What changed in this filing

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Item 7. Management’s Discussion and Analysis

2023-03-23 compared with 2022-03-24 · 245 added, 268 removed, 224 unchanged (70% of the section changed)

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Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available:

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

Immunity, 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.

10,259,865 related to methods of treatment and prevention of S.

10,259,865 related to methods of treatment and prevention of

pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S.

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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 sufficient quantities of our immune globulin (“IG”) products representing 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 two to four

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 five new plasma collection centers during the past 18 months, and we now have ten plasma collection centers in various stages of approval and development, including six that are operational and

collecting plasma.

With respect to our operational plasma collection centers, five plasma collection centers currently hold FDA licenses.

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 2021 with our plasma collection network expansion, we believe we remain on track to

achieve our goal of having 10 plasma collection centers licensed by the FDA by the end of 2023.

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.

revenues of $210 million or more in 2023, more than $250 million in annual revenue in 2024 and potentially in excess of $300 million of annual revenue thereafter, as well as achieving profitability during the first quarter of 2024.

revenue levels, we forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%.

These assumptions translate to potential annual gross profit and net income in the range of $100-150 million

and $50-100 million, respectively, during the 2024-2025 time period and beyond.

Through our ADMA BioCenters subsidiary, we currently operate ten 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 also allows us to sell certain quantities of source plasma to third-party customers for further manufacturing.

With respect to our operational plasma collection centers,

eight plasma collection centers currently hold FDA licenses, with the remaining plasma collection centers anticipated to receive FDA approvals throughout 2023.

In addition, three of our FDA-approved plasma collection centers also have 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 supply chain robustness initiatives undertaken in 2021 and 2022 as it pertains to our

plasma collection network expansion, we remain on track to achieve our goal of having 10 FDA-licensed plasma collection centers by the end of 2023.

A typical plasma collection center, such as those operated by ADMA BioCenters, can collect

approximately 30,000 to 50,000 liters of source and hyperimmune 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 is sold to third-party customers in the U.S.

and in other locations outside the U.S.

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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.

On September 8, 2021, we announced that the FDA granted approval for our aseptic fill-finish machine and our related internal fill-finish processes.

This approval provides us with in-house fill-finish operations

capable of sufficiently addressing our forecasted production requirements for our FDA approved commercial products.

With our fill-finish machine and related processes now operational, we anticipate improved gross margins, enhanced patient supply

consistency, potentially accelerated inventory production cycle times, and increased control and visibility of commercial product lot releases.

We also expect that the approval of our in-house fill-finish processes and capabilities will

potentially enable us with the opportunity to onboard new fill-finish contract manufacturing opportunities with third parties as a potential new revenue stream.

manufacturing services for certain third-party clients.

We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services utilizing our FDA-approved 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”),

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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 commence commercial sales of this product in the United States.

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.

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.

commercial sales for this product in August of 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 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.

increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has begun to have a favorable impact on our gross margins and operating results,

beginning in the third quarter of 2021.

increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has had a favorable impact on our gross margins, manufacturing efficiencies and

operating results since the beginning of the third quarter of 2021.

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

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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

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.

We may elect to work with the FDA and the immunology and infectious disease

community to potentially design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population or other appropriate populations.

Commercial sales of ASCENIV commenced in October of 2019

and the product is currently available to U.S.-based healthcare professionals for prescription and use in U.S.-based patients .

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 III clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) 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 potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time.

Due to the COVID-19 pandemic, our plans have been delayed.

In the future however, we may 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 and our commercial and medical education efforts are focused on the labeled indication of patients with PIDD.

ASCENIV’s prescriber and patient base continued

to expand during the fourth quarter of 2022, which drove record utilization and pull-through for the product.

These elevated demand trends have sustained into 2023, and ADMA currently expects the product’s rapid growth will continue throughout

2023 and beyond.

Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus.

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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.

It can cause chronic infection and places 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.

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.

continue to manufacture Nabi-HB under HHS License No.

IMPACT OF THE COVID-19 CRISIS

We continue to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta and Omicron variants and other resistant strains of the coronavirus, and its impacts to our

We continue to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta, Omicron and BA.2 variants and other resistant strains of the coronavirus, and its impacts to our

commercial and manufacturing operations and plasma collection facilities, including collections of source plasma, procurement of raw materials and packaging materials, a portion of which are sourced internationally, and the testing of finished

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A substantial portion of such testing has historically been performed by contract laboratories outside the United States.

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

experienced 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.

Due to a combination of previously mandated 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

experienced lower than normal donor collections at our FDA approved plasma collection centers during 2021.

We are 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.

In addition, we are 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 have elected to carry more raw materials inventory than we have in the past.

The COVID-19 pandemic has also impacted, to a certain

degree, our customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel have faced difficulties communicating directly with physicians and other healthcare professionals, as well as the cancellation or postponement

of a number of key scientific and medical meetings, further limiting our ability to communicate with potential customers.

We have implemented a comprehensive suite of virtual engagement initiatives;

however, clinician engagement has been reduced

due to rapidly evolving COVID-19 priorities at U.S.

medical centers.

The COVID-19 pandemic previously impacted, to a certain

degree, our customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel faced difficulties communicating directly with physicians and other healthcare professionals, as well as the cancellation or postponement of a

number of key scientific and medical meetings, further limiting our ability to communicate with potential customers.

