Agios Pharmaceuticals Inc. is a publicly trading American pharmaceutical company pioneering therapies for genetically defined diseases, with a near-term focus on developing therapies for hemolytic anemias. The company was founded in 2008 (or 2007) by Lewis Cantley, Tak Mak and Craig Thompson. Agios is a Delaware corporation headquartered in Cambridge, Massachusetts.3Wikipedia text CC BY-SA 4.0
Agios Pharmaceuticals Inc. is a publicly trading American pharmaceutical company pioneering therapies for genetically defined diseases, with a near-term focus on developing therapies for hemolytic anemias. The company was founded in 2008 (or 2007) by Lewis Cantley, Tak Mak and Craig Thompson. Agios is a Delaware corporation headquartered in Cambridge, Massachusetts. The company tendered an initial public offering in July 2013.3
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Research and developmentSelling, general and admin
Cost of revenue1¢$6.3M
Research and development64¢$339.5M
Selling, general and admin34¢$180.3M
Income tax0¢$1.0M
Out of $54.0M in revenue.10 The company lost money this year.
Financial statements
Revenue1112131410$54.0M in 2025−54% since 2019Operating income1512131410-$472.1M in 2025+49% since 2019Net income1512131410-$412.8M in 2025+0% since 2019
Revenue1617$44.7M in Q2 FY2026+116% since Q1 FY2026Operating income1617-$110.6M in Q2 FY2026+0% since Q1 FY2026Net income1617-$100.7M in Q2 FY2026+2% since Q1 FY2026
Every line of the income statement as filed: the last 3 fiscal years, latest first.10
Period ending
2025-12-31
2024-12-31
2023-12-31
Total product revenue, net
$54.0M
$36.5M
$26.8M
Cost of sales
$6.3M
$4.2M
$2.9M
Research and development
$339.5M
$301.3M
$295.5M
Total selling, general and administrative expenses
$180.3M
$156.8M
$119.9M
Total operating expenses
$526.2M
$462.2M
$418.3M
Loss from operations
-$472.1M
-$425.7M
-$391.5M
Gain on sale of contingent payments
$0
$889.1M
$0
Milestone payment from gain on sale of oncology business
$0
$200.0M
$0
Interest income, net
$56.4M
$48.1M
$33.3M
Other income, net
$2.0M
$6.5M
$6.1M
Net (loss) income before taxes
-$413.8M
$718.0M
-$352.1M
Income tax (benefit) expense
-$1.0M
$44.2M
$0
Net (loss) income
-$412.8M
$673.7M
-$352.1M
Net income (loss) per share - basic (in usd per share)
-$7.12
$11.86
-$6.33
Net income (loss) per share - diluted (in usd share)
-$7.12
$11.64
-$6.33
Weighted-average number of common shares used in computing net income (loss) per share basic (in shares)
58.0M shares
56.8M shares
55.7M shares
Weighted-average number of common shares used in computing net income (loss) per share diluted (in shares)
58.0M shares
57.9M shares
55.7M shares
No quarter-by-quarter statement was filed.
