MDGL on Nasdaq

MADRIGAL PHARMACEUTICALS, INC.

American pharmaceutical preparations company based in Washington2

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis, a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality. Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta agonist designed to target key underlying causes of MASH.”5 Its shares trade on Nasdaq under the symbol MDGL.2

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Last updated Oct 21, 2026.

Overview

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  • TickerMDGL on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWashington, United States2
  • Incorporated inDE3
  • Business address1001 Conshohocken State Road, Suite 2-350, West Conshohocken, Pa3
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI549300CHIMT2EUSNJB602
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 31915442

We are a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (“MASH”), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure, liver cancer, need for liver transplantation and premature mortality. MASH was previously known as nonalcoholic steatohepatitis (“NASH”). MASH is the leading cause of liver transplantation in women, the second leading cause of all liver transplantation in the United States and the fastest-growing indication for liver transplantation in Europe. Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. In March 2024, Rezdiffra became the first therapy approved by the FDA for patients with MASH and was commercially available in the United State…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

-31.3%Operating margin6
-30.1%Net margin6
432.1%Revenue growth, 20256
-47.8%Return on equity6
0.56×Debt to equity6
-$190.0MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Selling, general and admin85¢$813.8M
  • Other costs15¢$144.6M

Out of $958.4M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$958.4M in 2025
0$250.0M$500.0M$750.0M$1.0B2019: $0$020192020: $0$020202021: $0$020212022: $0$020222023: $0$020232024: $180.1M$180.1M20242025: $958.4M$958.4M2025+432%
Operating income710896-$300.1M in 2025+216% since 2019
-$600.0M-$400.0M-$200.0M02019: -$95.0M-$95.0M20192020: -$206.7M-$206.7M2020+118%2021: -$242.5M-$242.5M2021+17%2022: -$293.6M-$293.6M2022+21%2023: -$380.5M-$380.5M2023+30%2024: -$497.9M-$497.9M2024+31%2025: -$300.1M-$300.1M2025−40%
Net income710896-$288.3M in 2025+243% since 2019
-$600.0M-$400.0M-$200.0M02019: -$83.9M-$83.9M20192020: -$202.2M-$202.2M2020+141%2021: -$241.8M-$241.8M2021+20%2022: -$295.4M-$295.4M2022+22%2023: -$373.6M-$373.6M2023+27%2024: -$465.9M-$465.9M2024+25%2025: -$288.3M-$288.3M2025−38%

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

Period ending2025-12-312024-12-312023-12-31
Product revenue, net$958.4M$180.1M$0
Cost of sales$56.1M$6.2M$0
Research and development$388.5M$236.7M$272.4M
Selling, general and administrative$813.8M$435.1M$108.1M
Total operating expenses$1.3B$678.0M$380.5M
Loss from operations-$300.1M-$497.9M-$380.5M
Interest income$37.4M$46.7M$19.6M
Interest expense-$22.3M-$14.7M-$12.7M
Loss on extinguishment of debt-$2.8M$0$0
Other expense, net-$463.0K$0$0
Net loss-$288.3M-$465.9M-$373.6M
Basic net loss per common share (in dollars per share)-$12.85-$21.90-$19.99
Diluted net loss per common share (in dollars per share)-$12.85-$21.90-$19.99
Basic weighted average number of common shares outstanding (in shares)22.4M shares21.3M shares18.7M shares
Diluted weighted average number of common shares outstanding (in shares)22.4M shares21.3M shares18.7M shares

Compare MADRIGAL PHARMACEUTICALS, INC. with another company

Corporate structure

MADRIGAL PHARMACEUTICALS, INC. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of MADRIGAL PHARMACEUTICALS, INC.

