred Stock, and the Preferred Stock is excluded from the computation of basic net loss per share in periods in which the Company reports a net loss. However, the cumulative dividends that accrete on the Preferred Stock for the period, whether or not declared, reduce net income or increase net loss attributable to common stockholders. For the period from the Preferred Stock Closing Date to September 30, 2026, the Company recognized dividends of $ 26.3 million, which includes accretion of the implied discount of $ 9.9 million.

Basic net loss per share attributable to common stockholders of BridgeBio is computed by dividing net loss attributable to common stockholders of BridgeBio by the weighted-average number of shares of common stock outstanding. Diluted net loss per share attributable to common stockholders of BridgeBio is computed by dividing net loss attributable to common stockholders of BridgeBio by the weighted-average number of shares of common stock outstanding, plus all additional common shares that would have been outstanding, assuming dilutive potential common shares had been issued for other dilutive securities. For the three and ~~six~~ nine months ended ~~June~~ September 30, 2026 and 2025, diluted and basic net loss per share attributable to common stockholders of BridgeBio were identical since potential common shares were excluded from the calculation, as their effect was antidilutive.

1 unchanged paragraph

~~Unvested RSUs 9,074,136 11,852,773~~

Unvested RSUs 7,997,782 10,694,969

1 unchanged paragraph

~~Common stock options issued and outstanding 10,041,746 12,199,613~~

Unvested market-based RSUs ~~116,071~~ 375,000

Common stock options issued and outstanding 9,779,350 11,909,994

1 unchanged paragraph

~~compensation arrangements 902,775 1,681,209~~

compensation arrangements 1,735,060 1,330,341

Estimated shares issuable under the ESPP ~~71,990 112,977~~ 39,429 42,842

4 unchanged paragraphs

Assumed conversion of Preferred Stock 6,777,704

1 unchanged paragraph

We have performance-based milestone compensation arrangements, whose vesting is contingent upon meeting various regulatory and development milestones, with fixed monetary amounts known at inception that can be settled in the form of cash or equity at our sole election, upon achievement of each contingent milestone. The common stock equivalents of such arrangements were estimated as if the contingent milestones were achieved as of the reporting date and the arrangements were all settled in equity.

Holders of the Preferred Stock have the right, at any time and from time to time, to convert their shares of Preferred Stock into shares of common stock at the then-effective conversion price, which is initially $ 137.79 per share and, on and after the fifth anniversary of the Original Issuance Date, $ 153.10 per share, in each case subject to customary anti-dilution adjustments. As of September 30, 2026, the assumed conversion of the Preferred Stock excludes the accrued cash dividends of $ 13.7 million, which the Company has elected to pay in cash, as described in Note 13.

1 unchanged paragraph

MD&A 175 changes

3 unchanged paragraphs

We currently generate material revenues from one commercial product and have multiple product candidates in that have advanced into registrational and late-stage development. Acoramidis received U.S. Food and Drug Administration ( FDA ) approval in November 2024 as Attruby and also received approval as Attruby from the Australian Therapeutic Goods Administration in late October 2026, and it received approval as Beyonttra from (i) the European Commission ( EC ) on February 10, 2025, (ii) the Japanese Ministry of Health, Labour and Welfare on March 27, 2025 (pricing approval from the National Health Insurance in Japan was subsequently obtained on May 21, 2025), ~~and~~ (iii) the United Kingdom Medicines and Healthcare products Regulatory Agency in the UK in April 2025 and (iv) the Brazilian Health Regulatory Agency in Brazil in May 2026. On March 30, 2026, we submitted our New Drug Application ( NDA ) to the FDA for oral BBP-418 for the treatment of LGMD2I/R9. ~~On May 27, 2026,~~ The FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act ( PDUFA ) target action date of November 27, 2026, for BBP-418. On May 12, 2026, we submitted our NDA to the FDA for encaleret as a potential targeted treatment for ADH1. The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of May 8, 2027, for encaleret. On August 4, 2026, we submitted our NDA to the FDA for low-dose infigratinib for achondroplasia. The FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of February 4, 2027, for infigratinib.

1 unchanged paragraph

We have incurred significant operating losses since our inception. For the ~~six~~ nine months ended ~~June~~ September 30, 2026 and 2025, we incurred net losses of ~~$322.4~~ $382.9 million and ~~$353.4~~ $538.3 million, respectively. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the success of our commercialization strategy for Attruby and Beyonttra, and the development and eventual commercialization of our product candidates at our wholly-owned subsidiaries and controlled entities. Further, we may not realize the anticipated efficiencies and other benefits of our past and any future restructuring initiatives. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending may have a material adverse effect on our ability to achieve our intended business objectives. We expect to continue to incur operating and net losses for at least the next several years.

On July 1, 2026, we entered into an Investment Agreement (the Investment Agreement ) with Chinotto Investments, LLC (the Sixth Street Purchaser ) and HCRx Investments HoldCo, L.P. (the HCR Purchaser ) (collectively, the Purchasers ), providing for the issuance and sale of Series A Cumulative Convertible Participating Preferred Stock, par value $0.001 per share (the Preferred Stock ). Pursuant to the Investment Agreement, the Purchasers purchased an aggregate of 933,900 shares of Preferred Stock at a purchase price of $1,000 per share, for an aggregate purchase price of $933.9 million, consisting of 800,000 shares purchased by the Sixth Street Purchaser for an aggregate purchase price of $800.0 million and 133,900 shares purchased by the HCR Purchaser for an aggregate purchase price of $133.9 million. The Preferred Stock is convertible into shares of our common stock at an initial conversion price of $137.79 per share, subject to adjustment as set forth in the certificate of designations for the Preferred Stock. ~~The HCR Purchaser is an entity affiliated with Kohlberg Kravis Roberts & Co. L.P. , a related party .~~

In May 2026, we filed a shelf registration statement on Form S-3 (the 2026 Shelf ) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and units or any combination thereof. We also concurrently entered into an Equity Distribution Agreement (the 2026 ATM Agreement ) with Goldman Sachs & Co. LLC and Leerink Partners LLC (collectively, the 2026 ATM Sales Agents ), with respect to an at-the-market offering program under which we may issue and sell, from time to time at our sole discretion and pursuant to a prospectus supplement, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $500.0 million through the 2026 ATM Sales Agents. Under the 2026 ATM Agreement, we have agreed to pay the 2026 ATM Sales Agents a customary commission of up to 3.0% of the aggregate gross proceeds from all sales of the common stock. As of ~~June~~ September 30, 2026, $500.0 million remained available to be sold pursuant to the 2026 ATM Agreement under the 2026 Shelf.

In May 2026, our Board of Directors approved a stock repurchase program pursuant to which we may purchase up to $500.0 million of our outstanding common stock. Stock repurchases under the program may be made from time to time, in the open market, in privately negotiated transactions and otherwise, at the discretion of our management and in accordance with applicable federal securities laws, including Rule 10b-18 of the Exchange Act, and other applicable legal requirements. The timing, pricing, and amounts of these repurchases will depend on a number of factors, including the market price of our common stock and general market and economic conditions. The stock repurchase program does not obligate us to repurchase any dollar amount or number of shares, and the program may be suspended or discontinued at any time. As of ~~June~~ September 30, 2026, we had repurchased ~~1,904,001~~ 2,616,166 shares in the open market at an average price of ~~$66.96~~ $66.88 per share for a total of approximately ~~$127.5~~ $175.0 million. The repurchased shares were held as treasury stock as of ~~June~~ September 30, 2026.

1 unchanged paragraph

On June 27, 2025 (the Closing Date ), we and our subsidiary, Eidos Therapeutics, Inc. ( Eidos ), entered into a Royalty Interest Purchase and Sale Agreement (the Royalty Purchase Agreement ) with Acoramidis Royalty SPV, LP ( ARS ), an affiliate of HealthCare Royalty Management, LLC ( HCRx ), as a purchaser and the purchaser representative (in such capacity, the Purchaser Representative ), and LSI Financing Fund, LP, an affiliate of Blue Owl Capital Corporation, as a purchaser (together with ARS as a purchaser and any future permitted assignees of a purchaser , the Royalty Agreement Purchasers ). Subsequent to the Closing Date, on July 30, 2025, KKR & Co. Inc. ~~a beneficial holder of our common equity and a related party,~~ ( KKR ) acquired a majority ownership interest in HCRx. ~~Accordingly,~~ At that time, KKR beneficially owned more than five percent of the Company s outstanding common stock, and HCRx accordingly became ~~our~~ a related party. ~~following~~ On August 17, 2026, KKR ~~& Co. Inc. s acquisition~~ sold a portion of its shares of our common stock and is no longer a beneficial owner of more than five percent of our outstanding shares of common stock. Accordingly, KKR and HCRx ceased to be related parties of the Company as of August 17, 2026.

