Item 1A. Risk Factors

You should carefully consider the following risk factors, together with the other information contained in this annual report on Form 10-K, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before making a decision to purchase or sell shares of our common stock. We cannot assure you that any of the events discussed in the risk factors below will not occur. These risks could have a material and adverse impact on our business, results of operations, financial condition and growth prospects. If that were to happen, the trading price of our common stock could decline. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations or financial condition. In this section, we first provide a summary of the more principal risks and uncertainties we face and then provide a full set of risk factors and discuss them in greater detail.

SUMMARY RISKS FACTORS

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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;

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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;

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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;

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Our Revenue Interest Financing Agreement could limit cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations;

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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;

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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;

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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;

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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;

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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;

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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;

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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;

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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;

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The successful commercialization of VOQUEZNA, Voquezna Dual Pak and 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;

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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;

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We are subject to various foreign, federal, and state healthcare and privacy laws and regulations, and our failure to comply with these laws and regulations could harm our results of operations and financial condition;

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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

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The trading price of our securities is likely to be volatile, and purchasers of our securities could incur substantial losses.

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

We have a limited operating history as a commercial company, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

Biopharmaceutical commercialization and product development both involve a substantial degree of risk.

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.

We have incurred significant operating losses since inception and may never achieve or maintain profitability.

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:

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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;

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conduct clinical trials for new potential indications or formulations of vonoprazan or develop any future product candidates, including related support activities;

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make required royalty payments under the Revenue Interest Financing Agreement, or RIFA, entered into in May 2022, as amended;

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make required payments under the Loan and Security Agreement with Hercules Capital, Inc., or Loan Agreement, entered into in September 2021, as amended;

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build a portfolio of product candidates through the acquisition or in-license of additional product candidates or technologies;

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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

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incur additional legal, accounting and other expenses in connection with operating as a public company.

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.

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.

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.

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.

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.

Our future capital requirements will depend on many factors, including:

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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;

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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;

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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;

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the initiation, type, number, scope, results, costs and timing of our clinical trials of vonoprazan, and preclinical studies or clinical trials of other potential product candidates we may choose to pursue in the future, including feedback received from regulatory authorities;

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the costs, timing and outcome of regulatory review of future vonoprazan applications or such applications for any future product candidates;

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the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights, and the success of our enforcement efforts;

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the timing of market introduction, profile and impact of competitive products;

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the costs associated with hiring additional personnel and consultants as our business grows and enhancing our operational systems;

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the timing and amount of the milestone or other payments we must make to Takeda and any future licensors;

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the timing and impact of our obligations under our Loan and Security Agreement with Hercules Capital, Inc., and our Revenue Interest Financing Agreement; and

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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.

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.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

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

Agreement with Hercules contains minimum cash and performance financial covenants and our Revenue Interest Financing Agreement also contains minimum cash covenants.

If we raise funds through future collaborations, licenses and other similar arrangements, we may have to relinquish valuable rights to our future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock.

Risks Related to Commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and Any Future Product Candidates

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.

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:

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acceptance of our products for the relevant indication by healthcare providers and their patients;

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the pricing and cost-effectiveness of our products, as well as the cost of treatment with our products in relation to alternative treatments and therapies;

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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;

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the willingness of patients to pay all, or a portion of, out-of-pocket costs associated with our products in the absence of sufficient third-party coverage or adequate reimbursement;

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demonstration of clinical efficacy and safety compared to other more-established products;

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the timing of market introduction, profile and impact of competitive drugs;

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the effectiveness of our or any of our potential future collaborators’ sales and marketing strategies;

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the indications for which our current product or any product candidates are approved;

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the limitation of our targeted patient population and other limitations or warnings contained in any FDA-approved labeling or comparable approved labeling;

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any restrictions on the use of our products, and the prevalence and severity of any adverse effects;

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potential product liability claims; and

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unfavorable publicity relating to the product.

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.

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.

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.

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.

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.

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.

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:

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restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

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restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;

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fines, restitutions, disgorgement of profits or revenues, warning letters, untitled letters or holds on clinical trials;

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refusal by the FDA or comparable foreign regulatory authority to approve pending applications or supplements to approved applications filed by us or suspension or revocation of approvals;

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product seizure or detention, or refusal to permit the import or export of our products; and

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injunctions or the imposition of civil or criminal penalties.

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.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.

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 treatmentfor 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.

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.

The availability of coverage and the adequacy of reimbursement for VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK by private health insurers, governmental healthcare programs, such as Medicare and Medicaid, and other third-party payers are essential for most patients to be able to afford these medications, and will be essential with respect to any future product candidates that may be successfully developed and approved. Even when coverage is available, third-party payers may impose utilization management requirements, such as prior authorization, step therapy, quantity limits or other restrictions, which may delay or limit patient access, reduce prescribing, or increase administrative burden on healthcare providers. These access requirements may negatively affect adoption and persistence of our products in clinical practice. Our ability to achieve and maintain coverage and acceptable levels of reimbursement for our approved products by third-party payers will have an effect on our ability to successfully commercialize those products. Even if we obtain coverage for a given product by a third-party payer without onerous management utilization requirements, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Coverage and reimbursement policies for our approved products may be changed, reduced or eliminated over time, and we cannot be certain that coverage and reimbursement in the United States, the European Union, or elsewhere will be available for any product that we may develop in the future.

Third-party payers increasingly are challenging prices charged for pharmaceutical products and services, and many third-party payers may refuse to provide coverage and reimbursement for particular drugs when an equivalent generic drug or a less expensive therapy is available. It is possible that a third-party payer may consider our products as substitutable and only offer to reimburse patients for the less expensive product or with onerous restrictions. For example, utilization management with respect to VOQUEZNA in the treatment of GERD is largely defined by a generic PPI step edit via a prior authorization. Even if we are successful in demonstrating improved efficacy or improved convenience of administration with our future product candidates, if any, pricing of existing drugs may limit the amount we will be able to charge for our products. These payers may deny or revoke the reimbursement status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our products and may not be able to obtain a satisfactory financial return on products that we may develop.

There is significant uncertainty related to third-party payer coverage and reimbursement of newly approved products. In the United States, third-party payers, including private and governmental payers, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs will be covered. Some third-party payers may require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this time what third-party payers will decide with respect to the coverage and reimbursement for our products.

Obtaining and maintaining reimbursement status is time consuming, costly and uncertain. The Medicare and Medicaid programs increasingly are used as models for how private payers and other governmental payers develop their coverage and reimbursement policies for drugs. However, no uniform policy for coverage and reimbursement for products exists among third-party payers in the United States. Therefore, coverage and reimbursement for products can differ significantly from payer to payer. As a result, the coverage determination process may require us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

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.

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.

If we fail to comply with reporting and payment obligations 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, results of operations and prospects.

We participate in various governmental pricing and reimbursement programs, including the Medicaid Drug Rebate Program, or MDRP, that impose extensive drug price reporting and payment obligations on pharmaceutical manufacturers. Medicaid is a joint federal and state program administered by the states for low-income and disabled beneficiaries, and Medicare is a federal program administered by the federal government for individuals age 65 and older and certain disabled individuals.

