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ARDX on Nasdaq

Ardelyx (United States)

In its 2026 annual report the company says: “We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. We currently market two therapies from the active ingredient tenapanor, a sodium/hydrogen exchanger (NHE3) inhibitor that was discovered and developed by Ardelyx. We are seeking to further expand the IBSRELA eligible patient population to include patients with chronic idiopathic constipation (CIC), and have initiated a Phase 3 clinical trial evaluating tenapanor in adult CIC patients.”5 It was founded in 2007.1 It is headquartered in Fremont.1 Its shares trade on Nasdaq under the symbol ARDX.1

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Last updated Oct 21, 2026.

Overview

2007Founded1

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  • TickerARDX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersFremont1
  • Websitewww.ardelyx.com
  • Legal formDelaware corporation1
  • Incorporated inDE4
  • Business address34175 Ardenwood Blvd., Fremont, Ca 945554
  • Filer categoryLarge accelerated filer4
  • LEI549300F542QR4SXHCY323
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O PARACORP INCORPORATED, 19934 Camden, United States3
  • Registered withDivision of Corporations, Department of State, 44431803

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We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. We currently market two therapies from the active ingredient tenapanor, a sodium/hydrogen exchanger (NHE3) inhibitor that was discovered and developed by Ardelyx. NHE3 is an antiporter expressed on the apical surface of the small and large intestines. Tenapanor is a minimally absorbed, first-in-class, oral, small molecule therapy.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-10.1%Operating margin6
-15.1%Net margin6
22.1%Revenue growth, 20256
-36.9%Return on equity6
1.21×Debt to equity6
-$44.0MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product, IBSRELA brought in 67% of the revenue Ardelyx (United States) broke down this way in fiscal 2025.

  1. Product, IBSRELA$274.2M667%up 73% from 2024
  2. Product, XPHOZAH$103.6M625%down 36% from 2024
  3. Product Supply Revenue$15.9M64%up 36% from 2024
  4. Non-Cash Royalty Related To Sale of Future Royalties$8.5M62%up 217% from 2024
  5. License$5.1M61%up 6423% from 2024
Products and services by year
Products and services202320242025
Product, IBSRELA$80.1M$158.3M$274.2M
Product, XPHOZAH$2.5M$160.9M$103.6M
Product Supply Revenue$6.1M$11.6M$15.9M
Non-Cash Royalty Related To Sale of Future Royalties$0$2.7M$8.5M
License$35.8M$78.0K$5.1M

Regions

United States brought in 93% of the revenue Ardelyx (United States) broke down this way in fiscal 2025.

  1. United States$377.8M693%up 18% from 2024
  2. Asia Pacific$29.2M67%up 103% from 2024
  3. North America$342.0K60%up 338% from 2024
Regions by year
Regions202320242025
United States$83.3M$319.2M$377.8M
Asia Pacific$41.1M$14.3M$29.2M
North America$59.0K$78.0K$342.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue9¢$39.5M
  • Research and development16¢$71.5M
  • Selling, general and admin75¢$337.2M
  • Income tax0¢$969.0K