The pandemic could also 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.

received several FDA approvals and two FDA inspections of the Boca Facility were completed during the year ended December 31, 2021, no assurances can be provided as to the timing for completion of any other regulatory submissions or applications

that may be impacted by restrictions related to COVID-19.

During the year ended December 31, 2021, our revenue attributable to international customers was approximately 13% of our total revenues.

As we seek to grow this aspect of our business, we may also be subject to the

impacts of the COVID-19 pandemic in locations outside the United States.

received FDA approvals for four of our plasma collection centers during the year ended December 31, 2022, received several FDA approvals and two FDA inspections of the Boca Facility were completed during the year ended December 31, 2021, no

assurances can be provided as to the timing for completion of any future regulatory submissions or applications that may be impacted by restrictions related to COVID-19.

During the years ended December 31, 2022 and 2021, our revenue attributable to international customers was approximately 5% and 13%, respectively, of our total revenues.

As we seek to grow this aspect of our

business, we may also be subject to the impacts of the COVID-19 pandemic in locations outside the United States.

Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on our financial condition or results of operations, and we do not believe that our production operations at the Boca

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Although the COVID-19 pandemic has not, to date, materially adversely impacted our capital and financial resources, because we are unable to determine the ultimate severity or duration of the pandemic or its

long-term effects on, among other things, the global, national or local economies, the capital and credit markets or our workforce, customers or suppliers, at this time we are unable to predict whether COVID-19 will have a material adverse impact

on our business, financial condition, liquidity and results of operations.

government order, will have a material adverse impact on our business, financial condition, liquidity and results of operations.

After the COVID-19 global pandemic has settled, we may continue to experience adverse impacts to our business as a

result of evolving macroeconomic factors, including general economic uncertainty, unemployment rates, inflationary pressures and any actual economic recession that has occurred or may occur in the future.

RESULTS OF OPERATIONS

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these estimates.

Significant estimates include rebates and certain other deductions from gross revenues, impairment of long-lived assets, 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.

Significant estimates include rebates and certain other deductions from gross revenues, the realizable value of accounts receivable, valuation of inventory, impairment of long-lived assets, 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

Some of the estimates and assumptions we have to make under U.S.

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between the recording of the accrual and its ultimate settlement, an interval that can generally take up to several years or more.

While our results of operations to date have not required any material adjustment due to this risk, the lag time

While our results of operations to date have not required any material adjustment due to this risk, the delay

between when this obligation is initially recorded and ultimately settled could potentially materially impact our revenues and our results of operations in the future.

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For the purpose of valuing stock options granted to our employees, directors and officers, we use the Black-Scholes option pricing model.

The Black-Scholes option valuation model

was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.

The Black-Scholes option pricing model was

developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.

The Company’s employee stock options have characteristics significantly different from those of traded

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Any changes in

the foregoing Black-Scholes assumptions, or if we were to elect to utilize an alternative method for valuing stock options granted to employees, directors and officers, could potentially impact our stock-based compensation expense and our results

the foregoing Black-Scholes assumptions, or an election by us to utilize an alternative method for valuing stock options granted to employees, directors and officers, could potentially impact our stock-based compensation expense and our results

of operations.

We also use the Black-Scholes option valuation model for the purpose of estimating the fair value of warrants we issue from time to time in connection with the issuance of notes payable.

We also use the Black-Scholes option pricing model for the purpose of estimating the fair value of warrants we issue from time to time in connection with the issuance of notes payable.

Changes in our Black-Scholes

assumptions, or if we were to utilize an alternative method for valuing warrants issued to our lenders, could impact our interest expense and results of operations.

assumptions, or an election by us to utilize an alternative method for valuing warrants issued to our lenders, could impact our interest expense and results of operations.

Impairment of Long-Lived Assets

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Year Ended December 31,

Increase (Decrease)

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

Gross profit (loss)

Cost of product revenue

Research and development expenses

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Interest expense

Gain on extinguishment of debt

Other (expense) income, net

Loss on extinguishment of debt

Other expense, net

We recorded total revenues of $154.1 million during the year ended December 31, 2022, as compared to $80.9 million during the year ended December 31, 2021, an increase of $73.1 million, or approximately 90%.

increase is mainly due to increased sales of our immunoglobulin products and intermediate fractions generated by our Boca Facility manufacturing operations in 2021 totaling $38.1 million as we conclude our second full year of commercial sales of

increase is mainly due to increased sales of our immunoglobulin products and intermediate fractions generated by our Boca Facility manufacturing operations in 2022 totaling $69.2 million as we conclude our third full year of commercial sales of

BIVIGAM and ASCENIV.

We attribute this increase in revenue, which reflects sales volume increases across our entire portfolio of IVIG products, to an expansion of our customer base in 2021 and to increased physician, payer and patient acceptance

of both BIVIGAM and ASCENIV.

We also experienced a $0.5 million increase in plasma revenues generated by our plasma collection centers business segment.

Cost of Product Revenue

Cost of product revenue was $79.8 million for the year ended December 31, 2021, as compared to $61.3 million for the year ended December 31, 2020, an increase of $18.5 million.

