Protagonist Therapeutics, Inc. Files 2023 Annual Report on Form 10-K
Ticker: PTGX · Form: 10-K · Filed: Feb 27, 2024 · CIK: 1377121
Sentiment: neutral
Topics: 10-K, Annual Report, Protagonist Therapeutics, Pharmaceuticals, SEC Filing
TL;DR
<b>Protagonist Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and corporate information.</b>
AI Summary
Protagonist Therapeutics, Inc (PTGX) filed a Annual Report (10-K) with the SEC on February 27, 2024. Protagonist Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period ending December 31, 2023, and was filed on February 27, 2024. The company's principal business address is 7707 Gateway Blvd., Suite 140, Newark, CA 94560-1160. Protagonist Therapeutics, Inc. is classified under the SIC code 2834 for Pharmaceutical Preparations. The report details financial activities and corporate information for the fiscal year 2023.
Why It Matters
For investors and stakeholders tracking Protagonist Therapeutics, Inc, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Protagonist Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. As a pharmaceutical company, the detailed disclosures in the 10-K are essential for understanding its research and development efforts, regulatory compliance, and market positioning within the competitive biotech landscape.
Risk Assessment
Risk Level: medium — Protagonist Therapeutics, Inc shows moderate risk based on this filing. The company is in the pharmaceutical industry, which is subject to significant regulatory hurdles, lengthy development cycles, and intense competition, posing inherent risks to its financial performance and growth prospects.
Analyst Insight
Investors should review the detailed risk factors and financial statements in the 10-K to understand Protagonist Therapeutics' specific challenges and opportunities in the biopharmaceutical sector.
Key Numbers
- 20231231 — Fiscal Year End (Report period)
- 20240227 — Filing Date (Date of submission)
- 001-37852 — SEC File Number (SEC registration number)
- 2834 — SIC Code (Industry classification)
Key Players & Entities
- Protagonist Therapeutics, Inc. (company) — Filer name
- 20231231 (date) — Fiscal year end
- 20240227 (date) — Filing date
- 7707 Gateway Blvd., Suite 140, Newark, CA 94560-1160 (address) — Business address
- 2834 (industry_code) — Standard Industrial Classification
- DE (state) — State of incorporation
FAQ
When did Protagonist Therapeutics, Inc file this 10-K?
Protagonist Therapeutics, Inc filed this Annual Report (10-K) with the SEC on February 27, 2024.
What is a 10-K filing?
A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Protagonist Therapeutics, Inc (PTGX).
Where can I read the original 10-K filing from Protagonist Therapeutics, Inc?
You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Protagonist Therapeutics, Inc.
What are the key takeaways from Protagonist Therapeutics, Inc's 10-K?
Protagonist Therapeutics, Inc filed this 10-K on February 27, 2024. Key takeaways: Protagonist Therapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023.. The filing covers the period ending December 31, 2023, and was filed on February 27, 2024.. The company's principal business address is 7707 Gateway Blvd., Suite 140, Newark, CA 94560-1160..
Is Protagonist Therapeutics, Inc a risky investment based on this filing?
Based on this 10-K, Protagonist Therapeutics, Inc presents a moderate-risk profile. The company is in the pharmaceutical industry, which is subject to significant regulatory hurdles, lengthy development cycles, and intense competition, posing inherent risks to its financial performance and growth prospects.
What should investors do after reading Protagonist Therapeutics, Inc's 10-K?
Investors should review the detailed risk factors and financial statements in the 10-K to understand Protagonist Therapeutics' specific challenges and opportunities in the biopharmaceutical sector. The overall sentiment from this filing is neutral.
Risk Factors
- Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive government regulation, which can impact product development, approval, manufacturing, and marketing.
- Market Competition [high — market]: The company faces intense competition from other pharmaceutical and biotechnology companies, which could affect its ability to gain market share.
- Research and Development Risks [high — operational]: The success of Protagonist Therapeutics depends heavily on the successful development and commercialization of its drug candidates, which involves significant risks and uncertainties.
- Funding and Liquidity [medium — financial]: The company may require additional funding to support its ongoing operations and development programs, and there is no assurance that such funding will be available on favorable terms.
Key Dates
- 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
- 2024-02-27: Filing Date — Date the 10-K was officially submitted to the SEC.
