XERS on Nasdaq

Xeris Biopharma Holdings, Inc.

Pharmaceutical preparations company based in Chicago, listed on Nasdaq (XERS)1

In its 2026 annual report the company says: “We are a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. We offer Recorlev for the treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome, Gvoke for the treatment of severe hypoglycemia, and Keveyis for the treatment of Primary Periodic Paralysis. We are advancing our Phase 3-ready pipeline product, XP-8121, once-weekly subcutaneous levothyroxine, which leverages our proprietary technology XeriSol.”4

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Last updated Oct 21, 2026.

Overview

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  • TickerXERS on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersChicago, Illinois1
  • Business address1375 West Fulton Street, Suite 1300, Chicago, Il 606072
  • Filer categoryLarge accelerated filer2

Xeris Biopharma Holdings, Inc. along with its subsidiaries, is referenced herein as the "Company", "Xeris", "Xeris Biopharma", "we" or "our". Throughout this document, unless otherwise noted, references to Gvoke include Gvoke PFS, Gvoke HypoPen, and Gvoke Kit.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

8.5%Operating margin5
0.2%Net margin5
43.7%Revenue growth, 20255
4.0%Return on equity5
16.10×Debt to equity5

What sells

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

Products and services

Recorlev brought in 48% of the revenue Xeris Biopharma Holdings, Inc. broke down this way in fiscal 2025.

  1. Recorlev$139.3M548%up 117% from 2024
  2. Gvoke$94.1M532%up 14% from 2024
  3. Keveyis$47.6M516%down 4% from 2024
  4. Royalty, Contract And Other Revenue$8.8M53%up 37% from 2024
  5. Product - Other$2.0M51%
Products and services by year
Products and services202320242025
Recorlev$29.5M$64.3M$139.3M
Gvoke$67.0M$82.8M$94.1M
Keveyis$56.8M$49.5M$47.6M
Royalty, Contract And Other Revenue$10.6M$6.4M$8.8M
Product - Other$0$0$2.0M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development11¢$31.2M
  • Selling, general and admin62¢$182.4M
  • Other costs27¢$77.8M
  • Profit0¢$554.0K

Out of $291.8M in revenue.5

Where each dollar of operating cash went, fiscal 2025

  • Kept or used elsewhere100¢$28.6M

Out of $28.6M of cash from operations.5

Financial statements

Revenue6785$291.8M in 2025+1348% since 2020
0$100.0M$200.0M$300.0M2020: $20.2M$20.2M20202021: $49.6M$49.6M2021+146%2022: $110.2M$110.2M2022+122%2023: $163.9M$163.9M2023+49%2024: $203.1M$203.1M2024+24%2025: $291.8M$291.8M2025+44%
Operating income6785$24.9M in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2020: -$83.5M-$83.5M20202021: -$115.2M-$115.2M2021+38%2022: -$81.9M-$81.9M2022−29%2023: -$44.0M-$44.0M2023−46%2024: -$33.6M-$33.6M2024−24%2025: $24.9M$24.9M2025
Net income6785$554.0K in 2025
-$150.0M-$100.0M-$50.0M0$50.0M2020: -$91.1M-$91.1M20202021: -$122.7M-$122.7M2021+35%2022: -$94.7M-$94.7M2022−23%2023: -$62.3M-$62.3M2023−34%2024: -$54.8M-$54.8M2024−12%2025: $554.0K$554.0K2025

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

Period ending2025-12-312024-12-312023-12-31
Product revenue, net$291.8M$203.1M$163.9M
Cost of goods sold$42.6M$36.8M$28.6M
Research and development$31.2M$25.6M$22.3M
Selling, general and administrative$182.4M$163.5M$146.1M
Amortization of intangible assets$10.8M$10.8M$10.8M
Total costs and expenses$266.9M$236.7M$207.9M
Income (loss) from operations$24.9M-$33.6M-$44.0M
Interest and other income$4.7M$5.3M$4.8M
Loss on debt extinguishment, net$0$0-$2.8M
Debt refinancing costs$0-$2.7M$0
Interest expense-$29.1M-$30.5M-$26.6M
Change in fair value of warrants$0$8.0K$1.0K
Change in fair value of contingent value rights$0$4.4M$5.2M
Total other expense-$24.3M-$23.5M-$19.5M
Net income (loss) before income taxes$554.0K-$57.1M-$63.5M
Income tax benefit$0$2.3M$1.2M
Net income (loss)$554.0K-$54.8M-$62.3M
Unrealized gains (losses) on investments$0$0-$2.0K
Comprehensive income (loss)$554.0K-$54.8M-$62.3M
Net loss per common share - basic (in dollars per share)$0.00-$0.37-$0.45
Net loss per common share - Diluted (in dollars per share)$0.00-$0.37-$0.45
Weighted average common shares outstanding - basic (in shares)160.4M shares146.8M shares137.7M shares
Weighted average common shares outstanding - Diluted (in shares)172.7M shares146.8M shares137.7M shares

