ADMA Biologics Announces Second Quarter 2023 Financial Results and Provides Business Update
- Impressive 77% YoY revenue growth rate
- 160% Q-o-Q improvement in Adjusted EBITDA
- 74% Y-o-Y improvement in Adjusted Net Loss
- Increased revenue guidance for FY 2023, 2024, and 2025
- Strong momentum and prudent expense management
- None.
2Q2023 Total Revenues of
2Q2023 Adjusted EBITDA(1) of
2Q2023 Adjusted Net Loss(2) of
FY2023 Total Revenue Now Expected to Exceed
Adjusted EBITDA Growth Expected Over the Remainder of 2023
FY2024 and 2025 Total Revenue Guidance Increased to
Conference Call Scheduled for Today at 4:30 p.m. ET
RAMSEY, N.J. and BOCA RATON, Fla., Aug. 09, 2023 (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 plasma-derived biologics, today announced its second quarter 2023 financial results and provided a business update.
“We achieved an impressive
Mr. Grossman continued, “The strong momentum achieved in 2023 has given us the confidence to increase our total revenue guidance for FY 2023, 2024 and 2025. Our innovative business model has enabled ADMA to successfully establish inroads into the substantially underpenetrated immune deficient patient population. We are confident that identified growth opportunities within this targeted patient segment will enable us to meet or exceed the newly increased financial guidance."
(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 Loss is a non-GAAP financial measure. For a reconciliation of Adjusted Net Loss to the most comparable GAAP measure, please see the reconciliation included in the financial tables.
Second Quarter 2023 Milestones & Objectives:
- Increased Revenue Guidance for FY 2023, 2024 and 2025. Enabled by strong year-to-date momentum, ADMA increased its revenue outlook for FY 2023, 2024 and 2025. The Company now anticipates exceeding total revenues of
$240 million in 2023, and generating at least$275 million and$325 million for 2024 and 2025, respectively. - Significant Growth in Underlying Profitability. Driven by
77% year-over-year revenue growth, which reached$60.1 million during the second quarter of 2023, ADMA grew Adjusted EBITDA to$6.4 million . The rapid growth in Adjusted EBITDA excludes approximately$2.8 million in nonrecurring charges related to an IT disruption that took place during the second quarter of 2023, which impacted certain ADMA systems. The Company took responsive steps to the IT disruption and normal course production has resumed. Most of this nonrecurring charge was included in the cost of goods sold for the second quarter; normalizing for this impact, ADMA’s estimated consolidated gross margins would have been 31-32% for the second quarter. The Company anticipates maintaining this momentum throughout the remainder of 2023 by focusing on increasing gross profits, managing expenses, and building on the nascent Adjusted EBITDA baseline. - Clinically Meaningful Data Presented at Medical Symposia. At the Annual 2023 Clinical Immunology Society (CIS) Meeting, ADMA sponsored a symposium in conjunction with a national clinical expert, “Challenges Associated with Respiratory Viral Infections (RVI) in Patients with Primary Immunodeficiency: An Expert Discussion & Real-World Experience.” Despite traditional standard of care and standard immunoglobulin (IG) therapy, the expert presenter noted that >
90% of patients with primary immunodeficiency (PI) continue to suffer from recurrent infections and associated complications. Clinical data presented highlighted that more than one-third of this patient population continues to experience bronchiectasis, along with a rapid decline in lung function, adversely impacting outcomes and quality of life. Of particular significance, certain patients with PI exhibit T-cell defects and thus typically experience prolonged RVIs that present risk for bacterial superinfections and poor outcomes. The expert presented a clinical case report in which patients at risk were successfully treated with ADMA’s unique Immune Globulin Intravenous (IVIG) intervention, ASCENIV™. - Mix Continues to Favorably Evolve. ASCENIV’s prescriber and patient base continued to expand during the second quarter of 2023, which drove record utilization and pull-through for the product. ADMA currently expects that the product’s rapid growth will continue throughout 2023 and beyond. Continued product mix shift towards ADMA’s higher margin product beyond current levels represents potential upside to the newly increased revenue guidance, should it occur.
