ANI Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Results; Company Positioned for Sustainable Future Growth -- Fourth quarter 2020 net revenues of $57.3 million; net loss of $3.6 million

ANI Pharmaceuticals Reports Fourth Quarter

and Full Year 2020 Results; Company Positioned for Sustainable Future Growth

-- Fourth quarter 2020 net revenues of

$57.3 million; net loss of $3.6 million and diluted loss per share of $0.30 --

-- Fourth quarter adjusted non-GAAP EBITDA

of $17.2 million and adjusted non-GAAP diluted eps of $0.80 --

-- ANI defines strategy for sustainable

future growth and strengthens capital structure --

-- Definitive agreement to acquire Novitium

Pharma strengthens R&D engine, and expands generics and CDMO business --

-- Cortrophin Gel sNDA

re-filing planned for Q2 2021; aligned with FDA on path forward --

-- Key additions to leadership team deepen

commercial and manufacturing expertise --

Baudette, Minnesota (March 9, 2021) - ANI Pharmaceuticals, Inc.

("ANI" or the "Company") (NASDAQ: ANIP) today announced business highlights and financial results for

the three and 12 months ended December 31, 2020.

The Company's strategy for sustainable future growth is

based on four key pillars:

ANI's collaborative, purposeful and empowered team with

their high-performance orientation is prepared to execute this strategy.

Fourth Quarter and Recent Business Highlights:

Fourth Quarter 2020 Financial Highlights:

Full Year 2020 Financial Highlights:

Cash and cash equivalents were $7.9 million, net accounts receivable

was $95.8 million, and debt was $185.7 million as of December 31, 2020.

"Over the past six months, I have understood ANI's

core strengths and the landscape of potential opportunities to develop the four-pronged strategy for delivering sustainable future

growth," stated Nikhil Lalwani, President and CEO.

"The acquisition of Novitium creates a sustainable generics

growth engine and enhances scale of our CDMO business. Although the additional work we are doing on Cortrophin impacts our timeline

by one quarter, we believe it will result in a more comprehensive and robust refiling to support its approval. This is an important

and exciting time for ANI, and we look forward to providing updates as we move forward on our growth journey," concluded

Fourth Quarter 2020 Financial Results

Net revenues for generic pharmaceutical products were $38.7

million during the three months ended December 31, 2020, an increase of 32.7% compared to $29.1 million for the same period

in 2019. This increase primarily reflects the January 2020 launches of Paliperidone, Miglustat, Mixed Amphetamine Salts, Tolterodine,

Bexarotene and other products acquired from Amerigen, the January 2020 launch of Potassium Citrate ER, and increased revenues

of Candesartan. These increases were tempered by decreases in revenues of Ezetimibe Simvastatin, Esterified Estrogen with Methyltestosterone

("EEMT"), and Methazolamide.

Net revenues for branded pharmaceutical products were $15.8

million during the three months ended December 31, 2020, an increase of 0.9% compared to $15.6 million for the same period

in 2019, primarily due to increased revenues of Inderal LA, which were tempered by a decrease in unit sales of Innopran XL.

Contract manufacturing revenues were $2.2 million during the

three months ended December 31, 2020, a decrease of 16.8% compared to $2.6 million for the same period in 2019, due to a decreased

volume of orders from contract manufacturing customers in the period.

Royalty and other revenues were $0.6 million during the three

months ended December 31, 2020, and December 31, 2019.

Operating expenses increased to $56.9 million for the three

months ended December 31, 2020, from $52.6 million in the prior year period.

Cost of sales, excluding depreciation and amortization, increased

by $6.7 million to $24.5 million in the fourth quarter of 2020, primarily as a result of increased volumes during the quarter,

including a shift in product mix toward generic products, an increase related to sales of products subject to profit-sharing arrangements,

increased freight charges, and fourth quarter 2020 inventory reserve charges. The increases were tempered by the non-recurrence

of the fourth quarter 2019 inventory reserve charge primarily related to the exit from the market of Methylphenidate Extended Release.

Research and development expense decreased by $1.0 million in

the fourth quarter of 2020 to $3.7 million compared with $4.7 million in the fourth quarter of 2019, primarily due to a decrease

in expense related to the Cortrophin re-commercialization project and the non-recurrence of 2019 milestone expenses related to

the Bretylium Tosylate project.

The Company recognized Cortrophin pre-launch charges of $3.0

million in the three months ended December 31, 2020, compared to Cortrophin pre-launch charges of $6.5 million in the three

months ended December 31, 2019.

Selling, general, and administrative expenses rose by $0.4 million

in the fourth quarter of 2020 to $14.4 million compared to $14.0 million in the comparable quarter in 2019.

Depreciation and amortization increased by $1.3 million in the

fourth quarter of 2020 to $10.9 million compared to $9.6 million in the comparable quarter in 2019 due to amortization of the Abbreviated

New Drug Applications ("ANDAs") and marketing and distribution rights acquired in January 2020 from Amerigen and

the ANDA acquired in July 2020.

Net loss for the fourth quarter of 2020 was $3.6 million as

compared to net loss of $4.8 million in the prior year period. Diluted loss per share for the three months ended December 31,

2020 was ($0.30), compared to diluted loss per share of ($0.41) in the prior year period.

Adjusted non-GAAP diluted earnings per share was $0.80 in the

fourth quarter of 2020 compared to adjusted non-GAAP diluted earnings per share of $1.08 in the prior year period.

For reconciliations of adjusted non-GAAP EBITDA and adjusted

non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively.

As of December 31, 2020, the Company had $7.9 million in

unrestricted cash and cash equivalents plus $95.8 million in net accounts receivable. The Company had $185.7 million in outstanding

debt as of December 31, 2020.

As previously announced, ANI Pharmaceuticals management will

host its fourth quarter 2020 conference call as follows:

(live and replay) www.anipharmaceuticals.com, under the

A replay of the conference call will be available within two

hours of the call's completion and will remain accessible for one week by dialing (855) 859-2056 and entering access code

Non-GAAP Financial Measures

Adjusted non-GAAP EBITDA

ANI's management considers adjusted non-GAAP EBITDA to

be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure

of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital

investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted

non-GAAP EBITDA when analyzing Company performance.

Adjusted non-GAAP EBITDA is defined as net income, excluding

tax expense or benefit, interest expense, (net), other expense, (net), depreciation, amortization, the excess of fair value over

cost of acquired inventory, non-cash stock-based compensation expense, CEO transition expenses, expense from acquired in-process

research and development, transaction and integration expenses, Cortrophin pre-launch charges, asset impairments, and certain other

items that vary in frequency and impact on ANI's results of operations. Adjusted non-GAAP EBITDA should be considered in

addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most

directly comparable GAAP financial measure is provided below.

Adjusted non-GAAP Net Income