Full Press Release Details
ADMA Biologics Announces First Quarter 2023 Financial Results and Provides
1Q2023 Total Revenues of $57 Million, a 96% Y-o-Y Increase
1Q2023 Net Loss of $6.8 Million, a 73% Y-o-Y Improvement
Achieved Milestone First-Time Positive Adjusted EBITDA (1), Totaling $2.5 Million, Earlier Than Forecasted
FY2023 Total Revenue Now Expected to Exceed $220 Million, Increased from $210 Million
Adjusted EBITDA Growth Expected Over the Remainder of 2023
Conference Call Scheduled for Today at 4:30 p.m. ET
RAMSEY, N.J. and BOCA RATON, Fla., May 10, 2023 --
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 first quarter 2023
financial results and provided a business update.
"ADMA generated first-time Adjusted EBITDA profitability, totaling $2.5 million, during the first quarter of 2023. In addition to continued gross profit growth and
realization of operating efficiencies, this breakthrough achievement was propelled by an impressive 96% year-over-year increase in total revenues, which reached $57 million in the quarter," said Adam Grossman, President and Chief Executive Officer of
ADMA. "Based on these results, we have increased our 2023 total revenue guidance, now expected to exceed $220 million, and we anticipate continuing to grow EBITDA from the newly established baseline throughout the remainder of 2023."
Mr. Grossman continued, "With the recent reduction in interest expense resulting from the Hayfin credit amendment announced last week, as well as overall increased
operating efficiencies, we believe an opportunity to accelerate net income profitability earlier than previously anticipated is now likely. Lastly, during the first quarter, we made progress in advancing new growth initiatives that could allow ADMA
to potentially exceed 2024 and 2025 financial targets, setting the foundation for a highly profitable growth cycle over the near and longer term. We look forward to building on the momentum of early 2023 to drive further success."
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.
2023 Milestones & Objectives:
2023 & Long-Term Financial Guidance:
First Quarter 2023 Financial Results:
Total revenues for the three months ended March 31, 2023 were $56.9 million, as compared to $29.1 million during the three months ended March 31, 2022,
an increase of $27.8 million, or approximately 96%. The increase is due to increased sales of our immunoglobulin products, primarily ASCENIV and BIVIGAM, as we continue to experience increased physician, payer and patient acceptance and utilization
of ASCENIV and expand our customer base for BIVIGAM. We also benefitted from an increase in sales of normal source plasma through ADMA BioCenters of $4.0 million as we fulfilled our long-term plasma commitment for 2023 with our third-party customer.
Gross profit for the first quarter of 2023 was $16.5 million, translating to a 29.0% gross margin, as compared to $3.7 million, or a 12.6% gross
margin, for the same period of a year ago. This gross profit improvement of approximately $13.0 million was primarily driven by the revenue increases and the reduction in other manufacturing costs related to an extended, otherwise-routine plant
shutdown in the first quarter of 2022. Additionally, during the first quarter of 2023, ADMA sold a significant amount of the remaining 2,200-liter scale, lower margin BIVIGAM product. Moving forward, production throughput and sales recognition is
anticipated to be substantially confined to the higher margin 4,400-liter BIVIGAM product, along with ASCENIV.
Consolidated net loss for the quarter ended March 31, 2023 was $6.8 million, as compared to $25.0 million for the first quarter of 2022. The $18.2
million decrease in net loss was mainly due to the narrowed operating loss of $14.0 million and the loss on extinguishment of debt of $6.7 million we recorded in the first quarter of 2022 in connection with the refinancing of our senior credit
facility, partially offset by the increase in interest expense.
Adjusted EBITDA increased by $14.2 million for the three months ended March 31, 2023 to $2.5 million, as compared to an Adjusted EBITDA loss of $11.7
million the same period of a year ago. The improvement is driven primarily by increased sales and gross profit and, to a lesser extent, lower total operating expenses in 2023.
At March 31, 2023, ADMA had working capital of $227.4 million, primarily consisting of $164.0 million of inventory, cash and cash equivalents of $69.2
million and $26.5 million of accounts receivable, partially offset by current liabilities of $36.7 million.
Conference Call Information
To attend the conference call on May 10, 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.
ASCENIV (immune globulin intravenous, human - slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the 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 or ADMA Biologics and its products can be found on the Company's website at www.admabiologics.com.
BIVIGAM (immune globulin intravenous, human - 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019
and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich
syndrome, and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious
infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies. Certain data and other information about BIVIGAM or ADMA Biologics and its products can be found on the Company's
website at www.admabiologics.com.
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 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 a portion of its blood plasma for the manufacture of its
products. ADMA's mission is to manufacture, market and develop specialty plasma-derived, 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 and European Patent No.