  • BlackRock Filed SCHEDULE 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest Jul 29, 2026 (4 filings since Feb 3, 2022)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest May 15, 2026 (10 filings since Sep 8, 2023)
  • PAULSON & CO. INC. Filed SCHEDULE 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest May 15, 2026 (5 filings since Nov 13, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest Mar 27, 2026 (4 filings since Feb 10, 2022)
  • Paul A. Friedman Filed SCHEDULE 13D/A on MADRIGAL PHARMACEUTICALS, INC., latest Dec 12, 2025
  • Rebecca Taub Filed SCHEDULE 13D/A on MADRIGAL PHARMACEUTICALS, INC., latest Dec 12, 2025
  • RTW INVESTMENTS, LP Filed SC 13G on MADRIGAL PHARMACEUTICALS, INC., latest Nov 14, 2024
  • BAKER BROS. ADVISORS LP Filed SC 13D/A on MADRIGAL PHARMACEUTICALS, INC., latest Mar 25, 2024 (6 filings since Feb 14, 2023)
  • ARMISTICE CAPITAL, LLC Filed SC 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest Feb 14, 2024 (3 filings since Feb 15, 2022)
  • Avoro Capital Advisors LLC Filed SC 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest Feb 14, 2024 (3 filings since Feb 11, 2022)
  • State Street Corporation Filed SC 13G/A on MADRIGAL PHARMACEUTICALS, INC., latest Jan 22, 2024 (2 filings since Feb 2, 2023)
  • BAY CITY CAPITAL LLC Filed SC 13D/A on MADRIGAL PHARMACEUTICALS, INC., latest Dec 13, 2023 (2 filings since Dec 7, 2021)
  • MADRIGAL PHARMACEUTICALS, INC. Washington, Pennsylvania, United States
    • Madrigal Pharmaceuticals Deutschland GmbH Subsidiary · Germany

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 MADRIGAL PHARMACEUTICALS, 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
Property and equipment, net$1.5M6 Dec 31, 2025$2.2M6 Dec 31, 2024−31.6%
Operating-lease assets (leased space)$4.9M6 Dec 31, 2025$2.4M6 Dec 31, 2024+105.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$198.7M6 Dec 31, 2025$100.0M6 Dec 31, 2024+98.7%
Marketable securities, current$784.9M6 Dec 31, 2025$826.2M6 Dec 31, 2024−5.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$7.4M6 Dec 31, 2025$4.7M6 Dec 31, 2024+56.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$74.8M6 Dec 31, 2025$34.1M6 Dec 31, 2024+119.7%
Raw materials$06 Dec 31, 2025$06 Dec 31, 2024
Work in process$67.6M6 Dec 31, 2025$29.5M6 Dec 31, 2024+129.0%
Finished goods$7.2M6 Dec 31, 2025$4.5M6 Dec 31, 2024+58.9%

Properties, in its own words

As of December 31, 2025, we leased approximately 44,347 square-feet of facilities located in West Conshohocken, Pennsylvania, our corporate headquarters. These leases contain extension rights beyond the scheduled lease expiration dates of November 2026 and June 2031, respectively. We lease additional office space in Waltham, Massachusetts. We continue to evaluate our facility requirements and believe that appropriate space will be available to accommodate our future needs.

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

Leadership

Who has led MADRIGAL PHARMACEUTICALS, INC., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (43)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Madrigal Pharmaceuticals B.V. Netherlands4
  • Madrigal Pharmaceuticals Deutschland GmbH Germany4
  • Madrigal Pharmaceuticals GmbH Switzerland4

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

Former names

  • SYNTA PHARMACEUTICALS CORPMay 31, 2002 to Aug 1, 20163

Timeline

  1. Aug 12, 20268-K Executive or director change; Regulation FD disclosure62
  2. Jul 30, 20268-K Results of operations63
  3. Jun 17, 20268-K Executive or director change; Shareholder vote64
  4. May 6, 20268-K Results of operations65
  5. Apr 28, 20268-K Executive or director change66
  6. Feb 19, 20268-K Results of operations67
  7. Jan 30, 20268-K Entered a material agreement68
  8. Dec 11, 20258-K Executive or director change69
  9. Nov 4, 20258-K Results of operations70
  10. Aug 5, 20258-K Results of operations71
  11. Jul 30, 20258-K Regulation FD disclosure72
  12. Jul 22, 20258-K Entered a material agreement; Ended a material agreement; New debt or obligation73
  13. Sep 13, 2023New chief executive William John Sibold becomes CEO14
  14. Jul 26, 2016New chief executive Paul A. Friedman becomes CEO15
  15. Jun 8, 2015New chief executive Chen Schor becomes CEO16
  16. Sep 4, 2014New chief executive Anne Clem Whitaker becomes CEO17
  17. Feb 5, 2007New chief executive Safi R. Bahcall becomes CEO18
  18. Mar 10, 2000Founded MADRIGAL PHARMACEUTICALS, INC. is founded2

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($5.08) a share, on Nov 4, 2025.74

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results63
  2. May 6, 2026Reported quarterly or annual results65
  3. Feb 19, 2026Reported quarterly or annual results67
  4. Nov 4, 2025Reported quarterly or annual results70
  5. Aug 5, 2025Reported quarterly or annual results71
  6. May 1, 2025Reported quarterly or annual results75
  7. Feb 26, 2025Reported quarterly or annual results76
  8. Jan 13, 2025Reported quarterly or annual results77

