Sign in

VRP on London Stock Exchange

Verona Pharma

Logo: veronapharma.com4

In its 2025 annual report the company says: “We are a biopharmaceutical company focused on developing and commercializing innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs.”6 It is headquartered in London.1 Its shares trade on London Stock Exchange under the symbol VRP.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Wave Life Sciences, PALVELLA THERAPEUTICS, INC. or Biofrontera Inc., or pick any stock.

  • TickerVRP on London Stock Exchange1
  • IndustryPharmaceutical Preparations1
  • HeadquartersLondon1
  • Websitewww.veronapharma.com
  • Legal formpublic limited company1
  • Incorporated inUnited Kingdom5
  • Business address3 More London Riverside, London, X0 Se1 2Re5
  • Filer categoryLarge accelerated filer5
  • LEI213800EVI6O6J3TIAL063
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressONE CENTRAL SQUARE, CF10 1FS Cardiff, United Kingdom3
  • Registered withCompanies House, 053751563

See how the biggest companies compare on our leaderboards

Verona Pharma image from its website
Image: veronapharma.com4

We are a biopharmaceutical company focused on developing and commercializing innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs.6 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 2024

-365.7%Operating margin7
-410.2%Net margin7
-84.8%Return on equity7
0.59×Debt to equity7
-$122.8MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Research and development81¢$44.6M
  • Income tax19¢$10.3M

Out of $42.3M in revenue.7 The company lost money this year.

Financial statements

Revenue897$42.3M in 2024
0$20.0M$40.0M$60.0M2020: $0$020202021: $40.0M$40.0M20212022: $458.0K$458.0K2022−99%2023: $0$020232024: $42.3M$42.3M2024
Gross profit910$0 in 2023
0$10.0M$20.0M$30.0M$40.0M2021: $40.0M$40.0M20212022: $112.0K$112.0K2022−100%2023: $0$02023
Operating income1112897-$154.6M in 2024+504% since 2018
-$200.0M-$150.0M-$100.0M-$50.0M02018: -$25.6M-$25.6M20182019: -$52.4M-$52.4M2019+105%2020: -$74.3M-$74.3M2020+42%2021: -$73.3M-$73.3M2021−1%2022: -$75.8M-$75.8M2022+3%2023: -$67.6M-$67.6M2023−11%2024: -$154.6M-$154.6M2024+129%
Net income1112897-$173.4M in 2024+771% since 2018
-$200.0M-$150.0M-$100.0M-$50.0M02018: -$19.9M-$19.9M20182019: -$40.6M-$40.6M2019+104%2020: -$65.1M-$65.1M2020+61%2021: -$55.6M-$55.6M2021−15%2022: -$68.7M-$68.7M2022+24%2023: -$54.4M-$54.4M2023−21%2024: -$173.4M-$173.4M2024+219%
Fiscal year2018201920202021202220232024
Revenue$08$40.0M9$458.0K7$07$42.3M7
Cost of revenue$09$346.0K10$010
Gross profit$40.0M9$112.0K10$010
Research and development$42.4M12$44.5M8$79.4M9$49.3M7$17.2M7$44.6M7
Operating expenses$113.3M9$76.2M7$67.6M7$196.9M7
Operating income-25.6M GBP11-$52.4M12-$74.3M8-$73.3M9-$75.8M7-$67.6M7-$154.6M7
Interest$012$35.0K8$340.0K9$521.0K10$2.1M10
Income before tax-$55.6M9-$68.4M7-$53.9M7-$163.1M7
Income tax$72.0K12$146.0K8-$18.0K9$253.0K7$474.0K7$10.3M7
Net income-19.9M GBP11-$40.6M12-$65.1M8-$55.6M9-$68.7M7-$54.4M7-$173.4M7
Earnings per share-0 GBP/shares11-0 GBP/shares11-$0.129-$0.137-$0.097-$0.277
Earnings per share (diluted)-$0.129-$0.137-$0.097-$0.277
Shares (weighted, basic)473.2M shares9529.1M shares7634.1M shares7652.3M shares7
Shares (weighted, diluted)473.2M shares9529.1M shares7634.1M shares7652.3M shares7

Compare Verona Pharma with another company

Corporate structure

Verona Pharma is part of a group headed by Merck & Co.. 347 entities, 69 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Verona Pharma

