Apellis Pharmaceuticals Files 10-K/A Amendment

TL;DR

<b>Apellis Pharmaceuticals filed an amended annual report (10-K/A) detailing financial instruments, collaborations, and operational information for the fiscal year ending December 31, 2023.</b>

AI Summary

Apellis Pharmaceuticals, Inc. (APLS) filed a Amended Annual Report (10-K/A) with the SEC on February 29, 2024. Apellis Pharmaceuticals, Inc. filed a 10-K/A (Annual Report Amendment) on February 29, 2024, for the fiscal year ending December 31, 2023. The filing references various agreements and plans, including collaboration agreements with Swedish Orphan Biovitrum AB Publ and Beam Therapeutics Incorporation. It also details convertible senior notes due in 2026 and employee stock purchase plans. The company's business address is 100 Fifth Avenue, Waltham, MA 02451, with a business phone number of 617-977-5700. Apellis Pharmaceuticals operates in the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Apellis Pharmaceuticals, Inc., this filing contains several important signals. This amendment provides updated or corrected information for the annual filing, which is crucial for investors to have the most accurate view of the company's financial health and strategic partnerships. The detailed references to specific agreements and financial instruments like convertible notes and RSU's offer insights into Apellis's capital structure and ongoing business relationships.

Risk Assessment

Risk Level: medium — Apellis Pharmaceuticals, Inc. shows moderate risk based on this filing. The filing is an amendment (10-K/A), indicating potential prior inaccuracies or omissions in the original filing, which could suggest underlying issues with reporting or internal controls.

Analyst Insight

Review the specific changes made in this 10-K/A filing compared to the original 10-K to understand the nature of the amendments and their potential impact on financial reporting.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of report)
• 2024-02-29 — Filing Date (Date of filing)
• 001-38276 — SEC File Number (Company's SEC file number)
• 2834 — SIC Code (Industry classification)

Key Players & Entities

• Apellis Pharmaceuticals, Inc. (company) — Filer name
• Swedish Orphan Biovitrum AB Publ (company) — Collaboration partner
• Beam Therapeutics Incorporation (company) — Research collaboration partner
• University of Pennsylvania (company) — Mentioned in relation to an agreement
• Bachem Americas Inc (company) — Mentioned in relation to an agreement
• SFJ Agreement (company) — Specific agreement mentioned
• 2026 (dollar_amount) — Year for convertible senior notes
• 2023 (dollar_amount) — Fiscal year end

FAQ

Risk Factors

• Customer Concentration Risk [medium — financial]: The company faces risk due to reliance on a limited number of customers for a significant portion of its revenue.

Key Dates

• 2023-12-31: Fiscal Year End — Primary period covered by the filing
• 2024-02-29: Filing Date — Date the amended 10-K was submitted

Glossary

10-K/A

An amended annual report filed with the SEC. (Indicates updates or corrections to a previously filed annual report.)

Convertible Senior Notes

Debt securities that can be converted into shares of common stock. (Represents a form of financing and potential future dilution for the company.)

RSU

Restricted Stock Units, a form of equity compensation. (Indicates equity-based compensation plans impacting potential share count and employee incentives.)

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share APLS Nasdaq Glo
• $528.6 m — tain profitability. Our net losses were $528.6 million, $652.2 million, and $746.4 milli
• $652.2 m — ty. Our net losses were $528.6 million, $652.2 million, and $746.4 million for the years
• $746.4 million — ere $528.6 million, $652.2 million, and $746.4 million for the years ended December 31, 2023,
• $275.2 million — r ended December 31, 2023, we generated $275.2 million in U.S. net product revenue from sales
• $91.0 million — ecember 31, 2023 and 2022, we generated $91.0 million and $65.1 million, respectively, in U.S
• $65.1 m — nd 2022, we generated $91.0 million and $65.1 million, respectively, in U.S. net produc

Filing Documents

• apls-20231231.htm (10-K/A) — 3761KB
• apls-ex23_2.htm (EX-23.2) — 3KB
• apls-ex31_3.htm (EX-31.3) — 15KB
• apls-ex31_4.htm (EX-31.4) — 15KB
• apls-ex32_3.htm (EX-32.3) — 8KB
• apls-ex32_4.htm (EX-32.4) — 8KB
• img138179509_0.jpg (GRAPHIC) — 25KB
• img138179509_1.jpg (GRAPHIC) — 77KB
• img138179509_2.jpg (GRAPHIC) — 54KB
• 0000950170-24-023256.txt (&nbsp;) — 14341KB
• apls-20231231.xsd (EX-101.SCH) — 1987KB
• apls-20231231_htm.xml (XML) — 2334KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 48 Item 1B. Unresolved Staff Comments 98 Item 1C. Cybersecurity 98 Item 2.

Properties

Properties 99 Item 3.

Legal Proceedings

Legal Proceedings 99 Item 4. Mine Safety Disclosures 99 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 100 Item 6. Reserved 101 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 102 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 119 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 119 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 151 Item 9A.

Controls and Procedures

Controls and Procedures 151 Item 9B. Other Information 153 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 153 PART III Item 10. Directors, Executive Officers and Corporate Governance 154 Item 11.

Executive Compensation

Executive Compensation 154 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 154 Item 13. Certain Relationships and Related Transactions, and Director Independence 154 Item 14. Principal Accountant Fees and Services 154 PART IV Item 15. Exhibits, Financial Statement Schedules 155 i Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: the ongoing commercialization of EMPAVELI and SYFOVRE; our plans with respect to our ongoing and planned clinical trials for our product candidates, whether conducted by us or Swedish Orphan Biovitrum AB (Publ), or Sobi, or by any future collaborators, including the timing of initiation, dosing of patients, enrollment and completion of these trials and of the anticipated results from these trials; our sales, marketing and distribution capabilities and strategies, including for the commercialization and manufacturing of EMPAVELI, SYFOVRE and any future products; the rate and degree of market acceptance and clinical utility of EMPAVELI, SYFOVRE and any future products; our estimates regarding the rate of incidence of retinal vasculitis f

B usiness

Item 1. B usiness. Overview We are a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic compounds to treat diseases with high unmet needs through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control diseases with high unmet need and that are driven by excessive complement activation. In February 2023, the U.S. Food and Drug Administration, or the FDA, approved SYFOVRE (pegcetacoplan injection), the first approved treatment for geographic atrophy secondary to age-related macular degeneration, or GA. We believe SYFOVRE has the potential to be a best-in-class treatment for patients with GA, a disease that affects more than one million people in the United States and five million people worldwide. We launched SYFOVRE in the United States in March 2023. For the year ended December 31, 2023, we generated $275.2 million in U.S. net product revenue from sales of SYFOVRE. In December 2022,we also submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for intravitreal pegcetacoplan for the treatment of GA. The EMA subsequently provided MAA validation and the application is under review. In January 2024, the Committee for Medicinal Products for Human Use, or CHMP, adopted a negative opinion on the marketing authorization application, or MAA, for intravitreal pegcetacoplan. We are initiating the re-examination of the application. Marketing applications submitted to regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for the treatment of GA are currently under review. We have exclusive, worldwide commercialization rights for intravitreal pegcetacoplan. In November 2

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