Under the MDRP, as a condition of having federal funds being made available to the states for covered outpatient drugs under Medicaid and, if applicable, Medicare Part B, pharmaceutical manufacturers must enter into a rebate agreement with the Secretary of Health and Human Services and pay rebates to state Medicaid programs for each unit of covered outpatient drug dispensed to a Medicaid beneficiary and paid for by the state Medicaid program. Medicaid drug rebates are based on pricing data that pharmaceutical manufacturers report on a monthly and quarterly basis to the U.S. Centers for Medicare & Medicaid Services, or CMS, which is the federal agency that administers the MDRP and Medicare programs. For the MDRP, these data include the average manufacturer price, or AMP, for each drug and, in the case of innovator products, the Best Price, or BP, which represents the lowest price available from the manufacturer to any entity in the United States in any pricing structure, calculated to include all applicable sales and associated rebates, discounts and other price concessions. Manufacturers are required to submit pricing data on a monthly and quarterly basis and to correct and resubmit data for prior periods if inaccuracies are identified. If a manufacturer fails to provide information timely or is found to have knowingly submitted false information to the government, the manufacturer may be subject to civil monetary penalties and other sanctions, including termination from the MDRP.

Participation in the MDRP also requires participation in the Public Health Service’s 340B drug pricing program, or the 340B program, which is administered by the Health Resources and Services Administration, or HRSA. The 340B program requires participating manufacturers to agree to sell covered outpatient drugs to covered entities at or below a statutorily defined “ceiling price” which is calculated using MDRP pricing data. Manufacturers must report 340B ceiling prices to HRSA on a quarterly basis, and HRSA publishes them to 340B covered entities. Failure to comply with 340B requirements may subject manufacturers to civil

monetary penalties, repayment obligations, and administrative dispute resolution proceedings. Legislative or regulatory changes could further expand the scope or obligations of the 340B program.

In order to be eligible to have drug products paid for with federal funds under Medicaid and, if applicable, Medicare Part B, and purchased by certain federal agencies and grantees, a manufacturer must also participate in the U.S. Department of Veterans Affairs, or VA, Federal Supply Schedule, or FSS, pricing program. Under the VA/FSS program, a manufacturer must report the Non-Federal Average Manufacturer Price, or Non-FAMP, for its covered drugs to the VA and charge certain federal agencies no more than the Federal Ceiling Price, which is calculated based on Non-FAMP using a statutory formula. These federal agencies are the VA, the U.S. Department of Defense, the U.S. Coast Guard, and the U.S. Public Health Service (including the Indian Health Service). The manufacturer must also pay rebates on products purchased by military personnel and dependents through the TRICARE retail pharmacy program. If a manufacturer participating in the FSS program fails to provide timely information or is found to have knowingly submitted false information, the manufacturer may be subject to civil monetary penalties.

Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by pharmaceutical manufacturers, governmental or regulatory agencies, and the courts, which can change and evolve over time. Compliance with these requirements, including any necessary recalculations or restatements, may increase administrative burden and costs and could result in additional rebate liabilities or penalties for prior periods. We cannot assure you that our pricing submissions will not be found to be incomplete or incorrect, and any failure to comply with these requirements could materially adversely affect our business, results of operations and prospects

Individual states continue to consider and have enacted legislation to limit the growth of healthcare costs, including the cost of prescription drugs and combination products. A number of states have either implemented or are considering implementation of drug price transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies. Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and factors considered by manufacturers in taking such increases, wholesale acquisition cost disclosure to prescribers, purchasers, and state agencies, and new product notice and reporting. Such legislation could limit the price or payment for certain drugs, and a number of states are authorized to impose civil monetary penalties or pursue other enforcement mechanisms against manufacturers who fail to comply with drug price transparency requirements, including the untimely, inaccurate, or incomplete reporting of drug pricing information. If we are found to have violated state law requirements, we may become subject to penalties or other enforcement mechanisms, which could have a material adverse effect on our business.

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.

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. Our competitors have developed, are developing or may develop products, product candidates and processes competitive with VOQUEZNA. Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. We believe that a significant number of products are currently under development, and may become commercially available in the future, for the treatment of GI diseases for which we may attempt to develop vonoprazan or any future product candidates. Our competitors include larger and better funded pharmaceutical, biopharmaceutical, biotechnological and therapeutics companies. Moreover, we may also compete with universities and other research institutions who may be active in the indications we are targeting and could be in direct competition with us. We also compete with these organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business plan. 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.

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.

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.

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.

In July 2012, the Food and Drug Administration Safety and Innovation Act was passed, which included the GAIN Act. The GAIN Act is intended to provide incentives for the development of new, qualified infectious disease products. In December 2016, the 21st Century Cures Act was passed, providing additional support for the development of new infectious disease products. These incentives may result in more competition in the market for new antibiotics and may cause pharmaceutical and biotechnology companies with more resources than we have to shift their efforts towards the development of product candidates that could be competitive with vonoprazan or any future product candidates.

Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. We will face competition for our current products and any future product candidates based on many different factors, including the safety and effectiveness of our products, the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration, the scope of regulatory approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position. Competing products could present superior treatment alternatives, including by being more effective, safer, more convenient, less expensive or marketed and sold more effectively than any products we may develop. Competitive products may make any products we develop obsolete or noncompetitive before we recover the expense of developing and commercializing our current products or any future product candidates. If we are unable to compete effectively, our opportunity to generate revenue from the sale of our products we may develop, if approved, could be adversely affected.

If the market opportunities for our approved products, including VOQUEZNA, or for any future product candidates we may develop, are smaller than we expect, our business, results of operations and prospects could be adversely affected.

The precise incidence and prevalence for all the conditions we aim to address with our approved products as well as any future product candidates we may successfully develop are not known with certainty. Our projections of the number of people who have these diseases we target, and the subset of people with these diseases who have the potential to benefit from treatment of our approved products or any future product candidates, are based on our beliefs and estimates and assumptions derived from a variety of sources, including scientific literature, market research and surveys, and claims analysis, and may prove to be incorrect. In addition, future clinical studies or changes in medical practice may alter estimates of disease prevalence or treatment patterns.

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.

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.

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.

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.

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.

Our future growth may depend, in part, on our ability to operate in foreign markets, particularly Europe and Canada, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future growth may depend, in part, on our ability to develop and commercialize our current products and any future product candidates in foreign markets, particularly Europe and Canada. We are not permitted to market or promote vonoprazan and any future product candidates before we receive regulatory approval from applicable regulatory authorities in foreign markets, and we may never seek or receive such regulatory approvals for vonoprazan or any future product candidates. To obtain separate regulatory approval in any other countries we must comply with numerous and varying regulatory requirements regarding safety and efficacy and governing, among other things, clinical trials, commercial sales, pricing and distribution of vonoprazan and any future product candidates. If we obtain regulatory approval of our current products and any future product candidates and ultimately commercialize our products in foreign markets, we would be subject to additional risks and uncertainties, including:

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different regulatory requirements for approval of drugs in foreign countries;

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reduced protection for intellectual property rights;

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the existence of additional third-party patent rights of potential relevance to our business;

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unexpected changes in tariffs, trade barriers and regulatory requirements;

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economic weakness, including inflation, public health emergencies or political instability in particular foreign economies and markets;

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compliance with tax, employment, immigration and labor laws for employees living or traveling internationally;

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foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

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foreign reimbursement, pricing and insurance regimes;

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workforce uncertainty in countries where labor unrest is common;

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production shortages resulting from any events affecting raw material supply or manufacturing capabilities internationally; and

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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

Risks Related to the Development and Regulatory Approval of Product Candidates

Our future growth depends on our ability to develop vonoprazan for additional indications or formulations and to successfully develop or acquire additional product candidates.