Compare Xeris Biopharma Holdings, Inc. with another company

Corporate structure

Xeris Biopharma Holdings, Inc. sits at the top of its group. 6 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Xeris Biopharma Holdings, Inc.

  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Xeris Biopharma Holdings, Inc., latest Jul 31, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Xeris Biopharma Holdings, Inc., latest Mar 27, 2026 (3 filings since Feb 13, 2024)
  • Stonepine Capital Management, LLC Filed SC 13G/A on Xeris Biopharma Holdings, Inc., latest Feb 13, 2024 (3 filings since Jan 14, 2022)
  • BlackRock Filed SC 13G on Xeris Biopharma Holdings, Inc., latest Jan 26, 2024 (2 filings since Feb 10, 2023)
  • CAXTON CORP Filed SC 13G/A on Xeris Biopharma Holdings, Inc., latest Feb 14, 2023 (2 filings since Jan 5, 2022)
  • James E. Flynn Filed SC 13G/A on Xeris Biopharma Holdings, Inc., latest Feb 11, 2022
  • Xeris Biopharma Holdings, Inc. Chicago, Illinois
    • Cortendo AB Subsidiary · Sweden
    • Strongbridge Biopharma Limited Subsidiary · Ireland
    • Strongbridge Dublin Limited Subsidiary · Ireland
    • Xeris Pharmaceuticals Australia Pty Ltd Subsidiary · Australia
    • Xeris Pharmaceuticals, Inc. 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 Xeris Biopharma Holdings, 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$13.1M5 Dec 31, 2025$12.8M5 Dec 31, 2024+2.3%
Accumulated depreciation$8.2M5 Dec 31, 2025$7.3M5 Dec 31, 2024+12.6%
Property and equipment, net$4.9M5 Dec 31, 2025$5.6M5 Dec 31, 2024−11.1%
Operating-lease assets (leased space)$22.1M5 Dec 31, 2025$22.6M5 Dec 31, 2024−2.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$111.0M5 Dec 31, 2025$71.6M5 Dec 31, 2024+55.0%
Marketable securities, current$08 Dec 31, 2024$5.0M8 Dec 31, 2023−100.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$22.9M5 Dec 31, 2025$22.9M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$88.1M5 Dec 31, 2025$98.9M5 Dec 31, 2024−11.0%
Finite-lived intangibles, gross$132.0M5 Dec 31, 2025$132.0M5 Dec 31, 20240%
Accumulated amortization$43.9M5 Dec 31, 2025$33.1M5 Dec 31, 2024+32.8%
Finite-lived intangibles, net$88.1M5 Dec 31, 2025$98.9M5 Dec 31, 2024−11.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$68.7M5 Dec 31, 2025$48.2M5 Dec 31, 2024+42.5%
Raw materials$38.0M5 Dec 31, 2025$31.7M5 Dec 31, 2024+19.8%
Work in process$11.3M5 Dec 31, 2025$11.0M5 Dec 31, 2024+2.8%
Finished goods$19.4M5 Dec 31, 2025$5.5M5 Dec 31, 2024+255.2%

Properties, in its own words

Our principal office and development laboratory site are both located at 1375 West Fulton Street, Chicago, Illinois 60607 and occupy approximately 87,032 square feet of leased space. The lease term will expire on March 31, 2036. We believe that our offices are suitable and adequate to meet our needs.