This increase reflects higher product

revenue costs pertaining to the Company’s immunoglobulin product sales during the year of approximately $23.6 million due to higher sales volume, an increase in non-inventoriable manufacturing costs of approximately $1.9 million related to IVIG

production at our Boca Facility operations, largely due to higher prices, and to increased product revenue costs pertaining to plasma sales of $0.3 million.

These amounts were partially offset by non-recurring production charges of $7.5 million

in 2020 for the manufacture of BIVIGAM conformance lots at an increased plasma pool production scale in connection with our planned capacity expansion and other production initiatives and investments at the Boca Facility.

We attribute this increase in revenue to the continued expansion of our customer base in 2022 and to increasing physician, payer and patient acceptance of both BIVIGAM and ASCENIV.

We also experienced a $4.0 million increase

in plasma revenues generated by our Plasma Collection Centers business segment due to increased sales of plasma through spot market opportunities beyond our long-term supply agreement.

Cost of Product Revenue and Gross Profit

Cost of product revenue was $118.8 million for the year ended December 31, 2022, as compared to $79.8 million for the year ended December 31, 2021.

This increase of $39.0 million is primarily attributable to

volume-related increases in product revenue costs related to the sale of our immunoglobulin products of $30.4 million and increased product revenue costs related to our ADMA BioCenters business segment in the amount of $4.3 million.

we also experienced an increase in other manufacturing expenses of approximately $4.4 million in fiscal 2022 as compared to fiscal 2021, which is indicative of certain inflationary pressures being experienced by our industry for labor,

materials, freight, fuel surcharges and third-party services.

Our gross profit of $35.3 million for the year ended December 31, 2022 represents an improvement over the same period of a year ago of $34.1 million and is mainly due to the higher sales volume, the improved margins

we are experiencing with BIVIGAM at the larger plasma pool production scale, and to the increased relative contribution of ASCENIV to our total revenues.

As a result, we achieved a gross margin of 22.9% for the year ended December 31, 2022, as

compared to a gross margin of 1.4% for the year ended December 31, 2021.

Subsequent to the FDA approvals for BIVIGAM and ASCENIV received in 2019 through December 31, 2022, substantially all of the normal source plasma (“NSP”) used in our Boca Facility IG production was sourced under a

supply agreement we had in place with Grifols Worldwide Operations Limited, the successor-in-interest to BPC (“Grifols”).

This agreement expired on December 31, 2022 and was not renewed.

Although we have executed additional agreements with other

third-party suppliers of NSP, we anticipate that a substantial portion of the NSP used in IG production in 2023 and beyond will be sourced from our ADMA BioCenters plasma collection facilities.

As a number of these facilities are still in their

initial stages of operation, we expect that the cost of collecting NSP at many of these facilities will exceed the price per liter of NSP we were paying to Grifols and other third-party suppliers.

As a result, we expect the production costs for

our immune globulin products to increase in the near term, which could adversely impact our cost of product revenue and gross margins, without giving effect to other supply chain initiatives completed and anticipated manufacturing efficiencies

expected in the future.

Research and Development Expenses

Research and development expenses (“R&D”) totaled $3.6 million for the year ended December 31, 2021, as compared to $5.9 million for the year ended December 31, 2020.

The decrease is primarily due to several

non-recurring projects in 2020 aggregating to $2.2 million for which there are no comparable amounts in 2021, consisting of (i) $1.4 million for the testing and development of a new filling line at one of our third-party fill/finishers for a

process that had not been approved by the FDA, (ii) $0.4 million for a study we performed to potentially extend ASCENIV’s approved and labeled expiration dating, (iii) $0.2 million related to third-party assay

development and (iv) $0.2 million for assistance with a third-party clinical research project.

In addition, we experienced lower compensation expense (including stock-based compensation) related to R&D expenses of $1.1 million in 2021,

mainly due to the resignation of our former Chief Medical and Chief Scientific Officer.

These amounts were partially offset by $1.0 million of increased expenses associated with post-marketing commitment clinical studies for ASCENIV and BIVIGAM

Research and development expenses (“R&D”) of $3.6 million for the year ended December 31, 2022 was essentially unchanged from the year ended December 31, 2021, as the lower compensation costs (including

stock-based compensation) in 2022 resulting from the 2021 resignation of our former Chief Medical and Chief Scientific Officer was offset by increased expenses associated with post-marketing commitment clinical

studies for ASCENIV and BIVIGAM (see Note 10 to the Consolidated Financial Statements) .

Plasma Center Operating Expenses

Plasma center operating expenses were $12.3 million for the year ended December 31, 2021, as compared to $4.2 million for the year ended December 31, 2020.

Plasma center operating expenses consist of certain general

and administrative plasma center costs, including lease expenses, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion expenses and computer software fees related to donor collections.

At December 31, 2020 we had three plasma collection centers in operation.

At December 31, 2021, we had six plasma collection centers in operation.

In addition, for those plasma collection centers that are in

construction or development but not yet operational, we still need to incur staffing, training, travel and other costs during the build-out period so that these facilities can be operational on the day they open.

The increase in plasma center

operating expenses in 2021 is mainly attributable to increases in employee compensation costs of $4.8 million, donor fees of $2.5 million, softgoods and supplies of $0.8 million, depreciation expense of $0.7 million, rent expense of $0.7 million,

plasma testing expenses of $0.3 million, travel expense of $0.3 million and advertising expenses of $0.2 million.