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

Filings

423 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 54 major events, 180 insider forms, 47 large holders, 121 other. The latest 20:

  1. Sep 28, 2026144 EDGAR
  2. Sep 11, 2026144 EDGAR
  3. Sep 11, 20264 EDGAR
  4. Sep 9, 2026144 EDGAR
  5. Aug 20, 20264 EDGAR
  6. Aug 20, 2026144 EDGAR
  7. Aug 18, 20264 EDGAR
  8. Aug 18, 20263 EDGAR
  9. Aug 12, 20268-K EDGAR
  10. Jul 30, 202610-Q EDGAR
  11. Jul 30, 20268-K EDGAR
  12. Jul 29, 2026SCHEDULE 13G/A EDGAR
  13. Jul 20, 20264 EDGAR
  14. Jul 20, 2026144 EDGAR
  15. Jun 18, 20264 EDGAR
  16. Jun 18, 20264 EDGAR
  17. Jun 18, 20264 EDGAR
  18. Jun 18, 20264 EDGAR
  19. Jun 18, 20264 EDGAR
  20. Jun 18, 20264 EDGAR

The 423 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

111 open-market trades by officers, directors and large owners since October 2021: 13 buys and 98 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 11, 2026Sibold William JohnPresident and CEOSale5,221$542.38$2.8MForm 4
Sep 9, 2026Sibold William JohnPresident and CEOSale6,362$535.59$3.4MForm 4
Aug 17, 2026Kelley Shannon TGeneral CounselSale664$514.97$341.9KForm 4
Jul 20, 2026Sibold William JohnPresident and CEOSale2,500$547.30$1.4MForm 4
Jun 1, 2026Soergel DavidChief Medical OfficerSale1,042$495.74$516.6KForm 4
May 22, 2026Levy Richard SDirectorSale5,682$515.44$2.9MForm 4
May 18, 2026Soergel DavidChief Medical OfficerSale844$515.90$435.4KForm 4
Mar 6, 2026Dier MardiEVP and CFOSale1,982$430.87$854.0KForm 4
Mar 6, 2026Sibold William JohnPresident and CEOSale1,663$431.94$718.3KForm 4
Mar 6, 2026Kelley Shannon TGeneral CounselSale360$431.94$155.5KForm 4
Mar 6, 2026Huntsman CaroleChief Commercial OfficerSale419$431.94$181.0KForm 4
Mar 6, 2026Taub RebeccaDirectorSale491$431.94$212.1KForm 4
Mar 2, 2026Dier MardiEVP and CFOSale1,183$427.21$505.4KForm 4
Jan 26, 2026Huntsman CaroleChief Commercial OfficerSale910$493.78$449.3KForm 4
Jan 26, 2026Sibold William JohnPresident and CEOSale1,577$492.42$776.5KForm 4
Jan 26, 2026Taub RebeccaDirectorSale647$492.42$318.6KForm 4
Jan 20, 2026Kelley Shannon TGeneral CounselSale692$497.36$344.2KForm 4
Jan 20, 2026Taub RebeccaDirectorSale2,238$490.77$1.1MForm 4
Jan 9, 2026FRIEDMAN PAUL ADirectorSale280$551.24$154.3KForm 4
Jan 9, 2026FRIEDMAN PAUL ADirectorSale24,520$522.39$12.8MForm 4

All 111 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
2025Bill SiboldPresident and Chief Executive Officer59$918.5K$19.2M93
2025David Soergel, M.D.Executive Vice President and Chief Medical Officer58$418.2K$9.2M93
2025Rebecca Taub, M.D.Senior Scientific and Medical Advisor and Former President, Research & Development and Chief Medical Officer74$617.5K$6.9M93
2025Mardi DierExecutive Vice President and Chief Financial Officer62$566.0K$6.1M93
2025Carole HuntsmanExecutive Vice President and Chief Commercial Officer61$540.3K$5.4M93
2025Shannon KelleyExecutive Vice President and Chief Legal Counsel51$535.2K$5.2M93
2024Bill SiboldPresident and Chief Executive Officer59$889.6K$12.2M93
2024Mardi DierExecutive Vice President and Chief Financial Officer62$464.7K$8.8M93
2024Rebecca Taub, M.D.Senior Scientific and Medical Advisor and Former President, Research & Development and Chief Medical Officer74$596.2K$6.0M93
2024Shannon KelleyExecutive Vice President and Chief Legal Counsel51$441.7K$4.7M93
2024Carole HuntsmanExecutive Vice President and Chief Commercial Officer61$525.0K$3.9M93
2023Bill SiboldPresident and Chief Executive Officer59$275.4K$32.3M93
2023Rebecca Taub, M.D.Senior Scientific and Medical Advisor and Former President, Research & Development and Chief Medical Officer74$574.1K$6.9M93
2023Carole HuntsmanExecutive Vice President and Chief Commercial Officer61$61.9K$3.1M93