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

Leadership

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

Chief financial officer

  1. Steven Pieper2021
2025
Board members and other officers (15)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Cortendo AB Sweden3
  • Strongbridge Biopharma Limited Ireland3
  • Strongbridge Dublin Limited Ireland3
  • Xeris Pharmaceuticals Australia Pty Ltd Australia3
  • Xeris Pharmaceuticals, Inc. Delaware3

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

Timeline

  1. Oct 14, 20268-K Other events27
  2. Sep 9, 20268-K Regulation FD disclosure28
  3. Aug 6, 20268-K Results of operations29
  4. Jul 17, 20268-K Unregistered sale of shares; Other events30
  5. Jun 30, 20268-K Executive or director change; Regulation FD disclosure31
  6. Jun 11, 20268-K Unregistered sale of shares; Other events32
  7. Jun 5, 20268-K Shareholder vote33
  8. May 7, 20268-K Results of operations34
  9. Apr 21, 20268-K Executive or director change35
  10. Mar 2, 20268-K Results of operations36
  11. Feb 27, 20268-K Regulation FD disclosure37
  12. Jan 8, 20268-K Results of operations38

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/202639

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results29
  2. May 7, 2026Reported quarterly or annual results34
  3. Mar 2, 2026Reported quarterly or annual results36
  4. Jan 8, 2026Reported quarterly or annual results38
  5. Nov 6, 2025Reported quarterly or annual results40
  6. Aug 7, 2025Reported quarterly or annual results41
  7. May 8, 2025Reported quarterly or annual results42
  8. Mar 6, 2025Reported quarterly or annual results43

Drug trials and FDA: recently

  1. Mar 14, 2025FDA approved a new use FDA approved an efficacy supplement for Gvoke Kit (glucagon), a new use or patient group (NDA 212097, supplement 12).44

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

326 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 172 insider forms, 12 large holders, 65 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 1, 2026144 EDGAR
  6. Sep 29, 20264 EDGAR
  7. Sep 28, 2026144 EDGAR
  8. Sep 9, 20268-K EDGAR
  9. Sep 1, 20264 EDGAR
  10. Sep 1, 20264 EDGAR
  11. Sep 1, 20264 EDGAR
  12. Aug 21, 20264 EDGAR
  13. Aug 21, 20264 EDGAR
  14. Aug 12, 2026144 EDGAR
  15. Aug 12, 20264 EDGAR
  16. Aug 6, 202610-Q EDGAR
  17. Aug 6, 20268-K EDGAR
  18. Aug 4, 20264 EDGAR
  19. Aug 4, 20264 EDGAR
  20. Jul 31, 2026SCHEDULE 13G EDGAR

The 326 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

54 open-market trades by officers, directors and large owners since October 2021: 19 buys and 35 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 28, 2026McCulloch KevinSee RemarksSale25,000$10.00$250.0KForm 4
Sep 1, 2026McCulloch KevinSee RemarksSale15,000$8.49$127.3KForm 4
Sep 1, 2026Pieper StevenSee RemarksSale5,000$8.50$42.5KForm 4
Sep 1, 2026Hecht BethSee RemarksSale16,666$8.49$141.5KForm 4
Aug 12, 2026Pieper StevenSee RemarksSale5,000$8.50$42.5KForm 4
Aug 3, 2026McCulloch KevinSee RemarksSale15,000$8.02$120.3KForm 4
Aug 3, 2026Hecht BethSee RemarksSale16,666$8.01$133.5KForm 4
Jul 7, 2026Pieper StevenSee RemarksSale27,600$8.52$235.2KForm 4
Jul 6, 2026Pieper StevenSee RemarksSale17,400$8.50$147.9KForm 4
Jul 1, 2026McCulloch KevinSee RemarksSale90,000$8.03$722.7KForm 4
Jul 1, 2026Hecht BethSee RemarksSale16,666$8.03$133.8KForm 4
Jun 4, 2026HALKUFF DAWNDirectorSale20,000$6.09$121.8KForm 4
Jun 4, 2026BORMANN-KENNEDY BARBARA-JEAN ANNEDirectorSale16,000$6.09$97.4KForm 4
Jun 4, 2026JOHNSON JOHNDirectorSale15,000$6.09$91.3KForm 4
Jun 3, 2026PERSKY MARLADirectorSale15,500$5.90$91.5KForm 4
Jun 1, 2026Hecht BethSee RemarksSale16,667$6.06$101.0KForm 4
May 1, 2026Hecht BethSee RemarksSale16,667$6.23$103.8KForm 4
Apr 1, 2026Hecht BethSee RemarksSale16,667$5.99$99.8KForm 4
Mar 30, 2026Brady James AloysiusDirectorSale10,834$5.54$60.0KForm 4
Mar 2, 2026Hecht BethSee RemarksSale16,667$6.24$104.1KForm 4