  • Merck & Co. Rahway, New Jersey, United States
    • MSD Sharp & Dohme GmbH München, Germany
    • Verona Pharma London, United Kingdom
    • Merck (Japan) Subsidiary · Tokyo, Japan
    • Merck Sharp & Dohme Latvija, SIA Subsidiary · Riga, Latvia
    • Merck Sharp & Dohme, UAB Subsidiary · Vilnius, Lithuania
    • MSD (Netherlands) Subsidiary · Amsterdam, Netherlands
    • MSD Norway AS Subsidiary · Drammen, Norway
    • Sirna Therapeutics Subsidiary · San Francisco
    • 7728026 Canada Inc. Subsidiary · Canada
    • Abceutics, Inc. Subsidiary · Delaware, United States
    • Abmaxis Inc. Subsidiary · Delaware, United States
    • Acceleron Pharma Inc. Subsidiary · Delaware, United States
    • Afferent Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Agrident GmbH Subsidiary · Germany
    • Allflex (China) Intelligent Technology Co. Ltd. Subsidiary · China
    • Allflex Argentina S.A. Subsidiary · Argentina
    • Allflex Australia Pty. Ltd. Subsidiary · Australia
    • Allflex Dan-Mark ApS Subsidiary · Denmark
    • Allflex Europe S.A.S. Subsidiary · France
    • Allflex Group Germany GmbH Subsidiary · Germany
    • ALLFLEX INDIA PRIVATE LIMITED Subsidiary · Gurugram, India
    • Allflex Maroc S.A.R.L. Subsidiary · Morocco
    • Allflex New Zealand Subsidiary · New Zealand
    • Allflex Polska Spolka z ograniczona odpowiedzialnoscia Subsidiary · Poland
    • Allflex Romania S.R.L. Subsidiary · Romania
    • and 316 more

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; subsidiaries, stakes and holdings from Wikidata (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Verona Pharma 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$1.1M7 Dec 31, 2024$24.0K7 Dec 31, 2023+4504.2%
Operating-lease assets (leased space)$2.0M7 Dec 31, 2024$2.8M7 Dec 31, 2023−28.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$399.8M7 Dec 31, 2024$271.8M7 Dec 31, 2023+47.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$545.0K7 Dec 31, 2024$545.0K7 Dec 31, 20230%

Inventory

ItemLatestA year beforeChange
Inventory, total$6.2M7 Dec 31, 2024$07 Dec 31, 2023

Properties, in its own words

Our corporate headquarters is in leased office space at 3 More London Riverside, London, U.K. The leases for these offices expire in the first quarter of 2026. We also have office space at 33 Park of Commerce, Suite 300, Savannah, Georgia, 31405, which expires in the fourth quarter of 2025, and 8529 Six Forks Road, Suite 400, Raleigh, North Carolina, 27615, which expires in the fourth quarter of 2027. We believe that these facilities are adequate to meet our current and near term needs.

Item 2 of the 10-K filed Feb 27, 2025.6

Leadership

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

Chief executive

  1. David Zaccardelli2021–now

President

  1. David Zaccardelli2021–now

Chief financial officer

  1. Mark W. Hahn2021–now
2025
Board members and other officers (16)

Timeline

  1. Oct 7, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights34
  2. Sep 24, 20258-K Shareholder vote; Regulation FD disclosure; Other events35
  3. Sep 9, 20258-K Executive or director change36
  4. Jul 9, 20258-K Entered a material agreement; Regulation FD disclosure; Other events37
  5. Apr 29, 20258-K Results of operations38
  6. Apr 25, 20258-K Shareholder vote39
  7. Mar 28, 20258-K Entered a material agreement; Regulation FD disclosure; Other events40
  8. Feb 27, 20258-K Results of operations41
  9. Jan 7, 20258-K Results of operations42
  10. Nov 4, 20248-K Results of operations43
  11. Aug 8, 20248-K Results of operations44
  12. Jun 27, 20248-K Regulation FD disclosure; Other events45
  13. Feb 1, 2021New chief executive David Zaccardelli becomes CEO17

Calendar

When it reported results

  1. Apr 29, 2025Reported quarterly or annual results38
  2. Feb 27, 2025Reported quarterly or annual results41
  3. Jan 7, 2025Reported quarterly or annual results42
  4. Nov 4, 2024Reported quarterly or annual results43
  5. Aug 8, 2024Reported quarterly or annual results44
  6. May 9, 2024Reported quarterly or annual results46
  7. Feb 29, 2024Reported quarterly or annual results47
  8. Nov 2, 2023Reported quarterly or annual results48

