XBiotech Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>XBiotech Inc. filed its 2023 10-K, detailing fiscal year results and business operations.</b>

AI Summary

XBiotech Inc. (XBIT) filed a Annual Report (10-K) with the SEC on March 15, 2024. XBiotech Inc. filed its 2023 Form 10-K on March 15, 2024, reporting on its fiscal year ended December 31, 2023. The company's principal business address is 5217 Winnebago Lane, Austin, TX 78744. XBiotech Inc. operates within the Pharmaceutical Preparations industry (SIC code 2834). The filing includes data related to convertible debt and subsequent events, with a specific mention of January 3, 2024. Financial data points for the fiscal years ending December 31, 2023, and December 31, 2022, are detailed.

Why It Matters

For investors and stakeholders tracking XBiotech Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of XBiotech's financial performance and operational status for the fiscal year 2023, crucial for investors assessing the company's health and future prospects. The inclusion of specific financial data, such as convertible debt and subsequent events, offers insights into the company's financial structure and recent developments that could impact its valuation.

Risk Assessment

Risk Level: medium — XBiotech Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, as indicated by its SIC code and the nature of the industry.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand XBiotech's current financial position and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-15 — Filing Date (Date of submission)
• 2834 — SIC Code (Industry classification)

Key Players & Entities

• XBiotech Inc. (company) — Filer name
• 5217 Winnebago Lane, Austin, TX 78744 (location) — Business address
• 2834 (industry_code) — Standard Industrial Classification
• 2023-12-31 (date) — Fiscal year end
• 2024-03-15 (date) — Filing date
• 001-37347 (filing_number) — SEC file number

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government agencies, which can impact product development, approval, manufacturing, and marketing.
• Financing and Liquidity [medium — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance that such financing will be available on favorable terms.
• Research and Development Risks [high — operational]: The success of XBiotech's business depends on its ability to successfully develop and commercialize its product candidates, which involves significant R&D risks.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-15: Filing Date — Date XBiotech Inc. submitted its 10-K filing.

Key Financial Figures

• $1.35 billion — was developing that targeted IL-1a for $1.35 billion in cash and potential milestone payment
• $750 million — n antibody Bermekimab generated a total $750 million in income between December 30, 2019 and
• $495 million — 20, the Company has returned a total of $495 million to its shareholders through a combinati
• $247 billion — actual human antibodies. Today, in the $247 billion antibody market — apart from XBiotech's

Filing Documents

• xbit20231231_10k.htm (10-K) — 1128KB
• ex_636175.htm (EX-21.1) — 3KB
• ex_636176.htm (EX-23.1) — 2KB
• ex_636177.htm (EX-31.1) — 12KB
• ex_636178.htm (EX-31.2) — 12KB
• ex_636179.htm (EX-32.1) — 4KB
• ex_636180.htm (EX-32.2) — 4KB
• ex_639764.htm (EX-97) — 12KB
• 0001171843-24-001382.txt (&nbsp;) — 5343KB
• xbit-20231231.xsd (EX-101.SCH) — 44KB
• xbit-20231231_def.xml (EX-101.DEF) — 316KB
• xbit-20231231_lab.xml (EX-101.LAB) — 294KB
• xbit-20231231_pre.xml (EX-101.PRE) — 351KB
• xbit-20231231_cal.xml (EX-101.CAL) — 47KB
• xbit20231231_10k_htm.xml (XML) — 729KB

BUSINESS

ITEM 1. BUSINESS 6

RISK FACTORS

ITEM 1A. RISK FACTORS 9

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 32

PROPERTIES

ITEM 2. PROPERTIES 32

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 33

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 33 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 34

RESERVED

ITEM 6. RESERVED 34

MANAGEMENT ' S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

ITEM 7. MANAGEMENT ' S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION 34

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS 41

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 42

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 61

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES. 61

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 62 PART III

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 62

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 62

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 62

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 63

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 63

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 64

FORM 10 – K SUMMARY

ITEM 16. FORM 10 – K SUMMARY 66 3 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This annual report contains " forward-looking statements " within the meaning of Section 27A of the Securities Act of 1933, as amended (the " Securities Act " ), and Section 21E of the Securities Exchange Act of 1934, as amended (the " Exchange Act " ), and is subject to the safe harbor created by those sections. All statements, other than statements of historical facts, included in this annual report, including, without limitation, statements regarding the assumptions we make about our business and economic model, our dividend policy, business strategy and other plans and objectives for our future operations, are forward-looking statements for purposes of federal and state securities laws. Forward-looking statements involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions or future events. In some cases, you can identify forward-looking statements by terminology such as " may, " " will, " " should, " " would, " " could, " " expects, " " plans, " " contemplate, " " anticipates, " " believes, " " estimates, " " predicts, " " projects, " " intend " or " continue " or the negative of such terms or other comparable terminology denoting uncertainty or an action that may, will or is expected to occur in the future, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. Some, but not all, examples of the forward-looking statements contained in this annual report include, among other things, statements about the following: our ability to obtain regulatory approval to market and sell our product candidates in the United States, Europe and elsewhere; the initiation, timing

BUSINESS

ITEM 1. BUSINESS Overview XBiotech Inc. ("XBiotech" or the "Company") is a biopharmaceutical company that discovers and develops True Human monoclonal antibodies for treating a variety of diseases. XBiotech was incorporated in Canada on March 22, 2005. The Company's Internet address is www.xbiotech.com. The Company makes available free of charge on or through its website its annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as well as proxy statements, as soon as reasonably practicable after the Company electronically files such material with, or furnishes it to, the Securities and Exchange Commission. The Company's website is included in this annual report on Form 10-K as an inactive textual reference only. The information on, or accessible through, the Company's website is not a part of, or incorporated by reference in, this annual report on Form 10-K. The SEC maintains an Internet site that contains these reports at http://www.sec.gov. XBiotech's True Human monoclonal antibodies are derived from human donors that mount a natural human immune response. All other marketed antibody therapeutics are derived from animal immunization. It is intuitive that naturally occurring human antibodies have the potential to be safer, more effective and faster to develop than animal engineered counterparts. XBiotech has developed a pipeline of product candidates targeting both inflammatory and infectious diseases. The Company has also developed manufacturing technology that reduces the cost and time to launch new product candidates. The Company designed and built a state-of-the-art physical plant and infrastructure to discover manufacture and manage clinical trial operations for its therapeutic antibodies at its Company's 48 acre research campus in Austin, Texas. XBiotech is thus a fully integrated developer of bi

RISK FACTORS

ITEM 1A. RISK FACTORS Summary The following summarizes some of the key risks and uncertainties that could materially adversely affect us. You should read this summary together with the more detailed description of each risk factor contained below. Risks Related to our Business, Financial Condition and Capital Requirements We will incur significant losses during development of our current pipeline over the foreseeable future. We currently have limited opportunities to generate revenue and may never sustain profitability. Our future success may be dependent on the regulatory approval and commercialization of our product candidates. New laws or regulations could impact our ability to receive the necessary approvals to successfully market and commercialize our product candidates. Product candidates we advance into clinical trials may not have favorable results in clinical trials or receive regulatory approval. For various reasons, we may be unable to complete clinical trials on a timely basis, incurring higher costs and delayed development timelines. The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. 9 Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences prior to or following any marketing approval. Any product candidates that we commer

View Full Filing

View this 10-K filing on SEC EDGAR