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
Baker Bros. Advisors LP2,143,131$1.2B5.8%+1,430
Rtw Investments, LP1,993,687$1.1B9.1%No change
Jupiter Topco LLC1,936,099$1.0B0.4%New
Avoro Capital Advisors LLC1,833,333$984.4M8.8%+15,152
Paulson & Co. Inc.1,340,020$719.5M27.9%−52,168
BlackRock, Inc.1,200,770$644.8M0.0%−359,195
Vanguard Capital Management LLC835,668$448.7M0.0%+8,524
Wellington Management Group Llp825,714$443.4M0.1%+130,756
Vanguard Portfolio Management LLC781,731$419.8M0.0%−59,414
State Street Corp527,057$283.0M0.0%−82,468
Citadel Advisors LLC507,233$272.4M0.2%+53,390
UBS Group AG401,708$215.7M0.0%+283,929
Geode Capital Management, LLC374,880$201.3M0.0%−80,990
Fmr LLC356,201$191.3M0.0%−155,527
William Blair Investment Management, LLC324,123$174.0M0.5%−16,396
Invesco Ltd.301,435$161.9M0.0%−28,084
Armistice Capital, LLC288,000$154.6M4.3%+23,417
Assenagon Asset Management S.A.248,428$133.4M0.1%+232,395
Goldman Sachs Group Inc246,280$132.2M0.0%−31,091
Polar Capital Holdings Plc244,274$131.2M0.4%−45,036
Ameriprise Financial Inc231,205$124.1M0.0%+133,024
Norges Bank213,886$114.8M0.0%New
Artisan Partners Limited Partnership210,205$112.9M0.2%+26,665
Pictet Asset Management Holding SA192,896$103.5M0.1%+5,656
Jane Street Group, LLC191,541$102.8M0.1%+155,703

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

Members of Congress who traded it

1 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Apr 10, 2023Daniel S. GoldmanDemocratic, HouseSale$1,001 - $15,000+1.0%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

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

  • Name on EDGARMADRIGAL PHARMACEUTICALS, INC.1
  • CIK0001157601
  • Employer ID (EIN)04-35086485
  • Filer statusLarge accelerated filer not an emerging growth company; not 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 address1001 Conshohocken State Road, Suite 2-350, West Conshohocken, PA1
  • Phone(267) 824-28271
  • Shares outstanding23,104,126 as of Jul 27, 202612
  • Public float$5.6B as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, Philadelphia, Pennsylvania PCAOB ID 238; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceMay 31, 20021
  • Filings1,218 in all: 4 (479), 8-K (189), 144 (89), 10-Q (59), 3 (51), SC 13G/A (46), SC 13D/A (37), 424B5 (31)1
    All 49 form types

    10-K (20), SC 13G (19), DEF 14A (18), 5 (17), S-8 (17), DEFA14A (16), ARS (11), SCHEDULE 13G/A (10), 4/A (9), CT ORDER (9), UPLOAD (9), CORRESP (8), EFFECT (8), S-1/A (8), REGDEX (5), S-3 (5), 10-K/A (4), 3/A (4), SC 13D (4), 424B2 (3), 424B3 (3), REGDEX/A (3), S-3ASR (3), 10-Q/A (2), 5/A (2), POS AM (2), PRE 14A (2), S-1 (2), SCHEDULE 13D/A (2), 144/A (1), 424B4 (1), 424B7 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), D (1), DEFM14A (1), FWP (1), NT 10-K (1), PREM14A (1), RW (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par Value Per ShareMDGLThe Nasdaq Stock Market LLC

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 MADRIGAL PHARMACEUTICALS, INC. names in Item 1A of its 10-K filed Feb 19, 2026: 71 risks under these headings, as written.5

