INSM on Nasdaq

INSMED Inc

INSMED Inc is an American pharmaceutical preparations company based in Bridgewater.2

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Last updated Oct 21, 2026.

Overview

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  • TickerINSM on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersBridgewater, United States2
  • Incorporated inVA3
  • Business address700 Us Highway 202/206, Bridgewater, Nj 088073
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI529900Q55QAG41CCAC112
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered address10 Finderne Avenue, Building 10, 08807 Bridgewater, United States2
  • Registered withBusiness Records Service (Division of Revenue & Enterprise Services), 04003897012

We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Any forward-looking statement is based on information current as of the date of this Annual Report on Form 10-K and speaks only as of the date on which such statement is made. Actual events or results may differ materially from the results, plans, intentions or expectations anticipated in these forward-looking statements as a result of a variety of factors, many of which are beyond our control. More information on factors that could cause actual results to differ materially from those anticipated is included from time to time in our reports filed with the Securities and Exchange Commission (SEC), including, but not limited to, those described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results …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

-205.6%Operating margin6
-210.5%Net margin6
66.7%Revenue growth, 20256
-172.8%Return on equity6
0.73×Debt to equity6
-$967.6MFree cash flow6

What sells

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

Products and services

Arikayce brought in 72% of the revenue INSMED Inc broke down this way in fiscal 2025.

  1. Arikayce$433.8M672%up 19% from 2024
  2. Brinsupri$172.7M628%
Products and services by year
Products and services202320242025
Arikayce$305.2M$363.7M$433.8M
Brinsupri$0$0$172.7M

Regions

United States brought in 75% of the revenue INSMED Inc broke down this way in fiscal 2025.

  1. United States$453.0M675%up 78% from 2024
  2. Outside the United States$153.5M625%up 41% from 2024
Regions by year
Regions202320242025
United States$224.2M$254.8M$453.0M
Outside the United States$81.0M$108.9M$153.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue7¢$122.9M
  • Research and development46¢$771.1M
  • Selling, general and admin42¢$701.2M
  • Interest5¢$83.8M
  • Income tax0¢$5.0M

Out of $606.4M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$606.4M in 2025+344% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $136.5M$136.5M20192020: $164.4M$164.4M2020+20%2021: $188.5M$188.5M2021+15%2022: $245.4M$245.4M2022+30%2023: $305.2M$305.2M2023+24%2024: $363.7M$363.7M2024+19%2025: $606.4M$606.4M2025+67%
Operating income789106-$1.2B in 2025+430% since 2019
-$1.5B-$1.0B-$500.0M02019: -$235.2M-$235.2M20192020: -$265.2M-$265.2M2020+13%2021: -$375.1M-$375.1M2021+41%2022: -$457.3M-$457.3M2022+22%2023: -$709.6M-$709.6M2023+55%2024: -$878.3M-$878.3M2024+24%2025: -$1.2B-$1.2B2025+42%
Net income789106-$1.3B in 2025+402% since 2019
-$1.5B-$1.0B-$500.0M02019: -$254.3M-$254.3M20192020: -$294.1M-$294.1M2020+16%2021: -$434.7M-$434.7M2021+48%2022: -$481.5M-$481.5M2022+11%2023: -$749.6M-$749.6M2023+56%2024: -$913.8M-$913.8M2024+22%2025: -$1.3B-$1.3B2025+40%

