CRMD on Nasdaq

CorMedix Inc.

CorMedix Inc. is an American pharmaceutical preparations company based in Berkeley Heights.2 Its shares trade on Nasdaq under the symbol CRMD.2

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Last updated Oct 21, 2026.

Overview

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  • TickerCRMD on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersBerkeley Heights, United States2
  • Incorporated inDE3
  • Business address389 Interpace Pkwy, Suite 450, Parsippany, Nj 070543
  • Filer categoryNon-accelerated filer3
  • Legal formCorporation2
  • LEI5299006YIA3L0MBW83582
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 41973952

Analysis included within this Annual Report, for additional details on the arrangement with Mundipharma.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

88.5%Gross margin6
48.2%Operating margin6
52.3%Net margin6
617.0%Revenue growth, 20256
40.2%Return on equity6
$172.8MFree cash flow6

What sells

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

Products and services

Defen Cath brought in 83% of the revenue CorMedix Inc. broke down this way in fiscal 2025.

  1. Defen Cath$258.8M683%up 495% from 2024
  2. Melinta Portfolio$45.5M615%
  3. Contract Revenue$7.4M62%
Products and services by year
Products and services20242025
Defen Cath$43.5M$258.8M
Melinta Portfolio$45.5M
Contract Revenue$7.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue7¢$22.1M
  • Research and development6¢$19.3M
  • Other costs30¢$94.2M
  • Income tax4¢$13.0M
  • Profit52¢$163.1M

Out of $311.7M in revenue.6

Where each dollar of operating cash went, fiscal 2025

  • Capital spending1¢$2.3M
  • Kept or used elsewhere99¢$172.8M

Out of $175.0M of cash from operations.6

Financial statements

Revenue789106$311.7M in 2025+109941% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $283.3K$283.3K20192020: $239.2K$239.2K2020−16%2021: $190.9K$190.9K2021−20%2022: $65.4K$65.4K2022−66%2024: $43.5M$43.5M2024+66363%2025: $311.7M$311.7M2025+617%
Gross profit789106$275.7M in 2025
-$100.0M0$100.0M$200.0M$300.0M2019: -$90.0K-$90.0K20192020: $34.4K$34.4K20202021: $42.0K$42.0K2021+22%2022: $61.7K$61.7K2022+47%2024: $40.3M$40.3M2024+65214%2025: $275.7M$275.7M2025+585%
Operating income78910116$150.1M in 2025
-$50.0M0$50.0M$100.0M$150.0M$200.0M2019: -$21.0M-$21.0M20192020: -$27.2M-$27.2M2020+30%2021: -$29.4M-$29.4M2021+8%2022: -$30.6M-$30.6M2022+4%2023: -$49.0M-$49.0M2023+60%2024: -$22.4M-$22.4M2024−54%2025: $150.1M$150.1M2025
Net income78910116$163.1M in 2025
-$100.0M0$100.0M$200.0M2019: -$16.4M-$16.4M20192020: -$22.0M-$22.0M2020+34%2021: -$28.2M-$28.2M2021+28%2022: -$29.7M-$29.7M2022+5%2023: -$46.3M-$46.3M2023+56%2024: -$17.9M-$17.9M2024−61%2025: $163.1M$163.1M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Total Revenues$311.7M$43.5M
Cost of sales (exclusive of amortization of intangibles)$22.1M$3.0M
Amortization of intangibles$13.9M$156.0K
Gross profit$275.7M$40.3M
Research and development$19.3M$3.9M
Selling and marketing$38.1M$28.7M
General and administrative$68.2M$30.0M
Total operating expenses$125.6M$62.6M
Income (Loss) From Operations$150.1M-$22.4M
Interest income$3.8M$2.6M
Foreign exchange transaction loss-$52.0K-$31.0K
Unrealized gain on marketable security$5.4M
Other income$519.0K
Change in contingent consideration-$6.5M
Interest expense-$2.8M-$36.0K
Total other income (expense)-$125.0K$3.0M
Net Income (Loss) Before Income Taxes$150.0M-$19.3M
Income Tax (benefit)-$13.0M-$1.4M
Net Income (Loss)$163.1M-$17.9M
Unrealized (loss) from investments-$2.0K-$5.0K
Foreign currency translation gain (loss)-$86.0K$2.0K
Total other comprehensive (loss)-$88.0K-$3.0K
Comprehensive Income (Loss)$163.0M-$17.9M
Net Income (Loss) Per Common Share Basic (in Dollars per share)$2.25-$0.30
Net Income (Loss) Per Common Share Diluted (in Dollars per share)$2.04-$0.30
Weighted Average Common Shares Outstanding Basic (in Shares)72.0K shares58.9K shares
Weighted Average Common Shares Outstanding Diluted (in Shares)80.3K shares58.9K shares

Compare CorMedix Inc. with another company

Corporate structure

CorMedix Inc. sits at the top of its group. 8 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of CorMedix Inc.

