Phathom Pharmaceuticals, Inc.
For the period ended Dec 31, 2025. Filed Feb 26, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Feb 26, 2026
PHAT$5.25+3.3%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-06.
0000950170-25-034183
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-02-26.
0001193125-26-073379
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 412 previous paragraphs and 405 current paragraphs.
165 unchanged; 155 reworded; 78 added; 89 removed; 3 previous and 7 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (78)
Current report
In the future we will need to successfully acquire, develop and gain approval of one or more product candidates other than VOQUEZNA with significant market potential. If we are not successful in these efforts, our business prospects may be materially and adversely affected;
Current report
continue commercialization of VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK, and in the future, potentially expand marketing and sales efforts to target more broadly those primary care physicians who treat GERD;
Current report
To become profitable, we must successfully commercialize VOQUEZNA in the treatment of GERD. To build for long-term success, we must acquire, develop and gain approval of one or more product candidates with significant market potential. We may not be successful in these efforts.
Current report
our ability to achieve and maintain market acceptance, market share, coverage, reimbursement and revenues from sales of VOQUEZNA in its approved GERD indications, and patients’ willingness to pay out-of-pocket in the absence of coverage and/or adequate reimbursement from third-party payers;
Current report
the costs, timing and availability of manufacturing for vonoprazan as well as the costs of manufacturing for any potential product candidates we may pursue in the future;
Current report
the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights, and the success of our enforcement efforts;
Current report
the timing of market introduction, profile and impact of competitive products;
Current report
acceptance of our products for the relevant indication by healthcare providers and their patients;
Current report
our ability to obtain and maintain sufficient third-party coverage and adequate reimbursement from private health insurers, government healthcare programs, including, Medicare and Medicaid, and other third-party payers;
Current report
the timing of market introduction, profile and impact of competitive drugs;
Current report
As a commercial-stage company with FDA-approved products, we are subject to ongoing regulatory obligations and failure to comply with these requirements or changes in regulatory rules could materially adversely affect our business or result in significant additional expense.
Current report
Outside the United States, pharmaceutical products are often subject to extensive governmental price controls and other market regulations. In many countries, including those in Europe, pricing and reimbursement are subject to national health system controls or profit limitations, which may reduce the prices we are able to charge and the revenues we are able to generate. If we pursue commercialization outside the United States, reimbursement levels in those markets may be lower than in the United States and may be insufficient to generate commercially reasonable revenues or profitability.
Current report
Moreover, ongoing efforts by governmental authorities and third-party payers to contain healthcare costs, including through pricing controls, utilization management, and reimbursement reductions, may further limit coverage or reimbursement for our products. These factors could materially and adversely affect our ability to commercialize our products, generate revenue, and grow our business.
Current report
Competition in the markets for our approved products is expected to increase, and we may also face competition with respect to any product candidates we may develop, in each case which could materially adversely affect our business, results of operations and prospects.
Current report
For the treatment of Erosive GERD and Non-Erosive GERD, VOQUEZNA primarily competes with generic PPIs marketed by multiple pharmaceutical companies in both the prescription and OTC markets. Generic PPIs are widely available, inexpensive and well established in clinical practice. In addition, we are aware of other PPIs in development in the United States and in our licensed territories outside the United States that, if successfully developed and approved, may compete with vonoprazan.
Current report
We are also aware of several PCABs in development in the United States and in our licensed territories outside the United States, that, if approved or introduced, may compete with vonoprazan. For example, Sebela Pharmaceuticals, Inc. has publicly announced the submission of an NDA in the United States seeking approval of tegoprazan for the treatment of Erosive GERD and Non-Erosive GERD based on Phase 3 clinical trials. Outside the United States, tegoprazan is marketed in several countries, including South Korea, where it was originally developed. Daewoong Pharmaceutical Co., Ltd also markets a PCAB, fexuprazan, in certain countries outside the United States, and has indicated that it is seeking a partner to advance development of the compound in the United States. In addition, in 2025, Cinclus Pharma Holding AB initiated a Phase 3 clinical trial in Europe of another PCAB, linaprazan glurate, in patients with severe Erosive GERD and has publicly indicated its intention to initiate a second Phase 3 clinical trial in the United States to support a potential future NDA submission. Additional PCABs have been approved or are in development outside the United States and could compete with vonoprazan if introduced in our licensed territories.
Current report
For the treatment of H. pylori infection, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK compete primarily with generic PPI-based triple and quadruple therapies, as well as with branded therapies such as Talicia, a co-formulated capsule containing omeprazole, amoxicillin and rifabutin, marketed by RedHill Biopharma Ltd.
Current report
The total addressable market across indications for our approved products and any future product candidates will ultimately depend upon a number of factors, including the scope of the approved indications and labeling; the availability and acceptance of competing treatment; the safety, efficacy, convenience and cost of our approved products and any future product candidates relative competing treatments; physician prescribing practices; patient awareness, acceptance and access; and drug pricing and reimbursement. If patients are less willing or able to use our products than we expect, or if access to appropriate patients is more limited than anticipated, or if for other reasons, the market opportunity for our products turns out to be significantly lower than expected, our ability to generate revenues and grow our business could be materially adversely affected.
Current report
If our efforts to develop, maintain and effectively deploy sales, marketing and distribution capabilities are unsuccessful, we may not be able to successfully commercialize our approved products or any product candidates we may develop and generate revenues at the levels and on the timing we expect.
Current report
We currently market, sell and distribute VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK through our own sales and marketing organization, and our ability to successfully commercialize these products depends on the effectiveness of these capabilities. Our sales force may not be sufficient in size, reach or expertise to effectively address the markets we intend to target. Our commercial strategy for our approved products currently relies on a targeted national sales force focused primarily on gastroenterologists and other high-prescribing healthcare providers, including select primary care physicians. This strategy is designed to concentrate our resources on prescribers most likely to treat patients with GERD and H. pylori infection. However, this targeted approach may not result in sufficient adoption or utilization of our products. In addition, we may in the future seek to expand our sales and marketing efforts to reach a broader group of primary care physicians who treat GERD. Such an expansion could require significant additional investment, increase operational complexity, and may not result in increased prescribing or revenues. If we are unable to successfully execute, or derive sufficient benefit from, any expansion of our commercial strategy, our business, results of operations and prospects could be materially adversely affected. Any deficiencies in our sales, marketing or distribution capabilities or strategies or delays in optimizing or expanding these capabilities and strategies, could adversely impact the commercialization of our products.