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 revenues, net$606.4M$363.7M$305.2M
Cost of product revenues (excluding amortization of intangible assets)$122.9M$85.7M$65.6M
Research and development$771.1M$598.4M$571.0M
Selling, general and administrative$701.2M$461.1M$344.5M
Amortization of intangible assets$6.0M$5.1M$5.1M
Change in fair value of deferred and contingent consideration$252.0M$91.7M$28.7M
Total operating expenses$1.9B$1.2B$1.0B
Operating loss-$1.2B-$878.3M-$709.6M
Investment income$60.7M$53.3M$42.1M
Interest expense-$83.8M-$84.9M-$81.7M
Change in fair value of interest rate swap$0-$236.0K$320.0K
Other (expense) income, net-$1.8M$29.0K$1.9M
Loss before income taxes-$1.3B-$910.1M-$747.0M
Provision for income taxes$5.0M$3.7M$2.6M
Net loss-$1.3B-$913.8M-$749.6M
Basic net loss per share (in dollars per share)-$6.42-$5.57-$5.34
Diluted net loss per share (in dollars per share)-$6.42-$5.57-$5.34
Weighted average basic common shares outstanding (in shares)199.0M shares164.0M shares140.4M shares
Weighted average diluted common shares outstanding (in shares)199.0M shares164.0M shares140.4M shares
Net loss, basic-$1.3B-$913.8M-$749.6M
Net loss, diluted-$1.3B-$913.8M-$749.6M
Foreign currency translation gains (losses)$3.3M-$1.9M-$2.2M
Unrealized gain on marketable securities$444.0K$311.0K$713.0K
Total comprehensive loss-$1.3B-$915.3M-$751.1M

Compare INSMED Inc with another company

Corporate structure

INSMED Inc sits at the top of its group. 13 entities, 9 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of INSMED Inc

  • INSMED Inc Bridgewater, New Jersey, United States
    • Celtrix Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Insmed France SAS Subsidiary · France
    • Insmed Gene Therapy LLC Subsidiary · Delaware, United States
    • Insmed Germany GmbH Subsidiary · Germany
    • Insmed Godo Kaisha Subsidiary · Japan
    • Insmed Holdings Limited Subsidiary · Ireland
    • Insmed Innovation UK Limited Subsidiary · United Kingdom
    • Insmed Ireland Limited Subsidiary · Ireland
    • Insmed Italy S.R.L. Subsidiary · Italy
    • Insmed Netherlands B.V. Subsidiary · Netherlands
    • Insmed Netherlands Holdings B.V. Subsidiary · Netherlands
    • Insmed Switzerland GmbH Subsidiary · Switzerland

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 INSMED 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$163.7M6 Dec 31, 2025$130.4M6 Dec 31, 2024+25.6%
Accumulated depreciation$60.8M6 Dec 31, 2025$50.3M6 Dec 31, 2024+20.8%
Property and equipment, net$102.9M6 Dec 31, 2025$80.1M6 Dec 31, 2024+28.6%
Finance-lease assets$15.6M6 Dec 31, 2025$18.3M6 Dec 31, 2024−14.8%
Operating-lease assets (leased space)$20.7M6 Dec 31, 2025$17.3M6 Dec 31, 2024+20.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$510.4M6 Dec 31, 2025$555.0M6 Dec 31, 2024−8.0%
Marketable securities, current$919.6M6 Dec 31, 2025$878.8M6 Dec 31, 2024+4.6%
Debt securities available for sale$919.6M6 Dec 31, 2025$878.8M10 Dec 31, 2024+4.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$136.1M6 Dec 31, 2025$136.1M6 Dec 31, 20240%
Finite-lived intangibles, net$97.7M6 Dec 31, 2025$58.7M6 Dec 31, 2024+66.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$132.1M6 Dec 31, 2025$98.6M6 Dec 31, 2024+34.0%
Raw materials$30.6M6 Dec 31, 2025$19.7M6 Dec 31, 2024+55.6%
Work in process$41.3M6 Dec 31, 2025$39.9M6 Dec 31, 2024+3.5%
Finished goods$60.1M6 Dec 31, 2025$39.0M6 Dec 31, 2024+54.2%

Properties, in its own words

We currently lease 117,022 square feet of office space for our corporate headquarters in Bridgewater, New Jersey. The initial term of this lease will expire in 2030.

We lease laboratory space located in Bridgewater for which we exercised the renewal option to extend the lease term until December 2026. In July 2023, we expanded this lease to a total of 46,671 square feet and further extended the lease term until April 2027. We also lease facilities in California totaling 54,478 square feet and New Hampshire totaling 12,668 square feet. In addition, we lease space outside of the US in France, Ireland, the Netherlands, Switzerland, the UK, and Japan.