All 54 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
2025John Shannon64$742.3K$5.0M51
2025Kevin McCulloch63$543.8K$2.3M51
2025Anh Nguyen51$409.2K$2.0M51
2025Beth P. Hecht62$517.1K$1.9M51
2025Steven M. Pieper49$505.4K$1.9M51
2024Chief Executive Officer$629.2K$3.8M51
2024Chief Legal Officer and Corporate Secretary$491.7K$2.6M51
2024President and Chief Operating Officer$490.3K$2.6M51
2024Chief Financial Officer$479.6K$1.9M51
2023Chief Executive Officer$571.4K$1.8M51
2023Chief Financial Officer$436.0K$1.6M51
2023Chief Legal Officer and Corporate Secretary$460.6K$1.1M51

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.14,525,539$115.0M0.0%+1,579,754
D. E. Shaw & Co., Inc.7,804,758$61.8M0.0%+15,947
Vanguard Capital Management LLC7,340,229$58.1M0.0%+359,347
State Street Corp4,821,566$38.2M0.0%+163,392
Geode Capital Management, LLC4,718,183$37.4M0.0%+427,554
Nuveen, LLC4,385,141$34.7M0.0%+1,468,543
Rosalind Advisors, Inc.2,908,981$23.0M8.7%−322,719
Qube Research & Technologies Ltd2,893,749$22.9M0.0%−1,220,676
Vanguard Portfolio Management LLC2,626,208$20.8M0.0%−39,400
Wellington Management Group Llp2,365,103$18.7M0.0%+193,749
Morgan Stanley2,337,096$18.5M0.0%−235,558
Legal & General Group Plc2,012,792$15.9M0.0%+104,503
Armistice Capital, LLC1,958,702$15.5M0.4%+48,864
Two Sigma Investments, LP1,885,503$14.9M0.0%−38,699
Parkman Healthcare Partners LLC1,807,621$14.3M1.5%+86,357
Algert Global LLC1,742,942$13.8M0.2%+585,984
Northern Trust Corp1,597,749$12.7M0.0%+153,132
Goldman Sachs Group Inc1,594,072$12.6M0.0%−19,578
Aqr Capital Management LLC1,540,985$12.2M0.0%+146,609
Charles Schwab Investment Management Inc1,492,367$11.8M0.0%+132,710
Federated Hermes, Inc.1,434,433$11.4M0.0%+577,620
Bank Of America Corp /de/1,397,050$11.1M0.0%+522,653
UBS Group AG1,300,913$10.3M0.0%−345,465
Ishara Investments LP1,230,000$9.7M7.2%+205,000
Vanguard Fiduciary Trust Co1,224,398$9.7M0.0%+90,496

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

SEC filer profile

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

  • Name on EDGARXeris Biopharma Holdings, Inc.1
  • CIK0001867096
  • Employer ID (EIN)87-10820974
  • Filer statusLarge accelerated 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 address1375 West Fulton Street, Suite 1300, Chicago, IL 606071
  • Phone844-445-57041
  • Shares outstanding182,320,306 as of Jul 31, 202610
  • Public float$731.1M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Grand Rapids, Michigan PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJul 2, 20211
  • Filings334 in all: 4 (152), 8-K (56), 144 (24), 3 (18), 10-Q (15), S-8 (7), UPLOAD (7), CORRESP (6)1
    All 25 form types

    DEFA14A (6), 10-K (5), DEF 14A (5), SC 13G (5), ARS (4), EFFECT (4), SC 13G/A (4), S-3 (3), 4/A (2), 424B3 (2), 425 (2), SCHEDULE 13G/A (2), 424B5 (1), 8-K12B (1), S-4 (1), S-4/A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 2, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareXERSThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Xeris Biopharma Holdings, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 65 risks under these headings, as written.4

