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TBPH on Nasdaq

Theravance Biopharma, Inc.

American pharmaceutical preparations company, incorporated in California1

In its 2026 annual report the company says: “Theravance Biopharma, Inc. is a biopharmaceutical company primarily focused on the development and commercialization of medicines. Our focus is to deliver medicines that make a difference ® in people’s lives.”4 It is headquartered in Grand Cayman, California.1 Its shares trade on Nasdaq under the symbol TBPH.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTBPH on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersGrand Cayman, California1
  • Incorporated inCA2
  • Business addressUgland House, South Church Street, George Town, Grand Cayman, Ca Ky1-11042
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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Theravance Biopharma, Inc. (“we,” “our,” “Theravance Biopharma” or the “Company”) is a biopharmaceutical company primarily focused on the development and commercialization of medicines. Our focus is to deliver medicines that make a difference ® in people’s lives.4 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

-3.4%Operating margin5
98.5%Net margin5
66.9%Revenue growth, 20255
35.7%Return on equity5

What sells

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

Products and services

Collaborative revenue brought in 70% of the revenue Theravance Biopharma, Inc. broke down this way in fiscal 2025.

  1. Collaborative revenue$75.0M570%up 16% from 2024
  2. Milestone contingent consideration$25.0M523%
  3. License$7.5M57%
Products and services by year
Products and services20242025
Collaborative revenue$64.4M$75.0M
Milestone contingent consideration$25.0M
License$7.5M

Regions

United States brought in 70% of the revenue Theravance Biopharma, Inc. broke down this way in fiscal 2025.

  1. United States$75.0M570%up 16% from 2024
  2. Europe$32.5M530%
Regions by year
Regions20242025
United States$64.4M$75.0M
Europe$32.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development16¢$37.4M
  • Selling, general and admin31¢$73.7M
  • Income tax10¢$23.4M
  • Profit44¢$105.9M

Out of $107.5M in revenue.5

Where each dollar of operating cash went, fiscal 2025

  • Kept or used elsewhere100¢$238.5M

Out of $238.5M of cash from operations.5

Financial statements

Revenue67895$107.5M in 2025+46% since 2019
0$50.0M$100.0M$150.0M2019: $73.4M$73.4M20192020: $71.9M$71.9M2020−2%2021: $55.3M$55.3M2021−23%2022: $51.3M$51.3M2022−7%2023: $57.4M$57.4M2023+12%2024: $64.4M$64.4M2024+12%2025: $107.5M$107.5M2025+67%
Operating income67895-$3.6M in 2025−99% since 2019
-$300.0M-$200.0M-$100.0M02019: -$251.9M-$251.9M20192020: -$297.6M-$297.6M2020+18%2021: -$257.8M-$257.8M2021−13%2022: -$92.0M-$92.0M2022−64%2023: -$56.0M-$56.0M2023−39%2024: -$46.9M-$46.9M2024−16%2025: -$3.6M-$3.6M2025−92%
Net income67895$105.9M in 2025
-$500.0M0$500.0M$1.0B2019: -$236.5M-$236.5M20192020: -$278.0M-$278.0M2020+18%2021: -$199.4M-$199.4M2021−28%2022: $872.1M$872.1M20222023: -$55.2M-$55.2M20232024: -$56.4M-$56.4M2024+2%2025: $105.9M$105.9M2025

Every line of the income statement as filed: the last 2 fiscal years (annual) or 8 quarters (quarterly), latest first.5

Period ending2025-12-312024-12-31
Total revenues$107.5M$64.4M
Research and development$37.4M$37.6M
Selling, general and administrative$73.7M$69.2M
Impairment of long-lived assets (non-cash)$0$4.5M
Total expenses$111.1M$111.3M
Loss from operations-$3.6M-$46.9M
Net gain on realized contingent milestone and royalty assets$75.1M
TRELEGY milestone income$50.0M
Interest expense (non-cash)-$2.5M-$2.5M
Interest and other income, net$10.2M$4.9M
Income (loss) before income taxes$129.2M-$44.6M
Provision for income tax benefit (expense)-$23.4M-$11.8M
Net income (loss)$105.9M-$56.4M
Net income (loss) per share - basic (in dollars per share)$2.10-$1.15
Net income (loss) per share - diluted (in dollars per share)$2.06-$1.15
Shares used to compute net income (loss) per share - basic (in shares)50.3M shares48.8M shares
Shares used to compute net income (loss) per share - diluted (in shares)51.5M shares48.8M shares
Share-based compensation expense$18.5M$21.4M

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Corporate structure

Theravance Biopharma, Inc. sits at the top of its group. 6 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Theravance Biopharma, Inc.