Current report
To the extent that we enter into collaboration or other arrangements in the future for the marketing, sales or distribution of our products, including in Europe and Canada, our product revenues may be lower than if we were to commercialize such products directly. Any revenues we may generate in these markets would depend, in whole or in part, on the efforts of third parties that are not fully within our control and may not be successful. If we are unable to enter into such arrangements on acceptable terms, or if third parties do not perform as expected, we may not be able to successfully commercialize our products in those markets.
Current report
If we are not successful in commercializing our approved products, either through our own commercial organization or through third-party arrangements, our revenues could be materially reduced and our business, results of operations and prospects could be materially adversely affected.
Current report
Our future growth depends on our ability to develop vonoprazan for additional indications or formulations and to successfully develop or acquire additional product candidates.
Current report
We expect that a substantial portion of our efforts and expenses over the next few years will be devoted to the commercialization of VOQUEZNA and the potential development and regulatory approval of vonoprazan for additional indications for formulations in the U.S. We cannot be certain that we will pursue, successfully develop, or obtain regulatory approval of vonoprazan for additional indications or formulations on the timeframes we expect, or at all. Our future growth also depends on our ability to successfully develop or acquire additional product candidates and obtain regulatory approval for such candidates on timelines sufficient to contribute meaningfully to the growth of our business. We may not be successful in these efforts and, even if we are successful, the commercialization of such additional indications, formulations or products may not contribute meaningfully to future growth of our business.
Current report
obtaining and maintaining robust intellectual property protection or regulatory exclusivities.
Current report
Clinical development is lengthy, expensive and uncertain, and delays or failures in our clinical trials could limit our ability to obtain additional regulatory approvals and adversely affect our business.
Current report
Before obtaining regulatory approval to commercialize vonoprazan for additional indications or formulations or to commercialize any future product candidates, we must demonstrate through clinical trials that such products are safe and effective for use in the target indication. We may not achieve favorable results in our ongoing or future clinical trials, including our current trial of vonoprazan in eosinophilic esophagitis, or obtain regulatory approvals on a timely basis, or at all. Failure to obtain such approvals would prevent us from commercializing additional indications or formulations for vonoprazan or future product candidates.
Current report
The conduct of clinical trials is subject to extensive regulation in the United States and other territories, and regulatory requirements and policies may change. New processes and requirements for the authorization and oversight of clinical trials may affect the planning, conduct, timing and cost of trials.
Current report
The commencement, timing and completion of our clinical trials depend on many factors, including regulatory approvals to commence or continue trials, clinical trial design, manufacturing and supply of study drug, performance of third-party contractors and clinical sites, our ability to enroll and retain a sufficient number of eligible patients and the impact of interim results, if any. Patient enrollment may be delayed or limited by factors such as the size and characteristics of the patient population, eligibility criteria, proximity to trial sites, competing clinical trials, availability of approved therapies, and patient and physician perceptions of risks and benefits. If we are unable to enroll or retain sufficient patients, our trials may be delayed, suspended or terminated.
Current report
Delays, suspensions or failures in our clinical trials could increase our development costs, delay or prevent regulatory approval, prevent us from commercializing such products and generating revenues, or reduce the period during which we may have exclusive rights to commercialize our products, and allow competitors to bring competing products to market sooner. We do not know whether any of our ongoing or future studies will be completed on schedule and successfully, if at all. Any delays or adverse outcomes in our clinical trials could materially adversely affect our business, results of operations and prospects.
Current report
As is the case with pharmaceuticals generally, there are known side effects and adverse events associated with VOQUEZNA, VOQUEZNA Dual Pak and VOQUEZNA Triple Pak. As use of these approved products increases, or as we conduct further clinical trials in additional indications or formulations, we could see an unacceptable severity or prevalence of these known side effects or our products may be associated with other undesirable side effects, adverse events or product characteristics. Further, serious safety issues may be identified in connection with commercialization or development of vonoprazan by third parties outside the U.S. Our future product candidates may also be associated with undesirable side effects, adverse events and product characteristics.
Current report
requirements to conduct expensive additional post-approval safety studies;
Current report
failure to achieve or maintain market acceptance among patients, healthcare providers and patients;
Current report
Obtaining regulatory approval for product candidates, including additional indications or formulations of approved products, is subject to extensive regulation and is costly, time-consuming and uncertain.
Current report
Given our limited financial and managerial resources, our current focus is primarily on the commercialization of our approved products, and we may decide not to pursue or continue development of additional indications or formulations for vonoprazan. Even if we elect to pursue such opportunities, we may allocate our limited resources to particular indications or formulations that ultimately prove unsuccessful or less commercially viable than other potential opportunities. In addition, we may fail to generate the clinical data needed for approval or encounter other issues such as unexpected side effects or formulation-related technical hurdles, and we may decide to pause or such development efforts.
Current report
We may never apply for or receive regulatory approval for vonoprazan in any additional indication or formulation. Even if we do obtain approval, we may not have accurately assessed the commercial potential or target market for such new indication or new formulation or we may enter into collaborations, licenses and other similar arrangements under which we relinquish valuable rights that, in hindsight, would have been more advantageous to retain.
Current report
We enrolled patients in Europe in our Erosive GERD and H. pylori trials with VOQUEZNA, and the FDA accepted data from those sites as part of the basis for approval of VOQUEZNA, VOQUEZNA Dual Pak and VOQUEZNA Triple Pak. However, the FDA and other comparable foreign regulatory authorities may not accept data from future trials conducted outside the United States.
