XNCR on Nasdaq

Xencor Inc

Xencor Inc is an American pharmaceutical preparations company based in Monrovia.2 Its shares trade on Nasdaq under the symbol XNCR.2

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Last updated Oct 21, 2026.

Overview

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  • TickerXNCR on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersMonrovia, United States2
  • Incorporated inDE3
  • Business address465 N. Halstead St., Suite 200, Pasadena, Ca 911073
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI549300V5IF65437JKG302
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2

Xencor, XmAb and Proteins by Design are registered trademarks of Xencor, Inc. All other product and company names are trademarks of their respective companies. References in this Annual Report on Form 10-K to “we”, “our”, “us”, “Xencor” or “the Company” refer to Xencor, Inc.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

-141.4%Operating margin5
-73.2%Net margin5
13.7%Revenue growth, 20255
-14.5%Return on equity5
0.12×Debt to equity5
-$138.3MFree cash flow5

What sells

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

Products and services

Royalty brought in 64% of the revenue Xencor Inc broke down this way in fiscal 2025.

  1. Royalty$80.3M564%up 19% from 2024
  2. Milestone$45.3M536%up 31% from 2024
Products and services by year
Products and services202320242025
Royalty$55.8M$67.5M$80.3M
Milestone$88.5M$34.5M$45.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development99¢$239.4M
  • Income tax1¢$2.5M

Out of $125.6M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$125.6M in 2025−20% since 2019
0$100.0M$200.0M$300.0M2019: $156.7M$156.7M20192020: $122.7M$122.7M2020−22%2021: $275.1M$275.1M2021+124%2022: $164.6M$164.6M2022−40%2023: $174.6M$174.6M2023+6%2024: $110.5M$110.5M2024−37%2025: $125.6M$125.6M2025+14%
Operating income67895-$177.5M in 2025
-$200.0M-$100.0M0$100.0M2019: $13.8M$13.8M20192020: -$76.8M-$76.8M20202021: $43.8M$43.8M20212022: -$82.5M-$82.5M20222023: -$132.4M-$132.4M2023+60%2024: -$178.4M-$178.4M2024+35%2025: -$177.5M-$177.5M2025−1%
Net income67895-$91.9M in 2025
-$300.0M-$200.0M-$100.0M0$100.0M2019: $26.9M$26.9M20192020: -$69.3M-$69.3M20202021: $82.6M$82.6M20212022: -$55.2M-$55.2M20222023: -$133.1M-$133.1M2023+141%2024: -$232.6M-$232.6M2024+75%2025: -$91.9M-$91.9M2025−60%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Collaborations, milestones, and royalties$125.6M$110.5M$174.6M
Research and development$239.4M$227.7M$253.6M
General and administrative$63.6M$61.2M$53.4M
Total operating expenses$303.1M$288.9M$307.0M
Operating loss-$177.5M-$178.4M-$132.4M
Interest income$27.5M$31.9M$19.3M
Interest expense-$31.9M-$36.6M-$6.2M
Gain (loss) on marketable equity securities, net$101.5M-$31.4M-$395.0K
Asset impairment charges-$9.2M-$20.4M$0
Other, net-$73.0K$50.0K-$31.0K
Total other income (expense)$87.9M-$56.5M$12.7M
Loss before income tax expense and noncontrolling interest-$89.6M-$234.9M-$119.6M
Income tax expense$2.5M$1.6M$13.7M
Net loss including noncontrolling interest-$92.1M-$236.5M-$133.3M
Net loss attributable to noncontrolling interest-$214.0K-$3.9M-$163.0K
Net loss attributable to Xencor, Inc.-$91.9M-$232.6M-$133.1M
Net loss per share attributable to Xencor, Inc. - basic (in dollars per share)-$1.24-$3.58-$2.20
Net loss per share attributable to Xencor, Inc. - diluted (in dollars per share)-$1.24-$3.58-$2.20
Weighted-average shares used in calculating net loss per share - basic (in shares)74.2M shares65.0M shares60.5M shares
Weighted-average shares used in calculating net loss per share - diluted (in shares)74.2M shares65.0M shares60.5M shares
Net unrealized gain (loss) on marketable debt securities$2.2M-$2.0M$8.2M
Comprehensive loss-$89.9M-$238.5M-$125.1M
Less: comprehensive loss attributable to the noncontrolling interest-$214.0K-$3.9M-$163.0K
Comprehensive loss attributable to Xencor, Inc.-$89.7M-$234.6M-$124.9M

Compare Xencor Inc with another company

Corporate structure

Xencor Inc sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Xencor Inc

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (2 companies). Each entity in the chart links to its source.