These amounts were partially offset by an increase in plasma collections which resulted in a reduction in our plasma center

operating expenses by approximately $3.0 million.

We expect additional increases in our plasma center operating expenses in 2022 and beyond as we intend to have 10 plasma collection centers in operation and approved by the FDA by the end of 2023.

Plasma center operating expenses increased by $5.6 million to $17.8 million for the year ended December 31, 2022, as compared to $12.3 million for the year ended December 31, 2021.

Plasma center operating expenses

consist of certain general and administrative plasma center costs, initial opening, marketing and start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion

expenses and computer software fees related to donor collections.

The majority of our plasma collection centers have been in a development or start-up stage in fiscal 2022 and 2021.

During fiscal 2022, we opened three new plasma collection facilities, and an additional facility opened in March of 2023.

In addition, for those plasma collection centers that were in construction or development but

not yet operational, we still needed to incur staffing, training, travel and other costs during the build-out period so that these facilities can be operational on the day they open.

The increase in plasma center operating expenses in 2022 is

mainly attributable to increases in donor fees, some of which are specialty programs and promotions by the newly opened centers, of $10.7 million, employee compensation costs of $5.8 million, softgoods and supplies of $3.8 million, depreciation

expense of $1.1 million, rent expense of $0.5 million, plasma testing expenses of $2.8 million, travel expense of $0.2 million, software maintenance expense of $0.4 million, janitorial and utilities expense of $0.5 million, professional services

of $0.4 million, postage and freight of $0.3 million and advertising expenses of $0.3 million.

These amounts were partially offset by a substantial increase in plasma collections which resulted in a reduction in our plasma center operating

expenses by approximately $21.4 million.

Selling, General and Administrative Expenses

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increase in the size and scope of our Boca Facility manufacturing and commercial operations in 2022, we experienced increases in employee compensation and related expenses, including travel, relocation and recruiting, of $4.6 million, $1.8

experienced increased insurance expense of $1.3 million in 2021, recognized an expense and corresponding liability in the amount of $0.8 million related to the separation and transition agreement with our former Chief Medical and Chief Scientific

Officer and incurred increased expenses associated with the commercialization of our immunoglobulin portfolio of $0.7 million.

These amounts were partially offset by a reduction in market intelligence fees of approximately $2.1 million for a

one-time project related to ASCENIV that concluded in early 2021.

million of which is stock-based compensation.

We also experienced increases in insurance expense of $1.4 million and utilities of $0.5 million in 2022, as well as an increase in data services and market intelligence fees in the amount of $1.5

million in support of the commercialization efforts for BIVIGAM and ASCENIV.

In addition, we incurred professional fees in connection with the Morgan Stanley strategic alternatives process in the amount of $1.4 million, with no comparable amount

Amortization of Intangibles

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The decrease in operating loss was mainly due to the improved gross

profit/loss for the year ended December 31, 2021 of $20.2 million compared with the same period of a year ago and the $2.3 million of lower R&D expenses, largely offset by the increases in plasma center operating expenses and SG&A.

improvement in gross profit/loss is mainly due to the 92% increase in revenues in 2021, as well as to the absence of the $7.5 million of non-recurring production charges we incurred during 2020.

We expect further improvements to our gross margins

in 2022 as the efficiencies we anticipate from our expanded plasma pool production scale process that was approved by the FDA in April of 2021 and our in-house fill-finish capabilities that were approved in September of 2021 begin to take effect,

subject to the current rate of inflation and price increases we may receive from time to time from our suppliers.

profit for the year ended December 31, 2022 of $34.1 million, partially offset by the increases in plasma center operating expenses and SG&A.

Interest Expense

Interest expense was $19.3 million for the year ended December 31, 2022, as compared to $13.1 million for the year ended December 31, 2021.

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, which increased the interest rate on this indebtedness from 6% per annum to 11% per annum (see “Liquidity and Capital Resources”).

Interest expense also includes the amortization of debt discount in the amount of $1.9 million and

$1.8 million for the years ended December 31, 2021 and 2020, respectively.

In connection with the refinancing of our senior credit facility on March 23, 2022, we expect our annual interest expense, excluding amortization of debt discount, to

increase from approximately $11.2 million per year to a range between approximately $16.0 million and $19.0 million per year, depending on whether and when we access the second tranche of this facility in the amount of $25.0 million (see

“Liquidity and Capital Resources”) .

Gain/Loss on Extinguishment of Debt

On December 8, 2020, we refinanced our $15 million subordinated note payable to Biotest with an amendment to our senior credit facility and the corresponding Tranche IV draw on that facility.

As a result of this

transaction and the payoff of the Biotest note, we recorded a gain on the extinguishment of debt in the amount of $1.0 million (see Note 7 to the Consolidated Financial Statements).

The increase reflects the additional indebtedness and increase in

amortization of debt discount resulting from the refinancing of our senior credit facility on March 23, 2022 (see “Liquidity and Capital Resources”).

The refinancing transaction resulted in additional indebtedness at closing in the approximate

amount of $51.8 million, and our debt principal increased by an additional $3.0 million subsequent to closing as our new senior credit facility allows us to pay “in kind” a portion of our monthly interest obligation in the form of additional

indebtedness to the lender.

We expect to continue to pay a portion of our monthly interest obligation “in kind” during 2023.

