ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
- Strong financial performance in 4Q 2023 and FY 2023 with total revenue of $73.9 million and $258.2 million, respectively.
- Adjusted EBITDA for 4Q 2023 was $18.6 million, and FY 2023 was $40.3 million.
- Total revenue guidance for FY 2024 and 2025 increased to more than $330 million and $380 million, respectively.
- Net income guidance for FY 2024 and 2025 raised to more than $65 million and $115 million, respectively.
- Focus on innovative growth opportunities including manufacturing enhancements and a new pipeline for Hyperimmune Globulin.
- None.
Insights
The financial results announced by ADMA Biologics, Inc. reflect a significant milestone for the company, indicating a transition to profitability with a positive adjusted net income reported for the full year. The upward revision of revenue and earnings guidance for FY 2024 and 2025 suggests a strong confidence in the company's growth trajectory. An important aspect to consider is the margin expansion reflected by the increased Adjusted EBITDA projections, which implies improved operational efficiency and cost management. Investors should closely monitor the company's ability to meet these forecasts, as they will have material implications for the stock's valuation. The guidance increase may also lead to a re-rating of the stock by the market, potentially affecting the price multiples investors are willing to pay for future earnings.
ADMA's emphasis on the expansion of ASCENIV utilization within the immune deficient patient segment is crucial for sustained growth. The biologic production yield enhancement initiative is particularly noteworthy as it seeks to increase the output of immune globulin without additional raw materials, which could significantly improve cost-effectiveness. Additionally, the development of the S. pneumonia hyperimmune globulin pipeline addresses a clear unmet medical need given the prevalence of community-acquired pneumonia and rising anti-infective resistance. The success of these initiatives could not only bolster the company's financials but also enhance its competitive position within the specialty biologics market.
Understanding the broader market implications of ADMA's financial results and guidance is essential. The specialty biologics sector is highly competitive and ADMA's ability to carve out a niche in the immune deficient patient segment is indicative of a strategic focus that could pay dividends. The market will be observing how ADMA's innovative growth opportunities and R&D capabilities translate into capturing market share and whether these can offset potential risks such as regulatory hurdles and market saturation. The company's forward-looking statements about de-risking growth initiatives and potential impact on peak revenue and earnings targets suggest a calculated approach to scaling its operations and pursuing sustainable long-term growth.
4Q 2023 Total Revenue of
4Q 2023 Adjusted EBITDA(1) of
4Q 2023 Adjusted Net Income(2) of
FY 2024 and 2025 Total Revenue Guidance Increased to More Than
FY 2024 Net Income Guidance Increased to More Than
FY 2025 Net Income Guidance Increased to More than
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, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- 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:
- FY 2024 and 2025 total revenue now expected to be more than
$330 million and$380 million , respectively, increased from prior guidance of$320 million and$370 million , respectively - FY 2024 and 2025 net income now expected to exceed
$65 million and$115 million , respectively, increased from prior guidance of$60 million and$110 million , respectively - FY 2024 Adjusted EBITDA now anticipated to exceed
$90 million , increased from$85 million previously; FY 2025 Adjusted EBITDA expected to exceed$140 million
Innovative Growth Opportunities: Below are the Company’s ongoing initiatives which, if successful, represent potential upside to newly provided guidance ranges:
- Biologic Production Yield Enhancement: The Company continues to progress with development scale and laboratory analyses, advancing the Company’s initiative to capture additional immune globulin (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, we believe these yield enhancements will potentially provide significant upside to the Company’s peak financial targets in the future.
- New Pipeline Introduction - S. pneumonia Hyperimmune Globulin:
- 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$300 -500 million. - ADMA 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.
- 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
- ASCENIV Label Expansion: The ongoing post-marketing pediatric clinical study for ASCENIV may provide label expansion opportunities, further strengthening ADMA’s product portfolio compared to peers, if successful.
Fourth Quarter 2023 Financial Results:
Total revenues were
Adjusted EBITDA was
Net loss was
Adjusted net income was
Full Year 2023 Financial Results:
Total revenues were
Adjusted EBITDA was
Net loss was
Adjusted net income was
As of December 31, 2023, ADMA had working capital of approximately
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.
About ASCENIV™
ASCENIV (immune globulin intravenous, human – slra
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 (≥
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
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 measures because we believe that they facilitate operating performance comparisons from period to period that exclude potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as, in the case of Adjusted EBITDA, stock-based compensation or certain non-recurring items, and in the case of Adjusted net income, certain non-recurring items. The Company believes that investors should have access to the same set of tools used by our management and board of directors to assess our operating performance. Adjusted EBITDA/(loss) and Adjusted net income/(loss) should not be considered as measures of financial performance under GAAP, and the items excluded from Adjusted EBITDA/(loss) and Adjusted net income/(loss) are significant components in understanding and assessing the Company’s financial performance. Accordingly, these key business metrics have limitations as an analytical tool. They should not be considered as an alternative to net income/loss or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. Please refer to the tables below for the reconciliation of GAAP measures to these non-GAAP measures for applicable periods.