What it owns

What Xencor 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$104.8M5 Dec 31, 2025$102.0M5 Dec 31, 2024+2.7%
Accumulated depreciation$51.5M5 Dec 31, 2025$42.2M5 Dec 31, 2024+22.0%
Property and equipment, net$53.3M5 Dec 31, 2025$59.8M5 Dec 31, 2024−10.9%
Operating-lease assets (leased space)$37.6M5 Dec 31, 2025$38.3M5 Dec 31, 2024−2.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$54.1M5 Dec 31, 2025$40.9M5 Dec 31, 2024+32.3%
Debt securities available for sale$556.8M5 Dec 31, 2025$665.8M9 Dec 31, 2024−16.4%
Equity securities at fair value$112.5M5 Dec 31, 2025$47.9M5 Dec 31, 2024+134.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$8.4M5 Dec 31, 2025$18.5M5 Dec 31, 2024−54.6%
Indefinite-lived intangibles (excluding goodwill)$4.1M5 Dec 31, 2025$10.8M5 Dec 31, 2024−61.6%
Finite-lived intangibles, gross$11.8M5 Dec 31, 2025$19.3M5 Dec 31, 2024−39.0%
Accumulated amortization$7.5M5 Dec 31, 2025$11.6M5 Dec 31, 2024−35.2%
Finite-lived intangibles, net$4.2M5 Dec 31, 2025$7.7M9 Dec 31, 2024−44.9%

Properties, in its own words

The following table summarizes the Company’s leased facilities as of February 25, 2026.

Primary Use · Approximate Square Footage · Lease Expiration · Remaining Lease Term (years)

The rest of Item 2

Monrovia, California · Research and Office Facility · 24,573 · December 2026 · 0.8

Pasadena, California · Corporate Headquarters and Lab Facility · 129,543 · July 2035 · 9.4

San Diego, California · Research Facility · 9,044 · December 2027 · 1.8

On December 18, 2025, the Company entered into a sublease agreement to sublease a portion of its Pasadena space to a third party. The sublease term commenced on February 1, 2026 and expires on January 31, 2031.

Item 2 of the 10-K filed Feb 25, 2026.4

Leadership

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

Board members and other officers (24)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorA. Bruce Montgomery named Nov 19, 202139

Timeline

  1. Aug 5, 20268-K Results of operations40
  2. Jul 29, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure41
  3. Jun 18, 20268-K Shareholder vote42
  4. May 6, 20268-K Results of operations43
  5. May 5, 20268-K Regulation FD disclosure44
  6. Apr 27, 20268-K Executive or director change45
  7. Mar 9, 20268-K Ended a material agreement46
  8. Mar 4, 20268-K Regulation FD disclosure47
  9. Feb 25, 20268-K Results of operations48
  10. Jan 8, 20268-K Results of operations49
  11. Nov 5, 20258-K Results of operations50
  12. Oct 24, 20258-K Regulation FD disclosure51
  13. Dec 2, 2013New chief executive Bassil I. Dahiyat becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.08) a share, on Nov 5, 2025.52

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results40
  2. Jul 29, 2026Reported quarterly or annual results41
  3. May 6, 2026Reported quarterly or annual results43
  4. Feb 25, 2026Reported quarterly or annual results48
  5. Jan 8, 2026Reported quarterly or annual results49
  6. Nov 5, 2025Reported quarterly or annual results50
  7. Aug 6, 2025Reported quarterly or annual results53
  8. May 7, 2025Reported quarterly or annual results54

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

Filings

344 filings to the SEC since October 2021: 6 annual reports, 18 quarterly reports, 56 major events, 132 insider forms, 48 large holders, 1 private raises, 83 other. The latest 20:

