Full Press Release Details
ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
4Q 2023 Total Revenue of $73.9 Million; FY 2023 Total Revenue of $258.2 Million
4Q 2023 Adjusted EBITDA(1) of $18.6 Million; FY 2023 Adjusted EBITDA of $40.3 Million
4Q 2023 Adjusted Net Income(2) of $8.5 Million; FY 2023 Adjusted Net Income of $0.7 Million
FY 2024 and 2025 Total Revenue Guidance Increased to More Than $330 Million and $380 Million, Respectively
FY 2024 Net Income Guidance Increased to More Than $65 Million and Adjusted EBITDA Guidance Increased to More Than $90 Million
FY 2025 Net Income Guidance Increased to More than $115 Million and Adjusted EBITDA Guidance Increased to More Than $140 Million
Innovative Growth Opportunities Targeting Manufacturing and New Pipeline Hyperimmune Globulin to Advance During 2024
Conference Call Scheduled for Today at 4:30 p.m. ET
RAMSEY, N.J. and BOCA RATON, FL, February 28, 2024 -
ADMA Biologics, Inc. (Nasdaq: ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its fourth quarter and full year 2023
financial results and provided a business update.
"We are pleased with our 2023 performance, which marked first-time positive adjusted net income on a full year basis. This is a testament to
the exponential revenue growth of our commercial specialty biologics product portfolio and effective fiscal and operational management. As ADMA's forward-looking business trends gain momentum, we're revising financial guidance upwards for both 2024
and 2025, increasing top and bottom-line projections," said Adam Grossman, President and Chief Executive Officer of ADMA. "We believe our growing commercial success will be sustained by the recent and continuous expansion of ASCENIV utilization. We
believe our unwavering focus on the immune deficient patient segment has allowed ADMA to establish itself as a premier provider of specialty biologics. We are confident that there is significant growth for ASCENIV within its addressable market,
further penetrating the treatment setting comprised of immune deficient patients grappling with complex comorbidities."
Mr. Grossman continued, "In conjunction with the ongoing expansion of our commercial product portfolio, we look forward to advancing new growth initiatives, including
innovations to ADMA's manufacturing processes and potential yield enhancement, as well as progress with our preclinical S. pneumonia pipeline program. Based upon current market factors, we anticipate 2024 being defined by top-tier revenue and earnings growth, cash generation, and the further de-risking of growth initiatives which, if
successful, we believe have the potential to significantly impact ADMA's peak revenue and earnings targets. We believe our proven internal R&D capabilities, broad intellectual property estate and successful establishment of our innovative
commercial model position the Company for enduring success in the future."
(1) Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, please see the reconciliation included
in the financial tables.
(2) Adjusted net income is a non-GAAP financial measure. For reconciliation of Adjusted net income to the most comparable GAAP measure, please see the reconciliation
included in the financial tables.
2024-2025 Financial Guidance:
Innovative Growth Opportunities: Below are the Company's ongoing initiatives which, if successful, represent potential upside to newly provided guidance ranges:
o S. pneumonia is the primary cause of community-acquired pneumonia (CAP) in the United States, ranking ninth in overall mortality. The increasing prevalence of anti-infective
resistance underscores the urgent need for both prophylactic and therapeutic interventions. Annually, about one million U.S. adults contract pneumococcal pneumonia, leading to 400,000 hospitalizations and a 5-7% mortality rate, with approximately
7,000 deaths attributed to anti-infective resistance. Despite available vaccines, vaccine-naive and immune-compromised patients remain at risk, highlighting the potential benefits of immediately available neutralizing antibodies provided by a
hyperimmune globulin in both in-patient and out-patient settings. We estimate that, if approved, an S. pneumonia hyperimmune globulin could generate peak annual revenue of
holds various U.S. and foreign patents, including U.S. Patent Nos. 10,259,865 and 11,084,870, and EP Patent No. 3375789, each with patent terms extending to 2037, along with numerous pending applications. These patents cover ADMA's proprietary
pneumococcal hyperimmune technology, encompassing hyperimmune anti-pneumococcal immune globulin, methods of preparation, and utilization for treating S. pneumonia
infections or providing immunotherapy to patients. During 2024, ADMA intends to advance pre-clinical work for the S. pneumonia program.