The rest of Item 2

Furthermore, in 2025 we purchased a building intended for use as a laboratory space. The property is located in New Hampshire and consists of 60,000 square feet. The facility has not yet been placed into service.

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

Leadership

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

Board members and other officers (36)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Celtrix Pharmaceuticals, Inc. Delaware4
  • Insmed France SAS France4
  • Insmed Gene Therapy LLC Delaware4
  • Insmed Germany GmbH Germany4
  • Insmed Godo Kaisha Japan4
  • Insmed Holdings Limited Ireland4
  • Insmed Innovation UK Limited England and Wales4
  • Insmed Ireland Limited Ireland4
  • Insmed Italy S.R.L. Italy4
  • Insmed Limited England and Wales4
  • Insmed Netherlands B.V. The Netherlands4
  • Insmed Netherlands Holdings B.V. The Netherlands4
  • Insmed Switzerland GmbH Switzerland4

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

Timeline

  1. Oct 5, 20268-K Executive or director change; Regulation FD disclosure59
  2. Aug 6, 20268-K Results of operations60
  3. Jul 16, 20268-K Regulation FD disclosure61
  4. May 15, 20268-K Shareholder vote62
  5. May 7, 20268-K Results of operations63
  6. Apr 7, 20268-K Regulation FD disclosure; Other events64
  7. Mar 23, 20268-K Regulation FD disclosure; Other events65
  8. Feb 19, 20268-K Results of operations; Executive or director change66
  9. Jan 9, 20268-K Regulation FD disclosure67
  10. Dec 17, 20258-K Regulation FD disclosure; Other events68
  11. Nov 18, 20258-K Regulation FD disclosure; Other events69
  12. Oct 30, 20258-K Results of operations70
  13. May 1, 2011Founded INSMED Inc is founded2
  14. Jun 22, 2007New chief executive Geoffrey Allan becomes CEO15

Calendar

Coming up

  1. Oct 29, 2026 · Before the openReports results for the quarter ending Sep/2026 A year earlier it reported ($1.75) a share, on Oct 30, 2025.71

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results60
  2. May 7, 2026Reported quarterly or annual results63
  3. Feb 19, 2026Reported quarterly or annual results66
  4. Oct 30, 2025Reported quarterly or annual results70
  5. Aug 7, 2025Reported quarterly or annual results72
  6. May 8, 2025Reported quarterly or annual results73
  7. Feb 20, 2025Reported quarterly or annual results74
  8. Oct 31, 2024Reported quarterly or annual results75

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

Filings

689 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 318 insider forms, 40 large holders, 251 other. The latest 20:

  1. Oct 5, 20268-K EDGAR
  2. Sep 11, 20264 EDGAR
  3. Sep 10, 2026144 EDGAR
  4. Aug 19, 20264 EDGAR
  5. Aug 17, 2026144 EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 12, 20264 EDGAR
  8. Aug 10, 2026144 EDGAR
  9. Aug 7, 20264 EDGAR
  10. Aug 6, 2026144 EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Aug 6, 202610-Q EDGAR
  13. Aug 6, 2026SCHEDULE 13G/A EDGAR
  14. Jul 24, 20264 EDGAR
  15. Jul 23, 2026144 EDGAR
  16. Jul 22, 2026SCHEDULE 13G/A EDGAR
  17. Jul 16, 20268-K EDGAR
  18. Jul 10, 20264 EDGAR
  19. Jul 9, 2026144 EDGAR
  20. Jul 8, 20264 EDGAR

