CRISPR Therapeutics AG Files 2023 Annual Report on Form 10-K

TL;DR

<b>CRISPR Therapeutics AG has submitted its 2023 annual report (10-K), detailing its financial performance and business operations.</b>

AI Summary

CRISPR Therapeutics AG (CRSP) filed a Annual Report (10-K) with the SEC on February 21, 2024. CRISPR Therapeutics AG filed its 2023 Form 10-K on February 21, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is Baarerstrasse 14, Zug, Switzerland. CRISPR Therapeutics AG is classified under SIC code 2836 for Biological Products. The filing includes data related to various financial instruments and agreements, including those with Vertex Pharmaceuticals Incorporated.

Why It Matters

For investors and stakeholders tracking CRISPR Therapeutics AG, this filing contains several important signals. This 10-K filing provides a comprehensive overview of CRISPR Therapeutics' financial health, operational activities, and strategic partnerships for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. The detailed information within the filing, including financial statements and risk factors, is essential for stakeholders to understand the company's progress in gene editing therapies and its compliance with regulatory requirements.

Risk Assessment

Risk Level: medium — CRISPR Therapeutics AG shows moderate risk based on this filing. The company operates in the highly regulated and competitive biotechnology sector, facing risks related to clinical trial success, regulatory approvals, and market adoption of its gene-editing therapies.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand CRISPR Therapeutics' financial position and the potential challenges in bringing its novel therapies to market.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-21 — Filing Date (Date of submission)
• 2836 — SIC Code (Standard Industrial Classification)
• 001-37923 — SEC File Number (SEC filing identifier)

Key Players & Entities

• CRISPR Therapeutics AG (company) — Filer name
• Vertex Pharmaceuticals Incorporated (company) — Mentioned in relation to agreements
• Jefferies LLC (company) — Mentioned in relation to sales agreement
• 2023-12-31 (date) — Fiscal year end
• 2024-02-21 (date) — Filing date
• CH-6300 (location) — Company ZIP code
• 6173154600 (phone) — Business phone number
• 001-37923 (filing_id) — SEC file number

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The development and commercialization of gene-editing therapies are subject to extensive and evolving regulatory oversight, which could impact the timeline and approval of products.
• Market Adoption and Competition [high — market]: The success of CRISPR Therapeutics' products depends on market acceptance and competition from other companies developing similar or alternative therapies.
• Clinical Trial Risks [high — operational]: Clinical trials are inherently risky, and there is no guarantee that any product candidate will successfully demonstrate safety and efficacy to gain regulatory approval.
• Funding and Liquidity [medium — financial]: The company may require significant additional capital to fund its ongoing research, development, and commercialization activities, and may not be able to secure such funding on favorable terms.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.

Key Financial Figures

• $170 million — herapies for T1D, for which we received $170 million in upfront and milestone payments in 20

Filing Documents

• crsp-20231231.htm (10-K) — 3360KB
• crsp-ex4_1.htm (EX-4.1) — 25KB
• crsp-ex21_1.htm (EX-21.1) — 6KB
• crsp-ex23_1.htm (EX-23.1) — 7KB
• crsp-ex31_1.htm (EX-31.1) — 12KB
• crsp-ex31_2.htm (EX-31.2) — 12KB
• crsp-ex32_1.htm (EX-32.1) — 10KB
• crsp-ex97_1.htm (EX-97.1) — 36KB
• img133321815_0.jpg (GRAPHIC) — 6KB
• img168450911_0.jpg (GRAPHIC) — 266KB
• img168450911_1.jpg (GRAPHIC) — 474KB
• img168450911_2.jpg (GRAPHIC) — 147KB
• img168450911_3.jpg (GRAPHIC) — 595KB
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• img168450911_5.jpg (GRAPHIC) — 220KB
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• img168450911_7.jpg (GRAPHIC) — 153KB
• img168450911_8.jpg (GRAPHIC) — 110KB
• img168450911_9.jpg (GRAPHIC) — 245KB
• img168450911_10.jpg (GRAPHIC) — 197KB
• img168450911_11.jpg (GRAPHIC) — 115KB
• img168450911_12.jpg (GRAPHIC) — 268KB
• img168450911_13.jpg (GRAPHIC) — 338KB
• img168450911_14.jpg (GRAPHIC) — 42KB
• 0000950170-24-017571.txt (&nbsp;) — 22675KB
• crsp-20231231.xsd (EX-101.SCH) — 1652KB
• crsp-20231231_htm.xml (XML) — 2259KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 44 Item 1B. Unresolved Staff Comments 92 Item 1C. Cybersecurity 92 Item 2.