  1. Aug 5, 202610-Q EDGAR
  2. Aug 5, 20268-K EDGAR
  3. Jul 31, 2026SCHEDULE 13G EDGAR
  4. Jul 29, 20268-K EDGAR
  5. Jul 8, 20264 EDGAR
  6. Jul 8, 20264 EDGAR
  7. Jul 8, 20264 EDGAR
  8. Jul 8, 20264 EDGAR
  9. Jul 8, 20264 EDGAR
  10. Jul 8, 20264 EDGAR
  11. Jul 8, 20264 EDGAR
  12. Jul 8, 20264 EDGAR
  13. Jun 22, 20264 EDGAR
  14. Jun 18, 2026144 EDGAR
  15. Jun 18, 20268-K EDGAR
  16. Jun 17, 20264 EDGAR
  17. Jun 17, 20264 EDGAR
  18. Jun 17, 20264 EDGAR
  19. Jun 17, 20264 EDGAR
  20. Jun 15, 2026144 EDGAR

The 344 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

80 open-market trades by officers, directors and large owners since October 2021: 1 buys and 79 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 18, 2026Feigal EllenDirectorSale6,843$13.06$89.4KForm 4
Jun 15, 2026GUSTAFSON KURT ADirectorSale5,474$12.31$67.4KForm 4
Jun 15, 2026Montgomery Alan BruceDirectorSale5,064$12.31$62.3KForm 4
Jun 15, 2026RANIERI RICHARD JDirectorSale5,474$12.31$67.4KForm 4
Jun 15, 2026GORMAN KEVIN CHARLESDirectorSale7,527$12.31$92.7KForm 4
Apr 10, 2026Cornelissen Bart JanSR. VICE PRESIDENT & CFOSale3,499$12.29$43.0KForm 4
Mar 6, 2026Eckert CeliaSVP, GENERAL COUNSELSale1,767$11.02$19.5KForm 4
Mar 6, 2026Desjarlais John RSR. VICE PRESIDENT & CSOSale2,502$11.02$27.6KForm 4
Mar 6, 2026Dahiyat Bassil IPRESIDENT & CEOSale6,606$11.02$72.8KForm 4
Mar 5, 2026Cornelissen Bart JanSR. VICE PRESIDENT & CFOSale2,517$11.25$28.3KForm 4
Mar 5, 2026Eckert CeliaSVP, GENERAL COUNSELSale3,244$11.25$36.5KForm 4
Mar 5, 2026Desjarlais John RSR. VICE PRESIDENT & CSOSale4,118$11.25$46.3KForm 4
Mar 5, 2026Dahiyat Bassil IPRESIDENT & CEOSale14,870$11.25$167.3KForm 4
Mar 3, 2026Eckert CeliaSVP, GENERAL COUNSELSale1,492$11.90$17.8KForm 4
Mar 3, 2026Desjarlais John RSR. VICE PRESIDENT & CSOSale2,663$11.90$31.7KForm 4
Mar 3, 2026Dahiyat Bassil IPRESIDENT & CEOSale6,758$11.90$80.4KForm 4
Dec 19, 2025Desjarlais John RSR. VICE PRESIDENT & CSOSale73,367$15.72$1.2MForm 4
Dec 19, 2025Dahiyat Bassil IPRESIDENT & CEOSale114,377$15.71$1.8MForm 4
Jun 16, 2025Montgomery Alan BruceDirectorSale2,215$9.22$20.4KForm 4
Jun 16, 2025GUSTAFSON KURT ADirectorSale2,993$9.22$27.6KForm 4

All 80 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Stakes it holds

Xencor Inc has told the SEC it owns more than 5% of 2 companies, latest first (Schedules 13D and 13G).

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Bassil I. DahiyatPh.D.55$742.8K$5.5M69
2025John R. DesjarlaisPh.D.$547.9K$2.0M69
2025Bart Jan Cornelissen48$491.6K$1.6M69
2025Celia E. Eckert54$491.6K$1.6M69
2025Nancy K. ValenteM.D.$249.4K$430.8K69
2024PresidentChief Executive$721.2K$6.8M69
2024Chief Financial Officer$338.2K$3.7M69
2024Former Chief Development Officer$556.2K$2.9M69
2024Chief Scientific Officer$534.5K$2.8M69
2024General Counsel$475.0K$2.0M69
2023Officer and Director$700.2K$8.0M69
2023Chief Scientific Officer$518.9K$3.2M69
2023General Counsel$457.6K$2.0M69

