ANI Pharmaceuticals Reports Third Quarter 2021 Results -- Third quarter 2021 net revenues of $52.1 million; net loss of $4.4 million and diluted loss per share of ($0.37) -- -- Third quarter adjuste

Pharmaceuticals Reports Third Quarter 2021 Results

Third quarter 2021 net revenues of $52.1 million; net loss of $4.4 million and diluted loss per share of ($0.37) --

Third quarter adjusted non-GAAP EBITDA of $16.6 million and adjusted non-GAAP diluted earnings per share of $1.01 --

FDA approves supplemental new drug application for Purified Cortrophin Gel for the treatment of certain chronic autoimmune

disorders; full-scale launch planned for early Q1 2022 --

Acquisition of Novitium Pharma LLC is expected to close in November 2021--

Launched Nebivolol Tablets simultaneously from two manufacturing sites --

Minnesota (November 1, 2021) - ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ: ANIP) today announced business

highlights and financial results for the three months ended September 30, 2021.

Quarter and Recent Business Highlights:

Quarter 2021 Financial Highlights:

approval of Cortrophin Gel marks a critical milestone for ANI. During the past five years, we have made a significant investment in establishing

and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain for this important product. Physicians now have

a much-needed treatment option for patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis, as well as nephrotic

syndrome, who can benefit from a repository corticotropin. We have built an experienced rare disease leadership team to drive a full-scale

commercial launch early in the first quarter of 2022," said Nikhil Lalwani, President and CEO of ANI.

is at an inflection point, having achieved critical milestones against key strategic pillars which we believe will deliver

sustainable growth. Approval of the Cortrophin Gel sNDA enables ANI to serve patients in need and build new capabilities. In

addition, we have delivered a strong third quarter in our base business and the Novitium acquisition investment thesis is well on

track, achieving ten new product approvals since March of 2021," concluded Lalwani.

Quarter 2021 Financial Results

revenues for generic pharmaceutical products were $35.1 million during the three months ended September 30, 2021, a decrease of

6.8% compared to $37.7 million for the same period in 2020. From a product perspective, the net decrease was due to declines in sales

of Erythromycin Ethylsuccinate (EES), Methazolamide, Penicillamine, and Vancomycin. These decreases were partially offset

by the second quarter 2021 launch of Nicardipine and the third quarter 2021 launch of Nebivolol. The decrease in net generic revenues

was due in part to a decrease in average selling prices tempered by increased volumes among generic products.

revenues for branded pharmaceutical products were $14.3 million during the three months ended September 30, 2021, an increase of

15.3% compared to $12.4 million for the same period in 2020. The increase primarily reflects the April 2021 launch of the products

acquired in the Sandoz, Inc. asset acquisition. These increases were tempered by decreased unit sales of InnoPran XL. The increase

in net brand revenues was due in part to higher volumes tempered by a shift in mix towards brand products with lower average selling

manufacturing revenues were $2.4 million during the three months ended September 30, 2021, an increase of 10.7% compared to $2.2

million for the same period in 2020, due to a current year shift in mix towards customers with higher average selling prices, mostly

offset by a decrease in the volume of orders.

expenses increased by 10.9% to $55.6 million for the three months ended September 30, 2021, from $50.2 million in the prior year

of sales, excluding depreciation and amortization, increased by $4.3 million to $24.4 million in the third quarter of 2021 from the prior

year period, primarily as a result of $2.2 million in cost of sales representing the excess of fair value over cost of inventory acquired

in the Sandoz, Inc. asset acquisition and subsequently sold during the period and increased volumes in the current year period.

The increase was tempered by a $1.1 million decrease related to a decrease in sales of products subject to profit-sharing arrangements.

and development expenses decreased from $2.9 million to $2.5 million, a decrease of 16.4%, primarily due to a decrease in expense related

general and administrative expenses increased by $1.5 million in the third quarter of 2021 to $17.2 million compared to $15.7

million in the comparable quarter in 2020. The increase primarily reflects the $0.5 million of transaction expenses related to the

pending Novitium acquisition and $2.1 million in sales and marketing expenses related to Cortrophin pre-launch activities incurred

during the three months ended September 30, 2021. Depreciation and amortization expense was $11.3 million for the three months

ended September 30, 2021, essentially unchanged compared to $11.4 million for the same period in 2020.

loss for the third quarter of 2021 was $4.4 million as compared to net income of $0.4 million in the prior year period. Diluted loss

per share for the three months ended September 30, 2021 was ($0.37), compared to diluted earnings per share of $0.04 in the prior

non-GAAP diluted earnings per share was $1.01 in the third quarter of 2021 compared to $0.97 in the third quarter of 2020.

reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share, as well as adjusted non-GAAP net income, to the most directly comparable GAAP financial

measure, please see Table 3 and Table 4, respectively.

of September 30, 2021, the Company had $15.3 million in unrestricted cash and cash equivalents plus $106.7 million in net accounts

receivable. The Company had $202.9 million (face value) in outstanding debt as of September 30, 2021.

previously announced, ANI Pharmaceuticals management will host its third quarter 2021 conference call as follows:

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 800-938-2243 and entering access code 5412658.

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.

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, expense from acquired

in-process research and development, Novitium transaction expenses, Cortrophin pre-launch charges, asset impairments, legal settlement

expense, credit facility ticking fee expense, 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.

management considers adjusted non-GAAP net income to be an important financial indicator of ANI's operating performance, providing

investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired inventory

sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges, acquired

in-process research and development ("IPR&D") expense, Novitium transaction expenses, asset impairments, legal settlement

expense, credit facility ticking fee expense, and certain other items that vary in frequency and impact on ANI's results of operations.

Management uses adjusted non-GAAP net income when analyzing Company performance.

non-GAAP net income is defined as net income, plus the excess of fair value over cost of acquired inventory sold, non-cash stock-based

compensation expense, Novitium transaction expenses, non-cash interest expense, depreciation and amortization expense, expense from acquired

in-process research and development, Cortrophin pre-launch charges, asset impairments, legal settlement expense, credit facility ticking

fee expense, and certain other items that vary in frequency and impact on ANI's results of operations, less the tax impact of these

adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional

adjustments in the calculation in order to provide further understanding of ANI's results. Adjusted non-GAAP net income should

be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to

the most directly comparable GAAP financial measure is provided below.

non-GAAP Diluted Earnings per Share

management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI's operating performance,

providing investors and analysts with a useful measure of operating results unaffected by the excess of fair value over cost of acquired

inventory sold, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, Cortrophin pre-launch charges,

acquired IPR&D expense, Novitium transaction expenses, asset impairments, legal settlement expense, credit facility ticking fee expense,

and certain other items that vary in frequency and impact on ANI's results of operations. Management uses adjusted non-GAAP diluted

earnings per share when analyzing Company performance.

non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average

shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation

in order to provide further understanding of ANI's results. Adjusted non-GAAP diluted earnings per share should be considered in

addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted

earnings per share to the most directly comparable GAAP financial measure is provided below.

Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high

quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information,

please visit www.anipharmaceuticals.com.

the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within

the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about

the Company's corporate strategy, the pending acquisition of Novitium and expected closing, the planned commercial launch of Cortrophin

Gel in the first quarter of 2022 which will be the first rare disease pharmaceutical product to be sold by the Company, future operations,

products, financial position, operating results and prospects, including plans for sustainable growth, and other statements that are

not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects,"