The 689 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

303 open-market trades by officers, directors and large owners since October 2021: 9 buys and 294 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026Brennan David RDirectorSale25,000$124.00$3.1MForm 4
Aug 17, 2026SHAROKY MELVIN MDDirectorSale5,000$127.53$637.6KForm 4
Aug 10, 2026Adsett RogerChief Operating OfficerSale239,850$133.27$32.0MForm 4
Aug 6, 2026Flammer Martina M.D.Chief Medical OfficerSale27,173$128.61$3.5MForm 4
Jul 23, 2026Lewis WilliamChair and CEOSale10,700$106.06$1.1MForm 4
Jul 9, 2026Lewis WilliamChair and CEOSale10,699$117.40$1.3MForm 4
Jul 6, 2026Flammer Martina M.D.Chief Medical OfficerSale12,302$109.98$1.4MForm 4
Jun 25, 2026Lewis WilliamChair and CEOSale21,398$103.32$2.2MForm 4
Jun 22, 2026Smith Michael AlexanderChief Legal OfficerSale1,806$95.82$173.1KForm 4
Jun 8, 2026Lewis WilliamChair and CEOSale6,515$94.03$612.6KForm 4
Jun 5, 2026Flammer Martina M.D.Chief Medical OfficerSale1,858$103.78$192.8KForm 4
Jun 3, 2026Smith Michael AlexanderChief Legal OfficerSale2,159$102.27$220.8KForm 4
Jun 3, 2026Flammer Martina M.D.Chief Medical OfficerSale2,566$102.27$262.4KForm 4
Jun 3, 2026Adsett RogerChief Operating OfficerSale2,370$102.27$242.4KForm 4
Jun 3, 2026Bonstein SaraChief Financial OfficerSale2,404$102.27$245.9KForm 4
Jun 3, 2026Lewis WilliamChair and CEOSale7,605$102.27$777.8KForm 4
May 22, 2026Smith Michael AlexanderChief Legal OfficerSale6,149$108.47$667.0KForm 4
May 18, 2026Lewis WilliamChair and CEOSale25,564$106.33$2.7MForm 4
May 14, 2026Flammer Martina M.D.Chief Medical OfficerSale10,479$117.54$1.2MForm 4
May 13, 2026Smith Michael AlexanderChief Legal OfficerSale4,109$116.18$477.4KForm 4

All 303 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
2025William H. LewisCEO57$854.5K$14.5M87
2025Martina Flammer, M.D.Chief Medical Officer62$634.2K$4.7M87
2025Roger AdsettChief Operating Officer57$622.6K$4.7M87
2025Sara BonsteinChief Financial Officer45$583.2K$4.6M87
2025Michael A. SmithChief Legal Officer 649$595.3K$4.1M87
2024William H. LewisCEO57$810.0K$10.9M87
2024Roger AdsettChief Operating Officer57$598.6K$4.3M87
2024Martina Flammer, M.D.Chief Medical Officer62$576.5K$4.1M87
2024Sara BonsteinChief Financial Officer45$530.2K$4.0M87
2023William H. LewisCEO57$780.0K$10.4M87
2023Sara BonsteinChief Financial Officer45$511.0K$4.6M87
2023Martina Flammer, M.D.Chief Medical Officer62$555.7K$4.2M87
2023Roger AdsettChief Operating Officer57$577.0K$4.0M87

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
Fmr LLC16,143,583$1.7B0.1%+2,983,416
BlackRock, Inc.15,807,984$1.7B0.0%−870,162
Vanguard Portfolio Management LLC10,407,962$1.1B0.1%+36,160
Jpmorgan Chase & Co10,428,170$1.1B0.1%−13,722,329
Vanguard Capital Management LLC9,790,865$1.0B0.0%+148,734
Baker Bros. Advisors LP8,796,111$937.8M4.7%+1,375,000
Capital International Investors8,238,124$878.3M0.2%+2,642,930
Darwin Global Management, Ltd.6,431,163$673.6M17.9%−10,374,021
Ameriprise Financial Inc6,179,571$658.9M0.1%+3,121,853
Orbis Allan Gray Ltd6,076,487$647.9M2.2%+4,203,663
State Street Corp6,052,174$645.3M0.0%+500,475
D. E. Shaw & Co., Inc.5,877,959$626.7M0.4%+252,134
Artisan Partners Limited Partnership5,441,718$580.2M0.9%−1,085,583
Rtw Investments, LP4,842,880$516.3M4.4%No change
Geode Capital Management, LLC4,220,155$448.8M0.0%−230,234
Norges Bank3,377,641$360.1M0.0%New
Jupiter Topco LLC2,605,181$277.8M0.1%New
UBS Group AG2,584,446$275.6M0.0%+846,965
Citadel Advisors LLC2,556,973$272.6M0.2%+374,402
Franklin Resources Inc2,273,222$242.4M0.1%−344,029
Maverick Capital Ltd2,150,762$229.3M2.1%New
Millennium Management LLC2,048,005$218.4M0.2%+890,219
Qube Research & Technologies Ltd1,682,334$179.4M0.2%+1,533,819
Westfield Capital Management Co LP1,629,561$173.7M0.6%+161,102
Integral Health Asset Management, LLC1,600,000$170.6M7.0%+100,000

