ADMA BIOLOGICS: Discussion and analysis by management of the financial position and operating results. (form 10-Q)

The following discussion of our financial condition and results of operations,
which refers to our historical results, should be read in conjunction with the
other sections of this Quarterly Report on Form 10-Q, including "Risk Factors"
and our unaudited consolidated financial statements and the notes thereto
appearing elsewhere herein, and in conjunction with the Management's Discussion
and Analysis of Financial Condition and Results of Operations set forth in our
Annual Report on Form 10-K for the year ended December 31, 2020, filed on March
25, 2021 (the "2020 10-K"). The various sections of this discussion contain a
number of forward-looking statements, all of which are based on our current
expectations and could be affected by the uncertainties and risk factors
described throughout or referenced within this Quarterly Report on Form 10-Q.
See "Special Note Regarding Forward-Looking Statements."  Our actual results may
differ materially from our current expectations.

                                    OVERVIEW

Our business

ADMA Biologics, Inc. (the "Company," "ADMA," "we," "us" or "our") is an
end-to-end commercial biopharmaceutical company dedicated to manufacturing,
marketing and developing specialty plasma-derived biologics for the treatment of
immunodeficient patients at risk for infection and others at risk for certain
infectious diseases. Our targeted patient populations include immune-compromised
individuals who suffer from an underlying immune deficiency disorder or who may
be immune-suppressed for medical reasons.

We currently have three products with U.S. Food and Drug Administration (the
"FDA") approval, all of which are currently marketed and commercially available:
(i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin
("IVIG") product indicated for the treatment of Primary Humoral Immunodeficiency
("PI"), also known as Primary Immunodeficiency Disease ("PIDD"), and for which
we received FDA approval on May 9, 2019 and commenced commercial sales in August
2019; (ii) ASCENIV (Immune Globulin Intravenous, Human - slra 10% Liquid), an
IVIG product indicated for the treatment of PI, for which we received FDA
approval on April 1, 2019 and commenced first commercial sales in October 2019;
and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for
the treatment of acute exposure to blood containing HBsAg and other listed
exposures to Hepatitis B. We seek to develop a pipeline of plasma-derived
therapeutics, including a product based on our most recently approved patent
application under U.S. Patent No. 10,259,865 related to methods of treatment and
prevention of S. pneumonia infection for an immunoglobulin manufactured to
contain standardized antibodies to numerous serotypes of S. pneumoniae. Our
products and product candidates are intended to be used by physician specialists
focused on caring for immune-compromised patients with or at risk for certain
infectious diseases.

We manufacture these products at our FDA-licensed, plasma fractionation and
purification facility located in Boca Raton, Florida with a peak annual
processing capability of up to 600,000 liters (the "Boca Facility"). Based on
current production yields, our ongoing supply chain enhancements and capacity
expansion initiatives, we believe this facility has the potential to produce
quantities of our immune globulin ("IG") products of more than $250 million in
annual revenue beginning in 2024 and potentially in excess of $300 million of
annual revenue thereafter, as well as achieving profitability during the first
quarter of 2024, as we ramp-up production over the next three to five years. We
anticipate exiting 2021 approaching an annualized revenue run rate of
approximately $100 million or more.

Through our ADMA BioCenters subsidiary, we currently operate FDA-licensed source
plasma collection facilities in the U.S. This business unit, which we refer to
as our Plasma Collection Centers business segment, provides us with a portion of
our blood plasma for the manufacture of our products and product candidates, and
also allows us to sell certain quantities of source plasma to customers for
further manufacturing. As a part of our planned supply chain robustness
initiative, we have opened four new plasma collection centers during the past 18
months, and we now have eight plasma collection centers in various stages of
approval and development, including five that are fully operational and
collecting plasma. With respect to our fully operational plasma collection
centers, two plasma collection centers currently hold FDA licenses, while a
third collection center has a Biologics License Application ("BLA") under review
pending FDA approval. In addition, one of our FDA-approved plasma collection
centers also has approvals from the Korean Ministry of Food and Drug Safety
("MFDS"), as well as FDA approval to operate a Hepatitis B immunization program.
After giving effect to the progress we made in 2020 and thus far in 2021 with
our plasma collection network expansion, we believe we remain on track to
achieve our goal of having 10 or more plasma collection centers operating in the
U.S. by 2024. A typical plasma collection center, such as those operated by ADMA
BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma
annually, which may be sold for different prices depending upon the type of
plasma, quantity of purchase and market conditions at the time of sale. Plasma
collected from ADMA BioCenters' facilities that is not used to manufacture our
products or product candidates is sold to third-party customers in the U.S. and
in other locations outside the U.S. where we are approved under supply
agreements or in the open "spot" market.

                                       23

————————————————– ——————————

Index


We sell plasma-derived intermediate fractions to certain customers, which are
generated as part of our FDA-approved manufacturing process for IG and IVIG
products. In January 2020, we announced our entry into a five-year manufacturing
and supply agreement to produce and sell these intermediate by-products, which
are used as the starting raw material to produce other plasma-derived biologics.
In addition, from time to time we provide contract manufacturing and testing
services for certain third-party clients. We also provide laboratory contracting
services to certain customers and anticipate providing contract filling,
labeling and packing services upon FDA approval and implementation of our
in-house fill-finish capabilities.

On June 6, 2017, we completed the acquisition of certain assets (the "Biotest
Assets") of the Therapy Business Unit ("BTBU") of Biotest Pharmaceuticals
Corporation ("BPC" and, together with Biotest AG, "Biotest"), which included two
FDA-licensed products, Nabi-HB and BIVIGAM, and an FDA-licensed plasma
fractionation facility located in Boca Raton, FL (the "Boca Facility") (the
"Biotest Transaction").

Recent developments

On July 20, 2021, we announced that the FDA completed a Pre-Approval Inspection
of the Boca Facility related to our application for approval of our Vanrx SA25
aseptic fill-finish machine and our related internal fill-finish processes, the
drug product component of our manufacturing process. The inspection concluded
successfully with no Form 483 observations. The FDA review of our regulatory
filing related to approval of the new fill-finish machine remains ongoing, with
anticipated regulatory approval in the second half of 2021.  The anticipated
approval would provide us with internal fill-finish production capabilities for
our commercial products, which is expected to result in greater patient supply
consistency and, coupled with the approval of our expanded plasma pool
production scale process that we received earlier this year as discussed below,
significantly improved operational efficiencies and gross margins.

Effective as of May 12, 2021, we entered into a Second Amendment to our Plasma
Purchase Agreement  with Grifols Worldwide Operations Limited ("Grifols")
whereby, among other provisions, we extended the term of our supply agreement
for the purchase of normal source plasma ("NSP") through December 31, 2022,
while certain historical provisions were deleted. In order to maintain a
reliable supply of raw material plasma thereafter, we are in late-stage
discussions with multiple third-party plasma suppliers to provide us with a
long-term supply of NSP, which will be supplemented by our accelerated plasma
center expansion activities, whereby we expect to have more than 10 plasma
collection centers in operation by 2024.  We expect these initiatives will
ensure the raw material plasma supply necessary to meet our anticipated peak
annual plasma processing capability of up to 600,000 liters.

