BioCryst Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>BioCryst Pharmaceuticals filed its 2023 10-K report detailing its annual performance and financial standing.</b>

AI Summary

BIOCRYST PHARMACEUTICALS INC (BCRX) filed a Annual Report (10-K) with the SEC on February 27, 2024. BioCryst Pharmaceuticals, Inc. filed its annual report for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company is incorporated in Delaware and headquartered in Durham, North Carolina. The SIC code for BioCryst Pharmaceuticals is 2836, related to Biological Products. The filing was submitted on February 27, 2024.

Why It Matters

For investors and stakeholders tracking BIOCRYST PHARMACEUTICALS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of BioCryst's financial health, operational performance, and strategic direction for the fiscal year 2023, crucial for investors assessing the company's progress and future prospects. As a publicly traded company on NASDAQ, BioCryst's annual report is a key document for stakeholders to understand its business, risks, and financial results, influencing investment decisions.

Risk Assessment

Risk Level: medium — BIOCRYST PHARMACEUTICALS INC shows moderate risk based on this filing. The company operates in the highly competitive and regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market adoption, which could impact financial performance.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess BioCryst's long-term growth potential and the impact of ongoing research and development efforts.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-27 — Filing Date (Date of submission)
• 000-23186 — SEC File Number (SEC registration)
• 24686601 — Film Number (SEC processing number)

Key Players & Entities

• BIOCRYST PHARMACEUTICALS INC (company) — Filer name
• BCRX (company) — Ticker symbol
• 2023-12-31 (date) — Fiscal year end
• 2024-02-27 (date) — Filing date
• NASDAQ (company) — Stock exchange
• DURHAM (location) — Business address city
• DE (location) — State of incorporation
• 2836 (industry) — Standard Industrial Classification

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors to develop superior products or pricing strategies.
• Financial Stability [medium — financial]: The company's ability to fund its operations, research, and development activities depends on its access to capital and its financial performance.
• Product Development and Commercialization [high — operational]: Success in developing and commercializing new pharmaceutical products is uncertain and subject to numerous risks, including clinical trial failures and market acceptance.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-27: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.01 — ange on which registered Common Stock, $0.01 par value BCRX Nasdaq Global Select Mar
• $0 — er of shares of Common Stock, par value $0.01, of the registrant outstanding as of

Filing Documents

• bcrx-20231231.htm (10-K) — 2124KB
• exhibit21-subsidiaries1.htm (EX-21) — 8KB
• exhibit23-202310xkxdraftco.htm (EX-23) — 7KB
• bcrx-20231231xex311.htm (EX-31.1) — 10KB
• bcrx-20231231xex312.htm (EX-31.2) — 10KB
• bcrx-20231231xex321.htm (EX-32.1) — 6KB
• bcrx-20231231xex322.htm (EX-32.2) — 5KB
• exhibit97-nasdaqcompliantc.htm (EX-97) — 10KB
• bcrx-20231231_g1.jpg (GRAPHIC) — 104KB
• 0001628280-24-007205.txt (&nbsp;) — 11181KB
• bcrx-20231231.xsd (EX-101.SCH) — 80KB
• bcrx-20231231_cal.xml (EX-101.CAL) — 95KB
• bcrx-20231231_def.xml (EX-101.DEF) — 362KB
• bcrx-20231231_lab.xml (EX-101.LAB) — 971KB
• bcrx-20231231_pre.xml (EX-101.PRE) — 641KB
• bcrx-20231231_htm.xml (XML) — 1630KB

RISK FACTORS

ITEM 1A. RISK FACTORS 28

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 57 I TEM 1C. CYBERSECURITY 57

PROPERTIES

ITEM 2. PROPERTIES 59

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 59

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 59 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 60

RESERVED

ITEM 6. RESERVED 61

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 61

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 75

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 115

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES 115

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 116

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 117 PART III

DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 118

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 118

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 118

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 118

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 118 PART IV

EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES 119

FORM 10-K SUMMARY

ITEM 16. FORM 10-K SUMMARY 123

SIGNATURES

SIGNATURES 124 EX-21 EX-23 EX-31.1 EX-31.2 EX-32.1 EX-32.2 E X -97 i Table of Contents When used in this report, unless otherwise indicated, " we, " " our, " " us, " the " Company, " and " BioCryst " refer to BioCryst Pharmaceuticals, Inc. and, where appropriate, its subsidiaries. Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (this "report") includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are subject to the "safe harbor" created in Section 21E. In particular, statements about our expectations, beliefs, plans, objectives or assumptions of future events or performance are contained or incorporated by reference in this report. All statements other than statements of historical facts contained herein are forward-looking statements. These forward-looking statements can generally be identified by the use of words such as "may," "will," "intends," "plans," "believes," "anticipates," "expects," "estimates," "predicts," "potential," the negative of these words or similar expressions. Statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects are also forward-looking statements. Discussions containing these forward-looking statements are principally contained in the "Business," "Risk Factors," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of this report, as well as any amendments we make to those sections in filings with the Securities and Exchange Commission ("SEC"). These forward-looking statements include, but are not limited to, statements about: the preclinical development, clinical development, commercialization, or post-marketing studies of our products and product candidates, including ORLADEYO (berotralstat), BCX10013, and early-stage discovery programs (including BCX17725, avoralstat, and our comple

BUSINESS

ITEM 1. BUSINESS Our Business We are a global biotechnology company with a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. We leverage our expertise in structure-guided drug design with the goal of developing first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat rare diseases. Structure-guided drug design is a drug discovery approach by which we design synthetic compounds from detailed structural knowledge of the active sites of targets associated with particular diseases. We use X-ray crystallography, computer modeling of molecular structures and advanced chemistry techniques to focus on the three-dimensional molecular structure and active site characteristics of the protein targets that control cellular biology. Our goal generally is to design a compound that will fit in the active site of a protein target and thereby prevent its activity. In addition to these discovery and development efforts, our business strategy includes the efficient commercialization of these drugs in the United States and certain other regions upon regulatory approval. By focusing on rare disease markets, we believe that we can more effectively control the costs of, and our strategic allocation of financial resources toward, post-approval commercialization. Molecules from our discovery efforts that are commercially available or that are in active development are summarized in the table below and are discussed in further detail under "Products and Product Candidates" in this "Part I—Item 1—Business" section of this report. Drug/Drug Candidate Drug Class Therapeutic Area(s) Phase Rights* ORLADEYO (berotralstat) Oral Serine Protease Inhibitor Targeting Kallikrein (once-daily treatment) Hereditary angioedema Approved (United States and multiple global markets) BioCryst (worldwide)** Oral Serine Protease Inhibitor Targeting Kallikrein (once-daily treatment for patients who are

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View this 10-K filing on SEC EDGAR