2 unchanged paragraphs

On March 1, 2024, our subsidiaries, Eidos, BridgeBio International GmbH and BridgeBio Europe B.V. (collectively, the Seller Parties ), entered into an exclusive license agreement (the Bayer License Agreement ) with Bayer Consumer Care AG, a wholly-owned subsidiary of Bayer AG ( Bayer ), to develop and commercialize acoramidis as a treatment for transthyretin amyloidosis in the EU and all member and extension states of the European Patent Organization (the Licensed Territory ). Under the terms of the Bayer License Agreement, the Seller Parties granted Bayer an exclusive license on March 26, 2024 to certain of the Seller Parties intellectual property rights to develop, manufacture and commercialize acoramidis (previously known as AG10) in the Licensed Territory. In consideration for the license grant, the Seller Parties are entitled to receive an upfront payment of $135.0 million, up to $150.0 million in regulatory and sales milestone payments through 2026, and additional payments up to $450.0 million subject to the achievement of certain sales milestones under the Bayer License Agreement. To date, ~~we have received $210.0 million relating to~~ the upfront payment and the regulatory and sales milestones achieved under the Bayer License Agreement total $285.0 million. In addition, the Seller Parties are entitled to receive royalties according to a tiered structure starting in the low-thirties percent on net sales by Bayer of acoramidis in the Licensed Territory, subject to reduction under certain circumstances as provided in the Bayer License Agreement.

3 unchanged paragraphs

Due to the inherently unpredictable nature of ~~preclinical~~ nonclinical and clinical development, and given our novel therapeutic approaches and the stage of development of our product candidates, we cannot determine and are unable to estimate with certainty the timelines we will require and the costs we will incur for the development of our product candidates. Clinical and ~~preclinical~~ nonclinical development timelines and costs, and the potential of development success, can differ materially from expectations due to a variety of factors.

3 unchanged paragraphs

~~Three Months Ended June 30, Six Months Ended June 30,~~

~~(in thousands) (in thousands)~~

~~Total revenues, net $ 243,676 $ 110,565 $ 438,191 $ 227,198~~

~~Total cost of revenues $ 15,046 $ 3,653 $ 24,985 $ 6,292~~

~~Research and development $ 149,448 $ 111,231 $ 276,084 $ 222,662~~

~~Selling, general and administrative $ 186,261 $ 129,154 $ 350,157 $ 235,519~~

~~Loss from operations $ (107,079) $ (134,278) $ (213,035) $ (238,650)~~

~~Interest income $ 6,659 $ 3,898 $ 12,905 $ 9,283~~

~~Interest expense $ (13,278) $ (11,607) $ (26,220) $ (29,728)~~

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) (in thousands)

Total revenues, net $ 353,171 $ 120,700 $ 791,362 $ 347,898

Total cost of revenues $ 20,450 $ 6,563 $ 45,435 $ 12,855

Research and development $ 143,506 $ 112,874 $ 419,590 $ 335,536

Selling, general and administrative $ 200,854 $ 137,621 $ 551,011 $ 373,140

Loss from operations $ (11,639) $ (145,199) $ (224,674) $ (383,849)

Interest income $ 13,105 $ 6,239 $ 26,010 $ 15,522

Interest expense $ (13,255) $ (11,739) $ (39,475) $ (41,467)

Noncash interest expense on deferred royalty obligations (1) $ ~~(41,345)~~ (42,282) $ ~~(26,030)~~ (36,410) $ ~~(81,218)~~ (123,500) $ ~~(50,050)~~ (86,460)

Net loss from equity method investments $ (7,312) $ (15,834) $ (32,030) $ (51,579)

1 unchanged paragraph

~~Net loss from equity method investments $ (6,435) $ (20,189) $ (24,718) $ (35,745)~~

~~Other income, net $ 5,587 $ 6,548 $ 9,840 $ 14,779~~

~~Net loss $ (155,891) $ (183,758) $ (322,446) $ (353,366)~~

(1) Including related party amounts of $(5,575) and $(10,936), respectively, for the three and six months ended June 30, 2026 (as described in Note 9 to our condensed consolidated financial statements).

Other income, net $ 2,116 $ 16,461 $ 11,956 $ 31,240

Net loss $ (60,496) $ (184,937) $ (382,942) $ (538,303)

Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests $ ~~3,675~~ 3,786 $ ~~1,855~~ 2,194 $ ~~6,187~~ 9,973 $ ~~4,041~~ 6,235

Preferred stock dividends and accretion $ 26,293 $ $ 26,293 $

Net loss attributable to common stockholders of BridgeBio $ ~~(152,216)~~ (83,003) $ ~~(181,903)~~ (182,743) $ ~~(316,259)~~ (399,262) $ ~~(349,325)~~ (532,068)

(1) Including related party amounts of $(2,942) and $(13,878) for the period from July 1, 2026 to August 16, 2026 and for the period from January 1, 2026 to August 16, 2026, respectively, and $(5,383) and $(5,560) for the three and nine months ended September 30, 2025, respectively (as described in Note 9).

2 unchanged paragraphs

~~Marketable securities 42,249 17,363~~

~~June~~ September 30, 2026 December 31, 2025

Cash and cash equivalents $ ~~677,911~~ 1,533,363 $ 570,119

Marketable securities 5,492 17,363

Total cash, cash equivalents and marketable securities $ ~~720,160~~ 1,538,855 $ 587,482

1 unchanged paragraph

~~Three Months Ended June 30, Six Months Ended June 30,~~

Three Months Ended September 30, Nine Months Ended September 30,

2 unchanged paragraphs

~~Net product revenue $ 222,440 $ 71,501 $ 150,939 $ 403,036 $ 108,240 $ 294,796~~

~~License and services revenue 5,804 37,440 (31,636) 10,223 117,130 (106,907)~~

~~Royalty revenue 15,432 1,624 13,808 24,932 1,828 23,104~~

~~Total revenues, net $ 243,676 $ 110,565 $ 133,111 $ 438,191 $ 227,198 $ 210,993~~

Net product revenue $ 253,346 $ 108,111 $ 145,235 $ 656,382 $ 216,351 $ 440,031

License and services revenue 79,314 8,311 71,003 89,537 125,441 (35,904)

Royalty revenue 20,511 4,278 16,233 45,443 6,106 39,337

Total revenues, net $ 353,171 $ 120,700 $ 232,471 $ 791,362 $ 347,898 $ 443,464

Total revenues, net increased by ~~$133.1~~ $232.5 million for the three months ended ~~June~~ September 30, 2026, compared to the same period in 2025, which consisted of an increase of ~~$150.9~~ $145.3 million in net product revenue, ~~a decrease~~ an increase of ~~$31.6~~ $71.0 million in license and services revenue, and an increase of ~~$13.8~~ $16.2 million in royalty revenue. Total revenues, net increased by ~~$211.0~~ $443.5 million for the ~~six~~ nine months ended ~~June~~ September 30, 2026, compared to the same period in 2025, which consisted of an increase of ~~$294.8~~ $440.0 million in net product revenue, ~~a decrease~~ an increase of ~~$106.9~~ $39.4 million in ~~license and services~~ royalty revenue, and ~~an increase~~ a decrease of ~~$23.1~~ $35.9 million in ~~royalty~~ license and services revenue.

Net product revenue from Attruby increased for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, compared to the same periods in 2025, primarily due to continued commercial expansion driven by patient demand.

License and services revenue ~~decreased~~ increased for the three months ended ~~June~~ September 30, 2026, compared to the same period in 2025, primarily due to the ~~achievement~~ recognition of a ~~regulatory milestone of $30.0~~ $75.0 million ~~recognized~~ sales milestone under the ~~Eidos-Alexion~~ Bayer License Agreement, ~~in 2025.~~ which was achieved during the three months ended September 30, 2026. License and services revenue decreased for the ~~six~~ nine months ended ~~June~~ September 30, 2026, compared to the same period in 2025, primarily due to $105.0 million recognized for regulatory milestone achievements following approval of Beyonttra in the EU and pricing approval of Beyonttra in Japan in 2025 compared to the $75.0 million recognized for sales milestone achievement under the Bayer License Agreement during the three months ended September 30, 2026.

