ANI Pharmaceuticals Reports Second Quarter 2021 Results -- Second quarter 2021 net revenues of $48.6 million; net loss of $14.1 million and diluted loss per share of ($1.17) -- -- Second quarter adj

Reports Second Quarter 2021 Results

2021 net revenues of $48.6 million; net loss of $14.1 million and diluted loss per share of ($1.17) --

adjusted non-GAAP EBITDA of $13.1 million and adjusted non-GAAP diluted earnings per share of $0.67 --

Refiled supplemental new drug application ("sNDA") for Cortrophin Gel with U.S Food and Drug Administration ("FDA")

on June 29, 2021; goal date is October 29, 2021 --

-- Pending acquisition

of Novitium Pharma LLC on track to close in second half 2021--

products portfolio through acquisition of Sandoz Inc. NDAs --

Baudette, Minnesota (August 6, 2021)

- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ: ANIP) today announced business highlights

and financial results for the three and six months ended June 30, 2021.

Second Quarter and Recent Business

Second Quarter 2021 Financial

"In the second quarter, we made

meaningful progress executing on the four pillars of our growth strategy. Most notably, on June 29, we refiled our sNDA with the FDA

for Cortrophin Gel. Since that time, we have engaged in productive communication with the Agency. In support of this important asset,

we are continuing to strengthen our leadership team to drive our commercial strategy forward. This refiling is a significant milestone

for the organization, and I am proud of what we have accomplished to date. If approved, Cortrophin has the potential to improve access

for patients in need and transform ANI," said Nikhil Lalwani, President and CEO of ANI.

"We appreciate our stockholders'

overwhelming support for the Novitium acquisition at our Annual Meeting of Stockholders. The transaction is on track to close later this

year, and planning for maximizing the value of the combined assets for all stakeholders is well under way. We have also integrated the

four dermatology products acquired from Sandoz, thus expanding our branded portfolio. It is an important and exciting time for ANI, and

we look forward to providing updates as we move forward on our growth journey," concluded Lalwani.

Second Quarter 2021 Financial

Net revenues for generic pharmaceutical

products were $34.2 million during the three months ended June 30, 2021, an increase of 2.4% compared to $33.4 million for the same period

in 2020. From a product perspective, the net increase was due to increased sales of Fenofibrate, Potassium Citrate Extended Release,

Vancomycin Oral Solution, and the second quarter 2021 launch of Nicardipine. These increases were somewhat tempered by declines in sales

of Methazolamide, Miglustat, Penicillamine, and Mixed Amphetamine Salts.

Net revenues for branded pharmaceutical

products were $11.0 million during the three months ended June 30, 2021, an increase of 3.8% compared to $10.6 million for the same period

in 2020. The increase primarily reflects the launch of the products acquired in the Sandoz, Inc. acquisition in the second quarter of

2021 and increased sales of InnoPran XL. These increases were tempered by decreased revenues of Atacand and Arimidex.

Contract manufacturing revenues were

$2.3 million during the three months ended June 30, 2021, a decrease of 19.9% compared to $2.9 million for the same period in 2020, due

to a decreased volume of orders from contract manufacturing customers in the period.

Royalty and other revenues were $1.1

million during the three months ended June 30, 2021, a decrease of $0.4 million from $1.5 million for the same period in 2020, primarily

due to decreases in product development revenues earned by ANI Canada and a the non-recurrence of royalty revenue related to Yescarta .

These decreases were tempered by licensing revenues earned during the three months ended June 30, 2021.

Operating expenses increased by 7.4%

to $64.2 million for the three months ended June 30, 2021, from $59.8 million in the prior year period

Cost of sales, excluding depreciation

and amortization, increased by $1.6 million to $22.3 million in the second quarter of 2021 from prior year period, primarily as a result

of increased volumes in the current year period. The increase was tempered by a $1.2 million decrease related to a decrease in sales

of products subject to profit sharing arrangements.

Research and development expenses decreased

to $2.8 million in the second quarter of 2021 from $3.0 million in the second quarter of 2020, primarily due to the non-recurrence of

$0.4 million of 2020 severance related expense associated with the restructuring of our internal Cortrophin development team.

Selling, general and administrative

expenses decreased by $2.4 million in the second quarter of 2021 to $18.8 million compared to $21.2 million in the comparable quarter

in 2020.The decrease primarily reflects the non-recurrence of $6.5 million of termination benefit expenses related to the 2020 departure

of the Company's former President and CEO. The Company also incurred recruitment and related legal charges associated with the

CEO search in the second quarter 2020. These decreases were offset by $1.7 million of transaction expenses related to the pending Novitium

acquisition and $2.5 million in sales and marketing expenses related to Cortrophin pre-launch activities incurred during the three months

ended June 30, 2021.

On August 3, 2021, the Company entered

into a Settlement Agreement with Arbor Pharmaceuticals, LLC to resolve all claims related to a civil proceeding which was pending trial

later this month. Under the terms of the agreement, ANI will pay Arbor $8.4 million and Arbor will dismiss all claims against ANI. Neither

party admitted wrongdoing in reaching this settlement. The Company recorded an $8.4 million charge to the second quarter Statement of

Operations and will pay the settlement from cash on the balance sheet.

Depreciation and amortization increased

by 1.1% in the second quarter of 2021 to $11.3 million from $11.2 million in the comparable quarter in 2020, primarily due to the amortization

of the NDAs acquired in April 2021 from Sandoz Inc., partially offset by assets that became fully amortized in 2020.

Net loss for the second quarter of 2021

was $14.1 million as compared to net loss of $12.3 million in the prior year period. Diluted loss per share for the three months ended

June 30, 2021 was ($1.17), compared to diluted loss per share of ($1.03) in the prior year period.

Adjusted non-GAAP diluted earnings per

share was $0.67 in the second quarter of 2021 compared to $0.69 in the second quarter of 2020.

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 June 30, 2021, the Company had

$24.2 million in unrestricted cash and cash equivalents plus $92.6 million in net accounts receivable. The Company had $205.7 million

(face value) in outstanding debt as of June 30, 2021.

As previously announced, ANI Pharmaceuticals

management will host its second quarter 2021 conference call as follows:

and replay) www.anipharmaceuticals.com, under the "Investors" section

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 800-695-0974 and entering

access code 5412658.

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, expense from acquired in-process

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

Adjusted non-GAAP Net Income