Outlook Therapeutics Files 2024 10-K

TL;DR

Outlook Therapeutics 2024 10-K filed: $23.9M assets, $13.0M liabilities. Check financials.

AI Summary

Outlook Therapeutics, Inc. filed its 10-K for the fiscal year ending September 30, 2024. The company, formerly known as Oncobiologics, Inc., is in the biological products sector. Key financial data includes total assets of $23.9 million and total liabilities of $13.0 million as of September 30, 2024. The company's business address is in Iselin, NJ.

Why It Matters

This filing provides a comprehensive overview of Outlook Therapeutics' financial health and operational status for the past fiscal year, which is crucial for investors and stakeholders to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — The company's financial figures and the nature of the biotechnology industry suggest a medium level of risk.

Key Numbers

• $23.9B — Total Assets (As of September 30, 2024)
• $13.0B — Total Liabilities (As of September 30, 2024)

Key Players & Entities

• Outlook Therapeutics, Inc. (company) — Filer
• Oncobiologics, Inc. (company) — Former Company Name
• 2024-09-30 (date) — Fiscal Year End
• 23905635 (dollar_amount) — Total Assets
• 13012833 (dollar_amount) — Total Liabilities
• Iselin, NJ (location) — Business Address

FAQ

Key Financial Figures

• $0.01 — 5,635 shares of common stock, par value $0.01 per share. DOCUMENTS INCORPORATED BY R
• $1.00 — on September 30, 2024, or CHF 0.9015 = $1.00. We do not represent that CHF were, cou

Filing Documents

• otlk-20240930x10k.htm (10-K) — 2277KB
• otlk-20240930xex4d1.htm (EX-4.1) — 44KB
• otlk-20240930xex10d11.htm (EX-10.11) — 39KB
• otlk-20240930xex19d1.htm (EX-19.1) — 92KB
• otlk-20240930xex21d1.htm (EX-21.1) — 5KB
• otlk-20240930xex23d1.htm (EX-23.1) — 3KB
• otlk-20240930xex31d1.htm (EX-31.1) — 13KB
• otlk-20240930xex32d1.htm (EX-32.1) — 8KB
• otlk-20240930x10k006.jpg (GRAPHIC) — 49KB
• otlk-20240930x10k007.jpg (GRAPHIC) — 51KB
• 0001558370-24-016491.txt ( ) — 8921KB
• otlk-20240930.xsd (EX-101.SCH) — 46KB
• otlk-20240930_cal.xml (EX-101.CAL) — 54KB
• otlk-20240930_def.xml (EX-101.DEF) — 200KB
• otlk-20240930_lab.xml (EX-101.LAB) — 416KB
• otlk-20240930_pre.xml (EX-101.PRE) — 363KB
• otlk-20240930x10k_htm.xml (XML) — 1390KB

Business

Business 1 ITEM 1A.

Risk Factors

Risk Factors 27 ITEM 1B. Unresolved Staff Comments 83 ITEM 1C. Cybersecurity 83 ITEM 2.

Properties

Properties 84 ITEM 3.

Legal Proceedings

Legal Proceedings 84 ITEM 4. Mine Safety Disclosures 85 PART II 86 ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 86 ITEM 6. Reserved. 86 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 87 ITEM 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 101 ITEM 8. Consolidated Financial Statements and Supplementary Data 102 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 129 ITEM 9A.

Controls and Procedures

Controls and Procedures 129 ITEM 9B. Other Information 129 PART III 131 ITEM 10. Directors, Executive Officers and Corporate Governance 131 ITEM 11.

Executive Compensation

Executive Compensation 131 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 132 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 132 ITEM 14. Principal Accounting Fees and Services 132 PART IV 133 ITEM 15. Exhibits and Financial Statement Schedules 133 ITEM 16. Form 10-K Summary 136 In this report, unless otherwise stated or as the context otherwise requires, references to "Outlook Therapeutics," "Outlook," "the Company," "we," "us," "our" and similar references refer to Outlook Therapeutics, Inc. (formerly known as Oncobiologics, Inc.) and its consolidated subsidiaries. The Outlook logo, Oncobiologics logo, LYTENAVA and other trademarks or service marks of Outlook Therapeutics, Inc. appearing in this report are the property of Outlook Therapeutics, Inc. This report also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders. Currency translations between Swiss Francs, or CHF, and U.S. dollars provided herein are based on the noon buying rate in New York City for cable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York on September 30, 2024, or CHF 0.9015 = $1.00. We do not represent that CHF were, could have been, or could be, converted into U.S. dollars at such rate or at any other rate. Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. All statements other than statements of historical fact are "forw

Business

Item 1. Business Overview We are a biopharmaceutical company that is the first to receive marketing authorization for an ophthalmic formulation of ONS-5010/LYTENAVA ( bevacizumab-gamma) for use in treating wet age-related macular degeneration, or wet AMD, in the European Union, or EU, and United Kingdom, or UK. We are developing ONS-5010/LYTENAVA to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. We are also working to receive approval and launch ONS-0510/LYTENAVA in the United States. Our initial goal is to launch directly in the EU and the UK, and in the United States, if approved, as the first and only approved ophthalmic bevacizumab for the treatment of retina conditions, including wet age-related macular degeneration, or wet AMD. Our plans also include seeking approval and launching the product in Japan and other markets, either directly or through a strategic partner, if approved. We have entered into a collaboration agreement with Cencora (formerly AmerisourceBergen Corporation) to support the commercial launch of ONS-5010/LYTENAVA in Europe and the United States . Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. In October 2022, we submitted a Marketing Authorization Application, or MAA, for ONS-5010/LYTENAVA with the European Medicines Agency (EMA). On May 27, 2024, we received a marketing authorization from the European Commission for ONS-5010/LYTENAVA for the treatment of wet AMD, which is valid throughout the European Economic Area, or EEA. The marketing authorization in the EEA provides eight years of data exclusivity and 10 years of market exclusivity. On July 8, 2024, we also received approval from the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. Additionally, on December 4, 2024, the UK National Institute for

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View this 10-K filing on SEC EDGAR