Royalty revenue increased for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, compared to the same periods in 2025, primarily due to royalties earned from net product sales of Beyonttra in the EU, following EC approval in February 2025, and in Japan, following pricing approval in May 2025.

3 unchanged paragraphs

~~Three Months Ended June 30, Six Months Ended June 30,~~

Three Months Ended September 30, Nine Months Ended September 30,

2 unchanged paragraphs

~~Cost of goods sold $ 10,528 $ 2,848 $ 7,680 $ 18,260 $ 4,882 $ 13,378~~

~~Cost of license, services, and royalty revenue 4,518 805 3,713 6,725 1,410 5,315~~

~~Total cost of revenues $ 15,046 $ 3,653 $ 11,393 $ 24,985 $ 6,292 $ 18,693~~

Cost of goods sold $ 12,317 $ 4,028 $ 8,289 $ 30,577 $ 8,910 $ 21,667

Cost of license, services, and royalty revenue 8,133 2,535 5,598 14,858 3,945 10,913

Total cost of revenues $ 20,450 $ 6,563 $ 13,887 $ 45,435 $ 12,855 $ 32,580

Total cost of revenues increased by ~~$11.4~~ $13.9 million for the three months ended ~~June~~ September 30, 2026, compared to the same period in 2025 primarily due to an increase of ~~$7.7~~ $8.3 million in cost of goods sold and an increase of ~~$3.7~~ $5.6 million in cost of license, services, and royalty revenue. Total cost of revenues increased by ~~$18.7~~ $32.6 million for the ~~six~~ nine months ended ~~June~~ September 30, 2026, compared to the same period in 2025 primarily due to an increase of ~~$13.4~~ $21.7 million in cost of goods sold and an increase of ~~$5.3~~ $10.9 million in cost of license, services, and royalty revenue.

Cost of goods sold for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026 and 2025 consists of contract manufacturing costs, transportation and freight-in, and indirect overhead costs (including salary and benefits related and stock-based compensation expenses) associated with the commercial manufacturing and distribution of Attruby, and third-party royalties associated with our net product revenue.

Cost of license, services, and royalty revenue for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026 and 2025, consists mainly of third-party royalties and license fees associated with commercial sales of Beyonttra, contract manufacturing costs relating to product supply of Beyonttra to our collaboration partners, and amortization of intangible assets for milestones achieved upon FDA approval from our license and collaboration agreements. We began incurring royalties and manufacturing costs associated with commercial sales of Beyonttra upon its approval in the EU, Japan, and the UK in 2025.

2 unchanged paragraphs

~~Three Months Ended June 30, Six Months Ended June 30,~~

Three Months Ended September 30, Nine Months Ended September 30,

2 unchanged paragraphs

~~Research and development $ 149,448 $ 111,231 $ 38,217 $ 276,084 $ 222,662 $ 53,422~~

Research and development $ 143,506 $ 112,874 $ 30,632 $ 419,590 $ 335,536 $ 84,054

Research and development expenses increased by ~~$38.2~~ $30.6 million and ~~$53.4~~ $84.1 million for the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, respectively, compared to the same periods in 2025. The increases are primarily driven by the development of late-stage programs.

The increase of ~~$38.2~~ $30.6 million for the three months ended ~~June~~ September 30, 2026 was primarily driven by ~~a $28.8~~ an $18.2 million increase in external costs, ~~an $8.0~~ a $9.8 million increase in personnel-related expenses due to ~~increased~~ headcount growth, and a ~~$1.4~~ $2.6 million increase in stock-based compensation expenses.

The increase of ~~$53.4~~ $84.1 million for the ~~six~~ nine months ended ~~June~~ September 30, 2026 was primarily driven by a ~~$38.5~~ $56.8 million increase in external costs, a ~~$12.6~~ $22.4 million increase in personnel-related expenses due to ~~increased~~ headcount growth, and a ~~$2.3~~ $4.9 million increase in stock-based compensation expenses.

Research and development costs consist primarily of external costs, such as fees paid to consultants, contractors, CMOs, and contract research organizations ( CROs ), as well as purchase of APIs in connection with our ~~preclinical,~~ nonclinical, contract manufacturing and clinical development activities; internal costs such as personnel and facility costs, and are tracked on a program-by-program basis. License fees and other costs incurred after a product candidate has been designated and that are directly related to the product candidate are included in the specific program expense. License fees and other costs incurred prior to designating a product candidate are included in early-stage development and research programs, which are presented in the following table in Other development programs and Other research programs, respectively.

1 unchanged paragraph

~~Three Months Ended June 30, Six Months Ended June 30,~~

~~(in thousands) (in thousands)~~

~~Infigratinib for achondroplasia and hypochondroplasia 35,460 30,191 70,993 58,125~~

~~BBP-418 for LGMD2I/R9 26,653 11,243 42,261 25,452~~

~~Encaleret for ADH1 24,079 13,128 44,507 28,587~~

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and 95 more changes in the filing

Market risk 2 changes

As of ~~June~~ September 30, 2026, we held cash, cash equivalents and marketable securities of ~~$720.2 million.~~ $1.5 billion. Our cash equivalents consist of amounts invested in money market funds, agency discount notes, commercial paper, and high investment grade fixed income securities that are primarily invested in U.S. government securities and treasury bills. Our marketable securities consisted of high investment grade fixed income securities that were invested in U.S. treasury bills ~~and notes~~ and agency discount notes. We do not enter into investments for trading or speculative purposes and have not used any derivative financial instruments to manage our interest rate risk exposure. We have not been exposed, nor do we anticipate being exposed to material risks due to changes in interest rates. We do not believe that our cash, cash equivalents and marketable securities have a significant risk of default or illiquidity.

As of ~~June~~ September 30, 2026, our 2027 Notes, 2029 Notes, 2031 Notes, and 2033 Notes had principal balances of $550.0 million, $747.5 million, $575.0 million, and $632.5 million, respectively, which bear fixed interest rates that are not subject to variability as a result of changes in interest rates.

1 unchanged paragraph

Controls and procedures 1 change

2 unchanged paragraphs

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of ~~June~~ September 30, 2026, and our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of that date. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

2 unchanged paragraphs

Risk factors 66 changes

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There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize Attruby and Beyonttra and our product candidates, if approved. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates. For example, the current administration is pursuing a ~~two-fold strategy~~ range of strategies to reduce drug costs in the U.S., While it is unclear whether and how the current administration s proposals will be implemented, these policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for our products. The current administration published significant tariffs on certain pharmaceutical products and ingredients, effective in mid-2026, applying to companies that have not negotiated with the current administration to adopt pricing policies such as including voluntary most-favored-nation pricing ~~which would tie~~ agreements with manufacturers, the ~~price~~ GENEROUS (GENErating cost Reductions fOr ~~drugs in the~~ U.S. ~~to the lowest price in~~ Medicaid) Model, a ~~group of other countries. On the other hand,~~ voluntary model that launched in January 2026, implementing most-favored-nation pricing in Medicaid, and pharmaceutical trade measures. The ~~current~~ administration is also pursuing traditional regulatory pathways to impose drug pricing policies and published two proposed regulations in December 2025, ~~referred~~ the Global Benchmark for Efficient Drug Pricing ( GLOBE ) for Medicare Part B and the Guarding U.S. Medicare Against Rising Drug Costs ( GUARD ) for Medicare Part D. On October 2, 2026, CMS finalized the GLOBE regulation, effective November 30, 2026 and set to begin January 1, 2027, as a mandatory CMS Innovation Center payment model under Section 1115A of the Social Security Act. GUARD remains a proposed regulation that has not been finalized. GLOBE, ~~and~~ along with GUARD, if finalized, ~~these regulations would implement~~ implements a mandatory payment ~~models~~ model under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of ~~the units of~~ their ~~drugs~~ units that are reimbursed by Medicare, with the rebate amount based on most-favored-nation pricing. Imposing a rebate in the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical market, and while the impact of the GLOBE and GUARD ~~proposed~~ regulations, if GUARD is finalized, cannot yet be fully determined, it is likely to be significant depending on the final language and whether any exemptions from the regulations apply. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

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Healthcare reform efforts have been and may continue to be subject to scrutiny and legal challenge. In 2021, the U.S. Supreme Court dismissed the latest judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. As another example, revisions to regulations under the federal anti-kickback statute would remove protection for traditional Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health plans. Pursuant to court order, the removal was delayed and subsequent legislation imposed a moratorium on implementation of the rule until January 2032. The IRA drug price negotiation program has also been challenged in litigation filed by various pharmaceutical manufacturers and industry groups.

