What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2021-03-25 compared with 2020-03-13 · 13 added, 692 removed, 7 unchanged (99% of the section changed)

Market for Registrant’s Common Equity, Related

Stockholder Matters and Issuer Purchases of Equity Securities

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our Common Stock had been listed on the

Nasdaq Capital Market (“Nasdaq”) under the symbol “ADMA”

since November 10, 2014.

As of October 22, 2019,

our Common Stock has been listed on the Nasdaq Global Market.

As of December 31, 2019, there were nine

record holders of our Common Stock, based upon information received from our transfer agent.

However, this number does not include

beneficial owners whose shares were held of record by nominees or broker dealers.

As of February 1, 2020, we estimate that there

are more than 6,000 beneficial owners of our Common Stock.

Our Common Stock had been listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “ADMA” since November 10, 2014.

As of October 22, 2019, our Common Stock has been listed on the Nasdaq Global Market.

As of December 31, 2020, there were nine record holders of our Common Stock, based upon information received from our transfer agent.

However, this number does not include beneficial owners whose shares were held of record by nominees or broker dealers.

As of February 1, 2021, we estimate that there are more than 20,000 beneficial owners of our Common Stock.

Dividend Policy

We have never paid any cash dividends on

our capital stock.

We anticipate that we will retain earnings, if any, to support operations and to finance the growth

and development of our business.

In addition, the terms of our Credit Agreement with Perceptive precludes us from

paying cash dividends without their consent.

Therefore, we do not expect to pay cash dividends for the foreseeable

We have never paid any cash dividends on our capital stock.

We anticipate that we will retain earnings, if any, to support operations and to finance the growth and development of our business.

In addition, the terms of our Credit Agreement with Perceptive precludes us from paying cash dividends without their consent.

Therefore, we do not expect to pay any cash dividends for the foreseeable future.

Stock Performance Graph

1 unchanged sentence

Sale of Unregistered Securities

During the year ended December 31, 2019,

we had no sales of unregistered securities that have not been previously disclosed in a Current Report on Form 8-K or Quarterly

Reports on Form 10-Q.

Purchases of Equity Securities by the Issuer and Affiliated

We did not repurchase any of our securities

during the three months ended December 31, 2019.

During the year ended December 31, 2020, we had no sales of unregistered securities that have not been previously disclosed in a Current Report on Form 8-K or Quarterly Reports on Form 10-Q.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

We did not repurchase any of our securities during the three months ended December 31, 2020.

Selected Financial Data

Not applicable.

Management’s Discussion and Analysis of Financial

Condition and Results of Operations

The following discussion of our financial condition and results

of operations should be read in conjunction with the consolidated financial statements and notes thereto included elsewhere in

this Annual Report on Form 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 materially affected by the uncertainties and risk factors described throughout

this Annual Report.

See “Special Note Regarding Forward-Looking Statements.”

Our actual results

may differ materially.

ADMA Biologics, Inc.

(the “Company,”

“ADMA,”

“we,”

“us”

or “our”) is an end-to-end commercial biopharmaceutical and

specialty immunoglobulin 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 IVIG product indicated for the treatment of PI, also known as PIDD, and for

which we received FDA approval on May 9, 2019 for the commercial re-launch of the product and commenced the commercial re-launch

in August 2019;

(ii) ASCENIV (Immune Globulin Intravenous, Human –

slra 10% Liquid), previously referred to as RI-002, 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.

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.

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.

Through ADMA Bio Centers, we currently operate

one FDA-approved source plasma collection facility in the U.S., which provides us with a portion of our blood plasma for the manufacture

of our products and product candidates.

We intend to open five to 10 additional plasma collection centers in the U.S.

next three to five years.

A typical plasma collection center, such as those operated by ADMA Bio Centers, 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 Bio Centers’

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

where we are approved under supply agreements or in the open “spot”

We also sell plasma-derived intermediate

fractions to certain customers, which are generated as part of our FDA-approved manufacturing process for IVIG products.

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 services for certain historical clients.

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”).