Total assets111512131410$1.3B in 2025+46% since 2019Total liabilities111512131410$104.1M in 2025−58% since 2019Shareholders’ equity12131410$1.2B in 2025+86% since 2019Cash111512131410$89.1M in 2025+10% since 2019
Total assets1617$1.1B in Q2 FY2026−15% since Q1 FY2025Total liabilities1617$82.4M in Q2 FY2026−21% since Q1 FY2025Shareholders’ equity1617$1.0B in Q2 FY2026−14% since Q1 FY2025Cash1617$99.6M in Q2 FY2026+12% since Q1 FY2025
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.10
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$89.1M
$76.2M
Marketable securities
$765.3M
$817.5M
Accounts receivable, net
$10.6M
$4.1M
Inventory
$32.9M
$27.6M
Prepaid expenses and other current assets
$44.1M
$40.2M
Total current assets
$942.1M
$965.6M
Marketable securities
$310.0M
$638.3M
Operating lease assets
$30.5M
$42.9M
Property and equipment, net
$10.8M
$11.7M
Other non-current assets
$3.9M
$4.7M
Total assets
$1.3B
$1.7B
Accounts payable
$18.4M
$16.6M
Accrued expenses
$45.5M
$46.9M
Income taxes payable
$0
$871.0K
Operating lease liabilities
$18.4M
$16.8M
Total current liabilities
$82.2M
$81.2M
Operating lease liabilities, net of current portion
$21.8M
$40.2M
Other non-current liabilities
$90.0K
$880.0K
Total liabilities
$104.1M
$122.2M
Preferred stock, $0.001 par value; 25,000,000 shares authorized, no shares issued and outstanding at December 31, 2025 and 2024
$0
$0
Common stock, $0.001 par value; 125,000,000 shares authorized; 74,665,003 shares issued and 58,448,592 outstanding at December 31, 2025 and 73,372,696 shares issued and 57,156,285 outstanding at December 31, 2024
$75.0K
$73.0K
Additional paid-in capital
$2.6B
$2.5B
Accumulated other comprehensive income (loss)
$2.2M
-$1.5M
Accumulated deficit
-$561.7M
-$148.9M
Treasury stock, at cost (16,216,411 shares at December 31, 2025 and December 31, 2024)
-$802.5M
-$802.5M
Total stockholders equity
$1.2B
$1.5B
$811.0M
$1.1B
Total liabilities and stockholders equity
$1.3B
$1.7B
Preferred stock, par value (in usd per share)
$0.00
$0.00
Preferred stock, authorized (in shares)
25.0M shares
25.0M shares
Preferred stock, issued (in shares)
0 shares
0 shares
Preferred stock, outstanding (in shares)
0 shares
0 shares
Common stock, par value (in usd per share)
$0.00
$0.00
Common stock, authorized (in shares)
125.0M shares
125.0M shares
Common stock, issued (in shares)
74.7M shares
73.4M shares
Common stock, outstanding (in shares)
58.4M shares
57.2M shares
Treasury stock (in shares)
16.2M shares
16.2M shares
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$89.1M
$76.2M
Marketable securities
$765.3M
$817.5M
Accounts receivable, net
$10.6M
$4.1M
Inventory
$32.9M
$27.6M
Prepaid expenses and other current assets
$44.1M
$40.2M
Total current assets
$942.1M
$965.6M
Marketable securities
$310.0M
$638.3M
Operating lease assets
$30.5M
$42.9M
Property and equipment, net
$10.8M
$11.7M
Other non-current assets
$3.9M
$4.7M
Total assets
$1.3B
$1.7B
Accounts payable
$18.4M
$16.6M
Accrued expenses
$45.5M
$46.9M
Income taxes payable
$0
$871.0K
Operating lease liabilities
$18.4M
$16.8M
Total current liabilities
$82.2M
$81.2M
Operating lease liabilities, net of current portion
$21.8M
$40.2M
Other non-current liabilities
$90.0K
$880.0K
Total liabilities
$104.1M
$122.2M
Preferred stock, $0.001 par value; 25,000,000 shares authorized, no shares issued and outstanding at December 31, 2025 and 2024
$0
$0
Common stock, $0.001 par value; 125,000,000 shares authorized; 74,665,003 shares issued and 58,448,592 outstanding at December 31, 2025 and 73,372,696 shares issued and 57,156,285 outstanding at December 31, 2024
$75.0K
$73.0K
Additional paid-in capital
$2.6B
$2.5B
Accumulated other comprehensive income (loss)
$2.2M
-$1.5M
Accumulated deficit
-$561.7M
-$148.9M
Treasury stock, at cost (16,216,411 shares at December 31, 2025 and December 31, 2024)
-$802.5M
-$802.5M
Total stockholders equity
$1.2B
$1.5B
$811.0M
$1.1B
Total liabilities and stockholders equity
$1.3B
$1.7B
Preferred stock, par value (in usd per share)
$0.00
$0.00
Preferred stock, authorized (in shares)
25.0M shares
25.0M shares
Preferred stock, issued (in shares)
0 shares
0 shares
Preferred stock, outstanding (in shares)
0 shares
0 shares
Common stock, par value (in usd per share)
$0.00
$0.00
Common stock, authorized (in shares)
125.0M shares
125.0M shares
Common stock, issued (in shares)
74.7M shares
73.4M shares
Common stock, outstanding (in shares)