Drug trials and FDA: coming up

  1. Mar 1, 2027Phase 2 trial readout expected Phase 2 trial of Ensifentrine in COPD: primary completion expected Mar 1, 2027 (ClinicalTrials.gov NCT05270525).49
  2. Sep 24, 2027Phase 2 trial readout expected Phase 2 trial of Nebulized Ensifentrine Suspension; 3 mg in Non-cystic Fibrosis Bronchiectasis: primary completion expected Sep 24, 2027 (ClinicalTrials.gov NCT06559150).50

Drug trials and FDA: recently

  1. Aug 17, 2026Phase 2 trial completed Phase 2 trial of Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg and others in Chronic Obstructive Pulmonary Disease: primary completion Aug 17, 2026, no results posted yet (ClinicalTrials.gov NCT07016412).51
  2. Nov 28, 2025Phase 2 trial completed Phase 2 trial of Ensifentrine 3 mg, Glycopyrrolate 42.5 mcg and others in Chronic Obstructive Pulmonary Disease: primary completion Nov 28, 2025, no results posted yet (ClinicalTrials.gov NCT07132983).52
  3. Jan 2, 2025Phase 2 trial completed Phase 2 trial of Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg) and others in Chronic Obstructive Pulmonary Disease: primary completion Jan 2, 2025, results posted Feb 9, 2026 (ClinicalTrials.gov NCT06545500).53

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

367 filings to the SEC since October 2021: 4 annual reports, 12 quarterly reports, 38 major events, 212 insider forms, 40 large holders, 61 other. The latest 20:

  1. Nov 14, 2025EFFECT EDGAR
  2. Nov 14, 2025SCHEDULE 13G/A EDGAR
  3. Nov 14, 2025SCHEDULE 13G/A EDGAR
  4. Nov 14, 2025SCHEDULE 13G EDGAR
  5. Oct 17, 2025SCHEDULE 13G EDGAR
  6. Oct 17, 202515-12G EDGAR
  7. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  8. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  9. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  10. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  11. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  12. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  13. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  14. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  15. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  16. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  17. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  18. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  19. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR
  20. Oct 8, 20254 OWNERSHIP DOCUMENT EDGAR

The 367 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

149 open-market trades by officers, directors and large owners since October 2021: 7 buys and 142 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 1, 2025Cunningham KennethDirectorSale10,808$13.14$142.0KForm 4
Aug 1, 2025Deschamps LisaDirectorSale9,464$13.14$124.4KForm 4
Aug 1, 2025Fisher AndrewGeneral CounselSale9,584$13.14$125.9KForm 4
Aug 1, 2025Hahn Mark WChief Financial OfficerSale208,912$13.14$2.7MForm 4
Aug 1, 2025Rickard Kathleen A.Chief Medical OfficerSale58,336$13.14$766.5KForm 4
Aug 1, 2025ACKERMANN CHRISTINADirectorSale1,808$13.14$23.8KForm 4
Aug 1, 2025Austwick MichaelDirectorSale11,288$13.14$148.3KForm 4
Aug 1, 2025Brady James AloysiusDirectorSale824$13.14$10.8KForm 4
Aug 1, 2025ZACCARDELLI DAVIDPresident and CEOSale208,912$13.14$2.7MForm 4
Aug 1, 2025EBSWORTH DAVID RDirectorSale1,904$13.14$25.0KForm 4
Aug 1, 2025Edwards MartinDirectorSale10,808$13.14$142.0KForm 4
Aug 1, 2025SHAH MAHENDRADirectorSale3,608$13.14$47.4KForm 4
Aug 1, 2025Sinha VikasDirectorSale4,328$13.14$56.9KForm 4
Jun 16, 2025Fisher AndrewGeneral CounselSale80,000$11.53$922.4KForm 4
Jun 11, 2025Hahn Mark WChief Financial OfficerSale400,000$11.40$4.6MForm 4
Jun 11, 2025ZACCARDELLI DAVIDPresident and CEOSale400,000$11.40$4.6MForm 4
May 29, 2025Hahn Mark WChief Financial OfficerSale204,864$9.33$1.9MForm 4
May 29, 2025ZACCARDELLI DAVIDPresident and CEOSale208,696$9.33$1.9MForm 4
May 28, 2025Hahn Mark WChief Financial OfficerSale162,704$9.30$1.5MForm 4
May 28, 2025ZACCARDELLI DAVIDPresident and CEOSale157,704$9.30$1.5MForm 4