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 candidatesand 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.

The testing, manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain, subject to comprehensive regulation by the FDA and similar foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical studies and clinical trials that the product candidate is safe and effective for use in each target indication. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. As a result, 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. Failure to obtain regulatory approval for additional indications or formulations for vonoprazan that we may pursue or future product candidates in the United States will prevent us from commercializing in such new indications or as to such additional products.

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:

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completing clinical trials that demonstrate their efficacy and safety;

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receiving marketing approvals from applicable regulatory authorities;

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completing any post-marketing studies required by applicable regulatory authorities;

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maintaining adequate manufacturing capabilities;

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achieving market acceptance by patients, the medical community and third-party payers, including adequate coverage and reimbursement;

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maintaining successful commercial sales, marketing and distribution operations;

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maintaining a continued acceptable safety profile following approval;

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competing effectively with other therapies; and

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obtaining and maintaining robust intellectual property protection or regulatory exclusivities.

Many of these factors are beyond our control, including the time needed to adequately complete clinical testing, the outcome of such trials, the regulatory review process, potential challenges to our intellectual property rights and changes in the competitive landscape. It is possible that no new indications or formulations for vonoprazan and no future product candidates will ever be successfully developed and obtain regulatory approval even if we expend substantial time and resources conducting development programs and seeking such approval. If we are unable to achieve these objectives in a timely manner or at all, our ability to grow our business could be materially adversely affected.

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.

Clinical drug development is expensive, time-consuming and inherently uncertain, and the results of preclinical studies and early clinical trials are not necessarily predictive of results in later-stage trials. Even if we believe that interim or early clinical results are positive, such results may not be indicative of final outcomes, and product candidates may fail to demonstrate sufficient safety or efficacy despite progressing through earlier stages of development. Many companies in the pharmaceutical and biotechnology industries have experienced significant setbacks in clinical development after achieving promising early results.

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.

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.

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.

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.

Use of VOQUEZNA, VOQUEZNA Dual Pak or VOQUEZNA Triple Pak, any new vonoprazan formulation we may develop, or any future product candidates could be associated with side effects, adverse events or other safety risks, which could cause us to have to withdraw the product or could materially impair market acceptance, in the case of approved products, or cause us to suspend or discontinue clinical trials, abandon development, or narrow the target indications or patient population, in the case of product candidates, or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.

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.

If any of our product candidates is associated with undesirable side effects, adverse events or product characteristics in preclinical studies or clinical development, including development of vonoprazan in new indications or formulations, we may elect to abandon development of such product candidate, alter or delay our study plans, or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Any drug-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Even if we continue with development of such product candidates, the undesirable side effects, adverse events or product characteristics may cause us to have to conduct additional safety studies, limit our ability to gain regulatory approval or cause a regulatory authority to require warnings on the label, such as a “black box” warning or contraindications, or to impose other significant restrictions on our approval, any of which may limit the commercial expectations for the product candidate, if approved.

If any of our approved products is associated with undesirable side effects or adverse events or to have other negative product characteristics, a number of potentially significant negative consequences could result, including:

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withdrawal, suspension or limitation by regulatory authorities of approvals of such product;

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seizure of the product by regulatory authorities;

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recall of the product or changes to the manner in which it is administered;

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restrictions on the marketing of the product or the manufacturing process for any component thereof;

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requirements by regulatory authorities of additional warnings on the label, such as a “black box” warning or contraindications;

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requirements that we implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients;

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requirements to conduct expensive additional post-approval safety studies;

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failure to achieve or maintain market acceptance among patients, healthcare providers and patients;

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initiation of regulatory investigations and government enforcement actions;

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initiation of legal action against us to hold us liable for harm caused to patients; and

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harm to our reputation and resulting harm to physician or patient acceptance of our products.

Any of these events could significantly harm our business, financial condition, results of operations and prospects.

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.

We are not permitted to market a new product candidate or an approved product for a new indication or formulation until we receive the necessary regulatory approval from the relevant regulatory authority. Gaining regulatory approval of a product candidate is subject to extensive regulation by the FDA in the United States and by comparable foreign regulatory authorities in other foreign markets. The process of obtaining regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels and the ability to hire and retain key personnel. In addition, approval policies or regulations may change, and the FDA and EMA and comparable regulatory authorities have substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed.

Prior to obtaining approval to commercialize a product candidate in the United States or internationally, we must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for additional regulatory approvals for vonoprazan or for any future product candidates are promising, such data may not be sufficient to support approval by the FDA and comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials either prior to or post- approval, or may object to elements of our clinical development program.

The FDA, EMA or other comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:

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such authorities may disagree with the design or implementation of our clinical trials;

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negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance required by the FDA, EMA, or other comparable foreign regulatory agencies for approval;

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serious and unexpected drug-related side effects may arise;

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the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;

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such authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that of the United States;

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we may be unable to demonstrate to the satisfaction of such authorities that the product candidate is safe and effective for its proposed indication and that its clinical and other benefits outweigh its safety risks;

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such authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

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such authorities may not agree that the data collected from clinical trials are acceptable or sufficient to support the submission of an NDA, sNDA or other submission or to obtain regulatory approval, and such authorities may impose requirements for additional preclinical studies or clinical trials;

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such authorities may disagree regarding the proposed formulation, labeling and/or the specifications;

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approval may be granted only for indications that are significantly more limited than what we apply for and/or with other significant restrictions on distribution and use;

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such authorities may find deficiencies in the manufacturing processes or facilities of Evonik, Catalent, Sandoz, or any future third-party manufacturers with which we contract for clinical and commercial supplies;

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regulations of such authorities may significantly change in a manner rendering our clinical data insufficient for approval; or

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such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission.

With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities. In addition, events raising questions about the safety of certain marketed pharmaceuticals may result in increased cautiousness by the FDA, EMA, and other comparable foreign regulatory authorities in reviewing new drugs, new indications or new formulations based on safety, efficacy, or other regulatory considerations and may result in significant delays in obtaining regulatory approvals.

With respect to our approvals in the U.S., the FDA has granted approvals, and may grant future approvals, with the requirement that we perform additional costly clinical trials, including pediatric trials. Foreign regulatory authorities may also make their approvals contingent on similar requirements. The FDA or other comparable foreign regulatory authority also may approve a product candidate for a more limited indication or patient population than we originally requested, and the FDA or other comparable foreign regulatory authority may not approve the labeling that we believe is necessary or desirable for the successful commercialization of a product.