On April 28, 2021, we announced that the FDA granted approval for our expanded
IVIG plasma pool production scale process, allowing for a 4,400-liter plasma
pool for the manufacture of our commercial product BIVIGAM. We expect this
increased IVIG plasma pool scale, which will allow us to produce BIVIGAM at an
expanded capacity, will utilize the same equipment, release testing assays and
labor force, and to have a favorable impact on our gross margins and operating
results, potentially beginning late in the fourth quarter of 2021.

On April 26, 2021, we announced the opening of our fourth plasma collection
facility in the U.S. Pursuant to updated FDA guidance to obtain approval for
plasma collection centers, sponsors are now required to collect plasma donations
for three months prior to submitting a BLA filing. Accordingly, we filed a BLA
for this plasma collection facility during the third quarter of 2021. Prior to
receiving FDA approval, ADMA is permitted to collect plasma donations at this
site and upon receipt of FDA approval we can utilize the plasma collected for
further use in our IVIG manufacturing operations or for third party sale.

                                       24

————————————————– ——————————

  Index


Our Products

BIVIGAM

BIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies
similar to those found in normal human plasma. These antibodies are directed
against bacteria and viruses, and help to protect PI patients against serious
infections. BIVIGAM is a purified, sterile, ready-to-use preparation of
concentrated human Immunoglobulin G antibodies indicated for the treatment of
PI, a group of genetic disorders. This includes, but is not limited to, the
humoral immune defect in common variable immunodeficiency, X-linked
agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and
severe combined immunodeficiency. These PIs are a group of genetic
disorders. Based on recent estimates, these disorders are no longer considered
to be very rare, with as many as one in every 1,200 people in the United States
having some form of PI.

On May 9, 2019, the FDA approved the Prior Approval Supplement (the "PAS") for
the use of our IVIG manufacturing process, thereby enabling us to re-launch and
commercialize this product in the United States. We resumed production of
BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing,
using our FDA-approved IVIG manufacturing process under U.S. Department of
Health and Human Services ("HHS") License No. 2019. The commercial re-launch and
first commercial sales for this product commenced in August of 2019.

On April 28, 2021, we announced that the FDA has granted approval for our
expanded plasma pool production scale process, allowing for a 4,400-liter plasma
pool for the manufacture of our BIVIGAM IVIG product. We expect this increased
IVIG plasma pool scale, which will allow us to produce BIVIGAM at an expanded
capacity, will utilize the same equipment, release testing assays and labor
force, and to have a favorable impact on our gross margins and operating
results, potentially beginning late in the fourth quarter of 2021.

ASCENIV

ASCENIV is a plasma-derived IVIG that contains naturally occurring polyclonal
antibodies, which are proteins that are used by the body's immune system to
neutralize microbes, such as bacteria and viruses, and prevent against infection
and disease. We manufacture ASCENIV under HHS License No. 2019 using a process
known as fractionation. The Centers for Medicare and Medicaid Services ("CMS")
has issued a permanent, product-specific-J-code for ASCENIV.  Under the
Healthcare Common Procedure Coding System ("HCPCS"), the J-code (J1554) became
effective April 1, 2021. As part of our proprietary manufacturing process for
ASCENIV, we leverage our unique, patented plasma donor screening methodology and
tailored plasma pooling design, which blends normal source plasma and plasma
from donors tested to have high levels of neutralizing antibody titers to
respiratory syncytial virus ("RSV") using our proprietary microneutralization
testing assay. We are able to identify the high titer or "hyperimmune" plasma
that meets our internal and required specifications for ASCENIV with our
patented testing methods and assay. This type of high titer plasma is typically
found in less than 10% of the total donor collection samples we test.

ASCENIV is approved for the treatment of Primary Immune Deficiency Disorder
("PIDD"), a class of inherited genetic disorders that causes a deficient or
absent immune system in adults and adolescents (12 to 17 years of age). Our
pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of
no Serious Bacterial Infections reported during 12 months of treatment.
Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the
low incidence of infection, therapeutic antibiotic use, days missed from
work/school/daycare and unscheduled medical visits and hospitalizations. We
believe this clinical data together with the FDA approval for the treatment of
PIDD better positions ADMA to further evaluate ASCENIV in immune-compromised
patients infected with or at-risk for RSV infection or potentially other
respiratory viral pathogens. Due to the COVID-19 pandemic, our plans have been
delayed.  In the future however, we plan to work with the FDA and the immunology
and infectious disease community to design an appropriate clinical trial to
evaluate the use of ASCENIV in this patient population. Commercial sales of
ASCENIV commenced in October of 2019.

                                       25

————————————————– ——————————

  Index


Nabi-HB

Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B
virus. Nabi-HB is a purified human polyclonal antibody product collected from
plasma donors who have been previously vaccinated with a Hepatitis B vaccine.
Nabi-HB is indicated for the treatment of acute exposure to blood containing
HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual
exposure to HBsAg-positive persons and household exposure to persons with acute
Hepatitis B virus infection in specific, listed settings. Hepatitis B is a
potentially life-threatening liver infection caused by the Hepatitis B virus. It
is a major global health problem. It can cause chronic infection and puts people
at high risk of death from cirrhosis and liver cancer. Nabi-HB has a
well-documented record of long-term safety and effectiveness since its initial
market introduction. The FDA approved Nabi-HB on March 24, 1999.  Production of
Nabi-HB at the Boca Facility has continued under our leadership since the third
quarter of 2017. In early 2018, we received authorization from the FDA for the
release of our first commercial batch of Nabi-HB for commercial distribution in
the U.S. and we continue to manufacture Nabi-HB under HHS License No. 2019.

                         IMPACT OF THE COVID-19 CRISIS

We continue to closely monitor ongoing developments in connection with the
COVID-19 global pandemic, including the emergence of the Delta variant and other
resistant strains of the novel coronavirus, and its impacts to our commercial
and manufacturing operations and plasma collection facilities, including but not
limited to potential disruptions to our supply chain operations, including
collections of source plasma, procurement of raw materials and packaging
materials, a portion of which are sourced internationally, and testing of
finished drug product that is required prior to its availability for commercial
sale.  Such testing has historically been performed by contract laboratories
outside the United States. In addition, travel and other restrictions that have
been implemented in the United States have impacted our commercial engagement
efforts with respect to some of our products, including BIVIGAM and ASCENIV, as
trade shows, industry and medical conferences and other events we had been
planning to utilize and exhibit and attend with our staff to increase awareness
of our products by physicians and payers remain subject to reduction in scope,
rescheduling or outright cancellation due to the pandemic.