All 149 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
2024David Zaccardelli, Pharm.D.President and Chief Executive Officer60$873.0K$19.5M69
2024Mark W. HahnChief Financial Officer62$582.0K$19.0M69
2024Andrew Fisher General Counsel55$352.6K$10.8M69
2024Kathleen Rickard, M.D.Chief Medical Officer66$504.2K$7.5M69
2024Claire Poll Former General Counsel$326.0K69
2023David Zaccardelli, Pharm.D.President and Chief Executive Officer60$819.6K$6.6M69
2023Mark W. HahnChief Financial Officer62$551.3K$6.2M69
2023Kathleen Rickard, M.D.Chief Medical Officer66$458.3K$2.0M69
2022David Zaccardelli, Pharm.D.President and Chief Executive Officer60$524.8K$5.2M69
2022Mark W. HahnChief Financial Officer62$430.4K$4.8M69
2022Kathleen Rickard, M.D.Chief Medical Officer66$434.4K$1.5M69

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
Bank Of America Corp /de/12,168,127$295.8M0.0%+3,266,704
Morgan Stanley9,902,182$240.7M0.0%+500,402
Wells Fargo & Company/mn3,688,601$89.7M0.0%+196,954
LPL Financial LLC2,694,551$65.5M0.0%−199,519
UBS Group AG2,251,040$54.7M0.0%+11,246
Stephens Inc /ar/1,641,083$39.9M0.4%+162,286
Jpmorgan Chase & Co1,578,794$38.4M0.0%−80,749
Advisors Capital Management, LLC1,557,556$37.9M0.4%+74,357
Envestnet Asset Management Inc1,238,400$30.1M0.0%−196,440
HighTower Advisors, LLC1,208,761$29.4M0.0%+18,123
Insight Wealth Strategies, LLC930,732$22.7M2.2%New
Raymond James Financial Inc904,088$22.0M0.0%+74,414
Estate Counselors, LLC877,991$21.3M1.8%New
Royal Bank Of Canada818,546$19.9M0.0%+96,705
Mader & Shannon Wealth Management, Inc.723,418$17.6M8.2%+829
Ameriprise Financial Inc615,177$15.1M0.0%−37,289
Osaic Holdings, Inc.523,362$12.7M0.0%−11,277
Stifel Financial Corp504,921$12.3M0.0%+51,440
Benjamin Edwards Inc478,808$11.6M0.1%−33,470
Evolution Wealth Advisors, LLC470,496$11.4M1.3%+1,200
Spectrum Asset Management, Inc.445,782$10.8M15.6%+339,660
Mml Investors Services, LLC426,541$10.4M0.0%+46,174
Sanctuary Advisors, LLC412,328$10.0M0.0%−5,653
Cordoba Advisory Partners LLC399,681$9.7M2.1%+16,036
Matthew Goff Investment Advisor, LLC396,749$9.6M1.6%−8,092

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
Feb 11, 2022Steve CohenDemocratic, HouseBuy$50,001 - $100,000Report

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

SEC filer profile

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

  • Name on EDGARVerona Pharma plc2
  • CIK0001657312
  • Employer ID (EIN)98-14893896
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inUnited Kingdom6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address3 More London Riverside, London, X0 SE1 2RE2
  • Phone011-44-0-20328342002
  • Shares outstanding681,056,022 as of Apr 23, 202514
  • Public float$1.1B as of Jun 30, 20246
  • AuditorErnst & Young LLP, Raleigh, North Carolina PCAOB ID 42; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceJul 20, 20162
  • Filings584 in all: 4 (238), 6-K (61), 8-K (46), 144 (29), 3 (26), SC 13G/A (22), SC 13G (15), 10-Q (14)2
    All 54 form types