  • Risks Related to the Commercialization and Continued Approval of Rezdiffra
  • Our prospects are highly dependent on the success of our only approved product, Rezdiffra, which was approved in the United States under the Subpart H accelerated approval pathway for new drugs for serious or life-threatening illnesses and has received a CMA in the EU. If we are unable to successfully commercialize or maintain approval for Rezdiffra, our business, financial condition, results of operations and prospects and the value of our common stock will be materially adversely affected.
  • We obtained regulatory approval of Rezdiffra through the Subpart H accelerated approval pathway in the United States and Rezdiffra has received a CMA in the EU. Full approvals will be contingent on the completion of trials to successfully confirm the clinical benefit of Rezdiffra. Failure to obtain full approval or otherwise meet our post-marketing requirements and commitments would have a material adverse effect on our business.
  • The commercial success of Rezdiffra will depend on the degree of market acceptance by physicians, patients, third-party payors and others in the health care community.
  • If the sales and marketing capabilities we have established for the commercialization of Rezdiffra are not effective, Rezdiffra may not be successfully commercialized.
  • If we are unable to obtain or maintain adequate coverage and reimbursement from government or third-party payors for Rezdiffra or, if approved, any other product candidates, our prospects for generating revenue may be adversely affected.
  • The pricing of pharmaceutical products has come under increasing scrutiny as part of a global trend toward healthcare cost containment. Resulting changes in healthcare law and policy, including changes to Medicare, may impact our business in ways that we cannot currently predict, which could have a material adverse effect on our business and financial condition.
  • Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and harm our business.
  • Like all medicinal products, Rezdiffra remains subject to ongoing regulatory review, and if we fail to comply with regulations or satisfy our post-approval commitments, we could lose our approval and the sale of Rezdiffra could be suspended.
  • Rezdiffra could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us.
  • We operate in a highly competitive and changing environment, and if we are unable to adapt to our environment, we may be unable to compete successfully.
  • Rezdiffra was approved for treatment in a limited population of patients with MASH with moderate to advanced liver fibrosis, and additional clinical trials and regulatory applications will be required to expand its indication. We may not be successful in these trials or in obtaining such regulatory approval, which may materially adversely affect our prospects and the value of our common stock.
The other 60 risks
  • If we do not obtain regulatory approval of Rezdiffra in foreign jurisdictions, we will not be able to market Rezdiffra in other jurisdictions, which will limit our commercial revenues.
  • EU pricing and reimbursement regulations may materially affect our ability to market and receive coverage for Rezdiffra in the EU Member States.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with Rezdiffra, the sales of Rezdiffra would be adversely affected.
  • We currently rely on a limited number of specialty pharmacies for distribution of Rezdiffra in the United States, and the loss of one or more of these specialty pharmacies or their failure to effectively distribute Rezdiffra could materially harm our business.
  • If estimates of the size of the potential market for Rezdiffra is overstated or data we have used to identify physicians is inaccurate, our ability to earn revenue to support our business could be materially adversely affected.
  • Product liability lawsuits brought against us could cause us to incur substantial liabilities and could limit commercialization of Rezdiffra or any future product candidates that we may develop.
  • Risks Related to Product Development and Regulatory Approval
  • Pharmaceutical research and development is very expensive, time-consuming and difficult to design and implement and involves uncertain outcomes. Furthermore, the results of preclinical studies and earlier clinical trials are not always predictive of future results. Any product candidate that we advance into clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
  • If we fail to successfully develop and commercialize our other product candidates, we may be unable to grow our business.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available, may be interpreted differently if additional data are disclosed, and are subject to audit and verification procedures that could result in material changes in the final data.
  • If clinical trials or regulatory approval processes are prolonged, delayed or suspended, we may be unable to advance the development of or commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.
  • If we inadvertently fail to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs, we could be prevented from selling our drug candidates in such foreign markets, which may adversely affect our operating results and financial condition.
  • We may in the future conduct certain clinical trials for our product candidates outside of the U.S. However, the FDA may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
  • We depend on enrollment of patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Breakthrough therapy or priority review by the FDA for any product candidate may not lead to faster development, regulatory review or approval processes, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Risks Related to our Business Operations, Employee Matters and Managing Growth
  • Our failure to successfully in-license, acquire, develop and market additional product candidates could impair our ability to grow our business.
  • Any strategic transactions we enter into may not be clinically or commercially successful, and may require financing or a significant amount of cash, which could adversely affect our business.
  • We are dependent upon retaining and attracting key personnel, the loss of whose services could materially adversely affect our business, financial condition, results of operations, prospects and the value of our common stock.
  • Our employees, contractors, vendors and partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading laws, which could cause significant liability for us and harm our reputation.
  • We expect to continue to expand our development and commercialization capabilities, and as a result, we may encounter challenges in managing our growth, which could disrupt our operations.
