Puma Biotechnology, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Puma Biotechnology filed its 2023 10-K, detailing financial positions and operational segments.</b>

AI Summary

PUMA BIOTECHNOLOGY, INC. (PBYI) filed a Annual Report (10-K) with the SEC on February 29, 2024. Puma Biotechnology reported total assets of $100,000,000 as of December 31, 2023. The company's total debt was $47,646,787 as of December 31, 2023. Revenue from Product sales was $46,345,660 for the fiscal year ended December 31, 2023. The company's fiscal year ends on December 31st. Puma Biotechnology, Inc. is incorporated in Delaware.

Why It Matters

For investors and stakeholders tracking PUMA BIOTECHNOLOGY, INC., this filing contains several important signals. The filing provides a comprehensive overview of Puma Biotechnology's financial health and operational performance for the fiscal year 2023, which is crucial for investors to assess the company's stability and growth prospects. Key financial figures such as total assets, total debt, and revenue from product sales offer insights into the company's resource management, leverage, and core business performance.

Risk Assessment

Risk Level: medium — PUMA BIOTECHNOLOGY, INC. shows moderate risk based on this filing. The company's financial performance is subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, market competition, and patent expirations, which could impact revenue and profitability.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Puma Biotechnology's current financial standing and future outlook.

Revenue Breakdown

Key Numbers

• 100,000,000 — Total Assets (As of December 31, 2023)
• 47,646,787 — Total Debt (As of December 31, 2023)
• 46,345,660 — Revenue from Product (For the fiscal year ended December 31, 2023)
• 0.2 — Operating Margin (Fiscal year 2023)
• 9.7 — Gross Margin (Fiscal year 2023)

Key Players & Entities

• PUMA BIOTECHNOLOGY, INC. (company) — COMPANY CONFORMED NAME
• 2023 (date) — CONFORMED PERIOD OF REPORT
• 2024-02-29 (date) — FILED AS OF DATE
• DE (jurisdiction) — STATE OF INCORPORATION
• 10880 WILSHIRE BLVD. (address) — BUSINESS ADDRESS
• LOS ANGELES (location) — BUSINESS ADDRESS CITY
• CA (location) — BUSINESS ADDRESS STATE
• 90024 (postal_code) — BUSINESS ADDRESS ZIP

FAQ

Risk Factors

• Financial Performance Risks [medium — financial]: The company's financial results are subject to market conditions, competition, and regulatory approvals in the pharmaceutical sector.
• Regulatory Approval Risks [medium — regulatory]: Failure to obtain or maintain regulatory approvals for its products could adversely affect the company's business and financial condition.
• Market Competition [medium — market]: The pharmaceutical market is highly competitive, and increased competition could negatively impact sales and market share.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share PBYI The NASDAQ Stock Mar
• $3.53 — , 2023, based upon the closing price of $3.53 per share of the registrant's common st

Filing Documents

• pbyi20231231_10k.htm (10-K) — 2350KB
• ex_607302.htm (EX-21.1) — 2KB
• ex_607303.htm (EX-23.1) — 2KB
• ex_607304.htm (EX-31.1) — 8KB
• ex_607305.htm (EX-31.2) — 8KB
• ex_607306.htm (EX-32.1) — 5KB
• ex_607307.htm (EX-32.2) — 5KB
• ex_627486.htm (EX-97.1) — 22KB
• pipeline22424rdg.jpg (GRAPHIC) — 71KB
• yearperfsized4.jpg (GRAPHIC) — 24KB
• 0001437749-24-006121.txt (&nbsp;) — 10081KB
• pbyi-20231231.xsd (EX-101.SCH) — 81KB
• pbyi-20231231_cal.xml (EX-101.CAL) — 84KB
• pbyi-20231231_def.xml (EX-101.DEF) — 538KB
• pbyi-20231231_lab.xml (EX-101.LAB) — 503KB
• pbyi-20231231_pre.xml (EX-101.PRE) — 580KB
• pbyi20231231_10k_htm.xml (XML) — 1513KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 57 Item 1C. Cybersecurity 57 Item 2.

Properties

Properties 58 Item 3.

Legal Proceedings

Legal Proceedings 58 Item 4. Mine Safety Disclosure 60 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 60 Item 6. [Reserved] 61 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 62 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 72 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 72 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 72 Item 9A.

Controls and Procedures

Controls and Procedures 72 Item 9B. Other Information 73 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 73 Part III Item 10. Directors, Executive Officers and Corporate Governance 73 Item 11.

Executive Compensation

Executive Compensation 73 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 73 Item 13. Certain Relationships and Related Transactions, and Director Independence 73 Item 14. Principal Accounting Fees and Services 73 Part IV Item 15. Exhibits, Financial Statement Schedules 74 Item 16. Form 10-K Summary 74 Exhibit Index 75

Signatures

Signatures 79 Index to Consolidated Financial Statements F-1 Table of Contents CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Annual Report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). Any statements about our expectations, beliefs, plans, objectives, assumptions, future events or performance are not historical facts and may be forward looking. These forward-looking statements include, but are not limited to, statements about: the commercialization of NERLYNX (neratinib) tablets ( "NERLYNX"); the development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our drug candidates; the anticipated timing of regulatory filings; the regulatory approval of our drug candidates; our use of clinical research organizations ("CRO") and other contractors; our ability to find collaborative partners for research, development and commercialization of potential products; efforts of our sub-licensees to obtain regulatory approval and commercialize NERLYNX in areas outside the United States; our ability to market any of our products; our expectations regarding our costs and expenses; our anticipated capital requirements and estimates regarding our needs for additional financing; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our intention and ability to vigorously defend against any litigation to which we are or may become party; our ability to in-license additional drugs; our ability to attract and retain key personnel; and our ability to obtain adequate financing on favorable terms or at all. These statements are often, but not always, made through the use of words or phrases such as "anticipate," "estimate," "plan," "project," "continuing," "ongoing," "expect," "believe," "intend" and similar w

BUSINESS

BUSINESS Company Overview Unless otherwise provided in this Annual Report, references to the " Company, " " we, " " us, " and " our " refer to Puma Biotechnology, Inc. and our wholly owned subsidiaries. We are a biopharmaceutical company that develops and commercializes innovative products to enhance cancer care and improve treatment outcomes for patients. We are currently commercializing NERLYNX, an oral version of neratinib, for the treatment of HER2-positive breast cancer. Additionally, we have in-licensed, and are responsible for global development and commercialization of, alisertib. Alisertib is a selective, small-molecule inhibitor of aurora kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Prior to our licensing alisertib from Takeda, alisertib was tested in over 1,300 patients who were treated across 22 company-sponsored trials resulting in a large, well-characterized clinical safety database. Based on information in this database, we believe alisertib has potential application in the treatment of range of different cancer types, including hormone receptor positive breast cancer, triple negative breast cancer, small cell lung cancer and head and neck cancer. We intend to pursue development of alisertib initially in small cell lung cancer and hormone receptor positive breast cancer. The following figure provides an overview of our commercial product and drug candidates. * EBC: Early breast cancer ** MBC: Metastatic breast cancer *** HRc+: Hormone receptor positive **** NSCLC: Non small cell lung cancer Neratinib Breast cancer is the leading cause of cancer death among women worldwide, with approximately one million new cases reported each year and more than 400,000 deaths per year. Up to 20% of breast cancer tumors show over-expression of the HER2 protein. Women with breast cancer that over-expresses HER2, referred to as HER2-positive breast cancer,

View Full Filing

View this 10-K filing on SEC EDGAR