|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
|
|
(Address of principal executive offices)
|
(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
|
Item 9.01 |
Exhibits.
|
Exhibit No.
|
Description
|
ADMA Biologics, Inc. Press Release, dated August 9, 2023
|
|
104
|
Cover Page Interactive Data File (embedded with the Inline XBRL document)
|
August 9, 2023
|
ADMA Biologics, Inc.
|
||
By:
|
/s/ Brian Lenz
|
||
Name:
|
Brian Lenz
|
||
Title:
|
Executive Vice President and Chief Financial Officer
|
• |
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.
|
o |
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.
|
o |
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.
|
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. While the exploration of value-creating opportunities remains a top corporate priority for ADMA, ADMA
has terminated its financial advisory agreement with Morgan Stanley.
|
• |
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.
|
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
|
June 30,
2023 |
December 31,
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, $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, 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
|
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
|
)
|
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
|
)
|