Out of $407.3M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$407.3M in 2025+7613% since 2019
0$200.0M$400.0M$600.0M2019: $5.3M$5.3M20192020: $7.6M$7.6M2020+43%2021: $10.1M$10.1M2021+33%2022: $52.2M$52.2M2022+417%2023: $124.5M$124.5M2023+139%2024: $333.6M$333.6M2024+168%2025: $407.3M$407.3M2025+22%
Operating income789106-$41.0M in 2025−55% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$91.3M-$91.3M20192020: -$90.8M-$90.8M2020−1%2021: -$154.3M-$154.3M2021+70%2022: -$63.8M-$63.8M2022−59%2023: -$63.3M-$63.3M2023−1%2024: -$27.9M-$27.9M2024−56%2025: -$41.0M-$41.0M2025+47%
Net income789106-$61.6M in 2025−35% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$94.9M-$94.9M20192020: -$94.3M-$94.3M2020−1%2021: -$158.2M-$158.2M2021+68%2022: -$67.2M-$67.2M2022−58%2023: -$66.1M-$66.1M2023−2%2024: -$39.1M-$39.1M2024−41%2025: -$61.6M-$61.6M2025+57%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Total revenues$407.3M$333.6M$124.5M
Cost of sales$39.5M$50.6M$17.8M
Research and development$71.5M$52.3M$35.5M
Selling, general and administrative$337.2M$258.7M$134.4M
Total costs and operating expenses$448.3M$361.6M$187.7M
Loss from operations-$41.0M-$27.9M-$63.3M
Interest expense-$20.1M-$13.0M-$5.0M
Non-cash interest expense related to the sale of future royalties-$8.3M-$7.1M-$3.9M
Other income, net$8.7M$9.2M$6.6M
Loss before provision for income taxes-$60.6M-$38.9M-$65.5M
Provision for income taxes$969.0K$266.0K$547.0K
Net loss-$61.6M-$39.1M-$66.1M
Net loss per share of common stock - basic (in dollars per share)-$0.26-$0.17-$0.30
Net loss per share of common stock - diluted (in dollars per share)-$0.26-$0.17-$0.30
Shares used in computing net loss per share - basic (in shares)241.0M shares235.2M shares219.3M shares
Shares used in computing net loss per share - diluted (in shares)241.0M shares235.2M shares219.3M shares
Unrealized gains (losses) on available-for-sale securities$141.0K-$167.0K$278.0K
Comprehensive loss-$61.5M-$39.3M-$65.8M

Compare Ardelyx (United States) with another company

Corporate structure

Ardelyx (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Ardelyx (United States)

  • Ardelyx (United States) Fremont, California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Ardelyx (United States) 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.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$4.8M6 Dec 31, 2025$12.1M6 Dec 31, 2024−60.1%
Accumulated depreciation$2.6M6 Dec 31, 2025$10.6M6 Dec 31, 2024−75.0%
Property and equipment, net$2.2M6 Dec 31, 2025$1.5M6 Dec 31, 2024+46.1%
Operating-lease assets (leased space)$4.8M6 Dec 31, 2025$2.4M6 Dec 31, 2024+101.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$68.0M6 Dec 31, 2025$64.9M6 Dec 31, 2024+4.7%
Marketable securities, current$196.7M6 Dec 31, 2025$185.2M6 Dec 31, 2024+6.2%
Debt securities available for sale$196.7M6 Dec 31, 2025$185.2M6 Dec 31, 2024+6.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$123.1M6 Dec 31, 2025$91.2M6 Dec 31, 2024+35.0%
Raw materials$28.0M6 Dec 31, 2025$30.8M6 Dec 31, 2024−9.0%
Work in process$88.3M6 Dec 31, 2025$58.7M6 Dec 31, 2024+50.4%
Finished goods$6.8M6 Dec 31, 2025$1.7M6 Dec 31, 2024+300.6%

Properties, in its own words

We do not own any real estate or other physical properties materially important to our operations. Our Waltham, Massachusetts headquarters is leased for four suites, all of which expire in July 2029. In addition, we have lease agreements to lease office spaces in Milwaukee, Wisconsin and Newark, California which expire in February 2029 and May 2028, respectively.

Item 2 of the 10-K filed Feb 19, 2026.5

Leadership

Who has led Ardelyx (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Michael Raab2014–now

President

  1. Michael Raab2014–now

Chief financial officer

  1. Mark Kaufmann2014–2019
  2. Justin A. Renz2020–2025
  3. Susan Hohenleitner2025–now

Chief operating officer

  1. Reginald Seeto2016–2018
2010201520202025
Board members and other officers (36)

Former names

  • NTERYX INCJun 9, 2008 to Jun 9, 20084

Timeline

  1. Aug 17, 20268-K Other events54
  2. Aug 6, 20268-K Results of operations; Regulation FD disclosure55
  3. Jul 2, 20268-K New debt or obligation56
  4. Jun 17, 20268-K Executive or director change; Shareholder vote57
  5. Apr 30, 20268-K Results of operations; Regulation FD disclosure58
  6. Feb 19, 20268-K Results of operations; Regulation FD disclosure59
  7. Jan 8, 20268-K Results of operations; Other events60
  8. Dec 17, 20258-K Executive or director change; Other events61
  9. Oct 30, 20258-K Results of operations62
  10. Oct 14, 20258-K Executive or director change63
  11. Aug 4, 20258-K Results of operations; Executive or director change; Bylaws or fiscal year changed64
  12. Jul 3, 20258-K Entered a material agreement65
  13. Jun 18, 2014New chief executive Michael Raab becomes CEO15
  14. 2007Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026 · After the closeReports results for the quarter ending Sep/202666

