ANI Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results; Strong Foundation in Place to Drive Sustainable Growth -- Fourth quarter net revenues of $60.9 million; net loss of $24.1 million and diluted loss pe

ANI Pharmaceuticals Reports Fourth Quarter and

Full Year 2021 Results; Strong Foundation in Place to Drive Sustainable Growth

-- Fourth quarter net revenues of $60.9 million;

net loss of $24.1 million and diluted loss per share of $1.72 --

-- Fourth quarter adjusted non-GAAP EBITDA of

$16.2 million and adjusted non-GAAP diluted earnings per share of $0.54 --

-- Full year 2021 revenues of $216.1 million;

net loss of $42.6 million and adjusted non-GAAP EBITDA of $64.8 million --

-- Launched Purified Cortrophin Gel

for the treatment of certain chronic autoimmune disorders --

-- Experienced Rare Disease leadership and

team in place to drive successful commercial launch of Purified Cortrophin Gel --

-- Closed acquisition and seamlessly integrating

Novitium Pharma to strengthen generics business with technical capabilities to bring increased limited competition products to market

-- Strong balance sheet with new capital structure

can propel the next phase of ANI's growth --

BAUDETTE, Minn.--(BUSINESS WIRE) -- ANI Pharmaceuticals, Inc.

(Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three and twelve months ended December 31,

Fourth Quarter and Recent Business Highlights:

Fourth Quarter 2021 Financial Highlights:

Full Year 2021 Financial Highlights:

"The past few months have been an exciting time for ANI as we

completed the build out of our Rare Disease business team. Our senior leadership has experience across over 20 Rare Disease launches and

75% of our high-performing sales colleagues have won President's Club or equivalent in the past few years. In parallel, we invested

significantly in the infrastructure needed to drive a successful launch, including a secure supply chain, specialty pharmacy distribution

network, a hub and patient support programs. Our efforts culminated in the commercial launch of Cortrophin Gel in January, and we are

pleased with the early physician response for Cortrophin. After decades with only one treatment option, patients suffering from certain

chronic autoimmune conditions now have another choice in ACTH therapy," said Nikhil Lalwani, President and CEO of ANI.

"We are also pleased to have closed our acquisition of Novitium

Pharma, which brings a world-class R&D engine to ANI. Since deal closure, our integrated team has launched eight new products, filed

five new ANDAs, and initiated enhancement of R&D productivity and capture of procurement, distribution, and operational efficiencies.

These achievements, together with the strengthening of our balance sheet through our debt refinancing and recent $75 million equity raise,

position us well to deliver long-term sustainable growth," concluded Lalwani.

2022 Financial Guidance

For the twelve months ending December 31, 2022, ANI is providing

guidance on ex-Cortrophin Net Revenue and adjusted non-GAAP EBITDA, total Company Research and Development expense, and Cortrophin specific

SG&A. The following summarizes 2022 guidance:

Total Company Ex-Purified Cortrophin Gel measures:

Total Company measures:

Purified Cortrophin Gel specific measures:

In addition, we currently anticipate between 16.9 and 17.3 million

shares outstanding and an effective tax rate of approximately 24% prior to any federal tax reform.

Fourth Quarter 2021 Financial Results

Net revenues for generic pharmaceutical products were $41.6 million

during the three months ended December 31, 2021, an increase of 8% compared to $38.7 million for the same period in 2020. The net

increase was primarily due to the November 19th closure of the Novitium acquisition and the third quarter 2021 launch

of Nebivolol, tempered by sales declines for Tolterodine and Vancomycin and a decrease in average selling prices of generic products.

Net revenues for branded pharmaceutical products were $14.7 million

during the three months ended December 31, 2021, a decrease of 7% compared to $15.8 million for the same period in 2020. The change

was a result of fewer units sold of Arimidex and Inderal XL, partially offset by the second quarter 2021 launch of brand products acquired

Contract manufacturing revenues were $2.8 million during the three

months ended December 31, 2021, an increase of 26% compared to $2.2 million for the same period in 2020, principally due to the November 19th

closure of the Novitium acquisition.

Operating expenses increased by 49% to $84.7 million for the three

months ended December 31, 2021, up from $56.9 million in the prior year period.

Cost of sales, excluding depreciation and amortization, increased by

$9.4 million to $33.9 million in the fourth quarter of 2021 compared to $24.5 million in the prior year period, primarily as a result

of increased volumes. The increase also included a charge of $3.7 million to recognize the excess of fair value over cost for inventory

acquired in asset acquisitions and a business combination, and $1.9 million of legal settlement expense charged to royalties, which were

tempered by a $1.6 million decrease related to sales of products subject to profit sharing arrangements.

Research and development expenses declined from $3.7 million to $3.1

million, a decrease of 15%, primarily due to the timing of research and development activities, including the completion of the R&D

phase of the Cortrophin re-commercialization project, tempered by the addition of Novitium research and development expenses incurred

subsequent to the acquisition.

Selling, general and administrative expenses increased by $16.3 million

in the fourth quarter of 2021 to $30.7 million compared to $14.4 million in the comparable quarter in 2020. The increase primarily reflects

$4.3 million of transaction expenses related to the Novitium acquisition, $9.2 million in sales and marketing expenses related to Cortrophin

pre-launch activities, and increased headcount costs, including those associated with Novitium occurring subsequent to the acquisition.

Depreciation and amortization expense was $13.7 million for the three

months ended December 31, 2021, an increase of $2.8 million compared to $10.9 million for the same period in 2020. This increase

is primarily a result of amortization of intangible assets acquired in the Novitium transaction.

Net loss for the fourth quarter of 2021 was $24.1 million as compared

to a net loss of $3.6 million in the prior year period. Diluted loss per share for the three months ended December 31, 2021 was $1.72,

compared to diluted loss per share of $0.30 in the prior year period.

Adjusted non-GAAP diluted earnings per share was $0.54 in the fourth

quarter of 2021 compared to $0.80 in the fourth 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 December 31, 2021, the Company had $100.3 million in unrestricted

cash and cash equivalents plus $128.5 million in net accounts receivable. The Company had $300.0 million (face value) in outstanding debt

as of December 31, 2021.

As previously announced, ANI Pharmaceuticals management will host its

fourth quarter 2021 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 888-269-5332 and entering access code 8402712.

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 and royalty settlement expense, credit facility ticking fee expense,

contingent consideration fair value adjustment, 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