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

Members of Congress who traded it

10 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
Jun 10, 2026Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−1.6%Report
Oct 3, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseSale$1,001 - $15,000+52.2%Report
Sep 22, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+47.3%Report
Aug 8, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+30.6%Report
Jul 7, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+22.0%Report
Jun 16, 2025Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000−30.4%Report
Apr 9, 2025Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−6.2%Report
Jun 21, 2024Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−4.2%Report
May 28, 2024Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−60.8%Report
Dec 6, 2022Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000+326.7%Report

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

SEC filer profile

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

  • Name on EDGARINSMED Inc1
  • CIK0001104506
  • Employer ID (EIN)54-19727295
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inVirginia5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address700 Us Highway 202/206, Bridgewater, NJ 088071
  • Phone908-977-99001
  • Shares outstanding218,381,503 as of Jul 31, 202613
  • Public float$21.1B as of Jun 30, 20255
  • AuditorErnst & Young LLP, Iselin, New Jersey PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 11, 20001
  • Filings1,820 in all: 4 (719), 8-K (356), 144 (226), SC 13G/A (97), 10-Q (80), 3 (45), SC 13G (35), DEF 14A (32)1
    All 51 form types

    10-K (25), 424B5 (24), S-8 (18), SCHEDULE 13G/A (14), 5 (13), DEFA14A (13), 10-K/A (11), CT ORDER (11), UPLOAD (10), 8-K/A (6), ARS (6), CORRESP (6), S-3 (6), 10-Q/A (5), 424B2 (5), 424B3 (5), S-3ASR (5), 425 (4), FWP (4), 4/A (3), PRE 14A (3), REGDEX (3), SCHEDULE 13G (3), 3/A (2), 424B4 (2), 8-A12G (2), EFFECT (2), S-3/A (2), S-4/A (2), SEC STAFF LETTER (2), 10-K405 (1), 424A (1), 8-A12G/A (1), AW (1), D (1), DEFS14A (1), POS AM (1), POSASR (1), PRES14A (1), S-1 (1), S-1/A (1), S-1MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 1, 2026
    Latest 8-K (8-K) Oct 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareINSMNasdaq Global Select Market

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

Risk factors and legal proceedings

The risks INSMED Inc names in Item 1A of its 10-K filed Feb 19, 2026: 55 risks under these headings, as written.5