Properties

Properties 93 Item 3.

Legal Proceedings

Legal Proceedings 93 Item 4. Mine Safety Disclosures 93 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 94 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 97 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 109 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 109 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 109 Item 9A.

Controls and Procedures

Controls and Procedures 109 Item 9B. Other Information 112 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 112 PART III Item 10. Directors, Executive Officers and Corporate Governance 113 Item 11.

Executive Compensation

Executive Compensation 113 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 113 Item 13. Certain Relationships and Related Transactions, and Director Independence 113 Item 14. Principal Accountant Fees and Services 113 PART IV Item 15. Exhibits and Financial Statement Schedules 114 Item 16. Form 10-K Summary 118 i Risk Factor Summary Our business is subject to a number of risks and uncertainties of which you should be aware before making an investment decision in our business. These risks are discussed more fully in the "Risk Factors" section of this Annual Report on Form 10-K. These risks include, but are not limited to, the following: We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future. We will need to raise substantial additional funding, which will dilute our shareholders. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts. If we are unable to advance our product candidates to clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed. Our CRISPR/Cas9 gene editing product candidates are based on a relatively new gene editing technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all. There have only been a limited number of clinical trials of product candidates based on gene editing technology. The U.S. Food and Drug Administration, or FDA, the National Institutes of Health, or NIH, and the European Medicines Agency, or EMA, have demonstrated caution in their regulation of gene therapy treatments, and ethical and legal concerns about gene therapy and genetic testing may result in additional

BUSINESS

BUSINESS Overview We are a leading gene editing company focused on the development of CRISPR/Cas9-based therapeutics. CRISPR/Cas9 is a revolutionary technology for gene editing, the process of precisely altering specific sequences of genomic DNA. We aim to apply this technology to disrupt, delete, correct and insert genes to treat genetic diseases and to engineer advanced cellular therapies. We have advanced this technology from discovery to an approved medicine with unparalleled speed, culminating in the landmark first approval of a CRISPR-based therapy, CASGEVY (exagamglogene autotemcel [exa-cel]), in 2023 with our collaborators at Vertex Pharmaceuticals Incorporated, or Vertex. We believe that the combination of our technology, research and development capabilities, and proven ability to execute may enable us to create an entirely new class of highly effective and potentially curative therapies for patients with both rare and common diseases for whom current biopharmaceutical approaches have had limited success. The use of CRISPR/Cas9 for gene editing was co-invented by one of our scientific founders, Dr. Emmanuelle Charpentier, the Acting and Founding Director of the Max Planck Unit for the Science of Pathogens in Berlin, Germany. Dr. Charpentier and her collaborators published work elucidating the mechanism by which the Cas9 endonuclease, a key component of CRISPR/Cas9, can be programmed to cut double-stranded DNA at specific locations. Dr. Charpentier and her collaborator, Dr. Jennifer Doudna of the University of California, Berkeley, shared the 2020 Nobel Prize in Chemistry for their groundbreaking work. We acquired exclusive rights to intellectual property encompassing CRISPR/Cas9 and related technologies from Dr. Charpentier and continue to strengthen our intellectual property estate through our own research and additional in-licensing efforts, furthering our leadership in gene editing therapeutics. We have established a portfolio of therapeutic pro

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View this 10-K filing on SEC EDGAR