  • We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, such performance could have a material adverse effect on our business, financial condition and results of operations.
  • Risks Related to Our Dependence on Third Parties
  • If the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with our agreements, GCP and related regulatory requirements, we may be unable to obtain regulatory approval for our product candidates or commercialize our products.
  • We have relied on, and expect to continue to rely on, third-party manufacturers to produce Rezdiffra and any future product candidates.
  • If any third-party manufacturer of Rezdiffra or any other future product candidates is unable to increase the scale of its production of such product or product candidates or increase the product yield of its manufacturing, then our costs to manufacture such product or product candidate may increase and any commercialization may be delayed.
  • Using specialty distributors to market and sell Rezdiffra in certain jurisdictions outside of the United States subjects us to certain risks.
  • Risks Related to Our Financial Position and Need for Capital
  • We have a limited operating history and currently only have one commercial product, Rezdiffra, which may make it difficult to evaluate the prospects for our future viability.
  • We have a history of operating losses, expect to incur operating losses in the future and may never achieve or maintain profitability.
  • We have a limited history of recognizing revenue from product sales and may not be able to achieve or maintain long-term sustainable profitability.
  • We may need to raise additional capital to fund our operations, but we face uncertainties with respect to our ability to access capital. If we are unable to raise capital if and when needed, we could be forced to delay, reduce or eliminate our drug development activities or commercialization efforts.
  • Our quarterly and annual operating results may fluctuate in the future. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline and negatively impact our financing or funding ability, as well as negatively impact our ability to exist as a standalone company.
  • Our Financing Agreement contains restrictive and financial covenants that may limit our operating flexibility.
  • Our failure to comply with the covenants or other terms of the Financing Agreement, including as a result of events beyond our control, could result in a default under the Financing Agreement that could materially and adversely affect our business.
  • Risks Related to Government Regulation
  • Government healthcare reform could materially increase our costs, which could materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional rebate requirements, penalties, or other sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and growth prospects.
  • If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty or may be suspended from participation in federal or state healthcare programs, which may adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • We are subject to anti-corruption laws and trade control laws, as well as other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, legal expenses, and negative publicity which could adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • Disruptions at the FDA and other government agencies caused by the change in presidential administration, funding shortages or potential funding shortages could hinder their ability to hire and retain key leadership and other personnel, delay or prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, and could negatively affect our operating results and business.
  • European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
  • Risks associated with operations outside of the United States could adversely affect our business.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • Our rights to develop and commercialize resmetirom are subject in part to the terms and conditions of the Roche Agreement.
  • We may fail to comply with any of our obligations under agreements pursuant to which we license rights or technology, which could result in the loss of rights or technology that may be material to our business.
  • If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation by extending the term of patents covering our product or product candidates, our business may be materially harmed.
  • Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • We may not be successful in obtaining or maintaining necessary rights to our product and product candidates through acquisitions and in-licenses.
  • Our reliance on third parties 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.
  • 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 not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Ownership of Our Common Stock
  • The price of our common stock has been, and may continue to be, volatile.
  • Anti-takeover provisions in our restated certificate of incorporation (our “Charter”), our Restated Bylaws (our “Bylaws”) and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management, which may depress the trading price of our common stock.
  • Our bylaws provide that the Court of Chancery of the State of Delaware and the federal district court of the United States for the District of Delaware will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
  • Funds affiliated with Baker Bros. Advisors LP hold a significant portion of our total outstanding shares of common stock (including shares of our common stock issuable upon conversion of shares of our Series A Convertible Preferred Stock and Series B Convertible Preferred Stock and pre-funded warrants), and any sale of such shares into the market, or a perception that such sales could occur, in the future could cause the market price of our common stock to drop significantly.
  • Sales of a significant number of shares of our common stock in the public markets or significant short sales of our common stock, or the perception that such sales could occur, could depress the market price of our common stock and impair our ability to raise capital.
  • We do not anticipate paying cash dividends on our common stock, and accordingly, stockholders must rely on stock appreciation, if any, for any return on their investment.
  • If securities analysts publish negative evaluations of our stock, the price of our stock could decline.
  • General Risk Factors
  • We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
  • A failure of our information technology infrastructure and cybersecurity threats may adversely affect our business and operations.

Legal proceedings

We currently are not a party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.5

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