We had experienced some delays with our third-party vendors and testing
laboratories which perform final drug product GMP release testing. In response
to these delays, we added additional release testing laboratories to our FDA
approved consortium listed in our drug approval documents which we believe has
adequately addressed this issue. In July 2020, we began receiving FDA lot
releases with testing data from our new testing laboratory vendor. In addition,
due to a combination of previous state and local "shelter-in-place" orders, as
well as government stimulus packages, persisting social distancing measures and
varying roll-outs of vaccinations by state, we have been experiencing lower than
normal donor collections at our FDA-approved plasma collection centers. We were
also subject to delays in shipments of source plasma from our contracted
third-party suppliers, as well as delays in deliveries for personal protective
equipment, reagents and other non-plasma raw materials and supplies used in the
manufacture and distribution of our products. We are also subject to supply
chain delays as a result of certain of our suppliers diverting significant
resources towards the rapid development and distribution of COVID-19 vaccines
and, as a result, we may elect to carry more raw materials inventory than we
have in the past. In addition, we have also experienced challenges with respect
to our customer engagement initiatives, as our sales and medical affairs field
forces face difficulties communicating directly with physicians and other
healthcare professionals and the cancellation or postponement of a number of key
scientific and medical conferences, further limiting our ability to communicate
with potential customers.  We have implemented a comprehensive suite of virtual
engagement initiatives, though clinician engagement remains lower due to
continuing COVID-19-related priorities at U.S. medical centers.

The pandemic could further impact our ability to interact with the FDA or other
regulatory authorities and may result in delays in the conduct of inspections or
review of pending applications or submissions.  During the second quarter of
2021, we were notified by the FDA that our submission for the approval of our
in-house fill-finish process utilizing our Vanrx SA25 Workcell aseptic filling
machine will require a site inspection, either in person or virtually. Although
the inspection was completed in July of 2021, the FDA's review of our regulatory
filing with respect to our in-house fill-finish process and new aseptic filling
machine remains ongoing. Although we anticipate receiving regulatory approval of
this submission in the second half of 2021, no assurances can be provided as to
the timing for completion of this FDA review or any other regulatory submissions
or applications that may be impacted by restrictions related to COVID-19.

                                       26

————————————————– ——————————

Index


As of the date of this report, we do not believe that the operations and
immunoglobulin and plasma products production at our Boca Facility, our contract
fill/finishers or our plasma collection facilities have been significantly
impacted by the COVID-19 pandemic. As a result, as of the date of this report,
we have not experienced, and currently do not anticipate, any material
impairments with respect to any of our long-lived assets, including our property
and equipment, goodwill or intangible assets.

Although the COVID-19 pandemic has not, to date, materially adversely impacted
our capital and financial resources, due to the economic uncertainty that has
resulted from the pandemic, and the potential impact of such to our
stakeholders, we are unable to predict with certainty any potential impacts to
our business. Although we believe the effects of the COVID-19 pandemic on our
business and our operations will be temporary, at the present time we are unable
to determine the ultimate duration of the pandemic or its long-term effects on,
among other things, the global, national or local economies, the capital and
credit markets, our workforce, our customers or our suppliers.  As a result, we
are unable to predict whether the COVID-19 crisis will have a material adverse
impact on our business, financial condition, liquidity and results of
operations.

                             RESULTS OF OPERATIONS

Critical accounting conventions and estimates

This Management's Discussion and Analysis of Financial Condition and Results of
Operations is based on our consolidated financial statements, which have been
prepared in accordance with Accounting Principles Generally Accepted in the
United States of America ("U.S. GAAP"). The preparation of these consolidated
financial statements requires us to make estimates and assumptions that affect
the reported amounts of assets, liabilities, revenues and expenses. On an
ongoing basis, we evaluate these estimates and assumptions, including those
described below. We base our estimates on our historical experience and on
various other assumptions that we believe to be reasonable under the
circumstances. These estimates and assumptions form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results and experiences may differ
materially from these estimates. Significant estimates include the realizable
value of accounts receivable, valuation of inventory, assumptions used in
projecting future liquidity and capital requirements, assumptions used in the
fair value of awards granted under our equity incentive plans and warrants
issued in connection with the issuance of notes payable and the valuation
allowance for our deferred tax assets.

Some of the estimates and assumptions we have to make under U.S. GAAP require
difficult, subjective and/or complex judgments about matters that are inherently
uncertain and, as a result, actual results could differ from those estimates.
Due to the estimation processes involved, the following summary of accounting
policies and their application are considered to be critical to understanding
our business operations, financial condition and results of operations. For a
detailed discussion on the application of these and our other accounting
policies, see Note 2 to the Consolidated Financial Statements included elsewhere
in this Quarterly Report on Form 10-Q.

Revenue recognition

Revenues for the six months ended June 30, 2021 and 2020 are comprised of (i)
revenues from the sale of our FDA-approved immunoglobulin products, (ii) product
revenues from the sale of human plasma collected from our Plasma Collection
Centers business segment, (iii) product revenues from the sale of intermediate
fractions, (iv) contract manufacturing and testing revenue from certain clients,
and (v) license revenues attributable to the out-licensing of ASCENIV in
December 2012 to Biotest AG ("Biotest") to market and sell this product in
Europe and selected countries in North Africa and the Middle East. Biotest has
provided us with certain services and financial payments in accordance with the
related Biotest license agreement and is obligated to pay us certain amounts in
the future if certain milestones are achieved. Deferred revenue is amortized
into income over the term of the Biotest license, representing a period of
approximately 22 years.

                                       27

————————————————– ——————————

Index


Product revenue is recognized when the customer is deemed to have control over
the product. Control is determined based on when the product is shipped or
delivered and title passes to the customer. Revenue is recorded in an amount
that reflects the consideration we expect to receive in exchange. Revenue from
the sale of immunoglobulin products is generally recognized when the product
reaches the customer's destination, and is recorded net of distributor fees,
estimated rebates, price protection arrangements and customer incentives,
including prompt pay discounts, wholesaler chargebacks and other wholesaler
fees. These estimates are based on historical experience and certain other
assumptions, and we believe that such estimates are reasonable. For revenues
associated with sales of our intermediates or contract manufacturing, control
transfers to the customer and the performance obligation is satisfied when the
customer takes possession of the product from the Boca Facility or a third-party
warehouse that is utilized by the Company.

Product revenues from the sale of human plasma collected at our plasma
collection centers are recognized at the time control of the product has been
transferred to the customer, which generally occurs at the time of shipment.
Product revenues are recognized at the time of delivery if we retain control of
the product during shipment. Payments received from customers where the
foregoing revenue recognition criteria have not been satisfied are recorded as
deferred revenue, which is reflected as a liability in our consolidated balance
sheets.