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results55
  2. Apr 30, 2026Reported quarterly or annual results58
  3. Feb 19, 2026Reported quarterly or annual results59
  4. Jan 8, 2026Reported quarterly or annual results60
  5. Oct 30, 2025Reported quarterly or annual results62
  6. Aug 4, 2025Reported quarterly or annual results64
  7. May 1, 2025Reported quarterly or annual results67
  8. Feb 20, 2025Reported quarterly or annual results68

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

560 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 327 insider forms, 36 large holders, 117 other. The latest 20:

  1. Aug 25, 20264 EDGAR
  2. Aug 25, 20264 EDGAR
  3. Aug 25, 20264 EDGAR
  4. Aug 25, 20264 EDGAR
  5. Aug 25, 20264 EDGAR
  6. Aug 25, 20264 EDGAR
  7. Aug 25, 20264 EDGAR
  8. Aug 25, 20264 EDGAR
  9. Aug 21, 2026144 EDGAR
  10. Aug 21, 2026144 EDGAR
  11. Aug 21, 2026144 EDGAR
  12. Aug 21, 2026144 EDGAR
  13. Aug 21, 2026144 EDGAR
  14. Aug 21, 2026144 EDGAR
  15. Aug 21, 2026144 EDGAR
  16. Aug 21, 2026144 EDGAR
  17. Aug 17, 20268-K EDGAR
  18. Aug 14, 2026SCHEDULE 13G EDGAR
  19. Aug 11, 2026SCHEDULE 13G/A EDGAR
  20. Aug 10, 2026S-8 EDGAR

The 560 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

237 open-market trades by officers, directors and large owners since October 2021: 16 buys and 221 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 21, 2026Hohenleitner SusanChief Financial OfficerSale1,558$3.86$6.0KForm 4
Aug 21, 2026Brady James ParkerChief Human Resources OfficerSale15,136$3.86$58.4KForm 4
Aug 21, 2026Reilly Joseph JamesSee RemarksSale3,982$3.86$15.4KForm 4
Aug 21, 2026Foster Eric DuaneChief Commercial OfficerSale8,562$3.86$33.0KForm 4
Aug 21, 2026Kelliher MikeChief Business OfficerSale7,758$3.86$29.9KForm 4
Aug 21, 2026Williams Laura AChief Patient OfficerSale10,739$3.86$41.5KForm 4
Aug 21, 2026RAAB MICHAELPresident & CEOSale58,574$3.86$226.1KForm 4
Aug 21, 2026Bishop John ESee RemarksSale19,750$3.86$76.2KForm 4
Jul 15, 2026RAAB MICHAELPresident & CEOSale41,668$5.06$210.8KForm 4
Jun 18, 2026Williams Laura AChief Patient OfficerSale81,898$5.99$490.6KForm 4
Jun 15, 2026RAAB MICHAELPresident & CEOSale41,666$5.67$236.2KForm 4
May 21, 2026Hohenleitner SusanChief Financial OfficerSale1,455$6.27$9.1KForm 4
May 21, 2026Brady James ParkerChief Human Resources OfficerSale1,846$6.27$11.6KForm 4
May 21, 2026Reilly Joseph JamesSee RemarksSale3,719$6.27$23.3KForm 4
May 21, 2026Foster Eric DuaneChief Commercial OfficerSale7,998$6.27$50.1KForm 4
May 21, 2026Kelliher MikeChief Business OfficerSale7,248$6.27$45.4KForm 4
May 21, 2026Williams Laura AChief Patient OfficerSale6,989$6.27$43.8KForm 4
May 21, 2026RAAB MICHAELPresident & CEOSale54,748$6.27$343.3KForm 4
May 21, 2026Bishop John ESee RemarksSale2,306$6.27$14.5KForm 4
May 15, 2026RAAB MICHAELPresident & CEOSale41,666$6.28$261.7KForm 4

All 237 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

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.