Current report
We enrolled patients in Europe in our Erosive GERD and H. pylori trials with VOQUEZNA, and the FDA accepted data from those sites as part of the basis for approval of VOQUEZNA, VOQUEZNA Dual Pak and VOQUEZNA Triple Pak. We are not currently seeking regulatory approval for our VOQUEZNA products in Europe or any other foreign jurisdiction.
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Removed paragraphs (89)
Previous report
VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, and any future product candidates are subject to extensive regulation and compliance obligations, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize additional product candidates;
Previous report
make required milestone and royalty payments under license agreements by which we acquired rights to vonoprazan;
Previous report
To become and remain profitable, we must successfully commercialize one or more product candidates with significant market potential. This will require us to be successful in manufacturing, marketing and selling our currently approved products, particularly VOQUEZNA, and any future product candidates for which we may obtain marketing approval and satisfying any post-marketing requirements. We are only in the early stages of many of these activities and, in some cases, have not yet commenced certain of these activities.
Previous report
the costs and timing of manufacturing for vonoprazan or any future product candidates, including commercial scale manufacturing if any product candidate is approved;
Previous report
our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;
Previous report
our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payers and adequate market share and revenue for any approved products;
Previous report
Conducting clinical trials and preclinical studies is a time consuming, expensive, and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval of future product candidates. In addition, VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, or any future product candidate, may not achieve commercial success. Our commercial revenues will, for the foreseeable future, be derived exclusively from sales of products containing vonoprazan in the United States.
Previous report
Following receipt of regulatory approval, we are subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
Previous report
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 any future product candidates or additional indications for our current products. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approvals that we may have obtained, may be subject to enforcement action, and we may not achieve or sustain profitability.
Previous report
Additionally, the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission's proposal for revision of several legislative instruments related to medicinal products (potentially reducing the duration of regulatory data protection, revising the eligibility for expedited pathways, etc.) was published on April 26, 2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore be substantially revised before adoption, which is not anticipated before early 2026. The revisions may however have a significant impact on the pharmaceutical industry.
Previous report
Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe and other countries has and will continue to put pressure on the pricing and usage of our products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our products. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.
Previous report
Moreover, increasing efforts by governmental and third-party payers in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our products. We expect to experience pricing pressures in connection with the sale of any of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
Previous report
We face significant competition, and if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize products may be adversely affected.
Previous report
We expect that, for the treatment of H. pylori infection, healing and maintenance of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis and treatment of heartburn associated with Non-Erosive GERD, VOQUEZNA will primarily compete with generic PPIs marketed by multiple pharmaceutical companies in both the prescription and OTC markets. In addition to generic PPI-based triple and quad therapies, we expect VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK will compete with Talicia, a co-formulated capsule comprising generic omeprazole, amoxicillin, and rifabutin for the treatment of H. pylori infection, launched in March 2020 by RedHill Biopharma Ltd.
Previous report
We are aware of three PCABs in development in U.S. as well as additional PCABs in territories outside the U.S. If approved in our territories, these PCABs may compete with vonoprazan. In the U.S., Daewoong is seeking a partner to advance development of fexuprazan. Outside the U.S., fexuprazan is launched in five countries and under health authority review in nine countries or regions. In the U.S., Sebela initiated three tegoprazan Phase 3 studies in Erosive GERD, Non-Erosive GERD and long-term safety–with expected completion in 2025. Outside the U.S., tegoprazan is launched in 14 countries, registered but not launched in one country and under health authority review in four countries. In the U.S., Cinclus obtained FDA agreement on their linaprazan glurate pediatric plan and plans to initiate two linaprazan glurate Phase 3 studies in patients with severe Erosive GERD in 2025 and two H. pylori Phase 3 dual therapy (with amoxicillin) studies in 2026. Outside the U.S., Cinclus, via their local partner, received a 2024 approval in GERD for linaprazan glurate in China--facilitating a potential launch in 2025. No other registration activities are noted for linaprazan glurate. In Europe, Cinclus agreed to a pediatric investigation plan with the European Medicines Agency and received regulatory advice on Phase 2 and Phase 3 study designs. Lastly, there are two additional PCABs with registrations outside the U.S.—Jiangsu Carephar’s keverprazan which launched in China and Jeil’s zastaprazan which launched in South Korea. To the best of our knowledge, none of the above compounds have demonstrated superiority to PPIs in a Phase 3 clinical trial.
Previous report
Additionally, we are aware of two PPIs in territories outside of the U.S. that if developed and approved in our licensed territories may compete with vonoprazan. These include Dexa Medica’s DLBS-2411, launched in the Philippines and in Phase 3 in Indonesia and Sihuan Pharmaceutical’s anaprazole, launched in China.
Previous report
We have only recently built out our marketing, sales and distribution infrastructure. If our efforts in developing and maintaining sales, marketing and distribution capabilities are unsuccessful, or if we fail to achieve adequate pricing or reimbursement, we will not be successful in commercializing our current products or any future product candidates.
Previous report
We have only recently expanded our marketing, sales and distribution capabilities in advance of the launch of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. This expansion greatly increased our expenses and was very time consuming for management. We currently market, sell and distribute VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK through our own sales and marketing organization. Our current sales force may not be sufficient in size and may not have adequate expertise in the medical markets we intend to target. Any deficiency in our sales, marketing and distribution capabilities or delay in the future development of such capabilities would adversely impact the commercialization of our products. To the extent that in the future we enter into any collaboration agreements with respect to marketing, sales or distribution for our current products and any future product candidates our product revenue may be lower than if we directly marketed or sold any approved products. In addition, we plan on entering into collaboration agreements with respect to marketing, sales and distribution of our products in Europe and Canada. Any revenue we receive in these markets will depend in whole or in part upon the efforts of these third-party collaborators, which may not be successful and are generally not within our control.
Previous report
If we are unable to enter into these arrangements on acceptable terms or at all, we may not be able to successfully commercialize any approved products. If we are not successful in commercializing any approved products, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses.