Of the large number of drugs in development, only a small percentage successfully complete the FDA, EMA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results and regulatory decisions may result in our failing to obtain additional regulatory approvals to market vonoprazan in additional indications, or formulations or any future product candidates we may pursue. Any delay in obtaining, or inability to obtain, additional regulatory approvals, and any limitations on such approvals would delay or prevent commercialization of that indication or product candidate and would materially adversely impact our business and prospects, which would significantly harm our business, financial condition, results of operations and prospects.

We may not be successful in our efforts to expand our pipeline by pursuing and developing vonoprazan for additional indications and formulations. We may decide not to pursue additional indications or formulations, at all or we may expend our limited resources to pursue a particular indication or formulation for vonoprazan and fail to capitalize on indications or formulations or other product candidates for which there may be a greater likelihood of success or that may be more profitable.

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.

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.

In addition, we may seek to expand our pipeline through in-licenses or acquisitions of development-stage assets or programs, which entails additional risk to us. Identifying, evaluating and acquiring promising product candidates requires substantial technical, financial and human resources. Efforts to do so may not result in the actual acquisition or license of a particular product candidate, potentially diverting management’s attention and our resources without corresponding benefit.

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.

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.

We may conduct future clinical trials outside the United States for vonoprazan or any future product candidates. Although the FDA may accept data from clinical trials conducted outside the United States and not subject to an investigational new drug application, or IND, acceptance of such data is subject to certain conditions imposed by the FDA. For example, regardless of whether the applicable clinical trials were conducted under an IND, where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the United States population and United States medical practice; the trials were performed by clinical investigators of recognized competence; and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Similar requirements may apply in foreign jurisdictions. For trials that are conducted only at sites outside of the United States and not subject to an IND, the FDA requires the clinical trial to have been conducted in accordance with GCP and the FDA must be able to validate the data from the clinical trial through an on-site inspection if it deems such inspection necessary. For trials conducted outside the United States and not under an IND, the FDA generally does not provide advance input on trial design or protocols, which increases the risk that the FDA may later determine that such trials were inadequate and require additional clinical studies. In addition, foreign trials are subject to local laws and regulatory requirements, and there can be no assurance that the FDA or other regulatory authorities will accept data from such trials.

If regulatory authorities do not accept data from our foreign clinical trials for future regulatory submissions, we may be required to conduct additional clinical trials, which would be costly and time consuming and could delay or prevent our development efforts.

Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:

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additional foreign regulatory requirements;

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foreign exchange fluctuations;

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compliance with foreign manufacturing, customs, shipment and storage requirements;

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cultural differences in medical practice and clinical research; and

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diminished protection of intellectual property in some countries.

Interim, top-line and preliminary data from clinical trials that we or others announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. Even if final data from a clinical trial are positive, such results may not be replicated or confirmed in subsequent clinical trials.

From time to time, we or others, may publicly disclose preliminary or top-line data from clinical trials that are based on a preliminary analysis of then-available data and may be subject to change following more careful review and finalization of the results. Interim data are subject to the risk that the results and related findings and conclusions may change materially as patient enrollment continues, additional data are collected, longer follow-up periods are completed, or assumptions and conclusions change following a more comprehensive review of the data. As a result, the top-line or preliminary results that we or others report may differ from future results of the same clinical trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously published. As a result, top-line and preliminary data should be viewed with caution until the final data are available. Adverse differences between interim, preliminary or top-line data and final results could significantly harm our business prospects.

Even if final data from a clinical trial are positive, such results may not be replicated or confirmed in subsequent clinical trials, including larger trials, trials in different patient populations, or trials designed to support additional indications or regulatory approvals. Failure to replicate clinical results could limit, delay or prevent regulatory approval, restrict labeling, reduce commercial potential, or otherwise adversely affect the value of a product or development program.

Further, regulatory agencies and other third parties may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could affect further development, approvability, labeling, or commercialization of a particular product candidate or product. In addition, the information we publicly disclose regarding a clinical trial necessarily reflects our judgment regarding what is material or appropriate, and other parties may disagree with those judgments or later view omitted information as significant.

If the preliminary, interim or top-line data we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, are not replicated in subsequent studies, or are interpreted differently by regulatory authorities or other third parties, our ability to obtain regulatory approval for, or successfully commercialize, our current products or any future product candidates could be materially adversely affected, which could harm our business, financial condition, results of operations and prospects.

Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, government shutdowns or policy changes could delay regulatory review and approval processes and adversely affect our business.

The ability of the FDA and other government agencies to review and approve new or supplemental drug applications, modifications to approved products, or clinical development of new product candidates can be affected by a variety of factors, including government budget and funding levels, government shutdowns, statutory, regulatory and policy changes, a government agency’s ability to hire and retain key personnel, their ability to accept the payment of user fees, and other events that may otherwise impair the government agency’s ability to perform routine functions. As a result, average review times at the FDA and other government agencies have fluctuated in recent years. In addition, government funding for agencies 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 review or approval of new drugs, supplements or modifications to approved drugs or review of clinical trials, which could adversely affect our business. For example, in recent years, the United States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, which have led to substantial personnel changes, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities. If a prolonged government shutdown occurs, or if funding shortages, staffing limitations or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Risks Related to Our Reliance on Third Parties

Pursuant to the Takeda License, we have secured an exclusive license from Takeda to commercialize vonoprazan products using specified formulations for all human therapeutic uses in the United States, Europe, and Canada, and a non-exclusive license to develop and manufacture vonoprazan products anywhere in the world (subject to Takeda’s consent as to each country) for the purposes of commercializing the vonoprazan products in the United States, Europe, and Canada.

The Takeda License will continue until the expiration of the obligation to pay royalties in all countries and on all products, unless terminated earlier. We may terminate the Takeda License in its entirety without cause upon prior written notice. We and Takeda may terminate the Takeda License in the case of the other party’s insolvency or for the other party’s material uncured breach. Takeda may terminate the Takeda License in its entirety if we challenge the licensed patents, or if we assist any third party in challenging such patents. In addition, if any of the commercial milestones or other cash payments become due under the terms of the Takeda License, we may not have sufficient funds available to meet our obligations, which would allow Takeda to terminate the Takeda License. If the license agreement is terminated, we would lose our rights to develop and commercialize products containing vonoprazan, which in turn would have a material adverse effect on our business, operating results and prospects.

We rely on third parties to conduct our clinical trials. Any failure by a third party to conduct the clinical trials according to GCPs and other requirements and in a timely manner may delay or prevent our ability to seek or obtain additional regulatory approvals for vonoprazan and regulatory approvals for any future product candidates.