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.BPC had originally received FDA approval for BIVIGAM on December 19, 2012, prior to our acquisition of BTBU, and

product sales had commenced in the first quarter of 2013.

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 after the closing of the Biotest Transaction and commercial

production is ongoing, using our FDA-approved IVIG manufacturing process under U.S.

Department of Health and Human Services (“HHS”)

The commercial re-launch and first commercial sales commenced in August of 2019.

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 a HHS License No.

a process known as fractionation.

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 titers to RSV using our proprietary microneutralization assay.

We are able to identify

the high titer plasma that meets our internal specifications for ASCENIV with our patented testing 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

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.

We plan to work with the FDA and the immunology

and infectious disease community to design a clinical trial to evaluate the use of ASCENIV in this patient population in the near

Commercial sales of ASCENIV commenced in October of 2019.

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.

FDA approval for Nabi-HB was received on March 24, 1999.

Biotest acquired Nabi-HB from Nabi

Biopharmaceuticals in 2007.

Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter

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 continue to manufacture under HHS License No.

RESULTS OF OPERATIONS

Critical Accounting Policies 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

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 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 Annual Report on Form 10-K.

Revenue Recognition

Revenues for the years ended December 31,

2019 and 2018 are comprised of (i) revenues from the sale of our three 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 revenue from a contract assumed from BPC in the Biotest Transaction;

(v) license revenues attributable to the out-licensing of ASCENIV in December 2012 to 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 recognized over the term of the Biotest license.

Deferred revenue is amortized

into income for a period of approximately 22 years, the term of the Biotest license agreement.

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.

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 contract manufacturing and sales of our intermediates,

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.

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

Cost of Product Revenue

Cost of product revenue includes expenses

related to process development as well as scientific and technical operations when these operations are attributable to marketed

When the activities of these operations are attributable to new products in development, the expenses are classified

as research and development expenses.

Costs of production for ASCENIV and BIVIGAM prior to their FDA approval dates of April 1,

2019 and May 9, 2019, respectively, were not capitalized into inventory but were instead expensed as incurred.

In addition, expenses

associated with remediating the issues at the Boca Facility that were identified by the FDA prior to the closing of the Biotest

Transaction of approximately $0.2 million and $1.5 million for the years ended December 31, 2019 and 2018, respectively, were expensed

as incurred and are reflected in cost of product revenue in the accompanying consolidated statements of operations.

Stock-Based Compensation

equity-based payments, including grants of stock options, 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.

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 1,508,000 and 1,167,044 shares of Common Stock during the years ended December 31, 2019 and 2018, 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 Accounting Standards Update (“ASU”)

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.

Research and Development Expenses

Our research and development (“R&D”)

costs consist of clinical research organization costs, costs related to clinical trials, post-marketing commitment studies for

BIVIGAM, wages, benefits and stock-based compensation for employees directly related to research and development activities and,

prior to April 1, 2019, assay development and testing, storage and transportation costs for high-titer plasma used in the manufacture

All research and development costs are expensed as incurred.

Impairment of Long-Lived Assets

We assess the recoverability of our long-lived

assets, which include property and equipment and definite-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

For the years ended December 31, 2019 and 2018, 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 years ended December 31, 2019 and 2018.

Recent Accounting Pronouncements

In July 2017, the Financial Accounting Standards

Board (the “FASB”) issued Accounting Standards Update (“ASU”) No.

2017-11, Earnings Per Share (Topic

260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) ”

(“ASU 2017-11”).

ASU 2017-11 changed the classification analysis of certain equity-linked financial instruments (or embedded features within such

instruments) with down round features.

When determining whether certain financial instruments should be classified as liabilities

or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is

indexed to an entity’s own stock.

The amendments also clarify existing disclosure requirements for equity-classified instruments.

As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for

as a derivative liability at fair value as a result of the existence of a down round feature.

For freestanding equity classified

financial instruments, the amendments require entities that present earnings per share (“EPS”) in accordance with ASC

260 to recognize the effect of the down round feature when it is triggered.

