Date of Report (Date of earliest event reported):
|
|
|
(Exact name of registrant as specified in its charter)
|
|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Registrant’s telephone number, including area code:
|
(
|
(Former name or former address, if changed since last report.)
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
|
Item 2.02 |
Results of Operations and Financial Condition
|
Item 9.01 |
Exhibits.
|
(d) |
Exhibits
|
Exhibit No.
|
Description
|
ADMA Biologics, Inc. Press Release, dated August 10, 2022
|
|
104
|
Cover Page Interactive Data File (embedded with the Inline XBRL document)
|
* |
The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
|
August 10, 2022
|
ADMA Biologics, Inc.
|
||
By:
|
/s/ Brian Lenz
|
||
Name:
|
Brian Lenz
|
||
Title:
|
Executive Vice President and Chief Financial Officer
|
|
•
|
Significant Revenue Growth: Achieved
second quarter 2022 total revenues of $33.9 million, as compared to $17.8 million during the second quarter of 2021, an increase of $16.1 million, or approximately 90%. Due to a favorable product mix, as the Company continues to expand
its customer base for both BIVIGAM® and ASCENIV, ADMA realized a gross margin of approximately 23% during the second quarter of 2022, resulting from sales of higher margin products and continued supply chain operating
efficiencies.
|
•
|
Durable Mix Shift Toward Higher Margin Products: ADMA is particularly encouraged with the continued physician adoption and utilization of its proprietary IVIG product, ASCENIV. We believe that leading product demand indicators continue to support durable and sustained upside
for this product, with possible upside to peak potential.
|
•
|
Advancing Toward Profitability: The
Company maintains and reiterates its previously provided profitability timeline, which is expected no later than the first quarter of 2024, while taking into account current macroeconomic uncertainties. However, should current demand
trends and margin dynamics sustain, accelerated profitability timelines may be achievable.
|
•
|
On-Track BioCenters Expansion: At
present, the Company’s BioCenters segment has ten plasma collection centers under its corporate umbrella: six centers are United States Food and Drug Administration (“FDA”)-licensed, two additional centers are operational and collecting
plasma, and two centers are in various stages of construction. The Company remains on track to have ten BioCenter locations 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.
|
•
|
Expanded Patent Estate: In May 2022, the
United States Patent and Trademark Office issued U.S. Pat. No. 11,339,206 (the “‘206 Patent”). The ‘206 Patent relates to methods of treating respiratory infections and expands ADMA’s estate of patents encompassing its proprietary
immunotherapeutic compositions. In particular, the ‘206 Patent encompasses use of standardized, hyperimmune globulin for treating respiratory infections including those caused by respiratory syncytial virus (“RSV”), coronavirus,
influenza virus, parainfluenza virus, and metapneumovirus.
|
•
|
Ongoing Strategic Review: ADMA continues
to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley. The Company will communicate material developments as required by the U.S. Securities and Exchange Commission (“SEC”). The exploration
of strategic opportunities remains a top corporate priority for ADMA.
|
•
|
2022 Financial Guidance: Enabled by the
strong start to the year, ADMA anticipates total 2022 revenues will exceed $130 million. ADMA reiterates expectations for continued gross profit expansion and narrowing net losses as 2022 progresses.