3375789, among others, related to certain 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 EBITDA and Adjusted EBITDA are useful to investors in evaluating the Company's financial performance. The Company uses EBITDA and Adjusted EBITDA 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. 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 and Adjusted EBITDA should not be
considered as measures of financial performance under U.S. GAAP, and the items excluded from EBITDA and Adjusted EBITDA 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, financial condition and pro forma results, as well as certain underlying assumptions in
connection therewith; expected benefits from the recent Hayfin credit agreement amendment; the success of BIVIGAM and ASCENIV in future periods, including certain yield enhancement and label expansion opportunities for such products; the
higher production scale of ASCENIV and the timing for realizing related benefits; future growth opportunities; the timeline associated with net income profitability; the ability to obtain FDA approval of our ninth and tenth plasma collection centers
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.
Senior Director, Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:
Jason Finkelstein, MBA
Managing Director, Argot Partners | 212-600-1902 |
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| REVENUES | $ | 56,913,534 | $ | 29,103,093 | ||||
| Cost of product revenue | 40,400,544 | 25,441,046 | ||||||
| Gross profit | 16,512,990 | 3,662,047 | ||||||
| OPERATING EXPENSES: | ||||||||
| Research and development | 855,351 | 624,111 | ||||||
| Plasma center operating expenses | 1,780,463 | 3,974,589 | ||||||
| Amortization of intangible assets | 178,838 | 178,838 | ||||||
| Selling, general and administrative | 14,511,656 | 13,699,575 | ||||||
| Total operating expenses | 17,326,308 | 18,477,113 | ||||||
| LOSS FROM OPERATIONS | (813,318 | ) | (14,815,066 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Interest income | 166,971 | 33,068 | ||||||
| Interest expense | (6,115,484 | ) | (3,389,038 | ) | ||||
| Loss on extinguishment of debt | - | (6,669,941 | ) | |||||
| Other expense | (26,984 | ) | (166,880 | ) | ||||
| Other expense, net | (5,975,497 | ) | (10,192,791 | ) | ||||
| NET LOSS | $ | (6,788,815 | ) | $ | (25,007,857 | ) | ||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.03 | ) | $ | (0.13 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||||||
| Basic and Diluted | 221,921,750 | 195,871,932 |
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,204,163 | $ | 86,521,542 | ||||
| Accounts receivable, net | 26,518,495 | 15,505,048 | ||||||
| Inventories | 163,984,873 | 163,280,047 | ||||||
| Prepaid expenses and other current assets | 4,378,681 | 5,095,146 | ||||||
| Total current assets | 264,086,212 | 270,401,783 | ||||||
| Property and equipment, net | 57,370,783 | 58,261,481 | ||||||
| Intangible assets, net | 834,577 | 1,013,415 | ||||||
| Goodwill | 3,529,509 | 3,529,509 | ||||||
| Right to use assets | 10,247,700 | 10,485,447 | ||||||
| Deposits and other assets | 4,718,761 | 4,770,246 | ||||||
| TOTAL ASSETS | $ | 340,787,542 | $ | 348,461,881 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,956,486 | $ | 13,229,390 | ||||
| Accrued expenses and other current liabilities | 22,672,464 | 24,989,349 | ||||||
| Current portion of deferred revenue | 142,834 | 142,834 | ||||||
| Current portion of lease obligations | 956,045 | 905,369 | ||||||
| Total current liabilities | 36,727,829 | 39,266,942 | ||||||
| Senior notes payable, net of discount | 144,300,930 | 142,833,063 | ||||||
| Deferred revenue, net of current portion | 1,797,323 | 1,833,031 | ||||||
| End of term fee | 1,500,000 | 1,500,000 | ||||||
| Lease obligations, net of current portion | 10,468,109 | 10,704,176 | ||||||
| Other non-current liabilities | 338,731 | 350,454 | ||||||
| TOTAL LIABILITIES | 195,132,922 | 196,487,666 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding | - | - | ||||||
| Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 222,262,588 and 221,816,930 shares issued and outstanding | 22,226 | 22,182 | ||||||
| Additional paid-in capital | 630,437,880 | 629,968,704 | ||||||
| Accumulated deficit | (484,805,486 | ) | (478,016,671 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 145,654,620 | 151,974,215 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 340,787,542 | $ | 348,461,881 |
NON-GAAP RECONCILIATION
RECONCILIATION OF GAAP NET LOSS TO EBITDA AND ADJUSTED EBITDA
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Net loss | $ | (6,788,815 | ) | $ | (25,007,857 | ) | ||
| Depreciation | 1,854,127 | 1,411,378 | ||||||
| Amortization | 178,838 | 178,839 | ||||||
| Interest expense | 6,115,484 | 3,389,038 | ||||||
| EBITDA | 1,359,634 | (20,028,602 | ) | |||||
| Stock-based compensation | 1,110,166 | 1,641,388 | ||||||
| Loss on extinguishment of debt | - | 6,669,941 | ||||||
| Adjusted EBITDA | $ | 2,469,800 | $ | (11,717,273 | ) |