We are dependent on third parties to conduct our preclinical studies and clinical trials. Specifically, we have used and relied on, and intend to continue to use and rely on, medical institutions, clinical investigators, CROs and consultants to conduct our clinical trials in accordance with our clinical protocols and regulatory requirements. These CROs, investigators and other third parties will play a significant role in the conduct and timing of any ongoing or future trials and subsequent collection and analysis of data. While we have agreements governing the activities of our third-party contractors, we have limited influence over their actual performance. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs and other third parties does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs or trial sites fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. In addition, our clinical trials must be conducted with product produced under cGMP or similar regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

CROs, investigators or other third parties may not devote adequate time and resources to such trials or perform as contractually required. If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, or otherwise performs in a substandard manner, our clinical trials may be extended, delayed, or terminated. In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA or comparable regulatory authority concludes that the financial relationship may have affected the interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of any NDA, sNDA or similar marketing application we submit by the FDA or by comparable regulatory authority. Any such delay or rejection could prevent us from obtaining approval to commercialize vonoprazan for any additional indications or formulations we may decide to study and any future product candidates we may develop.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties or do so on commercially reasonable terms. Switching or adding additional CROs, investigators and other third parties involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development

timelines. Though we carefully manage our relationships with our CROs, investigators and other third parties, we may encounter challenges or delays in the future and these delays or challenges may have a material adverse impact on our business, financial condition and prospects.

We currently rely on, and expect to rely on for the foreseeable future, Evonik and Catalent for the manufacture of vonoprazan drug substance and drug product for commercial sale and any clinical development, and we expect to rely on Sandoz for commercial supplies of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK and the amoxicillin and clarithromycin in those products. This reliance on third parties increases the risk that we will not have sufficient quantities of finished product which could have a material adverse impact on our business, results from operation and prospects.

We do not own or operate manufacturing facilities and have no plans to build our own commercial or clinical scale manufacturing capabilities. We have entered into an agreement with Catalent for the supply of finished drug product, an agreement with Evonik for the supply of drug substance, and an agreement with Sandoz for commercial supply of amoxicillin, clarithromycin and finished convenience packs containing VOQUEZNA and one or both of those antibiotics. As a result, we currently rely, and expect to continue to rely, on third parties for the manufacture of vonoprazan and supply of related raw materials for commercial sale and any clinical development. If Catalent, Evonik or Sandoz fails to fulfill its obligations under its respective supply agreement, or if any of the vonoprazan drug product or drug substance supplied by Catalent or Evonik cannot be utilized due to quality or cGMP or similar concerns, adverse findings during regulatory inspections or other reasons, our commercialization of vonoprazan, and any ongoing or future development plans, could be significantly adversely affected. We have previously been informed by Sandoz of the potential for a disruption in the supply of clarithromycin tablets, a component of VOQUEZNA TRIPLE PAK. Based on more recent communications, we do not currently anticipate any near-term supply disruption; however, there can be no assurance that a disruption will not occur in the future, and we continue to actively monitor this situation. Our VOQUEZNA tablets and VOQUEZNA DUAL PAK are not affected, as they do not include clarithromycin.

The facilities used by Catalent and Evonik to manufacture vonoprazan, and by Sandoz to manufacture amoxicillin and clarithromycin and to package the antibiotics and vonoprazan, have been approved by the FDA for the manufacture of our current products in the United States and are subject to ongoing and periodic inspection by the FDA to ensure continued compliance with applicable cGMP and other regulatory requirements. Regulatory authorities may inspect these facilities at any time, and continued approval is not assured. We do not control the manufacturing processes of, and are completely dependent on, Catalent, Evonik and Sandoz for compliance with applicable cGMP and similar requirements. If the FDA identifies deficiencies during an inspection, issues a warning letter, or otherwise determines that a facility is not in compliance, use of that facility for our approved products could be withdrawn or approval of that facility for use in connection with any of our product candidates could be delayed, limited, suspended or withdrawn, which could disrupt the manufacture or supply of our products. In addition, if we seek regulatory approval for our products outside the United States, the facilities used to manufacture vonoprazan and related components would be subject to inspection and approval by foreign regulatory authorities, and we may be required to satisfy additional or different regulatory requirements. There can be no assurance that such facilities would be approved for ex-U.S. commercial supply on a timely basis or at all. If the FDA withdraws approval of facilities of any third-party manufacturer for the manufacture of our approved products or the FDA or a comparable foreign regulatory authority does not approve any other third party manufacturer we seek to use in the future with respect to vonoprazan or other products we may develop, we may need to find alternative manufacturing facilities which would significantly adversely impact our ability to continue to market our approved products and to continue our development programs and obtain additional regulatory approvals.

Our failure, or Catalent’s, Evonik’s, Sandoz’s or any other third-party manufacturer’s failure, to comply with applicable regulations could result in sanctions being imposed on us, including, suspension or withdrawal of approvals, seizures or recalls of products or product candidates, clinical holds, fines, injunctions, civil penalties, delays, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

Our or Catalent’s, Evonik’s or Sandoz’s failure, or the failure of any future third-party manufacturer, to execute on our manufacturing requirements, to do so on commercially reasonable terms and to comply with cGMP or similar foreign requirements, could adversely affect our business in a number of ways, including:

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inability to meet commercial demands for our approved products;

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recall of batches of our approved products or product candidates;

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inability to initiate and continue clinical trials of vonoprazan or any future product candidates;

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delays in submitting regulatory applications, or receiving marketing approvals for new indications or formulations of vonoprazan or future product candidates that we might successfully develop; and

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third-party manufacturing facilities or our facilities being subjected to additional inspections by regulatory authorities;

Reliance on third-party manufacturers entails additional risks, including:

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failure of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

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breach of the manufacturing agreement by the third party;

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failure to manufacture our product according to our specifications;

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failure to manufacture our product according to our schedule or at all;

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misappropriation of our proprietary information, including our trade secrets and know-how; and

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termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Our current products, including VOQUEZNA, and any product candidates that we may develop, may compete with other products and product candidates for access to manufacturing capacity, and there are a limited number of third-party manufacturers that operate under cGMP and similar regulations and are capable of manufacturing our products. We do not currently have arrangements in place for redundant supply or a second source for all required raw materials used in the manufacture of our current products.

If Catalent, Evonik, or Sandoz or any third-party manufacturer we rely on cannot perform as agreed, materially breaches its obligations or terminates or elects not to renew its agreement with us, or otherwise becomes unable or unwilling to continue manufacturing our products or product candidates, we may be required to identify and qualify alternative manufacturing facilities. The process of transferring manufacturing operations, validating processes, qualifying new suppliers and obtaining required regulatory approvals could be time-consuming, costly and subject to significant technical and regulatory risks, and may not be successful on a timely basis or at all. In addition, Catalent, Evonik, Sandoz and any other third-party manufacturers we may use in the future may experience manufacturing or shipping disruptions due to resource constraints or as a result of natural disasters, labor disputes, geopolitical instability, or public health emergencies or ongoing hostilities in the Ukraine, Middle East or elsewhere. Any such disruption could jeopardize our ability to meet demand for our approved products or the supply of product candidates for clinical trials.

In addition, our inventory of drug substance, drug product or finished goods, whether held by us or by third parties, could be lost, damaged, destroyed or rendered unusable as a result of natural disasters, power outages, equipment failures, contamination, transportation incidents or other unforeseen events, which could further disrupt our supply and adversely affect our ability to meet commercial demand and clinical trial needs.

Our current and anticipated future dependence upon others for the manufacture of our approved products or any future product candidatescould result in supply interruptions, increased manufacturing costs, reduced profit margins, an inability to meet patient or market demand on a timely and competitive basis and a decrease in market acceptance, any of which could materially adversely affect our business, financial condition, results of operations and prospects.

