What changed in this filing

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Item 1A. Risk Factors

2020-11-05 compared with 2020-08-11 · 209 added, 141 removed, 1414 unchanged (20% of the section changed)

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Our actual results could differ materially from those anticipated in the forward-looking statements as a result of factors that are described below and elsewhere in this Quarterly Report.

Those risk factors below denoted with an “*” are newly added or have been materially updated from our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or the SEC, on August 11, 2020.

Risks Related to Our Financial Position and Growth Strategy

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Our net losses for the years ended December 31, 2019, 2018 and 2017 were $288.6 million, $169.5 million and $43.8 million, respectively.

For the six months ended June 30, 2020, we incurred net losses of $240.3 million.

As of June 30, 2020, we had an accumulated deficit of $652.9 million.

For the nine months ended September 30, 2020, we incurred net losses of $370.5 million.

As of September 30, 2020, we had an accumulated deficit of $768.8 million.

We have no products approved for commercial sale and have not generated any revenues from product sales, and have financed operations solely through the sale of equity securities and debt financings.

We continue to incur significant research and development, or R&D, 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, such as enabling alternate site, telehealth and home visits, and at home drug delivery, with respect to our ongoing clinical trials, as a result of the COVID-19 pandemic, could increase our expenditures or draw out our expenditures over a longer period of time than originally estimated.

In addition, we believe that potential delays in our ongoing and planned clinical trials and adjustments to certain of our study procedures, such as enabling alternate site, telehealth and home visits, and at home drug delivery, with respect to our ongoing clinical trials, as a result of the coronavirus disease 2019, or COVID-19, pandemic, 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 for non-clinical laboratory activities and engagement with contract manufacturing organizations to mitigate any potential near-term impacts to our supply chain may increase our expenditures relative to initial expectations.

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In addition, our expenses could increase beyond our current expectations if we are required by the U.S.

Food and Drug Administration, or 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.

trials or the development of our product candidates that we may identify.

Even if our future product candidates that we may identify are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate and ongoing compliance efforts.

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Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

Our failure to achieve sustained profitability would depress the value of our company and could impair ou r ability to raise capital, expand our business, diversify our research and development pipeline, market our product candidates, if approved, that we may identify and pursue or continue our operations.

Our failure to achieve sustained profitability would depress the value of our company and could impair our ability to raise capital, expand our business, diversify our research and development pipeline, market our product candidates, if approved, that we may identify and pursue or continue our operations.

Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

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If we fail to properly evaluate potential acquisitions, in-licenses, investments or other transactions associated with the creation of new research and development programs or the maintenance of existing ones, we might not achieve the anticipated benefits of any such transaction, we might incur costs in excess of what we anticipate, and management resources and attention might be diverted from other necessary or valuable activities.

For instance, in August 2019, we announced a non-binding proposal to acquire all of the outstanding shares of common stock of Eidos that were not then owned by us or our subsidiaries, or the Eidos Buyout Offer.

Although discussions between a special committee comprised of Eidos’ disinterested and independent directors and us with respect to the proposed transaction have terminated, the attention of certain members of each company’s management and each company’s resources were diverted from day-to-day business operations during our exploration of the Eidos Buyout Offer, and we may engage in similar discussions in the future with respect to other potential transactions that may divert our time and resources from our ongoing operations.

For instance, in October 2020, we entered into an agreement and plan of merger to acquire all of the outstanding shares of common stock of Eidos that are not owned by us or our subsidiaries.

In connection with the proposed transaction, the attention of certain members of each company’s management and each company’s resources have been and may continue to be diverted from day-to-day business operations, and we may fail to complete the proposed transaction or fail to realize the anticipated benefits of the proposed transaction, if completed.

Additionally, to the extent we issue shares of our common stock to Eidos’ stockholders in connection with the proposed transaction, the interests of our stockholders in us will be diluted.

We may engage in similar discussions in the future with respect to other potential transactions that may divert our time and resources from our ongoing operations.

In addition, from time to time we have pursued, and may in the future pursue, research and development programs through our wholly-owned subsidiaries and variable interest entities that we may ultimately determine not to advance, based on our ongoing assessment of the likelihood of success relative to the costs and risks associated with the program.

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Public health crises such as pandemics or similar outbreaks could adversely impact our business.

In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), surfaced in Wuhan, China.

In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, surfaced in Wuhan, China.

Since then, COVID-19 has spread globally.

In response to the spread of COVID-19 and governmental shelter-in-place orders, we continue to encourage our administrative employees to work outside of our offices and allow staff in our laboratory facilities to operate under applicable government orders and protocols designed to protect their health and safety.

As a result of the COVID-19 outbreak or any future pandemics, we have experienced, and may in the future experience , disruptions that severely impact our business, clinical tri als and preclinical studies , including:

delays or difficulties in enrolling patients in our clinical trials;

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and regulatory approval.

In addit ion, we will need to obtain adequate manufacturing supply;

In addition, we will need to obtain adequate manufacturing supply;

build a commercial organization;

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and obtain reimbursement before we generate any significant revenue from commercial product sales, if ever.

Many of our product candidat es are in early-stage research or translational phases of development, and the risk of failure for these programs is high.

Many of our product candidates are in early-stage research or translational ph ases of development, and the risk of failure for these programs is high.

We cannot be certain that any of 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 do not receive regulatory approvals for our product candidates, we and our subsidiaries may not be able to continue operations, which may res ult in us winding down and dissolving the subsidiary, selling or out-licensing the technology or pursuing an alternative strategy.

Further, our product candidates may not receive regulator y approval even if they are successful in clinical trials.

If we do not receive 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 subsidia ry, selling or out-licensing the technology or pursuing an alternative strategy.

*If we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates that we may identify and develop, our business will be substantially harmed.

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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders the clinical trial design or data insufficient for approval.

In addition, even if an NDA or other submission for regulatory approval is filed and accepted for review, as in the case of our NDA for fosdenopterin in MoCD Type A, the FDA or comparable regulatory authorities may delay their review or approval process or may decline to grant regulatory approval for a variety of reasons.

The lengthy approval process, as well as the unpredictability of the results of clinical trials and evolving regulatory requirements, may result in our failure to obtain regulatory approval to market product candidates that we may pursue in the United States or elsewhere, which would significantly harm our business, prospects, financial condition and results of operations.