  • Risks Related to the Commercialization and Continued Approval of ARIKAYCE and BRINSUPRI, and the Potential Approval and Commercialization of our Product Candidates
  • Our prospects are highly dependent on the success of our approved products, ARIKAYCE and BRINSUPRI. If we are unable to successfully market, commercialize and maintain approval for ARIKAYCE and BRINSUPRI, our business, financial condition, results of operations and prospects and the value of our common stock may be materially adversely affected.
  • We may not be able to obtain regulatory approval for ARIKAYCE in front-line NTM lung disease, for ARIKAYCE or BRINSUPRI in additional markets or for our product candidates. Any such failure to obtain regulatory approvals may materially adversely affect us.
  • The commercial success of ARIKAYCE and BRINSUPRI depend on market acceptance by physicians, patients, third-party payors and others in the healthcare community, and the commercial success of our product candidates, if approved, may similarly depend on market acceptance.
  • We obtained regulatory approval of ARIKAYCE in the US through an accelerated approval process, and full approval will be contingent on successful and timely completion of a confirmatory post-marketing clinical trial. Failure to obtain full approval or otherwise meet our post-marketing requirements and commitments may have a material adverse effect on our business, prospects and the value of our common stock.
  • We are subject to substantial, ongoing regulatory requirements, including with respect to advertising and promotion, and failure to comply with these requirements may lead to enforcement action or otherwise materially harm our business.
  • If we are unable to obtain or maintain adequate reimbursement from government or third-party payors for ARIKAYCE, BRINSUPRI or our product candidates, if approved, or if we are unable to obtain or maintain acceptable prices for ARIKAYCE, BRINSUPRI or our product candidates, if approved, our prospects for generating revenue and achieving profitability may be materially adversely affected.
  • ARIKAYCE, BRINSUPRI, or any of our product candidates may develop unexpected safety or efficacy concerns, which may have a material adverse effect on us.
  • If our estimates of the size of the potential markets for ARIKAYCE, BRINSUPRI, or our product candidates prove inaccurate, our ability to generate revenue may be materially adversely affected.
  • Risks Related to the Development and Regulatory Approval of Our Product Candidates Generally
  • Pharmaceutical research and development is very costly and highly uncertain, and we may not succeed in developing product candidates in the future.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available, may be interpreted differently if additional data are disclosed, and are subject to audit and verification procedures that may result in material changes in the final data.
The other 43 risks
  • As ARIKAYCE is a drug/device combination product, we cannot sell ARIKAYCE without Lamira. Any failure to secure or maintain regulatory approval in each market for Lamira as a delivery system for ARIKAYCE may limit our ability to successfully commercialize ARIKAYCE. Additionally, we plan to submit an NDA for TPIP as a drug/device combination product or as a stand-alone marketing application, as dictated by local regulations. Failure to obtain or maintain regulatory approval or clearance of any of our devices or drug-device combination products may materially harm our business.
  • If our clinical studies do not produce positive results or our clinical trials are delayed, or if serious side effects are identified during drug development, we may experience delays, incur additional costs and ultimately be unable to obtain regulatory approval for and successfully commercialize our product candidates in the US, Europe, Japan or other markets.
  • We may not be able to enroll enough patients to conduct and complete our clinical trials or retain a sufficient number of patients in our clinical trials to generate the data necessary for regulatory approval of our product candidates or to gain approval of the use of ARIKAYCE in the broader population of patients with MAC lung disease.
  • If another party obtains orphan drug exclusivity for a product that is considered the same or essentially the same as a product we are developing for a particular indication, we may be precluded from or delayed in commercializing the product in that indication.
  • If we fail to obtain or maintain regulatory exclusivity for our product candidates, our business may be materially harmed.
  • Generic competition following the expiration or loss of exclusivity may significantly reduce our revenues.
  • Our clinical and pre-clinical research activities include the research and development of novel gene therapy product candidates. It will be difficult to predict the time and cost of development and of subsequently obtaining regulatory approval for any such gene therapy product candidates, or how long it will take to commercialize any gene therapy product candidates.
  • Risks Related to Our Reliance on Third Parties
  • If we are unable to form and sustain relationships with third-party service providers that are critical to our business, or if any third-party arrangements that we may enter into are unsuccessful, our ability to develop and commercialize our products may be materially adversely affected.
  • We may not have, or may be unable to obtain, sufficient quantities of ARIKAYCE, Lamira, BRINSUPRI, or our product candidates to meet our required supply for commercialization or clinical studies, which may materially harm our business.
  • Adverse consequences to our business may result if we or our manufacturing partners fail to comply with applicable regulations or maintain required approvals.
  • Risks Related to the Operation of our Business
  • We are dependent on retaining and attracting key personnel, the loss of whose services may materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • We expect to continue to expand our development, regulatory and sales and marketing capabilities and, as a result, may encounter difficulties in managing our growth, which may disrupt our operations.