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Nov 12, 2021Raised $25 million in a private offering of equity Form D: 1 investor so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.13,651,261$219.8M0.0%+615,343
Primecap Management Co/ca/10,181,322$163.9M0.1%−156,700
Bvf Inc/il7,133,720$114.9M2.9%No change
Rtw Investments, LP6,777,461$109.1M0.9%No change
Ra Capital Management, L.P.5,274,274$84.9M0.7%+377,037
State Street Corp4,954,016$79.8M0.0%+601,980
Vanguard Capital Management LLC3,278,802$52.8M0.0%+177,155
TCG Crossover Management, LLC2,452,138$39.5M0.9%No change
Vanguard Portfolio Management LLC2,215,690$35.7M0.0%−1,284,652
Geode Capital Management, LLC1,920,859$30.9M0.0%+105,282
Morgan Stanley1,752,556$28.2M0.0%+194,266
UBS Group AG1,306,174$21.0M0.0%+223,755
Baker Bros. Advisors LP1,102,106$17.7M0.1%No change
Legal & General Group Plc1,091,177$17.6M0.0%+24,397
Dimensional Fund Advisors LP1,011,119$16.3M0.0%−283,768
Goldman Sachs Group Inc968,778$15.6M0.0%+204,985
Millennium Management LLC853,677$13.7M0.0%+243,889
Two Sigma Investments, LP819,515$13.2M0.0%+14,094
Northern Trust Corp794,279$12.8M0.0%+49,760
Johnson & Johnson748,062$12.0M1.5%No change
Jefferies Financial Group Inc.720,440$11.6M0.1%No change
Charles Schwab Investment Management Inc707,242$11.4M0.0%+10,388
Panagora Asset Management Inc680,182$11.0M0.0%+59,426
Deep Track Capital, LP593,551$9.6M0.1%New
Toronto Dominion Bank491,000$7.9M0.0%No change

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

SEC filer profile

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

  • Name on EDGARXencor Inc1
  • CIK0001326732
  • Employer ID (EIN)20-16225024
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address465 N. Halstead St., Suite 200, Pasadena, CA 911071
  • Phone626-305-59001
  • Shares outstanding74,353,397 as of Jul 31, 202611
  • Public float$555.9M as of Jun 30, 20254
  • AuditorKPMG LLP, San Diego, California PCAOB ID 185; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceMay 6, 20051
  • Filings890 in all: 4 (359), 8-K (134), SC 13G/A (72), 144 (57), 10-Q (38), 3 (29), SC 13G (22), 4/A (15)1
    All 42 form types

    10-K (13), DEF 14A (13), DEFA14A (12), CORRESP (11), SC 13D/A (11), SCHEDULE 13G/A (11), CT ORDER (10), 424B5 (9), 3/A (8), UPLOAD (7), ARS (6), S-8 (6), SCHEDULE 13G (6), D (4), S-1/A (4), S-8 POS (4), 10-Q/A (3), EFFECT (3), S-3ASR (3), 10-K/A (2), 5 (2), REGDEX (2), S-3 (2), SEC STAFF LETTER (2), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERTNAS (1), DEFR14A (1), DRS (1), DRSLTR (1), S-1 (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareXNCRThe Nasdaq Global Market

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Xencor Inc names in Item 1A of its 10-K filed Feb 25, 2026: 58 risks under these headings, as written.4