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delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of product candidates that we may identify for use in clinical trials or the inability to do any of the foregoing.

Any inability to successfully initiate or complete clinical trials could result in additional costs to us or impair our ability to generate revenue.

In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional nonclinical studies or clinical trials to bridge data obtained from our modifie d product candidates to data obtained from nonclinical and clinical research conducted using earlier versions of these product candidates .

Clinical trial delays could also shorten any periods during which our products have patent protection and may allow o ur competitors to bring products to market before we do, which could impair our ability to successfully commercialize product candidates and may harm our business and results of operations.

Any inability to successfully initiate or complete clinical trials could result in additional c osts to us or impair our ability to generate revenue.

In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional nonclinical studies or clinical trials to bridge data obtained from our modified product candidates to data obtained from nonclinical and clinical research conducted using earlier versions of these product candidates .

Clinical trial delays could also shorten any periods during which our products have patent p rotection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize product candidates and may harm our business and results of operations.

We could also encounter delays if an ongoing or planned clinical trial is suspended or terminated by us, by the data safety monitoring board, or DSMB, including for our ongoing and planned Phase 3 clinical trials of acoramidis, our ongoing and planned Phase 2 and Phase 3 clinical trials of infigratinib and our ongoing Phase 3 and Phase 2b clinical trials of BBP-009, 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.

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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 gu arantee 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.

This is particularly true for clinical trials in very rare diseas es, such as with fosdenopterin for MoCD Type A, where the very small patient population makes it difficult or impossible to conduct two traditional, adequate and well-controlled studies, and therefore the FDA or comparable foreign regulatory authorities ar e often required to exercise flexibility in approving therapies for such diseases.

Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other ju risdiction.

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.

For example, subject to any delays that may occur as a result of the global COVID-19 pandemic, we intend to file an NDA in 2020 for infigratinib in second line and later advanced CCA with FGFR2 fusions or translocations.

However, the FDA could disagree that data from our Phase 2 trial are sufficient to file an NDA or to approve infigratinib for such an indication.

In addition, even if such clinical trials are success fully 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.

This is particularly true for clinic al trials in very rare diseases, such as with fosdenopterin for MoCD Type A, where the very small patient population makes it difficult or impossible to conduct two traditional, adequate and well-controlled studies, and therefore the FDA or comparable fore ign regulatory authorities are often required to exercise flexibility in approving therapies for such diseases.

Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulat ory 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, w hich 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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Given that our Phase 2 clinical trial of acoramidis includes an open-label clinical trial extension, the results from this clinical trial may not be predictive of future clinical trial results with this or other product candidates for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

We may encounter difficulties enrolling patients in clinical trials, an d clinical development activities could thereby be delayed or otherwise adversely affected.

We may encounter difficulties enrolling patients in clinical trials, and clinical development activities could thereby be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion.

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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.

It is possible that as we test our product candidates in larger, longer and more extensive clini cal trials, or as the use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other AEs that were observed in earlier trials, as well as conditions that did not occur or went undetec ted in previous trials, will be reported by subjects.

It is possible that as we test our product candidates in larger, long er and more extensive clinical trials, or as the use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other AEs that were observed in earlier trials, as well as conditions that di d not occur or went undetected in previous trials, will be reported by subjects.

If such side effects become known later in development or upon approval, if any, such findings may harm our business, financial condition and prospects significantly.

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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 United States or the applicable jurisdiction, including from our ongoing and planned Phase 3 clinical trials of acoramidis, for which we have enrolled, and plan to enroll, cohorts outside the United States.

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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Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business, financial condition, results of operations and prospects.

Even though we may apply for orphan drug designation for our product candidates, we may not be able to obtain orphan drug marketing exclusivity.

* Even though we may apply for orphan drug designation for our product candidates, we may no t be able to obtain orphan drug marketing exclusivity.

Our business strategy focuses on the development of product candidates for the treatment of genetic diseases, which may be eligible for FDA or EMA orphan drug designation.

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infigratinib for the treatment of cholangiocarcinoma;

and BBP-812 for the treatment of Canavan Disease.

BBP-812 for the treatment of Canavan Disease;

BBP-671 for the treatment of Pantothenate Kinase Associated Neurodegeneration, or PKAN, and Propionic Acidemia, or PA;

and BBP-711 for the treatment of Primary hyperoxaluria, or PH1 .

We have obtained from the EMA orphan drug designation for:

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fosdenopterin for the treatment of molybdenum cofactor deficiency type A;

and BBP-551 for the treatment of retinitis pigmentosa and for the treatment of Leber’s congenital amaurosis;

BBP-551 for the treatment of retinitis pigmentosa and for the treatment of Leber’s congenital amaurosis;

BBP-631 for the treatment of congenital adrenal hyperplasia;

and BBP-812 for the treatment of Canavan Disease.

BBP-812 for the treatment of Canavan Disease;

and BBP-418 for the treatment of limb-girdle muscular dystrophy.

We may seek orphan drug designation for other product candidates.

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Further, approvals by one regulatory agency may not be indicative of what other regulatory agencies may require for approval.

Regulatory re quirements governing gene therapy products have evolved and may continue to change in the future.

For example, the FDA established the Office of Tissues and Advanced Therapies within its Center for Biologics Evaluation and Research, or CBER, to consolidate the review of gene therapy and related products, and the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review.

These and other regulatory review agencies, committees and advisory groups and the requirements and guidelines th ey promulgate may lengthen the regulatory review process, require us to perform additional preclinical studies or clinical trials, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and co mmercialization of these treatment candidates or lead to significant post-approval limitations or restrictions.

Regulatory requirements governing gene therapy products have evolved and may continue to change in the future.

For example, the FDA established the Office of Tissues and Advanced Therapie s within its Center for Biologics Evaluation and Research, or CBER, to consolidate the review of gene therapy and related products, and the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review.

These and other regulatory revi ew agencies, committees and advisory groups and the requirements and guidelines they promulgate may lengthen the regulatory review process, require us to perform additional preclinical studies or clinical trials, increase our development costs, lead to cha nges in regulatory positions and interpretations, delay or prevent approval and commercialization of these treatment candidates or lead to significant post-approval limitations or restrictions.