That effect is treated as a dividend and as a reduction

of income available to common shareholders in basic EPS.

In addition, convertible instruments with embedded conversion options

that have down round features are now subject to the specialized guidance for contingent beneficial conversion features in ASC

470-20, “

Debt—Debt with Conversion and Other Options.

ASU 2017-11 became effective for us on January

1, 2019, and this update did not have a significant impact on our consolidated financial statements.

In February 2016, the FASB issued ASU No.

2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize assets and liabilities for

the rights and obligations created by most leases on their balance sheet.

The guidance became effective for fiscal years beginning

after December 15, 2018, including interim periods within those fiscal years.

ASU 2016-02 requires modified retrospective adoption

for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief.

We adopted ASU 2016-02 on January 1, 2019 using the option to recognize the cumulative-effect adjustment, if any, as of the date

of application, which was also January 1, 2019.

As a result, there was no restatement of comparative periods.

We recognized right-to-use

assets of approximately $1.4 million and corresponding lease liabilities of approximately $1.6 million at the date of adoption.

We also elected the “package of practical expedients,”

which permits us to not reassess under the new standard our

prior conclusions about lease identification, lease classification and initial direct costs.

In addition, we elected the short-term

lease recognition exemption for all or embedded leases that qualify.

In May 2014, the FASB issued new guidance

related to revenue recognition, ASU 2014-09, Revenue from Contracts with Customers (“ASC 606”), which outlines

a comprehensive revenue recognition model and supersedes most current revenue recognition guidance.

The new guidance requires a

company to recognize revenue upon transfer of goods or services to a customer at an amount that reflects the expected consideration

to be received in exchange for those goods or services.

ASC 606 defines a five-step approach for recognizing revenue, which may

require a company to use more judgment and make more estimates than under the current guidance.

The new guidance became effective

in calendar year 2018.

Two methods of adoption are permitted:

(a) full retrospective adoption, meaning the standard is applied

to all periods presented;

or (b) modified retrospective adoption, meaning the cumulative effect of applying the new guidance is

recognized at the date of initial application as an adjustment to the opening retained earnings balance.

In March 2016, April 2016 and December 2016,

the FASB issued ASU No.

2016-08, Revenue From Contracts with Customers (ASC 606):

Principal Versus Agent Considerations, ASU No.

2016-10, Revenue From Contracts with Customers (ASC 606):

Identifying Performance Obligations and Licensing, and ASU No.

Technical Corrections and Improvements to Topic 606, Revenue From Contracts with Customers, respectively, which further clarify

the implementation guidance on principal versus agent considerations contained in ASU No.

In May 2016, the FASB issued

ASU 2016-12, Revenue from Contracts with Customers, narrow-scope improvements and practical expedients which provides clarification

on assessing the collectability criterion, presentation of sales taxes, measurement date for non-cash consideration and completed

contracts at transition.

These standards became effective for us beginning in the first quarter of 2018.

We adopted the new revenue recognition standard

and related updates effective January 1, 2018, using the modified retrospective method of adoption.

Adoption of the new revenue

recognition guidance did not have a material impact on our consolidated financial statements.

Ended December 31, 2019 Compared to December 31, 2018

The following table presents a summary

of the changes in our results of operations for the year ended December 31, 2019 as compared to the year ended December 31, 2018:

Year Ended December 31,

Cost of product revenue (exclusive of amortization expense shown below)

(10,155,155 )

(25,209,345 )

Research and development expenses

Plasma center operating expenses

Amortization of intangibles

Selling, general and administrative expenses

Loss from operations

(41,424,327 )

(60,288,944 )

Interest expense

Loss on extinguishment of debt

Gain on transfer of plasma center assets

Other income, net

$ (48,279,317 )

$ (65,743,445 )

We recorded total revenues of $29.3 million

for the year ended December 31, 2019, as compared to $17.0 million for the year ended December 31, 2018.