As a result, and given the expected continued rise in global interest rates, we expect our principal debt balance and the

associated interest expense to increase over the course of fiscal 2023 as compared to previous years.

Loss on Extinguishment of Debt

In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to

retire our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements).

Our net loss was $65.9 million for the year ended December 31, 2022, as compared to $71.6 million for the year ended December 31, 2021.

The decrease in net loss of $5.7 million was mainly due to the decrease in

operating loss, partially offset by the higher interest expense in 2021 and the gain on extinguishment of debt in 2020.

operating loss, largely offset by the higher interest expense and loss on extinguishment of debt in 2022.

LIQUIDITY AND CAPITAL RESOURCES

As of December 31, 2021, we had working capital of $178.4 million, primarily consisting of $124.7 million of inventory, cash and cash equivalents of $51.1 million and accounts receivable of $28.6 million, partially

offset by $29.6 million of accounts payable and accrued expenses, as compared to working capital of $133.8 million, mainly comprised of $81.5 million of inventory, cash and cash equivalents of $55.9 million and accounts receivable of $13.2

million, partially offset by accounts payable and accrued expenses of $19.4 million, as of December 31, 2020.

We have incurred an accumulated deficit of $412.1 million since inception and had negative cash flows from operations of $112.4 million

and $102.0 million for the years ended December 31, 2021 and 2020, respectively.

At December 31, 2022, we had working capital of $231.1 million, primarily consisting of $163.3 million of inventory, cash and cash equivalents of $86.5 million and accounts receivable of $15.5 million, partially

offset by current liabilities of $39.3 million, as compared to working capital at December 31, 2021 of $178.4 million, primarily consisting of $124.7 million of inventory, cash and cash equivalents of $51.1 million and accounts receivable of

$28.6 million, partially offset by $30.4 million of current liabilities.

We have incurred an accumulated deficit of $478.0 million since inception and had negative cash flows from operations of $59.5 million and $112.4 million for the years ended

December 31, 2022 and 2021, respectively.

We have funded our operations over the past few years primarily from the sale of our equity and debt securities.

Our material cash requirements are primarily

comprised of:

Our material cash requirements are primarily comprised of:

The procurement of raw material plasma and other raw materials necessary to maintain and scale up our manufacturing operations;

Employee compensation and benefits;

Capital expenditures for the building of additional plasma collection facilities and for equipment upgrades and capacity expansion at the Boca Facility

Capital expenditures to complete the buildout for and maintain our plasma collection facilities and for equipment upgrades and capacity expansion at the Boca Facility;

Plasma donor fees and plasma center supplies;

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Boca Facility maintenance, repairs and supplies;

Conducting post-marketing clinical trials for our FDA-approved products.

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.

Conducting required post-marketing clinical trials for our FDA-approved products.

In addition, our end-to-end production cycle time from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial inventories of raw material plasma

and other manufacturing materials and single use disposables.

We expect that we will not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024.

We currently anticipate, based upon our projected revenue and expenditures,

that our current cash, cash equivalents and accounts receivable, including the proceeds received and expected to be received from the refinancing of our senior credit facility as discussed below, along with the remaining amounts available under

the distribution agreement for the sale of our common stock also discussed below, will be sufficient to fund our operations, as currently conducted, into the first quarter of 2024, at which time we believe we will begin to generate positive cash

flow from operations.

This time frame may change based several factors, including the success of our commercial sales of our products and the acceptability of our immune globulin products by physicians, patients or payers, and whether or not the

assumptions underlying our projected revenues and expenses are correct.

If we are unable to raise additional capital if needed, including due to widespread liquidity constraints or significant market instability that could result from the

COVID-19 pandemic, inflationary pressures or other factors beyond our control, we may have to delay, curtail or eliminate some of our commercialization efforts or product development activities.

We are also continuing to evaluate a variety of

strategic and financing alternatives through our ongoing engagement with Morgan Stanley as a financial advisor.

On March 23, 2022, (the “Hayfin Closing Date”) we and all of our subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin Credit

Agreement”) with Hayfin Services LLP (“Hayfin”).

T he Hayfin Credit Agreement provides for a senior secured term loan facility in a principal amount of up to

$175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $150.0 million (the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount

of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”).

The obligation of the lenders to make the Hayfin Delayed Draw Loan expires on March 22, 2023, and is subject to the

satisfaction of certain conditions, including, but not limited to, our meeting certain 12-month revenue targets as set forth in the Hayfin Credit Agreement.

The Hayfin Credit Facility has a maturity date of March 23, 2027 (the “Hayfin

Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).

On the Hayfin Closing Date, we used $100.0 million of the Hayfin Closing Date Loan to terminate and pay in full all of the

outstanding obligations under our previous senior credit facility with Perceptive (see Note 7 to the Consolidated Financial Statements).

We also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to

Perceptive and used approximately $0.3 million of the Hayfin Closing Date Loan proceeds to pay certain fees and expenses incurred in connection with this transaction.

In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind”

and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement.

The remainder of the proceeds received or to be received from the Hayfin Loans will be used for working capital and other general

corporate purposes.