The FDA, National Institutes of Health, or NIH, other regulatory agencies at both the federal and state level in the United States, U.S.

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Similarly, the EMA governs the development of gene therapies in the European Union and may issue new guidelines concerning the development and marketing authorization for gene therapy products and require that we comply with these new guidelines.

These regulatory review committees and advisory groups and the new guidelines they promulgate may lengthen the regulatory review process, require us to perform additional studies or trials, increase our development costs, le ad to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions.

These regulatory review committees and advisory groups and the new guidelines they promulgate may lengthen the regulatory review process, requ ire us to perform additional studies or trials, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limi tations or restrictions.

As we advance our product candidates, we will be required to consult with these regulatory and advisory groups and comply with applicable guidelines.

If we fail to do so, we may be required to delay or discontinue development of such product candidates.

These additional processes may result in a review and appro val process that is longer than we otherwise would have expected.

Delays as a result of an increased or lengthier regulatory approval process or further restrictions on the development of our product candidates can be costly and could negatively impact our ability to complete clinical trials and commercialize our current and future product candidates in a timely manner, if at all.

If we fail to do so, we may be required to delay or discontinue development of su ch product candidates.

These additional processes may result in a review and approval process that is longer than we otherwise would have expected.

Delays as a result of an increased or lengthier regulatory approval process or further restrictions on the d evelopment of our product candidates can be costly and could negatively impact our ability to complete clinical trials and commercialize our current and future product candidates in a timely manner, if at all.

Our product candidates based on gene therapy technology may cause undesirable and unforeseen side effects or be perceived by the public as unsafe, which could delay or prevent their advancement into clinical trials or regulatory approval, limit the commercial potential or result in significant negative consequences.

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Any actual or perceived negative effects of our AAV gene therapy product candidates or those under development by third parties could impair our ability to continue the development of these product candidates and have an adverse effect on our prospects.

The FDA has granted rare pediatric disease designation to fosdenopterin for the treatment of molybdenum cofactor deficiency type A.

However, a marketing application for fosdenopterin, if approved, may not meet the eligibility criteria for a priority review voucher.

The FDA has granted rare pediatric disease designation to fosdenopterin for the treatment of molybdenum cofactor deficiency type A, or MoCD Type A.

*The FDA has granted rare pediatric disease designation to each of fosdenopterin for the treatment of molybdenum cofactor deficiency type A, BBP-671 for the treatment of PKAN and PA, and BBP-711 for the treatment of PH1.

However, a marketing application for any of fosdenopterin, BBP-671 or BBP-711, if approved, may not meet the eligibility criteria for a priority review voucher.

The FDA has granted rare pediatric disease designation to each of fosdenopterin for the treatment of MoCD Type A, BBP-671 for the treatment of PKAN and PA, and BBP-711 for the treatment of PH1.

Designation of a drug as a drug for a rare pediatric disease does not guarantee that an NDA for such drug will meet the eligibility criteria for a rare pediatric disease priority review voucher at the time the application is approved.

Under the Federal Food, Drugs, and Cosmetic Act, or FDCA, we will need to request a rare pediatric disease priority review voucher in our original NDA for fosdenopterin.

The FDA may determine that an NDA for fosdenopterin, if approved, does not meet the eligibility criteria for a priority review voucher, including for the following reasons:

MoCD Type A no longer meets the definition of a rare pediatric disease;

Under the Federal Food, Drugs, and Cosmetic Act, or FDCA, we will need to request a rare pediatric disease priority review voucher in our original NDA for each of fosdenopterin, BBP-671 and BBP-711.

The FDA may determine that an NDA for any of fosdenopterin, BBP-671 or BBP-711, if approved, does not meet the eligibility criteria for a priority review voucher, including for the following reasons:

MoCD Type A, PKAN or PA, or PH1 no longer meets the definition of a rare pediatric disease;

the NDA contains an active ingredient (including any ester or salt of the active ingredient) that has been previously approved in an NDA;

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the NDA does not rely on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population (that is, if the NDA does not contain sufficient clinical data to allow for adequate labeling for use by the full range of affected pediatric patients);

the NDA is approved for a different adult indication than the rare pediatric disease for which fosdenopterin is designated (for example, if fosdenopterin is approved for an indication based on specific genetic alterations that would be inclusive of, but not limited to, fosdenopterin).

The authority for the FDA to awar d rare pediatric disease priority review vouchers for drugs that have received rare pediatric disease designation prior to September 30, 2020 currently expires on September 30, 2022 , although it is possible the FDA’s authority to award rare pediatric disea se priority review vouchers will be further extended through federal lawmaking .

Absent any such extension, i f the NDA for fosdenopterin is not approved prior to September 30, 2022 for any reason, regardless of whether it meets the criteria for a rare pediatric disease priority review voucher, it will not be eligible for a priority review voucher.

the NDA is approved for a different adult indication than the rare pediatric disease for which any of fosdenopterin, BBP-671 or BBP-711 is designated (for example, if any of fosdenopterin, BBP-671 or BBP-711 is approved for an indication based on specific genetic alterations that would be inclusive of, but not limited to, fosdenopterin, BBP-671 or BBP-711).

The authority for the FDA to award rare pediatric disease priority review vouchers for drugs that have received rare pediatric disease designation prior to September 30, 2020 currently expires on September 30, 2022 , although it is possible the FDA’s authority to award rare pediatric disease priority review vouchers will be further extended through federal lawmaking .

Absent any such extension, i f an NDA for any of fosdenopterin, BBP-671 or BBP-711 is not approved prior to September 30, 2022 for any reason, regardless of whether it meets the criteria for a rare pediatric disease priority review voucher, it will not be eligible for a priority review voucher.

We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to product candidates granted breakthrough therapy, fast track or regenerative medicine advanced therapy designation by the FDA.

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Our business may be harmed if we are unable to avail ourselves of these or any other expedited development and regulatory pathways.

If we are unable to successful ly validate, develop and obtain regulatory approval for companion diagnostic tests for our drug candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not realize the full commercial pote ntial of these drug candidates.

If we are unable to successfully validate, develop and obtain regulatory approval for companion diagnostic tests for our drug candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not re alize the full commercial potential of these drug candidates.

