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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Item 2.02 |
Results of Operations and Financial Condition
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Item 9.01 |
Exhibits.
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Exhibit No.
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Description
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ADMA Biologics, Inc. Press Release, dated November 8, 2023
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|
104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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November 8, 2023
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ADMA Biologics, Inc.
|
||
By:
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/s/ Brian Lenz
|
||
Name:
|
Brian Lenz
|
||
Title:
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Executive Vice President and Chief Financial Officer
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• |
Increased Revenue Guidance for Full Years (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
$250 million in 2023 and generating more than $290 million and $335 million for 2024 and 2025, respectively.
|
• |
Significant Growth in Underlying Profitability. Driven by 64% year-over-year revenue growth and an expansion of gross margins to 36.6%, ADMA grew Adjusted EBITDA to $12.7 million during the third quarter.
Additionally, ADMA achieved first-time net income profitability, totaling $2.6 million, and generated first-time positive operating cash flow of $12.0 million. The Company anticipates maintaining this momentum throughout the remainder of
2023 and beyond.
|
• |
Meaningful Presence at Medical Congress. At the Annual 2023 IDWeek International Conference, ADMA sponsored a symposium with two national clinical experts.
|
o |
Dr. Aliyah Baluch, MD, MSc discussed the heightened severity of respiratory viral infections (RVIs) in immunocompromised patients, with up to 80% mortality risk in some cases. She emphasized the lack of a standard RVI management approach,
leading to an unmet need. Dr. Baluch also touched on emerging therapies.
|
o |
Dr. Jolan Walter, MD, PhD highlighted the evolving approach to managing infectious diseases in immunocompromised patients, focusing on RVI management. She introduced ASCENIV, a unique intravenous immune globulin with increased titers
against respiratory pathogens. Dr. Walter presented a case where ASCENIV effectively managed recurrent respiratory infections that were unresponsive to standard immunoglobulin therapy, and shared her own real-world experience, demonstrating
its clinical impact.
|
o |
Dr. Jolan Walter stated, “Given the unique plasma composition and antibody titers of ASCENIV™, the product is well equipped to manage at-risk immunocompromised patients in both the preventive and treatment settings.”
|
• |
Mix Continues to Favorably Evolve. ASCENIV’s prescriber and patient base continued to expand during the third quarter of 2023, which drove record utilization and pull-through for the product. ADMA currently expects that the
product’s rapid growth will continue for the foreseeable future. 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 third 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.
|
o |
Expanded ASCENIV Production Scale: During the third quarter, ADMA successfully advanced production and filling of multiple ASCENIV batches produced 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 beginning in late 2023 and more
materially in 2024 and beyond.
|
o |
Yield Enhancement Opportunities: The Company continued to make progress during the third quarter of 2023 with development scale and laboratory analyses, advancing ADMA’s initiative to capture additional IG production yields.
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.
|
o |
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. The exploration of value-creating opportunities remains a top corporate priority.
|
• |
Updated 2023 Financial Guidance: ADMA now anticipates FY 2023 total revenues to exceed $250 million, increased from $240 million previously. Further, ADMA anticipates continued growth in Net Income and Adjusted EBITDA over the
remainder of 2023.
|
• |
Updated 2024-2025 Financial Guidance: The Company increased its intermediate term financial guidance, and now anticipates FY 2024 and 2025 total revenues to exceed $290 million and $335 million, respectively, raised from at
least $275 million and $320 million, respectively, previously. Importantly, continued product mix shifts as well as optionality from identified growth initiatives, notably yield enhancement, represent potential 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 excess of $110-$160 million and $55-$100 million, respectively, during the 2024-2025 time periods.
