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(Exact name of registrant as specified in its charter)
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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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(Former name or former address, if changed since last report.)
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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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(d) |
Exhibits
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Exhibit No. | Description |
ADMA Biologics, Inc. Press Release, dated May 10, 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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May 10, 2023
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ADMA Biologics, Inc.
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||
By:
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/s/ Brian Lenz
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||
Name:
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Brian Lenz
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||
Title:
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Executive Vice President and Chief Financial Officer
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• |
Accelerated Adjusted EBITDA Profitability. Driven by 96%
year-over-year revenue growth, which reached $57 million during the first quarter, and the resulting operating efficiencies, ADMA achieved first-time Adjusted EBITDA profitability, totaling $2.5 million and ahead of the forecasted
timeline. The Company anticipates maintaining this momentum throughout the remainder of 2023 by focusing on increasing gross profits, managing expenses, and building on the newly established Adjusted EBITDA baseline.
|
• |
Lowered Cost of Capital. The Company's financial position has
been strengthened by its recent credit amendment with Hayfin Capital Management (“Hayfin”), which reduced its interest rate and increased prepayment flexibility. The amendment includes
several favorable changes that are expected to benefit the Company and its stockholders. In addition to the 1% reduction in the nominal interest rate, the amendment allows for a newly structured 50% waiver of the prepayment fee upon an
acquisition of the Company, among other scenarios further detailed in our Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) on May 2, 2023. These changes are expected to provide the Company with greater
financial flexibility and support as it explores value-creating opportunities for its stockholders.
|
• |
Advanced Growth Initiatives. During the first quarter, the
Company made progress advancing its recently identified growth opportunities. These initiatives may provide an opportunity to accelerate net income profitability earlier than previously provided without requiring significant additional
resources.
|
o |
Expanded ASCENIV Production Scale: ADMA successfully commenced
manufacturing of ASCENIV at the 4,400 Liter production scale for the first time in corporate history. We expect 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 as early as the second half of 2023.
|
o |
Yield Enhancement Opportunities: The Company progressed
development scale and laboratory analyses to advance its initiative aiming to capture additional Immunoglobulin production yields, which could significantly increase both peak revenues as well as margin potential, if successful.
|
o |
Label Expansion: The post-marketing clinical studies have
progressed as planned, and if successful, may provide for label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric-aged primary humoral immunodeficiency (PI) patients as well as additional publications supporting
product safety.
|
• |
Legacy Lower Margin BIVIGAM Inventory Depleted. As previously
communicated, an appreciable portion of the BIVIGAM product revenues during the first quarter of 2023 were attributable to the lower margin, legacy product. The
accelerated monetization of the product was enabled by record product demand and channel pull-through. As a result, ADMA anticipates material BIVIGAM gross margin expansion over the coming quarters.
|
• |
On-Track BioCenters Expansion. The Company’s BioCenters
segment now has eight U.S. Food and Drug Administration (FDA)-licensed collection centers with two additional centers operational and collecting plasma 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.
|
• |
Product Mix Continues to Favorably Evolve. ASCENIV’s
prescriber and patient base continued to expand during the first quarter of 2023, which drove record utilization and pull-through for the product. ADMA currently expects the product’s rapid growth will continue throughout 2023 and beyond.
|
• |
Ongoing Strategic Review. ADMA continues to evaluate a
variety of strategic alternatives through its ongoing engagement with Morgan Stanley. The exploration of value-creating opportunities remains a top corporate priority for ADMA.
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• |
2023 Financial Guidance: ADMA now anticipates full year 2023
total revenues to exceed $220 million. From the newly established $2.5 million Adjusted EBITDA base, ADMA anticipates continued growth in Adjusted EBITDA profitability over the course 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.
|
• |
2024-2025 Financial Guidance: The Company anticipates
generating approximately $250 million or more in topline revenue in 2024, and approximately $300 million or more thereafter. At these revenue levels, ADMA forecasts achieving corporate 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 $100-150 million and $50-100 million, respectively, during the 2024-2025 time period and beyond.
|
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
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16,512,990
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3,662,047
|
||||||
OPERATING EXPENSES:
|
||||||||
Research and development
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855,351
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624,111
|
||||||
Plasma center operating expenses
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1,780,463
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3,974,589
|
||||||
Amortization of intangible assets
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178,838
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178,838
|
||||||
Selling, general and administrative
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14,511,656
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13,699,575
|
||||||
Total operating expenses
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17,326,308
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18,477,113
|
||||||
LOSS FROM OPERATIONS
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(813,318
|
)
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(14,815,066
|
)
|
||||
OTHER INCOME (EXPENSE):
|
||||||||
Interest income
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166,971
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33,068
|
||||||
Interest expense
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(6,115,484
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)
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(3,389,038
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)
|
||||
Loss on extinguishment of debt
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-
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(6,669,941
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)
|
|||||
Other expense
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(26,984
|
)
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(166,880
|
)
|
||||
Other expense, net
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(5,975,497
|
)
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(10,192,791
|
)
|
||||
NET LOSS
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$
|
(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
|
March 31,
|
December 31,
|
|||||||
2023
|
2022
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
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$
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69,204,163
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$
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86,521,542
|
||||
Accounts receivable, net
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26,518,495
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15,505,048
|
||||||
Inventories
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163,984,873
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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
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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
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10,485,447
|
||||||
Deposits and other assets
|
4,718,761
|
4,770,246
|
||||||
TOTAL ASSETS
|
$
|
340,787,542
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$
|
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
|
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
|
)
|