Prothena Corp. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Prothena Corp. filed its 2023 10-K report detailing its financial and operational status.</b>

AI Summary

PROTHENA CORP PUBLIC LTD CO (PRTA) filed a Annual Report (10-K) with the SEC on February 22, 2024. Prothena Corp. filed its 10-K report for the fiscal year ending December 31, 2023. The company is incorporated in L2 and its fiscal year ends on December 31. Prothena Corp. is classified under SIC code 2834 (Pharmaceutical Preparations). The filing details financial activities and business operations for the period. The report was filed on February 22, 2024.

Why It Matters

For investors and stakeholders tracking PROTHENA CORP PUBLIC LTD CO, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Prothena's financial health, strategic initiatives, and risk factors for the fiscal year 2023, crucial for investors to assess performance and future outlook. Understanding the company's financial position, including revenue streams, debt levels, and operational performance as detailed in this report, is essential for making informed investment decisions.

Risk Assessment

Risk Level: medium — PROTHENA CORP PUBLIC LTD CO shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory hurdles, clinical trial risks, and intense competition, as is typical for companies in this sector.

Analyst Insight

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

Key Numbers

• 20231231 — Fiscal Year End (Conformed Period of Report)
• 20240222 — Filing Date (As of Date)
• 2023-01-01 — Reporting Period Start Date (2023 FY)
• 2023-12-31 — Reporting Period End Date (2023 FY)

Key Players & Entities

• PROTHENA CORP PUBLIC LTD CO (company) — Filer name
• 0001559053 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification
• L2 (company) — State of Incorporation
• DUBLIN 2 (company) — Business Address City
• D02 VK60 (company) — Business Address Zip
• 001-35676 (company) — SEC File Number
• 24665792 (company) — Film Number

FAQ

Industry Context

Prothena Corp. operates within the pharmaceutical preparations industry, focusing on the development of novel therapies for rare protein misfolding diseases.

Regulatory Implications

As a pharmaceutical company, Prothena is subject to stringent regulatory oversight from bodies like the FDA and EMA concerning drug development, clinical trials, and market approval processes.

What Investors Should Do

1. Analyze Prothena's financial statements for revenue, expenses, and cash flow to understand its financial health.
2. Review the 'Risk Factors' section to identify potential challenges and uncertainties affecting the company's operations and future prospects.
3. Examine management's discussion and analysis (MD&A) for insights into the company's strategy, performance drivers, and outlook.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, following previous filings which would have covered prior periods.

Key Financial Figures

• $0.01 — Registered Ordinary Shares, par value $0.01 per share PRTA The Nasdaq Global Select

Filing Documents

• prta-20231231.htm (10-K) — 1886KB
• prta2023xex42descriptionof.htm (EX-4.2) — 99KB
• prta2023xex1023firstthroug.htm (EX-10.23) — 73KB
• prta2023ex211listofsubsidi.htm (EX-21.1) — 6KB
• prta2023xex231consentofind.htm (EX-23.1) — 2KB
• prta202310-kxex311.htm (EX-31.1) — 11KB
• prta202310-kxex312.htm (EX-31.2) — 11KB
• prta202310-kxex321.htm (EX-32.1) — 9KB
• prta2023xex97policyonrecou.htm (EX-97) — 18KB
• prta-20231231_g1.jpg (GRAPHIC) — 114KB
• prta-20231231_g2.jpg (GRAPHIC) — 55KB
• 0001559053-24-000008.txt (&nbsp;) — 8964KB
• prta-20231231.xsd (EX-101.SCH) — 65KB
• prta-20231231_cal.xml (EX-101.CAL) — 94KB
• prta-20231231_def.xml (EX-101.DEF) — 306KB
• prta-20231231_lab.xml (EX-101.LAB) — 859KB
• prta-20231231_pre.xml (EX-101.PRE) — 544KB
• prta-20231231_htm.xml (XML) — 907KB

Risk Factors

Item 1A. Risk Factors 21

Unresolved Staff Comments 57

Item 1B. Unresolved Staff Comments 57 I tem 1C . Cybersecurity 57

Properties

Item 2. Properties 58

Legal Proceedings

Item 3. Legal Proceedings 58

Mine Safety Disclosures 58

Item 4. Mine Safety Disclosures 58 PART II. 59

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 59

[Reserved] 62

Item 6. [Reserved] 62

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 62

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 69

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 71

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 103

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 103

Controls and Procedures

Item 9A. Controls and Procedures 103

Other Information

Item 9B. Other Information 104

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 104 PART III. 105

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 105

Executive Compensation

Item 11. Executive Compensation 107

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 107

Certain Relationships and Related Transactions, and Director Independence 107

Item 13. Certain Relationships and Related Transactions, and Director Independence 107

Principal Accountant Fees and Services 107

Item 14. Principal Accountant Fees and Services 107 PART IV. 108

Exhibit and Financial Statement Schedules 108

Item 15. Exhibit and Financial Statement Schedules 108 EXHIBIT INDEX 109

Form 10-K Summary 113

Item 16. Form 10-K Summary 113

SIGNATURES

SIGNATURES 114 Unless the context requires otherwise, references in this Form 10-K to "Prothena," the "Company," "we," "our," or "us" refer to Prothena Corporation plc and its subsidiaries. Note Regarding Forward-Looking Statements In addition to historical information, this Form 10-K contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may include words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective" "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements, which reflect our beliefs, assumptions, expectations, estimates, forecasts, and projections about our business and the industry in which we operated as of the date hereof, are estimates based on our best judgment. These statements relate to, among other things, our goal to continue building a biology-directed discovery engine targeting protein dysregulation; the treatment potential, designs, proposed mechanisms of action, and potential administration of our drug candidates; potential indications and attributes of epitopes and antibodies we have identified in our programs; plans for ongoing and future clinical studies of our drug candidates; our potential to advance, initiate, and complete investigational new drug ("IND") enabling studies for our discovery and preclinical programs; the expected timing of reporting data from clinical trials of our drug candidates, including any topline study results for our Phase 3 AFFIRM-AL c

BUSINESS

ITEM 1. BUSINESS Overview Prothena is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by our deep scientific expertise built over decades of research, we are advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which our ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Our wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis and a portfolio of programs for the potential treatment of Alzheimer's disease including PRX012, which targets amyloid beta (A), and PRX123, a novel dual A-tau vaccine. Our partnered programs include prasinezumab, in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau (BMS-986446, formerly PRX005), TDP-43, and an undisclosed target (PRX019) in collaboration with Bristol Myers Squibb (BMS) for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and other neurodegenerative diseases, respectively. We are also entitled to certain potential milestone payments pursuant to our share purchase agreement with Novo Nordisk pertaining to our ATTR amyloidosis business (NNC6019, formerly PRX004). We were formed on September 26, 2012, under the laws of Ireland and re-registered as an Irish public limited company on October 25, 2012. Our ordinary shares began trading on The Nasdaq Global Market under the symbol "PRTA" on December 21, 2012, and currently trade on The Nasdaq Global Select Market. Our Strategy Our goal is to be a leading biotechnology company focused on the discovery and development of novel therapies to treat diseases caused by protein dysregulation. Under cert

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View this 10-K filing on SEC EDGAR