  • Aymen Abdalkader Shaibatalhamd Filed SCHEDULE 13G/A on CorMedix Inc., latest Jun 12, 2026 (6 filings since Apr 4, 2025)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on CorMedix Inc., latest May 15, 2026 (2 filings since Dec 1, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on CorMedix Inc., latest Mar 26, 2026 (2 filings since Feb 13, 2024)
  • BlackRock Filed SCHEDULE 13G/A on CorMedix Inc., latest Feb 5, 2025 (4 filings since Feb 3, 2022)
  • Nomura Holdings Filed SC 13G/A on CorMedix Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • CorMedix Inc. Berkeley Heights, New Jersey, United States
    • AcelRx Pharmaceuticals (United States) Stake · Redwood City
    • CEM-102 Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Cempra Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Melinta Subsidiary Corp. Subsidiary · Delaware, United States
    • Melinta Therapeutics, LLC Subsidiary · Delaware, United States
    • Rempex Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Targanta Therapeutics Corporation Subsidiary · Delaware, 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; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.

What it owns

What CorMedix Inc. 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
Accumulated depreciation$674.0K11 Dec 31, 2024$521.0K11 Dec 31, 2023+29.4%
Property and equipment, net$6.0M6 Dec 31, 2025$1.8M6 Dec 31, 2024+225.8%
Finance-lease assets$946.0K6 Dec 31, 2025
Operating-lease assets (leased space)$3.0M6 Dec 31, 2025$493.0K6 Dec 31, 2024+512.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$144.8M6 Dec 31, 2025$40.7M6 Dec 31, 2024+256.3%
Marketable securities, current$10.4M6 Dec 31, 2025
Debt securities available for sale$8.5M6 Dec 31, 2025$34.2M6 Dec 31, 2024−75.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$30.0M6 Dec 31, 2025
Intangible assets, net (excluding goodwill)$379.1M6 Dec 31, 2025$1.8M6 Dec 31, 2024+20457.0%
Finite-lived intangibles, gross$393.1M6 Dec 31, 2025$2.0M6 Dec 31, 2024+19555.0%
Accumulated amortization-$14.0M6 Dec 31, 2025-$156.0K6 Dec 31, 2024−8892.3%
Finite-lived intangibles, net$236.1K6 Dec 31, 2025

Inventory

ItemLatestA year beforeChange
Inventory, total$29.7M6 Dec 31, 2025$7.6M6 Dec 31, 2024+291.0%
Raw materials$3.6M6 Dec 31, 2025$1.1M6 Dec 31, 2024+227.2%
Work in process$11.7M6 Dec 31, 2025$3.5M6 Dec 31, 2024+231.4%
Finished goods$14.4M6 Dec 31, 2025$3.0M6 Dec 31, 2024+386.0%

Properties, in its own words

Our corporate headquarters is located in Parsippany, New Jersey, representing a leased facility which expires in March, 2030. We have additional leased office facilities in Lake Forest, Illinois, expiring in September 2031 and an office located in Berkeley Heights, NJ which we are actively marketing for sub-lease, expiring in October 2027.

We believe that our existing facilities are adequate to meet our current needs.

Item 2 of the 10-K filed Mar 5, 2026.5

Leadership

Who has led CorMedix Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (35)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • CEM-102 Pharmaceuticals, Inc. Delaware4
  • Cempra Pharmaceuticals, Inc. Delaware4
  • Melinta Subsidiary Corp. Delaware4
  • Melinta Therapeutics, LLC Delaware4
  • Rempex Pharmaceuticals, Inc. Delaware4
  • Targanta Therapeutics Corporation Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Aug 13, 20268-K Results of operations59
  2. Aug 7, 20268-K Other events60
  3. Jul 2, 20268-K Other events61
  4. Jul 1, 20268-K Change of auditor62
  5. Jun 24, 20268-K Shareholder vote63
  6. Jun 8, 20268-K Regulation FD disclosure64
  7. May 14, 20268-K Results of operations65
  8. Apr 27, 20268-K Regulation FD disclosure66
  9. Mar 6, 20268-K Regulation FD disclosure67
  10. Mar 5, 20268-K Results of operations68
  11. Jan 8, 20268-K Results of operations; Executive or director change; Other events69
  12. Nov 12, 20258-K Results of operations70
  13. May 12, 2022New chief executive Joseph Todisco becomes CEO14
  14. Nov 10, 2021New chief executive Matthew T. David becomes CEO15
  15. Oct 5, 2016New chief executive Khoso Baluch becomes CEO16
  16. Mar 22, 2013New chief executive Randy Milby becomes CEO17
  17. Mar 26, 2010New chief executive John C. Houghton becomes CEO18