Our reliance on third parties, including Sandoz, Catalent and Evonik, requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Because we rely, and expect to continue to rely, on Sandoz, Catalent and Evonik to manufacture our current approved products and to perform quality testing, we must, at times, share our proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology, in part, by entering into confidentiality agreements, consulting agreements or other similar agreements with our advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our current and future competitors, are intentionally or inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets and despite our efforts to protect our trade secrets, a competitor’s discovery of our proprietary technology and confidential information or other unauthorized use or disclosure

may impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and prospects.

The loss of, or significant reduction in business from, one or more of our major customers could significantly reduce our revenue, earnings or other operating results.

We sell our products primarily to established wholesale distributors and retailers in the pharmaceutical industry. A significant portion of our revenue is derived from a relatively small number of these customers. Three of our customers combined provided approximately 69% of our product sales during the year ended December 31, 2025, with each of these individual customers ranging from 22% to 23% of our product sales. The loss of any of these customers, or any of our other large customers, or reductions in business from them, could have a material adverse effect on our business, financial condition, results of operations, and cash flow. There can be no assurance that revenue from any customer will continue at their historical levels.

In addition, we work with third-party pharmacy support service providers to facilitate patient access to our VOQUEZNA products. Through these arrangements, eligible patients may access programs designed to help identify lower out-of-pocket costs, support prior authorization submissions and offer home delivery from licensed pharmacies, including for certain cash-pay patients. If any of these third-party service providers were to discontinue or materially limit their services, experience operational disruptions, or otherwise be unable to support patient access on acceptable terms, patient utilization of our products could be adversely affected, which could in turn negatively impact demand for our products and our revenue.

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.

We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.

We continue to evaluate the potential for vonoprazan in Europe and Canada. In the future we will also need to successfully acquire, develop and gain approval of one or more product candidates other than our vonoprazan products. We may seek to enter into collaborations, joint ventures, licenses and other similar arrangements for the development or commercialization of vonoprazan in Europe or Canada or to acquire future product candidates. We may not be successful in our efforts to establish such arrangements because, among other reasons, third parties may not view our current products or future product candidates as having sufficient commercial potential, acceptable pricing or reimbursement prospects, or an appropriate risk-return profile or because potential licensors or sellers of product candidates may prefer to retain rights, partner with larger or better-capitalized companies, pursue alternative transactions, or may not agree with us on valuation, deal structure, development plans, intellectual property terms or other key transaction terms. In addition, we face significant competition in seeking appropriate strategic partners and attractive product candidates, and the negotiation process can be time consuming and complex. Further, any future arrangements may restrict us from entering into additional agreements with potential collaborators. Following a strategic transaction or license, we may not achieve an economic benefit that justifies such transaction.

Even if we are successful in our efforts to establish such arrangements, the terms that we agree upon may not be favorable to us, and we may not be able to maintain such arrangements if, for example, development or approval of a product candidate is delayed, the safety of a product candidate is questioned or sales of an approved product candidate are unsatisfactory.

In addition, any potential future collaborations may be terminable by our strategic partners, and we may not be able adequately to protect our rights under these agreements. Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the development and commercialization of vonoprazan in Europe or Canada or any future product candidates and may not conduct those activities in the same manner as we do. Any termination of arrangements we enter into in the future, or any delay in entering into such arrangements, could delay or impair the development and commercialization of vonoprazan in Europe and Canada or the development and commercialization of any future product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Business Operations and Industry

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.

Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our performance. As a commercial-stage company with a limited product portfolio, a substantial portion of our revenue is derived from sales of our VOQUEZNA products, and our operating results are highly sensitive to factors affecting these products, and even modest changes in market acceptance, payer access, pricing, demand or supply could have a disproportionate impact on our operating results, particularly changes related to VOQUEZNA as a treatment for GERD. These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to:

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variability in the level of demand VOQUEZNA for the treatment of GERD, including market acceptance, prescribing trends among gastroenterologists and primary care physicians, use of cash-pay or access programs, and seasonality;

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the timing, cost and level of investment in our commercialization activities, including sales force deployment, marketing initiatives and payer access efforts;

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pricing, coverage and reimbursement decisions and prior authorization requirements for our approved products, and potential changes in payer policies;

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competitive dynamics affecting our approved products, including competition from generic therapies, new branded products, or alternative treatment approaches, and the impact of the introduction of competitive products on demand, market share, pricing, payor coverage, reimbursement and policies and other market dynamics;

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the timing, cost of, and level of investment in, research, development and regulatory activities for any future indications or formulations of vonoprazan or new product candidates, which may change from time to time, and the results of such efforts;

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the cost of manufacturing of our current products or any future product candidates, which may vary depending on the quantity of production and the terms of our agreements with Catalent, Evonik, Sandoz and any future third-party manufacturers;

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business interruptions resulting from geopolitical actions, including war, such as the ongoing hostilities in the Ukraine or the Middle East, and terrorism, or natural disasters such as earthquakes, typhoons, floods and fires or public health emergencies or pandemics;

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the timing and amount of the milestone or other payments we will be required to pay to Takeda pursuant to the Takeda License;

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our obligations under our Loan Agreement with Hercules Capital and under our Revenue Interest Financing Arrangement, or RIFA, including required interest, royalty or other payments, compliance with financial and other covenants, and limitations on our operating flexibility, which may affect the timing and availability of capital and our ability to manage expenses and investments;

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expenditures that we may incur to acquire, develop or commercialize additional product candidates and technologies; and

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future accounting pronouncements or changes in our accounting policies.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet our expectations or the expectations of industry or financial analysts or investors for any period. If our revenue or 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. Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.

Our indebtedness may limit our flexibility in operating our business and adversely affect our financial health and competitive position, and all of our obligations under our indebtedness are secured by substantially all of our assets, excluding our licensed intellectual property and certain other assets. If we default on these obligations, our lenders could foreclose on our assets.

In September 2021, we entered into, and in December 2023 we increased the amounts available under and extended the maturity date of, a Loan Agreement with Hercules. We borrowed $100 million at the inception of the Loan Agreement, $40 million in December 2023, $10 million in March 2024, $25 million in June 2024, and $25 million in December 2024. In February 2026, we entered into an amendment to the Loan Agreement which provided for a new term loan tranche of $175 million with a new maturity date of February 1, 2029. We used the proceeds from the new loan tranche, along with cash on our balance sheet, to repay in full the existing secured obligations outstanding under the Loan Agreement among other changes. All obligations under the Loan Agreement are secured by a first priority lien on substantially all of our assets, excluding our licensed intellectual property and certain other assets. As a result, if we default on any of our obligations under the Loan Agreement, Hercules could foreclose on its security interest and liquidate some or all of the collateral, which would harm our business, financial condition and results of operations and could require us to reduce or cease operations.

The Loan Agreement contains customary affirmative and negative covenants that limit our ability to engage in certain transactions that may be in our long-term best interest. The affirmative covenants include, among others, covenants requiring us to maintain certain levels of cash subject to a control agreement in favor of Hercules, and certain levels of trailing three-month net product revenue from the sale of VOQUEZNA and other products containing vonoprazan, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding our operating accounts. The negative covenants include, among others, limitations on our ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies, engage in new lines of business, make certain investments, pay dividends, transfer or dispose of assets, amend certain material agreements or enter into various specified transactions.