- Advanced Growth Initiatives. During the second quarter of 2023, the Company made progress advancing its identified growth opportunities. These initiatives, if successful, may provide potential upside to the FY 2024 and 2025 revenue and earnings guidance.
- Expanded ASCENIV Production Scale: During the second quarter, ADMA successfully advanced production of multiple batches of ASCENIV at the expanded, 4,400 Liter production scale. The Company expects that this expansion will meaningfully improve the product’s margin profile and increase plant production capacity as fewer batches will be needed to support revenue goals. We believe these benefits could be realized in earnest beginning in late 2023.
- Yield Enhancement Opportunities: The Company continued to make progress during the second quarter of 2023 with development scale and laboratory analyses, advancing ADMA’s initiative to capture additional IG production yields, from the same quantities of starting plasma. These initiatives are subject to further evaluation, validation of commercial-scale production as well as requisite regulatory review. Should they prove successful, these yield enhancements will potentially provide significant upside to the Company’s peak financial targets.
- Label Expansion: The ongoing post-marketing clinical studies are progressing and may provide label expansion opportunities, further strengthening ADMA’s product portfolio compared to peers, if successful.
- On-Track BioCenters Expansion. The Company’s BioCenters segment now has nine U.S. Food and Drug Administration (FDA)-licensed collection centers with one additional center operational, collecting plasma and pending FDA licensure. The Company remains on track to have all ten BioCenters FDA-licensed by year-end 2023 and, in the same period, forecasts raw material plasma supply self-sufficiency. ADMA anticipates its strong plasma supply position will support its upwardly revised production and revenue forecasts.
- Ongoing Strategic Review. ADMA continues to evaluate a variety of strategic alternatives. While the exploration of value-creating opportunities remains a top corporate priority for ADMA, ADMA has terminated its financial advisory agreement with Morgan Stanley.
2023 & Long-Term Financial Guidance:
- Updated 2023 Financial Guidance: ADMA now anticipates full year 2023 total revenues to meet or exceed
$240 million , increased from$220 million previously. Further, ADMA anticipates continued growth in Adjusted EBITDA profitability over the remainder of 2023. While the guidance framework considers several macroeconomic uncertainties, should ADMA’s current demand trends and margin dynamics sustain, accelerated net income profitability timelines may be achievable. - Updated 2024-2025 Financial Guidance: The Company increased its intermediate term financial guidance, and now anticipates FY 2024 and 2025 total revenues to reach at least
$275 million and$325 million , respectively, raised from at least$250 million and$300 million , respectively, previously. Importantly, continued product mix shifts as well as optionality from identified growth initiatives, notably yield enhancement, represent upside to these newly provided ranges. At these revenue levels, ADMA continues to forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30% . These assumptions translate to potential annual gross profit and net income in the range of$110 -160 million and$55 -100 million, respectively, during the 2024-2025 time period and beyond.
Second Quarter 2023 Financial Results:
Total revenues for the three months ended June 30, 2023 were
Gross profit for the three months ended June 30, 2023 was
Consolidated net loss was
ADMA grew Adjusted EBITDA to
At June 30, 2023, ADMA had working capital of
Conference Call Information
To attend the conference call on August 9, 2023 at 4:30 PM ET, participants may register for the call here to receive the dial-in numbers and unique PIN to access the call seamlessly. 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
About BIVIGAM®
BIVIGAM (immune globulin intravenous, human –
About ADMA BioCenters
ADMA BioCenters operates FDA-licensed facilities specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional, and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived 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 EBITDA, Adjusted EBITDA and Adjusted Net Loss are useful to investors in evaluating the Company’s financial performance. The Company uses EBITDA, Adjusted EBITDA and Adjusted Net 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 and Adjusted Net Loss, stock-based compensation or 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. EBITDA, Adjusted EBITDA and Adjusted Net Loss should not be considered as measures of financial performance under U.S. GAAP, and the items excluded from EBITDA, Adjusted EBITDA and Adjusted Net 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 U.S. 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.