In connection with the clinical development of our drug candidates for certain indications, we may work with collaborators to develop or obtain access to in vitro companion diagnostic tests to identify patient subsets within a disease category who may derive selective and meaningful benefit from our drug candidates.

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If competitors are able to obtain marketing approval for biosimilars referencing any of our products, if approved, our products may become subject to competition from such biosimilars, which would impair our ability to successfully commercialize and generate revenues from sales of such products.

Even if we obtain regulatory approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product c andidates.

Even if we obtain regulatory approval for a product ca ndidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipat ed problems with our product candidates.

If any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

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The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administ rative action, either in the United States or abroad.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrati ve action, either in the United States or abroad.

For example, certain policies of the Trump administration may impact our business and industry.

Namely, the Trump administration has taken several executive actions, including the issuance of a number o f Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and a pproval of marketing applications.

Namely, the Trump administration has taken several executive actions, including the issuance of a number of Ex ecutive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and appro val of marketing applications.

If these executive actions impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

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a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

we could grant exclusive rights to our collabor ators that would prevent us from collaborating with others;

collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

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Risks Related to Our Intellectual Property

If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, including acoramidis, infigratinib, BBP-454, BBP-631, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our product candidates may be impaired.

If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, including acoramidis, infigratinib, BBP-454 and BBP-631, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize our product candidates may be impaired.

As is the case with other pharmaceutical and biopharmaceutical companies, our success depends in large part on our ability to obtain and maintain protection of the intellectual property we may own solely and jointly with others, particularly patents, in the United States and other countries with respect to our product candidates and technology.

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In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa.

Further, we may not be aware of all third-party intellectual property rights potentially relating to our product candidates.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all.

Further, we may not be aware of all third-party intellectual property rights potentially relating to our p roduct candidates.

Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

Furthermore, the scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history and can involve other factors such as expert opinion.

Our analysis of these issues, including interpreting the r elevance or the scope of claims in a patent or a pending application, determining applicability of such claims to our proprietary technologies or product candidates, predicting whether a third party’s pending patent application will issue with claims of re levant scope, and determining the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates.

We do not always conduct indepe ndent reviews of pending patent applications of and patents issued to third parties.

Our analysis of these issues, including interpreting the re levance or the scope of claims in a patent or a pending application, determining applicability of such claims to our proprietary technologies or product candidates, predicting whether a third party’s pending patent application will issue with claims of rel evant scope, and determining the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates.

We do not always conduct indepen dent reviews of pending patent applications of and patents issued to third parties.

As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent applications may n ot result in patents being issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive product candidates.

Even if our patent applications issue as patents, they may not issue in a f orm that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be able to circumvent our patents by developing similar or alternative product c andidates in a non-infringing manner.

Our pending and future patent applications may no t result in patents being issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive product candidates.

Even if our patent applications issue as patents, they may not issue in a fo rm that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be able to circumvent our patents by developing similar or alternative product ca ndidates in a non-infringing manner.

Our ability to enforce patent rights also depends on our ability to detect infringement.

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Any exercise by the government of such rights or by any third party of its reserved rights could harm our competitive position, business, financial condition, results of operations, and prospects.

Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our product candidates may be d ependent on our licensors.

We currently are reliant upon licenses of certain intellectual property rights and proprietary technology from third parties that are important or necessary to the development of our proprietary technology, including technology related to our product candidates.

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for infigratinib under which we are required to use commercially reasonable efforts to develop infigratinib, and to obtain regulatory approval for and commercialize at least one therapeutic product incorporating infigratinib in the United States and the European Union.

In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.

For example, if our license agreement with Stanford is terminated, competitors or other third parties would have the freedom to seek regulatory approval of, and to marke t, products identical to acoramidis and we may be required to cease our development and commercialization of acoramidis .

Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operat ions and prospects.

In spite of our efforts, our licensors might conclude that we have materiall y breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.

For example, i f our license agreement with Stanford is terminated, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical to acoramidis and we may be required to cease our development and commercializa tion of acoramidis .

Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.

Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:

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In either case, such a license may not be available on commercially reasonable terms or at all, or it may be non-exclusive, which could result in our competitors gaining access to the same intellectual property rights.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further d evelop and commercialize our product candidates.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

In the event of a successful cla im of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be im possible or require substantial time and monetary expenditure.

In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

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.

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If one of product candidates is approved and a patent covering that product candidate is not listed in the Orange Book, a manufacturer of generic drugs would not have to provide advance notice to us of any abbreviated new drug application, or ANDA, filed with the FDA to obtain permission to sell a generic version of such product candidate.

If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.

If we are unable to pr otect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.

We seek to protect our confidential proprietary information, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and collaborators.

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Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our competitive position, business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

We may become invo lved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents or other intellectual property.

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The outcome following legal assertions of invalidity and unenforceability is unpredictable.

Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to

determine the priority of inventions with respect to our pat ents or patent applications.

Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications.

An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party.

Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology.

Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in su bstantial costs and distract our management and other employees.

In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue clinical trials, continue research progr ams, license necessary technology from third parties, or enter into development partnerships that would help us bring product candidates to market.

Furthermore, because of the substantial amount of discovery required in connection with intellectual propert y litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

There could also be public announcements of the results of hearings, motions, or other interim proceedings or develop ments.

Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.

In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue clinical trials, continue research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring product candidates to market.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

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Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

The legal systems of certain countries, part icularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical products, which could make it difficult for us to sto p the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and diver t our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We ma y not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a signif icant commercial advantage from the intellectual property that we develop or license.

Changes in U.S.

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the efficacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals;

the potential and perceived advantages compared to alternative treatments, including any similar generic treatments;

the potential and perceived advantag es compared to alternative treatments, including any similar generic treatments;

the ability to offer these products for sale at competitive prices;

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restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population;

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

the lack of complementary products to be offere d by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

unforeseen costs and expenses associated with creating an independent commercialization organization.

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The insurance coverage and reimbursement status of newly-approved products is uncertain.

Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practice s, or healthcare reform initiatives, which would harm our business.

Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business.

Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.

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It is difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products.

Reimbursement agencies in Europe may be more conservative than CMS.

For example, a number of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement in certain European countries.

Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale, and distribution.

Reimbursement agencies in Europe may be more

conservative than CMS.

For example, a number of cancer drugs have been approved f or reimbursement in the United States and have not been approved for reimbursement in certain European countries.

Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, includi ng research, development, manufacture, sale, and distribution.

Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.

Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved products we may develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize product candidates, and our overall financial condition.

Our inability to promptly obtain coverage and profitable payment rat es from both government-funded and private payors for any approved products we may develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize product candidates, and our overall financial con dition.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

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federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which impose criminal and civil penalties, including through civil “qui tam” or “whistleblower” actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent;

knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government;

knowingly making or causing a

false statement material to a false or fraudulent claim or an obligation to pay money to the federal government;

or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose r equirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health informa tion, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization;

the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S.

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Depending on the facts and circumstances, we could be subject to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

California recently enacted the California Consumer Privacy Act, or CCPA, which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.

California recently enacted the California Consumer Privacy Act, or CCPA, which creates new individual privacy rights for California consumers (as defined in the law) an d places increased privacy and security obligations on entities handling personal data of consumers or households.

The CCPA will require covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information.

The CCPA went into effect on January 1, 2020, and the California Attorney General will commence enforcement actions against violators beginning July 1, 2020.

The CCPA went into effect on January 1, 2020, and the California Attorney General will commence enforcement actions against violators begi nning July 1, 2020.

While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact certain of our business activities.

The California Attorney General has proposed draft regulations, which have not been finalized to date, that may further impact our business activities if they are adopted.

The uncertainty surrounding the implementation of CCPA exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.

The California Attorney Genera l has proposed draft regulations, which have not been finalized to date, that may further impact our business activities if they are adopted.

The uncertainty surrounding the implementation of CCPA exemplifies the vulnerability of our business to the evolvi ng regulatory environment related to personal data and protected health information.

Compliance with U.S.

and international data protection laws and regulation s could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

Failure to comply with these laws and regulations cou ld result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information.

Claims that we have v iolated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.

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The Tax Cuts and Jobs Act of 2017, or Tax Act, includes a provision that repealed effective January 1, 2019 the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14, 2018, a U.S.

District Court Judge in the Northern District of Texas, or the Texas District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well.

On December 18, 2019, the Fifth Circuit U.S.

Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to reconsider its earlier invalidation of the full ACA.

District Court Judge in the Northern District of Texas, or the Texas District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the T ax Act, the remaining provisions of the ACA are invalid as well.

On December 18 , 2019, the Fifth Circuit U .

Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to reconsider its earlier invalida tion of the full ACA.

It is unclear how this decision, subsequent appeals and other efforts to repeal and replace the ACA will impact the ACA and our business.

On January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay t he implementation of any provision of the ACA that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.

On Oc tober 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA.

On January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.

On October 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the ACA.

Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017.

On June 14, 2018, U.S.

Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor pa yments to third-party payors who argued were owed to them.

Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in ACA risk corridor payments to third-party payors who argued were owed to them.

On December 10, 2019, the U.S.

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United States , which will determine whether the government must make risk corridor payments.

Supre me Court’s decision will be released in the coming months, but we cannot predict how the U.S.

Supreme Court’s decision will be released in the coming months, but we cannot predict how the U.S.

Supreme Court will rule.

The effects of this gap in reimbursement on third-party payors, the viability of the ACA marketplace, providers, and potentially our busi ness, are not yet known.

The effects of this gap in reimbursement on third-party payors, the viability of the ACA marketplace, providers, and potentially our business, are not yet known.

Moreover, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices.

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Department of Health and Human Services, has already started the process of soliciting feedback on some of these measures and, at the same time, is immediately implementing others under its existing authority.

In May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020.

This final rule codified CMS’s policy change that was effective January 1, 2019.

In May 2019, CMS issued a final rule to allow Medicare Advantage

Plans the option of using step therapy , a type of prior authorization, for Part B drugs beginning January 1, 2020.

This final rule codified CMS’s policy c hange that was effective January 1, 2019.

Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.

At the state level, legislatures have increasingly passed legislation and implemented 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.

At the state level, legislatures have increasingly passe d legislation and implemented 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 transpare ncy measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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 a ble to generate revenue, attain profitability, or commercialize our product.

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 a ffect our overall financial condition and ability to develop product candidates.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product.

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.

We cannot predict the initiatives that may be adopted in the future.

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tafamidis, a TTR tetramer stabilizer (presently marketed by Pfizer Inc.

as Vyndamax and Vyndaqel), a competitor to acoramidis;

pemigatinib, a small molecule FGFR inhibitor, a competitor to infigratinib;

as Vyndamax and Vyndaqel), a competitor to

pemigatinib, a small molecule FGFR inhibitor, a competitor to infigrati nib ;

NBI-74788, a corticotropin releasing factor receptor antagonist, a competitor to BBP-631;

and MRTX849, a KRAS G12C inhibitor, a competitor to BBP-454.

If any of these or other competitors, including competitors for our other product candidates, receive FDA approval before we do, our product candidates would not be the first treatment on the market, and our market share may be limited.

If any of these or other competitors, including competitors for our other product candidates, receiv e FDA approval before we do, our product candidates would not be the first treatment on the market, and our market share may be limited.

In addition to competition from other companies targeting our target indications, any products we may develop may also face competition from other types of therapies.

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 testing, conducting clinical trials, obtaining regulatory approvals, and marke ting approved products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

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Sinha also serving as a director of Eidos);

Eric Aguiar and Ali Satvat each serve as a director of both us and Eidos;

Ali Satvat serves as a director of both us and Eidos;

and Eric David serves as chief executive officer of both Adrenas Therapeutics, Inc.

and Aspa Therapeutics, Inc.

As a result, these executive officers, directors and members of our Management Committee may not be able to devote their full attention to us, which could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

While we believe that we have put in place policies and procedures to i dentify such conflicts and any such policies and procedures were negotiated at arm’s length in conformity with fiduciary duties, such conflicts of interest may nonetheless arise.

Therapeutics, Inc.

As a result, these executive officers, directors and members of our Managem ent Committee may not be able to devote their full attention to us, which could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

While we believe that we have put in place policies and procedures to identify such conflicts and any such policies and procedures were negotiated at arm’s length in conformity with fiduciary duties, such conflicts of interest may nonetheless arise.