Borrowings under the Hayfin Credit Agreement will bear interest at our election, at either (a) a base rate (equal to the

highest of (i) the rate of interest per annum last quoted by The Wall Street Journal as the “Prime Rate” in the United States, (ii) the federal funds rate in effect on such day plus 0.50% and (iii) the adjusted Term SOFR for a one-month tenor

in effect on such day plus 1.00%) plus an applicable margin of 8.50% or (b) adjusted Term SOFR for either a one-month or three-month tenor, as elected by us, and subject to a floor of 1.25%, plus an applicable margin of 9.5% (the “Applicable

that our current cash, cash equivalents and accounts receivable will be sufficient to fund our operations, as currently conducted, through the end of the first quarter of 2024, at which time we believe we will begin to generate positive cash flow

from operations.

This time frame may change based on several factors, including the success of our commercial efforts with respect to the sale of our products and the acceptability of our immune globulin products by physicians, patients or

payers, and whether or not the assumptions underlying our projected revenues and expenses are correct.

If we are unable to achieve positive cash flow by the beginning of 2024, we may need to raise additional capital and if such capital is not

available due to widespread liquidity constraints or significant market instability that could result from the COVID-19 pandemic, inflationary pressures or other factors beyond our control, we may have to delay, curtail or eliminate some of our

commercialization efforts or product development activities.

If we are unable to generate sufficient revenue to achieve positive cash flow by the beginning of 2024 and need to raise additional capital, we may decide to do so through public or

private equity offerings or debt financings, or we may enter into a corporate collaboration or licensing arrangement.

The sale of additional or equity debt securities, if convertible, could result in dilution to our stockholders and, in such

event, the value and potential future market price of our common stock may decline.

ADMA continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley.

The exploration of value-creating opportunities remains a top corporate priority for ADMA.

On March 23, 2022, (the “Hayfin Closing Date”) we and all of our subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin Credit Agreement”) with Hayfin Services LLP (“Hayfin”).

Hayfin Credit Agreement, as amended, provides for a senior secured term loan facility in a principal amount of up to $175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal

amount of $150.0 million (the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”).

to an amendment to the Hayfin Credit Agreement dated March 22, 2023, the obligation of the lenders to make the Hayfin Delayed Draw Loan expires on June 30, 2023.

The obligation of the lenders to make the Hayfin Delayed Draw Loan is subject to the

satisfaction of certain conditions, including, but not limited to, our meeting certain 12-month revenue targets as set forth in the Hayfin Credit Agreement which have been met.

The Hayfin Credit Facility has a maturity date of March 23, 2027 (the

“Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).

On the Hayfin Closing Date, we used $100.0 million of the Hayfin Closing Date Loan to terminate and pay in full all of the outstanding obligations under our previous senior credit facility with

Perceptive (see Note 7 to the Consolidated Financial Statements).

We also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $1.0 million of the Hayfin Closing Date Loan

proceeds to pay certain fees and expenses incurred in connection with this transaction.

In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms

of the Hayfin Credit Agreement.

The remainder of the proceeds received or to be received from the Hayfin Loans will be used for working capital and other general corporate purposes.

Borrowings under the Hayfin Credit Agreement currently bear interest at the adjusted Term Secured Overnight Financing Rate (“SOFR”) for either a one-month or three-month tenor, as elected by us, and

subject to a floor of 1.25%, plus an applicable margin of 9.5% (the “Applicable Margin”);

provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin shall increase by an additional 3% per annum.

We will also pay “in kind” a portion of the interest on the Hayfin Loans for each

monthly or quarterly interest period in an amount equal to 2.5% per annum.

Such interest paid “in kind” will reduce our quarterly cash interest obligation by approximately $1.0 million and will be added to the principal amount of the

outstanding debt under the Hayfin Credit Facility.

On the Hayfin Closing Date, our interest rate was 10.75%.

On the last day of each calendar month or quarter during the term of the Hayfin Credit Facility, we are required to pay accrued

interest to Hayfin of approximately $1.0 million per month or $3.1 million per quarter, after giving effect to the “in kind” interest of 2.5% per annum, but without giving effect to the Hayfin Delayed Draw Loan.

On the Hayfin Maturity Date, we will pay Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any

accrued and unpaid interest thereon, as well as an exit fee of 1.0% of the outstanding principal amount being paid.

Prior to the Hayfin Maturity Date, there will be no scheduled principal payments on the Hayfin Loans.

We may prepay outstanding

principal on the Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin of, (A) any accrued but unpaid interest on the prepaid principal amount plus (B) an early prepayment

fee in the amount equal to (i) 7.0% of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Closing Date, (ii) 3.0% of the prepaid principal amount, if prepaid after the first anniversary of the Hayfin

Closing Date and on or prior to the second anniversary of the Hayfin Closing Date, or (iii) 1.0% of the prepaid principal amount, if prepaid after the second anniversary of the Hayfin Closing Date and on or prior to the third anniversary of the

Hayfin Closing Date.

In addition, for any prepayments of principal or payment of principal on the Hayfin Maturity Date, we are required to pay an exit fee of 1.0% of the amount of principal being paid.

All of our obligations under the Hayfin 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 Hayfin 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 the ability of our subsidiaries to, among other things and subject to certain exceptions contained

in the Hayfin Credit Agreement, incur new indebtedness;

create liens on assets;

will also pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount equal to 2.5% per annum.

Such interest paid “in kind” will reduce our quarterly cash interest obligation by

approximately $1.0 million and will be added to the principal amount of the outstanding debt under the Hayfin Credit Facility.