Previous report
We depend entirely on the success of VOQUEZNA and other products containing vonoprazan. If we do not successfully commercialize VOQUEZNA in its approved indications, or we experience significant delays in doing so, we may never become profitable.
Previous report
We expect that a substantial portion of our efforts and expenses over the next few years will be devoted to the commercialization of vonoprazan and the development and regulatory approval of vonoprazan for additional indications. We cannot be certain that we will be able to submit or obtain approval for any additional NDA or NDA supplement, or sNDA, for vonoprazan within the timeframes we expect, that any NDAs or sNDAs we submit will be accepted by the FDA for filing in a timely manner or at all, or that any of our product candidates will receive regulatory approval or will be successfully commercialized even if they receive regulatory approval.
Previous report
maintaining adequate commercial manufacturing capabilities;
Previous report
the prevalence and severity of adverse events experienced with vonoprazan and our future product candidates;
Previous report
obtaining and maintaining healthcare coverage and adequate reimbursement for VOQUEZNA and our future product candidates;
Previous report
qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.
Previous report
Clinical drug development is expensive and can take many years to complete, and its outcome is inherently uncertain. Even if we believe the results of our clinical trials are positive, obtaining regulatory approval may not occur on a timely basis, if at all. The results from clinical trials or preclinical studies of a product candidate may not predict the results of later clinical trials of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after the product candidate achieved promising results in earlier clinical trials. The results of our trials may not be comparable to those achieved previously, whether as a result of differences in trial design, patient population or otherwise.
Previous report
For example, in our Phase 3 clinical trial for the treatment of H. pylori infection, the vonoprazan dual therapy arm was not double-blinded because patients in this arm were administered amoxicillin three times daily, versus twice daily for the triple therapy regimens. Both triple therapy regimens were double-blinded. The inability to double-blind the dual therapy arm may impact how regulatory agencies or healthcare payers interpret such results. For example, the EMA has noted that it expects additional analyses of treatment compliance and drop-out rates in the dual therapy arm because it will not be double-blinded.
Previous report
Further, in July 2019, we received scientific advice from the EMA on our Phase 3 clinical trial of vonoprazan in the healing and maintenance of healing of Erosive GERD. For the healing phase of the study, the EMA recommended that we include an endoscopy to assess healing at Week 4 in addition to the planned endoscopies at Week 2 and Week 8 because the summary of product characteristics for lansoprazole suggests four weeks of treatment to assess healing in Erosive GERD. We decided not to incorporate this change into the study design given the additional burden on study subjects to return for a third endoscopy in an eight-week period. This decision may impact the future summary of product characteristics for vonoprazan or may cause the EMA to require us to conduct additional clinical trials for vonoprazan to support marketing approval.
Previous report
In addition, Takeda, a third party over which we have no control, has the right to develop and commercialize vonoprazan outside of the United States, Europe, and Canada. Takeda has marketing approval for vonoprazan in certain countries in Asia and Latin America, and Takeda has ongoing clinical trials of vonoprazan in certain indications that we are also pursuing. If such ongoing trials fail to meet their primary endpoints, have serious adverse events or encounter other problems, the development potential of vonoprazan could be materially and adversely affected. In addition, if serious adverse events or other problems occur with patients using vonoprazan marketed outside of our licensed territories, or if the results of ongoing or future clinical trials of vonoprazan conducted by Takeda or others generate negative results or results that conflict with the results of our clinical trials, the FDA or other regulatory authorities may delay, limit, or deny approval of vonoprazan for additional indications, require us to conduct additional clinical trials as a condition to marketing approval, withdraw their approval of our products containing vonoprazan or otherwise restrict our ability to market and sell our products containing vonoprazan, if approved. In addition, treating physicians may be less willing to prescribe vonoprazan due to concerns over such trial results or adverse events, which would limit our ability to commercialize our vonoprazan products.
Previous report
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the EU recently evolved. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR foresees a three-year transition period. The extent to which ongoing and new clinical trials will be governed by the CTR varies. Clinical trials for which an application was submitted (i) prior to January 31, 2022 under the EU Clinical Trials Directive, or (ii) between January 31, 2022 and
Previous report
January 31, 2023 and for which the sponsor has opted for the application of the EU Clinical Trials Directive remain governed by said Directive until January 31, 2025. After this date, all clinical trials (including those which are ongoing) will become subject to the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such as CROs, may impact our developments plans.
Previous report
It is currently unclear to what extent the United Kingdom, or UK, will seek to align its regulations with the EU. The UK regulatory framework in relation to clinical trials is derived from existing EU legislation (as implemented into UK law, through secondary legislation). A decision by the UK not to closely align its regulations with the new approach that has been adopted in the EU may have an effect on the cost of conducting clinical trials in the UK as opposed to other countries.
Previous report
For the foregoing reasons, our ongoing and future clinical trials and our efforts to obtain additional regulatory approvals for vonoprazan may not be successful. Further, any safety concerns observed in any one of our ongoing or future clinical trials for the targeted indications could limit the prospects for additional regulatory approvals of vonoprazan or any future product candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations.