YearExecutiveAgeSalaryTotal pay
2025Michael RaabPresident, Chief Executive Officer and Director61$797.0K$7.8M81
2025Edward Conner, M.D.Former Chief Medical Officer$213.0K$3.6M81
2025Justin RenzFormer Chief Financial and Operations Officer$464.4K$3.6M81
2025Susan HohenleitnerChief Financial Officer55$120.9K$3.4M81
2025John Bishop, Ph.D.Chief Technical and Quality Officer64$240.0K$2.5M81
2025Elizabeth Grammer, Esq.Former Chief Legal and Administrative Officer$527.1K$2.3M81
2024Michael RaabPresident, Chief Executive Officer and Director61$770.0K$9.6M81
2024Justin RenzFormer Chief Financial and Operations Officer$517.0K$3.0M81
2024Elizabeth Grammer, Esq.Former Chief Legal and Administrative Officer$509.3K$3.0M81
2023Michael RaabPresident, Chief Executive Officer and Director61$700.0K$4.1M81
2023Elizabeth Grammer, Esq.Former Chief Legal and Administrative Officer$463.3K$1.6M81

Held by these funds

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.

FundSharesValueShare of the fundChange
BlackRock, Inc.23,504,630$119.9M0.0%+2,340,498
Rubric Capital Management LP16,202,700$82.6M0.8%+14,341,804
Millennium Management LLC13,900,773$70.9M0.0%−3,941,597
State Street Corp13,356,128$68.1M0.0%−248,179
Vanguard Capital Management LLC10,471,494$53.4M0.0%+105,982
Nomura Asset Management International Inc.9,546,732$48.7M0.1%+1,377,363
Vanguard Portfolio Management LLC8,026,774$40.9M0.0%+1,365,081
Geode Capital Management, LLC6,401,736$32.7M0.0%+394,281
Jupiter Topco LLC5,302,311$27.0M0.0%New
Two Sigma Investments, LP5,209,823$26.6M0.0%+935,780
Nuveen, LLC3,997,099$20.4M0.0%−1,237,584
Goldman Sachs Group Inc3,685,034$18.8M0.0%+468,824
AIGH Capital Management LLC3,200,000$16.3M1.5%New
Morgan Stanley2,389,546$12.2M0.0%+680,573
Aqr Capital Management LLC2,316,220$11.8M0.0%−123,230
Northern Trust Corp2,280,143$11.6M0.0%+209,096
Rock Springs Capital Management LP2,241,769$11.4M0.6%−57,704
Charles Schwab Investment Management Inc2,211,760$11.3M0.0%+97,662
Bank Of America Corp /de/2,163,500$11.0M0.0%−173,494
Qube Research & Technologies Ltd2,090,675$10.7M0.0%−344,873
Jones Financial Companies Lllp1,765,932$9.8M0.0%−92,959
Vanguard Fiduciary Trust Co1,754,819$8.9M0.0%+76,708
Eversept Partners, LP1,678,345$8.6M0.5%−551,101
J. Goldman & Co LP1,579,828$8.1M0.3%−1,420,685
Invesco Ltd.1,368,868$7.0M0.0%+1,056,156

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Ardelyx (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARARDELYX, INC.2
  • CIK0001437402
  • Employer ID (EIN)26-13039445
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address34175 Ardenwood Blvd., Fremont, CA 945552
  • Phone510-745-70472
  • Shares outstanding249,187,572 as of Jul 30, 202613
  • Public float$923.7M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceJun 9, 20082
  • Filings1,180 in all: 4 (632), 8-K (153), 144 (87), 3 (50), SC 13G/A (41), 10-Q (37), SC 13G (22), S-8 (15)2
    All 41 form types