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.57 a share, on Nov 12, 2025.71

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results59
  2. May 14, 2026Reported quarterly or annual results65
  3. Mar 5, 2026Reported quarterly or annual results68
  4. Jan 8, 2026Reported quarterly or annual results69
  5. Nov 12, 2025Reported quarterly or annual results70
  6. Oct 20, 2025Reported quarterly or annual results72
  7. Aug 7, 2025Reported quarterly or annual results73
  8. May 6, 2025Reported quarterly or annual results74

Drug trials and FDA: recently

  1. Nov 15, 2023FDA approval FDA approved Defencath (heparin sodium), a new molecular entity, priority review (NDA 214520).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

279 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 132 insider forms, 18 large holders, 49 other. The latest 20:

  1. Sep 18, 20264 EDGAR
  2. Sep 1, 20264 EDGAR
  3. Sep 1, 20264 EDGAR
  4. Sep 1, 20264 EDGAR
  5. Aug 13, 202610-Q EDGAR
  6. Aug 13, 20268-K EDGAR
  7. Aug 7, 20268-K EDGAR
  8. Jul 2, 20268-K EDGAR
  9. Jul 1, 20268-K EDGAR
  10. Jun 25, 2026S-8 POS EDGAR
  11. Jun 24, 20268-K EDGAR
  12. Jun 12, 2026SCHEDULE 13G/A EDGAR
  13. Jun 12, 2026SCHEDULE 13G/A EDGAR
  14. Jun 8, 20268-K CURRENT REPORT EDGAR
  15. May 15, 2026SCHEDULE 13G/A EDGAR
  16. May 14, 202610-Q EDGAR
  17. May 14, 20268-K EDGAR
  18. Apr 29, 2026ARS EDGAR
  19. Apr 29, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
  20. Apr 29, 2026DEF 14A PROXY STATEMENT EDGAR

The 279 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

34 open-market trades by officers, directors and large owners since October 2021: 20 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 21, 2026Dillione JanetDirectorSale10,000$6.88$68.8KForm 4
Dec 30, 2025DUNTON ALAN WDirectorSale20,000$13.00$260.0KForm 4
Dec 18, 2025Todisco JosephChief Executive OfficerSale30,000$12.00$360.0KForm 4
Dec 9, 2025Dillione JanetDirectorSale34,000$12.00$408.0KForm 4
Dec 9, 2025Lefkowitz Steven WDirectorSale40,000$11.88$475.2KForm 4
Dec 2, 2025Dillione JanetDirectorSale46,657$10.00$466.6KForm 4
Nov 24, 2025Dillione JanetDirectorSale26,343$9.93$261.6KForm 4
Nov 14, 2025Dillione JanetDirectorSale30,000$11.42$342.6KForm 4
Oct 23, 2025Kaplan MyronDirectorBuy25,000$11.02$275.5KForm 4
Sep 12, 2025DUNTON ALAN WDirectorSale10,000$13.13$131.3KForm 4
Sep 12, 2025Todisco JosephChief Executive OfficerSale50,000$13.00$650.0KForm 4
Sep 11, 2025Hurlburt ElizabethChief Operating OfficerSale41,121$13.08$537.9KForm 4
Sep 9, 2025Zelnick Kaufman BethChief Legal OfficerSale50,000$13.41$670.3KForm 4
Sep 9, 2025Hurlburt ElizabethChief Operating OfficerSale12,876$13.51$174.0KForm 4
Nov 14, 2024Hurlburt ElizabethChief Operating OfficerSale140,027$11.18$1.6MForm 4
Oct 31, 2024Mistry ErinEVP, Chief Commercial OfficerBuy1,500$9.99$15.0KForm 4
Mar 13, 2024Todisco JosephChief Executive OfficerBuy13,561$3.74$50.7KForm 4
Dec 15, 2023DUNTON ALAN WDirectorBuy3,000$3.30$9.9KForm 4
Dec 14, 2023DUNTON ALAN WDirectorBuy3,000$3.45$10.3KForm 4
Nov 17, 2023Mistry ErinEVP, Chief Commercial OfficerBuy1,000$4.00$4.0KForm 4

All 34 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.