As a result, our outstanding debt principal on the Hayfin Loans will increase each month as long as we elect to

continue to pay a portion of our interest obligation “in kind.” On the Hayfin Closing Date and as of December 31, 2022, the stated interest rate on the Hayfin Loans interest rate was 10.75% and approximately 13.9%, respectively.

interest rate in effect as of the date of this report, on the last day of each calendar month or quarter during the term of the Hayfin Credit Facility, we are required to pay accrued interest to Hayfin of approximately $1.6 million per month or

approximately $4.7 million per quarter, after giving effect to the “in kind” interest of 2.5% per annum, but without giving effect to the Hayfin Delayed Draw Loan, which we have yet to draw upon.

Our interest obligations under the Hayfin credit agreement are subject to variable interest rates based on the Term SOFR in effect at the beginning of each monthly interest period.

With the global

rise in interest rates, we expect our interest rate and our monthly cash interest obligation to be higher in fiscal 2023 as compared to previous years.

For example, our stated interest rate, which was 10.75% for the month of June 2022, increased

to approximately 12.06% for the month of September and was approximately 14.16% for the month of February 2023.

On the Hayfin Maturity Date, we will pay Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any accrued and unpaid interest thereon, as well as an exit fee of 1.0% of the

outstanding principal amount being paid.

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

We may prepay outstanding principal on the Hayfin Loans at any time and from time to time upon five

business days’ prior written notice, subject to the payment to Hayfin of, (A) any accrued but unpaid interest on the prepaid principal amount plus (B) a prepayment fee in the amount equal to (i) 7.0% of the prepaid principal amount, if prepaid on

or prior to the first anniversary of the Hayfin Closing Date, (ii) 3.0% of the prepaid principal amount, if prepaid after the first anniversary of the Hayfin Closing Date and on or prior to the second anniversary of the Hayfin Closing Date, or

(iii) 1.0% of the prepaid principal amount, if prepaid after the second anniversary of the Hayfin Closing Date and on or prior to the third anniversary of the Hayfin Closing Date.

In addition, for any prepayments of principal, we are required to

pay the 1.0% exit fee for the amount of principal being paid.

All of our obligations under the Hayfin 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 Hayfin Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar

The negative covenants restrict or limit our ability and the ability of our subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness;

create liens on

engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to our or our subsidiaries’ business activities;

Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement);

make certain Investments or Restricted Payments (each as defined in the Hayfin Credit

change our fiscal year;

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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 Hayfin Credit Agreement.

or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan

repayments under the Hayfin Credit Agreement.

In addition, we are required (i) at all times prior to the Maturity Date to maintain a minimum cash balance of $6.0 million;

and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending June 30, 2022, report IVIG product and related revenues for the trailing 12-month period that exceed the amounts set forth in the Hayfin Credit

Agreement, which range from $75.0 million for the fiscal quarter ending June 30, 2022 to $250.0 million for the fiscal quarter ending December 31, 2026 and each fiscal quarter thereafter.

and (ii) as of the last day of each fiscal quarter, report IVIG product and

related revenues for the trailing 12-month period that exceed the amounts set forth in the Hayfin Credit Agreement, which range from $75.0 million for the fiscal quarter ending June 30, 2022 to $250.0 million for the fiscal quarter ending

December 31, 2026 and each fiscal quarter thereafter.

As of December 31, 2022, we were in compliance with all of the financial covenants contained in the Hayfin Credit Agreement.

On December 9, 2022, we completed an underwritten public offering whereby we issued 24,125,873 shares of our common stock.

Net proceeds after underwriting discounts and expenses associated with the offering were

approximately $64.6 million and are being used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and

for working capital, capital expenditures and general corporate purposes.

On October 25, 2021, we completed an underwritten public offering whereby we issued 57.5 million shares of our common stock and received gross proceeds of $57.5 million.

Net proceeds, after underwriting discounts and

expenses associated with the offering, were approximately $53.8 million, and are being used (i) to advance the commercial sales of our FDA approved products through the procurement of raw materials for the

manufacturing of BIVIGAM and ASCENIV;

(ii) to expand our plasma collection facility network;

(iii) to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP compliance;

explore business development opportunities;

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

expenses associated with the offering, were approximately $53.8 million, and were used to advance the commercial sales of our FDA approved products through the procurement of raw materials for the manufacturing of

BIVIGAM and ASCENIV, to expand our plasma collection facility network, to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP compliance, to explore business development

opportunities and for general corporate purposes and other capital expenditures.

On September 3, 2021, we entered into a distribution agreement with Raymond James & Associates, Inc., as agent (“Agent”), pursuant to which we may offer and sell, from time to

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Distribution Agreement and received net proceeds of $6.9 million.

We currently have approximately $42.8 million of shares available to sell under the Distribution Agreement.

On August 5, 2020, we entered into an open market sale agreement (as amended from time to time, the “Sale Agreement”) with Jefferies LLC (“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 amended the Sale Agreement to provide for increases in the aggregate offering amount

under the Sale Agreement such that we could sell shares having an aggregate offering price of up to $105.4 million under the Sale Agreement, as amended.

For the year ended December 31, 2021, we issued and sold 27,805,198 shares of common stock

under the Sale Agreement and received net proceeds of $60.4 million.