The increase in total

revenue of $12.4 million is primarily due to increased revenue generated by our Boca Facility manufacturing operations in 2019

totaling $15.4 million, which includes sales of our immunoglobulin products, including ASCENIV and BIVIGAM, for which we received

FDA approval in 2019, and the related intermediate fractions, as well as contract manufacturing revenue, partially offset by $3.0

million decrease in plasma center revenues due to the transfer of two of our plasma collection centers to BPC on January 1, 2019

as part of the purchase price for the Biotest Transaction.

Immunoglobulin production revenues derived from contract manufacturing

were generally related to an agreement we assumed from BPC as part of the Biotest Transaction.

This contract expired at the end

Cost of Product Revenue

of product revenue was $39.5 million for the year ended December 31, 2019, as compared to $42.2 million for the year ended December

31, 2018, a decrease of $2.7 million.

The decrease is mainly attributable to the decrease in pre-approval production expenses for

ASCENIV and BIVIGAM in 2019 in the amount of $5.2 million, partially offset by cost of product revenue related to contract manufacturing

and the sale of intermediate byproducts in the amount of $2.7 million not present in 2018.

Research and Development Expenses

R&D expenses totaled $2.3 million for

the year ended December 31, 2019, as compared to $3.9 million for the year ended December 31, 2018.

As a result of the FDA approval

of ASCENIV on April 1, 2019, we no longer charge the RSV assay and other testing, storage and transportation costs for high-titer

plasma used in the manufacture of ASCENIV to R&D expense, but instead reflect those costs as part of the cost of the raw material

We expect R&D expenses to increase in 2020 as we seek to leverage our existing patents to develop new therapies, as

well as the existence of certain FDA commitments related to the approvals of ASCENIV and BIVIGAM in 2019.

Plasma Center Operating Expenses

Plasma center operating expenses were $2.2

million for the year ended December 31, 2019, as compared to $7.8 million for the year ended December 31, 2018.

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

The decrease in plasma center operating expenses is attributable to the transfer of two of our plasma collection centers

to BPC on January 1, 2019, as well as increased plasma collections at our existing plasma collection facility, which are recorded

as inventory.

We expect plasma operating expenses to increase in the next few years as we plan to build an additional five to 10

plasma collection centers over the next three to five years.

Selling, General and Administrative Expenses

SG&A was $25.9 million for the year

ended December 31, 2019, an increase of $3.4 million as compared to the year ended December 31, 2018.

The increase reflects professional

services of $1.8 million in 2019 related to enhancements to our information technology and customer support infrastructure necessary

to support our overall growth and commercialization plans, as well as $0.9 million of higher employee related expenses due to increased

headcount, increased marketing expenses of $0.4 million resulting from new product launches and $0.3 million of increased insurance

Amortization of Intangibles

Amortization expense for intangible assets

acquired in the Biotest Transaction was $0.8 million for the years ended December 31, 2019 and 2018.

Loss from Operations

Our operating loss was $41.4 million for

the year ended December 31, 2019, as compared to $60.3 million for the year ended December 31, 2018.

The decrease was mainly due

to the increase in revenues and to decreases in cost of product revenue and other operating expenses aggregating to $6.5 million.

Interest Expense

Interest expense was $9.0 million for the

year ended December 31, 2019, as compared to $5.5 million for the year ended December 31, 2018.

The increase reflects a higher

average debt principal balance carried in 2019 as compared to 2018 due to the senior debt refinancing transaction in February 2019

and the amendment to our senior credit facility in May 2019 (see “Liquidity and Capital Resources”), which resulted

in additional debt principal of $42.5 million.

Loss on Extinguishment of Debt

In connection with the refinancing of our

senior credit facility in 2019, we incurred a loss on the extinguishment debt for the retirement of our previously existing credit

facility, consisting of a $6.5 million prepayment penalty, and the write-off of $3.5 million of unamortized debt discount related

to the previous credit facility.

Gain on Transfer of Plasma Center Assets

As part of the purchase price for the Biotest

Assets, we agreed to transfer two of our plasma collection centers to BPC effective January 1, 2019.