Individual states have also been increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. We expect that additional state and federal healthcare reform measures will be adopted in the future, particularly in light of the current presidential administration, any of which could limit the amounts that federal and state governments will pay for healthcare products and services.

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Since the May 12, 2025 order, the current administration has continued to exert pressure on drug manufacturers to implement MFN pricing, including by publishing tariffs, effective in mid-2026, that in part depend on whether manufacturers reach agreements with the administration to implement MFN pricing. Further, in November 2025, the Centers for Medicare & Medicaid Services ( CMS ) introduced the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model, a voluntary Medicaid payment initiative under which participating drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs that are intended to provide such Medicaid programs with an MFN price for the manufacturers products. Additionally, in December 2025, CMS announced proposals for new mandatory demonstration payment models through two proposed rules under its Center for Medicare and Medicaid Innovation ( CMMI ) authority, the Global Benchmark for Efficient Drug Pricing ( GLOBE ) for Medicare Part B and Guarding U.S. Medicare Against Rising Drug Costs ( GUARD ) for Medicare Part D. If finalized, these models would impose additional mandatory rebates on manufacturers of certain Medicare Part B and Medicare Part D drugs, for select Medicare populations intended to represent 25% of Medicare patients, if the Medicare prices for such products exceed those paid in economically comparable countries. Both the GLOBE and GUARD models have proposed seven-year testing periods, with the GLOBE model proposed to begin on October 1, 2026 and the GUARD model proposed to begin on January 1, 2027.

The costs of prescription pharmaceuticals have also been the subject of considerable discussion in the United States. To date, there have been several recent U.S. congressional inquiries, as well as proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

The Trump Administration has issued executive orders and supported proposed regulatory initiatives in 2025 that could have a significant impact on the prices that we, or any collaborators, may receive for any approved products. On May 12, 2025, the current administration issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. and directing the Secretary of Health and Human Services ( HHS ) to communicate most-favored-nation ( MFN ) price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing.

Since the May 12, 2025 order, the current administration has continued to exert pressure on drug manufacturers to implement MFN pricing, including by encouraging manufacturers to enter into voluntary MFN agreements and implementing trade measures. In August 2026, we entered into a voluntary MFN agreement with the Administration, which will expand state Medicaid access to Attruby via the GENEROUS Model. We expect any pricing commitment for future medicines under the agreement to exclude medicines approved exclusively for orphan indications. If under the MFN agreement, or subject to other policy developments, our currently marketed or future medicines become subject to additional MFN pricing obligations, this may affect our pricing and commercialization strategies. Further, in November 2025, the Centers for Medicare & Medicaid Services ( CMS ) introduced the GENEROUS Model, a voluntary Medicaid payment initiative under which participating drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs that are intended to provide such Medicaid programs with an MFN price for the manufacturers products. The GENEROUS Model launched in January 2026, and CMS has announced that all state Medicaid programs, along with the District of Columbia and Puerto Rico, have applied to participate in the model. Additionally, in December 2025, CMS announced proposals for new mandatory demonstration payment models through two proposed rules under its Center for Medicare and Medicaid Innovation ( CMMI ) authority, the GLOBE for Medicare Part B and the GUARD for Medicare Part D. On October 2, 2026, CMS finalized the GLOBE regulation, effective November 30, 2026, as a mandatory CMS Innovation Center payment model under Section 1115A of the Social Security Act. As finalized, GLOBE will require manufacturers of specified single source drugs and sole source biologics, within designated therapeutic classes and that have incurred more than $100.0 million of Medicare Part B spending over a 12-month period, to pay incremental rebates based on an alternative, internationally benchmarked calculation of the existing Medicare Part B drug inflation rebate. The GLOBE model will begin on January 1, 2027 with the collection of voluntary manufacturer-submitted international drug net pricing data, and will be tested over five performance years, running from April 1, 2027 through March 31, 2032. The associated payment period will run from April 1, 2027 through March 31, 2034. GLOBE excludes orphan-only drugs, cell and gene therapy products, plasma-derived products, and drugs with an effective Medicare-negotiated maximum fair price. GUARD remains a proposed regulation that has not been finalized and, as proposed, would similarly mandate manufacturer rebates for qualifying sole source drugs where the Medicare net price exceeds an MFN benchmark derived from international reference pricing methodologies, with its performance period proposed to begin in 2027. The GLOBE model has been subject to legal challenge, and both the GLOBE model and the proposed GUARD model may face additional legal challenges, which could delay implementation or modify their impact on manufacturer pricing and revenue.

If the GLOBE model is implemented as finalized and the GUARD ~~models are~~ model is finalized as proposed under CMMI authority and if exemptions do not apply to our products, we could be required to pay additional rebates on products reimbursed by Medicare for the covered populations during the applicable model periods. In addition, if MFN pricing or similar reference pricing policies are enacted or implemented in the U.S. outside of the CMMI framework and applied more broadly, we could be required to pay rebates on ~~products~~ product utilization by a broader portion of U.S. patients to align with prices in certain reference countries. We currently derive the substantial portion of our revenue from U.S. sales, and any requirement to pay additional rebates in the U.S. to match international reference prices would impact our overall net product revenue.

MFN pricing models in the U.S. could also affect our international pricing strategy and future decisions on reimbursement and commercialization in certain jurisdictions. If our U.S. pricing becomes tied to international reference prices, especially in light of our licensing agreements with Bayer and Alexion, we may face decisions regarding pricing in foreign markets that could result in reduced patient access internationally, affect our relationships with foreign regulatory authorities and payers, or impact our ability to obtain or maintain reimbursement approvals in ex-U.S. markets. ~~These reforms~~ The GLOBE model and the proposed GUARD model remain subject to ~~change,~~ potential legal challenges, and the proposed GUARD model remains subject to change, potential finalization, or expansion through additional rulemaking or sub regulatory guidance, creating uncertainty for our overall pricing strategy. It remains to be seen whether and how these drug pricing initiatives will apply to our products, how they will affect the broader pharmaceutical industry, and whether similar reform measures may be adopted in the future.

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We face competition in the U.S. for Attruby and may face competition for our product candidates if approved, from therapies sourced from foreign countries that have placed price controls on pharmaceutical products. In the U.S., the Medicare Modernization Act contains provisions that may change U.S. importation laws and expand pharmacists and wholesalers ability to import ~~cheaper~~ lower priced versions of an approved drug and competing products from Canada, where there are government price controls. The FDA also issued a final guidance document outlining a pathway for manufacturers to obtain an additional National Drug Code ( NDC ) for an FDA-approved drug that was originally intended to be marketed in a foreign country and that was authorized for sale in that foreign country. See the section titled, ~~Business-Government Regulation-Current~~ Business - Government Regulation - Current and Future Legislation in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 24, 2026 for more information regarding legislative and regulatory changes and proposed changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or lowering the cost of healthcare. If certain of these changes are implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our product candidates. The regulatory and market implications of the final rule and guidance are unknown at this time. Proponents of drug reimportation may attempt to pass legislation that would directly allow reimportation under certain circumstances. Legislation or regulations allowing the reimportation of drugs, if enacted, could decrease the price we receive for any products that we may develop and adversely affect our future revenues and prospects for profitability. We will continue to monitor developments and their potential effect on our business.