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 ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s future results of operations, including, but not limited to, revenue, net income and Adjusted EBITDA guidance in future periods, and certain assumptions in connection therewith; the market for ASCENIV and BIVIGAM; and additional growth opportunities, including but not limited to, the Company’s yield enhancement initiative, the newly announced hIG pipeline program targeting S. pneumonia (including the revenue potential) and ASCENIV label expansion. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT:
Skyler Bloom
Senior Director, Corporate Strategy and Business Development | 201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:
Michelle Pappanastos
Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com
| ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| REVENUES | $ | 73,904 | $ | 49,981 | $ | 258,215 | $ | 154,080 | ||||||||
| Cost of product revenue | 42,817 | 35,804 | 169,273 | 118,815 | ||||||||||||
| Gross profit | 31,087 | 14,177 | 88,942 | 35,265 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | 445 | 1,074 | 3,300 | 3,614 | ||||||||||||
| Plasma center operating expenses | 685 | 5,088 | 4,266 | 17,843 | ||||||||||||
| Amortization of intangible assets | 187 | 179 | 724 | 715 | ||||||||||||
| Selling, general and administrative | 15,535 | 13,895 | 59,020 | 52,458 | ||||||||||||
| Total operating expenses | 16,852 | 20,236 | 67,310 | 74,630 | ||||||||||||
| INCOME (LOSS) FROM OPERATIONS | 14,235 | (6,059 | ) | 21,632 | (39,365 | ) | ||||||||||
| OTHER INCOME (EXPENSE): | ||||||||||||||||
| Interest income | 612 | 2 | 1,617 | 45 | ||||||||||||
| Interest expense | (6,215 | ) | (5,737 | ) | (25,027 | ) | (19,279 | ) | ||||||||
| Loss on extinguishment of debt | (26,174 | ) | - | (26,174 | ) | (6,670 | ) | |||||||||
| Other expense | (101 | ) | (438 | ) | (287 | ) | (635 | ) | ||||||||
| Other expense, net | (31,878 | ) | (6,173 | ) | (49,871 | ) | (26,539 | ) | ||||||||
| NET LOSS | $ | (17,643 | ) | $ | (12,232 | ) | $ | (28,239 | ) | $ | (65,904 | ) | ||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.08 | ) | $ | (0.06 | ) | $ | (0.13 | ) | $ | (0.33 | ) | ||||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||||||||||||||
| Basic and Diluted | 225,968,387 | 202,830,446 | 223,977,315 | 197,874,895 | ||||||||||||
| ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS | |||||||
| December 31, | December 31, | ||||||
| 2023 | 2022 | ||||||
| (Unaudited) | |||||||
| (In thousands, except share data) | |||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 51,352 | $ | 86,522 | |||
| Accounts receivable, net | 27,421 | 15,505 | |||||
| Inventories | 172,906 | 163,280 | |||||
| Prepaid expenses and other current assets | 5,334 | 5,095 | |||||
| Total current assets | 257,013 | 270,402 | |||||
| Property and equipment, net | 53,835 | 58,261 | |||||
| Intangible assets, net | 499 | 1,013 | |||||
| Goodwill | 3,530 | 3,530 | |||||
| Right-to-use assets | 9,635 | 10,485 | |||||
| Deposits and other assets | 4,670 | 4,770 | |||||
| TOTAL ASSETS | $ | 329,182 | $ | 348,461 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 15,660 | $ | 13,229 | |||
| Accrued expenses and other current liabilities | 32,919 | 24,990 | |||||
| Current portion of deferred revenue | 182 | 143 | |||||
| Current portion of lease obligations | 1,045 | 905 | |||||
| Total current liabilities | 49,806 | 39,267 | |||||
| Senior notes payable, net of discount | 130,594 | 142,833 | |||||
| Deferred revenue, net of current portion | 1,690 | 1,833 | |||||
| End of term fee | 1,688 | 1,500 | |||||
| Lease obligations, net of current portion | 9,779 | 10,704 | |||||
| Other non-current liabilities | 419 | 350 | |||||
| TOTAL LIABILITIES | 193,976 | 196,487 | |||||
| COMMITMENTS AND CONTINGENCIES | |||||||
| STOCKHOLDERS' EQUITY | |||||||
| Preferred Stock, | - | - | |||||
| Common Stock - voting, | 23 | 22 | |||||
| Additional paid-in capital | 641,439 | 629,969 | |||||
| Accumulated deficit | (506,256 | ) | (478,017 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY | 135,206 | 151,974 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 329,182 | $ | 348,461 | |||
| NON-GAAP RECONCILIATION RECONCILIATION OF GAAP NET (LOSS) TO ADJUSTED NET INCOME (LOSS) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||
| Net loss | $ | (17,643 | ) | $ | (12,232 | ) | $ | (28,239 | ) | $ | (65,904 | ) | |||
| Loss on extinguishment of debt | 26,174 | - | 26,174 | 6,670 | |||||||||||
| IT systems disruption | - | - | 2,770 | - | |||||||||||
| Adjusted net income (loss) | $ | 8,531 | $ | (12,232 | ) | $ | 705 | $ | (59,234 | ) | |||||
| NON-GAAP RECONCILIATION RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||
| Net loss | $ | (17,643 | ) | $ | (12,232 | ) | $ | (28,239 | ) | $ | (65,904 | ) | |||
| Depreciation | 1,921 | 1,758 | 7,608 | 6,398 | |||||||||||
| Amortization | 188 | 178 | 724 | 715 | |||||||||||
| Interest expense | 6,215 | 5,737 | 25,027 | 19,279 | |||||||||||
| EBITDA | (9,319 | ) | (4,559 | ) | 5,120 | (39,512 | ) | ||||||||
| Stock-based compensation | 1,745 | 1,069 | 6,187 | 5,215 | |||||||||||
| IT systems disruption | - | - | 2,770 | - | |||||||||||
| Loss on extinguishment of debt | 26,174 | - | 26,174 | 6,670 | |||||||||||
| Adjusted EBITDA | $ | 18,600 | $ | (3,490 | ) | $ | 40,251 | $ | (27,627 | ) | |||||
FAQ
What was ADMA Biologics, Inc.'s total revenue for 4Q 2023?
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What growth opportunities is ADMA focusing on?