  • Weiss Asset Management LP Filed SCHEDULE 13D/A on Theravance Biopharma, Inc., latest Sep 25, 2026 (7 filings since Jun 16, 2022)
  • Madison Avenue Partners, LP Filed SCHEDULE 13G/A on Theravance Biopharma, Inc., latest Aug 14, 2026 (5 filings since Feb 14, 2022)
  • Newtyn Management, LLC Filed SCHEDULE 13G/A on Theravance Biopharma, Inc., latest Aug 14, 2026 (4 filings since Aug 16, 2024)
  • BlackRock Filed SCHEDULE 13G/A on Theravance Biopharma, Inc., latest Apr 30, 2025 (5 filings since Feb 3, 2022)
  • VANGUARD GROUP INC Filed SC 13G/A on Theravance Biopharma, Inc., latest Nov 12, 2024 (6 filings since Feb 10, 2022)
  • BAUPOST GROUP LLC/MA Filed SC 13G/A on Theravance Biopharma, Inc., latest Sep 9, 2024 (5 filings since Feb 11, 2022)
  • 2005 Slu Odre Filed SC 13G/A on Theravance Biopharma, Inc., latest Jun 11, 2024 (2 filings since Apr 21, 2022)
  • Irenic Capital Management LP Filed SC 13G on Theravance Biopharma, Inc., latest Feb 14, 2024
  • ORBIMED ADVISORS LLC Filed SC 13G/A on Theravance Biopharma, Inc., latest Feb 14, 2023 (2 filings since Feb 11, 2022)
  • Barclays Filed SC 13G on Theravance Biopharma, Inc., latest Jan 30, 2023
  • GSK Filed SC 13D/A on Theravance Biopharma, Inc., latest Sep 20, 2022 (3 filings since Feb 10, 2022)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Theravance Biopharma, Inc., latest Feb 14, 2022
  • Theravance Biopharma, Inc. Grand Cayman, California
    • Theravance Biopharma Antibiotics IP, LLC Subsidiary · Delaware, United States
    • Theravance Biopharma Ireland Limited Subsidiary · Ireland
    • Theravance Biopharma R&D IP, LLC Subsidiary · Delaware, United States
    • Theravance Biopharma US Holdings, Inc. Subsidiary · Delaware, United States
    • Theravance Biopharma US, LLC Subsidiary · Delaware, United States

Built from 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 Theravance Biopharma, 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, before depreciation$29.7M5 Dec 31, 2025$29.8M5 Dec 31, 2024−0.3%
Accumulated depreciation$23.8M5 Dec 31, 2025$22.4M5 Dec 31, 2024+6.3%
Property and equipment, net$5.9M5 Dec 31, 2025$7.4M5 Dec 31, 2024−20.5%
Operating-lease assets (leased space)$24.4M5 Dec 31, 2025$28.4M5 Dec 31, 2024−14.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$167.8M5 Dec 31, 2025$37.8M5 Dec 31, 2024+344.0%
Marketable securities, current$147.6M5 Dec 31, 2025$50.6M5 Dec 31, 2024+191.9%
Marketable securities, non-current$11.1M5 Dec 31, 2025$5.0M12 Dec 31, 2019+123.2%
Debt securities available for sale$240.0M5 Dec 31, 2025$58.0M5 Dec 31, 2024+313.7%

Properties, in its own words

Our principal physical properties in the US consist of approximately 162,000 square feet of office and laboratory space leased in two buildings in South San Francisco, California. Of this office and laboratory space, approximately 130,000 square feet was subleased to subtenants as of December 31, 2025. The South San Francisco lease expires in May 2030, and our subleases expire between September 2028 and May 2030. Our Irish subsidiary operates from approximately 700 square feet of leased office space in Dublin, Ireland, that expires in May 2026.