    SC 13D/A (11), CORRESP (9), SCHEDULE 13G/A (8), UPLOAD (8), DEFA14A (7), EFFECT (7), S-8 (7), S-8 POS (7), 10-K (5), DEF 14A (5), DFAN14A (5), 4/A (4), SC 13D (4), 20-F (3), ARS (3), F-1/A (3), SCHEDULE 13G (3), 424B5 (2), D (2), DRS/A (2), F-1 (2), POS AM (2), 15-12G (1), 20-F/A (1), 25-NSE (1), 3/A (1), 424B3 (1), 424B4 (1), 6-K/A (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), CT ORDER (1), DEFM14A (1), DRS (1), DRSLTR (1), F-1MEF (1), F-3 (1), F-6 (1), F-6EF (1), POSASR (1), PRE 14A (1), PREM14A (1), S-3 (1), S-3ASR (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2025
    Quarterly report (10-Q) Aug 6, 2025
    Proxy statement (DEF 14A) Mar 18, 2025
    Latest 8-K (8-K) Oct 7, 2025

Securities registered for trading

ClassSymbolExchange
Ordinary shares, nominal value £0.05 per share*VRNANasdaq Global Market

From the cover page of the 10-K filed Feb 27, 2025 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Verona Pharma names in Item 1A of its 10-K filed Feb 27, 2025: 69 risks under these headings, as written.6