  • Risks Related to our Financial Position and Need for Financing
  • We have a limited operating history and limited experience commercializing pharmaceutical products and have incurred significant losses since inception.
  • We have a history of operating losses and may not be able to achieve or sustain profitability in the future, and we may not be able to continue operations without additional fundings.
  • We may require additional capital to sustain our business, and this capital may cause dilution to our stockholders and might not be available on terms favorable to us, or at all, which could force us to delay, reduce or eliminate our product development programs or commercialization efforts.
  • We may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due, or to repurchase our Convertible Notes for cash following a fundamental change, if required, and our existing and future indebtedness may limit our ability to repurchase the Convertible Notes.
  • Our PPP Loan, which we repaid in full in June 2020, was subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act, and we may be subject to an audit or enforcement action related to the PPP Loan.
  • Greater than expected product returns may exceed our reserve for returns.
  • Risks Related to the Commercialization and Marketing of our Products and Product Candidates
  • Our business depends entirely on the commercial success of our products and product candidates. Even if approved, our product candidates may not be accepted in the marketplace and our business may be materially harmed.
  • We operate in a competitive business environment, which may have an adverse impact on our revenue. If we are unable to compete successfully against our existing or future competitors, our sales and operating results may be negatively affected and we may not successfully commercialize our products or product candidates, even if approved.
  • If we are unable to establish or do not maintain sufficient marketing, sales and distribution capabilities or enter into agreements with third parties to market, sell and distribute our products on terms acceptable to us, we may not be able to generate product revenue and our business, results of operations, and financial condition will be materially adversely affected.
  • Our reliance on third-party suppliers, including single-source suppliers, together with a limited number of possible suppliers and long development lead times to establish alternative sources for our products, product candidates, components and other key materials has in the past and may in the future impact our ability to develop our product candidates or to continue to commercialize Recorlev, Gvoke, Keveyis, or any product candidates that are approved.
The other 54 risks
  • We are party to a number of material agreements which contain complex commercial terms that could result in litigation or liability that could adversely affect our business, results of operations and financial condition.
  • Reimbursement decisions by third-party payors and consolidation within the healthcare industry and among competitors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that they will be widely used and pricing pressure may impact our ability to sell our products at prices necessary to support our current business strategies.
  • Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business.
  • The success of Recorlev, Gvoke, Keveyis and our product candidates will be dependent on their proper use by patients, healthcare practitioners and caregivers. Additionally, individual devices may fail.
  • A small number of major customers account for a high percentage of our revenue, thus, the loss of any of these customers and our inability to enter into new customer relationships could negatively impact our business.
  • Risk Related to our Dependence on Third Parties for Clinical Trials
  • We depend on third parties to conduct the clinical trials for our product candidates, and any failure of those parties to fulfill their obligations could harm our development and commercialization plans.
  • Risks Related to the Product Development and Regulatory Approval of Our Product Candidates
  • We cannot be certain that our product candidates will receive marketing approval. Without marketing approval, we will not be able to commercialize our product candidates.
  • Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed indications for our product candidates. If our clinical trials fail to demonstrate efficacy and safety to the satisfaction of the FDA or other regulatory authorities, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidates.
  • We intend to utilize the 505(b)(2) pathway for the regulatory approval of certain of our product candidates. If the FDA does not conclude that such product candidates meet the requirements of Section 505(b)(2), final marketing approval of our product candidates by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.
  • Additional time may be required to obtain regulatory approval for certain of our product candidates because they are combination products.
  • Recorlev, Gvoke, Keveyis and our product candidates may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to include safety warnings, require them to be taken off the market or otherwise limit their sales.
  • We have received orphan drug designation for Recorlev, Keveyis, and certain of our product candidates with respect to certain indications and may pursue such designation for others, but we may be unable to obtain such designation or to maintain the benefits associated with orphan drug status, including market exclusivity, even if that designation is granted.
  • Even with the FDA approval of Recorlev, Gvoke and Keveyis in the United States, and the EMA and MHRA approval of Ogluo in the EU and the United Kingdom ("UK"), we may not be able to obtain or maintain foreign regulatory approvals to market our products in other countries.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and product candidates and affect the prices we may obtain.
  • Risks Related to our Industry and Ongoing Legal and Regulatory Requirements
  • Even after approval of our products and product candidates, we may still face future development and regulatory difficulties. If we fail to comply with continuing United States and non-United States regulations or new adverse safety data arise, we could lose our marketing approvals and our business would be seriously harmed.
  • Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency, privacy, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside the United States and require us to develop and implement costly compliance programs.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sales of our products and product candidates, if approved, could be adversely affected.
  • Our failure to successfully identify, develop and market additional product candidates, or acquire additional product candidates or enter into collaborations or other commercial agreements could impair our ability to grow.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect our intellectual property and proprietary formulation science, as well as the ability of our collaborators to protect their intellectual property and proprietary formulation science.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • Our unpatented trade secrets, know-how, confidential and proprietary information, and technology may be inadequately protected.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • The pharmaceutical industry is characterized by frequent patent litigation, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages or prevent us from marketing our existing or future products.
  • Others may challenge inventorship or claim an ownership interest in our intellectual property, which could expose it to litigation and have a significant adverse effect on its prospects.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our product candidates.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • Risk Related to Intellectual Property Laws
  • Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products.
  • Risks Related to Employee Matters, Managing Growth and Ongoing Operations
  • Disruptions at the FDA, the SEC and other U.S. government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our business could suffer if we lose the services of key members of our senior management or if we are not able to attract and retain other key employees and consultants.
  • Risks Related to Our Common Stock
  • Our stock price has been and will likely continue to be volatile, and you may lose part or all of your investment.
  • The conversion of the 2028 Convertible Notes or other convertible securities into shares of common stock could have a material dilutive effect that could cause our share price to decline.
  • We do not anticipate paying any cash dividends in the foreseeable future, and accordingly, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
  • Changes in tax law may adversely affect us or our investors.
  • Provisions in the Indenture for our 2028 Convertible Notes and corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us.
  • Our bylaws designate certain courts as the sole and exclusive forums for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees and may discourage such lawsuits with respect to such claims.
  • If we experience significant disruptions in our information technology systems, our business may be adversely affected.
  • If products liability lawsuits are brought against us, our business may be harmed, and we may be required to pay damages that exceed our insurance coverage.
  • 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, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • As a result of being a public company, we have incurred and will continue to incur significant additional costs which may adversely affect our operating results and financial condition.
  • Securities analysts may publish inaccurate or unfavorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline.
  • Our data collection and processing activities are governed by restrictive regulations governing the use, processing and, in certain jurisdictions, cross-border transfer of personal information.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • The increasing use of social media platforms presents risks and challenges.
  • Our employees, independent contractors, consultants, collaborators, CMOs, and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm to our reputation.
  • Global economic uncertainty and weakening product demand caused by political instability, changes in trade agreements and conflicts, such as the conflicts between Russia and Ukraine and Israel and Hamas, or other events could adversely affect our business and financial performance.
  • Our operations are subject to the effects of fluctuating inflation.
  • We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations, ability to pay operational expenses or make other payments, and its financial condition and results of operations.
  • Our business could be negatively impacted by environmental, social and corporate governance matters or our reporting of such matters.