We had estimated the combined

fair value of the two facilities to be $12.6 million, and we recorded a liability in our financial statements for this amount as

of the date of the Biotest Transaction.

On January 1, 2019, the two plasma collection facilities were transferred to BPC and we

recorded a gain on this transfer in the amount of $11.5 million, which reflects the derecognition of the obligation to transfer

ownership of the two facilities net of the carrying value of the assets associated with these facilities, primarily property and

equipment and inventory, in the amount of $1.1 million.

Net loss was $48.3 million for the year

ended December 31, 2019, as compared to $65.7 million for the year ended December 31, 2018.

The reduction in net loss of $17.5

million was due to the decrease in operating loss and the gain on transfer of plasma center assets, partially offset by the loss

on extinguishment of debt and the increased interest expense.

LIQUIDITY AND CAPITAL RESOURCES

As of December 31, 2019, we had working

capital of $71.8 million, including cash and cash equivalents of $26.8 million, and stockholders’

equity of $26.2 million,

as compared to working capital of $34.9 million, including cash and cash equivalents of $22.8 million, and stockholders’

equity of $19.8 million as of December 31, 2018.

We have had limited revenue from operations, incurred an accumulated deficit of

$264.7 million since inception and had negative cash flows from operations of $76.2 million and $62.7 million for the years ended

December 31, 2019 and 2018, respectively.

We have funded our operations to date primarily from the sale of our equity and debt

securities, acquisition proceeds from the Biotest Transaction and loans from our primary stockholders.

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.

We expect that we will not be able to generate a sufficient amount of product revenue

to achieve profitability before 2021 and, as a result, we expect that we will need to finance our operations through additional

equity or debt financings or corporate collaboration and licensing arrangements.

Based upon our current projected revenue and 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, along with the proceeds received from the February

2020 public offering of our common stock discussed below and the additional $12.5 million we are able to access under the Perceptive

Credit Facility, as defined below, will be sufficient to fund our operations, as currently conducted, into the second quarter of

In order to have sufficient cash to fund our operations thereafter, we will need to raise additional capital before the end

of the second quarter of 2021.

These estimates and timeframe may change based upon 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.

Other than the $12.5 million commitment currently available under the Perceptive

Credit Facility through March 31, 2020 as discussed below, 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.

if our assumptions underlying our estimated expenses and revenues are incorrect, we may have to raise additional capital sooner

than currently anticipated.

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.

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 FDA approvals related

to the commercialization of our products, ongoing remediation, compliance 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.

We may decide to raise capital through public

or private equity offerings or debt financings, or 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.

we are exploring additional contract manufacturing arrangements and other business development opportunities, which may provide

additional liquidity to us.

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 $88.5 million.

The proceeds from this offering are expected to be used (i) for the

procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV;

(ii) to support the ongoing commercial sales of BIVIGAM

(iii) to expand the manufacturing capacity of our Boca Facility and enhance our supply chain capabilities;

expand our plasma collection facility network;

(v) for research and development and business development opportunities;

for general corporate purposes and other capital expenditures.

On May 21, 2019, we issued 12,937,500 shares

of our Common Stock in an underwritten public offering for gross proceeds of $51.75 million, before deducting underwriting discounts

and commissions and other offering expenses payable by us.

The net proceeds of $48.4 million from the offering have been used (i)

to support the commercial launch of ASCENIV, which commenced in October 2019, (ii) for the commercial re-launch of BIVIGAM, (iii)

to expand the manufacturing capacity of the Boca Facility, (iv) for the procurement of raw materials for the manufacturing of ASCENIV

and BIVIGAM, (v) to expand our plasma collection facility network;

and (vi) for general corporate purposes and other capital expenditures.

On February 11, 2019 (the “Perceptive

Closing Date”), we and all of our subsidiaries entered into the Perceptive Credit Agreement with Perceptive.

The Perceptive

Credit Agreement provided for the Perceptive Credit Facility in a principal amount of up to $72.5 million, comprised of (i) the

Perceptive Tranche I Loan in the principal amount of $45.0 million, and (ii) the Perceptive Tranche II Loan in the principal amount

of up to $27.5 million, but no less than $10.0 million.