For the six months ended June 30, 2021, five customers, BioCARE, Inc.
("BioCare"), Biolife Plasma Services, L.P. ("Biolife"), Reliance Life Sciences
Pvt Limited ("Reliance"), Priority Healthcare Distribution, Inc. ("Curascript")
and AmerisourceBergen Drug Corporation ("AmerisourceBergen") represented an
aggregate of 85% of our consolidated revenues. For the six months ended June 30,
2020, BioCare, Biolife and Reliance represented an aggregate of 81% of our
consolidated revenues.

Accounts receivable

Accounts receivable are reported at realizable value, net of allowances for
contractual credits and doubtful accounts, which are recognized in the period
the related revenue is recorded. We extend credit to our customers based upon an
evaluation of each customer's financial condition and credit history.
Evaluations of the financial condition and associated credit risk of customers
are performed on an ongoing basis. Based on these evaluations, we have concluded
that our credit risk is minimal.

Product revenue cost

Cost of product revenue includes costs associated with the manufacture of the
Company's FDA approved products, intermediates and the sale of human source
plasma, as well as expenses related to conformance batch production, process
development and scientific and technical operations when these operations are
attributable to marketed products. When the activities of these operations are
attributable to new products in development, their expenses are classified as
research and development expenses.

As a manufacturer of biological products, we are subject to the risks inherent
in biological production, which could include normal course losses and failures
inherent in the manufacturing process. As our biologics production levels
increase there may be normal course inventory losses as we ensure product
quality and compliance with current Good Manufacturing Practices ("cGMP"), FDA,
state and local regulations, or due to testing results not meeting
specifications. Such losses are charged to cost of product revenue in the period
they are incurred.

Stock-Based Compensation

All equity-based payments, including grants of stock options and restricted
stock units ("RSUs") are recognized at their estimated fair value at the grant
date, and compensation expense is recognized on a straight-line basis over the
grantee's requisite vesting period. During the six months ended June 30, 2021,
we granted RSUs to certain members of our management and employees representing
an aggregate 542,244 shares of common stock, and during the six months ended
June 30, 2020, we granted RSUs to members of our Board of Directors and certain
members of our management and employees representing an aggregate of 341,000
shares of common stock. For the purpose of valuing stock options granted to our
employees, directors and officers, we use the Black-Scholes option pricing
model. We granted options to purchase an aggregate of 1,658,050 and 1,232,500
shares of common stock to management, employees and directors during the six
months ended June 30, 2021 and 2020, respectively. To determine the risk-free
interest rate, we utilized the U.S. Treasury yield curve in effect at the time
of the grant with a term consistent with the expected term of our awards. The
expected term of the options granted is in accordance with SEC Staff Accounting
Bulletins 107 and 110, and is based on the average between vesting terms and
contractual terms. The expected dividend yield reflects our current and expected
future policy for dividends on our common stock. The expected stock price
volatility for our stock options was calculated by examining the historical
volatility of our common stock since our common stock became publicly traded in
the fourth quarter of 2013. We will continue to analyze the expected stock price
volatility and expected term assumptions and will adjust our Black-Scholes
option pricing assumptions as appropriate. In accordance with ASU No. 2016-09,
Improvements to Employee Share-Based Payment Accounting (Topic 718), we have
elected not to establish a forfeiture rate, as stock-based compensation expense
related to forfeitures of unvested stock options is fully reversed at the time
of forfeiture.

                                       28

————————————————– ——————————

Index

Research and development costs

Our research and development ("R&D") costs consist of clinical research
organization costs, costs related to clinical trials, testing and evaluation of
new or alternative products or processes, studies for potentially extending a
product's approved and labeled expiration dating and other potential label
expansions, post-marketing commitment studies for BIVIGAM and ASCENIV and wages,
benefits and stock-based compensation for employees directly related to research
and development activities. All research and development costs are expensed as
incurred.

Inventories

Raw materials inventory consists of various materials purchased from suppliers,
including normal source plasma, that are used in the production of our
products.  Work-in-process and finished goods inventories reflect the cost of
raw materials as well as costs for direct and indirect labor, primarily
salaries, wages and benefits for applicable employees, as well as an allocation
of overhead costs related to the Boca Facility including utilities, property
taxes, general repairs and maintenance, consumable supplies and depreciation.
The allocation of Boca Facility overhead to inventory is generally based upon
the estimated square footage of the Boca Facility that is used in the production
of our products relative to the total square footage of the facility.

Inventories, including plasma intended for resale and plasma intended for
internal use in the Company's manufacturing, commercialization or research and
development activities, are carried at the lower of cost or net realizable value
determined by the first-in, first-out method.  Net realizable value is generally
determined based upon the consideration we expect to receive when the inventory
is sold, less costs to deliver the inventory to the recipient. The estimates for
net realizable value of inventory are based on contractual terms or upon
historical experience and certain other assumptions which we believe are
reasonable. Inventory is periodically reviewed to ensure that its carrying value
does not exceed its net realizable value, and adjustments are recorded to write
down such inventory, with a corresponding charge to cost of product revenue,
when the carrying value or historical cost exceeds its estimated net realizable
value.

Impairment of long-lived assets

We assess the recoverability of our long-lived assets, which include property
and equipment and finite-lived intangible assets, whenever significant events or
changes in circumstances indicate impairment may have occurred. If indicators of
impairment exist, projected future undiscounted cash flows associated with the
asset are compared to its carrying amount to determine whether the asset's
carrying value is recoverable. Any resulting impairment is recorded as a
reduction in the carrying value of the related asset in excess of fair value and
a charge to operating results. For the six months ended June 30, 2021 and 2020,
we determined that there was no impairment of our long-lived assets.

Goodwill is not amortized, but is assessed for impairment on an annual basis or
more frequently if impairment indicators exist. We have the option to perform a
qualitative assessment of goodwill to determine whether it is more likely than
not that the fair value of the reporting unit associated with the goodwill is
less than its carrying amount, including goodwill and other intangible assets.
If we conclude that this is the case, then we must perform a goodwill impairment
test by comparing the fair value of the reporting unit to its carrying value.
An impairment charge is recorded to the extent the reporting unit's carrying
value exceeds its fair value, with the impairment loss recognized not to exceed
the total amount of goodwill allocated to that reporting unit.  We did not
recognize any impairment charges related to goodwill for the six months ended
June 30, 2021 and 2020.

                                       29

————————————————– ——————————

Index

Recent accounting positions

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit
Losses (Topic 326) ("ASU 2016-13"), which requires financial assets to be
presented at the net amount expected to be collected, with an allowance for
credit losses to be deducted from the amortized cost basis of the financial
asset such that the net carrying value of the asset is presented as the amount
expected to be collected. Under ASU 2016-13, the entity's statement of
operations is required to reflect the measurement of credit losses for newly
recognized financial assets, as well as expected increases or decreases in
expected credit losses that have taken place during the period. For public
business entities, ASU 2016-13 is effective for fiscal years beginning after
December 15, 2019.  We adopted ASU 2016-13 on January 1, 2020, and the adoption
of this update did not have a significant impact on our consolidated financial
statements.