Stakes it holds

CorMedix Inc. has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).

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
2025Joseph Todisco50$684.4K$6.1M82
2025Beth Zelnick Kaufman66$497.6K$3.8M82
2025Elizabeth Hurlburt47$479.6K$3.7M82
2024Chief Executive Officer$639.2K$2.4M82
2024Executive Vice PresidentChief Operating Officer$405.9K$1.1M82

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.6,324,111$49.6M0.0%+356,536
Deep Track Capital, LP6,274,076$49.3M0.7%No change
Vanguard Capital Management LLC3,135,075$24.6M0.0%+5,419
State Street Corp2,316,845$18.2M0.0%+125,002
Royce & Associates LP2,176,362$17.1M0.1%+288,830
Geode Capital Management, LLC1,947,014$15.3M0.0%+130,107
UBS Group AG1,877,940$14.7M0.0%+339,695
Oberweis Asset Management Inc/1,323,915$10.4M0.2%+112,800
Alyeska Investment Group, L.P.850,000$6.7M0.0%No change
Marshall Wace, Llp779,535$6.1M0.0%+276,570
Northern Trust Corp756,430$5.9M0.0%+118,747
Vanguard Portfolio Management LLC708,604$5.6M0.0%−33,967
Trexquant Investment LP623,797$4.9M0.0%+63,160
Charles Schwab Investment Management Inc618,172$4.9M0.0%+15,206
Armistice Capital, LLC500,000$3.9M0.1%New
Vanguard Fiduciary Trust Co484,322$3.8M0.0%−21,357
Goldman Sachs Group Inc466,393$3.7M0.0%−44,936
Raymond James Financial Inc446,142$3.5M0.0%+117,918
Hennion & Walsh Asset Management, Inc.438,629$3.4M0.1%+263,618
Bridgeway Capital Management, LLC434,132$3.4M0.1%New
Palisades Investment Partners, LLC426,543$3.3M1.0%−183,605
Morgan Stanley423,341$3.3M0.0%−12,298
Kennedy Capital Management LLC419,284$3.3M0.1%−254,018
Private Advisor Group, LLC415,406$3.3M0.0%−89,262
Bank of New York Mellon Corp395,907$3.1M0.0%+29,394

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

SEC filer profile

How CorMedix Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCorMedix Inc.1
  • CIK0001410098
  • Employer ID (EIN)20-58948905
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address389 Interpace Pkwy, Suite 450, Parsippany, NJ 070541
  • Phone908-517-95001
  • Shares outstanding77,944,324 as of Aug 10, 202613
  • Public float$909.7M as of Jun 30, 20255
  • AuditorCBIZ CPAs P.C, Morristown, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 14, 20071
  • Filings1,134 in all: 4 (439), 8-K (289), 10-Q (50), 3 (41), 4/A (28), 424B5 (21), DEF 14A (21), DEFA14A (18)1
    All 50 form types

    10-K (16), EFFECT (16), 144 (15), S-3 (13), SC 13G (13), CORRESP (12), SC 13G/A (12), UPLOAD (12), SC 13D/A (10), CT ORDER (9), PRE 14A (8), SCHEDULE 13G/A (8), 10-Q/A (7), 424B3 (7), 10-K/A (6), S-8 (6), POS AM (5), S-3/A (5), 8-K/A (4), RW (4), S-1/A (4), 3/A (3), ARS (3), 25-NSE (2), 424B1 (2), 424B4 (2), 8-A12B (2), D (2), FWP (2), REGDEX (2), S-3ASR (2), SC 13D (2), SCHEDULE 13G (2), 25 (1), CERT (1), CERTNYS (1), NT 10-Q (1), PRER14A (1), REGDEX/A (1), S-1 (1), S-8 POS (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 13, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 Par ValueCRMDNasdaq Global Market

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

Risk factors and legal proceedings

The risks CorMedix Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 31 risks under these headings, as written.5