  • Risks Related to Our Business and Industry
  • We have a limited operating history and have not generated any significant product revenue.
  • We may need additional funding to complete development and commercialization of any future product candidates and to continue to commercialize Ohtuvayre. If we are unable to raise capital when needed, or if a failure of any financial institution where we maintain our cash and cash equivalents prevents or delays us from accessing uninsured funds, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Our limited operating history may make it difficult for investors to evaluate the success of our business to date and to assess our future viability.
  • The terms of our credit facility place restrictions on our operating and financial flexibility, and our existing and any future indebtedness could adversely affect our ability to operate our business.
  • The terms of the RIPSA place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RIPSA, our results of operations and financial condition may be harmed.
  • Raising additional capital may cause dilution to our holders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our business may become subject to economic, political, regulatory and other risks associated with international operations.
  • Exchange rate fluctuations may materially affect our results of operations and financial condition.
  • Risks Related to Development, Clinical Testing and Regulatory Approval
  • Clinical drug development and regulatory approval involve a lengthy and expensive process, with uncertain outcomes. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and regulatory approval of our product candidates.
  • Our product and product candidates may have serious adverse, undesirable or unacceptable side effects which may delay or prevent marketing approval. If such side effects are identified during product development or following approval, if any, we may need to abandon our development programs, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences following marketing approval, if any.
The other 59 risks
  • We may not be successful in our efforts to develop ensifentrine in different formulations, including fixed-dose combinations, and/or for other targeted indications, including bronchiectasis, CF, asthma or other respiratory diseases.
  • We depend on enrollment of patients in our clinical trials. If we are unable to enroll patients in our clinical trials, or enrollment is slower than anticipated, our research and development efforts could be adversely affected.
  • We may become exposed to costly and damaging liability claims, either when testing product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • The regulatory approval processes of the FDA, the EMA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for ensifentrine for the maintenance treatment of COPD in adult patients in jurisdictions outside the U.S. or for ensifentrine for additional targeted indications and formulations, our business will be substantially harmed.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Even though the FDA has approved Ohtuvayre, we remain subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, Ohtuvayre and any other
  • approved products could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems.
  • The FDA and other foreign regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses which may result in significant liability if we are found to have violated such laws.
  • We may never obtain approval or commercialize ensifentrine in other major markets outside of the U.S., which would limit our ability to realize its full market potential.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, vendors and collaboration partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Interim, “top-line,” or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Risks Related to Healthcare Laws and Other Legal Compliance Matters
  • Enacted and future legislation and regulation may increase the difficulty and cost for us to commercialize our products and may affect the prices we may set.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • 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.
  • The varied and differing positions on environmental sustainability and social initiatives by government and other stakeholders could increase our costs, harm our reputation and adversely impact our financial results.
  • We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and 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 and legal expenses.
  • Risks Related to Commercialization
  • We operate in a highly competitive and rapidly changing industry, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  • Forecasting potential sales for Ohtuvayre is difficult, and if our projections are inaccurate, our business may be harmed and our share price may be adversely affected.
  • The successful commercialization of Ohtuvayre will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies for it. Failure to obtain or maintain adequate coverage and reimbursement for Ohtuvayre could limit our ability to market it and decrease our ability to generate revenue.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in which we participate, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • If our products, including Ohtuvayre, do not gain market acceptance or if we fail to accurately forecast demand or manage our inventories, our business will suffer because we might not be able to fund future operations.
  • Our commercial capabilities and infrastructure, including sales, marketing, operations, distribution, and reimbursement infrastructure, may not be adequate to successfully commercialize Ohtuvayre.
  • If we are unable to establish effective sales and marketing capabilities to market and sell our approved product, Ohtuvayre, we may be unable to generate adequate revenue.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct our pre-clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approvals for or commercialize our product candidates and our business could be substantially harmed.
  • The collaboration and license agreement with Nuance Pharma is important to our business. If Nuance Pharma is unable to develop and commercialize products containing ensifentrine in Greater China, if we or Nuance Pharma fail to adequately perform under the Nuance Agreement, or if we or Nuance Pharma terminate the Nuance Agreement, our business would be adversely affected.
  • If we fail to enter into new strategic relationships for ensifentrine, our business, research and development and commercialization prospects could be adversely affected.
  • Risks Related to Intellectual Property
  • We rely on patents and other intellectual property rights to protect our products and product candidates, the enforcement, defense and maintenance of which may be challenging and costly. Failure to enforce or protect these rights adequately could harm our ability to compete and impair our business.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop, manufacture and market our products and our product candidates, if approved.
  • We may be involved in lawsuits to protect or enforce patents covering our products or product candidates, which could be expensive, time consuming and unsuccessful, and issued patents could be found invalid or unenforceable if challenged in court.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we fail to comply with our obligations under our existing and any future intellectual property licenses, the 2024 Loan Agreement, the RIPSA or any other future loan agreements with third parties, we could lose rights that are important to our business.
  • We may not be successful in maintaining the necessary rights to our products or product candidates or obtaining other intellectual property rights important to our business through acquisitions and in-licenses.
  • 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 competitive position may be adversely affected.
  • If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering Ohtuvayre and any of our product candidates, our ability to compete effectively could be impaired.
  • We enjoy only limited geographical protection with respect to certain patents and may face difficulties in certain jurisdictions, which may diminish the value of our intellectual property rights in those jurisdictions.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products or any existing or future product candidates.
  • Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and protect other proprietary information.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Risks Related to Information Technology
  • Our information technology systems, and those of our manufacturers, suppliers and other third parties that we use to perform services for us or otherwise collaborate with, may fail or suffer security breaches, which could distract our operations and cause delays in our research and development and commercialization activities, and may adversely affect our business, operations and financial performance.
  • Risks Related to Employee Matters and Managing Growth
  • Our future growth and ability to compete depends on our ability to retain our key personnel and recruit additional qualified personnel.
  • We are continuing to expand our development, regulatory, commercial, sales, marketing, reimbursement and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Risks Related to Our ADSs
  • Certain of our shareholders, members of our board of directors, and senior management who own our ordinary shares (including ordinary shares represented by ADSs) may be able to exercise significant control over us.
  • Because we do not anticipate paying any cash dividends on our ADSs or ordinary shares in the foreseeable future, capital appreciation, if any, will be our ADS holders’ and shareholders’ sole source of gains and they may never receive a return on their investment.
  • Holders of our ADSs may not have the same voting rights as the holders of our ordinary shares and may not receive voting materials in time to be able to exercise their right to vote.
  • Holders of our ADSs may not receive distributions on our ordinary shares represented by our ADSs or any value for them if it is illegal or impractical to make them available to them.
  • Holders of our ADSs may be subject to limitations on transfer of their ADSs.
  • The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
  • Claims of U.S. civil liabilities may not be enforceable against us.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ADSs.
  • Risks Related to Taxation
  • Changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods.
  • If we are classified as a passive foreign investment company, certain adverse U.S. federal income tax consequences could apply to U.S. Holders.
  • If a U.S. Holder is treated as owning at least 10% of our ordinary shares or ADSs, such holder may be subject to adverse U.S. federal income tax consequences.
  • General Risks
  • The price of our ADSs may be volatile and may fluctuate due to factors beyond our control.
  • Future sales, or the possibility of future sales, of a substantial number of our ADSs or ordinary shares could adversely affect the price of our ADSs.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.6

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
    Company websiteVerona Pharma logo
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69