Three months ended June 30, 2021 Compared to the three months ended June 30, 2020

The following table presents a summary of the evolution of our operating results for the three months ended. June 30, 2021, our second fiscal quarter, compared to the three months ended June 30, 2020:

                                                                   Three

Ended months June 30th,

                                                                                               Increase
                                                             2021              2020           (Decrease)
Revenues                                                 $  17,830,590

$ 7,787,594 $ 10,042,996
Cost of revenue from products (excluding depreciation charges shown below)

                                        18,832,624        13,495,629        5,336,995
Gross loss                                                  (1,002,034 )      (5,708,035 )      4,706,001
Research and development expenses                            1,158,866         1,656,420         (497,554 )
Plasma center operating expenses                             2,803,326           877,902        1,925,424
Amortization of intangibles                                    178,838           178,838                -
Selling, general and administrative expenses                10,438,168         8,702,630        1,735,538
Loss from operations                                       (15,581,232 )     (17,123,825 )      1,542,593
Interest expense                                            (3,246,680 )      (3,067,306 )       (179,374 )
Other (expense) income, net                                    (77,391 )          13,040          (90,431 )
Net loss                                                 $ (18,905,303 )   $ (20,178,091 )   $  1,272,788



Revenues

We recorded total revenues of $17.8 million during the three months ended June
30, 2021, as compared to $7.8 million during the three months ended June 30,
2020, an increase of $10.0 million, or approximately 130%. The increase is due
to increased sales of our immunoglobulin products generated by our Boca Facility
manufacturing operations in 2021.

Our revenues for the second quarter of 2021 as compared to the same period of a
year ago were favorably impacted by the continued commercial scale-up, expanding
customer base at both our ADMA BioManufacturing and ADMA BioCenters plasma
collection center business segments and physician/payer acceptance of BIVIGAM
and ASCENIV following these products' FDA approvals on May 9, 2019 and April 1,
2019, respectively, while we continued to benefit from the manufacturing and
supply agreement we entered into in January 2020 to produce and sell
intermediate fractions to a certain customer. In addition, revenues in the
second quarter of 2020 were negatively impacted by COVID-19-related delays with
some of our third-party vendors and testing laboratories which perform final
drug product GMP release testing. In response to these delays, we added
additional release testing laboratories to our FDA approved consortium listed in
our drug approval documents which we believe has adequately addressed this
issue.

Product revenue cost

Cost of product revenue was $18.8 million for the three months ended June 30,
2021, as compared to $13.5 million for the three months ended June 30, 2020.
This increase reflects higher product revenue costs in 2021 of $7.6 million
corresponding to the increase in immunoglobulin revenues, partially offset by
the absence of conformance batch production expenses in 2020 of $3.2 million.

                                       30

————————————————– ——————————

Index

Research and development costs

R&D expenses totaled $1.2 million for the three months ended June 30, 2021, as
compared to $1.7 million for the three months ended June 30, 2020. The decrease
is primarily due to reduced compensation costs associated with R&D activities
during the quarter of $0.3 million, and the absence of $0.2 million of
non-recurring costs incurred in 2020 associated with our participation in a
third-party clinical research project.

Plasma center operating expenses

Plasma center operating expenses were $2.8 million for the three months ended
June 30, 2021, as compared to $0.9 million for the three months ended June 30,
2020. Plasma center operating expenses consist of certain general and
administrative plasma center costs, including rent, maintenance, utilities,
compensation and benefits for center and administrative staff, advertising and
promotion expenses and computer software fees related to donor collections. The
increase in plasma center operating expenses is mainly attributable to increased
staffing and travel expenses related to our plasma center expansion activities.
We had four plasma collection centers in operation during the second quarter of
2021, as compared to one plasma collection center in operation during the second
quarter of 2020. We also had four other plasma collection centers in various
stages of construction or development during the second quarter of 2021.

Amortization of intangible assets

Amortization expense pertains to the amortization of intangible assets acquired
in the Biotest Transaction and was $0.2 million for the three months ended June
30, 2021 and 2020.

Selling, general and administrative expenses

Selling, general and administrative ("SG&A") expenses were $10.4 million for the
three months ended June 30, 2021, an increase of $1.7 million from the three
months ended June 30, 2020. The increase was primarily due to higher employee
compensation and related expenses of $1.2 million related to staffing increases,
largely in support of our commercialization efforts for BIVIGAM and ASCENIV and
increased insurance expense of $0.3 million. In addition, in connection with the
resignation of our former Chief Medical Officer in the second quarter of 2021,
we recognized an expense and corresponding liability in the amount of $0.8
million for estimated payments we expect to make under a separation and
transition agreement. These increases were partially offset by lower third-party
market intelligence and consulting fees associated with our ASCENIV
commercialization efforts.

Operating loss

Our operating loss was $15.6 million for the second quarter of 2021, as compared
to $17.1 million for the second quarter of 2020. The $1.5 million decrease in
operating loss was mainly due to the significant narrowing of our gross loss of
$4.7 million and the reduction in R&D expenses, partially offset by the
increases in SG&A and plasma center operating expenses.

Interest charges

Interest expense increased by approximately $0.2 million for the three months
ended June 30, 2021 as compared to the same period of a year ago. The increase
reflects the refinancing of $15 million of subordinated debt in December 2020
whereby the interest rate increased from 6% to 11% per annum, as the maturity
date on this indebtedness was extended from June 2022 to March 2024 (see
"Liquidity and Capital Resources").

Net loss

Our net loss was $18.9 million for the three months ended June 30, 2021, as
compared to $20.2 million for the three months ended June 30, 2020.  The $1.3
million decrease in net loss was primarily due to the decreased operating loss
for the quarter of $1.5 million, partially offset by the increase in interest
expense.