|
•
|
2024-2025 Financial Guidance: The
Company continues to anticipate generating approximately $250 million or more in topline revenue in 2024, and approximately $300 million or more thereafter. At these revenue levels, and based upon current assumptions, ADMA continues to
forecast 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 June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Product revenue
|
$
|
33,869,298
|
$
|
17,794,881
|
$
|
62,936,683
|
$
|
33,807,791
|
||||||||
License revenue
|
35,709
|
35,709
|
71,417
|
71,417
|
||||||||||||
Total revenues
|
33,905,007
|
17,830,590
|
63,008,100
|
33,879,208
|
||||||||||||
Cost of product revenue
|
26,135,614
|
18,832,624
|
51,576,660
|
36,602,746
|
||||||||||||
Gross profit (loss)
|
7,769,393
|
(1,002,034
|
)
|
11,431,440
|
(2,723,538
|
)
|
||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
873,386
|
1,158,866
|
1,497,497
|
2,146,515
|
||||||||||||
Plasma center operating expenses
|
3,921,486
|
2,803,326
|
7,896,075
|
5,045,669
|
||||||||||||
Amortization of intangible assets
|
178,838
|
178,838
|
357,676
|
357,676
|
||||||||||||
Selling, general and administrative
|
11,970,422
|
10,438,168
|
25,669,997
|
20,472,083
|
||||||||||||
Total operating expenses
|
16,944,132
|
14,579,198
|
35,421,245
|
28,021,943
|
||||||||||||
LOSS FROM OPERATIONS
|
(9,174,739
|
)
|
(15,581,232
|
)
|
(23,989,805
|
)
|
(30,745,481
|
)
|
||||||||
OTHER INCOME (EXPENSE):
|
||||||||||||||||
Interest income
|
2,269
|
5,926
|
35,337
|
27,985
|
||||||||||||
Interest expense
|
(4,573,015
|
)
|
(3,246,680
|
)
|
(7,962,053
|
)
|
(6,442,430
|
)
|
||||||||
Loss on extinguishment of debt
|
-
|
-
|
(6,669,941
|
)
|
-
|
|||||||||||
Other expense
|
(19,421
|
)
|
(83,317
|
)
|
(186,301
|
)
|
(125,318
|
)
|
||||||||
Other expense, net
|
(4,590,167
|
)
|
(3,324,071
|
)
|
(14,782,958
|
)
|
(6,539,763
|
)
|
||||||||
NET LOSS
|
$
|
(13,764,906
|
)
|
$
|
(18,905,303
|
)
|
$
|
(38,772,763
|
)
|
$
|
(37,285,244
|
)
|
||||
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.07
|
)
|
$
|
(0.15
|
)
|
$
|
(0.20
|
)
|
$
|
(0.31
|
)
|
||||
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
|
||||||||||||||||
Basic and Diluted
|
196,353,185
|
127,416,126
|
196,113,888
|
121,571,501
|
June 30,
2022
|
December 31,
2021
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
52,415,053
|
$
|
51,089,118
|
||||
Accounts receivable, net
|
18,883,847
|
28,576,857
|
||||||
Inventories
|
146,075,459
|
124,724,091
|
||||||
Prepaid expenses and other current assets
|
5,399,928
|
4,339,245
|
||||||
Total current assets
|
222,774,287
|
208,729,311
|
||||||
Property and equipment, net
|
54,951,267
|
50,935,074
|
||||||
Intangible assets, net
|
1,371,092
|
1,728,768
|
||||||
Goodwill
|
3,529,509
|
3,529,509
|
||||||
Right to use assets
|
10,550,236
|
7,262,658
|
||||||
Deposits and other assets
|
3,755,938
|
4,067,404
|
||||||
TOTAL ASSETS
|
$
|
296,932,329
|
$
|
276,252,724
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
11,388,048
|
$
|
12,429,409
|
||||
Accrued expenses and other current liabilities
|
15,961,070
|
17,214,988
|
||||||
Current portion of deferred revenue
|
142,834
|
142,834
|
||||||
Current portion of lease obligations
|
579,661
|
591,084
|
||||||
Total current liabilities
|
28,071,613
|
30,378,315
|
||||||
Senior notes payable, net of discount
|
139,810,931
|
94,866,239
|
||||||
Deferred revenue, net of current portion
|
1,904,448
|
1,975,865
|
||||||
End of term fee
|
1,500,000
|
-
|
||||||
Lease obligations, net of current portion
|
10,870,907
|
7,462,388
|
||||||
Other non-current liabilities
|
373,903
|
397,351
|
||||||
TOTAL LIABILITIES
|
182,531,802
|
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, 196,356,232 and 195,813,817 shares issued and
outstanding
|
19,636
|
19,581
|
||||||
Additional paid-in capital
|
565,266,375
|
553,265,706
|
||||||
Accumulated deficit
|
(450,885,484
|
)
|
(412,112,721
|
)
|
||||
TOTAL STOCKHOLDERS' EQUITY
|
114,400,527
|
141,172,566
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
296,932,329
|
$
|
276,252,724
|