The existence and consequences of such potential conflicts could expose us to loss of profits, claims by our investors and creditors, and harm our business and our results of operations.

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Kumar or any of our other executives or key personnel, we may not be able to find appropriate replacements on a timely basis.

In addition, because certain of our employees provide a cen tralized source of support across multiple subsidiaries, the loss of any of these employees could negatively affect the operations of the affected subsidiaries, and our financial condition and results of operations could be materially adversely affected.

In addition, because certain of our employees provide a centralized source of support across multiple subsidiaries, the loss of any of these employees could negatively affect the operations of the affected subsidiaries, and our financial condition and results of operations could be materially adversely affected.

Furthermore, each of our executive officers may terminate their employment with us at any time.

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Our reliance on a central team consisting of a limited number of employees who provide various administrative, research and development and other services across our organization, and on dedicated teams at the subsidiary level presents operational challenges that may adversely affect our business.

As of June 30, 2020, we had 77 employees who are employed by our wholly-owned subsidiary, BridgeBio Services, Inc., upon which we rely for various administrative, research and development and other support services shared among us.

As of September 30, 2020, we had 100 employees who are employed by our wholly-owned subsidiary, BridgeBio Services, Inc., upon which we rely for various administrative, research and development and other support services shared among us.

While we believe this structure enables us to reduce certain infrastructure costs, the small size of our central team 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 financial and accounting and reporting matters.

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The ability of the FDA to review and approve new products or take action with respect to other regulatory matters can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, the availability of personnel and other resources in light of governmental “stay at home” orders in response to the COVID-19 pandemic, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

Average review times at the agency have fluctuated in recent

years as a resu lt.

In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved, or for other actions to be take n, by relevant government agencies, which would adversely affect our business.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved, or for other actions to be taken, by relevant government agencies, which would adversely affect our business.

For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities and it is anticipated that the FDA’s ability to conduct clinical site investigations will be impaired as a result of the COVID-19 pandemic.

If a prolonged government shutdown or disruption to the operations of the FDA occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on ou r business.

Similarly, a prolonged government shutdown or disruption to the operations of the USPTO could prevent the timely review of our patent applications, which could delay the issuance of any U.S.

patents to which we might otherwise be entitled.

Futu re government shutdowns and similar events could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Future government shutdowns and similar events could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.

As of June 30, 2020, we had 328 full-time employees across all of our companies.

As of September 30, 2020, we had 369 full-time employees across all of our companies.

As we mature, we expect to expand our full-time employee base and to hire more consultants and contractors.

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We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although we maintain workers’ compensation insurance to cover us for costs a nd expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

We do not maintain insurance for environmental liability or toxi c tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

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Further, our insurance may not cover all claims made against us and defending a suit, regardless of its merit, could be costly and divert management’s attention.

Furthermore, the loss of clinical trial data from completed or fut ure clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Likewise, we rely on other third parties for the manufacture of our product candidates and to conduct clini cal trials, and similar events relating to their computer systems could also have a material adverse effect on our business.

Furthermore, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Likewise, we rely on other third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.

We or the third parties upon whom we depend may be adversely affected by earthquakes , outbreak of disease, or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

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Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.

As of June 30, 2020, we and our subsidiaries had total consolidated indebtedness of $642.5 million, including $550.0 million of indebtedness outstanding under our unsecured 2.50% Convertible Senior Notes due 2027, or the 2027 Notes, $75.0 million of indebtedness under our Amended and Restated Loan and Security Agreement and $17.5 million of indebtedness outstanding under the Eidos’ SVB and Hercules Loan Agreement.

As of September 30, 2020, we and our subsidiaries had total consolidated indebtedness of $642.5 million, including $550.0 million of indebtedness outstanding under our unsecured 2.50% Convertible Senior Notes due 2027, or the 2027 Notes, $75.0 million of indebtedness under our Amended and Restated Loan and Security Agreement and $17.5 million of indebtedness outstanding under the Eidos’ SVB and Hercules Loan Agreement.

In addition, with the Fourth Amendment to our Credit Agreement in April 2020 increasing the available facilities to $125.0 million, we may borrow additional amounts thereunder from Hercules and become subject to additional obligations and restrictions in connection with these additional borrowings.

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In addition, our subsidiary, Eidos Therapeutics, Inc.

is also party to a loan and security agreement with Silicon Valley Bank and Hercules Capital, Inc., under which the lenders have agreed to loan to Eidos up to $55.0 million and Eidos is required to make and maintain certain financial covenants, representations and warranties and other customary agreements and is subject to customary events of default.

is also party to a loan and security agreement with SVB and Hercules Capital, Inc., under which the lenders have agreed to loan to Eidos up to $55.0 million and Eidos is required to make and maintain certain financial covenants, representations and warranties and other customary agreements and is subject to customary events of default.

Any breach by us or Eidos of, or any event of default under, our respective loan agreements could result in a material adverse effect on our business, financial condition and operating results.

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In July 2019, the FASB issued an exposure draft that proposes to change the accounting for the convertible debt instruments described above.

Under the exposure draft, an entity may no longer be required to separately account for the liability and equity components of convertible debt instruments.

Under the exposure draft, an entity may no longer be required to separately account for the liabi lity and equity components of convertible debt instruments.

This could have the impact of reducing non-cash interest expense, and thereby increasing net income.

Additionally, as currently proposed, the treasury stock method for calculating earnings per share will no longer be allowed for convertible de bt instruments whose principal amount may be settled using shares.

Additionally, as currently proposed, the treasury stock method for calculating earnings per sha re will no longer be allowed for convertible debt instruments whose principal amount may be settled using shares.

Rather, the if-converted method may be required.

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We cannot be sure that this exposure draft will be issued, or will be issued in its current format.

We also cannot be sure whether other changes may be made to the current accounting standards related to the 2027 Notes , or otherwise, that could have an adverse impact on our financial statements.

We also cannot be sure whether other changes may be made to the current accounting standards related to the 2027 Notes , or otherwise, that could have an adv erse impact on our financial statements.