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., and its subsidiaries (collectively, “our”, “ADMA” 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 “anticipates,” “believes,” “could,” “can,” “estimates,” “expects,” “forecasts,” “intends,” “may,” “plans,” “predicts,” “projects,” “should,” “targets,” “will,” “would,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA’s future results of operations and certain non-GAAP reconciliations, expense management, financial condition and pro forma results, as well as certain underlying assumptions in connection therewith; the success of ASCENIV™ in future periods and its impact on future results of operations; yield enhancement and label expansion opportunities for the Company’s product portfolio; the higher production scale of ASCENIV and the timing for realizing related benefits; the impact of growth initiatives on our financial outlook; the timeline associated with net income profitability; the ability to obtain FDA approval of our tenth plasma collection center and the associated timing in connection therewith; and the ability to achieve source plasma self-sufficiency and the associated timing in connection therewith, as well as benefits thereof. 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 SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT:
Skyler Bloom
Senior Director, Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:
Jason Finkelstein
Managing Director, Argot Partners | 212-600-1902 | jason@argotpartners.com
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
REVENUES | $ | 60,123,191 | $ | 33,905,007 | $ | 117,036,725 | $ | 63,008,100 | |||||||
Cost of product revenue | 43,433,188 | 26,135,614 | 83,833,732 | 51,576,660 | |||||||||||
Gross profit | 16,690,003 | 7,769,393 | 33,202,993 | 11,431,440 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | 1,403,260 | 873,386 | 2,258,611 | 1,497,497 | |||||||||||
Plasma center operating expenses | 1,333,424 | 3,921,486 | 3,113,887 | 7,896,075 | |||||||||||
Amortization of intangible assets | 178,838 | 178,838 | 357,676 | 357,676 | |||||||||||
Selling, general and administrative | 14,247,558 | 11,970,422 | 28,759,214 | 25,669,997 | |||||||||||
Total operating expenses | 17,163,080 | 16,944,132 | 34,489,388 | 35,421,245 | |||||||||||
LOSS FROM OPERATIONS | (473,077 | ) | (9,174,739 | ) | (1,286,395 | ) | (23,989,805 | ) | |||||||
OTHER INCOME (EXPENSE): | |||||||||||||||
Interest income | 414,304 | 2,269 | 581,275 | 35,337 | |||||||||||
Interest expense | (6,299,107 | ) | (4,573,015 | ) | (12,414,591 | ) | (7,962,053 | ) | |||||||
Loss on extinguishment of debt | - | - | - | (6,669,941 | ) | ||||||||||
Other expense | (12,827 | ) | (19,421 | ) | (39,811 | ) | (186,301 | ) | |||||||
Other expense, net | (5,897,630 | ) | (4,590,167 | ) | (11,873,127 | ) | (14,782,958 | ) | |||||||
NET LOSS | $ | (6,370,707 | ) | $ | (13,764,906 | ) | $ | (13,159,522 | ) | $ | (38,772,763 | ) | |||
BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.03 | ) | $ | (0.07 | ) | $ | (0.06 | ) | $ | (0.20 | ) | |||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||||||
Basic and Diluted | 222,683,393 | 196,353,185 | 222,304,676 | 196,113,888 | |||||||||||
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, | December 31, | ||||||
2023 | 2022 | ||||||