  • Any acquisitions we have made or may make in the future, or collaborative relationships we have entered into or may enter into in the future, may not be clinically or commercially successful, and may require financing or a significant amount of cash, which may adversely affect our business.
  • We may be subject to product liability claims, and we have only limited product liability insurance.
  • Our business and operations, including our drug development and commercialization programs, may be materially disrupted and/or subject to reputational harm in the event of system failures, security breaches, cyber-attacks, deficiencies in cybersecurity, violations of data protection laws or data loss or damage by us or third parties.
  • We are subject to laws and regulations that govern how we can collect, process, store, and transfer personal data and sensitive data, and violations may result in meaningful penalties, enforcement, and/or reputational harm and have a significant impact on our operations.
  • Our inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology may have a material adverse effect on our business or results of operations.
  • We are subject to a number of risks associated with our international activities and operations and may not be successful in any efforts to further expand internationally.
  • 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.
  • We have a limited number of significant customers and losing any of them may have an adverse effect on our financial condition and results of operations.
  • Deterioration in general economic conditions in the US, Europe, Japan and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, may harm our business and results of operations.
  • The emergence of a pandemic, and efforts to reduce its spread, may negatively impact our business and operations.
  • Our current and potential future use of AI and machine learning may not be successful and presents new risks and challenges to our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to protect our intellectual property rights adequately, the value of ARIKAYCE, BRINSUPRI, and our product candidates may be materially diminished.
  • If we do not obtain patent term extension for BRINSUPRI or our product candidates, if needed, our business may be harmed.
  • If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of ARIKAYCE, BRINSUPRI, and our product candidates may be materially diminished.
  • We may not be able to enforce our intellectual property rights throughout the world, which may harm our business.
  • The drug research and development industry has a history of intellectual property litigation, and we may become involved in costly intellectual property disputes, which may delay or impair our product development efforts or prevent us from, or increase the cost of, commercializing ARIKAYCE, BRINSUPRI, or any other product candidates, if approved.
  • If we fail to comply with obligations in our third-party agreements, our business may be adversely affected, including by the loss of license rights that are important to our business.
  • Risks Related to Government Regulation
  • Healthcare legislation or other government action may materially adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • 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 negative publicity, civil or criminal penalties, other remedial measures, and legal expenses, which may adversely affect our business, financial condition, results of operations and prospects and the value of our common stock.
  • Our research, development and manufacturing activities used in the production of ARIKAYCE, BRINSUPRI, and our product candidates involve the use of hazardous materials, which may expose us to damages, fines, penalties and sanctions and materially adversely affect our results of operations and financial condition.
  • Inadequate funding for the FDA and other government agencies and/or shifting perspectives and/or priorities under the Trump Administration could continue to hinder the FDA's and/or those other government agencies' ability to hire and retain key leadership and other personnel or otherwise continue to negatively impact staffing, 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 may negatively impact our business.
  • Risks Related to Our Financial Condition and Need for Additional Capital
  • We have a history of operating losses, expect to incur operating losses in the near term, and may never achieve or maintain profitability.
  • We may need to raise additional funds to continue our operations, and any failure to obtain capital when needed on acceptable terms, or at all, may force us to delay, reduce, or eliminate our development programs, commercialization efforts or other operations.
  • We have outstanding indebtedness in the form of a term loan and a royalty financing arrangement and may incur additional indebtedness in the future, which may adversely affect our financial position, prevent us from implementing our strategy, and, in certain cases, dilute the ownership interest of our existing shareholders.
  • We may be unable to use certain of our net operating losses and other tax assets.
  • Changes in our effective income tax rate and future changes to US and non-US tax laws may adversely affect our results of operations.
  • Goodwill impairment charges in the future may have a material adverse effect on our business, results of operations and financial condition.
  • Risks Related to Ownership of Our Common Stock
  • Our shareholders may experience dilution of their ownership interests because of the future issuance of additional shares of our common stock.
  • The market price of our stock has been and may continue to be highly volatile, which may lead to shareholder litigation against us.
  • Certain provisions of Virginia law, our articles of incorporation and amended and restated bylaws and arrangements between us and our employees may hamper a third party’s acquisition of us or discourage a third party from attempting to acquire control of us.

Legal proceedings

From time to time, we are a party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on our consolidated financial position, results of operations or cash flows.

The opening of Item 3, Legal Proceedings.5

Sources

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