  • Risks Related to Our Financial Position
  • Although we achieved profitability in 2025, we have a history of operating losses, may incur additional operating losses in the future, and may never achieve sustained profitability.
  • Risks Related to the Development and Commercialization of DefenCath
  • We are highly dependent on the continued successful commercialization of our lead product, DefenCath.
  • The continued successful commercialization of DefenCath will depend on maintaining coverage and reimbursement for use of DefenCath from third-party payors.
  • We have significant DefenCath customer concentration, with a limited number of customers accounting for a large portion of our revenues.
  • Our revenue and profitability may be adversely affected by DefenCath’s transition from TDAPA to the post-TDAPA add-on adjustment and broader reimbursement dynamics that could have a material adverse impact on our results of operations and business.
  • Risks Related to the Development and Commercialization of our other Products
  • Successful development and commercialization of our Products and new product lines is uncertain.
  • Infective pathogens might develop resistance to our Products or product candidates, which would decrease the efficacy and commercial viability of that product.
  • Clinical trials and regulatory approval for our product lines are expensive, time-consuming, and uncertain, and failure or delay in obtaining approval could materially harm our business.
  • Off-label marketing or use of our Products or future product candidates may expose us to significant fines, penalties, sanctions, or product liability claims, and our reputation could be harmed.
The other 22 risks
  • Risks Related to Regulatory and Legal Compliance Matters
  • Our approved Products are, and our pipeline product lines (if approved) will be, subject to extensive post-approval regulation.
  • Healthcare policy changes, including reimbursement policies for drugs and medical devices, may have an adverse effect on our business, financial condition and results of operations.
  • Changes in funding for the FDA and other government agencies or future government shutdowns or disruptions could cause delays in the submission and regulatory review of our product lines, which could negatively impact our business or prospects.
  • Risks relating to cybersecurity and data privacy could create additional liabilities for us.
  • Clinical trials required for our Products and any future product lines may be expensive, time consuming and their outcome is uncertain.
  • Our BARDA development contract requires ongoing funding decisions by the U.S. Government. Any reduction or discontinuation of funding of this contract could cause our business, financial condition, operating results and cash flows to suffer materially.
  • Risks Related to Our Business and Industry
  • We may not successfully manage the growth of our Products.
  • We have pursued and may continue to pursue acquisitions. Acquisitions could be difficult to integrate, divert the attention of key personnel, disrupt our business, dilute stockholder value and impair our financial results.
  • Competition and technological change may make our Products, product lines or indications, less attractive or obsolete.
  • If we lose key management, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in compensation costs, our business may materially suffer.
  • We face the risk of product liability claims and the amount of insurance coverage we hold now or in the future may not be adequate to cover all liabilities we might incur.
  • Risks Related to Our Intellectual Property
  • If we and our licensors do not obtain protection for and successfully defend our respective intellectual property rights, competitors may be able to take advantage of our research and development efforts to develop competing products.
  • Intellectual property disputes require us to spend time and money to address such disputes could limit our intellectual property rights and if generic entrants of our Products are approved, it could have a material adverse impact on our results of operations and financial condition.
  • Our business, financial condition, and results of operations could be materially and adversely affected by an adverse outcome in the ongoing litigation.
  • Risks Related to Dependence on Third Parties
  • Our ability to pursue the development and commercialization of certain of our Products depends upon the continuation of certain licenses and actions taken by our licensors.
  • We depend on third-party suppliers and contract manufacturers for the supply and manufacture of our product lines, as well as our APIs, which subjects us to potential cost increases and manufacturing delays that are not within our control.
  • We rely on third parties to conduct our clinical trials and pre-clinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, our product lines may not advance in a timely manner or at all.
  • The timing of the milestone and royalty payments we are required to make to third parties is uncertain and could adversely affect our cash flows and results of operations.
  • Risks Related to our Common Stock
  • Our common stock price has fluctuated considerably and is likely to remain volatile, in part due to the limited market for our common stock and you could lose all or a part of your investment.
  • General Risk Factors
  • Our business may be adversely affected by tariffs, trade sanctions or similar government actions.
  • We have identified a material weakness in our internal control over financial reporting, which could, if not effectively remediated, result in material misstatements in our financial statements, and a failure to meet our reporting and financial obligations.
  • Our internal control over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. For information regarding our legal proceedings, see Note 9, Commitments and Contingencies, included in the Financial Statements in this Annual Report on Form 10-K, which is incorporated into this item by reference.

The opening of Item 3, Legal Proceedings.5

Sources

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    SEC EDGAROther events
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    SEC EDGAROther events
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