                                       31

————————————————– ——————————

Index

Six months ended June 30, 2021 Compared to the six months ended June 30, 2020

The following table presents a summary of the changes in our results of
operations for the six months ended June 30, 2021, compared to the six months
ended June 30, 2020:

                                                                    Six Months Ended June 30,
                                                                                               Increase
                                                             2021              2020           (Decrease)
Revenues                                                 $  33,879,208

$ 17,987,338 $ 15,891,870
Cost of revenue from products (excluding depreciation charges shown below)

                                        36,602,746        30,324,855        6,277,891
Gross loss                                                  (2,723,538 )     (12,337,517 )      9,613,979
Research and development expenses                            2,146,515         3,185,158       (1,038,643 )
Plasma center operating expenses                             5,045,669         1,378,546        3,667,123
Amortization of intangibles                                    357,676           357,676                -
Selling, general and administrative expenses                20,472,083        16,634,714        3,837,369
Loss from operations                                       (30,745,481 )     (33,893,611 )      3,148,130
Interest expense                                            (6,442,430 )      (5,784,397 )       (658,033 )
Other (expense) income, net                                    (97,333 )         254,687         (352,020 )
Net loss                                                 $ (37,285,244 )   $ (39,423,321 )   $  2,138,077



Revenues

We recorded total revenues of $33.9 million during the six months ended June 30,
2021, as compared to $18.0 million during the six months ended June 30, 2020, an
increase of $15.9 million, or approximately 88%. The increase is due to
increased sales of our immunoglobulin products generated by our Boca Facility
manufacturing operations in 2021, largely driven by the expansion of our
customer base at both of our business segments that took place subsequent to
June 30, 2020.

Our revenues for the first six months of 2021 as compared to the same period of
a year ago were favorably impacted by the continued commercial scale-up and
increasing physician/payer acceptance of BIVIGAM and ASCENIV following these
products' FDA approvals on May 9, 2019 and April 1, 2019, respectively, while we
also continued to benefit from the manufacturing and supply agreement we entered
into in January 2020 to produce and sell intermediate fractions to a certain
customer. Revenues in the first six months of 2021 were also favorably impacted
by the approvals we received from the FDA to implement a Hepatitis B
immunization program at one of our FDA-approved plasma collection centers and
from MFDS for the sale of source plasma into South Korea.

Product revenue cost

Cost of product revenue was $36.6 million for the six months ended June 30,
2021, as compared to $30.3 million for the six months ended June 30, 2020. This
increase reflects higher product revenue costs in 2021 of $13.6 million
corresponding to the increase in immunoglobulin revenues, partially offset by
the absence of conformance batch production expenses in 2020 of $7.3 million.
The lack of such expenses in 2021, combined with the increase in revenues,
resulted in a reduction of our gross loss in the amount of $9.6 million, or 78%,
in the first half of 2021 as compared to the first half of 2020.

Research and development costs

R&D expenses totaled $2.1 million for the six months ended June 30, 2021, as
compared to $3.2 million for the six months ended June 30, 2020. R&D expenses in
2020 included non-recurring charges of $0.4 million related to a study we
conducted to potentially extend ASCENIV's approved and labeled expiration
dating, and $0.2 million related to our participation in a third-party clinical
research project. We also experienced a reduction in R&D related compensation
expenses due to the resignation of our former Chief Medical Officer on June 8,
2021.

Plasma center operating expenses

Plasma center operating expenses were $5.0 million for the six months ended June
30, 2021, as compared to $1.4 million for the six months ended June 30, 2020.
The increase in plasma center operating expenses is mainly attributable to
increased staffing and related expenses, including travel expenses, of $2.3
million, as well as increases in rent expense of $0.4 million, depreciation
expense of $0.3 million, donor fees of $0.2 million, advertising expenses of
$0.1 million and utilities of $0.1 million, all related to our plasma center
expansion activities.

                                       32

————————————————– ——————————

  Index


Amortization of Intangibles

Amortization expense pertains to the amortization of intangible assets acquired
in the Biotest Transaction and was $0.4 million for the six months ended June
30, 2021 and 2020.

Selling, general and administrative expenses

SG&A expenses were $20.5 million for the six months ended June 30, 2021, an
increase of $3.8 million from the six months ended June 30, 2020. The increase
was primarily due to higher employee compensation and related expenses of $2.2
million related to staffing increases, largely in support of our
commercialization efforts for BIVIGAM and ASCENIV, recognition of the $0.8
million related to the separation and transition agreement with our former Chief
Medical Officer and $0.7 million of increased insurance expense.

Operating loss

Our operating loss was $30.7 million for the first six months of 2021, as
compared to $33.9 million for the first six months of 2020. The $3.1 million
decrease in operating loss was mainly due to the increase in revenues and
corresponding reduction in gross loss and decrease in R&D expenses, partially
offset by the increases in SG&A and plasma center operating expenses.

Interest charges

Interest expense was $6.4 million for the six months ended June 30, 2021, as
compared to $5.8 million for the six months ended June 30, 2020. The increase
reflects the additional interest expense associated with the Perceptive Tranche
III Loan which we drew down on March 20, 2020, as well as the higher interest on
the $15 million note formerly due to Biotest that we refinanced in December 2020
(see "Liquidity and Capital Resources").

Net loss

Our net loss was $37.3 million for the six months ended June 30, 2021, as
compared to $39.4 million for the six months ended June 30, 2020.  The decrease
in net loss of $2.1 million was primarily due to the decreased operating loss
for the quarter of $3.1 million, the increase in interest expense of $0.7
million, and the decrease in interest income of $0.2 million due to the
reduction of interest rates that took place during the first quarter of 2020.

                        LIQUIDITY AND CAPITAL RESOURCES

As of June 30, 2021, we had working capital of $153.2 million, including cash
and cash equivalents of $42.4 million, and stockholders' equity of $111.6
million, as compared to working capital of $133.8 million, including cash and
cash equivalents of $55.9 million, and stockholders' equity of $88.2 million as
of December 31, 2020. We have incurred an accumulated deficit of $377.8 million
since inception, had negative cash flows from operations of $65.5 million and
$45.9 million for the six months ended June 30, 2021 and 2020, respectively, and
negative cash flows from operations of $102.0 million and $76.2 million for the
years ended December 31, 2020 and 2019, respectively. We have funded our
operations over the past few years primarily from the sale of our equity and
debt securities.

We expect to continue to spend substantial amounts on procurement of raw
material plasma and other raw materials necessary to scale up our manufacturing
operations, commercial product launches, capacity expansion at the Boca
Facility, building additional plasma collection facilities, product development,
quality assurance, regulatory affairs and conducting clinical trials for our
product candidates and purchasing clinical trial materials, some of which may be
required by the FDA. In addition, our end-to-end production cycle from
procurement of raw materials to commercial release of finished product can take
between seven and 12 months or potentially longer, requiring substantial
investments in raw material plasma and other manufacturing materials. We expect
that we will not be able to generate a sufficient amount of product revenue to
achieve profitability until the beginning of 2024 and, as a result, we expect
that we will need to continue to finance our operations through additional
equity or debt financings or through corporate collaboration and licensing
arrangements. Based upon our projected revenues and projected expenditures,
including capital expenditures and continued implementation of our
commercialization and expansion activities, we currently believe that our cash,
cash equivalents, projected revenue and accounts receivable will be sufficient
to fund our operations, as currently conducted, into the fourth quarter of 2021.
In order to have sufficient cash to fund our operations thereafter, we will need
to raise additional capital before the end of the fourth quarter of 2021. These
estimates and timeframes may change based upon several factors, including the
success of our commercial manufacturing ramp-up activities, the acceptability
and reimbursement of BIVIGAM and ASCENIV by physicians, patients or payers, and
the various financing options that may be available to us. We currently have no
firm commitments for additional financing, and there can be no assurances that
we will be able to secure additional financing on terms that are acceptable to
us, or at all. Furthermore, if our assumptions underlying our estimated expenses
and revenues are incorrect, we may have to raise additional capital sooner than
currently anticipated.