Previous report
Any difficulties or delays in the commencement or completion, or termination or suspension, of our ongoing or future clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
Previous report
Before obtaining marketing approvals from regulatory authorities for the sale of vonoprazan for additional indications or approval of any future product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of vonoprazan in such new indication or of any future product candidates in humans. We do not know whether any ongoing studies will be completed on schedule, if at all, or if any future clinical trials will begin on time. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:
Previous report
the FDA, EMA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials and reaching consensus among the FDA and EMA over the design of the same clinical trial;
Previous report
any failure or delay in obtaining regulatory authorizations to commence a trial;
Previous report
institutional review boards, or IRBs, or other reviewing bodies refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
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Reworded paragraphs (155)
Previous wording
We may never become profitable or, if we achieve profitability, we may not be able to sustain it;
Current wording
We have a limited operating history, have incurred significant operating losses since our inception and may never become profitable or, if we achieve profitability, we may not be able to sustain it;
Previous wording
We currently depend entirely on the success of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQEUZNA DUAL PAK, which were launched in the fourth quarter of 2023. If we are unable to successfully commercialize these products, our business will be materially harmed;
Current wording
We currently depend entirely on the success of our approved VOQUEZNA products, and in particular on the success of VOQUEZNA for the treatment of GERD. If we are unable to successfully commercialize VOQUEZNA at the levels we expect, our business, results of operations, and prospects will be materially harmed;
Previous wording
We may require additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our commercialization activities, product development programs, or other operations;
Current wording
We may require additional financing to achieve our goals, finance our operations and meet our financial obligations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our commercialization activities, product development programs, or other operations;
Previous wording
Vonoprazan may not have favorable results in our future clinical trials, or receive additional regulatory approvals on a timely basis, if at all;
Current wording
We may not achieve favorable results in our ongoing clinical trial of vonoprazan in the treatment of EoE or in future clinical trials of vonoprazan or of any other product candidate we may develop, or receive additional regulatory approvals on a timely basis, if at all;
Previous wording
We may not be successful in our efforts to expand our pipeline by identifying additional indications and formulations for which to investigate vonoprazan in the future. We may expend our limited resources to pursue a particular indication or formulation for vonoprazan and fail to capitalize on product candidates, indications or formulations that may be more profitable or for which there is a greater likelihood of success;
Current wording
We may not decide to develop vonoprazan for additional indications and formulations beyond the ongoing EoE trial, or even if we proceed with such development, our efforts may not be successful or, if successful, may not result in increased revenues. We may expend our limited resources to pursue a particular indication or formulation for vonoprazan and fail to capitalize on product candidates, indications or formulations that may be more profitable or for which there is a greater likelihood of success;
Previous wording
We currently have limited experience as a company in commercializing products. We may lack the necessary expertise, personnel and resources to successfully commercialize any of our product candidates that have received or may receive regulatory approval, including VOQUEZNA;
Current wording
We currently have limited experience as a company in commercializing products. We may lack the necessary expertise, personnel and resources to successfully commercialize VOQUEZNA or any future product candidates that may receive regulatory approval;
Previous wording
We currently engage third-party manufacturers for all of our clinical and commercial supplies. The loss of any of these suppliers, or any future single source suppliers, could harm our business;
Current wording
We currently engage third-party manufacturers for all of our commercial and clinical supplies. The loss of any of these suppliers, or any future single source suppliers, could harm our business;
Previous wording
We rely on third parties to conduct our preclinical and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain additional regulatory approvals for or commercialize vonoprazan and our business could be harmed;
Current wording
We rely on third parties to conduct our clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to complete ongoing development activities on the timelines we expect and the delays may harm our business;
Previous wording
We rely on the Takeda License to provide us rights to develop and commercialize vonoprazan in the United States, Europe, and Canada. If the license agreement is terminated, we would lose our rights to develop and commercialize vonoprazan.
Current wording
We rely on the Takeda License to provide us rights to develop and commercialize vonoprazan in the United States, Europe, and Canada. If the license agreement is terminated, we would lose our rights to develop and commercialize vonoprazan which would materially adversely affect our business, results of operations, and prospects;
Previous wording
If the scope of any patent protection or non-patent regulatory exclusivity we obtain is not sufficiently broad, or if we lose or fail to obtain any of our patent protection or non-patent regulatory exclusivity, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
Current wording
If the scope of any patent protection or non-patent regulatory exclusivity we obtain is not sufficiently broad, or if we lose or fail to obtain or failure to maintain any of our patent protection or non-patent regulatory exclusivity, our ability to prevent our competitors from commercializing similar or identical products would be adversely affected which could materially and adversely affect our business, results of operations, and prospects;
Previous wording
The successful commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK and Voquezna Dual Pak will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products successfully and decrease our ability to generate revenue;
Current wording
The successful commercialization of VOQUEZNA, Voquezna Dual Pakand VOQUEZNA TRIPLE PAK will depend in part on the extent to which private health insurers and governmental authorities establish and maintain coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products successfully and decrease our ability to generate revenue at the levels we expect which could materially and adversely affect our business, results of operations, and prospects;
Previous wording
If we fail to comply with reporting and payment obligations for VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects;
Current wording
If we fail to comply with reporting and payment obligations for VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and prospects;
Previous wording
We are highly dependent on the services of our key executives and personnel, and if we are not able to retain these members of our management or recruit additional management, clinical and commercial personnel, our business will suffer; and
Current wording
We are highly dependent on the services of our key executives and personnel, and if we are not able to retain these members of our management or recruit additional management, clinical and commercial personnel, our business could suffer; and
Previous wording
Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk.
Current wording
Biopharmaceutical commercialization and product development both involve a substantial degree of risk.
Previous wording
We received our first regulatory approvals in 2022, and prior to our commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in the fourth quarter of 2023, we had not manufactured products on a commercial scale, or arranged for a third party to do so on our behalf or conducted sales and marketing activities necessary for successful commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer history of successfully developing and commercializing products. We expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. We have transitioned from a company with solely a clinical development focus to a company also undertaking commercial activities. We may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in such a transition.
Current wording
We launched VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK in the fourth quarter of 2023. Prior to such launch, we had not conducted sales and marketing activities necessary for successful commercialization of a product or manufactured products on a commercial scale, or arranged for a third party to do so on our behalf. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer history of successfully developing and commercializing products. We expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. We may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in our commercialization or development efforts.
Previous wording
We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
Current wording
We have incurred significant operating losses since inception and may never achieve or maintain profitability.