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Many of our current or potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, ~~preclinical~~ nonclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

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inability to generate sufficient ~~preclinical,~~ nonclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

delays in confirming target engagement, patient selection or other relevant biomarkers to be utilized in ~~preclinical~~ nonclinical and clinical product candidate development;

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delays in reaching agreement on acceptable terms with prospective contract research organizations ( CROs ) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

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delays in clinical trial enrollment or clinical trial initiation resulting from any global health emergency; ~~such as the COVID-19 pandemic;~~

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We could also encounter delays if an ongoing or planned clinical trial is suspended or terminated by us, by the data safety monitoring board ( DSMB ), or by the FDA or other regulatory authority, or if the IRBs of the institutions in which such trials are being conducted suspend or terminate the participation of their clinical investigators and sites subject to their review. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. We have in the past received, and may receive in the future, partial or full clinical hold notices from the FDA or other regulatory authorities, which have required, and may in the future require, us to conduct additional studies, generate additional data, amend our clinical trial protocols and/or delay or halt the initiation or continuation of our clinical trials. We may be required or may voluntarily determine to place one or more of our product candidates on clinical hold in the future for various reasons, which could delay or otherwise impair our clinical development efforts and ability to obtain regulatory approval for any such product candidate. Additionally, the FDA may determine, upon review of an IND submission, that we have not provided sufficient information needed to assess the risks to subjects of the proposed studies, or that our IND submission is otherwise insufficient to support initiation of a clinical trial. There is no guarantee that the FDA will agree that our responses are sufficient, and we may be required to conduct additional ~~preclinical~~ nonclinical studies or manufacturing steps before the FDA allows our proposed clinical trials to proceed.

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The results of nonclinical ~~and preclinical~~ studies and clinical trials may not be predictive of the results of later-stage clinical trials, and interim results of a clinical trial do not necessarily predict final results. In addition, for certain of our product candidates that we acquired, we did not undertake the ~~preclinical~~ nonclinical studies and clinical trials ourselves. The results of ~~preclinical~~ nonclinical studies and clinical trials in one set of patients or disease indications, or from ~~preclinical~~ nonclinical studies or clinical trials that we did not lead, may not be predictive of those obtained in another. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocols and the rate of dropout among clinical trial participants. In addition, ~~preclinical~~ nonclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in ~~preclinical~~ nonclinical studies and clinical trials have nonetheless failed to obtain marketing approval. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through nonclinical studies and initial clinical trials. A number of companies in the pharmaceutical and biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, despite promising results in earlier studies, and we cannot be certain that we will not face similar setbacks. Even if early-stage clinical trials are successful, we may need to conduct additional clinical trials of our product candidates in additional patient populations or under different treatment conditions before we are able to seek approvals from the FDA and regulatory authorities outside the U.S. to market and sell these product candidates. Our failure to obtain marketing approval for our product candidates for commercially viable indications, or at all, would substantially harm our business, prospects, financial condition and results of operations.

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Moreover, if our product candidates are associated with undesirable side effects in ~~preclinical~~ nonclinical studies or clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the product candidate if approved. We may also be required to modify or terminate our study plans based on findings in our ~~preclinical~~ nonclinical studies or clinical trials. AEs that we may observe in our ongoing and future ~~preclinical~~ nonclinical studies and clinical trials of our product candidates could require us to delay, modify or abandon our development plans for the affected product candidate or other product candidates that share properties of the affected product candidate. Many product candidates that initially show promise in early-stage testing may later be found to cause side effects that prevent further development. As we work to advance existing product candidates and to identify new product candidates, we cannot be certain that later testing or trials of product candidates that initially showed promise in early testing will not be found to cause similar or different unacceptable side effects that prevent their further development.

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Additionally, if any of our product candidates receives marketing approval, the FDA could impose a boxed warning in the labeling of our product and could require us to adopt a risk evaluation and mitigation strategy ( REMS ), and could apply elements to assure safe use to ensure that the benefits of the product outweigh its risks, which may include, among other things, a Medication Guide outlining the risks of the product for distribution to patients and a communication plan to ~~health care~~ healthcare practitioners. Furthermore, if we or others later identify undesirable side effects caused by our product candidates once approved, several potentially significant negative consequences could result, including:

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From time to time, we have and may in the future publish or report preliminary, interim or topline data from our clinical trials, such as the release of our topline results ~~for~~ from PROPEL 3, our Phase 3 study of ~~encaleret~~ oral infigratinib in ~~autosomal dominant hypocalcemia type 1.~~ children with achondroplasia. Preliminary, interim or topline data from clinical trials may not be indicative of the final results of the trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. The results of ~~preclinical~~ nonclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trial, and favorable data from interim analysis do not ensure the final results of a trial will be favorable. Preliminary, interim or topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary, interim or topline data we previously published. As a result, preliminary, interim or topline data should be viewed with caution until the final data are available. Material adverse changes between preliminary, interim or topline data and final data could significantly harm our business, financial condition, results of operations and prospects.

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Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. We cannot be certain that any clinical trials will be conducted as planned or completed on schedule, if at all. Our inability to successfully complete ~~preclinical~~ nonclinical and clinical development could result in additional costs to us and negatively impact our ability to generate revenue. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize product candidates.

Our product candidates require additional development; management of ~~preclinical,~~ nonclinical, clinical and manufacturing activities; and regulatory approval. In addition, we will need to obtain adequate manufacturing supply; complete the build-out of a commercial organization; commence product candidate-specific marketing efforts; and obtain reimbursement before we generate any significant revenue from commercial product sales from such product candidates, if ever. Some of our product candidates are in early-stage research or translational phases of development, and the risk of failure for these programs is high. We cannot be certain that our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we are not able to successfully commercialize an approved drug or if we do not receive additional regulatory approvals for our product candidates, we and our subsidiaries may not be able to continue operations, which may result in us winding down and dissolving the subsidiary, selling or out-licensing the technology or pursuing an alternative strategy.

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We cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Approval by the FDA and comparable foreign regulatory authorities is lengthy and unpredictable, and depends upon numerous factors, including substantial discretion of the regulatory authorities. Approval policies, regulations or the type and amount of nonclinical or clinical data necessary to gain approval may change during the course of a product candidate s development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. In addition, the U.S. Supreme Court s July 2024 decision to overturn prior established case law giving deference to regulatory agencies interpretations of ambiguous statutory language has introduced uncertainty regarding the extent to which the FDA s regulations, policies and decisions may become subject to increasing legal challenges, delays, and/or changes. It is possible that our current product candidates and any other product candidates which we may seek to develop in the future will not ever obtain regulatory approval. Although Attruby and Beyonttra received regulatory approval for commercial sale in the U.S., EU, UK, Brazil, Australia and Japan, we cannot be certain that any of our product candidates will receive regulatory approval or if approved, will be successfully commercialized.

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the FDA or comparable foreign regulatory authorities may require additional ~~preclinical~~ nonclinical studies or clinical trials beyond those that we currently anticipate;

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Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical studies, ~~preclinical studies~~ and clinical trials that the applicable product candidate is both safe and effective for use in each target indication, and in the case of our product candidates regulated as biological products, that the product candidate is safe, pure, and potent for use in its targeted indication. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

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We cannot be certain that our current clinical trials or any other future clinical trials will be successful. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations. In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. Success in clinical trials in a particular indication does not ensure that a product candidate will be successful in other indications. Similarly, approval of a product candidate in a particular indication does not ensure that ~~that~~ the product candidate will be successful in other indications. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA or comparable foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Even if regulatory approval is secured for a product candidate, the terms of such approval may limit the scope and use of the specific product candidate, which may also limit its commercial potential.

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We have conducted and plan to conduct clinical trials outside the U.S., including in Europe. The acceptance by the FDA or comparable foreign regulatory authority of study data from clinical trials conducted outside the U.S. or another jurisdiction may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such as inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction, and the FDA has discussed proposals to increase user fees for marketing applications containing certain foreign clinical data. In addition, the FDA recently signaled increased scrutiny of foreign clinical trial data submitted in support of marketing applications, indicating plans for increased foreign site inspections and increased transparency of inspection results. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in product candidates that we may develop not receiving approval or clearance for commercialization in the applicable jurisdiction.

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In order to market any products outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in the U.S., including additional ~~preclinical~~ nonclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products, once approved is also subject to approval.

Seeking and maintaining foreign regulatory approval could result in difficulties and costs and require additional nonclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. While we previously had two products approved for sale in the U.S., we ~~do not~~ only have ~~any~~ one product ~~candidates~~ approved for sale in international markets, and we have only limited experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approval in international markets is delayed, our target market will be reduced and our ability to realize the full market potential of any approved products will be harmed.

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The Consolidated Appropriations Act of 2026 reauthorized the FDA s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029. Under current law, after September 30, 2029, the FDA may not award any rare pediatric disease priority review vouchers, although the FDA s authority to do so could be extended by Congress in the future. Accordingly, there is no guarantee that we will be granted PRVs for any of our existing or future product candidates.