Fourth Quarter 2023 Financial Results:
Total revenues were $73.9 million for the quarter ended December 31, 2023, as compared to $50.0 million for the quarter ended December 31, 2022, an increase of $23.9
million, or approximately 48%. The increase is primarily related to increased sales of our immunoglobulin products, partially offset by a planned decrease in sales of plasma to third parties due to the increasing retention of plasma for internal
intravenous immune globulin (IVIG) production.
Adjusted EBITDA was $18.6 million for the quarter ended December 31, 2023, as compared to an Adjusted EBITDA loss of $3.5 million for the quarter ended December 31, 2022.
Adjusted EBITDA for the quarter includes all non-GAAP reconciliation items, including stock-based compensation, depreciation, amortization and interest expense totaling $10.1 million and loss on debt extinguishment of $26.2 million.
Net loss was $17.6 million for the quarter ended December 31, 2023, compared to a net loss of $12.2 million for the quarter ended December 31, 2022.
Adjusted net income was $8.5 million for the quarter ended December 31, 2023, accounting for the non-GAAP reconciliation of a $26.2 million loss on extinguishment of debt
incurred during the period, compared to an Adjusted net loss of $12.2 million for the quarter ended December 31, 2022.
Full Year 2023 Financial Results:
Total revenues were $258.2 million for the year ended December 31, 2023, as compared to $154.1 million for the year ended December 31, 2022, an increase of $104.1 million,
or approximately 68%.
The increase is primarily related to increased sales of our immunoglobulin products, partially offset by a planned decrease in sales of plasma to third parties due to the
increasing retention of plasma for internal IVIG production.
Adjusted EBITDA was $40.3 million for the year ended December 31, 2023, as compared to an Adjusted EBITDA loss of $27.6 million for the year ended December 31, 2022.
Adjusted EBITDA for the full year includes all non-GAAP reconciliation items, including depreciation and amortization, interest expense, stock-based compensation, loss on debt extinguishment and costs related to the IT disruption.
Net loss was $28.2 million for the year ended December 31, 2023, as compared to a net loss of $65.9 million for the year ended December 31, 2022.
Adjusted net income was $0.7 million for the year ended December 31, 2023, accounting for the non-recurring costs related to the IT systems disruption totaling $2.8 million
and the loss on extinguishment of debt totaling $26.2 million, as compared to Adjusted net loss of $59.2 million for the year ended December 31, 2022.
As of December 31, 2023, ADMA had working capital of approximately $207.2 million, primarily consisting of $172.9 million of inventory, $51.4 million of cash and cash
equivalents and $27.4 million of net accounts receivable, partially offset by current liabilities of $49.8 million, as compared to working capital at December 31, 2022 of $231.1 million, primarily consisting of $163.3 million of inventory, $86.5
million of cash and cash equivalents and $15.5 million of net accounts receivable, partially offset by current liabilities of $39.3 million.
Conference Call Information
To access the conference call seamlessly on February 28, 2024 at 4:30 PM ET, participants may register for the call here
to receive the dial-in numbers and unique PIN. It is recommended that you join 10 minutes prior to the event starting (although you may register and dial in at any time during the call). A live audio webcast of the call will be available under
"Events & Webcasts" in the investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.
An archived webcast will be available on the Company's website approximately two hours after the event.
ASCENIV (immune globulin intravenous, human - slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United
States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is
manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company's
proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and
disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company's
website at www.admabiologics.com.
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
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 ADMA Biologics at (800) 458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of
immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of
immune deficiencies and the prevention of certain infectious diseases: BIVIGAM (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV (immune globulin intravenous, human - slra 10%
liquid) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and
purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products. ADMA's
mission is to manufacture, market and develop specialty biologics, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations
who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
Use of Non-GAAP Financial Measures
This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States
("GAAP"). The Company believes Adjusted EBITDA/(loss) and Adjusted net income/(loss) are useful to investors in evaluating the Company's financial performance. The Company uses Adjusted EBITDA/(loss) and Adjusted net income/(loss) as key performance