Risk Related to our Need for Additional Capital

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Because the outcome of any preclinical 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 30, 2020, we had working capital of $769.3 million and cash, cash equivalents and marketable securities of $840.9 million.

As of September 30, 2020, we had working capital of $669.7 million and cash, cash equivalents and marketable securities of $710.7 million.

We expect that our cash and cash equivalents will be sufficient to fund our operations through at least the next 12 months from the date of this report.

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the diversion of our management’s attention from our existing product programs and initiatives in pursuing such an acquisition or strategic partnership;

difficulties in retaining key personnel and uncertainties in our ability to maintain key business relationships;

difficulties in retaining key employees and personnel and uncertainties in our ability to maintain key business relationships;

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;

our inability to generate revenue from acquired intellectual property, technology and/or products sufficient to meet our objectives or even to offset the associated transaction and maintenance costs.

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.

Risks Related to O ur C ommon Stock

In addition, if we undertake such a transaction, we may issue dilutive securities, assume or incur debt obligat ions, 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 .

The Eidos Merger in particular may result in reduction of our cash and dilutive issuances of our equity securities given the option of the Eidos stockholders to receive cash or stock consideration, the payment of either of which could harm our financial condi tion and negatively impact our stockholders.

Risks Related to Our Common Stock

We are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.

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announcements we make regarding our current product candidates, acquisition of potential new product candidates and companies and/or in-licensing;

failure to maintain our existing license arrangements or enter into new licensing and collaboration agreements;

failure to maintain our existing license arrangements or enter into new licensi ng and collaboration agreements;

failure by us or our licensors to prosecute, maintain or enforce our intellectual property rights;

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Shares of unvested restricted stock and common stock issued and outstanding as of the 2019 Reorganization will become available for sale immediately upon the vesting of such shares.

Shares issued upon the exercise of stock options outstanding under our equity incentive plans or pursuant to future awards granted under those plans will become available for sale in the public market to the extent permitted by the provisions of applicable vesting schedules, any applicable market standoff agreement, and Rule 144 and Rule 701 under the Securities Act of 1933, as amended, or the Securities Act.

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 regi stration statements that we may file for ourselves or other stockholders.

Shares issued upon the exercise of stock options outstanding under our equity inc entive plans or pursuant to future awards granted under those plans will become available for sale in the public market to the extent permitted by the provisions of applicable vesting schedules, any applicable market standoff agreement , and Rule 144 and Ru le 701 under the Securities Act of 1933, as amended, or the Securities Act.

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.

In July 2020, we filed a registration statement on Form S-3/ASR that became effective automatically upon filing.

Pursuant to this registration statement, we may issue up to $350.0 mi llion in common stock in sales deemed to be an “at the market offering” as defined by the Securities Act and, so long as we qualify as a “well-known seasoned issuer” as defined in Rule 405 of the Securities Act, an unlimited amount of shares of our common stock, preferred stock, debt securities, warrants and/or units.

Pursuant to this registration statement, we may issue up to $350.0 million in common stock in sales deemed to be an “at the market offering” as defined by the Securities Act and, so long as we qualify as a “well-known seasoned issuer” as defined in Rule 405 of the Securities Act, an unlimited amount of shares of our common stock, preferred stock, debt securities, warrants and/or units.

In July 2020, we filed a registration statement on Form S-3/ASR relating to the offer and resale from time to time by certain of our stockholders, of up to an aggregate of 65,121,374 shares of our common stock.

We have also filed registration statement s 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 th e s e reg istration statement s on Form S-8 can be freely sold in the public market upon issuance and once vested, subject to volume limitations applicable to affiliates.

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.

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.

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Our principal stockholders and certain members of our management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

Based upon our common stock outstanding as of June 30, 2020 , KKR Genetic Disorder L.P., or together with its affiliates, KKR, Viking Global Opportunities Illiquid Investments Sub-Master LP and Neil Kumar, our chief executive officer, beneficially own 54.3% of our outstanding common stock.

Based upon our common stock outstanding as of September 30, 2020 , KKR Genetic Disorder L.P., or together with its affiliates, KKR, Viking Global Opportunities Illiquid Investments Sub-Master LP and Neil Kumar, our chief executive officer, beneficially own 56.4% of our outstanding common stock.

These stockholders will have the ability to influence us through their ownership positions.

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This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.

If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially.

If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the fore casts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially.

Our future ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

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In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.

Pursuant to Section 404 of the Sarbanes-Oxley Act, we are required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

However, while we are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, our auditors are not required to formally attest to the effectiveness of our internal control over financial reporting.

As of the end of our fiscal year ending December 31, 2020, we will qualify as a “large accelerated filer” as defined in the Exchange Act and, as a result, will cease to qualify as an emerging growth company.

Accordingly, commencing with our Annual Report on Form 10-K

for the year ending December 31, 2020, we will be required to have our auditors formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404.

Our compliance with Section 404 will necessita te that we incur substantial accounting expense and expend significant management efforts.

We will continue to dedicate internal resources, potentially engage outside consultants, and adopt a detailed work plan to assess and document the adequacy of intern al control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over fi nancial reporting.

Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as requir ed by Section 404.

This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted.

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Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.

Additionally, there continues to be public interest and increased legislative pressure related to environmental, social and governance (“ESG”) activities of public companies.

We risk negative stockholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, if we do not act responsibly in a number of key areas, including diversity and inclusion, environmental stewardship, support for local communities, corporate governance and transparency and considering ESG and human capital factors in our operations.

There is a growing number of states requiring organizations to report their board composition as well or mandating gender diversity and representation from underrepresented communities, including New York and California.

We expect the rules and regulations applicable to us as a public company to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly.

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The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

Risks Related to the Acquisition of Eidos

*The proposed acquisition of Eidos is subject to conditions, as well as other uncertainties, and there can be no assurances as to whether or when it may be completed.

Failure to complete the proposed transaction could have material adverse effects on us and our business and operations.

On October 5, 2020, we and Eidos issued a joint press release announcing the execution of an Agreement and Plan of Merger, or the Merger Agreement, providing for the acquisition by us of all outstanding shares of Eidos Common Stock that we do not already own (the “Eidos Merger”).