While we believe we are currently in compliance with the covenants contained in the Loan Agreement, we may breach these covenants in the future. Our ability to comply with these covenants may be affected by events and factors beyond our control. In the event that we breach one or more covenants, the lenders may choose to declare an event of default and require that we immediately repay all amounts outstanding under the applicable agreement, terminate any commitment to extend further credit and foreclose on the collateral. The occurrence of any of these events could have a material adverse effect on our business, financial condition and results of operations.

In order to service our current indebtedness and any additional indebtedness we may incur in the future, including meeting cash covenants, we need to generate cash from our operating activities or other financings. Our ability to generate cash 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 service our indebtedness, meet our cash covenant obligations and fund our other liquidity needs. To the extent we are required to use cash from operations or the proceeds of any future financing to service our indebtedness or meet our cash covenant obligation instead of funding working capital or other general corporate purposes, we will be less able to plan for, or react to, changes in our business, industry and in the economy generally. This could place us at a competitive disadvantage compared to our competitors that have less indebtedness.

In May 2022, we entered into a Revenue Interest Financing Agreement with the Initial Investors pursuant to which we can receive up to $260 million in funding from the Initial Investors, and in October 2022, we entered into the Joinder Agreement under which we can receive up to $40 million from the Additional Investor, bringing the total funding available under the Revenue Interest Financing Agreement to up to $300 million. Under the terms of the Revenue Interest Financing Agreement and Joinder Agreement, we received $100 million at the initial closing and received an additional $175 million in November 2023 following FDA approval of vonoprazan in its Erosive GERD indication. In addition, we were eligible for $25 million in additional funding for achievement of a sales milestone. On December 23, 2024, CO Finance LVS XXXVII LLC agreed to assign and transfer to OC III LVS LX LP all of its rights, title and interest as an Additional Investor and in connection therewith, OC III LVS LX LP executed a Joinder Agreement. As of December 31, 2025, no additional funding is available under the Revenue Interest Financing Agreement.

Under the Revenue Interest Financing Agreement, the Initial Investors and the Additional Investors, are entitled to receive a 10% royalty on net sales of products containing vonoprazan. The royalty rate is subject to a step-down on net sales exceeding

certain annual thresholds and upon FDA approval for vonoprazan for an indication relating to the treatment of heartburn associated with Non-Erosive GERD, which occurred on July 17, 2024. The investors’ right to receive royalties on net sales will terminate when the investors have aggregate payments equal to 200% of the Investment Amount. In addition, we have the right to make a cap payment equal to 200% of the Investment Amount less any royalties already paid, at which time the agreement will terminate.

If the investors have not received aggregate payments of at least 100% of the Investment Amount by December 31, 2028, and at least 200% of the Investment Amount by December 31, 2037, each a Minimum Amount, then we will be obligated to make a cash payment to the investors in an amount sufficient to gross the investors up to the applicable Minimum Amount.

Pursuant to the Revenue Interest Financing Agreement, we also agreed to specified affirmative and negative covenants, including covenants to use commercially reasonable efforts to promote products containing vonoprazan in the United States and covenants requiring us to maintain certain levels of cash. The Revenue Interest Financing Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature. In the event of an event of default under the Revenue Interest Financing Agreement, the investors may be entitled to foreclose on the pledged collateral which includes the applicable royalty under the Revenue Interest Financing Agreement from net sales of VOQUEZNA and other products containing vonoprazan.

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.

Our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel.

We are highly dependent on the management, commercial, development, clinical, and financial experience of our senior management. Although we have entered into employment agreements with our executive officers, each of them may terminate their employment with us at any time. We do not maintain “key person” insurance for any of our executives or employees. This lack of insurance means that we may not have adequate compensation for the loss of the services of these individuals. For example, effective April 1, 2025, Steven Basta was appointed as our President and Chief Executive Officer, replacing Terrie Curran. In addition, effective April 30, 2025, Azmi Nabulsi, M.D., our Chief Operating Officer, Molly Henderson, our Chief Financial Officer, Martin Gilligan, our Chief Commercial Officer, and Tom Harris, our Chief Development Sciences Officer resigned as officers and we announced that Jonathan Bentley will join us as our Senior Vice President, Head of Sales. On October 6, 2025, Sanjeev Narula joined us as Chief Financial and Business Officer. Executive leadership transitions can be inherently difficult to manage and, as a result, if we have further resignations or terminations, we may experience disruption or have difficulty in managing our operations and achieving our business objectives. Competition for qualified personnel in the biopharmaceutical field is intense, and our future success depends upon our ability to attract, retain and motivate highly skilled commercial, scientific, technical and managerial employees. We face competition for personnel from other biopharmaceutical companies and other organizations. If our recruitment and retention efforts are unsuccessful in the future, it may be difficult for us to implement business strategy, which could harm our business. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating and implementing our commercialization and development strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract, retain and motivate necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede achievement of our commercial and development objectives, our ability to raise additional capital and our ability to implement our business strategy.

We are subject to various foreign, federal, and state healthcare laws and regulations, and our failure to comply with these laws and regulations could result in significant fines, damages and penalties and harm our results of operations and financial condition.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payers, patient organizations and customers expose us to broadly applicable foreign, federal and state fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through

which we conduct our operations, including how we research, market, sell and distribute any products for which we obtain marketing approval. Such laws include, but are not limited to:

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the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, or order, or arranging for or recommending the purchase, lease, or order of any good, facility, item or service, for which payment may be made, in whole or in part, under any U.S. federal healthcare program, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;

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the U.S. civil and criminal federal false claims laws, including the civil False Claims Act, which can be enforced through civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

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the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation;

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the U.S. federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

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the U.S. federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS, information related to certain payments and other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) , certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiology assistants and certified nurse midwives) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members; and

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers, or by the patients themselves; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information or which require tracking gifts and other remuneration and items of value provided to physicians, other healthcare providers and entities.

We may also be subject to additional regulation in the conduct of our business. For example, we may be subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations and foreign government owned or affiliated entities, candidates for foreign political office, and foreign political parties or officials thereof.

Ensuring that our internal operations and business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that our business practices

do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from U.S. government funded healthcare programs, such as Medicare and Medicaid, or similar programs in other countries or jurisdictions, disgorgement, imprisonment, contractual damages, reputational harm, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, diminished profits and the curtailment or restructuring of our operations. Further, defending against any such actions can be costly, time consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. If any of the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusion from government funded healthcare programs and imprisonment. If any of the above occur, it could adversely affect our ability to operate our business and our results of operations.

Enacted and future legislation and healthcare reform measures may increase the difficulty, cost and uncertainty for us of commercializing vonoprazan and any future product candidates and may adversely affect pricing, reimbursement and patient access.

In the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system, including cost-containment measures, that may reduce or limit coverage and reimbursement for newly approved drugs and affect our ability to profitably sell any product candidates for which we obtain marketing approval. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare.