Previous wording
Since our inception, we have incurred significant operating losses. Our net loss was $334.3 million and $201.6 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $1.3 billion. We expect to continue to incur expenses and operating losses for the foreseeable future. It could be several years, if ever, before VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK or other product candidates, if approved, generate significant revenues to offset these expenses and operating losses. As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain it. The net losses we incur may fluctuate significantly from quarter to quarter and year to year. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will continue as we:
Current wording
Since our inception, we have incurred significant operating losses. Our net loss was $221.2 million and $334.3 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $1.5 billion. Given our limited history as a commercial-stage company, we face numerous risks associated with our ability to achieve operating profitability and cash flow positivity based on expected revenue and expense levels, and there is no certainty that we will achieve operating profitability or cash flow positivity on the timeline we expect or at all, or that, even if we achieve profitability, that we will be able to sustain it. The net losses we incur may fluctuate significantly from quarter to quarter and year to year. We expect to continue to incur significant expenses for the foreseeable future as we:
Previous wording
initiate, continue, or complete planned or ongoing clinical trials for VOQUEZNA, vonoprazan or any future product candidates, including related support activities;
Current wording
conduct clinical trials for new potential indications or formulations of vonoprazan or develop any future product candidates, including related support activities;
Previous wording
pursue regulatory approvals for new indications for vonoprazan and future product candidates that successfully complete clinical trials; and
Current wording
pursue regulatory approvals for new indications or formulations of vonoprazan or future product candidates, if we conduct and successfully complete clinical trials, seek approvals, and engage in commercialization activities related to such indications, formulations or future product candidates, if approved; and
Previous wording
Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, continue our product development efforts, diversify our product candidate pipeline or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
Current wording
Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, continue our product commercialization and development efforts, diversify our product candidate pipeline or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
Previous wording
We may require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Current wording
We may require substantial additional financing to achieve our goals, finance our operations or meet our financial obligations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could materially adversely affect our business.
Previous wording
The development and commercialization of biopharmaceutical product candidates is capital-intensive. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue to achieve product sales for VOQUEZNA and our other approved products and progress our current and planned development programs. In addition, we are required to make milestone and royalty payments to Takeda, from whom we have in-licensed the rights to develop and commercialize vonoprazan in the United States, Europe, and Canada pursuant to the Takeda License. Furthermore, if and to the extent we seek to acquire or in-license additional product candidates in the future, we may be required to make significant upfront payments, milestone payments, and/or royalty payments. If we obtain additional regulatory approvals for vonoprazan or regulatory approval for any future product candidates, we also expect to incur significant additional commercialization expenses related to product manufacturing, marketing, sales and distribution. Because the outcome of any clinical trial is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of vonoprazan for additional populations, such as patients with EoE, or other product candidates. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
Current wording
The development and commercialization of biopharmaceutical products are capital-intensive. We expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we commercialize VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK in the United States, and advance our current, planned or future development programs. In the future, we may decide to expand our commercialization efforts, including increasing our marketing activities or the size of our field force, or to expand our development efforts, including pursuing additional indications or formulations of vonoprazan or acquiring, in-licensing and developing additional product candidates. Any such activities could significantly increase our operating expenses. We cannot reliably estimate the amounts required to generate revenues from VOQUEZNA at the levels we expect, to complete development of additional indications or formulations of vonoprazan or future product candidates, or to successfully commercialize any future products that may be approved. In addition, we are required to make milestone and royalty payments to Takeda, from whom we have in-licensed the rights to develop and commercialize vonoprazan in the United States, Europe, and Canada pursuant to the Takeda License, and we have ongoing financial obligations under our Loan Agreement and RIFA. If we pursue additional product acquisitions or in-licenses, we may also be required to make significant upfront, milestone or royalty payments. We may require additional financing to achieve our goals, finance our operations and meet our financial obligations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, limit, reduce or terminate our commercialization activities, product development programs, or other operations.
Previous wording
We believe that our existing cash and cash equivalents together with the drawdown of the remaining $100 million under our Loan Agreement, with Hercules Capital, or Hercules, are sufficient to fund operations for at least the next 12 months and along with anticipated product revenues and we believe will be sufficient to enable us to reach cashflow positivity. In particular, we expect that these funds will allow us to finance the ongoing launch of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, and any other clinical activities. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop vonoprazan or any future product candidates.
Current wording
We believe that our existing cash and cash equivalents are sufficient to fund operations for at least the next 12 months and along with anticipated product revenues and the $122.2 million of net proceeds from our January 2026 offering, will be sufficient to enable us to reach operating profitability, beginning in the third quarter of 2026, excluding stock-based compensation. We have based these estimates on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to commercialize VOQUEZNA, develop vonoprazan for additional indications or formulations or develop or any future product candidates.
Previous wording
the costs of sales and marketing activities in support of the commercial launch of VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK, or any future product candidate;
Current wording
the costs of sales and marketing activities in support of the continued commercial launch of VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK, or any future product candidates we may choose to pursue, if successfully developed and approved;
Previous wording
the costs associated with hiring additional personnel and consultants as our business grows particularly commercial personnel;
Current wording
the costs associated with hiring additional personnel and consultants as our business grows and enhancing our operational systems;
Previous wording
the costs associated with any products or technologies that we may in-license or acquire.
Current wording
the costs associated with building a portfolio of product candidates through the acquisition or in-license of additional product candidates or technologies, including the terms and timing of establishing and maintaining future collaborations, licenses and other similar arrangement and the costs associated with development of any products or technologies that we may in-license or acquire.
Previous wording
Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.
Current wording
We expect that, for the foreseeable future, our revenues will be derived exclusively from sales of products containing vonoprazan in the U.S., particularly arising from the use of VOQUEZNA in its current indications in the treatment of GERD. Until we can generate a sufficient amount of product revenue and cash flow from operations to achieve profitability and to fund our future growth opportunities, we may need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans.
Previous wording
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through equity offerings, our Loan Agreement with Hercules, our Revenue Interest Financing Agreement, other debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Our Loan Agreement and our Revenue Interest Financing Agreement include, and any future debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. For example, our Loan Agreement with Hercules contains minimum cash and performance financial covenants.