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We may seek approval of our product candidates using the FDA s accelerated approval pathway. This pathway may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval. A product may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies, and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. As a condition of approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled post-marketing confirmatory clinical trials. These confirmatory trials must be completed with due diligence. Under the Food and Drug Omnibus Reform Act of 2022 ( FDORA ), the FDA is permitted to require, as appropriate, that a post-approval confirmatory trial or trials be underway prior to approval or within a specified time period after the date accelerated approval was granted. FDORA also requires sponsors to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. Furthermore, under FDORA, the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory trial or submit timely reports to the agency on their progress. In addition, for products under consideration for accelerated approval, the FDA currently requires, unless otherwise requested by the agency, pre-approval of promotional materials prior to dissemination or publication, which could adversely impact the timing of the commercial launch of the product. Thus, even if we seek to utilize the accelerated approval pathway, we may not be able to obtain accelerated approval and, even if we do, we may not experience a faster development or regulatory review or approval process for that product. In addition, receiving accelerated approval does not assure that the product s accelerated approval will eventually be converted to a traditional approval.

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We may rely on third parties for the design, development and manufacture of companion diagnostic tests for our therapeutic product candidates that may require such tests. If we enter into such collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and obtaining approval for these companion diagnostics. It may be necessary to resolve issues such as selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics during the development and regulatory approval processes. Moreover, even if data from ~~preclinical~~ nonclinical studies and early clinical trials appear to support development of a companion diagnostic for a product candidate, data generated in later clinical trials may fail to support the analytical and clinical validation of the companion diagnostic. We and our future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our therapeutic candidates and therapeutics themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop companion diagnostics for these therapeutic product candidates, or experience delays in doing so, the development of these therapeutic product candidates may be adversely affected, these therapeutic product candidates may not obtain marketing approval, and we may not realize the full commercial potential of any of these therapeutics that have or may obtain marketing approval. As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our therapeutic candidates.

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The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA ), includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 ( BPCIA ), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a BLA for the competing product containing the sponsor s own ~~preclinical~~ nonclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity, and potency of the other company s product.

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our ability to initiate and conduct our ~~preclinical~~ nonclinical studies and clinical trials for our product candidates, and otherwise progress our business could be materially and adversely impacted if our single-source suppliers upon which we rely were to experience any significant business challenges, disruption or failures due to issues such as financial difficulties or bankruptcy, issues relating to regulatory or quality compliance, or other legal or reputational issues.

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If we enter into R&D collaborations during the early phases of product development, success will in part depend on the performance of research collaborators. We will not directly control the amount or timing of resources devoted by research collaborators to activities related to product candidates. Research collaborators may not commit sufficient resources to our R&D programs. If any research collaborator fails to commit sufficient resources, the ~~preclinical~~ nonclinical or clinical development programs related to the collaboration could be delayed or terminated. Also, collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to collaborators or to observe other obligations in agreements with them, the collaborators may have the right to terminate or stop performance of those agreements.

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We expect to rely on third parties to conduct our clinical trials and some aspects of our research and ~~preclinical~~ nonclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.

We currently rely and expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct some aspects of research and ~~preclinical~~ nonclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or be unable to fulfill their contractual obligations. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. If we need to enter into alternative arrangements, it will delay our product development activities.

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If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for any product candidates we may develop and will not be able to, or may be delayed in our efforts to, successfully commercialize our medicines. Our failure or the failure of these third parties to comply with applicable regulatory requirements or our stated protocols could also subject us to enforcement action.

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Similarly, the EMA conducts the scientific evaluation of marketing authorization applications for gene therapies in the European Union and the EMA or other relevant authorities may issue new guidelines concerning the development and marketing authorization for gene therapy products and require that we comply with these new guidelines.

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Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.

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With the change in the U.S. Presidential Administration in 2025, there continues to be substantial uncertainty as to whether and how the current administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges as we navigate development and approval of our product candidates. Some of these efforts have manifested to date in the form of personnel cuts and measures that could impact the FDA s ability to hire and retain key personnel, which could result in delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory approvals in the future. There remains general uncertainty regarding future activities. The current administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations. If we become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the current administration or otherwise, there could be a material adverse effect on us and our business.

6 unchanged paragraphs

As of ~~June~~ September 30, 2026, we had ~~999~~ 1,081 full-time employees and 4 part-time employees. While we believe our structure enables us to reduce certain infrastructure costs, the small size of our central team, consisting of employees engaged in providing administrative, research and development and other services across our entire organization, may cause us to be unable to devote adequate personnel, time and resources to support the operations of all of our subsidiaries, including their research and development activities, employee recruiting and retention efforts and the management of financial and accounting and reporting matters. From time to time, members of our central team may not have access to adequate information regarding aspects of the business and operations of our subsidiaries to sufficiently manage these affairs. Additionally, because our dedicated subsidiary-level employees and management are primarily incentivized at the subsidiary level, these employees and management team members may not be sufficiently incentivized to maximize the overall value of our entire organization. If our central team fails to provide adequate administrative, research and development or other services across our entire organization, or our subsidiary-level employees and management do not perform in a manner that aligns with the interests of our entire organization, our business, financial condition and results of operations could be harmed.

1 unchanged paragraph

As of ~~June~~ September 30, 2026, we had ~~999~~ 1,081 full-time employees and 4 part-time employees across all of our affiliates and controlled entities. As we mature, we expect to expand our full-time employee base and to hire more consultants and contractors. Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time toward managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the commercialization of our product candidates, if approved, and development of additional product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize product candidates if approved, and compete effectively will depend, in part, on our ability to effectively manage any future growth.

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As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls. The Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act ), requires that we evaluate and determine the effectiveness of our internal control over financial reporting and, pursuant to Section 404(b) of the ~~Sarbanes Oxley~~ Sarbanes-Oxley Act ( Section 404 ) provide a management report on internal control over financial reporting. In addition, we are required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm our results of operations, cause us to fail to meet our reporting obligations, result in a restatement of our financial statements for prior periods, or adversely affect the results of management evaluations and independent registered public accounting firm audits of our internal control over financial reporting that we will ~~eventually~~ be required to include in our periodic reports that will be filed with the SEC.

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In addition, any further deterioration in ~~the~~ macroeconomic ~~economy~~ conditions or the financial services industry could lead to losses or defaults by our collaboration partners, suppliers or other parties with whom we do business, which in turn, could have a material adverse effect on our current and/or projected business operations and results of operations and financial condition. Any bankruptcy or insolvency of a collaboration partner, supplier or other party with whom we do business, or the failure of any such party to make payments when due, or any breach or default by any such party, or the loss of any significant business relationships, could result in material losses to us and may have a material adverse impact on our business.

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We are not profitable and have incurred losses since our inception in April 2015. For the three and ~~six~~ nine months ended ~~June~~ September 30, 2026, we incurred net losses of ~~$155.9~~ $60.5 million and ~~$322.4~~ $382.9 million, respectively. For the three and ~~six~~ nine months ended ~~June~~ September 30, 2025, we incurred net losses of ~~$183.8~~ $184.9 million and ~~$353.4~~ $538.3 million, respectively. As of ~~June~~ September 30, 2026, we had an accumulated deficit of ~~$4.1~~ $4.2 billion. In November 2024, Attruby was approved for commercial sale in the U.S. and in February 2025, Beyonttra was approved for commercial sale in the European Union. In addition, we previously had two products approved for commercial sale, NULIBRY and TRUSELTIQ TM , but did not generate any significant revenues from product sales, and have until recently financed operations solely through the sale of equity securities, debt financings, royalty monetization, and the sale of certain assets. We continue to incur significant research and development ( R&D ), costs for the commercialization of Attruby and Beyonttra, and other expenses related to ongoing operations and expect to incur losses for the foreseeable future. In addition, we believe that potential delays in our ongoing and planned clinical trials and adjustments to certain of our study procedures for various reasons, such as challenges in enrollment, additional requirements imposed by regulatory authorities or investigative sites, or supply chain issues, could increase our expenditures or draw out our expenditures over a longer period of time than originally estimated. Additionally, changes to our selection of ~~contract research organizations (~~ CROs ) for non-clinical laboratory activities and engagement with CMOs, to mitigate any potential impacts to our supply chain may increase our expenditures relative to initial expectations. We anticipate these losses will increase substantially in future periods.

