Xeris Biopharma Holdings, Inc. Files 2023 Annual Report on Form 10-K
Ticker: XERS · Form: 10-K · Filed: Mar 6, 2024 · CIK: 1867096
| Field | Detail |
|---|---|
| Company | Xeris Biopharma Holdings, Inc. (XERS) |
| Form Type | 10-K |
| Filed Date | Mar 6, 2024 |
| Risk Level | medium |
| Pages | 15 |
| Reading Time | 17 min |
| Key Dollar Amounts | $0.0001, $5.0 billion, $3.0 billion, $0.5 billion |
| Sentiment | neutral |
Sentiment: neutral
Topics: 10-K, Xeris Biopharma, Annual Report, Pharmaceuticals, Financials
TL;DR
<b>Xeris Biopharma Holdings, Inc. has submitted its 2023 annual report (10-K), detailing financial performance and business operations for the fiscal year ending December 31, 2023.</b>
AI Summary
Xeris Biopharma Holdings, Inc. (XERS) filed a Annual Report (10-K) with the SEC on March 6, 2024. Xeris Biopharma Holdings, Inc. filed its 2023 Form 10-K on March 6, 2024. The filing covers the fiscal year ending December 31, 2023. The company is classified under SIC code 2834 (Pharmaceutical Preparations). Key financial data for 2023, 2022, and 2021 is included. The report details revenue from product sales and royalty contracts.
Why It Matters
For investors and stakeholders tracking Xeris Biopharma Holdings, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Xeris Biopharma's financial health, operational strategies, and risk factors for investors and stakeholders. The detailed financial statements and disclosures will allow for a thorough assessment of the company's performance and future prospects in the pharmaceutical sector.
Risk Assessment
Risk Level: medium — Xeris Biopharma Holdings, Inc. shows moderate risk based on this filing. The company faces customer concentration risk, with revenue from four customers representing a significant portion of product sales, indicating potential vulnerability if these relationships change.
Analyst Insight
Investors should analyze Xeris Biopharma's revenue streams, particularly the reliance on key customers, and evaluate the company's strategies for diversification and growth.
Revenue Breakdown
| Segment | Revenue | Growth |
|---|---|---|
| Product | ||
| Royalty Contract and Other Revenue |
Key Numbers
- 2023-12-31 — Fiscal Year End (Reporting period)
- 2024-03-06 — Filing Date (Date of submission)
- 2834 — SIC Code (Industry classification)
Key Players & Entities
- Xeris Biopharma Holdings, Inc. (company) — Filer name
- 2023-12-31 (date) — Fiscal year end
- 2024-03-06 (date) — Filing date
- 2834 (industry_code) — Standard Industrial Classification
- 1375 WEST FULTON STREET, SUITE 1300 (address) — Business address
- CHICAGO (location) — Business address city
- IL (location) — Business address state
- 60607 (postal_code) — Business address zip
FAQ
When did Xeris Biopharma Holdings, Inc. file this 10-K?
Xeris Biopharma Holdings, Inc. filed this Annual Report (10-K) with the SEC on March 6, 2024.
What is a 10-K filing?
A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Xeris Biopharma Holdings, Inc. (XERS).
Where can I read the original 10-K filing from Xeris Biopharma Holdings, Inc.?
You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Xeris Biopharma Holdings, Inc..
What are the key takeaways from Xeris Biopharma Holdings, Inc.'s 10-K?
Xeris Biopharma Holdings, Inc. filed this 10-K on March 6, 2024. Key takeaways: Xeris Biopharma Holdings, Inc. filed its 2023 Form 10-K on March 6, 2024.. The filing covers the fiscal year ending December 31, 2023.. The company is classified under SIC code 2834 (Pharmaceutical Preparations)..
Is Xeris Biopharma Holdings, Inc. a risky investment based on this filing?
Based on this 10-K, Xeris Biopharma Holdings, Inc. presents a moderate-risk profile. The company faces customer concentration risk, with revenue from four customers representing a significant portion of product sales, indicating potential vulnerability if these relationships change.
What should investors do after reading Xeris Biopharma Holdings, Inc.'s 10-K?
Investors should analyze Xeris Biopharma's revenue streams, particularly the reliance on key customers, and evaluate the company's strategies for diversification and growth. The overall sentiment from this filing is neutral.
Risk Factors
- Customer Concentration Risk [medium — market]: Revenue from four customers represents a significant portion of product sales, posing a risk if these relationships are disrupted.
Key Dates
- 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
- 2024-03-06: Filing Date — Date the 10-K was officially filed with the SEC.