58.4M shares
57.2M shares
Treasury stock (in shares)
16.2M shares
16.2M shares
Cash from operations1512131410-$373.0M in 2025+1% since 2019Capital spending1512131410$4.3M in 2025−64% since 2019Free cash flow1512131410-$377.3M in 2025−1% since 2019
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.10
Period ending
2025-12-31
2024-12-31
2023-12-31
Net (loss) income
-$412.8M
$673.7M
-$352.1M
Depreciation and amortization
$5.2M
$5.7M
$6.6M
Stock-based compensation expense
$52.6M
$42.8M
$44.8M
Net accretion of discount on marketable securities
-$7.2M
-$14.5M
-$5.1M
Gain on sale of contingent payments
$0
-$889.1M
$0
Loss (gain) on disposal of property and equipment
$5.0K
-$39.0K
$553.0K
Non-cash operating lease expense
$12.4M
$11.5M
$10.7M
Expense associated with license agreement
$10.0M
$0
$17.5M
Realized gain on investments
-$118.0K
-$167.0K
-$28.0K
Milestone payment from gain on sale of oncology business
$0
-$200.0M
$0
Accounts receivable, net
-$6.5M
-$1.3M
-$604.0K
Inventory
-$5.3M
-$8.5M
-$10.6M
Prepaid expenses and other current and non-current assets
-$3.2M
-$5.8M
$3.8M
Accounts payable
$1.7M
$6.6M
-$8.7M
Accrued expenses
-$1.4M
$3.7M
$12.8M
Income taxes payable
-$871.0K
$871.0K
$0
Operating lease liabilities
-$16.8M
-$15.0M
-$13.7M
Other liabilities
-$790.0K
-$276.0K
-$2.1M
Net cash used in operating activities
-$373.0M
-$389.8M
-$296.1M
Purchases of marketable securities
-$641.8M
-$1.5B
-$417.9M
Proceeds from maturities and sales of marketable securities
$1.0B
$818.4M
$674.7M
Proceeds from sale of contingent payments
$0
$889.1M
$0
Proceeds from milestone payment from gain on sale of oncology business
$0
$200.0M
$0
Payments associated with license agreement
-$10.0M
$0
-$17.5M
Purchases of property and equipment
-$4.3M
-$1.7M
-$999.0K
Proceeds from sale of equipment
$0
$40.0K
$1.3M
Net cash provided by investing activities
$377.2M
$363.4M
$239.6M
Net proceeds from stock option exercises and employee stock purchase plan
$8.7M
$14.4M
$5.4M
Net cash provided by financing activities
$8.7M
$14.4M
$5.4M
Net change in cash and cash equivalents
$12.9M
-$12.0M
-$51.1M
Additions to property and equipment in accounts payable and accrued expenses
Agios Pharmaceuticals sits at the top of its group. 8 entities, 7 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
VANGUARD GROUP INCFiled SCHEDULE 13G/A on Agios Pharmaceuticals, latest Mar 26, 2026 (6 filings since Dec 9, 2021)
Farallon Capital Partners, L.P.Filed SCHEDULE 13G/A on Agios Pharmaceuticals, latest Feb 9, 2026 (5 filings since Nov 9, 2023)
State Street CorporationFiled SCHEDULE 13G on Agios Pharmaceuticals, latest Feb 9, 2026 (4 filings since Feb 9, 2022)
Bellevue GroupFiled SCHEDULE 13G/A on Agios Pharmaceuticals, latest Dec 5, 2025 (2 filings since Jul 7, 2025)
Paradigm Biocapital Advisors LPFiled SCHEDULE 13G/A on Agios Pharmaceuticals, latest Nov 14, 2025 (2 filings since Aug 28, 2025)
BlackRockFiled SCHEDULE 13G/A on Agios Pharmaceuticals, latest Jul 17, 2025 (5 filings since Feb 3, 2022)
BB BiotechFiled SCHEDULE 13G/A on Agios Pharmaceuticals, latest Jun 13, 2025 (5 filings since Feb 11, 2022)
Agios PharmaceuticalsCambridge, Massachusetts, United States
Agios France SARL Subsidiary · France
Agios Germany GmbH Subsidiary · Germany
Agios International Sarl (GmbH) Subsidiary · Switzerland
Agios Italy S.R.L. Subsidiary · Italy
Agios Limited Subsidiary · Bermuda
Agios Netherlands B.V. Subsidiary · Netherlands
Agios Securities Corporation Subsidiary · Massachusetts, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Agios Pharmaceuticals reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
We currently lease approximately 146,000 square feet at 88 Sidney Street, 43,000 square feet at 64 Sidney Street, and 13,000 square feet at 38 Sidney Street, Cambridge, Massachusetts. All leases, as amended, expire on February 29, 2028. At the end of the initial lease period, we have the option to extend the leases at all facilities for two consecutive five-year periods at the fair market rent at the time of the extension. In July 2025, we entered into a long-term sublease agreement with a new tenant for 7,407 square feet of office space on the first floor of 64 Sidney Street, Cambridge, Massachusetts, which began in November 2025 with the term of the sublease running through February 2028. We believe our existing facilities are adequate for our current needs.
