(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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Exhibit No.
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Description
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ADMA Biologics, Inc. Press Release, dated March 23, 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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March 23, 2023
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ADMA Biologics, Inc.
|
||
By:
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/s/ Brian Lenz
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||
Name:
|
Brian Lenz
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||
Title:
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Executive Vice President and Chief Financial Officer
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• |
Unlock New Growth Opportunities: ADMA has identified
several growth opportunities that can potentially increase revenue and improve margins beyond previously provided financial targets. With an unwavering emphasis on achieving near term profitability, the incremental investments required to
pursue these initiatives are not significant and are not expected to impact ADMA’s strong funding position.
|
o |
Expanded ASCENIV Production Scale: In 2023, ADMA will
commence manufacturing of ASCENIV at the 4,400 Liter production scale for the first time in corporate history. We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity
as fewer batches will be needed to support revenue goals. The Company’s successful experience in ramping up BIVIGAM to this production scale over the last two years lends confidence to its ability to leverage these same processes for
ASCENIV. We believe these benefits could be realized as early as the second half of 2023.
|
o |
Yield Enhancement Opportunities: The Company is pursuing new
initiatives to capture additional IG production yields, which could meaningfully increase both peak revenues as well as margin potential if successful.
|
o |
Label Expansion: The ongoing post-marketing clinical
studies may provide for label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric-aged PI patients as well as additional publications supporting product safety.
|
• |
Accelerated Sales of Legacy, Lower Margin BIVIGAM. ADMA’s
estimated fourth quarter 2022 corporate gross margins would have been approximately 200-300 basis points higher if the impact of selling lower margin, 2,200-liter scale BIVIGAM were excluded. At the midpoint, the estimated operating loss
for the quarter would have been approximately $4.7 million, which is 64% improved compared to the prior year's fourth quarter when accounting for transient gross margin dynamics amounting to approximately $1.3 million. Due to record
product demand, ADMA expects to monetize a substantial portion of the remaining lower margin inventory in the first quarter of 2023, incrementally earlier than previous expectations of mid-year 2023.
|
• |
Product Mix Continues to Favorably Evolve: ASCENIV’s
prescriber and patient base continued to expand during the fourth quarter of 2022, which drove record utilization and pull-through for the product. These elevated demand trends have sustained into 2023, and ADMA currently expects the
product’s rapid growth will continue throughout 2023 and beyond.
|
• |
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.
|
• |
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 anticipates full year 2023
total revenues to exceed $210 million. As a result, ADMA anticipates generating first-time positive EBITDA no later than the second half of 2023. The guidance framework considers several macroeconomic uncertainties; however, should
ADMA’s current demand trends and margin dynamics sustain, accelerated 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.
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Three Months Ended December 31,
|
Years Ended December 31,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Product revenue
|
$
|
49,945,746
|
$
|
26,347,158
|
$
|
153,936,858
|
$
|
80,799,791
|
||||||||
License revenue
|
35,709
|
35,709
|
142,834
|
142,834
|
||||||||||||
Total revenues
|
49,981,455
|
26,382,867
|
154,079,692
|
80,942,625
|
||||||||||||
Cost of product revenue
|
35,804,379
|
22,871,382
|
118,814,535
|
79,769,341
|
||||||||||||
Gross profit
|
14,177,076
|
3,511,485
|
35,265,157
|
1,173,284
|
||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
1,074,320
|
728,988
|
3,613,764
|
3,646,060
|
||||||||||||
Plasma center operating expenses
|
5,087,571
|
4,096,833
|
17,843,096
|
12,288,723
|
||||||||||||
Amortization of intangible assets
|
178,839
|
178,839
|
715,353
|
715,353
|
||||||||||||
Selling, general and administrative
|
13,894,888
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11,698,009
|
52,458,024
|
42,896,889
|
||||||||||||
Total operating expenses
|
20,235,618
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16,702,669
|
74,630,237
|
59,547,025
|
||||||||||||
LOSS FROM OPERATIONS
|
(6,058,542
|
)
|
(13,191,184
|
)
|
(39,365,080
|
)
|
(58,373,741
|
)
|
||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
Interest income
|
2,260
|
2,291
|
44,833
|
34,532
|
||||||||||||
Interest expense
|
(5,736,954
|
)
|
(3,315,724
|
)
|
(19,279,373
|
)
|
(13,056,834
|
)
|
||||||||
Loss on extinguishment of debt
|
-
|
-
|
(6,669,941
|
)
|
-
|
|||||||||||
Other expense
|
(438,447
|
)
|
(144,803
|
)
|
(634,389
|
)
|
(251,575
|
)
|
||||||||
Other expense, net
|
(6,173,141
|
)
|
(3,458,236
|
)
|
(26,538,870
|
)
|
(13,273,877
|
)
|
||||||||
NET LOSS
|
$
|
(12,231,683
|
)
|
$
|
(16,649,420
|
)
|
$
|
(65,903,950
|
)
|
$
|
(71,647,618
|
)
|
||||
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.06
|
)
|
$
|
(0.09
|
)
|
$
|
(0.33
|
)
|
$
|
(0.51
|
)
|
||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||||||||||
Basic and Diluted
|
202,830,446
|
180,813,817
|
197,874,895
|
139,578,538
|
December 31,
|
December 31,
|
|||||||
2022
|
2021
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
86,521,542
|
$
|
51,089,118
|
||||
Accounts receivable, net
|
15,505,048
|
28,576,857
|
||||||
Inventories
|
163,280,047
|
124,724,091
|
||||||
Prepaid expenses and other current assets
|
5,095,146
|
4,339,245
|
||||||
Total current assets
|
270,401,783
|
208,729,311
|
||||||
Property and equipment, net
|
58,261,481
|
50,935,074
|
||||||
Intangible assets, net
|
1,013,415
|
1,728,768
|
||||||
Goodwill
|
3,529,509
|
3,529,509
|
||||||
Right to use assets
|
10,485,447
|
7,262,658
|
||||||
Deposits and other assets
|
4,770,246
|
4,067,404
|
||||||
TOTAL ASSETS
|
$
|
348,461,881
|
$
|
276,252,724
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
13,229,390
|
$
|
12,429,409
|
||||
Accrued expenses and other current liabilities
|
24,989,349
|
17,214,988
|
||||||
Current portion of deferred revenue
|
142,834
|
142,834
|
||||||
Current portion of lease obligations
|
905,369
|
591,084
|
||||||
Total current liabilities
|
39,266,942
|
30,378,315
|
||||||
Senior notes payable, net of discount
|
142,833,063
|
94,866,239
|
||||||
Deferred revenue, net of current portion
|
1,833,031
|
1,975,865
|
||||||
End of term fee
|
1,500,000
|
-
|
||||||
Lease obligations, net of current portion
|
10,704,176
|
7,462,388
|
||||||
Other non-current liabilities
|
350,454
|
397,351
|
||||||
TOTAL LIABILITIES
|
196,487,666
|
135,080,158
|
||||||
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, 221,816,930 and 195,813,817 shares issued and outstanding
|
22,182
|
19,581
|
||||||
Additional paid-in capital
|
629,968,704
|
553,265,706
|
||||||
Accumulated deficit
|
(478,016,671
|
)
|
(412,112,721
|
)
|
||||
TOTAL STOCKHOLDERS' EQUITY
|
151,974,215
|
141,172,566
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
348,461,881
|
$
|
276,252,724
|