Filing Stats: 4,371 words · 17 min read · ~15 pages · Grade level 16 · Accepted 2024-03-06 16:10:13
Key Financial Figures
- $0.0001 — ange on which registered Common Stock, $0.0001 par value per share XERS The Nasdaq Glo
- $5.0 billion — e market for this drug is approximately $5.0 billion in the United States. Recorlev is a co
- $3.0 billion — arket for this therapy is approximately $3.0 billion in the United States. Keveyis is the f
- $0.5 billion — market for this therapy is greater than $0.5 billion in the United States. Our Proprietary
Filing Documents
- xers-20231231.htm (10-K) — 2032KB
- exhibit1039redacted-amen.htm (EX-10.39) — 10KB
- xeris-ex211xlistofsubsidia.htm (EX-21.1) — 5KB
- a202310-kexhibit231.htm (EX-23.1) — 4KB
- a202310-kexhibit232.htm (EX-23.2) — 2KB
- a202310-kexhibit311.htm (EX-31.1) — 10KB
- a202310-kexhibit312.htm (EX-31.2) — 10KB
- a202310-kexhibit321.htm (EX-32.1) — 5KB
- a202310-kexhibit322.htm (EX-32.2) — 5KB
- exhibit971final-xerisxco.htm (EX-97.1) — 14KB
- exhibit1039redacted-amen001.jpg (GRAPHIC) — 162KB
- exhibit1039redacted-amen002.jpg (GRAPHIC) — 175KB
- exhibit1039redacted-amen003.jpg (GRAPHIC) — 170KB
- exhibit1039redacted-amen004.jpg (GRAPHIC) — 116KB
- exhibit1039redacted-amen005.jpg (GRAPHIC) — 47KB
- exhibit971final-xerisxco001.jpg (GRAPHIC) — 214KB
- exhibit971final-xerisxco002.jpg (GRAPHIC) — 233KB
- exhibit971final-xerisxco003.jpg (GRAPHIC) — 213KB
- exhibit971final-xerisxco004.jpg (GRAPHIC) — 224KB
- exhibit971final-xerisxco005.jpg (GRAPHIC) — 60KB
- xers-20231231_g1.jpg (GRAPHIC) — 56KB
- xers-20231231_g2.jpg (GRAPHIC) — 103KB
- 0001867096-24-000031.txt ( ) — 11882KB
- xers-20231231.xsd (EX-101.SCH) — 63KB
- xers-20231231_cal.xml (EX-101.CAL) — 104KB
- xers-20231231_def.xml (EX-101.DEF) — 344KB
- xers-20231231_lab.xml (EX-101.LAB) — 733KB
- xers-20231231_pre.xml (EX-101.PRE) — 540KB
- xers-20231231_htm.xml (XML) — 1118KB
Risk Factors
Item 1A. Risk Factors 30
Unresolved Staff Comments
Item 1B. Unresolved Staff Comments 64
Cybersecurity
Item 1C. Cybersecurity 64
Properties
Item 2. Properties 65
Legal Proceedings
Item 3. Legal Proceedings 65
Mine Safety Disclosures
Item 4. Mine Safety Disclosures 65 Part II.
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 65
[ Reserved]
Item 6. [ Reserved] 66
Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 67
Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 73
Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data 74
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 109
Controls and Procedures
Item 9A. Controls and Procedures 109
Other Information
Item 9B. Other Information 109
Disclosure R egarding F oreign J urisdictions T hat P revent I nspections
Item 9C. Disclosure R egarding F oreign J urisdictions T hat P revent I nspections 109 Part III
Directors, Executive Officers and Corporate Governance
Item 10. Directors, Executive Officers and Corporate Governance 110
Executive Compensation
Item 11. Executive Compensation 110
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 110
Certain Relationships and Related Transactions, and Director Independence
Item 13. Certain Relationships and Related Transactions, and Director Independence 110
Principal Accountant Fees and Services
Item 14. Principal Accountant Fees and Services 110 Part IV.
Exhibits and Financial Statement Schedules
Item 15. Exhibits and Financial Statement Schedules 111
Form 10-K Summary
Item 16. Form 10-K Summary 111 Index to Exhibits 112
Signatures
Signatures 119 Solely for convenience, the trademarks and trade names in this Annual Report on Form 10-K (this "Annual Report") are referred to without the and symbols, but absence of such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. The trademarks, trade names, and service marks appearing in this Annual Report are the property of their respective owners. 3 Table of Contents Cautionary Statements for Forward-Looking Information This Annual Report on Form 10-K contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about: the rate and degree of market acceptance and clinical utility of Gvoke, Recorlev and Keveyis; the pricing and reimbursement of Gvoke, Recorlev and Keveyis or any of our product candidates, if approved; our estimates regarding the market opportunities for Gvoke, Recorlev and Keveyis and our product candidates; the commercialization, marketing and manufacturing of Gvoke, Recorlev and Keveyis and our product candidates, if approved; our ability to manufacture, or the ability of third parties to deliver, sufficient quantities of components and drug product for commercialization of Gvoke, Recorlev and Keveyis or any of our product candidates, if appr
BUSINESS
ITEM 1. BUSINESS As used herein, the "Company", "Xeris", "we" or "our" refers to Xeris Biopharma Holdings, Inc. ("Xeris Biopharma"). Throughout this document, unless otherwise noted, references to Gvoke include Gvoke PFS, Gvoke HypoPen, Gvoke Kit and Ogluo. Overview We are focused on building an innovative, self-sustaining, growth-oriented biopharmaceutical company committed to improving patients' lives by developing and commercializing clinically meaningful products across a range of therapies. We are uniquely positioned to achieve this through our three commercial products and our proprietary formulation science (XeriSol and XeriJect), which generates partnerships and enhances our product candidates. Commercial Products Our top priority is maximizing the potential of our three commercial products: Gvoke is a ready-to-use, liquid-stable glucagon for the treatment of severe hypoglycemia. The product is indicated for use in pediatric and adult patients with diabetes age two years and above and can be administered in two simple steps. The estimated total addressable market for this drug is approximately $5.0 billion in the United States. Recorlev is a cortisol synthesis inhibitor approved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing's syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. The estimated total addressable market for this therapy is approximately $3.0 billion in the United States. Keveyis is the first therapy approved in the United States to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis ("PPP"). PPP is a rare genetic, neuromuscular disorder that can cause extreme muscle weakness and/or paralysis; some forms are also commonly associated with myotonia or muscle stiffness. The estimated total addressable market for this therapy