                                       33

————————————————– ——————————

Index


On May 28, 2021, we entered into an Open Market Sale AgreementSM (the "2021 Sale
Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may offer and
sell, from time to time, at our option, through or to Jefferies, up to an
aggregate of $50,000,000 of shares of our common stock. We intend to use the net
proceeds from any offering under the 2021 Sale Agreement for general corporate
purposes, including procurement of raw materials, source plasma, supply chain
initiatives and production expenditures, funding expansion of plasma centers,
working capital, capital expenditures, expansion and resources for
commercialization activities, and other potential research and development and
business opportunities. We may decide to utilize the 2021 Sale Agreement from
time to time in order to supplement our cash resources and fund our operations
beyond the fourth quarter of 2021. As of the date of this report, there have
been no sales of common stock under the 2021 Sale Agreement.

Our long-term liquidity depends upon our ability to raise additional capital,
fund capacity expansion and commercial programs and generate sufficient revenues
from our products, several of which have only recently achieved commercial
status, to cover our operating expenses and meet our obligations on a timely
basis. The COVID-19 pandemic has negatively affected the global economy and
created significant volatility and disruption to the financial markets. Failure
to secure any necessary financing in a timely manner and on commercially
reasonable terms could have a material adverse effect on our business plan and
financial performance and we could be forced to delay or discontinue our
capacity expansion, commercialization, product development or clinical trial
activities, delay or discontinue the approval efforts for any of our product
candidates, or potentially cease operations. In addition, we could also be
forced to reduce or forgo sales and marketing efforts and forgo attractive
business opportunities.

Due to numerous risks and uncertainties associated with the COVID-19 pandemic,
FDA reviews, inspections and approvals related to our products and processes,
patient/payer acceptance of our products, ongoing compliance and maintenance
requirements and capacity expansion efforts at the Boca Facility, we are unable
to estimate with certainty the amounts of increased capital outlays and
operating expenditures required to fund our commercialization and other
development activities. Our current estimates may be subject to change as
circumstances regarding our business requirements evolve and are also subject to
the effect of potential new government orders, policies and procedures that we
must comply with which are outside of our control.  As such, these factors raise
substantial doubt about our ability to continue as a going concern.

We may decide to raise capital through public or private equity offerings or
debt financings, obtain a bank credit facility or enter into corporate
collaboration and licensing arrangements. The sale of additional equity or debt
securities, if convertible, could result in dilution to our stockholders and, in
such event, the market value of our common stock may decline. The incurrence of
additional indebtedness would result in increased fixed obligations and could
also result in covenants that would restrict our operations or other financing
alternatives. In addition, we are exploring additional contract manufacturing
arrangements and other business development opportunities, which may provide
additional liquidity to us. We are also considering alternative business
opportunities to maximize stockholder value including, for example, the
acquisition or sale of specific assets or businesses, collaboration and/or
license agreements or co-development agreements.

On August 5, 2020, we entered into an Open Market Sale Agreement (the "2020 Sale
Agreement") with Jefferies, pursuant to which we could offer and sell, from time
to time, at our option, through or to Jefferies, up to an aggregate of $50
million of shares of our common stock. On November 5, 2020 and February 3, 2021,
we and Jefferies entered into amendments to the 2020 Sale Agreement (as amended,
the "Amended 2020 Sale Agreement") to provide for an increase in the aggregate
offering amount under the Amended 2020 Sale Agreement, such that, as of February
3, 2021, we could sell shares having a gross aggregate offering price of up to
$105.4 million.

                                       34

————————————————– ——————————

Index


For the year ended December 31, 2020, we sold 18,537,907 shares of our common
stock under the Amended 2020 Sale Agreement and received net proceeds in the
amount of $42.5 million.  During the six months ended June 30, 2021, we sold an
additional 26,907,753 shares of our common stock and received net proceeds of
$59.1 million, and during July of 2021 we sold an additional 897,445 shares of
our common stock under the Amended 2020 Sale Agreement and received net proceeds
of approximately $1.5 million. As of the date of this report, we cannot raise
any additional funds under the Amended 2020 Sale Agreement. The net proceeds
from this offering were or are being used for general corporate purposes, which
may include (i) the procurement of raw materials for the manufacturing of
BIVIGAM and ASCENIV; (ii) supporting the ongoing commercial sales of our IVIG
products; (iii) expanding the manufacturing capacity of our Boca Facility,
including supply chain functions, and enhancing the robustness of our supply
chain oversight; (iv) expanding our plasma collection facility network; and (v)
research and development and business development opportunities.

On February 11, 2019 (the "Perceptive Closing Date"), we and all of our
subsidiaries entered into a Credit Agreement and Guaranty (the "Perceptive
Credit Agreement") with Perceptive Credit Holdings II, LP, as the lender and
administrative agent ("Perceptive"). The Perceptive Credit Agreement, as
amended, provides for a senior secured term loan facility in a principal amount
of $100.0 million (the "Perceptive Credit Facility"), comprised of (i) a term
loan made on the Perceptive Closing Date in the principal amount of $45.0
million, as evidenced by the Company's issuance of a promissory note (the
"Perceptive Tranche I Note") in favor of Perceptive on the Perceptive Closing
Date (the "Perceptive Tranche I Loan"), (ii) a term loan in the principal amount
of $27.5 million (the "Perceptive Tranche II Loan") evidenced by the Company's
issuance of a promissory note (the "Perceptive Tranche II Note") in favor of
Perceptive on May 3, 2019, (iii) a term loan in the principal amount of $12.5
million evidenced by the Company's issuance of a promissory note (the
"Perceptive Tranche III Note") in favor of Perceptive on March 20, 2020 (the
"Perceptive Tranche III Loan"); and (iv) a term loan in the principal amount of
$15 million evidenced by our issuance of a promissory note in favor of
Perceptive on December 8, 2020 (the "Perceptive Tranche IV Loan", and together
with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the
Perceptive Tranche III Loan, the "Perceptive Loans"). The Perceptive Tranche III
Loan is the result of an amendment to the Perceptive Credit Agreement that the
Company and Perceptive entered into on May 3, 2019 (the "First Perceptive
Amendment"), and the Perceptive Tranche III Loan became available to the Company
upon the approval of BIVIGAM on May 9, 2019. The Perceptive Tranche IV Loan is
the result of an amendment to the Perceptive Credit Facility entered into on
December 8, 2020 (the "Second Perceptive Amendment"), which also extended the
maturity date of the Perceptive Credit Facility to March 1, 2024 (the "Maturity
Date"), subject to acceleration pursuant to the Perceptive Credit Agreement,
including upon an Event of Default (as defined in the Perceptive Credit
Agreement).