The Sale Agreement was terminated on August 31, 2021.

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.

On February 11, 2019 (the “Perceptive Closing Date”), we and all of our subsidiaries entered into the Perceptive Credit Agreement.

The Perceptive Credit Agreement, as amended, provided for a senior secured term loan

facility in a principal amount of $100.0 million 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 note we had

payable to Biotest, which had a maturity date of June 17, 2022.

All of the Perceptive Loans were retired and our other obligations under the Perceptive Credit Facility were satisfied using the proceeds we received from the Hayfin Closing Date Loan.

We did not issue any shares under this agreement during the year ended December 31, 2022, and we currently have approximately $42.8 million of shares available to sell under

the Distribution Agreement.

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

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Net change in cash and cash equivalents

Cash and cash equivalents - beginning of year

Cash and cash equivalents - end of year

Cash and cash equivalents - beginning of period

Cash and cash equivalents - end of period

Net Cash Used in Operating Activities

Cash used in operations for the year ended December 31, 2021 was $112.4 million, an increase of $10.4 million from the same period of a year ago, mainly due to the increase in inventories as we continue to increase

production resulting from the FDA approval of the 4,400 liter scale-up expansion for BIVIGAM.

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

Cash used in operations for the year ended December 31, 2022 was $59.5 million, a decrease of $52.9 million from the same period of a year ago, mainly due to the improvement in our operating results after giving

effect to non-cash items, driven by higher revenues and gross margins, and reductions in accounts receivable related to the timing of shipments and collections from customers.

The following table illustrates the primary components of our cash

flows from operations:

Year Ended December 31,

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Net Cash Used in Investing Activities

Net cash used in investing activities for the year ended December 31, 2021 was $13.5 million, which consisted of $8.6 million for the construction and buildout of new plasma collection facilities and $4.9 million of

capital expenditures at the Boca Facility, which included equipment purchases and continued implementation of our in-house fill/finish capabilities.

Cash used in investing activities of $12.7 million for the year ended December 31, 2020 was

mainly comprised of $7.6 million of capital expenditures at the Boca Facility and $5.1 million for the construction and buildout of new plasma collection facilities.

We expect our total capital expenditures will be between $12.0 million and $18.0

million for fiscal 2022 as we seek to have 10 FDA-approved plasma collection centers in operation by the end of 2023.

Net cash used in investing activities for the year ended December 31, 2022 was $13.9 million, which consisted of $8.7 million for the construction and buildout of several new plasma collection facilities and $5.2

million for equipment purchases and upgrades to the Boca Facility.

Net cash used in investing activities for the year ended December 31, 2021 was $13.5 million, which consisted of $8.6 million for the construction and buildout of new plasma

collection facilities and $4.9 million of capital expenditures at the Boca Facility, which included equipment purchases and continued implementation of our in-house fill/finish capabilities.

While we do not have any firm commitments for material

capital expenditures in 2023, we expect our total capital expenditures will be between $8.0 million and $12.0 million for fiscal 2023.

Net Cash Provided by Financing Activities

Cash provided by financing activities during the year ended December 31, 2021 was $121.0 million, which is mainly comprised of the net proceeds of $60.4 received from the Sale Agreement, $53.8 million from the

October 2021 underwritten public offering and $6.9 million from the Distribution Agreement.

Cash provided by financing activities of $143.9 million for the year ended December 31, 2020 mainly consisted of $88.7 million of net proceeds received

from our underwritten public offering in February 2020, $42.5 million of proceeds received from the Sale Agreement during the second half of 2020 and $12.5 million of proceeds from the Perceptive Tranche III Loan received in March 2020.

Net cash provided by financing activities for the year ended December 31, 2022 was $108.9 million, as we received approximately $47.0 in net proceeds from the refinancing of our senior credit facility in March of

2022 and $64.6 million in net proceeds from the December 9, 2022 public offering of our common stock.

Cash provided by financing activities during the year ended December 31, 2021 was $121.0 million, which is mainly comprised of the net proceeds

of $67.3 million from the sale of our common stock through several sale agreements and $53.8 million from the October 2021 underwritten public offering.

Effect of Inflation

Although inflation or changing prices did not have a significant impact on our revenues or net loss for the year ended December 31, 2020, inflation however did impact a number of facets of our business during the

year ended December 31, 2021 at both of our business segments.

We experienced price increases for, among other items, raw materials, consumable supplies, services for repairs and maintenance of our facilities and labor costs.

We expect this trend

to continue at least into the first half of 2022, which could have a significant impact on our future results of operations.

In addition, some of our plasma purchase agreements provide for annual price increases that are tied to various consumer

price indices, which have resulted in higher than historical price increases and is expected to result in higher source plasma costs in 2022.

Inflation impacted a number of facets of our business during the years ended December 31, 2022 and 2021 at each of our business segments.

We experienced price increases for, among other items, certain raw materials,

consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs.

We expect this trend to continue at least into 2023 or longer, which could have a significant

impact on our future results of operations.

In addition, some of our plasma purchase agreements provide for annual price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price

increases and has resulted in and is expected to continue to result in higher source plasma and other raw material and supplies costs in fiscal 2023.

Quantitative and Qualitative Disclosures About Market Risk

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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 7. Management’s Discussion and Analysis