    DEFA14A (14), 10-K (12), DEF 14A (12), SCHEDULE 13G/A (12), CORRESP (11), UPLOAD (9), 424B5 (8), EFFECT (7), SC 13D/A (7), S-3 (6), 4/A (5), ARS (5), SCHEDULE 13G (5), D (4), 5 (3), S-1/A (3), 144/A (2), CT ORDER (2), PRE 14A (2), 10-K/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DEFR14A (1), DRS (1), FWP (1), REGDEX (1), S-1 (1), S-1MEF (1), S-3/A (1), S-3ASR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 17, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareARDXThe Nasdaq Global Market

From the cover page of the 10-K filed Feb 19, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Ardelyx (United States) names in Item 1A of its 10-K filed Feb 19, 2026: 53 risks under these headings, as written.5

  • Risks Related to our Financial Condition and Capital Requirements
  • We have incurred losses in each year since our inception, and if we are unable to continue to increase revenue and/or, depending upon our pursuit of future business opportunities, we may not achieve expected cash flow positivity, and even if we do, we may not be able to sustain cash flow positivity quarter over quarter and year over year.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • We may require additional financing for the foreseeable future as we invest in the growth of IBSRELA and XPHOZAH in the U.S. and build a pipeline. The inability to access necessary capital when needed on acceptable terms, or at all, could force us to delay or limit our pursuit of other future business opportunities.
  • Principal Risks Related to Our Business
  • We are substantially dependent on the successful commercialization of IBSRELA, and there is no guarantee that we will maintain sufficient market acceptance for IBSRELA, grow market share for IBSRELA, secure and maintain adequate coverage and reimbursement for IBSRELA, or generate sufficient revenue from product sales of IBSRELA.
  • There is no guarantee that we will achieve sufficient market acceptance for XPHOZAH, or that we will be able to secure and maintain adequate coverage and reimbursement for XPHOZAH, or generate sufficient revenue from product sales of XPHOZAH. The inclusion of XPHOZAH in the ESRD PPS creates additional uncertainty as to the commercial opportunity for XPHOZAH.
  • XPHOZAH became part of the ESRD PPS on January 1, 2025, which means coverage for XPHOZAH for Medicare beneficiaries is no longer available under Medicare Part D; this resulted in a negative and material impact on our XPHOZAH revenue in 2025; and the continued lack of Medicare Part D coverage for XPHOZAH will result in a materially lower pace of revenue growth as compared to expectations before XPHOZAH became part of the ESRD PPS.
  • IBSRELA and/or XPHOZAH may cause undesirable side effects or have other properties that could limit the commercial success of the products.
  • Third-party payor coverage and reimbursement status of newly commercialized products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for IBSRELA and XPHOZAH could limit our ability to market those products and decrease our ability to generate revenue.
  • We rely completely on third parties, including certain single-source suppliers, to manufacture IBSRELA and XPHOZAH. If they are unable to comply with applicable regulatory requirements, unable to source sufficient raw materials, experience manufacturing or distribution difficulties or are otherwise unable to manufacture sufficient quantities to meet demand, our commercialization of IBSRELA and XPHOZAH may be materially harmed.
  • Our future business prospects may depend on our ability, alone or through our current or future collaborations, to successfully develop, gain regulatory approval of and commercialize our current and future product candidates.
The other 43 risks
  • Our future results depend on CMOs, many of whom are our single source manufacturers.
  • Our operating activities may be restricted as a result of covenants related to the indebtedness under our loan and security agreement with SLR, as amended, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
  • Additional Risks Related to Our Business and Industry
  • We face substantial competition, and our competitors may discover, develop or commercialize products faster or more successfully than us.
  • We may experience difficulties in managing our current activities and growth given our level of managerial, operational, financial and other resources.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of IBSRELA and/or XPHOZAH.
  • If we fail to attract, retain and motivate our executives, senior management and key personnel, our business will suffer.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
  • We and our collaborators, CROs and other contractors and consultants depend on information technology systems, and any failure of these systems could harm our business. Security breaches, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us and could have a material adverse effect on the price of our common stock.
  • We have formed in the past, and may form in the future, collaboration partnerships, joint ventures and/or licensing arrangements, and we may not realize the benefits of such collaborations.
  • We will rely on third parties to conduct all of our nonclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for additional products or commercialize our product candidates.