In 2012, Agios was named among the defendants in a lawsuit against one of its founders, Craig Thompson, alleging that Thompson used research illegally taken from the Abramson Family Cancer Research Institute in research at Agios.
In May 2016, the company announced it would launch partnership with Celgene, developing metabolic immuno-oncology therapies and licensing AG-221 as well as AG-881 to Celgene, potentially garnering Agios $120 million in drug licensing payments.
In April 2017, the company raised $250 million in a new stock offering in anticipation of approval for its first cancer drug, enasidenib, by the US Food and Drug Administration.
In December 2017, the company filed a New Drug Application with the US FDA for ivosidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation.
In November 2019, Agios announced an underwritten public offering of 8,250,000 shares of common stock at a price of $31.00 per share which would result in approximately $256 million aggregate gross proceeds.
In April 2022, the FDA approved mitapivat as first disease-modifying therapy for hemolytic anemia in adults with pyruvate kinase deficiency.
Feb 13, 2025Reported quarterly or annual results70
Oct 31, 2024Reported quarterly or annual results71
Drug trials and FDA: recently
May 12, 2026Phase 2 trial completed Phase 2 trial of Tebapivat in Sickle Cell Disease: primary completion May 12, 2026, no results posted yet (ClinicalTrials.gov NCT06924970).72
Dec 23, 2025FDA approved a new use FDA approved an efficacy supplement for Pyrukynd (mitapivat sulfate), a new use or patient group (NDA 216196, supplement 3).73
Oct 30, 2025Phase 2/3 trial completed Phase 2/3 trial of Mitapivat in Sickle Cell Disease: primary completion Oct 30, 2025, no results posted yet (ClinicalTrials.gov NCT05031780).74
Jul 3, 2024Phase 3 trial completed Phase 3 trial of Mitapivat in Pyruvate Kinase Deficiency: primary completion Jul 3, 2024, results posted Nov 18, 2025 (ClinicalTrials.gov NCT03853798).75
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
458 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 49 major events, 253 insider forms, 50 large holders, 86 other. The latest 20:
112 open-market trades by officers, directors and large owners since October 2021: 0 buys and 112 sales. Grants, option exercises and gifts are left out.
FMR LLCSC 13G/A, 2 filings Feb 9, 2022 to Sep 12, 202292
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).
SEC filer profile
How Agios Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
From the cover page of the 10-K filed Feb 12, 2026 (Section 12(b) of the Exchange Act).18
Risk factors and legal proceedings
The risks Agios Pharmaceuticals names in Item 1A of its 10-K filed Feb 12, 2026: 56 risks under these headings, as written.18
Risks Related to the Discovery, Development, and Commercialization of our Products and Product Candidates
If we do not successfully commercialize PYRUKYND®, AQVESME™ and other products for which we receive approval, our prospects may be substantially harmed.
We depend heavily on the success of our clinical-stage product candidates, including the potential approval of mitapivat for the treatment of thalassemia in the EU, or SCD in the United States and in other jurisdictions. Clinical trials of our product candidates may not be successful for a number of important reasons. If we or our collaborators are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
PYRUKYND®, AQVESME™ or any of our product candidates that may receive marketing approval in the future, may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
If we are unable to maintain sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing PYRUKYND®, AQVESME™ or any of our product candidates if they are approved.