The proceeds from the Perceptive Tranche IV Loan were used to retire the $15.0
million subordinated note we had payable to Biotest, which had a maturity date
of June 17, 2022.

Borrowings under the Perceptive Credit Agreement bear interest at a rate per
annum equal to 7.5% plus the greater of (i) one-month LIBOR and (ii) 3.5%;
provided, however, that upon, and during the continuance of, an Event of
Default, the interest rate will automatically increase by an additional 400
basis points. Accrued interest of approximately $0.9 million per month is
payable to Perceptive on the last day of each month during the term of the
Perceptive Credit Facility.  The rate of interest in effect as of the Perceptive
Closing Date and at June 30, 2021 was 11.0%.

On the Maturity Date, we are required to pay Perceptive the entire outstanding
principal amount underlying the Perceptive Loans and any accrued and unpaid
interest thereon. There are no scheduled principal payments on the Perceptive
Loans prior to the Maturity Date. We may prepay outstanding principal on the
Perceptive Loans at any time and from time to time upon three business days'
prior written notice, subject to the payment to Perceptive of (A) any accrued
but unpaid interest on the prepaid principal amount plus (B) a redemption
premium amount equal to (i) 5.0% of the prepaid principal amount, if prepaid on
or prior to December 31, 2021, (ii) 2.0% of the prepaid principal amount, if
prepaid after December 31, 2021 and on or prior to December 31, 2022, (iii) 4.0%
of the prepaid principal amount, if prepaid after December 31, 2022 and on or
prior to December 31, 2023, and (iv) 5.0% of the prepaid principal amount, if
prepaid any time thereafter and prior to the Maturity Date.

                                       35

————————————————– ——————————

Index


All of our obligations under the Perceptive Credit Agreement are secured by a
first-priority lien and security interest in substantially all of our tangible
and intangible assets, including intellectual property and all of the equity
interests in our subsidiaries. The Perceptive Credit Agreement contains certain
representations and warranties, affirmative covenants, negative covenants and
conditions that are customarily required for similar financings. The negative
covenants restrict or limit our ability and that of our subsidiaries to, among
other things and subject to certain exceptions contained in the Perceptive
Credit Agreement, incur new indebtedness; create liens on assets; engage in
certain fundamental corporate changes, such as mergers or acquisitions, or
changes to our or our subsidiaries' business activities; make certain
Investments or Restricted Payments (each as defined in the Perceptive Credit
Agreement); change our fiscal year; pay dividends; repay other certain
indebtedness; engage in certain affiliate transactions; or enter into, amend or
terminate any other agreements that have the impact of restricting our ability
to make loan repayments under the Perceptive Credit Agreement. In addition, we
must (i) at all times prior to the Maturity Date maintain a minimum cash balance
of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing
with the fiscal quarter ended June 30, 2019, report revenues for the trailing
12-month period that exceed the amounts set forth in the Perceptive Credit
Agreement, which range from $37.3 million for the fiscal quarter ended June 30,
2021 to $55.0 million for the fiscal quarter ending December 31, 2021. At June
30, 2021, we were in compliance with all of the covenants contained in the
Perceptive Credit Agreement.

In February 2020, we completed an underwritten public offering of 27,025,000
shares of our common stock and received net proceeds, after underwriting
discounts and other expenses associated with the offering, of approximately
$88.7 million. The proceeds from this offering were used (i) for the procurement
of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) to support
the ongoing commercial sales of BIVIGAM and ASCENIV; (iii) to expand the
manufacturing capacity of our Boca Facility and enhance our supply chain
capabilities; (iv) to expand our plasma collection facility network; (v) for
research and development and business development opportunities; and (vi) for
general corporate purposes and other capital expenditures.

Cash flow

The following table sets forth a summary of our cash flows for the periods
indicated:
                                                     Six Months Ended June 30,
                                                      2021              2020
Net cash used in operating activities             $ (65,491,363 )   $ (45,931,435 )
Net cash used in investing activities                (7,046,735 )      (6,241,284 )
Net cash provided by financing activities            59,025,904

101 201 706

Net change in cash and cash equivalents             (13,512,194 )

49 028 987

Cash and cash equivalents – start of period 55,921 152 26,752 135 Cash and cash equivalents – end of period $ 42,408,958 $ 75,781,122

Net cash used in operating activities
Cash used in operations for the six months ended June 30, 2021 was $65.5
million, an increase of $19.6 million from the same period of a year ago, mainly
due to an increases in inventory and accounts receivable. The following table
illustrates the primary components of our cash flows from operations:

                                                          Six Months Ended June 30,
                                                           2021              2020
Net loss                                               $ (37,285,244 )   $ (39,423,321 )
Non-cash expenses, gains and losses                        5,057,077

3,873,479

Changes in accounts receivable                           (10,307,304 )      (3,044,246 )
Changes in inventories                                   (18,164,144 )      (2,936,614 )
Changes in prepaid expenses and other current assets      (2,655,397 )      (2,159,834 )
Changes in accounts payable and accrued expenses          (1,925,710 )      (1,865,637 )
Other                                                       (210,641 )        (375,262 )
Cash used in operations                                $ (65,491,363 )   $ (45,931,435 )



                                       36

————————————————– ——————————

Index

Net cash used in investment activities
Net cash used in investing activities for the six months ending June 30, 2021
was $7.0 million, which primarily consisted of $4.3 million for the construction
and buildout of new plasma centers and related equipment and capital
expenditures at the Boca Facility of $2.7 million, which includes equipment
purchases and implementation of our in-house fill/finish capabilities. Cash used
in investing activities of $6.2 million for the six months ended June 30, 2020
was mainly attributable to capital expenditures at the Boca Facility. Although
we have no specific material commitments for capital expenditures as of June 30,
2021, we expect our total capital expenditures will be between $6.0 million and
$12.0 million for the remainder of fiscal 2021.

Net cash provided by financing activities

Cash provided by financing activities was $59.0 million for the six months ended
June 30, 2021 and primarily consisted of proceeds received from the Amended Sale
Agreement.  Cash provided by financing activities of $101.2 million for the same
period of a year ago was comprised of $88.7 million of net proceeds received
from our underwritten public offering in February 2020 and $12.5 million of
proceeds from the Perceptive Tranche III Loan received in March 2020.

Effect of inflation

Inflation or price changes did not have a material impact on our net income, operating expenses or net loss for the six months ended. June 30, 2021
or in 2020 or 2019.

Off-balance sheet provisions

Nothing.

© Edgar online, source Previews


Source link

Comments are closed.