While we expect to complete the proposed transaction in the first quarter of 2021, the proposed Eidos Merger is subject to a number of conditions that must be satisfied in order for the transaction to be consummated, including, among others, the approval of the Eidos Merger by Eidos stockholders, the approval of the issuance of shares of our common stock in connection with the Eidos Merger by BridgeBio stockholders, and the SEC having declared effective our Form S-4 registration statement.

Also, either we or Eidos may terminate the Merger Agreement if the Eidos Merger has not been consummated by June 4, 2021, as well as for certain other reasons enumerated in the Merger Agreement.

Prior to closing, the Eidos Merger may present certain risks to our business and operations, which could materially affect our business, financial results and stock price, including, among other things, that:

a failure to complete the Eidos Merger, including due to the failure to receive the requisite approvals from either Eidos or BridgeBio stockholders, the occurrence of events that may give rise to the right of one or both of us and Eidos to terminate the Merger Agreement, a ruling or judgment by a government authority enjoining or prohibiting the Eidos Merger, or the failure of us or Eidos to satisfy another closing condition outside of our control, could negatively impact our stock price and our future business and financial results;

we expect to incur substantial expenses related to the Eidos Merger whether or not the Eidos Merger is completed;

we could be required to pay Eidos a termination fee of $100 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement;

we are subject to restrictive interim operating covenants during the pendency of the Eidos Merger;

we may encounter costly and time-consuming transaction-related litigation;

the pendency of the Eidos Merger could adversely affect our business and operations, including by diverting significant focus of management and other resources and limiting our ability to execute certain business strategies.

Similarly, delays in the completion of the proposed Eidos Merger could, among other things, result in additional transaction costs, loss of revenue or personnel, or other negative effects associated with uncertainty about completion of the proposed transaction.

In addition, certain risks may continue to exist at and following the closing of the Eidos Merger, including, among other things, that:

we may encounter potential unknown liabilities and unforeseen increased expenses, delays or unfavorable conditions in connection with the closing of the Eidos Merger and the subsequent integration;

our future results will suffer if we do not effectively manage our expanded operations;

the market price of our common stock may decline as a result of the Eidos Merger.

*We may not realize the anticipated benefits and synergies from the proposed Eidos Merger or do so within the anticipated timeframe.

While we and Eidos will continue to operate independently until the completion of the Eidos Merger, the success of the merger will depend, in part, on our ability to realize the anticipated benefits of acquiring all of the shares of Eidos.

As a result, the anticipated benefits of the Eidos Merger may not be realized fully within the expected timeframe or at all or may take longer to realize or cost more than expected, which could materially impact the business, cash flow, financial condition or results of operations as well as adversely impact the price of our shares of common stock.

Potential difficulties that we may encounter in connection with the Eidos Merger, many of which may be beyond the control of management, include the following:

the inability of BridgeBio to successfully integrate Eidos’ business in a manner that permits BridgeBio to achieve the full synergies anticipated to result from the Eidos Merger;

the loss of key employees that may be difficult to replace in the very competitive biopharmaceutical field;

the disruption of each company’s ongoing businesses, which may adversely affect our ability to maintain relationships with suppliers, distributors, alliance partners, creditors, clinical trial investigators or managers of its clinical trials;

unanticipated changes in applicable laws and regulations;

potential unknown liabilities and unforeseen increased or new expenses, delays or regulatory conditions associated with the Eidos Merger.

In addition, at times, the attention of certain members of each company’s management and each company’s resources may be focused on completion of the Eidos Merger and diverted from day-to-day business operations, which may disrupt each company’s ongoing business.

* The pendency of the Eidos M e rger could materially adversely affect the business, financial condition, results of operations or cash flows of BridgeBio or Eidos.

Uncertainty about the effect of the Eidos Merger on stockholders, suppliers, strategic partners and employees may have an adverse effect on BridgeBio or Eidos.

Some suppliers, strategic partners, employees and others who deal with Eidos may seek to change existing relationships with Eidos or delay decisions to continue or expand their relationships with Eidos.

Current and prospective employees may experience uncertainty about their future roles.

This uncertainty may impair our and/or Eidos’ ability to attract, retain and motivate key personnel.

Due to the specialized scientific and managerial nature of our business, we and Eidos rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.

The competition for qualified personnel in the pharmaceutical field is intense and our success after the transaction will depend in part on our ability to retain scientific and technical personnel and other key employees of Eidos.

If employees depart because of issues related to the uncertainty and difficulty of integration or a desire not to remain with the businesses, BridgeBio, following the Eidos Merger, could face disruptions in its operations, loss of expertise or know-how, and unanticipated additional recruitment and training costs.

In addition, the loss of key personnel could diminish the anticipated benefits of the Eidos Merger.

*If our pending proposed Eidos Merger is consummated, our stockholders’ ownership percentage will be diluted.

If the proposed Eidos Merger is consummated, we will issue to Eidos stockholders shares of our common stock.

As a result of the issuance of these shares of our common stock, our stockholders will own a smaller percentage of our company after the Eidos Merger and will therefore have a reduced voting interest.

Immediately upon consummation of the Eidos Merger, pre-closing Eidos stockholders are expected to own between 16% and 18% of the outstanding shares of our common stock and our pre-closing stockholders are expected to own between 82% and 84% of the outstanding shares of our common stock, in each case, depending on the amount of cash Eidos stockholders elect to receive.

*We may be subject to litigation in connection with the pending Eidos Merger.

Lawsuits may be filed against us, Eidos, our subsidiaries, or our respective directors or executive officers in connection with the Eidos merger and the related transactions, which could result in substantial costs to BridgeBio and Eidos, and may delay or prevent the Eidos Merger from being completed.

In addition, if the pending proposal is completed, lawsuits may be filed against the combined company following the pending proposal.

If any such lawsuit is filed, it could result in a reduction in our current stock price and our stock price following the pending proposal, substantial costs and diversion of management’s attention and resources, which could adversely affect our business, financial condition or results of operations, whether or not a settlement or other resolution is achieved.

The defense or settlement of any legal proceedings or future litigation could be time-consuming and expensive, divert the attention of BridgeBio management and/or Eidos management away from their regular business, and, if any one of these legal proceedings or any future litigation is adversely resolved against either BridgeBio or Eidos, could have a material adverse effect on their respective financial condition, results of operations or liquidity.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors