Rani Therapeutics Holdings, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Rani Therapeutics Holdings, Inc. has submitted its 2023 annual 10-K filing detailing its financial performance and business operations.</b>

AI Summary

Rani Therapeutics Holdings, Inc. (RANI) filed a Annual Report (10-K) with the SEC on March 20, 2024. Rani Therapeutics Holdings, 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's principal business address is 2051 Ringwood Avenue, San Jose, CA 95131. Rani Therapeutics Holdings, Inc. is classified under SIC code 2834 for Pharmaceutical Preparations. The report was filed on March 20, 2024, under the Securities Exchange Act of 1934.

Why It Matters

For investors and stakeholders tracking Rani Therapeutics Holdings, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Rani Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. As a pharmaceutical preparations company, the detailed disclosures in this filing are essential for understanding regulatory compliance, research and development progress, and market positioning within the healthcare industry.

Risk Assessment

Risk Level: medium — Rani Therapeutics Holdings, Inc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, and market approval, as evidenced by the nature of its business and the typical challenges in this sector.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Rani Therapeutics' current financial position and potential challenges in its drug development pipeline.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-20 — Filing Date (Filed as of date)
• 2834 — SIC Code (Standard Industrial Classification)
• 001-40672 — SEC File Number (SEC File Number)

Key Players & Entities

• Rani Therapeutics Holdings, Inc. (company) — Filer name
• 2051 Ringwood Avenue, San Jose, CA 95131 (address) — Business address
• 2834 (SIC Code) — Standard Industrial Classification
• 1934 Act (regulation) — SEC Act
• 001-40672 (file number) — SEC File Number
• 24767864 (film number) — Film Number
• 2023-12-31 (date) — Conformed period of report
• 2024-03-20 (date) — Filed as of date

FAQ

Industry Context

Rani Therapeutics operates in the pharmaceutical preparations industry, focusing on the development and commercialization of novel drug delivery systems.

Regulatory Implications

As a pharmaceutical company, Rani Therapeutics is subject to extensive regulation by bodies such as the FDA, governing drug development, manufacturing, and marketing.

What Investors Should Do

1. Review Rani Therapeutics' detailed financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section to understand potential challenges and uncertainties in the company's operations and drug development pipeline.
3. Examine any disclosures regarding research and development activities and their progress.

Key Dates

• 2024-03-20: 10-K Filing — Annual report submission for fiscal year 2023

Year-Over-Year Comparison

This filing represents the company's annual report for the fiscal year 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.0001 — tered Class A common stock, par value $0.0001 per share RANI The Nasdaq Stock Mar
• $4.12 — k on the Nasdaq Global Select Market of $4.12 per share. As of March 14, 2024, the
• $6.4 billion — otech, Inc. with sales of approximately $6.4 billion in the United States and approximately
• $9.7 billion — in the United States and approximately $9.7 billion worldwide in 2022. The latest expiring

Filing Documents

• rani-20231231.htm (10-K) — 2870KB
• rani-ex10_15.htm (EX-10.15) — 26KB
• rani-ex10_17.htm (EX-10.17) — 41KB
• rani-ex21_1.htm (EX-21.1) — 4KB
• rani-ex23_1.htm (EX-23.1) — 5KB
• rani-ex31_1.htm (EX-31.1) — 14KB
• rani-ex31_2.htm (EX-31.2) — 15KB
• rani-ex32_1.htm (EX-32.1) — 9KB
• img175254529_0.jpg (GRAPHIC) — 109KB
• img175254529_1.jpg (GRAPHIC) — 12KB
• img175254529_2.jpg (GRAPHIC) — 75KB
• img175254529_3.jpg (GRAPHIC) — 71KB
• img175254529_4.jpg (GRAPHIC) — 68KB
• img175254529_5.jpg (GRAPHIC) — 73KB
• img175254529_6.jpg (GRAPHIC) — 19KB
• img175254529_7.jpg (GRAPHIC) — 12KB
• img175254529_8.jpg (GRAPHIC) — 60KB
• 0000950170-24-034163.txt (&nbsp;) — 12328KB
• rani-20231231.xsd (EX-101.SCH) — 1873KB
• rani-20231231_htm.xml (XML) — 1725KB

Forward-Looking Statements

Forward-Looking Statements 3 PART I. Item 1.

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 34 Item 1B. Unresolved Staff Comments 95 Item 1C. Cybersecurity 95 Item 2.

Properties

Properties 96 Item 3.

Legal Proceedings

Legal Proceedings 96 Item 4. Mine Safety Disclosures 96 PART II. Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 97 Item 6. [Reserved] 97 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 98 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 112 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 113 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 139 Item 9A.

Controls and Procedures

Controls and Procedures 139 Item 9B. Other Information 140 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 140 PART III. Item 10. Directors, Executive Officers and Corporate Governance 141 Item 11.

Executive Compensation

Executive Compensation 141 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 141 Item 13. Certain Relationships and Related Transactions, and Director Independence 141 Item 14. Principal Accountant Fees and Services 141 Item 15. Exhibit and Financial Statement Schedules 142 Item 16. Form 10-K Summary 144

Signatures

Signatures 145 2 Unless otherwise stated or the context otherwise requires, throughout this Annual Report on Form 10-K, the terms "we," "us," and "our," and similar references refer to Rani Therapeutics Holdings, Inc. ("Rani Holdings") and its consolidated subsidiary, Rani Therapeutics, LLC ("Rani LLC") and, prior to December 15, 2022, Rani Management Services, Inc. ("RMS"). RMS was dissolved as of December 15, 2022. We use Rani, Rani Therapeutics, RaniPill, the Rani Therapeutics logo, the R logo and other marks as trademarks in the United States and other countries. This Annual Report on Form 10-K contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Annual Report on Form 10-K, including logos, artwork, and other visual displays, may appear without the or TM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights, or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities' trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, including the section titled " Management's Discussion and Analysis of Financial Condition and Results of Operations ," contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and consolidated financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, manufacturing costs, regulatory approvals, development and advancement of our oral delivery techno

Business

Item 1. Business Overview We are a clinical stage biotherapeutics company focusing on advancing technologies to enable the administration of biologics and drugs orally, to provide patients, physicians, and healthcare systems with a convenient alternative to painful injections. We are advancing a portfolio of oral therapeutics using our proprietary delivery technology and we are actively pursuing partnering the technology with third party biopharmaceutical companies for the oral delivery of their biologics and drugs. Our technology comprises a drug-agnostic oral delivery platform, the RaniPill capsule, which is designed to deliver a wide variety of drug substances, including antibodies, proteins, peptides, and oligonucleotides. We are currently developing two configurations of the platform – the RaniPill GO and the RaniPill HC. The RaniPill GO is designed to deliver up to a 3 mg dose of drug in microtablet form with high bioavailability. We have completed three Phase 1 clinical trials using the RaniPill GO. We are also developing a high-capacity version of the RaniPill capsule known as the RaniPill HC, which is intended to enable delivery of drug payloads up to 200L in liquid form with high bioavailability. We have tested preclinically the RaniPill HC with multiple therapeutics, including antibodies and a peptide. We intend to initiate clinical testing of the RaniPill HC in the second half of 2024. We believe that, together, the RaniPill GO and RaniPill HC could enable us to deliver most biologics currently on the market with convenient, oral dosing. Data Overview We have completed three Phase 1 clinical trials with the RaniPill capsule technology. In February 2024, we announced completion of a Phase 1 clinical trial with RT-111, a RaniPill GO capsule containing our proprietary formulation of an ustekinumab biosimilar supplied by Celltrion, Inc. ("Celltrion"), in Australia. The study evaluated the safety and tolerability of a single administration of RT-1

View Full Filing

View this 10-K filing on SEC EDGAR