For example, in March 2010, the Patient Protection and Affordable Care Act, the Affordable Care Act, was enacted in the United States, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. Among other things, the Affordable Care Act includes:

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an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, which is apportioned among these entities according to their market share in certain government healthcare programs;

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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the AMP for branded and generic drugs, respectively;

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a methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

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an extension of a manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

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expansion of the entities eligible for discounts under the 340B drug pharmaceutical pricing program;

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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research; and

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establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

While the Affordable Care Act remains in effect, more recent federal and state initiatives, including drug pricing reform, reimbursement constraints and coverage management tools, may have a more direct impact on the commercialization of branded pharmaceutical products such as vonoprazan. Since its enactment, there have been judicial and political challenges to certain aspects of the Affordable Care Act. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the Affordable Care Act without specifically ruling on the constitutionality of the Affordable Care Act. Thus, the Affordable Care Act remains in effect in its current form.

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

January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. On March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory cap on manufacturers' Medicaid drug rebate liability, beginning January 1, 2024. Previously, the rebate was capped at 100% of a drug’s AMP.

Further, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs. At the federal level, such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products.

On August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaced the Part D coverage gap discount program with a new discounting program (which began in 2025). The IRA permits the Secretary of the Department of Health and Human Services, or HHS, to implement many of these provisions through guidance, as opposed to regulation, for the initial years HHS has and will continue to issue and update guidance as these programs are implemented. CMS has published the negotiated prices for the initial ten drugs, which went into effect in 2026, and the subsequent 15 drugs, which will first be effective in 2027, as well as the next set of 15 drugs that will be subject to negotiation, although program is currently subject to legal challenges. The impact of the IRA on the pharmaceutical industry cannot yet be fully determined, but is likely to be significant. The likelihood of implementation of these and other reform initiatives is uncertain. Even if our products are not selected for negotiation, the IRA may indirectly affect our business by influencing payer formulary decisions, coverage restrictions, utilization management practices and pricing expectations for branded drugs. In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates.

The One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our sales of VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK or any other product candidate that we commercialize.

The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. The Trump administration is also pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.

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, drug price reporting and other transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states or impose additional administrative burdens that could delay access or complicate commercialization. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. Furthermore, there has been increased interest by third party payers and governmental authorities in reference pricing systems and publication of discounts and list prices. These

reforms could reduce the ultimate demand for vonoprazan and any future product candidates, if approved, or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects.

We expect that these healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize vonoprazan and any future product candidates, if approved. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers, limit patient access, reduce prescribing or require additional discounts, any of which could materially adversely affect our ability to generate revenue, achieve or maintain profitability and successfully commercialize vonoprazan and any future products.

We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.

We and any of our third-party manufacturers or suppliers will use biological materials, potent chemical agents and may use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety of the environment. Our operations and the operations of our third-party manufacturers and suppliers also produce hazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our efforts. In addition, we cannot eliminate the risk of accidental injury or contamination from these materials or wastes. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. In the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended.

Although we maintain workers’ compensation insurance for certain costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials or other work-related injuries, and this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for toxic tort claims that may be asserted against us in connection with our storage or disposal of biologic, 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, which have tended to become more stringent over time. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions or liabilities, which could materially adversely affect our business, financial condition, results of operations and prospects.

U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements could adversely impact the supply of material from foreign CROs and CMOs to us or our ability to secure government commitments to purchase potential therapies.

We currently and may in the future rely on foreign CROs and CMOs, such as Evonik based in Germany and Sandoz based in Austria. Such foreign CROs and CMOs may be subject to U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase potential therapies. For example, members of the U.S. Congress have introduced bills aimed at commercial supply of pharmaceutical products and the Trump Administration has announced tariffs on certain industries, such as steel and aluminum imports, and the intent to impose additional tariffs for other industries or countries. If these bills become law, or similar laws are passed, or if sanctions applicable to our commercial supply chain are imposed, they would have the potential to severely increase our costs or we may be required to shift manufacturing to other third parties which could be costly and cause supply disruptions which could adversely impact our operations. In addition, the U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern”, or entering into, extending, or renewing any contracts with entities that use such biotechnology equipment or services from “biotechnology companies of concern”. Congress has interpreted a “biotechnology company of concern” as an entity that is under the control of a foreign adversary and that poses a risk to national security based on its research or multiomic data collection (e.g., collection of genomic information). While the U.S. BIOSECURE Act has a grandfathering period of five years for existing contracts, and has

carveouts for manufacture of drugs for supply under Medicaid and Medicare Part B, subject to the Secretary of Veteran Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. If the foreign CROs and CMOs we rely on become subject to trade restrictions, sanctions, increased tariffs or other regulatory requirements by the U.S. government (including designation as a “biotechnology company of concern” under the U.S. BIOSECURE Act), or if the U.S. or Chinese or other foreign governments take retaliatory actions due to recent or increased tensions between the U.S. and China or other countries, it may have the potential to severely restrict the ability of U.S. biopharmaceutical companies like us to purchase services or products from, or otherwise collaborate with, certain “biotechnology companies of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.

We are exposed to potential product liability risks that are inherent in the development, manufacturing, marketing, and use of pharmaceutical products. The current and future sale and use of VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK, and any other approved products in the future, and the use of product candidates by us in clinical trials, may expose us to liability claims. These claims might be made by patients that use the product, healthcare providers, distributors, pharmaceutical companies, or others selling such products. Any claims against us, regardless of their merit, could be difficult and costly to defend or settle, and could compromise the market acceptance and commercialization of our products, and, if approved, our future product candidates, and could negatively impair our results of operations and prospects.

Although the clinical trial process and post-marketing surveillance are designed to identify and characterize potential side effects, it is possible that a drug, including an approved product, may be associated with adverse events that were not observed during clinical development or that occur at a greater frequency or severity in broader patient populations or with longer-term use. While VOQUEZNA, VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK have been approved and have been evaluated in clinical trials, additional adverse events or safety signals may be identified through continued clinical experience, post-marketing surveillance or real-world use. If our products or any future product candidates are associated with serious or unexpected adverse events, we could be subject to product liability claims, regulatory actions, labeling changes, additional post-marketing study requirements, restrictions on use, or other actions that could limit or delay commercialization. In addition, physicians and patients may not comply with prescribing information, contraindications or warnings, including limitations on patient populations for whom use may be appropriate, which could increase the risk of adverse events and potential liability.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease the commercialization of our products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

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decreased demand for our products;

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injury to our reputation and significant negative media attention;

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withdrawal of clinical trial participants;

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costs to defend the related litigation;

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a diversion of management’s time and our resources;

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substantial monetary awards to trial participants or patients;

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product recalls, withdrawals or labeling, marketing or promotional restrictions;

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significant negative financial impact;

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the inability to commercialize our current products and any future product candidates; and

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a decline in our stock price.

Although we maintain product liability insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our

coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts in which case our business operations could be impaired. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses.

PHAT US Equity

PHAT · 10-K · period ended 2025-12-31

Item 1A. Risk Factors

PHAT US Equity☆

PHAT · 10-K · period ended 2025-12-31

Item 1A. Risk Factors

PHAT US Equity