Because of the numerous risks and uncertainties associated with drug development and commercialization, we are unable to predict the timing or amount of our expenses, or when we will be able to generate any meaningful revenue from our product candidates or achieve or maintain profitability, if ever. In addition, our expenses could increase beyond our current expectations if we are required by the FDA, or comparable foreign regulatory authorities, to conduct nonclinical ~~or preclinical~~ studies or clinical trials in addition to those that we currently anticipate or to otherwise provide data beyond that which we currently believe is necessary to support an application for marketing approval or to continue clinical development, or if there are any delays in any of our or our future collaborators clinical trials or the development of our product candidates, that we may identify. We anticipate incurring significant costs associated with commercializing any future product candidates, if approved, and ongoing compliance efforts.

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Developing and commercializing biopharmaceutical products is expensive and time-consuming, and we may require substantial additional capital to conduct research, ~~preclinical~~ nonclinical testing and human studies, may establish pilot scale and commercial scale manufacturing processes and facilities, and establish and develop quality control, regulatory, marketing, sales and administrative capabilities to support our existing programs and pursue potential additional programs. We are also responsible for the payments to third parties of expenses that may include milestone payments, license maintenance fees and royalties, including in the case of certain of our agreements with academic institutions or other companies from whom intellectual property rights underlying their respective programs have been in-licensed or acquired. Because the outcome of any ~~preclinical~~ nonclinical or clinical development and regulatory approval process is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of any future product candidates we may identify.

As of ~~June~~ September 30, 2026, we had working capital of ~~$202.5 million,~~ $1.1 billion, of which cash, cash equivalents and marketable securities amounted to ~~$720.2 million.~~ $1.5 billion. We expect that our cash and cash equivalents, and marketable securities, and proceeds from Attruby product revenue will be sufficient to fund our operations through at least the next 12 months from the date of filing of this report. However, our operating plan may change as a result of many factors currently unknown to us, including our need for, and ability to raise, capital to support our research, development and commercialization plans, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as royalty monetization, strategic collaborations or license and development agreements. Any additional fundraising efforts for us may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize product candidates that we may identify and pursue. Moreover, such financing may result in dilution to stockholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect our business. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

5 unchanged paragraphs

the progress, timing, scope and costs of our nonclinical studies, ~~preclinical studies,~~ clinical trials and other related activities, including the ability to enroll patients in a timely manner, for the ongoing and planned clinical trials set forth above, and potential future clinical trials;

12 unchanged paragraphs

As of ~~June~~ September 30, 2026, we and our subsidiaries had total consolidated indebtedness of $2.5 billion related to the Notes and deferred royalty obligations of ~~$908.7~~ $920.1 million. The Notes include $550.0 million of indebtedness outstanding under our unsecured 2.50% Convertible Senior Notes due 2027 (the 2027 Notes ), $747.5 million of indebtedness outstanding under our 2.25% Convertible Senior Notes due 2029 (the 2029 Notes ), $575.0 million of indebtedness outstanding under our 1.75% Convertible Senior Notes due 2031 (the 2031 Notes ) and $632.5 million of indebtedness outstanding under our 0.75% Convertible Senior Notes due 2033 (the 2033 Notes ). Subject to the limitations in the terms of our existing and future indebtedness, we and our subsidiaries may incur additional indebtedness, secure existing or future indebtedness, or refinance our indebtedness. We may be required to use a substantial portion of our cash to pay interest and principal on our indebtedness. Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, depends on our future performance and our ability to generate sufficient cash flow from our operations, which are subject to economic, financial, competitive and other factors beyond our control. Such payments will reduce the funds available to us for working capital, capital expenditures, and other corporate purposes and limit our ability to obtain additional financing for working capital, capital expenditures, expansion plans, and other investments, which may in turn limit our ability to implement our business strategy, heighten our vulnerability to downturns in our business, the industry, or in the general economy, limit our flexibility in planning for, or reacting to, changes in our business and the industry, and prevent us from taking advantage of business opportunities as they arise. Additionally, if we are unable to generate sufficient cash flow to service our indebtedness and fund our operations, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.

2 unchanged paragraphs

In the event the conditional conversion feature of the Notes is triggered, holders of the Notes will be entitled to convert the notes at any time during specified periods at their option. If one or more holders elect to convert their Notes, we may satisfy our conversion obligation, at our election, in cash, shares of our common stock, or a combination of cash and shares of our common stock (other than paying cash in lieu of delivering any fractional share). To the extent we elect to settle any conversion in cash or in a combination of cash and shares, the cash portion of such settlement could reduce our liquidity. For example, the 2027 Notes and 2031 Notes ~~became~~ are convertible for a limited period starting on ~~July~~ October 1, 2026 ~~under the conversion condition met~~ and will remain convertible until ~~September 30,~~ December 31, 2026 because an early conversion condition based on the trading price of BridgeBio s common stock was satisfied. Separately, on or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its 2027 Notes at any time.

9 unchanged paragraphs

~~For example,~~ In May 2026, we entered into an Equity Distribution Agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC, which ~~provided~~ provides for the offer and sale of up to $500.0 million of our common stock in an at-the-market offering program. Sales under any equity distribution agreements or at-the-market offering arrangements, including those we may enter into in the future, could result in substantial dilution to the interests of other holders of our common stock. Additionally, the sale of a substantial number of shares of our common stock or other securities, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

2 unchanged paragraphs

In addition, if one of our subsidiaries raises funds through the issuance of equity securities to third parties, our ~~stockholders deficit~~ equity interests in such subsidiary could be substantially diminished. If one of our subsidiaries raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our intellectual property rights, technologies or product candidates, or grant licenses on terms that are not favorable to us.

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The Preferred Stock may initially be converted at any time at the option of the respective holders into an aggregate of 6,777,704 shares of our common stock. Any conversion of the Preferred Stock may significantly dilute the holders of our common stock. Unless we obtain stockholder approval in accordance with the listing requirements of Nasdaq, the maximum number of shares of common stock into which the Preferred Stock may be converted will be limited such that, upon any conversion of Preferred Stock, the number of shares of our common stock being issued upon conversion will not cause the holder thereof, when taken together with all other shares of our common stock beneficially owned by such holder at the time of conversion, to beneficially own shares of our common stock exceeding 19.9% of the total voting power of our common stock (on an as-converted basis). We are obligated under the Investment Agreement to seek stockholder approval to have such restriction removed. The conversion price of the Preferred Stock is initially $137.79 per share and will increase to $153.10 per share on and after the fifth anniversary of the original issuance date, and is subject to customary anti-dilution adjustments, including in the event of any stock split, stock dividend, recapitalization or similar event. In addition, we may require conversion of all outstanding shares of Preferred Stock on or after the third anniversary of the original issuance date if specified trading price and liquidity conditions are satisfied.

For additional details about the Preferred Stock, refer to Note 18 13 to our condensed consolidated financial statements.

9 unchanged paragraphs

In addition, if we undertake such a transaction, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense, any of which could have a material adverse effect on our business, prospects, financial condition and results of operations. For example, our acquisition in January 2021 of all of the outstanding shares of common stock of Eidos that were not previously owned by us or our subsidiaries (the Eidos Merger ) resulted in a reduction of our cash and dilutive issuances of our equity securities to the former Eidos stockholders. Any similar transactions in the future that require us to provide cash or stock consideration could harm our financial condition and negatively impact our existing stockholders.

18 unchanged paragraphs

adverse results or delays in our clinical trials, particularly those of our late-stage product candidates, or ~~preclinical~~ nonclinical studies;

7 unchanged paragraphs

changes in laws or regulations applicable to our current and future products or product candidates;

14 unchanged paragraphs

general economic and market conditions, including inflationary pressures and stock market volatility; and continued increases in interest rates that increase the cost of our existing indebtedness and any potential new indebtedness.