The Perceptive Credit Facility has a maturity date of March 1, 2022 (the

“Perceptive Maturity Date”), subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an

Event of Default (as defined in the Perceptive Credit Agreement).

On the Perceptive Closing Date, we used

$30.0 million of the Perceptive Tranche I Loan to terminate and pay in full all of the outstanding obligations under our previously

existing credit agreement with Marathon Healthcare Finance Fund, L.P.

(“Marathon”) (the “Marathon Credit Facility”)

that we entered into in October 2017.

We also used proceeds from the Perceptive Tranche I Loan to (i) pay a deferred facility fee

to Marathon of $2.8 million, (ii) pay a prepayment penalty to Marathon of $6.5 million, (iii) pay outstanding accrued interest

to Marathon of $0.7 million and (iv) pay certain fees and expenses incurred in connection with the Perceptive Credit Facility of

approximately $1.5 million.

In addition, on the Perceptive Closing Date, Marathon released to us the $4.0 million of cash held

in a debt service reserve account, per the terms of the Marathon Credit Facility.

As consideration for the Perceptive Credit

Agreement, we issued to Perceptive, on the Perceptive Closing Date, a warrant to purchase 1,360,000 shares of our Common Stock

(the “Perceptive Warrant”).

The Perceptive Warrant has an exercise price equal to $3.28 per share, which is equal to

the trailing 10-day volume weighted average price (“VWAP”) of our Common Stock on the business day immediately prior

to the Perceptive Closing Date multiplied by 1.15.

We valued the Perceptive Warrant at $2.7 million as of the Perceptive Closing

Date, and it has an expiration date of February 11, 2029.

On May 3, 2019, as a result of the FDA’s

approval of ASCENIV, we accessed the additional $27.5 million available under the Perceptive Credit Facility through the issuance

of a promissory note evidencing the Perceptive Tranche II Loan.

The proceeds from the Perceptive Tranche II Loan were used to support

the commercial launches of ASCENIV and BIVIGAM, including the procurement of raw material inventory, and for working capital and

general corporate purposes.

Also on May 3, 2019, we and Perceptive entered

into an amendment to the Perceptive Credit Agreement (the “Perceptive Amendment”) whereby Perceptive agreed to an additional

commitment under the Perceptive Credit Facility in the principal amount of up to $12.5 million (the “Perceptive Tranche III

and, together with the Initial Perceptive Loans, the “Perceptive Loans”).

The Perceptive Tranche III Loan

was subject to the satisfaction of certain conditions, including, but not limited to, FDA approval of the BIVIGAM PAS, which we

received on May 9, 2019, and no Material Adverse Changes (as defined in the Perceptive Credit Agreement) having occurred since

December 31, 2018;

provided that the Perceptive Tranche III Loan would not be made later than March 31, 2020.

The Perceptive Tranche

III Loan has terms that are substantially identical to those of the Initial Perceptive Loans.

The Perceptive Tranche III Loan required

us to pay certain proceeds of the Perceptive Tranche II Loan to Perceptive on May 3, 2019 as a facility fee.

In addition, we issued

a warrant (the “Perceptive Tranche III Warrant”

and, together with the Perceptive Warrant, the “Perceptive Warrants”)

to purchase 250,000 shares of our Common Stock to Perceptive with an exercise price equal to $4.64 per share, which represents

the trailing 10-day VWAP of our Common Stock as of May 2, 2019.

The Perceptive Tranche III Warrant has an expiration date of May

The Perceptive Warrants were issued in reliance on an exemption from registration under Section 4(2) of the Securities

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

Under the terms of the Perceptive Credit Facility, we pay accrued interest to Perceptive on the last day of each month

of approximately $0.7 million per month.

The rate of interest in effect as of the Perceptive Closing Date and as of December 31,

2019 was 11.0%.