Item 2 of the 10-K filed Mar 23, 2026.4

Leadership

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

Chief executive

  1. Rick E. Winningham2014–now

President

  1. Ann Brady2019–2022

Chief financial officer

  1. Renee D. Gala2015–2018
  2. Andrew A. Hindman2019–2022
  3. Aziz Sawaf2023–now
201520202025
Board members and other officers (33)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Theravance Biopharma Antibiotics IP, LLC Delaware3
  • Theravance Biopharma Ireland Limited Ireland3
  • Theravance Biopharma R&D IP, LLC Delaware3
  • Theravance Biopharma US Holdings, Inc. Delaware3
  • Theravance Biopharma US, LLC Delaware3

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

Timeline

  1. Sep 23, 20268-K Entered a material agreement; Completed an acquisition or sale; Listing notice or transfer50
  2. Sep 18, 20268-K Shareholder vote51
  3. Sep 10, 20268-K Other events52
  4. Aug 25, 20268-K Other events53
  5. Aug 10, 20268-K Results of operations54
  6. Jun 29, 20268-K Entered a material agreement; Regulation FD disclosure; Other events55
  7. Jun 23, 20268-K Executive or director change56
  8. Jun 12, 20268-K Shareholder vote57
  9. May 7, 20268-K Results of operations58
  10. Mar 30, 20268-K Other events59
  11. Mar 19, 20268-K Results of operations60
  12. Mar 3, 20268-K Results of operations; Exit or restructuring costs; Regulation FD disclosure61
  13. May 14, 2014New chief executive Rick E. Winningham becomes CEO13

Calendar

Coming up

  1. Around Nov 13, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results54
  2. May 7, 2026Reported quarterly or annual results58
  3. Mar 19, 2026Reported quarterly or annual results60
  4. Mar 3, 2026Reported quarterly or annual results61
  5. Nov 10, 2025Reported quarterly or annual results62
  6. Aug 12, 2025Reported quarterly or annual results63
  7. May 8, 2025Reported quarterly or annual results64
  8. Feb 26, 2025Reported quarterly or annual results65

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

Filings

429 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 73 major events, 228 insider forms, 44 large holders, 63 other. The latest 20:

  1. Oct 5, 202615-12G EDGAR
  2. Sep 28, 20264 PRIMARY DOCUMENT EDGAR
  3. Sep 25, 2026SCHEDULE 13D/A EDGAR
  4. Sep 24, 20264 EDGAR
  5. Sep 24, 20264 EDGAR
  6. Sep 24, 20264 EDGAR
  7. Sep 24, 20264 EDGAR
  8. Sep 24, 20264 EDGAR
  9. Sep 24, 20264 EDGAR
  10. Sep 24, 20264 EDGAR
  11. Sep 24, 20264 EDGAR
  12. Sep 24, 20264 EDGAR
  13. Sep 24, 20264 EDGAR
  14. Sep 24, 2026S-8 POS EDGAR
  15. Sep 24, 2026S-8 POS EDGAR
  16. Sep 24, 2026S-8 POS EDGAR
  17. Sep 24, 2026S-8 POS EDGAR
  18. Sep 24, 2026S-8 POS EDGAR
  19. Sep 24, 2026S-8 POS EDGAR
  20. Sep 24, 2026S-8 POS EDGAR

The 429 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

42 open-market trades by officers, directors and large owners since October 2021: 2 buys and 40 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale13,314$17.03$226.7KForm 4
Jul 7, 2026Samaha Eli10% ownerSale5,564$17.17$95.5KForm 4
Jul 6, 2026Samaha Eli10% ownerSale1,400$17.04$23.9KForm 4
Jul 1, 2026Samaha Eli10% ownerSale37,799$17.00$642.6KForm 4
Jun 30, 2026Samaha Eli10% ownerSale25,027$17.13$428.7KForm 4
Jun 29, 2026Samaha Eli10% ownerSale273,871$17.23$4.7MForm 4
Jun 15, 2026Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale13,314$16.39$218.2KForm 4
Mar 16, 2026Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale31,067$13.96$433.7KForm 4
Dec 3, 2025Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale31,067$18.75$582.5KForm 4
Nov 26, 2025BROSHY ERANDirectorSale29,501$20.00$590.0KForm 4
Nov 11, 2025BROSHY ERANDirectorSale45,000$17.98$809.2KForm 4
Nov 11, 2025BROSHY ERANDirectorSale59,000$18.11$1.1MForm 4
Jul 14, 2025Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale10,000$11.39$113.9KForm 4
Jun 2, 2025Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale24,000$11.00$264.0KForm 4
Apr 21, 2025Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale4,000$9.00$36.0KForm 4
Jan 21, 2025Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale4,000$9.00$36.0KForm 4
Nov 11, 2024Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale4,000$9.00$36.0KForm 4
Aug 7, 2024Samaha Eli10% ownerBuy999,800$7.80$7.8MForm 4
Jul 10, 2024Farnum RhondaSVP, COMM & MEDICAL AFFAIRSSale4,000$9.00$36.0KForm 4
May 1, 2024Samaha Eli10% ownerBuy1,499,124$8.75$13.1MForm 4