8 unchanged paragraphs

Certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. Sales of a substantial number of shares of our common stock underlying the resale registration statements on Form S-3/ASR filed on ~~July 26, 2023 and~~ November 2, 2023 and July 24, 2026 in the public market by the selling stockholders named in these registration statements, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities or other securities convertible into or exchangeable for equity securities, regardless of whether there is any relationship between such sales and the performance of our business. We may also file registration statements in the future that register a substantial number of shares of our common stock where if any additional shares are sold pursuant to these registration statements, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline. We have also filed registration statements on Form S-8 registering the issuance of shares of common stock issued or reserved for future issuance under our equity compensation and equity inducement plans. Shares registered under these registration statements on Form S-8 can be freely sold in the public market upon issuance and once vested, subject to volume limitations applicable to affiliates. In addition, certain of our directors, executive officers, employees and affiliates have established or may in the future establish programmed selling plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended, for the purpose of effecting sales of our common stock. If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

3 unchanged paragraphs

Based upon our common stock outstanding as of ~~June~~ September 30, 2026, our beneficial stockholders, directors, and executive officers beneficially own 40.9% of our outstanding common stock. These stockholders will have the ability to influence us through their ownership positions. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders, acting together, may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. In turn, this may have an adverse effect on the market price of our common stock. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may believe are in your best interest as one of our stockholders. In certain circumstances, these stockholders interests as stockholders may differ or even conflict with the interests of our other stockholders.

35 unchanged paragraphs

We have never paid and do not currently intend to pay dividends on our common stock, and, consequently, our stockholders ability to achieve a return on their investment will depend on appreciation in the price of our common stock.

We have never paid cash dividends on any of our ~~capital~~ common stock and do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We currently intend to invest our future earnings, if any, to fund our growth. Therefore, you are not likely to receive any dividends on your common stock for the foreseeable future. Since we do not intend to pay dividends on our common stock, your ability to receive a return on your investment will depend on any future appreciation in the market value of our common stock. There is no guarantee that our common stock will appreciate or even maintain the price at which our holders have purchased it.

4 unchanged paragraphs

We operate globally and plan to sell our products in countries throughout the world. Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from ~~the change in the~~ U.S. federal ~~administration,~~ elections, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, in April 2025, the U.S. imposed reciprocal tariffs, which were broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. The U.S. Supreme Court invalidated the reciprocal tariffs on February 20, 2026; however, the current administration has imposed new historically elevated tariffs under different authorities, which remain subject to ongoing legal challenge, and ~~President Trump~~ has ~~stated~~ active investigations that ~~he intends to use additional authorities to effect historically elevated~~ may result in tariffs on certain countries or products. In response to higher U.S. tariffs, some countries have implemented retaliatory tariffs on U.S. goods, while others have negotiated agreements regarding U.S.-imposed tariffs. Historically, increased tariffs have led to more trade and political tensions and the status of these agreements between the U.S. and the various countries ~~in light of the U.S. Supreme Court s February 20, 2026 decision,~~ remains unclear. Moreover, starting in mid-2026, the U.S. has ~~published~~ imposed special tariffs on certain imported pharmaceutical products, ~~the administration has scheduled~~ encompassing some of our products, ranging from 10% to ~~take effect in mid-2026.~~ 100% depending on the exporting country and the importing company. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.

22 unchanged paragraphs

Unregistered sales of stock 11 changes

During the period covered by this Quarterly Report on Form 10-Q, we did not issue or sell any unregistered securities other than as disclosed in Note 8 to Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q.

Except as previously disclosed in our Current Report on Form 8-K filed on July 2, 2026, we did not make any unregistered sales of equity securities during the period covered by this Quarterly Report on Form 10-Q.

3 unchanged paragraphs

The table below sets forth information regarding repurchases during the period covered by this Quarterly Report on Form 10-Q:

2 unchanged paragraphs

~~April 1 April 30, 2026 $ 500,000~~

~~May 1 May 31, 2026 893,531 $67.15 893,531 $ 444,001~~

~~June 1 June 30, 2026 1,010,470 $66.79 1,010,470 $ 372,514~~

~~Total 1,904,001 $66.96 1,904,001 $ 372,514~~

July 1 July 31, 2026 $ 372,514

August 1 August 31, 2026 $ 372,514

September 1 September 30, 2026 712,165 $66.68 712,165 $ 325,025

Total 712,165 $66.68 712,165 $ 325,025

1 unchanged paragraph

Other information 1 change

3 unchanged paragraphs

On ~~May 13,~~ September 4, 2026 , ~~Neil Kumar~~ Charles Homcy , our ~~Chief Executive Officer and a member~~ Chairman of Pharmaceuticals and Lead Director on our Board of Directors , adopted a trading plan (the ~~Kumar~~ Homcy Trading Plan ) intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c). The ~~Kumar~~ Homcy Trading Plan provides for the potential sale of ~~(i) a number~~ an aggregate of 120,000 shares of our common stock ~~to be determined based on the net shares resulting from~~ underlying the ~~vesting of restricted~~ stock ~~units and performance stock units~~ options held by Dr. ~~Kumar, representing 100% of the net shares vested under each applicable grant, and (ii) up to 120,000 shares of our common stock held by the Kumar Haldea Family Irrevocable Trust, of which~~ Homcy. Dr. ~~Kumar~~ Homcy is ~~a trustee. Dr. Kumar and the Kumar Haldea Family Irrevocable Trust are~~ not permitted to transfer, sell or otherwise dispose of any shares under the ~~Kumar~~ Homcy Trading Plan until the Earliest Sell Date, which is the later of (i) the 91st day after the adoption date of the ~~Kumar~~ Homcy Trading Plan; or (ii) the earlier of: (a) the third business day following the disclosure of the Company s financial results in a Form 10-Q or Form 10-K for the completed fiscal quarter in which the ~~Kumar~~ Homcy Trading Plan is adopted; or (b) the 121st day after the adoption date. The ~~Kumar~~ Homcy Trading Plan is expected to remain in effect until the earlier of (a) ~~July 30,~~ September 4, 2027 ; (b) the first date on which all trades have been executed or all trading orders relating to such trades set forth in ~~Part II of~~ Addendum A to the ~~Kumar~~ Homcy Trading Plan have expired; (c) as soon as practicable following the date on which Dr. ~~Kumar~~ Homcy gives written notice to Morgan Stanley Smith Barney LLC ( MSSB ) to terminate the ~~Kumar~~ Homcy Trading Plan; (d) as soon as practicable following the date on which MSSB receives written notice of a termination of an additional contract, instruction or plan that is being treated as a single plan with the ~~Kumar~~ Homcy Trading Plan (or MSSB receives written notice of a modification of such additional contract, instruction or plan and the requirements for a modification of the ~~Kumar~~ Homcy Trading Plan are not or cannot be satisfied); (e) as soon as practicable following the date on which MSSB receives written notice of a legal, regulatory or contractual restriction applicable to the Company or to Dr. ~~Kumar~~ Homcy that would result in a modification or change to the amount, price or timing of the sale of shares under the ~~Kumar~~ Homcy Trading Plan but the requirements for a modification of the ~~Kumar~~ Homcy Trading Plan are not or cannot be satisfied; and (f) as soon as practicable following the date on which MSSB receives notice of certain events, including the public announcement of a tender or exchange offer with respect to the Company s common stock or that the Company is the target of a merger, acquisition, reorganization, recapitalization or comparable transaction as a result of which the Company s common stock will be converted into shares of another company, or the commencement of bankruptcy or insolvency proceeding with respect to the Company.

Unchanged: Financial Statements (Unaudited), Note 2: Summary of Significant Accounting Policies, Note 5: Equity Method Investments, Note 15: Restructuring, Impairment, and Related Charges, Legal proceedings, Defaults on senior securities, Mine safety disclosures

Only in this filing: Note 13: Stockholders Deficit

Only in the earlier filing: Note 13: Public Offerings and Share Repurchase Program, Note 18: Subsequent Event

Compared by code from the two filings' text and XBRL. Not advice.

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What changed

Cover page 2 changes

Forward-looking statements 3 changes

Exhibits 210 changes

Note 1: Organization and Description of Business 5 changes

Note 3: Fair Value Measurements 1 change

Note 4: Cash Equivalents and Marketable Securities 1 change

Notes to the financial statements 3 changes

Note 6: Intangible Assets, net 5 changes

Note 7: Commitments and Contingencies 8 changes

Note 8: Debt 2 changes

Note 9: Deferred Royalty Obligations, net 2 changes

Note 10: License and Collaboration Agreements 5 changes

Note 11: In-licensing and Other Research and Development Agreements 4 changes

Note 12: Leases 16 changes

Note 14: Stock-Based Compensation 13 changes

Note 16: Income Taxes 4 changes

Note 17: Net Loss Per Share 13 changes

MD&A 175 changes

Market risk 2 changes

Controls and procedures 1 change

Risk factors 66 changes

Unregistered sales of stock 11 changes

Other information 1 change

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