  • Our CMOs manufacture tenapanor API outside of the U.S. Our collaboration partners outside of the U.S. have sought and obtained and may continue to seek and obtain approval to commercialize tenapanor outside of the U.S., and as a result, a variety of risks associated with international operations could materially adversely affect our business.
  • Changes in U.S. and international trade policies may adversely impact our business and operating results.
  • Our business involves the use of hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters, severe weather, public health emergencies and other catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Government Regulation
  • Current and future healthcare reform legislation, regulation or action by the current administration may increase the difficulty and cost for us to commercialize our approved products and may adversely affect the prices we, or they, may obtain and may have a negative impact on our business and results of operations.
  • Despite having received regulatory approval for IBSRELA and XPHOZAH, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, IBSRELA and XPHOZAH could be subject to other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise review and process regulatory submissions in a timely manner, which could negatively impact our business.
  • We and our CMOs are subject to significant regulation with respect to manufacturing IBSRELA and XPHOZAH. The manufacturing facilities on which we rely may not continue to meet regulatory requirements or may not be able to meet supply demands.
  • If we fail to comply or are found to have failed to comply with FDA and other regulations related to the promotion of our products for unapproved uses, other sales practices, as well as the design and implementation of our patient assistance programs, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
  • IBSRELA and/or XPHOZAH may cause or contribute to adverse medical events that we are required to report to regulatory agencies and if we fail to do so we could be subject to sanctions that would materially harm our business.
  • Our employees, independent contractors, principal investigators, CROs, collaboration partners, consultants, CMOs and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Failure to obtain regulatory approvals in foreign jurisdictions would prevent us from marketing our products internationally.
  • We and our collaboration partners are subject to healthcare laws, regulation and enforcement; our failure or the failure of any such collaboration partners to comply with these laws could have a material adverse effect on our results of operations and financial conditions.
  • Legislative or regulatory healthcare reforms in the U.S. may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates and to produce, market and distribute our products after clearance or approval is obtained.
  • If we fail to comply with our reporting and payment obligations under the MDRP or other governmental pricing programs in the U.S., 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 financial condition.
  • Risks Related to Intellectual Property
  • Our success will depend on our ability to obtain, maintain and protect our intellectual property rights.
  • We may become subject to third-party claims alleging infringement, misappropriation or violation of such third parties’ patents or other intellectual property rights and/or third-party claims seeking to invalidate our patents, which would be costly, time consuming and, if successfully asserted against us, delay or prevent the development, manufacture or commercialization of our products or product candidates.
  • If we are not able to successfully enforce our intellectual property rights, the commercial value of IBSRELA and XPHOZAH or other product candidates may be adversely affected and we may not be able to compete effectively in our market.
  • Although we have obtained patent term extension in the U.S. under the Hatch-Waxman Act, extending the term of exclusivity for tenapanor, if we do not obtain patent term extension in foreign countries under similar legislation, our business may be materially harmed. Furthermore, we have obtained patent term adjustment in the U.S. under the American Inventors Protection Act extending the patent term for certain patents covering tenapanor.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We may be subject to claims that we or our employees have misappropriated the intellectual property, including know-how or trade secrets, of a third party, or claiming ownership of what we regard as our own intellectual property.
  • Risks Related to Our Common Stock
  • Our stock price may continue to be volatile and our stockholders may not be able to resell shares of our common stock at or above the price they paid.
  • If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
  • General Risk Factors
  • We incur significant costs as a result of operating as a public company, and our management devotes substantial time to new compliance initiatives. We may fail to comply with the rules that apply to public companies, including Section 404 of the Sarbanes-Oxley Act of 2002, which could result in sanctions or other penalties that would harm our business.
  • We may be adversely affected by the global economic environment.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.

Legal proceedings

See information under the “Legal Proceedings and Claims” caption in Note 19. Commitments and Contingencies which we incorporated here by reference.

The opening of Item 3, Legal Proceedings.5

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