Current wording
We expect to continue to finance our cash needs through revenue from product sales and equity offerings, other debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Our Loan Agreement and our Revenue Interest Financing Agreement include, and any future debt financing and preferred equity financing, if available, may involve agreements that include cash covenants and covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. For example, our Loan
Previous wording
The commercial success of our current products or any future product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payers and others in the medical community.
Current wording
We currently rely entirely on the commercial success of our VOQUEZNA products, which depends upon the degree of market acceptance of such products by physicians, patients, healthcare payers and others in the medical community.
Previous wording
VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and any future product candidates, if approved, may not be commercially successful. The commercial success of our current products or any future product candidates will depend significantly on the broad adoption and use of such product by physicians and patients for approved indications. The degree of market acceptance of our current products or any future products, if approved, will depend on a number of factors, including:
Current wording
We currently depend entirely on the success of our approved VOQUEZNA products, and we may not be able to successfully commercialize such products or achieve revenues at the level and timing we expect. The commercial success of our approved products will depend significantly on the broad adoption and use of such products by physicians and patients for the approved indications. The degree of market acceptance of our current products or any product candidates, if approved, will depend on a number of factors, including:
Previous wording
the effectiveness of our or any of our potential future collaborators’ sales and marketing strategies; and
Current wording
the effectiveness of our or any of our potential future collaborators’ sales and marketing strategies;
Previous wording
the indications for which our current or any future product candidates are approved;
Current wording
the indications for which our current product or any product candidates are approved;
Previous wording
If our current products or any future product candidates, if approved, does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payers or patients, we may not generate sufficient revenue from that product and may not become or remain profitable. Our efforts to educate the medical community and third-party payers regarding the benefits of our products may require significant resources and may never be successful.
Current wording
If VOQUEZNA, or any product candidate, if approved, does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payers or patients, we may not generate revenue at the levels or on the timing we expect which could have a material adverse effect on our business, financial condition, results of operations and prospects. Our efforts to educate the medical community and third-party payers regarding the benefits of our products may require significant resources and may never be successful.
Previous wording
Takeda has the right to develop and commercialize vonoprazan outside of the United States, Europe, and Canada and has received marketing approval for vonoprazan in numerous countries in Asia and Latin America as well as in Russia. We have little or no control over Takeda’s commercialization activities with respect to vonoprazan outside of our licensed territories even though those activities could impact our ability to successfully commercialize vonoprazan. For example, Takeda can make statements or use promotional materials with respect to vonoprazan outside of our licensed territories that are inconsistent with our positioning of the product in the United States, Europe, and Canada, and could sell vonoprazan in foreign countries at prices that are dramatically lower than the prices we would charge in our licensed territories. These activities and decisions, while occurring outside of our licensed territories, could harm our commercialization strategy. In addition, product recalls or safety issues with vonoprazan outside our licensed territories could result in serious damage to the brand and impair our ability to successfully market our products containing vonoprazan in our licensed territories.
Current wording
Takeda has the right to develop and commercialize vonoprazan outside of the United States, Europe, and Canada and has received marketing approval for vonoprazan in numerous countries in Asia and Latin America as well as in Russia. We have no control over Takeda’s commercialization activities with respect to vonoprazan outside of our licensed territories even though those activities could impact our ability to successfully commercialize vonoprazan. For example, Takeda can make statements or use promotional materials with respect to vonoprazan outside of our licensed territories that are inconsistent with our positioning of the product in the United States, and could sell vonoprazan in foreign countries at prices that are dramatically lower than the prices we would charge in our licensed territories. These activities and decisions, while occurring outside of our licensed territories, could harm our commercialization strategy. In addition, product recalls or safety issues with vonoprazan outside our licensed territories could result in serious damage to the brand and impair our ability to successfully market our products containing vonoprazan in our licensed territories.
Previous wording
We may lack the necessary expertise, personnel and resources to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and any future product candidates that may receive regulatory approval, on our own or together with collaborators.
Current wording
We may lack the necessary expertise, personnel and resources to successfully commercialize VOQUEZNA, VOQUEZNA DUAL PAK, and VOQUEZNA TRIPLE PAK and any future product candidates that may receive regulatory approval, on our own or together with collaborators.
Previous wording
Until 2023, our operations were primarily limited to organizing and staffing our company, business planning, raising capital, acquiring the rights to, and undertaking clinical trials of, vonoprazan. Although we started developing marketing and distribution capabilities in 2021 in advance of the planned commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, due to approval and launch delays, we did not hire our field force until late 2023. The success of the commercialization of our approved products in the United States and any of our future product candidates that may be approved by the FDA will depend on such marketing, sales and distribution capabilities. Factors that may affect our ability to commercialize our approved products and future product candidates successfully on our own include obtaining access to or persuading adequate numbers of physicians to prescribe our products. Building and maintaining a sales and marketing organization has required, and will continue to require, significant investment, and is time-consuming. Our sales and marketing organization may prove not to be effective. If we are unable to maintain effective sales and marketing capabilities for our approved products including VOQUEZNA, or to find suitable partners for such commercialization, we may have difficulties generating revenue from them.