  • Risks Related to Our Unique and Specific Business Operations as a Small Biotechnology Company
  • Our success depends on our ability to use and expand our XmAb technology platform to build a pipeline of product candidates and develop marketable products. We cannot be certain our candidates will receive regulatory approval or be successfully commercialized.
  • The clinical development stage of our operations may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Preliminary, interim, and topline data from our clinical trials that we announce or publish may change as more patient data become available that could result in material changes in the final data.
  • Our business and results of operations could be adversely impacted by inflation.
  • Our operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by a wildfire and earthquake or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Our Financial Position, Capital Requirements and Ownership of Our Common Stock
  • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
  • Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We may never be profitable.
  • We will require additional financing and may be unable to raise sufficient capital, which could lead us to delay, reduce or abandon research and development programs or commercialization.
  • The market price of our common stock is likely to be highly volatile, and you could lose all or part of your investment.
  • Our principal stockholders, directors and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
The other 46 risks
  • Raising additional funds through debt or equity financing may be dilutive and raising funds through licensing may require us to relinquish rights to our technology or product candidates.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • New federal and state income tax legislation may affect our current and future income tax liabilities.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Provisions in our amended and restated certificate of incorporation and second amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
  • Our ability to effectively monitor and respond to the rapid and evolving developments and expectations relating to sustainability, including environmental, social and governance matters, may impose unexpected costs or result in reputational or other harm that could have a material adverse effect on our business.
  • If we identify material weaknesses in our internal control over financial reporting in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, investors may lose confidence in the accuracy and completeness of our financial reports and the trading price of our common stock may decline.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain and enforce intellectual property protection covering our products and any future products we may develop, others may be able to make, use or sell products substantially the same as ours, which could adversely affect our ability to compete in the market.
  • We have in-licensed, and may in the future in-license, a portion of our intellectual property, and, if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property.
  • We may be required to reduce the scope of our intellectual property due to third-party intellectual property claims.
  • Others may allege that our products infringe their patents and other property rights, which may result in costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products, which could have a material adverse effect on our business.
  • Our intellectual property may be infringed upon by a third party.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
  • If we do not obtain patent term extension and data exclusivity for any therapeutic candidates we develop, our business may be materially harmed.
  • Risks Related to Our Dependence on Third Parties
  • Our patent protection and prosecution for some of our product candidates is dependent on third parties.
  • We rely on third-party manufacturers to manufacture our product candidates and provide supplies for our studies. If any of our third-party manufacturers encounter problems or loss of drug material during production or otherwise fail to comply with their contractual obligations, the development of our product candidates could be delayed or stopped.
  • Our existing partnerships are important to our business, and future partnerships may also be important to us. If we are unable to maintain any of these partnerships, or if these partnerships are not successful, our business could be adversely affected.
  • We rely upon third-party contractors, and service providers for the execution of most aspects of our development programs. Failure of these collaborators to provide services of a suitable quality and within acceptable timeframes may cause the delay or failure of our development programs.
  • We rely on third parties to manufacture supplies of our preclinical and clinical product candidates. The development of such candidates could be stopped or delayed if any such third party fails to provide us with sufficient quantities of product or fails to do so at acceptable quality levels or prices or fails to maintain or achieve satisfactory regulatory compliance.
  • Risks Related to Our Industry
  • Clinical trials are expensive and take years to conduct, the outcome of such clinical trials is uncertain and results of earlier studies and trials may not be predictive of future trial results. Clinical trials may fail to prove our product candidates are safe and effective.
  • Adverse side effects or other safety risks associated with our product candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials and abandon product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • We have conducted, are currently conducting, and may in the future conduct clinical trials for our product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Delays in the commencement or completion of clinical trials could result in increased costs to us and delay our ability to establish strategic collaborations.
  • Our industry is subject to competition for skilled personnel and the challenges we face to identify and retain key personnel could impair our ability to effectively conduct and grow our operations.
  • The development and commercialization of biologic products is subject to extensive regulation, and we may not obtain regulatory approvals for any of our product candidates.
  • We may seek Fast Track or other accelerated review designations for some or all of our product candidates. We may not receive such designation, and even for those product candidates for which we do, it may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that product candidates will receive marketing approval.
  • A variety of risks associated with conducting research and clinical trials abroad and marketing our product candidates internationally could materially adversely affect our business.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
  • Our current and future relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to penalties.
  • Present and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
  • Even if we are able to commercialize any product candidates, our product candidates may be subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives.
  • Our business involves the controlled use of hazardous materials and as such we are subject to environmental and occupational safety laws. Continued compliance with these laws may incur substantial costs and failure to maintain compliance could result in liability for damages that may exceed our resources.
  • We may become subject to the risk of product liability claims.
  • General Risk Factors
  • Disruptions at the FDA, SEC and other government agencies caused by changing priorities or funding shortages could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our employees’ former employers.
  • Our business could be negatively impacted by cybersecurity threats and other disruptions, including the theft of our intellectual property, and could compromise our information and expose us to liability, which would cause our business and reputation to suffer.
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • The increasing use of social media platforms presents new risks and challenges.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could have a material adverse effect on our business, financial condition or results of operations.
  • We may be vulnerable to disruption, damage and financial obligation as a result of system failures.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.

Legal proceedings

Legal Proceedings are set forth in the Company’s financial statement schedules in Part II, Item 8 of this Annual Report on Form 10-K and are incorporated herein by reference. See Note 7 - Commitments and Contingencies of Notes to Consolidated Financial Statements of Part II, “Item 8. Financial Statements and Schedules.”

The opening of Item 3, Legal Proceedings.4

Sources

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