ANI Pharmaceuticals Reports Second Quarter 2020 Results - Second quarter 2020 net revenues of $48.5 million - - Nikhil Lalwani named President and CEO, effective

ANI Pharmaceuticals Reports Second Quarter

- Second quarter 2020 net revenues of

- Nikhil Lalwani named President and CEO, effective

- Pharmaceutical industry executives,

Jeanne Thoma and Tony Pera, join Board of Directors -

Baudette, Minnesota (August 6, 2020) - 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, 2020.

Business and Recent Highlights:

Second Quarter 2020 Financial Highlights:

"Despite the negative impact of the COVID-19 pandemic,

we had a productive quarter by adding to our stable of generic products, successfully launching our first product from our manufacturing

site in Oakville, Canada, a plant that we expect will play an important role in future launches, and making progress to advance

our lead product candidate, Cortrophin Gel. I am proud of how our company has navigated these challenges, ensuring the continued

manufacturing and availability of our products while keeping our employees safe," stated Patrick Walsh, Interim President

"In addition, we are delighted to welcome Nikhil, Jeanne

and Tony, all exceptionally talented executives with deep industry knowledge who will collectively enable us to drive our future

growth initiatives, execute on our corporate vision and achieve our strategic goals," concluded Walsh.

Second Quarter 2020 Financial Results

Net revenues were $48.5 million in the second quarter of 2020

compared with $54.5 million in the second quarter of 2019. Net revenues for generic pharmaceutical products were $33.4 million

during the three months ended June 30, 2020, a decrease of 8% compared to $36.3 million for the same period in 2019.

Net revenues for branded pharmaceutical products were $10.6 million during the three months ended June 30, 2020, a decrease

of 24% compared to $14.0 million for the same period in 2019. During the three months ended June 30, 2020, the Company's

generic and branded product revenue results were negatively impacted by the COVID-19 pandemic.

Contract manufacturing revenues were $2.9 million during the

three months ended June 30, 2020, a decrease of 21% compared to $3.7 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 $1.5 million during the three months

ended June 30, 2020, an increase of $1.1 million from $0.4 million for the same period in 2019, primarily due to increases

in product development revenues earned by ANI Canada and an increase in royalty and laboratory service revenues.

Operating expenses increased to $59.8 million for the three

months ended June 30, 2020, from $45.1 million in the prior year period.

Cost of sales, excluding depreciation and amortization, increased

by $5.1 million to $20.7 million in the second quarter of 2020, primarily due to increased volumes related to a shift in product

mix toward generic products, $1.4 million in cost of sales representing the excess of fair value over cost for inventory acquired

in the Amerigen acquisition and subsequently sold during the period, inventory reserve charges related to excess inventory on hand

and discontinued projects, and increased sales of products subject to profit-sharing arrangements. Excluding the $1.4 million impact,

cost of sales as a percentage of net revenues increased to 40% during the three months ended June 30, 2020,

from 29% during same period in 2019 for the reasons mentioned above.

Research and development expense decreased by $2.7 million in

the second quarter of 2020 to $3.0 million compared with $5.8 million in the second quarter of 2019, primarily due to the non-recurrence

of $2.3 million of expense related to in-process research and development acquired from Coeptis Pharmaceuticals, Inc. in the second

quarter of 2019 and a decrease in expense related to the Cortrophin re-commercialization project. These decreases were tempered

by $0.4 million of severance expense associated with the restructuring of the Company's internal Cortophin development team.

The Company currently anticipates that Cortrophin-related expenses in the second half of 2020 will approximate the first half of

2020, as we continue to focus on our supplemental New Drug Application ("sNDA") resubmission efforts.

Selling, general and administrative costs rose by $7.0 million

in the second quarter of 2020 to $21.2 million compared to $14.2 million in the comparable quarter in 2019. The increase primarily

reflects $6.5 million of one-time termination expenses related to the departure of the Company's former President and CEO

and costs incurred for the CEO recruitment process.

Depreciation and amortization increased by $1.7 million in the

second quarter of 2020 to $11.2 million compared to $9.5 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.

The Company also had $3.6 million in the build of Cortrophin

pre-launch commercial inventories, which are expensed for U.S. GAAP; there were no such comparable activities in the second quarter

Net loss for the second quarter of 2020 was $12.3 million as

compared to net income of $6.6 million in the prior year period. The effective consolidated tax benefit rate for the three months

ended June 30, 2020 was 10.5%. Diluted loss per share for the three months ended June 30, 2020 was $1.03, compared to diluted earnings

per share of $0.53 in the prior year period.

Adjusted non-GAAP diluted earnings per share was $0.69 in the

second quarter of 2020 compared to adjusted non-GAAP diluted earnings per share of $1.44 in the prior year period.

For a reconciliation of adjusted non-GAAP diluted earnings per

share to the most directly comparable GAAP financial measure, please see Table 4.

Guidance for the Full Year 2020

Due to inherent uncertainties regarding the duration and impact

of the COVID-19 pandemic, ANI has suspended its previously announced 2020 financial guidance.

As of June 30, 2020, the Company had $27.7 million in unrestricted

cash and cash equivalents plus $73.2 million in net accounts receivable. The Company had $190.2 million in outstanding debt as

Cortrophin Gel Re-commercialization Update

The Company has made progress in advancing its lead product,

Cortrophin Gel. In collaboration with a prominent consulting firm, the Company completed a comprehensive gap assessment and made

significant changes to the project's leadership team. The majority of the identified deficiencies have already been remediated,

and timelines for completing the remaining tasks, including additional data to bolster analytical comparability to the legacy drug

product, have been established. The Company expects to resubmit the sNDA no later than the first quarter of 2021.

As previously announced, ANI Pharmaceuticals management will

host its second quarter 2020 conference call as follows:

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) 585-8367 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, depreciation, amortization, the excess of fair value over cost of acquired inventory,

stock-based compensation expense, CEO transition expenses, expense from acquired in-process research and development, gains on

inventory reserve recoveries, transaction and integration expenses, Cortrophin pre-launch charges, other income/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

ANI's 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,

CEO transition expenses, non-cash interest expense, depreciation and amortization, inventory reserve recoveries, Cortrophin pre-launch