On the Perceptive Maturity Date, we will

pay Perceptive the entire outstanding principal amount underlying the Perceptive Loans and any accrued and unpaid interest thereon.

Prior to the Perceptive Maturity Date, there are no scheduled principal payments on the Perceptive Loans.

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 the first anniversary of the Perceptive Closing

Date, (ii) 4.0% of the prepaid principal amount, if prepaid after the first anniversary of the Perceptive Closing Date and on or

prior to the second anniversary of the Perceptive Closing Date, or (iii) 3.0% of the prepaid principal amount, if prepaid after

the second anniversary of the Perceptive Closing Date and on or prior to the third anniversary of the Perceptive Closing Date.

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 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 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 ending 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 $7.0 million for the fiscal quarter ending June 30, 2019 to $55.0 million for the fiscal quarter

ending December 31, 2021.

At December 31, 2019, we were in compliance with all of the covenants under the Perceptive Credit Facility.

On June 18, 2018, we completed an underwritten

public offering of 9,623,430 shares of our Common Stock for gross proceeds of $46.0 million.

We received net proceeds from this

offering, after underwriters’

commissions and other offering expenses, of $42.9 million.

The net proceeds were used (i) for

continued remediation and ongoing improvement and enhancements at the Boca Facility, (ii) to submit the PAS for, and re-launch

of, BIVIGAM, (iii) to resubmit the RI-002 BLA, (iv) for expenses associated with obtaining FDA approval of our Kennesaw, GA plasma

collection facility;

and (v) for general corporate purposes, including capital expenditures.

The following

table sets forth a summary of our cash flows for the periods indicated:

Year Ended December 31,

Net cash used in operating activities

$ (76,193,504 )

$ (62,678,682 )

Net cash used in investing activities

Net cash provided by financing activities

Net change in cash and cash equivalents

(21,852,722 )

Cash and cash equivalents, including restricted cash - beginning of year

Cash and cash equivalents, including restricted cash - end of year

Net Cash Used in Operating Activities

used in operations for the year ended December 31, 2019 was $76.2 million, an increase of $13.5 million from the same period of

a year ago, mainly due to increases in inventory in preparation for the initial commercial sales and the commercial launches of

ASCENIV and BIVIGAM.

The following table illustrates the primary components of our cash flows from operations:

Year Ended December 31,

$ (48,279,317 )

$ (65,743,445 )

Non-cash expenses, gains and losses

Changes in accounts receivable

Changes in inventories

(34,650,132 )

Changes in prepaid expenses and other current assets

Changes in accounts payable and accrued expenses

Cash used in operations

$ (76,193,504 )

$ (62,678,682 )

Net Cash Used in Investing Activities

Net cash used in investing activities for

the years ended December 31, 2019 and 2018 was $3.8 million and $2.1 million, respectively, consisting of capital expenditures

at the Boca Facility.

Although we have no specific material commitments for capital expenditures as of December 31, 2019, we expect

our total capital expenditures will be between $10.0 million and $20.0 million for fiscal 2020.

Net Cash Provided by Financing Activities

Cash provided by financing activities during

the year ended December 31, 2019 was $80.0 million, which is comprised of the net proceeds received from our May 2019 equity offering

in the amount of $48.4 million and the $31.6 million of net proceeds received from the refinancing of our senior credit facility

and the subsequent Perceptive Tranche II Loan.

Net cash provided by financing activities for the year ended December 31, 2018 of

$42.9 million reflects the net proceeds received from our June 2018 equity offering.

Effect of Inflation

Inflation or changing prices did not have

a significant impact on our net sales, revenues or net loss for the years ended December 31, 2019 or 2018.

Off-Balance Sheet Arrangements

Quantitative and Qualitative Disclosures About Market

Not applicable.

Financial Statements and Supplementary Data

Our financial statements required to be

filed pursuant to this Item 8 appear in a separate section of this Annual Report on Form 10-K, beginning on page F-1.

Changes in and Disagreements With Accountants on

Accounting and Financial Disclosure

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 5. Market for Registrant’s Common Equity