All 42 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
2025Rick E WinninghamChief Executive Officer66$1.0M$1.5M80
2025Aine Miller Senior Vice President, Development and Head of Ireland Office49$701.2K$1.4M80
2025Rhonda F. Farnum Chief Business Officer and Senior Vice President, Commercial & Medical Affairs61$506.3K$1.4M80
2024Rick E WinninghamChief Executive Officer66$1.0M$4.0M80

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
Mar 24, 2025George WhitesidesDemocratic, HouseSale$15,001 - $50,000Report

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

SEC filer profile

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

  • Name on EDGARTheravance Biopharma, Inc.1
  • CIK0001583107
  • Employer ID (EIN)98-12266284
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inCayman Islands4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business addressUgland House, South Church Street, George Town, Grand Cayman, CA KY1-11041
  • Phone650-808-60001
  • Shares outstanding51,918,754 as of Jul 31, 202611
  • Public float$448.6M as of Jun 30, 20254
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceAug 1, 20131
  • Filings1,154 in all: 4 (628), 8-K (180), SC 13G/A (61), 3 (41), 10-Q (38), 144 (18), SC 13G (18), 10-K (12)1
    All 41 form types

    DEF 14A (12), SC 13D/A (12), 424B5 (11), CORRESP (11), SC TO-I/A (11), CT ORDER (10), S-8 (10), S-8 POS (10), UPLOAD (10), 8-K/A (8), DEFA14A (8), 10-12B/A (6), 3/A (6), SCHEDULE 13G/A (5), S-3ASR (3), SC TO-C (3), SC TO-I (3), FWP (2), SC 13D (2), SCHEDULE 13D/A (2), 10-12B (1), 10-Q/A (1), 15-12G (1), 25-NSE (1), 4/A (1), 8-A12B (1), CERTNAS (1), DEFM14A (1), EFFECT (1), PRE 14A (1), PREM14A (1), S-3 (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 23, 2026

Securities registered for trading

ClassSymbolExchange
Ordinary Share $0.00001 Par ValueTBPHThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Theravance Biopharma, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 45 risks under these headings, as written.4

