UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 5.02 | Results of Operations and Financial Condition. |
On January 9, 2023, Apellis Pharmaceuticals, Inc. (the “Company”) posted on its website a corporate presentation, which it plans to present at the 41st Annual J.P. Morgan Health Care Conference on January 9, 2023. In the corporate presentation, the Company disclosed that based on preliminary financial information it expects to report that it recorded approximately $65 million in net product revenue from sales of EMPAVELI in the United States for the year ended December 31, 2022. The related excerpt from the presentation is attached as Exhibit 99.1 hereto.
The Company’s net product revenue figure is preliminary and unaudited, represents management’s estimate as of the date of this report and is subject to completion of the Company’s financial closing procedures. The Company’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the Company’s net product revenue from sales of EMPAVELI.
The information in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Excerpt from corporate presentation dated January 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Apellis Pharmaceuticals, Inc. | ||||||
| Date: January 9, 2023 | By: | /s/ Timothy Sullivan | ||||
| Timothy Sullivan | ||||||
| Chief Financial Officer | ||||||
2022 was a transformational year Submitted NDA to U.S. FDA Submitted MAA to EMA U.S. commercial preparations complete; deployed ~100 field-based employees mid-2022 Appointed leading retina specialist, Dr. Caroline Baumal as Chief Medical Officer (effective Q1 2023) ~$65 million1 in U.S. net product sales Submitted sNDA for PRINCE & 48-week PEGASUS data Submitted sNDA for EMPAVELI injector Completed >800 patient years of systemic dosing2 Progressed late-stage clinical studies with partner Sobi Advanced early-stage pipeline across therapeutic areas Completed enrollment in Phase 2 ALS study Geographic Atrophy (GA): Ready to launch first-ever treatment Paroxysmal Nocturnal Hemoglobinuria (PNH): Continued growth in demand Pipeline: Leaders in complement 1 Estimated 2022 EMPAVELI U.S. net product sales are unaudited, preliminary and based on management’s estimate as of the date of this presentation and are subject to completion of the Company’s financial closing procedures. 2. Includes 694 patients as of November 2022 from all subcutaneous pegcetacoplan clinical trials and post-marketing exposure of EMPAVELI. Exhibit 99.1