ASSETS | (Unaudited) | ||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 62,512,889 | $ | 86,521,542 | |||
Accounts receivable, net | 36,731,612 | 15,505,048 | |||||
Inventories | 161,780,063 | 163,280,047 | |||||
Prepaid expenses and other current assets | 5,218,735 | 5,095,146 | |||||
Total current assets | 266,243,299 | 270,401,783 | |||||
Property and equipment, net | 56,305,620 | 58,261,481 | |||||
Intangible assets, net | 655,740 | 1,013,415 | |||||
Goodwill | 3,529,509 | 3,529,509 | |||||
Right to use assets | 10,003,826 | 10,485,447 | |||||
Deposits and other assets | 6,289,048 | 4,770,246 | |||||
TOTAL ASSETS | $ | 343,027,042 | $ | 348,461,881 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 12,084,529 | $ | 13,229,390 | |||
Accrued expenses and other current liabilities | 28,745,598 | 24,989,349 | |||||
Current portion of deferred revenue | 142,834 | 142,834 | |||||
Current portion of lease obligations | 979,536 | 905,369 | |||||
Total current liabilities | 41,952,497 | 39,266,942 | |||||
Senior notes payable, net of discount | 140,312,070 | 142,833,063 | |||||
Deferred revenue, net of current portion | 1,761,614 | 1,833,031 | |||||
End of term fee | 1,567,139 | 1,500,000 | |||||
Lease obligations, net of current portion | 10,221,914 | 10,704,176 | |||||
Other non-current liabilities | 449,513 | 350,454 | |||||
TOTAL LIABILITIES | 196,264,747 | 196,487,666 | |||||
COMMITMENTS AND CONTINGENCIES | |||||||
STOCKHOLDERS' EQUITY | |||||||
Preferred Stock, | |||||||
no shares issued and outstanding | - | - | |||||
Common Stock - voting, | |||||||
224,526,748 and 221,816,930 shares issued and outstanding | 22,453 | 22,182 | |||||
Additional paid-in capital | 637,916,035 | 629,968,704 | |||||
Accumulated deficit | (491,176,193 | ) | (478,016,671 | ) | |||
TOTAL STOCKHOLDERS' EQUITY | 146,762,295 | 151,974,215 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 343,027,042 | $ | 348,461,881 | |||
NON-GAAP RECONCILIATIONS
RECONCILIATION OF GAAP NET LOSS TO EBITDA AND ADJUSTED EBITDA
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Net loss | $ | (6,370,707 | ) | $ | (13,764,906 | ) | $ | (13,159,522 | ) | $ | (38,772,763 | ) | |||
Depreciation | 1,918,739 | 1,545,444 | 3,772,866 | 2,956,824 | |||||||||||
Amortization | 178,838 | 178,838 | 357,676 | 357,676 | |||||||||||
Interest expense | 6,299,107 | 4,573,015 | 12,414,591 | 7,962,053 | |||||||||||
EBITDA | 2,025,977 | (7,467,609 | ) | 3,385,611 | (27,496,210 | ) | |||||||||
Stock-based compensation | 1,637,038 | 1,191,047 | 2,747,204 | 2,832,435 | |||||||||||
IT systems disruption | 2,769,972 | - | 2,769,972 | - | |||||||||||
Loss on extinguishment of debt | - | - | - | 6,669,941 | |||||||||||
Adjusted EBITDA | $ | 6,432,987 | $ | (6,276,562 | ) | $ | 8,902,787 | $ | (17,993,834 | ) | |||||
RECONCILIATION OF GAAP NET LOSS TO ADJUSTED NET LOSS
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Net loss | $ | (6,370,707 | ) | $ | (13,764,906 | ) | $ | (13,159,522 | ) | $ | (38,772,763 | ) | |||
IT systems disruption | 2,769,972 | - | 2,769,972 | - | |||||||||||
Adjusted Net Loss | $ | (3,600,735 | ) | $ | (13,764,906 | ) | $ | (10,389,550 | ) | $ | (38,772,763 | ) |
FAQ
What are ADMA Biologics, Inc.'s 2Q2023 Total Revenues?
What is the Adjusted EBITDA growth expected over the remainder of 2023?
What is the FY2024 and 2025 Total Revenue Guidance?