  • RISKS RELATING TO THE COMPANY
  • If YUPELRI’s acceptance by physicians, patients, third-party payors, or the medical community in general does not continue to grow, we may not receive significant additional revenues from sales of this product.
  • In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks.
  • If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with us, we may not be able to develop or commercialize our partnered products as planned.
  • We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products more successfully than we do.
  • Our strategic review process may not result in an executed or consummated transaction or other strategic alternative, and the process of reviewing strategic alternatives or its conclusion could adversely affect our business and our shareholders.
  • We may not sustain profitability from our operations.
  • There is a single source of supply for YUPELRI, and our business will be harmed if manufacturers are not able to satisfy demand and alternative sources are not available.
  • We are subject to extensive and ongoing regulation, oversight and other requirements by the FDA and failure to comply with these regulations and requirements may subject us to penalties that may adversely affect our financial condition or our ability to commercialize any approved products.
  • We and/or our collaboration partners and those commercializing products with respect to which we have an economic interest or right to receive royalties may face competition from companies seeking to market generic versions of any approved products in which we have an interest, such as YUPELRI.
  • If we are unable to enter into future collaboration arrangements or if any such collaborations are unsuccessful, we may be unable to fully develop and commercialize products and our business will be adversely affected.
  • If there are any adverse developments or perceived adverse developments with respect to TRELEGY, we may not receive Milestone Payments, which would harm our business and could cause the price of our securities to fall.
The other 34 risks
  • We do not control the commercialization of TRELEGY; accordingly, our receipt of Milestone Payments will depend on, among other factors, GSK’s ability to further commercialize TRELEGY.
  • If we lose key management, sales, or other personnel, or if we fail to attract and retain key employees, our ability to develop product candidates, commercialize our products and maximize shareholder value will be impaired.
  • Our business and operations would suffer in the event of significant disruptions of information technology systems or security breaches.
  • Global economic, political, and social conditions may harm our ability to do business, increase our costs and negatively affect our stock price.
  • Our US operating subsidiary’s facility is located near known earthquake fault zones, and the occurrence of an earthquake, extremist attack or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.
  • We may be treated as a US corporation for US federal income tax purposes.
  • Future tax reform, including changes in tax rates and imposition of new taxes, could impact our results of operations and financial condition.
  • Taxing authorities may challenge our structure and transfer pricing arrangements.
  • We were a passive foreign investment company, or “PFIC,” for 2014, but we were not a PFIC from 2015 through 2025, and we do not expect to be a PFIC for the foreseeable future.
  • If we are unable to maintain effective internal controls, our business, financial position, and results of operations could be adversely affected.
  • If sufficient capital is not available, we may have to further curtail operations or we could be forced to sell or license assets on terms that may not be favorable to us.
  • Our drug development efforts might not generate additional approvable drugs.
  • Any adverse results from clinical or non-clinical studies or regulatory obstacles any product candidates or product may face would harm our business and the price of our securities could fall.
  • If any product candidate is not approved by regulatory authorities, including the FDA, we will be unable to commercialize it.
  • We depend on third parties in the conduct of our non-clinical and clinical studies for product candidates.
  • RISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our current or future markets.
  • Litigation to protect or defend our intellectual property or third-party claims of intellectual property infringement will require us to divert resources and may prevent or delay our drug development and commercialization efforts.
  • If the efforts of our partners or future partners to protect the proprietary nature of the intellectual property related to collaboration assets are not adequate, the future commercialization of any medicines resulting from collaborations could be negatively impacted, which would materially harm our business and could cause the price of our securities to fall.
  • Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.
  • If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business.
  • Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor and distributor cost-containment initiatives, may negatively impact us, our collaboration partners, or those commercializing products with respect to which we have an economic interest or right to receive royalties.
  • If we failed 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 reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • The coverage and reimbursement status of products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for products could limit our ability to market those products and decrease our ability to generate revenue.
  • Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion, contractual damages, reputational harm and diminished profits and future earnings.
  • Our business and operations, including prior use of hazardous and biological materials, may result in liabilities with respect to environmental, health and safety matters.
  • RISKS RELATING TO OUR ORDINARY SHARES
  • The market price for our shares has and may continue to fluctuate widely and may result in substantial losses for purchasers of our ordinary shares.
  • Activist shareholders could negatively impact our business and cause disruptions.
  • Concentration of ownership will limit your ability to influence corporate matters.
  • Certain provisions in our constitutional and other documents may discourage our acquisition by a third party, which could limit your opportunity to sell shares at a premium.
  • Our shareholders may face difficulties in protecting their interests because we are incorporated under Cayman Islands law.
  • There is uncertainty as to shareholders’ ability to enforce certain foreign civil liabilities in the Cayman Islands.
  • If securities or industry analysts cease coverage of us or do not publish research, or publish inaccurate or unfavorable research, about our business, the price of our ordinary shares and trading volume could decline.
  • Capital appreciation, if any, of our ordinary shares may be your sole source of gain for the foreseeable future.
  • We are a smaller reporting company, and any decision on our part to comply only with reduced reporting and disclosure requirements applicable to such companies could make our ordinary shares less attractive to investors.

Legal proceedings

During January 2023, the Company received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc. (collectively, the “generic companies”), that they have each filed with the FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a Paragraph IV certification with respect to five of the Company’s patents listed in the FDA’s Orange Book for YUPELRI on the date of the Company’s receipt of the notice. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, the Company filed patent infringement suits against the generic companies in federal district courts, including the US District Court for the District of New Jersey, the US District Court for the District of Delaware, and the US District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of the Company’s Orange Book listed patents. The Company is seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe the Company’s patents. Additional patents covering YUPELRI, granted on July 4, 2023 and January 2, 2024, were subsequently listed in FDA’s

Orange Book. The Company filed additional patent infringement suits in the US District Court for the District of New Jersey during August 2023 and January 2024. These suits have been consolidated with the above action. Further, the original complaint was amended during December 2023 to include certain patents not listed in the Orange Book.

The opening of Item 3, Legal Proceedings.4

Sources

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  29. 29
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  32. 32
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  51. 51
  52. 52
    SEC EDGAROther events
  53. 53
    SEC EDGAROther events
  54. 54
  55. 55
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    SEC EDGAROther events
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
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  74. 74
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  79. 79
  80. 80