We may engage in in-licensing transactions or acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
Results of preclinical studies and early clinical trials may not be predictive of results of later-stage clinical trials.
Interim and preliminary data from clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
We conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
We or others may later discover that PYRUKYND®, AQVESME™ or any of our product candidates that may receive marketing approval in the future, is less effective than previously believed or causes undesirable side effects that were not previously identified, which could compromise our ability, or that of any collaborators, to market the product.
The other 44 risks
We provide certain development estimates related to the development and regulatory approval of our product candidates, including mitapivat. If we do not achieve our projected development or regulatory approval estimates in the timeframes we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
If the FDA does not grant our products, if and when approved, appropriate periods of regulatory exclusivity before approving generic or follow-on versions of our products, the sales of our products could be adversely affected.
Product liability lawsuits against us or any collaborators could cause us or our collaborators to incur substantial liabilities and could limit commercialization of any medicines that we or they may develop.
Our internal information technology systems, or those of any third parties with which we contract, may fail or suffer security breaches, loss of data or other disruptions which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, trigger legal obligations, potentially exposing us to liability, competitive or reputational harm or otherwise adversely affecting our business and financial results.
We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
Risks Related to Our Financial Position
We face challenges as a less diversified company.
Raising additional capital may restrict our operations, require us to relinquish rights to our technologies or product candidates or cause dilution to our stockholders.
If our existing capital is insufficient to fund our operating expenses and capital expenditures, we will need to raise capital, and if we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
We have historically incurred operating losses. We expect to incur losses in the future and may never achieve or maintain profitability.
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
Risks Related to Our Dependence on Third Parties
We rely and expect to continue to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and for commercialization.
We may depend on collaborations with third parties for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
Risks Related to Our Intellectual Property
If we are unable to obtain and maintain patent or trade secret protection for our medicines and technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize medicines and technology similar or identical to ours, and our ability to successfully commercialize our medicines and technology may be adversely affected.
We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful.
Third parties may initiate legal proceedings alleging that we or our collaborators are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
If we are unable to protect the confidentiality of our confidential information related to our proprietary platforms and technology, our business and competitive position could be harmed.
Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
The marketing approval process is expensive, time-consuming and uncertain, and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. If we or our collaborators are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we or they will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
Failure to obtain marketing approval in foreign jurisdictions would prevent our medicines from being marketed in such jurisdictions and any of our medicines that are approved for marketing in such jurisdictions will be subject to risk associated with foreign operations.
Fast track designation, priority review designation, PRIME designation or other expedited review designations or vouchers may not actually lead to a faster development or regulatory review or approval process, nor does it ensure approval of the product candidate.
We, or any collaborators, may not be able to obtain or maintain orphan drug designation or orphan drug exclusivity for our drug candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing drugs.
Any product or product candidate for which we or our collaborators obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our medicines, when and if any of them are approved.
Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
Our relationships with healthcare providers, physicians and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished future profits and future earnings.
PYRUKYND®, AQVESME™ or any product candidate that we commercialize may become subject to unfavorable pricing regulations and third-party reimbursement practices, which would harm our business.
Current and future healthcare reform legislation may increase the difficulty and cost for us and any collaborators to commercialize our drug candidates.
The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our drug products, if and when approved, and/or the sustainability of those prices.
We are subject to U.S. and foreign export control, import, sanctions, anti-corruption and anti-money laundering laws with respect to our operations, and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.
Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
The CREATES Act exposes us to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms for testing in support of their ANDAs and 505(b)(2) applications.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
Risks Related to Employee Matters and Managing Growth
Our future success depends on our ability to retain our key executives and scientific leadership and to attract, retain and motivate qualified personnel.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
Risks Related to Our Common Stock and Other Matters
Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
The price of our common stock is volatile, which could result in substantial losses for purchasers of our common stock.
Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
We incur costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices.
Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
Legal proceedings
As of December 31, 2025, we were not a party to any material legal or arbitration proceedings. No governmental proceedings are pending or, to our knowledge, contemplated against us. We are not a party to any material proceedings in which any director, member of senior management or affiliate of ours is either a party adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.
