ADMA Biologics Announces Preliminary Fourth Quarter 2023 Revenue and Provides Business Update - Seite 2

2024-2025 Financial Guidance:

• FY 2024-2025 Total Revenue expected to be in the range of $320 Million to $370 Million, respectively, increased from $290 Million and $335 Million previously.
• FY 2024-2025 Net Income expected to exceed $60 Million to $110 Million, respectively, increased from $55 Million and $100 Million previously.
• FY 2024 Adjusted EBITDA anticipated to reach $85 Million or more.
  

⁽¹⁾ Adjusted EBITDA is a non-GAAP financial measure. The estimated Adjusted EBITDA amounts included herein are preliminary and reconciliations cannot be produced at this time without unreasonable effort. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2023 financial results.

New Growth Opportunities: These initiatives, if successful, represent upside to newly provided guidance ranges:

Biologic Production Yield Enhancement: The Company continues to make progress with development scale and laboratory analyses, advancing ADMA’s initiative to capture additional IG production yields with the same quantities of starting raw material. These initiatives are subject to further evaluation, validation of commercial-scale production and requisite regulatory review. If proven successful, these yield enhancements will potentially provide significant upside to the Company’s peak financial targets.

New Pipeline Introduction - S. pneumonia Hyperimmune Globulin:

• S. pneumonia is the predominant cause of community-acquired pneumonia (CAP) in the United States, ranking as the ninth leading cause of overall mortality. We believe the strategic importance and unmet need are evident in both the prophylactic and therapeutic settings where documented anti-infective resistance is on the rise. Annually, approximately one million U.S. adults contract pneumococcal pneumonia, resulting in 400,000 hospitalizations and a 5-7% mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance. Despite vaccine availabilities, vaccine-naive and immune-compromised patient populations remain at risk and could potentially benefit from the immediately available neutralizing antibodies conferred with a hyperimmune globulin in both the in-patient and out-patient treatment settings. We estimate that an S. pneumonia hyperimmune globulin, if approved, has the potential to generate peak revenue of $300-500 Million.  
• ADMA holds multiple U.S. and foreign patents and patent applications encompassing various aspects of its proprietary pneumococcal hyperimmune technology. These include U.S. Patent Nos. 10,259,865 and 11,084,870, EP Patent No. 3375789, and other patents, each with patent term through 2037, as well as numerous pending U.S. and foreign applications. Issued and pending claims encompass ADMA’s hyperimmune anti-pneumococcal immune globulin, methods of preparing the immune globulin, and methods of using the immune globulin (e.g., to treat S. pneumonia infection or to provide immunotherapy to a patient).

ASCENIV Label Expansion: The ongoing post-marketing pediatric clinical study for ASCENIV is progressing and may provide label expansion opportunities, further strengthening ADMA’s product portfolio compared to peers, if successful.