4Q 2023 Preliminary Unaudited Total Revenue of
FY 2023 Preliminary Unaudited Total Revenue of
FY 2024 and 2025 Total Revenue Guidance Increased to More than
FY 2024 Net Income Expected to Exceed
Growth Opportunities Targeting Manufacturing and New Pipeline Hyperimmune Globulin to Advance During 2024
“Entering 2024 from a position of strength, we're increasing both top and bottom-line financial guidance due to robust business trends and strong forward-looking product demand indicators. Additionally, we've identified new growth opportunities that we believe have the potential to approximately double currently provided peak revenue and earnings by the end of this decade,” said
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 millionU.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 includeU.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 pendingU.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.
About ASCENIV™
ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the
Additional Important Safety Information About ASCENIV™
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE |
Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. |
ASCENIV™ Contraindications:
History of anaphylactic or severe systemic reactions to human immunoglobulin.
IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
ASCENIV™ Warnings and Precautions:
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1]
Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4]
In patients at risk of developing acute renal failure. monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9]
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5]
Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6]
Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7]
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ASCENIV™ Adverse Reactions:
The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact
About
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about
COMPANY CONTACT:
Senior Director, Corporate Strategy and Business Development | 201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:
Senior Managing Director,
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