Filing Stats: 4,432 words · 18 min read · ~15 pages · Grade level 14.3 · Accepted 2024-02-27 16:33:25
Key Financial Figures
- $0.00001 — nge on which registered Common Stock, $0.00001 par value PTGX The Nasdaq Stock Mar
- $300 million — expect to receive an upfront payment of $300 million and to be eligible to receive additiona
- $330 m — commercial milestone payments of up to $330 million, as well as tiered royalties from
- $50.0 million — completed by JNJ in 2023. We earned a $50.0 million milestone payment upon dosing of the th
- $10.0 million — received in December 2023. We earned a $10.0 million milestone payment upon the dosing of th
- $172.5 million — n January 2024. To date, we have earned $172.5 million in nonrefundable payments from JNJ. We
- $795.0 million — remain eligible for up to approximately $795.0 million in future development and sales milesto
- $115.0 million — he potential milestones listed below: $115.0 million milestone payment upon JNJ-2113 meeting
- $35.0 million — he four ICONIC program Phase 3 trials; $35.0 million milestone payment upon the filing of a
- $15.0 million — on approval of the NDA by the FDA; and $15.0 million milestone payment upon the advancement
- $4.0 billion — n percent applicable for net sales over $4.0 billion. At JNJ's Enterprise Business Review
- $5.0 billion — potential peak year sales projection of $5.0 billion plus. JNJ IL-23 monoclonal antibody ("m
- $14.0 billion — b") drugs Stelara and Tremfya generated $14.0 billion in revenues in 2023. In February 2024
Filing Documents
- ptgx-20231231x10k.htm (10-K) — 2506KB
- ptgx-20231231xex4d2.htm (EX-4.2) — 19KB
- ptgx-20231231xex21d1.htm (EX-21.1) — 3KB
- ptgx-20231231xex23d1.htm (EX-23.1) — 4KB
- ptgx-20231231xex31d1.htm (EX-31.1) — 11KB
- ptgx-20231231xex31d2.htm (EX-31.2) — 11KB
- ptgx-20231231xex32d1.htm (EX-32.1) — 11KB
- ptgx-20231231xex97d1.htm (EX-97.1) — 12KB
- ptgx-20231231x10k006.jpg (GRAPHIC) — 102KB
- ptgx-20231231x10k007.jpg (GRAPHIC) — 83KB
- ptgx-20231231x10k008.jpg (GRAPHIC) — 107KB
- ptgx-20231231x10k009.jpg (GRAPHIC) — 93KB
- 0001558370-24-001850.txt ( ) — 11515KB
- ptgx-20231231.xsd (EX-101.SCH) — 71KB
- ptgx-20231231_cal.xml (EX-101.CAL) — 65KB
- ptgx-20231231_def.xml (EX-101.DEF) — 290KB
- ptgx-20231231_lab.xml (EX-101.LAB) — 562KB
- ptgx-20231231_pre.xml (EX-101.PRE) — 492KB
- ptgx-20231231x10k_htm.xml (XML) — 1889KB
Business
Business 3 Item 1A.
Risk Factors
Risk Factors 30 Item 1B. Unresolved Staff Comments 52 Item 1C . Cybersecurity 52 Item 2.
Properties
Properties 53 Item 3.
Legal Proceedings
Legal Proceedings 53 Item 4. Mine Safety Disclosures 53 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 54 Item 6. Reserved 55 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 56 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 73 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 107 Item 9A.
Controls and Procedures
Controls and Procedures 107 Item 9B. Other Information 109 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 109 PART III Item 10. Directors, Executive Officers, and Corporate Governance 109 Item 11.
Executive Compensation
Executive Compensation 109 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 109 Item 13. Certain Relationships and Related Transactions, and Director Independence 109 Item 14. Principal Accountant Fees and Services 110 PART IV Item 15. Exhibits, Financial Statement Schedules 110 Item 16. Form 10-K Summary 114
SIGNATURES
SIGNATURES 115 Table of Contents PART I
Business
Item 1. Business OVERVIEW We are a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of development, both derived from our proprietary peptide technology platform. Our clinical programs fall into two broad categories of diseases: (i) hematology and blood disorders, and (ii) inflammatory and immunomodulatory ("I&I") diseases. Figure 1: Our Product Pipeline Rusfertide Our most advanced clinical asset, rusfertide (generic name for PTG-300), is an injectable hepcidin mimetic in development for the potential treatment of polycythemia vera ("PV") and other blood disorders. Hepcidin is a key hormone in regulating iron equilibrium and is critical to the proper development of red blood cells ("RBCs"). Rusfertide mimics the effect of the natural hormone hepcidin, but with greater potency, solubility and stability. Data from our rusfertide Phase 2 clinical trials presented at medical conferences from 2021 through 2023 provided evidence regarding the potential of rusfertide for managing hematocrit, reducing thrombotic risk and improving iron deficiency symptoms. Rusfertide has a unique mechanism of action in the potential treatment of PV, which may enable it to specifically decrease and maintain hematocrit levels within the range of recommended clinical guidelines without causing the iron deficiency that can occur with frequent phlebotomy. Our rusfertide Phase 2 clinical trials include the following: REVIVE, a Phase 2 proof of concept ("POC") trial, was initiated in the fourth quarter of 2019. We completed enrollment of patients in the first quarter of 2022 and 70 patients were enrolled through the 3 Table of Contents end of the randomized withdrawal portion of the trial, which was completed during the first quarter of 2023 and is continuing in an ongoing open-label extension ("OLE"); THRIVE, a Phase 2 long-term extension trial for REVIVE patients on years three through five of treatm