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
REVENUES
|
$
|
67,274,598
|
$
|
41,090,137
|
$
|
184,311,323
|
$
|
104,098,237
|
||||||||
Cost of product revenue
|
42,622,013
|
31,433,496
|
126,455,745
|
83,010,156
|
||||||||||||
Gross profit
|
24,652,585
|
9,656,641
|
57,855,578
|
21,088,081
|
||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
595,903
|
1,041,947
|
2,854,514
|
2,539,444
|
||||||||||||
Plasma center operating expenses
|
466,898
|
4,859,450
|
3,580,785
|
12,755,525
|
||||||||||||
Amortization of intangible assets
|
178,838
|
178,838
|
536,514
|
536,514
|
||||||||||||
Selling, general and administrative
|
14,725,787
|
12,893,139
|
43,485,001
|
38,563,136
|
||||||||||||
Total operating expenses
|
15,967,426
|
18,973,374
|
50,456,814
|
54,394,619
|
||||||||||||
INCOME (LOSS) FROM OPERATIONS
|
8,685,159
|
(9,316,733
|
)
|
7,398,764
|
(33,306,538
|
)
|
||||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
Interest income
|
423,276
|
7,236
|
1,004,551
|
42,573
|
||||||||||||
Interest expense
|
(6,397,553
|
)
|
(5,580,366
|
)
|
(18,812,144
|
)
|
(13,542,419
|
)
|
||||||||
Loss on extinguishment of debt
|
-
|
-
|
-
|
(6,669,941
|
)
|
|||||||||||
Other expense
|
(145,827
|
)
|
(9,641
|
)
|
(185,638
|
)
|
(195,942
|
)
|
||||||||
Other expense, net
|
(6,120,104
|
)
|
(5,582,771
|
)
|
(17,993,231
|
)
|
(20,365,729
|
)
|
||||||||
NET INCOME (LOSS)
|
$
|
2,565,055
|
$
|
(14,899,504
|
)
|
$
|
(10,594,467
|
)
|
$
|
(53,672,267
|
)
|
|||||
BASIC INCOME (LOSS) PER COMMON SHARE
|
$
|
0.01
|
$
|
(0.08
|
)
|
$
|
(0.05
|
)
|
$
|
(0.27
|
)
|
|||||
DILUTED INCOME (LOSS) PER COMMON SHARE
|
$
|
0.01
|
$
|
(0.08
|
)
|
$
|
(0.05
|
)
|
$
|
(0.27
|
)
|
|||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||||||||||
Basic
|
225,276,980
|
196,383,935
|
223,306,331
|
196,204,893
|
||||||||||||
Diluted
|
233,761,262
|
196,383,935
|
223,306,331
|
196,204,893
|
September 30,
|
December 31,
|
|||||||
2023
|
2022
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
74,156,765
|
$
|
86,521,542
|
||||
Accounts receivable, net
|
31,318,680
|
15,505,048
|
||||||
Inventories
|
163,116,105
|
163,280,047
|
||||||
Prepaid expenses and other current assets
|
5,107,455
|
5,095,146
|
||||||
Total current assets
|
273,699,005
|
270,401,783
|
||||||
Property and equipment, net
|
54,814,607
|
58,261,481
|
||||||
Intangible assets, net
|
476,902
|
1,013,415
|
||||||
Goodwill
|
3,529,509
|
3,529,509
|
||||||
Right to use assets
|
9,753,725
|
10,485,447
|
||||||
Deposits and other assets
|
6,722,817
|
4,770,246
|
||||||
TOTAL ASSETS
|
$
|
348,996,565
|
$
|
348,461,881
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
10,851,446
|
$
|
13,229,390
|
||||
Accrued expenses and other current liabilities
|
29,863,726
|
24,989,349
|
||||||
Current portion of deferred revenue
|
142,834
|
142,834
|
||||||
Current portion of lease obligations
|
982,891
|
905,369
|
||||||
Total current liabilities
|
41,840,897
|
39,266,942
|
||||||
Senior notes payable, net of discount
|
142,025,542
|
142,833,063
|
||||||
Deferred revenue, net of current portion
|
1,725,906
|
1,833,031
|
||||||
End of term fee
|
1,567,139
|
1,500,000
|
||||||
Lease obligations, net of current portion
|
9,965,088
|
10,704,176
|
||||||
Other non-current liabilities
|
434,647
|
350,454
|
||||||
TOTAL LIABILITIES
|
197,559,219
|
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, 225,958,084 and 221,816,930 shares issued and outstanding
|
22,596
|
22,182
|
||||||
Additional paid-in capital
|
640,025,888
|
629,968,704
|
||||||
Accumulated deficit
|
(488,611,138
|
)
|
(478,016,671
|
)
|
||||
TOTAL STOCKHOLDERS' EQUITY
|
151,437,346
|
151,974,215
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
348,996,565
|
$
|
348,461,881
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Net income (loss)
|
$
|
2,565,055
|
$
|
(14,899,504
|
)
|
$
|
(10,594,467
|
)
|
$
|
(53,672,267
|
)
|
|||||
Depreciation
|
1,913,669
|
1,683,154
|
5,686,536
|
4,639,978
|
||||||||||||
Amortization
|
178,838
|
178,838
|
536,514
|
536,514
|
||||||||||||
Interest expense
|
6,397,553
|
5,580,366
|
18,812,144
|
13,542,419
|
||||||||||||
EBITDA
|
11,055,115
|
(7,457,146
|
)
|
14,440,727
|
(34,953,356
|
)
|
||||||||||
Stock-based compensation
|
1,694,641
|
1,313,494
|
4,441,845
|
4,145,929
|
||||||||||||
IT systems disruption
|
-
|
-
|
2,769,972
|
-
|
||||||||||||
Loss on extinguishment of debt
|
-
|
-
|
-
|
6,669,941
|
||||||||||||
Adjusted EBITDA
|
$
|
12,749,756
|
$
|
(6,143,652
|
)
|
$
|
21,652,544
|
$
|
(24,137,486
|
)
|