Current wording
Until 2023, our operations were primarily limited to organizing and staffing our company, business planning, raising capital, acquiring the rights to, and undertaking clinical trials of, vonoprazan. Although we started developing marketing and distribution capabilities in 2021 in advance of the then planned commercialization of VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK, due to approval and launch delays, we did not hire our field force until late 2023. The success of commercialization of our approved products in the United States and any of our future product candidates that may be successfully developed and approved by the FDA will depend on such marketing, sales and distribution capabilities or any additional capabilities we may build. Factors that may affect our ability to commercialize successfully our approved products and future product candidates, if any, on our own include obtaining access to or persuading adequate numbers of physicians to prescribe our products for the approved indications. Building and maintaining a sales and marketing organization has required, and will continue to require, significant investment, and is time-consuming. Our sales and marketing organization and strategy may prove not to be effective. If we are unable to maintain effective sales and marketing capabilities for our approved products including VOQUEZNA, or to adopt a successful strategy, or to find suitable partners for such commercialization, we may have difficulties generating revenue at the levels and on the timing we expect, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
Previous wording
With respect to VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and any future product candidates, the FDA, EMA or other comparable regulatory authority may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly and time-consuming post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the product. The FDA and comparable regulatory authorities may also require a risk evaluation and mitigation strategy, or REMS, or similar risk management measures as a condition of approval of any future product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, for our approved products or future products that obtain approval, particularly following commercial launch of any such products, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our products will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and similar requirements and GCP requirements for any clinical trials that we conduct. Later discovery of previously unknown problems with our products, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
Current wording
In connection with approval of a pharmaceutical product, regulatory authorities may impose ongoing requirements for potentially costly and time-consuming post-approval studies, post-market surveillance or clinical trials to monitor the safety and efficacy of the product. For example, with respect to VOQUEZNA our post-marketing requirements include pregnancy registries and pediatric studies. The FDA and comparable regulatory authorities may also require a risk evaluation and mitigation strategy, or REMS, or similar risk management measures as a condition of approval of any future product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, the manufacture, labeling, packaging, distribution, adverse-event reporting, storage, advertising, promotion, import, export and recordkeeping for our approved products, as well as for any future product candidates that may receive regulatory approval, are subject to extensive and ongoing regulatory requirements. These requirements include periodic safety reporting, facility registration, inspections, and continued compliance with current good manufacturing practices, or cGMPs, as well as good clinical practice, or GCP requirements for any clinical trials we conduct.
Previous wording
The occurrence of any event or penalty described above may inhibit our ability to commercialize our current products and any future product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity.
Current wording
The occurrence of any event or penalty described above may inhibit our ability to commercialize our current products or any future product candidates and impair our ability to generate revenue and could require us to expend significant time and resources in response or generate negative publicity. In addition, regulatory requirements and policies are subject to change. New laws, regulations or guidance, or changes in interpretation or enforcement of existing requirements, could increase the cost or complexity of maintaining compliance or pursuing additional indications, formulations or product candidates. If we are slow or unable to adapt to regulatory changes or maintain compliance, we could be subject to enforcement actions. Any of the consequences of these events could have a material adverse effect on our business, financial condition, results of operations and prospects.
Previous wording
The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products such as our currently approved products, and any additional product candidates containing vonoprazan and any future product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. For example, the FDA has approved VOQUEZNA for the treatment for healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults, for the relief of heartburn associated with Non-Erosive GERD in adults and, in combination with either amoxicillin, or amoxicillin and clarithromycin, treatment of H. pylori infection in adults, and we are not currently permitted to promote this product for any other uses unless and until such uses are approved by the FDA. For any product for which we have obtained a marketing approval, however, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our current products or any product candidates, we could become subject to significant liability, which would materially adversely affect our business and financial condition.
Current wording
The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products such as our currently approved products, and any additional product candidates containing vonoprazan and any future product candidates, if successfully developed and approved. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. For example, the FDA has approved VOQUEZNA for the treatment for healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults, for the relief of heartburn associated with Non-Erosive GERD in adults and, in combination with either amoxicillin, or amoxicillin and clarithromycin, treatment of H. pylori infection in adults, and we are not currently permitted to promote this product for any other uses unless and until such uses are approved by the FDA. For any product for which we have obtained a marketing approval, however, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our current products or any product candidates we may successfully develop in the future, we could become subject to significant liability, which would materially adversely affect our business and financial condition.
Previous wording
The successful commercialization of our current products or any future product candidate, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
Current wording
Successful commercialization of our current products or any future product candidate, will depend in part on the extent to which private health insurers or governmental authorities provide and maintain coverage with adequate reimbursement levels and without onerous utilization management requirements. Failure to obtain or maintain favorable pricing and adequate coverage and reimbursement policies for our products could limit our ability to market those products and decrease our ability to generate revenue at the levels and on the timelines we expect.
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Current report — wording carried from elsewhere
the timing and impact of our obligations under our Loan and Security Agreement with Hercules Capital, Inc., and our Revenue Interest Financing Agreement; and
Current report — wording carried from elsewhere
Agreement with Hercules contains minimum cash and performance financial covenants and our Revenue Interest Financing Agreement also contains minimum cash covenants.
Current report — wording carried from elsewhere
The later discovery of previously unknown problems with our products, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:
Current report — wording carried from elsewhere
The success of vonoprazan for additional indications or formulations we may pursue and of any future product candidates will depend on several additional factors, including:
Current report — wording carried from elsewhere
Further, as of December 31, 2025, three customers accounted for 78% of our accounts receivable balance, with each of these individual customers ranging from 19% to 30% of the accounts receivable balance. As a result, we are exposed to credit risk from these customers and if any of these customers were to fail to pay us in a timely manner, our cash flows could be materially harmed.
Current report — wording carried from elsewhere
To meet our obligations under the Revenue Interest Financing Agreement, including meeting future cash covenants and Minimum Amounts, we need to generate cash from our operating activities. Our ability to generate cash from our operating activities is subject, in part, to our ability to successfully execute our business strategy, as well as general economic, financial, competitive, regulatory and other factors beyond our control. Our business may not be able to generate sufficient cash flow from operations, and future borrowings or other financings may not be available to us, in an amount sufficient to enable us to meet our obligations under the Revenue Interest Financing Agreement and fund our other liquidity needs. A failure to meet our obligations under the Revenue Interest Financing Agreement could have a material adverse effect on our business, financial condition and results of operations.
Current report — wording carried from elsewhere
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, beginning April 1, 2013, Medicare payments to providers were reduced under the sequestration required by the Budget Control Act of 2011, which will remain in effect through 2032, unless additional Congressional action is taken. Additionally, on
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Previous report — wording carried elsewhere
We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future;
Previous report — wording carried elsewhere
We will also face competition in establishing clinical trial sites, enrolling patients for clinical trials and in identifying and in-licensing new product candidates. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Previous report — wording carried elsewhere
Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. If a prolonged government shutdown occurs, or if funding shortages, staffing limitations or renewed global health concerns hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.