Legal proceedings

We received Paragraph IV certification notice letters (each, a “Notice Letter”) from three pharmaceutical companies (each, an “ANDA Filer”), providing notification to us that each ANDA Filer had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of RECORLEV®. The ANDAs each contained Paragraph IV certifications alleging that four of our Orange Book listed patents covering RECORLEV® that are scheduled to expire in March 2040 (U.S. Patent Numbers 11,020,393, 11,278,547, 11,903,940, and 12,377,096) are invalid, unenforceable and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the generic product described in its respective ANDA submission.

On February 26, 2026, our wholly-owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court for the District of New Jersey against Torrent Pharmaceuticals Limited (along with its affiliate, "Torrent") and Somerset Therapeutics, LLC (along with its affiliates, "Somerset"). Our complaint alleges that, by filing the ANDAs, each of Torrent and Somerset has infringed RECORLEV®’s Orange Book patents included in its respective Paragraph IV certification, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent Torrent and Somerset from commercializing a generic version of RECORLEV®, until the expiration of the asserted patents, including any applicable extensions and additional periods of exclusivity. No trial date has been set. The filing of the lawsuit within 45 days of receipt of each of the respective Notice Letters triggered an automatic stay of the FDA’s approval of each of the respective ANDAs for up to 30 months in accordance with the Hatch-Waxman Act.

The opening of Item 3, Legal Proceedings.4

Sources

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